nitinol and Postoperative-Complications

Nitinol compression implants are fast and simple to insert and have a high radiographic union rate for midfoot and hindfoot arthrodeses. Applications of nitinol technology in orthopedic surgery are rapidly expanding with the improved and broadened portfolio of implants available.

Topics: Alloys; Ankle; Arthrodesis; Biomechanical Phenomena; Compressive Strength; Foot; Humans; Postoperative Complications; Sutures

There is growing interest in minimally invasive (MI) treatment options for male lower urinary tract symptoms (LUTS). Among these options, the temporary implantable nitinol device (TIND; Medi-Tate, Or Akiva, Israel) is a novel instrument used to alleviate symptoms by creating incisions in the prostate via mechanical stress.. To review recent data for TIND as an MI procedure to improve LUTS.. Medline, PubMed, the Cochrane Database, and Embase were screened for clinical trials, randomized controlled trials, and review articles on the use of TIND in patients with male LUTS.. Preliminary data suggest that TIND is a safe and effective MI technique for patients with male LUTS. Symptom relief and increase in urinary flow after 36mo are promising. However, long-term results are needed.. Various treatment options for male patients suffering from urinary voiding symptoms are emerging. TIND, a temporary implantable nitinol device, appears to be a safe option that improves symptoms without affecting sexuality.

Topics: Alloys; Clinical Trials as Topic; Humans; Israel; Lower Urinary Tract Symptoms; Male; Minimally Invasive Surgical Procedures; Postoperative Complications; Prostate; Prostatic Hyperplasia; Prostheses and Implants; Randomized Controlled Trials as Topic; Stress, Mechanical; Urinary Retention; Urinary Tract Infections

Tibiotalocalcaneal (TTC) arthrodesis using an intramedullary hindfoot nail is a common procedure for deformity correction and the treatment of combined tibiotalar and subtalar end-stage arthritis. Nonunion at one or both fusion sites is a difficult complication that can result in reoperation, significant morbidity, and below-knee amputation. There is currently a need for sustained compression across fusion sites using a TTC hindfoot nail with good mechanical stability. The DynaNail TTC Fusion System (MedShape, Inc, Atlanta, GA) uses an internal nitinol compression element to apply sustained compression across the tibiotalar and subtalar joints after surgery. In preliminary clinical cases, we have found that the nail is safe, reliable, and has promising clinical and radiographic results in settings of hindfoot arthritis, complex deformity, Charcot arthropathy, and talar avascular necrosis.. Expert opinion, Level V.

Topics: Adult; Alloys; Ankle Injuries; Arthrodesis; Arthropathy, Neurogenic; Bone Nails; Equipment Design; Female; Fluoroscopy; Follow-Up Studies; Humans; Osteoarthritis; Postoperative Complications; Risk Assessment; Subtalar Joint; Treatment Outcome

The authors present etiology, diagnosis and operative treatment of thoracoabdominal aneurysms based on their own experiences, especially in performing proximal anastomosis between vascular graft and aorta. The protheses are made of polytertafluoroethylene or dacron. They are impregnated with colagen or soaked with argentum or antibiotics. Spinal cord and visceral organ protection is described. The authors present also endovascular treatment of aorta. Internal chasis of vascular protheses (stentgrafts) is made of biologically neutral metal (like stainless stell, nitinol, other alloys). Its diameter is simmilar to abdominal or thoracic aorta dimension. The chasis is covered by material used also to produce classic vascular protheses (polytetrafluoroethylene, dacron). Thoracoabdominal aneurysms occur rarely, but they are the most difficult problem in vascular surgery. According to literature occurrence of aneurysms in this section value from 4% to 10%. Atherosclerotic process is a exciting cause of this type of aneurysms. According to modified Crawfords classification there are five basic types of thoracoabdominal aneurysms. For pioneer of thoracoabdominal aneurysms surgical treatment one should to recognize S. Etheredge, who in 1954 as a first performed human, aortal homograft implantation with using temporary by-pass. In 1973 E. S. Crawford proposed a new way of management depended on in situ anastomosis between arterial trunks with prosthesis, without use of temporary bypass. In Anglo-Saxon literature this technique gained descriptive qualification "clamp and sew". Using this method, thoracoabdominal aneurysms surgery stood himself decidedly shorter and safer for patients.

Topics: Alloys; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Humans; Intraoperative Complications; Polytetrafluoroethylene; Postoperative Complications; Risk Factors; Stents; Survival Rate; Vascular Surgical Procedures

This article describes the classification of endoleaks after endovascular treatment of abdominal aortic aneurysms, thereby summarizing the most important problems of this endovascular technique. The correct classification of endoleaks is a prerequisite for interdisciplinary discussion. It is indispensable for professional reporting of the pathological findings and for the decision making as to the adequate treatment of endoleaks. Irrespective of the types of stent graft and property of the material, five endoleak types are defined in the literature: leakage at the anchor sites (type I); leakage due to collateral arteries (type II); defective stent grafts (type III); leakage due to porosity of the graft material (type IV); and endotension (type V). The causes of endoleaks are discussed and treatment options are reviewed for the diverse pathologic findings.

Topics: Alloys; Angiography; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Catheterization; Collateral Circulation; Embolization, Therapeutic; Humans; Postoperative Complications; Risk Factors; Stents; Time Factors

Ultraflex esophageal stents have contributed to the tremendous success of self-expanding metal stents (SEMS) in the treatment of esophageal cancer because they are easy and safe to insert. With an eye to improving clinical outcome, the Ultraflex stent design has been in a state of constant evolution since its introduction. However, as with other SEMS, a high reintervention rate remains a challenging problem.

Topics: Alloys; Biocompatible Materials; Esophageal Neoplasms; Esophageal Stenosis; Esophagoscopy; Humans; Palliative Care; Plastics; Pliability; Postoperative Complications; Prosthesis Design; Prosthesis Implantation; Stents

Topics: Alloys; Female; Foreign-Body Migration; Humans; Middle Aged; Portal Vein; Portasystemic Shunt, Transjugular Intrahepatic; Postoperative Complications; Radiography; Reoperation; Stents; Time Factors

Nitinol alloy occluders are widely used in the transcatheter intervention treatment of congenital heart diseases like patent ductus arteriosus (PDA). However, nitinol alloy contains high levels of nickel, which can lead to toxic effects in the immune and hematopoietic systems if released in sufficient quantities. A new type of single-rivet occluder coated with nano-film has been developed to limit the release of nickel. In total, 23 patients were recruited and randomly assigned to the experimental group (n=12) with the new nano-film single-rivet occluders or the control group (n=11) with the traditional occluders. One case in the control group was lost to follow-up. The remaining 22 cases were followed up at 24 h, 7 days, 1 month, 3 months, and 6 months after the procedure. There were no statistically significant differences in routine blood test, alanine aminotransferase, creatinine, and troponin between the experimental and control groups. Serum nickel concentration in both two groups increased at 24 h after the procedure, peaked at 1 month, and returned to preoperative levels at 6 months. Serum nickel levels in the experimental group were significantly lower than in the control group at 24 h, 7 days, 1 month, and 3 months after the procedure. These data suggested that the nano-film coating effectively prevented nickel release from the new occluders, and therefore has a preferable safety profile.

Topics: Adolescent; Adult; Alloys; Cardiac Surgical Procedures; Child; Child, Preschool; Double-Blind Method; Ductus Arteriosus, Patent; Female; Humans; Infant; Male; Middle Aged; Nanostructures; Nickel; Postoperative Complications; Septal Occluder Device

Topics: Alloys; Bronchoscopy; Exercise Tolerance; Female; Follow-Up Studies; France; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Pulmonary Emphysema; Quality of Life; Treatment Outcome

OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [mRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.

Topics: Adult; Aged; Alloys; Angiography, Digital Subtraction; Cause of Death; Combined Modality Therapy; Diffusion Chambers, Culture; Embolization, Therapeutic; Endovascular Procedures; Female; Follow-Up Studies; Humans; Intracranial Aneurysm; Male; Middle Aged; Outcome and Process Assessment, Health Care; Patient Safety; Platelet Aggregation Inhibitors; Postoperative Complications; Prospective Studies; Prostheses and Implants; Stents; Thromboembolism; Treatment Outcome

This study compared midterm results using low-profile stent grafts (LPSGs; 18F) and standard-profile stent grafts (SPSGs; 22F-24F) for endovascular pararenal and thoracoabdominal aortic aneurysm (TAAA) repair.. From July 2005 to March 2015, 134 asymptomatic patients underwent endovascular repair of a pararenal or TAAA using multibranched aortic stent grafts. In March 2011, we started using a LPSG with nitinol stents and thin-walled polyester fabric. Prospectively collected data on operative repair, complications, and outcomes were compared between the two groups.. LPSGs were used in 37 patients (8 women [21.6%]; mean ± standard deviation age, 72.5 ± 8 years) and SPSGs in 97 patients (25 [26%] women; mean age, 73 ± 8 years). Medical comorbidities, aneurysm size, and aneurysm extent were similar in the LPSG and SPSG groups. Mean follow-up time was longer in the SPSG group (3.1 ± 2 years) than in the LPSG group (1.3 ± 0.9 years; P < .001). Operative time, renal failure, stroke, myocardial infarction, and perioperative death were not significantly different between the two groups (P > .05). Aneurysm-related death, rupture, stent graft migration, type I or III endoleaks, aneurysm enlargement >5 mm, branch vessel occlusion, and reintervention rates were similar between the two groups (P > .05). However, the combined outcome of conduit use or access artery injury occurred at a lower rate in the LPSG group than in the SPSG group (16% vs 36%; P = .03). Women experienced significantly higher rates of conduit use and access artery injury than men after repair with SPSGs (64% vs 26%, respectively; P = .001) but similar rates after repair with the LPSG (25% vs 14%, respectively; P = .45).. LPSGs had similar safety profile and midterm outcomes compared with the SPSGs for treatment of pararenal and TAAA. The substitution of LPSGs for SPSGs lowered the number of patients who required conduit insertion to avoid access artery injury, especially in women, thereby reducing an otherwise striking gender difference.

Topics: Aged; Aged, 80 and over; Alloys; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Female; Healthcare Disparities; Humans; Male; Middle Aged; Polyesters; Postoperative Complications; Prospective Studies; Prosthesis Design; Risk Factors; San Francisco; Sex Factors; Stents; Time Factors; Treatment Outcome

Covered self-expandable metal stents (SEMSs) are increasingly used as alternatives to uncovered SEMSs for the palliation of inoperable malignant distal biliary obstruction to counteract tumor ingrowth. We aimed to compare the outcomes of partially covered and uncovered SEMSs with identical mesh structures and anti-migration properties, such as low axial force and flared ends.. One hundred and three patients who were diagnosed with inoperable malignant distal biliary obstruction between January 2006 and August 2013 were randomly assigned to either the partially covered (n = 51) or uncovered (n = 52) SEMS group.. There were no significant differences in the cumulative stent patency, overall patient survival, stent dysfunction-free survival and overall adverse events, including pancreatitis and cholecystitis, between the two groups. Compared to the uncovered group, stent migration (5.9% vs. 0%, p = 0.118) and tumor overgrowth (7.8% vs. 1.9%, p = 0.205) were non-significantly more frequent in the partially covered group, whereas tumor ingrowth showed a significantly higher incidence in the uncovered group (5.9% vs. 19.2%, p = 0.041). Stent migration in the partially covered group occurred only in patients with short stenosis of the utmost distal bile duct (two in ampullary cancer, one in bile duct cancer), and did not occur in any patients with pancreatic cancer.. For the palliation of malignant distal biliary obstruction, endoscopic placement of partially covered SEMSs with anti-migration designs and identical mesh structures to uncovered SEMSs failed to prolong cumulative stent patency or reduce stent migration.

Topics: Aged; Alloys; Bile Duct Neoplasms; Cholecystitis; Endoscopes, Gastrointestinal; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Palliative Care; Pancreatitis; Postoperative Complications; Proportional Hazards Models; Prospective Studies; Republic of Korea; Stents; Treatment Outcome

The MiCardia DYANA annuloplasty system (MiCardia Corp, Irvine, Calif) is a nitinol-based dynamic complete ring that allows modification of the septal-lateral diameter under transesophageal echocardiography guidance in the loaded beating heart after mitral valve repair. Shape alteration is induced by radiofrequency via detachable activation wires. This multicenter study reports the first human experience with this device.. Patients (n = 35, 67 ± 8 years) with degenerative (n = 29), functional/ischemic (n = 5), or rheumatic (n = 1) mitral regurgitation underwent mitral valve repair using the new device. We analyzed the occurrence of death, endocarditis, ring dehiscence, systolic anterior motion, thromboembolism, pulmonary edema, heart block, ventricular arrhythmia, hemolysis, or myocardial infarction at 30 days (primary end point) and 6 months (secondary end point) postprocedure.. All patients exhibited mitral regurgitation of 2 or less early postoperatively and at 6 months follow-up. In 29 patients, the initial mitral valve repair result was satisfactory and no ring activation was required. In 6 patients, the nitinol-based ring was deformed intraoperatively postrepair with further improvement of mitral regurgitation in all cases (preactivation: 0.9 ± 0.2, postactivation: 0.2 ± 0.3; P = .001). One death (2.9%, multisystem organ failure, non-device related), 2 ventricular arrhythmias (5.7%), and 1 heart block (2.9%) occurred, all in the first 30 days after surgery. No additional major adverse clinical events occurred later than 1 month postprocedure (total observed major adverse clinical event rate 11.5%).. The implantation of the new dynamic annuloplasty ring allows for safe mitral valve repair. The option of postrepair modification of the septal-lateral diameter by radiofrequency may further optimize repair results.

Topics: Aged; Alloys; Female; Germany; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Michigan; Middle Aged; Mitral Valve Annuloplasty; Mitral Valve Insufficiency; Postoperative Complications; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome

Endoscopic retrograde cholangiopancreatography (ERCP) is a valuable tool in the diagnosis and management of various pancreatobiliary disorders. Our aim was to evaluate whether the combination of a thin guide wire and a thin sphincterotome would facilitate selective cannulation of the bile duct and reduce the incidence of post-ERCP pancreatitis (PEP) by reducing papillary trauma when compared with a regular-sized hydrophilic guide wire.. Between June 2011 and February 2012, we performed 100 biliary cannulations for a native papilla in a randomized controlled trial. Having given their written informed consent, patients were randomly assigned to a 0.025-inch guide wire and sphincterotome group (n = 50) or to a 0.035-inch guide wire and sphincterotome group (n = 50). Number of cannulation attempts, number of accidental guide wire passages into the pancreatic duct, secondary cannulation techniques after failed primary cannulation, time to change the technique, and time for successful cannulation were collected in a database. Patients were followed up after ERCP, and all post-ERCP complications were recorded.. Primary cannulation was successful in 80 %. With accessory techniques, cannulation of the biliary duct was achieved in every case except one. There was no difference in primary cannulation rate between the 0.025-inch and 0.035-inch wire groups (n = 40 in each group). PEP was diagnosed in two patients (2.0 %), one in each study group. Postsphincterotomy bleeding occurred in one patient (1.0 %).. The thickness of the hydrophilic guide wire does not appear to affect either the success rate of primary cannulation or the risk of complications.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Antibiotic Prophylaxis; Catheterization; Cholangiopancreatography, Endoscopic Retrograde; Coated Materials, Biocompatible; Dilatation; Equipment Design; Female; Fluorine; Humans; Hydrophobic and Hydrophilic Interactions; Male; Middle Aged; Ofloxacin; Pancreatitis; Postoperative Complications; Prospective Studies; Radiography, Interventional; Sphincterotomy, Endoscopic; Stents; Time Factors; Tomography, X-Ray Computed

Angioplasty and stenting using nitinol stents is a recognized treatment option for intracranial atherosclerosis.. To identify procedure-related factors that may affect patient safety and technical outcome.. In this prospective study of 57 consecutive patients, the primary end points were intraprocedural technical problems, periprocedure morbidity, and complications. Major periprocedure complication was defined as all stroke or death at 30 days. Technical failure was defined as the inability to complete the procedure because of technical or safety problems. Procedure failure was defined as a procedure outcome of technical failure or major periprocedure complication. Secondary end points were procedure-related factors that may affect patient safety and technical outcome.. Procedure failure rate was 12.3% (7/57) (major periprocedure complication rate, 5.3% [3/57]; technical failure rate, 7% [4/57]). Initial failure in tracking of balloon or stent occurred in 20 patients, other technical problems occurred in 11 patients, including kinking or trapping of balloon catheter (2 cases), difficulty in unsheathing of stent (3 cases), forward migration of stent during deployment (4 cases), trapping of nose cone after stent deployment (1 case), fracture of delivery system (2 cases), and guidewire fracture (1 case). Unfavorable vascular morphology signified by the presence of 2 or more reverse curves along the access path was found to associate with initial failure in the tracking of instruments (OR = ∞), and occurrence of other technical problems (OR = 25).. Procedure-related factors could be identified and lead to improvements in patient safety and technical outcome. Tortuous vascular morphology is a key factor to be overcome.

Topics: Aged; Alloys; Angioplasty; Angioplasty, Balloon; Cerebral Arteries; Constriction, Pathologic; Equipment Failure; Female; Humans; Intracranial Arteriosclerosis; Male; Middle Aged; Patient Safety; Postoperative Complications; Process Assessment, Health Care; Prospective Studies; Radiography; Stents; Treatment Outcome

The results of laparoscopic transabdominal (transabdominal preperitoneal--TAPP) hernioplasty, using conventional polypropylene nets in 28 patients (group I) and nets, manufactured by firm MMDI in 22 patients (group II), were analyzed. The operation duration in group I had constituted (56 +/- 18) min at average and in group II--(38 +/- 7) min. The pain syndrome severity was lesser in group II patients by 40-50%. The patients of group I were discharged in 24-48 h and of group II--in 12-18 h. While following up in 3, 6 and 12 months the recurrence of hernia was revealed in 2 patients of group I. Application of nets, manufactured by firm MMDI opens new perspectives in laparoscopic herniology. Cosy unfolding and installation in preperitoneal space without additional fixation constitutes their advantage.

Topics: Alloys; Female; Hernia, Inguinal; Humans; Laparoscopy; Male; Middle Aged; Polypropylenes; Postoperative Complications; Recurrence; Surgical Mesh; Treatment Outcome

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder.

Topics: Alloys; Cardiac Catheterization; Chi-Square Distribution; Female; Foramen Ovale, Patent; Humans; Male; Middle Aged; Polytetrafluoroethylene; Postoperative Complications; Prostheses and Implants; Statistics, Nonparametric; Treatment Outcome

The purpose of this study was to analyze the usefulness of the BioFlex, a Nitinol spring rod dynamic stabilization system, and the Nitinol shape memory loop (KIMPF-DI Fixing System) as a posterior dynamic stabilization system in surgery for low-back pain.. The 103 patients who underwent treatment with the BioFlex system were divided into two groups: Group 1, dynamic stabilization with or without posterior lumbar interbody fusion (PLIF); and Group 2, rigid fixation (PLIF + BioFlex system only). A total of 66 segments were treated with only the BioFlex system; in these the preoperative range of motion (ROM) was 10.0 +/- 4.3 degrees , which changed to 4.1 +/- 1.9 degrees after surgery. Adjacent-segment ROM changed from 8.4 +/- 3.4 degrees to 10.7 +/- 3.2 degrees in Group 1 and from 6.5 +/- 3.2 degrees to 10.5 +/- 4.6 degrees in Group 2 postoperatively. A total of 110 segments received both BioFlex and PLIF, with a fusion rate of 90.0%. The visual analog scale score for back pain improved from 7.3 +/- 3.1 to 1.4 +/- 1.8 in Group 1 and from 7.4 +/- 2.4 to 2.1 +/- 2.3 in Group 2. The Oswestry Disability Index improved from 35.2 +/- 6.4 to 12.1 +/- 4.5 in Group 1 and from 37.8 +/- 5.7 to 13.6 +/- 4.2 in Group 2. (The ROM and assessment scores expressed are the mean +/- standard deviation.) The 194 patients in whom Nitinol memory loops were implanted were analyzed based on the preoperative and 1-year postoperative ROM of each lumbar segment. The change of ROM in looped segments treated with PLIF was significantly reduced, but the change of ROM in looped segments without PLIF was not significant. The change of ROM at the segment adjacent to the loop was not significant, and the change of kyphosis reflected a slight recovery.. The Nitinol BioFlex dynamic stabilization system can achieve stabilization and simultaneously allow physiological movement, which can in turn decrease the degeneration of adjacent segments. When used with PLIF, the fusion rate can be expected to increase. The flexible Nitinol shape memory loop, a posterior dynamic stabilization device, is an adequate tension band that displays strength similar to the posterior ligamentous structures. In combination with PLIF at the main lesion, the BioFlex system or the Nitinol memory loop can provide posterior dynamic stabilization to the transitional upper or lower segments, enhance the fusion rate, reduce the adjacent segment degeneration, and provide dynamic stabilization of the spine.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Female; Follow-Up Studies; Humans; Intervertebral Disc Displacement; Low Back Pain; Lumbar Vertebrae; Male; Middle Aged; Movement; Postoperative Complications; Prostheses and Implants; Radiography; Spinal Fusion; Treatment Outcome

The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures.. A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis.. The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different.. The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

Topics: Aged; Alloys; Cardiac Catheterization; Equipment Design; Equipment Safety; Female; Femoral Artery; Follow-Up Studies; Hemostasis; Hemostatic Techniques; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Surgical Instruments; Treatment Outcome; United States; Vascular Diseases

The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial.. A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images.. DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients.. DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.

Topics: Adult; Aged; Alloys; Aneurysm, False; Arterial Occlusive Diseases; Arteriovenous Fistula; Cardiac Catheterization; Collateral Circulation; Equipment Design; Equipment Safety; Female; Femoral Artery; Femoral Vein; Follow-Up Studies; Hematoma; Hemostasis; Hemostatic Techniques; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Reproducibility of Results; Saphenous Vein; Surgical Instruments; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Vascular Patency; Venous Thrombosis

The StarClose Vascular Closure System (Abbott Vascular Devices, Redwood City, California) utilizes a small, flexible nitinol clip to complete a circumferential, extravascular closure of the femoral arteriotomy site. The StarClose is an investigational device in the United States, limited by Federal law to investigational use. The StarClose is CE Mark approved.. The CLIP study was a prospective, randomized, multicenter trial utilizing a noninferiority design to compare the rate of major vascular complications and time-to-hemostasis using the StarClose system versus manual compression. A total of 596 subjects were enrolled, 208 of whom underwent diagnostic angiography. This diagnostic subset is the focus of this report. The primary safety endpoint was major vascular complications and the primary efficacy endpoint was time-to-hemostasis. All patients were followed at 30 days with a clinical exam.. Subjects were randomized 2:1 to the StarClose (n = 136) or manual compression (n = 72). There were no major vascular complications in either group. Minor vascular complications occurred in 3 StarClose patients (2.2%), and 1 manual compression patient (1.4%) (p = 1.00). Use of the StarClose device reduced mean time-to-hemostasis from 15.47 +/- 11.4 to 1.46 +/- 4.5 minutes (p < 0.001) when compared to manual compression, and reduced the average time-to-ambulation from 269 +/- 135 to 163 +/- 105 minutes (p < or = 0.001). Device success was 94.1% (127/135), and procedural success was 100% (136/136).. The clinical results of this study concluded that the StarClose Vascular Closure System is noninferior to standard compression with respect to the the primary safety endpoint of closing arteriotomies in patients who undergo percutaneous diagnostic procedures.

Topics: Alloys; Angiography; Bleeding Time; Early Ambulation; Female; Femoral Artery; Hemostasis; Hemostatic Techniques; Humans; Male; Middle Aged; Postoperative Complications; Postoperative Hemorrhage; Pressure; Prospective Studies

We report results of a pivotal prospective clinical trial that compared standard surgical repair with endovascular exclusion of abdominal aortic aneurysm (AAA) with the Talent LPS stent graft system.. Between March 24, 1999, and September 19, 2000, 240 patients with AAA who underwent stent graft placement and 126 patients who concurrently underwent surgery to treat AAA were enrolled at 17 centers in the United States. All patients were considered to be at low risk from aortic surgery. Patients who underwent endovascular repair received a bifurcated Talent LPS stent graft; surgical control subjects underwent standard operative techniques. Inclusion criteria were AAA larger than 4.0 cm in diameter, with proximal neck > 5 mm long and 14 to 32 mm in diameter, and a 15 mm landing zone in at least one common iliac artery. Access requirements included one external iliac artery of 7 mm caliber or larger. Preoperative anatomic evaluation included computed tomography and angiography. After stent-graft placement, evaluation involved plain radiography and computed tomography performed before discharge and at 1, 6, and 12 months and yearly thereafter.. There was no significant difference in early (<30 days) or late mortality between the two groups. Complications were slightly higher in the surgical cohort. The stent graft group did better in terms of procedure duration, requirement for general anesthesia and blood transfusion, and intensive care unit and hospital stay. There were three access or deployment failures. Immediate surgical conversion was necessary in only 1 patient, and late conversion in 5 additional patients. There were no aneurysm ruptures. Endoleak rate detected at CT (core laboratory validated) was 14% at 1 month, 12% at 6 months, and 10% at 12 months.. Compared with surgical control subjects, patients with AAA treated with the Talent LPS stent graft had fewer complications and the same low operative mortality. Likewise, endovascular repair performed better than surgery in the perioperative period, as measured with several key procedural indicators. Long-term follow-up of patients with the stent graft will be essential to assess durability of these early results.

Topics: Aged; Alloys; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cohort Studies; Equipment Failure; Female; Humans; Male; Polymers; Postoperative Complications; Prospective Studies; Stents; Treatment Outcome

Because first-generation stent-grafts did not meet initial expectations, a recently designed nitinol-expanded polytetrafluoroethylene (ePTFE) stent-graft was tested for treatment of abdominal aortic aneurysms (AAAs) in a prospective clinical study. The primary study endpoints were technical success and safety.. A nitinol-ePTFE self-expandable stent-graft (Excluder) was used to treat 72 patients with AAAs. The median follow-up period was 21.5 months +/- 13 (range, 1-46 mo).. Primary technical success in accurate placement of the device was achieved in 70 of 72 patients (97%). Complete exclusion of the aneurysm from arterial flow was achieved in 57 of 72 patients (79.2%). Three type I leaks were observed during implantation and were immediately corrected with a proximal cuff prosthesis in two patients. Fourteen of 72 patients (19.4%) had a type II leak. Major complications were observed in three patients (4.1%), including one death in the early postinterventional period (one of 72, 1.4%). At 3 months, aneurysms were excluded in 70 of 71 patients (98.6%), and at 12 months, aneurysms were occluded in 29 of 30 patients (96.7%). The maximum diameter of the aneurysm decreased from 55 mm +/- 11 (median +/- SD) before intervention to 53 mm +/- 13 at 6 and 12 months. None of the patients showed aneurysm growth.. This newly designed stent-graft proved to be effective and safe for treatment of AAAs.

Topics: Aged; Aged, 80 and over; Alloys; Aortic Aneurysm, Abdominal; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; C-Reactive Protein; Coated Materials, Biocompatible; Combined Modality Therapy; Endpoint Determination; Equipment Safety; Female; Follow-Up Studies; Humans; Iliac Artery; Inflammation; Length of Stay; Leukocyte Count; Male; Middle Aged; Polytetrafluoroethylene; Postoperative Complications; Prospective Studies; Prosthesis Design; Radiography, Interventional; Stents; Survival Analysis; Time Factors; Treatment Outcome; Vascular Resistance

The treatment of aortic aneurysms with endovascular stents or stent-graft prostheses is receiving increasing attention as an alternative to major abdominal surgery. To define the clinical value of this technique, we prospectively studied the use of stent-graft endoprostheses made of nitinol and covered with polyester fabric for the treatment of infrarenal abdominal aortic aneurysms.. We treated a total of 154 patients at three academic hospitals. Twenty-one patients with aortic aneurysms not involving the aortic bifurcation received straight stent-grafts, and 133 patients with aortic aneurysms involving the bifurcation and the common iliac arteries received bifurcated stent-grafts. After a unilateral surgical arteriotomy, the endoprostheses were advanced through the femoral arteries and placed under fluoroscopic guidance. Computed tomography and intraarterial angiography were performed during an average follow-up of 12.5 months.. The primary success rate, defined as complete exclusion of the abdominal aortic aneurysm from the circulation, was 86 percent in the group receiving straight grafts and 87 percent in the group receiving bifurcated grafts. In three patients the procedure had to be converted to an open surgical operation. Minor (n=13) or major (n=3) complications associated with the procedure (including 1 death) occurred in 10 percent of the patients. All patients had a postimplantation syndrome, with leukocytosis and elevated C-reactive protein levels.. Our results suggest that endovascular treatment of infrarenal abdominal aortic aneurysms is technically feasible and can effectively exclude abdominal aortic aneurysms from the circulation. With further refinement, endoluminal repair may emerge as an interventional strategy to treat infrarenal aortic aneurysms, especially in patients at high surgical risk.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis; Female; Humans; Male; Middle Aged; Polyesters; Postoperative Complications; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome

To report the results of a two-center study of endovascular abdominal aortic aneurysm (AAA) exclusion using a polyester-covered nitinol stent-graft.. Candidates were evaluated with arteriography and computed tomography. Criteria for endovascular therapy were a proximal aortic neck > 10 mm in length and < 25 mm in diameter, no bilateral internal iliac artery involvement in the aneurysm, no markedly tortuous common iliac arteries (CIAs) or CIAs < 7 mm in diameter, and no superior mesenteric artery occlusive disease. Patients were treated with the Mialhe Stentor and Vanguard stent-grafts in either tube or bifurcated versions.. Between August 1994 and November 1996, 149 patients (mean age 67 years, range 49 to 90) were admitted to the study. Overall primary technical success (aneurysm exclusion without endoleak) was 87% (130 patients): 78% (7 patients) for tube grafts and 88% (123 patients) for bifurcated endografts. The rate of local, remote, or systemic complications was 10.8%, with a 30-day mortality rate of 0.7%. During an average 13.5-month follow-up, there were no late deaths. Four of 20 endoleaks sealed spontaneously, 14 were treated with endoluminal techniques, and 2 remain untreated by patient request. Three graft limb thromboses occurred; one was treated surgically, one with lytic therapy, and one was untreated. Secondary patency was 96%.. Endoluminal repair of infrarenal AAAs using straight or bifurcated grafts is a feasible alternative to conventional surgical repair. Longer follow-up and more experience with refined endograft models will elucidate the durability of this endovascular approach to treating AAAs.

Topics: Aged; Aged, 80 and over; Alloys; Aortic Aneurysm, Abdominal; Aortography; Blood Vessel Prosthesis; Follow-Up Studies; Germany; Humans; Image Processing, Computer-Assisted; Middle Aged; Postoperative Complications; Prospective Studies; Prosthesis Failure; Reoperation; Stents; Survival Rate; Thrombosis; Tomography, X-Ray Computed

The aim of our study was to evaluate the performance and efficacy of a new self-expanding stent (nitinol Strecker stent) in the transjugular intrahepatic portosystemic shunt (TIPS) procedure. We have successfully placed 64 nitinol Strecker stents in 48 patients. The average portosystemic gradient decreased from 22 to 11 mm Hg. Balloon dilatation was necessary in 12 of 35 angiographically controlled cases at 5 days (34%), because of incomplete stent expansion, small thrombi within the stent or obstruction. At 1-6 months stent malfunctions occurred in 8 of 23 patients who underwent control angiography (34%) and at 6-24 months in 6 of 7 patients (85%). Rebleeding occurred in 2 of 39 patients (follow-up > 1 month) (5%) and temporary crises of de novo encephalopathy were observed in 11 of 48 patients (23%). Refractory ascites completely resolved in 4 of 6 patients (66%) and improved in the remaining 2 cases. Compared with other self-expanding stents, nitinol Strecker stents seem to be equally effective in TIPS; no increase in complication rate was observed, either clinical or stent-related.

Topics: Adult; Aged; Alloys; Female; Fluoroscopy; Follow-Up Studies; Humans; Hypertension, Portal; Male; Middle Aged; Portasystemic Shunt, Transjugular Intrahepatic; Postoperative Complications; Radiology, Interventional; Retrospective Studies; Stents; Tomography, X-Ray Computed; Ultrasonography, Doppler, Color

With 70 cm "cutter" valvulotomes for valvulotomy and an electronically steerable nitinol catheter to occlude venous tributaries with platinum coils, endovascular in situ saphenous vein (EISV) bypass can be safely performed from within the saphenous vein. To determine whether EISV bypass could reduce hospital length of stay (LOS) and perioperative morbidity without compromising patency, another 53 EISV bypasses for limb salvage were performed.. Tributary occlusion was accomplished with only fluoroscopic surveillance with a new, smaller, and more steerable silicone-tipped nitinol catheter.. Two (3.7%) wound complications occurred. The mean hospital LOS after operation was 4.2 days (range 2 to 29 days). All tributaries initially embolized remained occluded, and three "missed" arteriovenous fistulas were identified during follow-up extending to 15 month (mean 8.4 months). Eighty-eight percent (49 of 54) of phase II bypasses remained patent, whereas life-table analysis of all bypasses (phase I and II) was 77% (69/99) at 24 months follow-up (mean 13.6 months). By comparison, 41 infrainguinal saphenous vein in situ bypasses with "classic" open techniques were performed concurrently. The mean postoperative LOS was 11.6 days (range 4 to 42 days), wound complications occurred in 24% (10) of patients, and two "missed" arteriovenous fistulas were identified during follow-up. Eighty-three percent (34 of 41) of bypasses remain patent at 24 months follow-up (mean 16.2 months).. If EISV bypass long-term patency rates remain similar to classic in situ bypass patency results, the additional benefits of decreased hospital LOS, reduced wound-related complications, shortened recuperation, and therefore increased health care savings gives this endovascular technique strong consideration as the possible future operation for infrainguinal saphenous veins in situ bypass.

Topics: Aged; Aged, 80 and over; Alloys; Catheterization; Catheterization, Peripheral; Combined Modality Therapy; Female; Femoral Vein; Follow-Up Studies; Graft Occlusion, Vascular; Groin; Humans; Leg; Length of Stay; Life Tables; Male; Middle Aged; Peripheral Vascular Diseases; Popliteal Vein; Postoperative Complications; Saphenous Vein; Silicones; Stents; Ultrasonography; Vascular Patency

To evaluate the efficiency and safety of using an intraocular foreign body forceps with two nitinol loops at its tip to capture and chop dropped nucleus (DN) during vitrectomy as an alternative method and to evaluate the outcomes and complications of this surgical technique.. The eyes that underwent 23-gauge vitrectomy with removal of DN using nitinol forceps with a minimum follow-up time of 1 year are included in this study. The efficiency of surgical technique and anatomical and functional results with complications is recorded.. Nine patients with a mean age of 73.11 ± 2.15 years were included in this study. The mean time between DN and vitrectomy was 7.67 ± 3.74 (5-14) days. In all eyes, DN was easily chopped and removed with aspiration. Argon laser photocoagulation was performed in 4 eyes (44.44%) during surgery. All eyes were followed up for a mean time of 21.11 ± 12.36 (12-48) months. The mean preoperative best-corrected visual acuity increased significantly during the postoperative follow-up ( P < 0.001). No complications related to the cataract surgery or DN removal were observed.. Surgical removal of DN with the help of these forceps with nitinol loops is found to be safe and effective in this study. This method avoids ultrasonographic energy and enables 23-gauge vitrectomy without a fragmatome.

Topics: Aged; Eye Foreign Bodies; Humans; Postoperative Complications; Retrospective Studies; Surgical Instruments; Treatment Outcome; Vitrectomy

To evaluate the feasibility of new adjustable intraocular lens (IOL) technology.. The foldable adjustable IOL consists of a nitinol mechanism placed in a haptic-optic cradle. Heating actuators on the nitinol mechanism with a continuous green laser achieve controlled movement of the mechanism and optic. Activation occurs in controlled steps: rotation in 1-degree steps over 360 degrees, and anterior posterior movement in 0.25-diopter (D) steps with a range of +1.50 D. The IOL was tested in vitro and in vivo in a rabbit eye. Foldability and unfolding were demonstrated through a 2.6-mm cartridge.. The adjustable lens mechanism was successfully tested in vitro and in vivo. Activation resulted in a change in optic position relative to the haptics and the capsular bag. Activation of the lever and ratchet mechanism showed radial advancement of the IOL clockwise and counterclockwise. In vivo rotatory movement was achieved after activation by the argon laser at 1 week after implantation. Anterior to posterior movement was accomplished by activating the circular spring actuator mechanism in the laboratory model. Uneventful folding and unfolding were performed.. A new adjustable IOL with a mechanism that responds in measured steps had been shown to move as planned after activation by argon laser. This was successful in the laboratory in both radial and anterior posterior movement. The radial movement was also proven in vivo in an animal model. Further refinement of the prototype is currently being undertaken.

Topics: Animals; Argon; Lens Capsule, Crystalline; Lens Implantation, Intraocular; Lenses, Intraocular; Phacoemulsification; Postoperative Complications; Prosthesis Design; Rabbits; Technology

Prosthesis infection after aortic surgery is a critical complication that most commonly requires surgical treatment with removal of the infected material. In this video tutorial, we remove a novel nitinol wire braided stent. It was introduced to stabilize the true lumen and prevent distal anastomotic new entry. Both the stent type and surgical approach were new and therefore constituted a major challenge. Despite these issues, removal with bilateral subclavian and femoral cannulation under hypothermic circulatory arrest proved successful.

Topics: Alloys; Aorta, Thoracic; Aortic Aneurysm, Thoracic; Aortic Dissection; Blood Vessel Prosthesis Implantation; Humans; Postoperative Complications; Stents; Treatment Outcome

We report 8-year experience with vascular access complications (VACs) after percutaneous transfemoral transcatheter aortic valve implantation (TAVI). From January 2010 to January 2018, patients with iliofemoral VAC treated by an intervention following percutaneous transfemoral TAVI were included. Major VAC was defined according to the Valve Academic Research Consortium 2 classification. As first-line strategy, VACs were treated using covered nitinol stents (CS). Among 795 percutaneous transfemoral TAVI, 74 (9.3%) patients (female, 57%; 82 ± 8 years) with VAC treated by CS and/or open repair were included in this study: 59 CS cases and 15 open repair cases. Two CS patients were converted to open repair. Technical success for stent implantation was 97%. The main VAC was a persistent bleeding related to percutaneous closure device failure (72%). Thirty-day mortality in the study cohort was 5.4% (4/74), including 1 VAC-related death. One patient had postoperative lower limb ischemia successfully treated by open repair. No amputation, new-onset claudication or in-stent occlusion was recorded. Endovascular intervention using self-expandable nitinol covered stent is safe and effective as a first-line strategy for the treatment of VAC in percutaneous transfemoral TAVI. However, open repair is needed in case of unfeasibility or failure of endovascular therapy.

Topics: Aged, 80 and over; Alloys; Aortic Valve Stenosis; Coated Materials, Biocompatible; Female; Humans; Male; Postoperative Complications; Retrospective Studies; Self Expandable Metallic Stents; Transcatheter Aortic Valve Replacement

Conventional coiling is standard for treatment of ruptured intracranial aneurysms. We compared clinical and angiographic outcomes between intrasaccular flow disruption with the Woven EndoBridge (WEB) and conventional coiling in patients with aneurysmal subarachnoid hemorrhage (aSAH) using a propensity score-matched analysis.. This is a retrospective study of consecutive patients with aSAH treated with the WEB or conventional coiling between 2010 and 2019. Baseline characteristics, procedural complications, angiographic results, and functional outcome were compared between both groups.. Fifty-two patients treated with the WEB and 236 patients treated by coiling were included. The WEB group was characterized by a higher patient age (P = 0.024), a wider aneurysm neck (P < 0.001), and more frequent location at the posterior circulation (P = 0.004). Procedural complications were comparable between WEB (19.2%) and coiling (22.7%, P = 0.447). In-hospital mortality rates were higher in the coiling group (WEB: 5.8%, coiling: 17.8%; P = 0.0034). Favorable outcome (modified Rankin scale ≤2) was obtained in 51.3% after WEB embolization and in 55.0% after coiling (P = 0.653). Retreatment was performed in 26.4% of patients after WEB and in 25.8% after coiling (P = 0.935). Propensity score analysis confirmed these results and revealed higher adequate occlusion rates at midterm follow-up for WEB-treated aneurysms (WEB: 93.9%, coiling: 76.2%, P = 0.058).. Compared with conventional coiling, aSAH patients treated with the WEB have a similar clinical and potentially improved angiographic outcome at midterm follow-up. The WEB might be considered as an alternative to conventional coiling for the treatment of RIAs, in particular for those with wide-necked and thus challenging anatomy.

Topics: Adult; Aged; Alloys; Aneurysm, Ruptured; Cerebral Angiography; Endovascular Procedures; Female; Hospital Mortality; Humans; Intracranial Aneurysm; Male; Middle Aged; Postoperative Complications; Propensity Score; Retrospective Studies; Subarachnoid Hemorrhage; Surgical Mesh; Treatment Outcome

To understand the histologic changes of prostate tissue induced by temporary implantable nitinol device (cTIND) in a canine model.. The cTIND is a small, symmetric device comprised of nitinol wire loops welded together on an axis, which exert radial force on the tissue to induce a targeted ischemic effect. The cTIND was implanted in three live canine models, which were monitored for 14 days post-index procedure. Device placement was monitored via serial fluoroscopy and biologic effects of cTIND were studied via histopathology.. The cTIND was successfully placed in the canine models and remained securely in position until the animal was sacrificed on postoperative day 14. The cTIND treated tissue demonstrated an abrupt transition from normal, viable prostatic glandular tissue to an area of shrunken necrosis and fibrosis between the two.. In the canine models, the cTIND created focal areas of ischemic necrosis resulting in incisions in the peri-urethral prostate with minimal inflammation.

Topics: Alloys; Animals; Dogs; Ischemia; Male; Minimally Invasive Surgical Procedures; Necrosis; Postoperative Complications; Prostate; Prostheses and Implants; Urologic Surgical Procedures, Male

To evaluate clinical outcomes from a postmarket registry of the Zenith Spiral-Z abdominal aortic aneurysm iliac leg graft with a continuous, spiral nitinol stent that was designed for improved conformability, kink, and migration resistance.. This prospective, multicenter registry was designed to evaluate physician-reported outcomes of the Spiral-Z leg graft in up to 600 patients who underwent endovascular repair of abdominal aortic or aortoiliac aneurysms at up to 30 investigative sites in the United States and Canada. Study outcomes were focused on iliac limb occlusion, limb-related reintervention, limb-related endoleak, component separation, and device integrity. Short-term data were collected during an interval of 1 to 6 months, with longer term data collected at 12 months.. Between March 2012 and March 2015, 599 patients (mean age 74 ± 8 years; 87% male; 26% with aortoiliac aneurysm) were treated, with Spiral-Z iliac leg grafts placed in 564 left iliac arteries and 559 right iliac arteries. The mean iliac inner diameters (both left and right) were 9 ± 3 mm; moderate/severe occlusive disease, calcification, and vessel tortuosity were present in 14%, 25%, and 36% and 15%, 25%, and 34% of the left and right iliac arteries, respectively. Iliac artery adjunctive procedures (iliac artery angioplasty and/or stent placement) were performed intraoperatively in 112 patients (19%; bilateral in 52 patients). Mortality within 30 days was 1.7% (10/599); cumulative mortality at 1 year was 6.2% (37/599). There were no aortic ruptures and only one open conversion (0.2%). Limb occlusions occurred in 11 of 599 patients (2%; 3 within 30 days and 8 after 30 days, all unilateral, none had received procedural iliac artery adjuncts at implantation); of these, 7 patients underwent reinterventions. Other limb-related reinterventions were performed on eight patients for nonocclusive kink, compression, or thrombus (six within 30 days and three after 30 days). In total, 13 patients (2%) underwent 15 limb-related reinterventions (7 for occlusions and 8 for nonocclusive causes). In one patient, a distal type I endoleak and device migration (>10 mm) involving a right iliac leg was noted at the 12-month follow-up visit. No other limb-related endoleak, migration, component separation, or stent fracture was reported during a mean follow-up of 11 ± 6 months.. The Spiral-Z leg graft demonstrated excellent patency and required infrequent limb-related reinterventions in routine clinical care in a postmarket registry.

Topics: Aged; Aged, 80 and over; Alloys; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Canada; Endovascular Procedures; Female; Humans; Iliac Artery; Male; Middle Aged; Postoperative Complications; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; United States

To investigate the healing process and nickel release of the Hyperion occluder (Comed BV, Netherlands), as compared to the Amplatzer septal occluder (ASO) (St. Jude Medical Inc., St. Paul, MN, USA) in a chronic swine model.. Some long-term complications occurring after percutaneous atrial septal defect (ASD) closure may be partially associated with an inappropriate healing of the device and increased nickel release. There is no direct comparative study of different occluders for healing and nickel release.. After percutaneous ASD creation, 12 pigs were implanted with 15 mm Hyperion (. Implantation was successful in 100% without complications. Device coverage was observed as early as 1 month after implantation and was almost complete after 3 months. A granulation tissue with a predominantly mononuclear inflammatory reaction was observed in contact with nitinol wires while an inflammatory reaction was seen in contact with textile fibers. We found no statistically significant difference between the 2 devices whether for histological grading scores or systemic nickel release, regardless to follow-up duration.. In this preclinical study, we demonstrated that Amplatzer septal occluder and Hyperion occluder were not significantly different for device healing and nickel release processes.

Topics: Alloys; Animals; Comparative Effectiveness Research; Heart Septal Defects, Atrial; Long Term Adverse Effects; Materials Testing; Nickel; Outcome Assessment, Health Care; Postoperative Complications; Prosthesis Design; Prosthesis Implantation; Septal Occluder Device; Swine; Trace Elements; Treatment Outcome

To evaluate the Covera Plus (Bard, Tempe, Arizona) covered stent as a bridging stent in branched thoraco-abdominal endovascular aneurysm repair (BEVAR).. Retrospective analysis of 112 self-expandable stents was performed at 2 university centers between August 2017 and March 2019. Thirty-one consecutive BEVAR procedures were studied (21 males; mean age, 75 years; 29 American Society of Anesthesiologists grade III/IV) with 119 patent target vessels (7 did not receive the studied device). Primary endpoints were technical success, branch instability, and primary/secondary clinical success. Secondary endpoints included primary/secondary patency and any adverse events.. Technical success was 100%. Median follow-up was 12 months (interquartile range, 6-14 months). Branch instability was registered twice (2/112), due to immediate renal occlusion and type Ic endoleak; no additional events occurred during the follow-up. Primary clinical success was 84%. There were 2 immediate deaths, 1 upper limb ischemia, 1 hemorrhage from splenic artery, and 1 type Ic endoleak; these last 3 events were successfully treated, with a secondary clinical success of 100% that was maintained during the follow-up. One late death occurred. Primary patency was 99% (111/112) and 100% (105/105) within 30 days and at the end of the study period,respectively. Adverse events included 4 acute kidney injuries and 2 spinal cord ischemia. No type I/III endoleaks, occlusion, fracture, or dislodging were diagnosed after 30 days.. The stent graft seems safe and effective for bridging in BEVAR with low branch instability and high patency rate. Longer follow-up is required to confirm these promising results.

Topics: Aged; Alloys; Aortic Aneurysm, Thoracic; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Female; Humans; Italy; Male; Postoperative Complications; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Animals; Aorta, Thoracic; Aortic Aneurysm, Thoracic; Aortic Dissection; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Disease Models, Animal; Dogs; Humans; Postoperative Complications; Prosthesis Design; Self Expandable Metallic Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

Hammertoe deformation is a frequent motive for consultation in forefoot surgery, and proximal interphalangeal joint arthrodesis is a classic treatment for fixed deformation, which tends to be achieved more and more thanks to specific implants. This work evaluated and compared clinical improvement, radiologic fusion, and complication rates between dynamic (Difuse®) and static (TinyFix®) implants from Biotech Ortho. A total of 95 patients (110 feet and 166 toes; 97 static and 69 dynamic implants) were included. Mean age was 63.6 (±12.6) years in the dynamic group and 62.3 (±14.01) years in the static group. Epidemiologic and intraoperative radiologic data were collected. Pain, toes deformity, complications, and radiologic findings (bone fusion and osteolysis) were recorded at 4 months postoperatively and at the last follow-up. Mean follow-up was 11.5 (range 4 to 28) months, and the position of the implants was more often satisfying in the dynamic group (p = .01). Fusion rates at 4 months were 67% and 80% in the dynamic and static groups, respectively (p = .05). Radiologic osteolysis occurred more frequently in the dynamic group (p = .05 at 4 months), and pain was still present in 3% in the dynamic group at the last follow-up compared with 7% in the static group. Complication rate was 7% in the dynamic group (implant fractures) and 4% in the static group. Revision was considered more often in the dynamic group (p = .01). The static titanium implant seems superior to the dynamic memory shape implant in Nitinol alloy with regard to fusion (p = .04), complications (p = .03), and revision rates (p = .01). The literature review seems to support the good results of static implants compared with the rest of the available arthrodesis implant solutions.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Arthrodesis; Bone Wires; Female; Follow-Up Studies; Hammer Toe Syndrome; Humans; Joint Prosthesis; Male; Middle Aged; Osteolysis; Postoperative Complications; Prosthesis Design; Radiography; Retrospective Studies; Toe Joint; Treatment Outcome

A multitude of procedures has been described in the literature for the treatment of lesser toe deformities and there is currently no general consensus on the optimal method of fixation. The aim of this study is to assess the clinical and radiological outcomes of an intramedullary nitinol implant for the correction of lesser toe deformities, and to determine if the distal interphalangeal (DIP) joint and metatarsophalangeal (MTP) joint are modified during patient follow-up after correction of the PIP joint.. A prospective analysis of 36 patients with claw toe or hammertoe who were treated with an intramedullary nitinol implant. Clinical manifestations and angulation of the metatarsophalangeal, proximal and distal interphalangeal (MTP, PIP, DIP) joints were evaluated in radiographic studies preoperatively, at first medical revision post-surgery, and after a minimum of 1 year of follow-up. Complications such as non-union rate, implant rupture, and implant infection were also evaluated during follow-up.. All patients were women with an average age of 65.5 (range 47-82) years. The average follow-up time was 2.4 (range 1-5.7) years. Fifty intramedullary nitinol implants were used. The MTP joint extension and PIP joint flexion decreased by 15.9° (95% CI - 19.11 to - 12.63) and 49.4° (95% CI - 55.29 to - 43.52), respectively, at the end of follow-up. Moreover, the DIP joint flexion increased progressively during follow-up (13.7° pre-surgery versus 35.6 in last medical check-up, 95% CI 13.24-30.57). There were four (8%) asymptomatic implant ruptures. The rate of fusion was 98%.. The reduction of the PIP joint using an intramedullary nitinol implant is a good option in lesser toe deformities, with few complications and a high rate of arthrodesis. Moreover, the PIP joint reduction affects both the MTP and DIP joints.

Topics: Aged; Aged, 80 and over; Alloys; Arthrodesis; Female; Hammer Toe Syndrome; Humans; Male; Middle Aged; Physical Examination; Plastic Surgery Procedures; Postoperative Complications; Prospective Studies; Prostheses and Implants; Range of Motion, Articular

Central airway obstruction (CAO) is defined as obstruction of the airway lumen in the trachea or mainstem bronchi, most commonly due to primary or metastatic malignancy; and is classified as extraluminal, endoluminal, or mixed. The majority of malignant CAO are advanced stage and require a multimodality palliative approach, including stent placement. We describe a retrospective review of a novel self-expandable metallic stent, the Bonastent; a fully covered, nitinol-braided airway stent which conforms to airway tortuosity without loss of diameter in the management of CAO.. We performed a retrospective chart review of patients with CAO who underwent Bonastent placement at a single center between February 2017 and March 2018. Ease of stent placement, short-term complications (within 24 h of stent placement) and long-term complications (within 3 mo of stent placement) were recorded.. Eleven patients were identified, reviewed and included in the study. Thirteen stents in 11 patients were placed for predominantly malignant CAO. One patient had a short-term complication of stent migration. Four patients had long-term complications; of which 3 patients had in-stent mucus impaction requiring bronchoscopy. In our study, the stent-related complication rates were comparable to the reported literature.. In our experience, Bonastent is an easy to use option which adds to the armamentarium of the self-expandable metallic stent to treat malignant CAO.

Topics: Adult; Aged; Aged, 80 and over; Airway Obstruction; Alloys; Bronchi; Bronchoscopy; Cohort Studies; Feasibility Studies; Female; Humans; Male; Middle Aged; Mucus; Neoplasms; Palliative Care; Postoperative Complications; Prosthesis Failure; Retrospective Studies; Self Expandable Metallic Stents; Trachea

The interwoven nitinol design of the Supera stent has been shown to have superior radial strength and fracture resistance resulting in higher patency rates at 6 and 12months. A detailed sub-analysis of SUPERB trial showed differences in patency based on stent conformation post deployment. We evaluated the patency of the stent within the SAKE study cohort based on stent deployment conformation.. We retrospectively evaluated the medical records of 63 patients (77 limbs) with Rutherford class 2-5 symptoms who received Supera stents in the femoro-popliteal artery from March 2010 through May 2011 as part of the SAKE study. These patients were followed for patency and the need for re-intervention over a mean follow up of 15months. Compression or Elongation was defined as follows based on previous sub-analyses: Moderate Compression (-40 to -21%); Minimal Compression (-20 to -11%); Nominal (-10 to 10%); Minimal Elongation (11 to 20%); Moderate Elongation (21 to 40%); and Severe Elongation (>40%). Significance was determined using Chi X. The best patency rates (85.2% primary patency and 92.6% assisted primary patency) and lowest re-intervention rates (14.8%) were achieved with stent compression, followed by nominal deployment or minimal elongation, and worst outcomes (64.7% primary patency; 82.3% assisted primary patency; and 35.3% re-intervention) with stent elongation to moderate or severe degree.. Patency rates and re-intervention rates are variable based on deployment characteristics of the Supera stent. Best outcomes are achieved with compression of the stent during deployment.

Topics: Aged; Aged, 80 and over; Alloys; Endovascular Procedures; Female; Humans; Lower Extremity; Male; Medical Records; Middle Aged; Peripheral Arterial Disease; Postoperative Complications; Prosthesis Design; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the usefulness of different types of nitinol baskets to capture, lift and hold the lens material, dropped during a complicated phacoemulsification, as an adjunctive surgical tool in vitreoretinal surgery and to evaluate the outcomes and complication of this new surgical technique in a small series of patients.. Patients who underwent pars plana vitrectomy (PPV) for retained lens fragments operated during December 2014 and March 2015 at the Academic Medical Center (AMC), Amsterdam, were included in this study. The PPV was performed using different settings and types of nitinol stone extractors (NSE). Three different stone extractors were used for the above-mentioned purpose. Preoperative (pre-op) and postoperative (post-op) data including best corrected visual acuity at 6 months follow-up visit, intra- and postoperative complications were recorded.. Seven eyes of seven patients with a follow-up of 6 months were included in this study. All the vitrectomies were performed the same day of the complicated cataract extraction. Mean pre-op Snellen visual acuity was 20/160; mean post-op visual acuity was 20/32. No complications were encountered due to the use of the NSE intraocularly. No retinal breaks were observed due to traction of the catheter at the site of insertion or due to his movement in and out the vitreous cavity.. The use of the nitinol lens cage seemed feasible and showed no complications in our small group of patients. It made easier the management of dropped nucleus without the need for a larger scleral opening also in case of very hard lens.

Topics: Aged; Alloys; Equipment Design; Female; Follow-Up Studies; Humans; Lens Nucleus, Crystalline; Lenses, Intraocular; Male; Middle Aged; Phacoemulsification; Postoperative Complications; Retrospective Studies; Time Factors; Treatment Outcome; Visual Acuity; Vitrectomy

We report a case in which an intracranial dural arteriovenous fistula (DAVF) developed after endovascular treatment of a patient with idiopathic intracranial hypertension with venous sinus stenting (VSS). The pathogenesis may involve hemodynamic alterations secondary to increased poststenting venous sinus pressure, which may cause new arterial ingrowth into the fistulous sinus wall without capillary interposition. Despite administration of dual antiplatelet therapy, there may also be subclinical cortical vein thrombosis that contributed to DAVF formation. In addition to the aforementioned mechanisms, increased inflammation induced by VSS may upregulate vascular endothelial growth factor and platelet-derived growth factor expression and also promote DAVF pathogenesis. Since VSS has been used to obliterate DAVFs, DAVF formation after VSS may seem counterintuitive. Previous stents have generally been closed cell, stainless steel designs used to maximize radial compression of the fistulous sinus wall. In contrast, our patient's stent was an open cell, self-expandable nitinol design (Protégé Everflex). Neurointerventionalists should be aware of this potential, although rare complication of DAVF formation after VSS.

Topics: Alloys; Central Nervous System Vascular Malformations; Cerebral Veins; Cranial Sinuses; Female; Humans; Neurosurgical Procedures; Postoperative Complications; Pseudotumor Cerebri; Stents; Treatment Outcome; Young Adult

Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium.. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation.. We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7% of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3% of patients (69/180).. Mean deviation of trailing edge of esophagus with EsoSure was 2.45 ± 0.9 cm (range 1-4.5). LET rise >1°C was significantly lower in the ED than non-ED group (3% vs 79.4%; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted.. Mechanical displacement of the esophagus with EsoSure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.

Topics: Alloys; Atrial Fibrillation; Body Temperature; Catheter Ablation; Echocardiography, Transesophageal; Esophagus; Female; Follow-Up Studies; Heart Atria; Humans; Male; Middle Aged; Monitoring, Intraoperative; Postoperative Complications; Pulmonary Veins; Retrospective Studies; Time Factors; Treatment Outcome

 Various stent retrievers differing in stent design and mechanical properties are currently available for the treatment of ischemic stroke. We conducted this in vitro study to compare the efficacy, embolism rate, and safety of commercially available stent retrievers and prototypes..  Whole blood thrombi were produced in a Chandler loop. The thrombi were inserted into the curved M1 segment of a silicone model of the anterior cerebral circulation. Thrombectomy maneuvers were performed with six commercially available stent retrievers and 2 prototypes with different strut thickness. Wall-stent apposition, first pass recanalization rate, retraction force, and embolism rate were compared..  Devices with complete wall-stent apposition had the highest first pass recanalization rate and lowest embolism rate, but showed the highest retraction force. The prototype with thinner struts had a comparable recanalization and embolism rate, while a lower retraction force had to be applied compared to the prototype with thicker struts..  Complete wall-stent apposition facilitates a higher recanalization rate and lower embolism rate but also correlates to a higher necessary retraction force and thus possibly higher risk of endothelium damage. Stent modifications leading to a reduced retraction force do not compromise efficacy and embolism rate..   · Complete wall-stent apposition facilitates an effective thrombectomy. · Complete wall-stent apposition leads to higher retraction force and possibly greater endothelium damage. · Modifications of strut thickness do not compromise recanalization and embolism rate. · Thinner struts correlate with a lower retraction force.. · Larsen N, Oberbeck K, Lima de Miranda R et al. Comparison of Efficacy, Embolism Rate and Safety of Thrombectomy with Stent Retrievers in an Anterior Circulation Stroke Model. Fortschr Röntgenstr 2018; 190: 1053 - 1058.. ZIEL:  In der Therapie des ischämischen Schlaganfalles kommen verschiedene Stentretriever zum Einsatz, die sich in Stentdesign und mechanischen Eigenschaften unterscheiden. Wir führten diese in vitro-Studie durch, um Effektivität, Embolisationsrate und notwendige Retraktionskraft von kommerziell erhältlichen Stentretrievern und zwei Prototypen zu vergleichen..  In einem Chandler loop generierte Vollblutthromben wurden in das bogig verlaufende M1-Segment eines Silikonmodells der vorderen intrakraniellen Zirkulation eingebracht. Thrombektomiemanöver wurden mit 6 kommerziell erhältlichen Stentretrievern und 2 Prototypen, die sich in der Stärke der Stentstreben unterschieden, durchgeführt. Die Adaptation des Stentretrievers an die Gefäßwand, first pass-Rekanalisierungsrate, Retraktionskraft und Embolisationsrate wurden verglichen..  Die Stentretriever, die eine vollständige Adaptation an die Gefäßwand zeigten, wiesen eine höhere first pass-Rekanalisierungsrate und geringere Embolisationsrate auf als Stentretriever, die sich nicht in voller Länge an die Gefäßwand anlegten. Andererseits war bei ersteren eine höhere Retraktionskraft notwendig. Der Prototyp mit dünneren Stentstreben erreichte eine vergleichbare Rekanalisations- und Embolierate bei geringerer aufzuwendender Retraktionskraft im Vergleich zum Prototypen mit stärkeren Stentstreben..  Eine vollständige Adaptation des Stentretrievers an die Gefäßwand ermöglicht eine effektive Thrombektomie mit geringer Embolierate, ist jedoch mit einer höheren notwendigen Retraktionskraft und damit potentiell höheren Gefahr einer Endothelverletzung verbunden. Veränderungen des Stentdesigns in den Prototypen mit Verminderung der Stärke der Stentstreben führen zu einer geringeren Retraktionskraft, beeinträchtigten jedoch nicht die Rekanalisierungs- und Embolierate..   · Die vollständige Adaptation des Stentretrievers an die Gefäßwand ermöglicht eine effektive Thrombektomie. · Diese ist mit einer höheren Retraktionskraft und möglicherweise Gefahr der Endothelverletzung verbunden. · Durch Verringerung der Strebendicke wird die Rekanalisations- und Embolierate nicht beeinträchtigt. · Die Retraktionskraft kann hierdurch vermindert werden.

Topics: Alloys; Brain Infarction; Device Removal; Endovascular Procedures; Equipment Design; Humans; In Vitro Techniques; Intracranial Embolism; Models, Cardiovascular; Postoperative Complications; Proof of Concept Study; Stents; Stroke; Thrombectomy

Deposition of dystrophic calcifications on the posterior surface of silicone intraocular lenses (IOLs) has been reported in patients with asteroid hyalosis. Accumulation of silicone oil droplets on the posterior surface of silicone IOLs in silicone-filled eyes has also been reported. Recently, a novel technique to manually remove dystrophic calcifications using a nickel titanium loop (Finesse Flex Loop; Alcon, Fort Worth, TX) was described, obviating the need for IOL exchange. Here, the authors report their outcomes with this technique in five eyes with IOL dystrophic calcifications as well as one eye with IOL silicone oil droplet accumulation. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:422-426.].

Topics: Aged; Aged, 80 and over; Alloys; Calcinosis; Equipment Design; Eye Diseases; Female; Follow-Up Studies; Humans; Lenses, Intraocular; Male; Middle Aged; Ophthalmologic Surgical Procedures; Postoperative Complications; Prosthesis Failure; Silicone Oils

To investigate outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after treatment with the Stentys self-apposing stent (Stentys SAS; Stentys S.A.) for bifurcation culprit lesions.. The nitinol, self-expanding Stentys was initially developed as a dedicated bifurcation stent. The stent facilitates a provisional strategy by accommodating its diameter to both the proximal and distal reference diameters and offering an opportunity to "disconnect" the interconnectors, opening the stent toward the side branch.. The APPOSITION (a post-market registry to assess the Stentys self-expanding coronary stent in acute myocardial infarction) III study was a prospective, multicenter, international, observational study including STEMI patients undergoing primary percutaneous coronary intervention (PCI) with the Stentys SAS. Clinical endpoints were evaluated and stratified by bifurcation vs non-bifurcation culprit lesions.. From 965 patients included, a total of 123 (13%) were documented as having a bifurcation lesion. Target-vessel revascularization (TVR) rates were higher in the bifurcation subgroup (16.4% vs 10.0%; P=.04). Although not statistically significant, other endpoints were numerically higher in the bifurcation subgroup: major adverse cardiac events (MACE; 12.7% vs 8.8%), myocardial infarction (MI; 3.4% vs 1.8%), and definite/probable stent thrombosis (ST; 5.8% vs 3.1%). However, when postdilation was performed, clinical endpoints were similar between bifurcation and non-bifurcation lesions: MACE (8.7% vs 8.4%), MI (1.2% vs 0.7%), and definite/probable ST (3.7% vs 2.4%).. The use of the Stentys SAS was safe and feasible for the treatment of bifurcation lesions in the setting of primary PCI for STEMI treatment with acceptable 1-year cardiovascular event rates, which improved when postdilation was performed.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Vessels; Female; Humans; Male; Middle Aged; Outcome and Process Assessment, Health Care; Postoperative Complications; Product Surveillance, Postmarketing; Self Expandable Metallic Stents; ST Elevation Myocardial Infarction

This study aims to evaluate the nitinol (X-Fuse®) implant in arthrodesis of the distal interphalangeal and the thumb joints with respect to bone fusion and clinical efficiency.. This prospective study included 24 consecutive patients (7 males, 17 females; mean age 56.8 years; range 27 to 79 years) with nitinol (X-Fuse®) implants in their 41 joints. All patients were followed-up clinically and radiographically with respect to fusion, complications and outcome at a minimum of 14 months postoperatively (mean 28±6 months). X-rays, Disabilities of the Arm, Shoulder and Hand, and visual analog scale scores were recorded preoperatively and at postoperative fifth week, third month, first year, and subsequent visits.. The Disabilities of the Arm, Shoulder and Hand score improved significantly from preoperative 37.7 points to postoperative 14.5 points at first year. The visual analog scale score improved significantly from preoperative 5.5 to postoperative 0.85 points at first year. Failure to fuse only occurred in two joints (5%), resulting in fusion after reoperation. No other severe complications such as deep infection, intraoperative fracture, wound healing problems or regional dystrophy were observed.. The X-Fuse® implant may be a reliable alternative method for finger joint arthrodesis.

Topics: Adult; Aged; Alloys; Arthrodesis; Female; Finger Joint; Humans; Male; Middle Aged; Osteoarthritis; Outcome and Process Assessment, Health Care; Postoperative Complications; Prospective Studies; Prostheses and Implants; Radiography; Reoperation; Treatment Outcome

The purpose of this study was to examine the outcomes of a vascular hybrid polytetrafluoroethylene (PTFE) graft, provided with a nitinol-reinforced section (NRS) on one end, in hemodialysis vascular access placement.. A retrospective study was conducted including all the consecutive patients who underwent Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) implantation for hemodialysis access placement between October 2013 and November 2015. A propensity-matched control group was obtained from consecutive patients who underwent standard PTFE arteriovenous graft implantation between January 2010 and July 2013. The selection criteria were inadequate venous material for autogenous arteriovenous fistula placement, patent deep venous circulation, and vein diameter of 4 to 8.5 mm. The implantation technique involves the insertion of the NRS some centimeters into the target vein. Fluoroscopic guidance helps deploy the device in the desired landing zone (ie, position of the proximal end of the NRS), based on anatomic landmarks. Survival, functional patency rates, and complications were compared with a propensity-matched historical control group. Vein diameter, previous vascular access placement, and diabetes were tested as predictors of reintervention with a logistic regression analysis.. There were 32 patients (14 men; mean age, 69 ± 14 years) who received the GHVG graft. The historical control group included 43 patients. Technical success was 100%. The graft configuration was brachial-axillary (n = 22 [69%]), brachial-basilic loop (n = 5 [16%]), brachial-antecubital loop (n = 3 [9%]), axilloaxillary loop (n = 1 [3%]), and femoral-femoral loop (n = 1 [3%]). Mean NRS oversize was 20% ± 7% (range, 3%-34%; median, 19%). Perioperative complications requiring revision included acute limb ischemia treated with thrombectomy (n = 1 [3%]) and graft infection requiring explantation (n = 2 [6%]). Two patients (6%) died in the hospital of unrelated causes. The mean follow-up was 15 ± 11 months (range, 0-33 months; median, 15.5). The propensity-matched groups included 25 patients each. Survival estimates at 24 months for the GHVG and standard PTFE groups were 91% ± 6% and 82% ± 9% (P > .05), respectively. The 12-month patency estimates were as follows: functional primary patency, 66% ± 10% vs 51% ± 10% (P > .05); functional assisted primary patency, 75% ± 9% vs 51% ± 10% (P > .05); and functional secondary patency, 79% ± 9% vs 67% ± 10% (P > .05). Reduction in vein diameter was associated with reintervention.. The GHVG is a safe and effective alternative to standard PTFE in hemodialysis access surgery. Careful planning for the landing zone is advisable, especially for small outflow veins. Larger studies and randomized trials are needed to define the role for this device. A study including a greater number of centers experienced with this device is currently under way.

Topics: Aged; Aged, 80 and over; Alloys; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chi-Square Distribution; Female; Humans; Italy; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Phlebography; Polytetrafluoroethylene; Postoperative Complications; Propensity Score; Proportional Hazards Models; Prosthesis Design; Renal Dialysis; Reoperation; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency; Veins

The use of a self-expanding nitinol framed prosthesis (ReboundHRD. All patients who underwent a TEP-IHR using the ReboundHRD. In total, 69 TEP-IHR procedures were performed in 54 patients (15 bilateral hernias). No perioperative and 5 (9%) postoperative complications occurred, all graded Clavien-Dindo I-II. The median length of stay was 1 day (range 0-3), with 78% of the operations performed in an ambulatory setting. Median VAS score decreased from 3 (range 0-4) on the day of surgery to 1 (range 0-2) on day 7. Patients were completely pain-free at a median time of 5 (range 1-60) days. The majority (80.4%, 37/46) of the active patients went back to work within 2 weeks (maximum 6 weeks). At a median follow-up of 19 months (range 16-26 months), no recurrences occurred.. TEP-IHR using a self-expanding nitinol framed hernia repair device is a safe technique in longterm follow-up. The technique is associated with a low incidence of postoperative pain, a short hospital stay and quick return to normal activities.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Female; Hernia, Inguinal; Herniorrhaphy; Humans; Laparoscopy; Length of Stay; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Postoperative Complications; Prospective Studies; Recurrence; Surgical Mesh

Transcatheter embolization has evolved from the use of autologous clot as the embolic agent, to stainless-steel coils, to braided-nitinol vascular plugs. However, there are disadvantages to platinum and metal coils, including procedural time, radiation exposure, mass effect, risk of distal embolization, recanalization, imaging artifacts, and cost. Therefore, a large vessel-occluding device is needed to mitigate these current disadvantages. The Medusa Multi-Coil (MMC; EndoShape, Inc) is a Food and Drug Administration (FDA)-approved embolization device constructed primarily of radioopaque coils with synthetic fibers to promote thrombogenicity, and a unique delivery platform with both proximal and distal attachment to assist with precise placement. We report our experience with the endovascular treatment of internal iliac artery aneurysms using platinum coils vs MMCs.

Topics: Aged; Aged, 80 and over; Alloys; Comparative Effectiveness Research; Computed Tomography Angiography; Embolization, Therapeutic; Female; Humans; Iliac Aneurysm; Male; Platinum; Polymers; Postoperative Complications; Prosthesis Retention; Septal Occluder Device; Treatment Outcome

Topics: Alloys; Cold Temperature; Cutaneous Fistula; Device Removal; Enteral Nutrition; Gastric Fistula; Gastrostomy; Humans; Male; Middle Aged; Mycosis Fungoides; Postoperative Complications; Skin Neoplasms; Sodium Chloride; Surgical Instruments; Suture Techniques; Treatment Failure

To test the effectiveness of nitinol stents in restoring patency of pyeloureteral segment (PUS).. Endoureteral nitinol stents were used in 54 patients. The indications for stenting were recurrent strictures of upper urinary tract and ureteral tumor obstruction in 34 and 20 patients, respectively. In 9 (16.6%) of them, including 4 women and 5 men aged 28-65 years, stenting was performed for extensive recurrent PUS strictures. In 8 patients extensive strictures resulted from various surgical interventions on the PUS. In 2 patients, PUS narrowing was caused by open pyelolithotomy, in 6 patients by pyeloplasty, both open (4) and laparoscopic (2). A female patient with solitary right kidney and Bourneville - Pringle disease of the PUS received two metal prostheses.. In all cases, nitinol stents were adequately installed in PUS. Hematuria was observed in 1 patient. During the follow-up period of 8 to 60 months, the results of stenting were considered good in 6 (66.7%) and satisfactory in 2 (22.2%) patients. At month 10, 1 (11.1%) patient developed the stent obstruction by proliferative tissue and underwent ureteroscopy with recanalization of the nitinol stent. The patient with Bourneville - Pringle disease was found to have a stone formed in the renal pelvic end of the endoprosthesis; she underwent percutaneous nephrolithotripsy. In another patient a lower calyceal stone migrated and wedged into the proximal end of the stent. The stone was extracted using percutaneous nephroscopy.. Pyeloureteral stenting is an effective method to restore patency of the PUS in patients with extensive recurrent strictures. For adequate functioning of the stents, they need to be of optimal length and correctly installed.

Topics: Adult; Aged; Alloys; Female; Humans; Kidney Pelvis; Male; Middle Aged; Postoperative Complications; Stents; Treatment Outcome; Ureteral Obstruction; Urologic Surgical Procedures

To report the first clinical experience with a temporary implantable nitinol device (TIND; Medi-Tate(®) ) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).. In all, 32 patients with LUTS were enrolled in this prospective study, which was approved by our Institutional Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) of ≥10, maximum urinary flow rate (Qmax ) of ≤12 mL/s, and prostate volume of <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, using a rigid cystoscope. The device was removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien system), functional results and quality of life (QoL) were evaluated. Follow-up assessments were made at 3 and 6 weeks, and 3, 6 and 12 months postoperatively. The Student's t-test, analysis of variance (anova), Kruskall-Wallis test, and simple and multiple linear regression models were used in the statistical analyses.. The mean patient age was 69.4 years, the mean (standard deviation, sd) prostate volume was 29.5 (7.4) mL and the Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and QoL score was 3 (3-4). All the implantations were successful, with no intraoperative complications recorded. The mean operative time (sd) was 5.8 (2.5) min and the median (IQR) postoperative stay was 1 (1-2) day. All but one of the devices (96%) was removed 5 days at after implantation in an outpatient setting. Four complications (12.5%) were recorded, including urinary retention (one, 3.1%), transient incontinence due to device displacement (one, 3.1%), prostatic abscess (one, 3.1%), and urinary tract infection (one, 3.1%). Multiple regression analysis failed to identify any independent prognostic factor for complications. There were statistically significant differences in the IPSS, QoL score and Qmax when comparing pre- and postoperative results at every time point. After 12 months, the median (IQR) IPSS and QoL score were 9 (7-13) and 1 (1-2), respectively, and the mean (sd) Qmax was 12 (4.7) mL/s. The mean variations with respect to baseline conditions at the same time points were -45% for the IPSS and +67% for Qmax . At 12 months after surgery (last follow-up visit), no patients required medical therapy or surgical procedures for BPH.. TIND implantation is a feasible and safe minimally invasive option for the treatment of BPH-related LUTS. The functional results are encouraging and the treatment significantly improved patient QoL. Further studies are required to assess durability of TIND results and to optimise the indications of such a procedure.

Topics: Aged; Alloys; Cystoscopy; Feasibility Studies; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Minimally Invasive Surgical Procedures; Postoperative Complications; Prospective Studies; Prostatic Hyperplasia; Prostheses and Implants

The Supera stent (Abbott Laboratories, Abbott Park, Ill) has a unique biomimetic design allowing axial and longitudinal flexibility and fracture resistance. The aim of this retrospective study was to assess the midterm patency of Supera stents used to treat patients with superficial femoral and popliteal arterial disease by a single practice.. From April 2010 to December 2011, 53 patients and 59 limbs with symptomatic femoropopliteal lesions underwent angioplasty and stenting with the Supera stent. Five patients had no follow-up and were excluded. Demographics of the patients, radiographic images, morphologic features of the lesions, procedural reports, reinterventions, and follow-up clinical visit notes were reviewed. Primary patency was defined as clinical resolution of symptoms with no secondary interventions. Primary and secondary patency rates at 12, 24, and 36 months were estimated by Kaplan-Meier analysis.. A total of 48 patients (42 men, six women; 54 limbs; mean age, 64.3 years [range, 51-87]) received Supera stents and had at least one follow-up visit as part of their treatment for femoropopliteal disease. Primary indications for intervention included claudication, rest pain, and tissue loss, at rates of 54% (29 of 54), 26% (14 of 54), and 20% (11 of 54), respectively; 22% of lesions were TransAtlantic Inter-Society Consensus type A or B and 78% were type C or D. Mean lesion length was 24.0 cm (range, 3-51). Mean follow-up was 27.5 months (range, 1-45). The ankle-brachial index increased from 0.58 ± 0.20 preoperatively to 0.77 ± 0.18 postoperatively (P = .00004). Primary, primary assisted, and secondary patency rates at latest follow-up were 79.6%, 88.9%, and 92.3%, respectively. Cumulative primary patency rates by Kaplan-Meier analysis at 12, 24, and 36 months were 85.6%, 83.1%, and 76.7%, respectively. Secondary patency rates by Kaplan-Meier estimates at 12, 24, and 36 months were 93.8%, 93.8%, and 89.3%, respectively. No stent fractures were found at the time of any reinterventions. Long lesions >30 cm (n = 18) showed equivalent patency to lesions of 1 to 15 cm (n = 18) and lesions 15 to 30 cm in length (n = 18).. Our midterm results show that Supera stents are durable in treating femoropopliteal lesions, with notably high patency rates in patients with long lesion lengths.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Missouri; Peripheral Arterial Disease; Popliteal Artery; Postoperative Complications; Prosthesis Design; Retreatment; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the technical and clinical success of percutaneous superior mesenteric vein (SMV) stenting in symptomatic patients using self-expanding nitinol stents.. We retrospectively analyzed the technical and clinical success of percutaneous SMV stenting of 6 symptomatic patients (3 men, mean age 67 years, range 48-81 years). Stenosis of the SMV was caused by postoperative stricture (n=3), pancreas carcinoma (n=1) and pancreatitis (n=2). As a result of the stenosis, 3 patients had symptomatic ascites, 2 patients showed signs of mesenteric ischemia and 1 patient had recurrent gastrointestinal bleeding. Stenting was performed by a percutaneous transhepatic approach using self-expanding nitinol stents.. Stenting of the SMV was technically and clinically successful in all patients. No peri-interventional complications occurred. The stent diameters ranged from 6 to 14 mm. During the mean follow-up of 6 months (range, 2-10 months) 1 patient presented early stent occlusion 2 weeks after placement.. Stenting of a symptomatic SMV stenosis using self-expanding nitinol stents is feasible and clinically effective.

Topics: Aged; Aged, 80 and over; Alloys; Anticoagulants; Ascites; Catheterization; Constriction, Pathologic; Female; Follow-Up Studies; Heparin, Low-Molecular-Weight; Humans; Male; Mesenteric Ischemia; Mesenteric Vascular Occlusion; Mesenteric Veins; Middle Aged; Pancreatic Neoplasms; Pancreatitis; Portal Vein; Postoperative Complications; Punctures; Retrospective Studies; Self Expandable Metallic Stents; Treatment Outcome; Ultrasonography, Doppler, Color

This paper reports our experience with a new over-the-scope clip in the setting of recurrent bleeding and oesophageal fistula. We treated five patients with the over-the-scope Padlock Clip™. It is a nitinol ring, with six inner needles preassembled on an applicator cap, thumb press displaced by the Lock-It™ delivery system. The trigger wire is located alongside the shaft of the endoscope, and does not require the working channel. Three patients had recurrent bleeding lesions (bleeding rectal ulcer, post polypectomy delayed bleeding and duodenal Dieulafoy's lesion) and two patients had a persistent respiratory-esophageal fistula. In all patients a previous endoscopic attempt with standard techniques had been useless. All procedures were conducted under conscious sedation but for one patient that required general anaesthesia due to multiple comorbidities. We used one Padlock Clip™ for each patient in a single session. Simple suction was enough in all of our patients to obtain tissue adhesion to the instrument tip. A remarkably short application time was recorded for all cases (mean duration of the procedure: 8 min). We obtained technical and immediate clinical success for every patient. No major immediate, early or late (within 24 h, 7 d or 4 wk) adverse events were observed, over follow-up durations lasting a mean of 109.4 d. One patient, treated for duodenal bulb bleeding from a Dieulafoy's lesion, developed signs of mild pancreatitis 24 h after the procedure. The new over-the-scope Padlock Clip™ seems to be simple to use and effective in different clinical settings, particularly in "difficult" scenarios, like recurrent bleeding and respiratory-oesophageal fistulas.

Topics: Aged; Aged, 80 and over; Alloys; Equipment Design; Esophageal Fistula; Esophagoscopes; Esophagoscopy; Gastrointestinal Hemorrhage; Humans; Male; Middle Aged; Operative Time; Postoperative Complications; Surgical Instruments; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

The study objective was to evaluate the safety and efficacy of sutureless self-expanding nitinol stent-frame aortic valve prostheses made of equine pericardium implanted in patients with symptomatic aortic valve disease.. We performed a retrospective analysis of 120 patients (mean age, 76.7 ± 5.9 years) who underwent isolated aortic valve replacement or in combination with other cardiovascular procedures. Preoperatively, Society of Thoracic Surgeons score was determined. Transthoracic echocardiography and clinical outcome evaluation were performed at the time of discharge and at 6, 12, and 18 months follow-up, respectively.. A total of 71 of 120 patients underwent isolated sutureless aortic valve replacement (mean aortic crossclamp time, 37 ± 11 minutes; mean bypass time, 62 ± 18 minutes). Coronary bypass grafting was performed in 30 patients. Overall mean Society of Thoracic Surgeons score was 14.8% ± 10%. Thirty-day mortality rate was 6.7% overall and 1.4% in stand-alone procedures. During a mean follow-up of 313 days, 3 more deaths occurred. The reoperation rate was 4.2%. Mean and peak transvalvular pressure gradients were 9 mm Hg (4-13 mm Hg) and 14 mm Hg (8-22 mm Hg) at discharge, respectively. In 8 patients (6.7%), permanent pacemaker implantation was necessary. No thromboembolic events or bleedings related to the bioprosthesis were observed.. In this large single-center experience with sutureless aortic valve replacement, the surgical procedure is shown to be safe and time-saving. In view of the excellent hemodynamic results and shortening of aortic crossclamp and bypass times, we notice advantages especially in high-risk patients. Minimally invasive access seems to be facilitated. The long-term durability of this prosthesis has yet to be determined.

Topics: Aged; Aged, 80 and over; Alloys; Animals; Aortic Valve; Bioprosthesis; Coronary Artery Bypass; Female; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemodynamics; Horses; Humans; Male; Middle Aged; Pericardium; Postoperative Complications; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Suture Techniques; Time Factors; Treatment Outcome; Ultrasonography

To evaluate the long-term clinical outcomes and the negative predictors after the deployment of double-layered stents in malignant esophageal strictures.. This is a single-center study of patients who received a double-layered covered stent for the palliation of dysphagia due to malignant esophageal strictures in a 3-year period. 56 patients fulfilled the inclusion criteria. The study's primary end points were technical success, dysphagia improvement, stent migration, and complication rates; secondary end points were the stent's primary patency and overall survival. Cox regression analysis was used to adjust for confounding variables and to identify predictors of survival outcomes.. Technical success was 95%. Median dysphagia score improved significantly after stenting (p < 0.0001). Stent migration rate was 7.1% and occurred exclusively in the group of patients who received chemoradiotherapy (p < 0.01). The median stent patency was 87 days (range 5-444 days). Dysphagia reoccurred in 39.3% and was successfully managed with restenting in 98.2%. The median survival was 127 days (range 15-1480 days). Chemoradiotherapy and baseline histology did not influence survival outcomes. Survival was adversely affected by metastases (p = 0.005) and poor oral intake (p = 0.048). Patient survival was improved by repeat stenting in case of tissue overgrowth (p = 0.06).. The device is safe and effective for the treatment of patients with dysphagia due to esophageal cancer. Migration rate is zero for patients who do not receive chemoradiotherapy. Reintervention when required is a positive survival predictor.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Chemoradiotherapy; Deglutition Disorders; Esophageal Neoplasms; Female; Fluoroscopy; Foreign-Body Migration; Humans; Male; Middle Aged; Palliative Care; Postoperative Complications; Predictive Value of Tests; Prosthesis Design; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Stents; Survival Rate; Treatment Outcome

A study was designed to describe a novel approach to the treatment of tracheal collapse (TC) in dogs using self-expandable nitinol stents. Medical records were reviewed retrospectively for 26 client owned dogs in which nitinol stents were deployed. The entire length of trachea was supported independently of the extent of TC. Two overlapping stents were used instead of one in cases where one stent was not spanning the entire trachea adequately. The diameter of the cranial radiolucent portion of trachea, just behind the cricoid cartilage, was measured as a specific landmark to select the appropriate size of the stent. Two self-expandable nitinol stents were inserted in 9 of 26 dogs; the trachea in the rest of the cases was supported with only one stent. A follow up tracheoscopy was performed in 10 of 26 cases with recurrent clinical signs. Secondary tracheal stenosis in these cases was caused by stent fracture, granuloma or excessive stent shortening. Additional stents were placed successfully to expand the stenotic lumen. A support of the entire trachea may decrease risk of nitinol fracture at the end of the implant. Long term clinical improvement (25 of 26 dogs, 96 %) is comparable with the results of other studies.. Bei 26 Hunden wurde ein Tracheakollaps mit selbst-expandierenden Nitinol Stents behandelt und die Ergebnisse retrospektiv evaluiert. Die Trachea wurde über ihre gesamte Länge unterstützt unabhängig von der Lokalisation des Kollapses. Falls kein Stent mit ausreichender Länge zur Verfügung stand, wurden zwei überlappende Sents gesetzt, um die gesamte Länge der Trachea zu expandieren. Der Durchmesser des Stents wurde anhand des Durchmesseres der Trachea unmittelbar kaudal des Cricoids gewählt. Bei 9 der 26 Patienten wurden zwei überlappende Stents gesetzt. Bei allen anderen Patienten konnte die gesamte Länge der Trachea mit einem Stent unterstützt werden. Bei 10 Patienten wurde eine «second look» Tracheoskopie durchgeführt, da sich erneut klinische Zeichen eines Tracheakollapses zeigten. Eine sekundäre Tracheastenose wurde konstatiert als Folge einer Stentfraktur, Granulation oder einer exzessiven Stentverkürzung. Ein zuätzlicher Stent wurde erfolgreich gesetzt um das eingeengte Lumen zu expandieren. Die Unterstützung der Trachea über die gesamte Länge kann die Bruchgefahr des Nitinols am Ende des Stents vermindern. Die langfristige Verbesserung des klinischen Zustandes in 25 von 26 Fällen (96 %) ist mit Resultaten anderer Studien vergleichbar.. Des stents auto-expansifs en nitinol ont été utilisés pour traiter 26 chiens atteints de collapsus trachéal et les résultats ont été évalués rétrospectivement. La trachée a été renforcée sur toute sa longueur, indépendamment de la localisation du collapsus. Si aucun stent d'une longueur suffisante n'était disponible, on a utilisé deux stents se recouvrant pour dilater l'ensemble de la trachée. Le diamètre du stent a été choisi sur la base du diamètre de la trachée directement caudalement au cricoïde. Chez 9 des 26 patients, on a posé deux stents se recouvrant. Chez tous les autres patients, il a été possible de renforcer la trachée sur toute sa longueur au moyen d'un seul stent. On a procédé chez dix patients à une seconde trachéoscopie, car de nouveaux signes de collapsus trachéal étaient apparus. Une sténose trachéale secondaire a été constatée suite à une fracture du stent, à du tissus de granulation ou à un raccourcissement excessif du stent. Un stent supplémentaire a été placé avec succès, pour dilater la lumière trachéale rétrécie. Le renforcement de la trachée sur toute sa longueur peut diminuer le risque de fracture du stent à son extrémité. L'amélioration clinique à long terme obtenue chez 25 des 26 patients (96 %) est comparable aux résultats d'autres études.. Sono stati retrospettivamente valutati i risultati del trattamento con stent in nitinol autoespandente su 26 cani affetti da collasso tracheale. La trachea è stata sostenuta sulla sua intera lunghezza, indipendentemente dalla posizione del collasso. Nel caso non fosse disponibile uno stent sufficientemente lungo, sono stati usati due stent sovrapposti per giungere all'intera lunghezza della trachea. Il diametro dello stent è stato scelto sulla base del diametro della parte caudale della trachea immediata della cricoide. In 9 pazienti su 26 sono stati usati due stent sovrapposti. Per tutti gli altri pazienti, la lunghezza totale della trachea era supportata da una stent. In 10 pazienti è stata eseguita una tracheoscopia «second look» che ha rilevato di nuovo segni clinici di un collasso tracheale. Una stenosi tracheale secondaria è stata costatata come risultato di una frattura dello stent, granulazione o eccessivo accorciamento dello stent. Uno stent supplementare è stato collocato con successo per espandere il lume ristretto. Il sostegno della trachea lungo l'intera lunghezza può ridurre il rischio di frattura del nitinol alla fine dello stent. Il miglioramento clinico a lungo termine in 25 su 26 casi (96 %) è comparabile con i risultati di altri studi.

Topics: Alloys; Animals; Cough; Dog Diseases; Dogs; Female; Male; Postoperative Complications; Stents; Tracheal Stenosis

Treatment with lung volume reduction coils (LVRC) may be effective in patients with severe heterogeneous emphysema and incomplete fissures.. We hypothesized that LVRC placement improves pulmonary function, exercise tolerance and quality of life in these patients.. Twenty-six patients with chronic obstructive pulmonary disease (COPD), 13 males and 13 females, aged 66 ± 8 years with heterogeneous emphysema and incomplete fissures were included in this retrospective analysis. The coils were implanted unilaterally in the upper or lower lobe. Patients were followed up at 30, 90 and 180 days after treatment and changes in pulmonary function test and 6-minute-walk-test (6MWT) values as well as scores for the modified Medical Research Council (mMRC) dyspnea scale and the St. George's Respiratory Questionnaire (SGRQ) were recorded.. FEV1 improved significantly at 90 days and tended to decrease at the 180-day follow-up (0.67 ± 0.17 vs. 0.78 ± 0.25 vs. 0.73 ± 0.21 liters, respectively, p < 0.001). The 6MWT score had improved significantly at 90 days and had tended to decrease at the 180-day follow-up (216 ± 107 vs. 262 ± 97 vs. 262 ± 112 m, respectively, p = 0.001). SGRQ was significantly improved at 90 days. Multivariate analysis showed that worse 6MWT performance at baseline was independently associated with a greater improvement in 6MWT at the 90-day follow-up. The total complication rate was 54% (n = 14) and included light hemorrhage in 6 patients, COPD exacerbation in 6, pneumothorax in 1 and both COPD exacerbation and pneumothorax in 1 patient.. This is the first study to show that LVRC in patients with heterogeneous emphysema and incomplete fissures improves exercise capacity, quality of life and lung function up to 90 days after the intervention. Further studies are needed to assess the long-term effects of LVRC in these patients.

Topics: Aged; Alloys; Bronchoscopy; Exercise Tolerance; Female; Follow-Up Studies; Forced Expiratory Volume; Germany; Humans; Male; Middle Aged; Postoperative Complications; Pulmonary Emphysema; Quality of Life; Retrospective Studies

Retrospective case series study.. To clarify the results of a long-term (30 yr) follow-up study of artificial disk replacement (ADR) for the treatment of cervical disk disease.. The use of the ADR procedure has become widespread during the past 10 years. Its purpose is to preserve motion of the functional spinal unit. However, the long-term results are unknown.. Thirty-seven patients underwent ADR between 1980 and 1985 in the Department of Orthopedic Surgery, Changzheng Hospital. Twenty-one patients, who had a complete follow-up, underwent radiographical evaluation to detect heterotopic ossification, segmental range of motion, and adjacent segmental changes. In addition, patients were asked to complete preoperative and postoperative visual analogue scale, neck disability index, and 36-Item Short Form Health Survey questionnaires for evaluation of neurological function and pain severity. The occurrence of adverse events and reoperations was examined and these parameters served as indicators of device safety.. Twenty-one patients had a complete follow-up average of 30 years (range, 28-33 yr). The 21 patients reported improvement of the preoperative neurological symptoms. At the last follow-up, the motion was preserved in 19 of the 26 (73%) segments. None of the patients presented with symptomatic adjacent segment degeneration. Nineteen of the 21 (90%) patients presented heterotopic ossification, but none of them underwent reoperation correlated with heterotopic ossification. No device-related adverse events were recorded.. Artificial disk replacement to treat degenerative cervical disk disorders can preserve the motion of the spinal unit in young patients, which fulfills the original purpose of its design. We consider this procedure is worth applying in such a population. However, whether this procedure can prevent adjacent segment degeneration will require further investigation.. 2.

Topics: Adult; Alloys; Cervical Vertebrae; Decompression, Surgical; Equipment Safety; Female; Follow-Up Studies; Humans; Intervertebral Disc Degeneration; Male; Middle Aged; Neck Pain; Ossification, Heterotopic; Postoperative Complications; Radiculopathy; Radiography; Range of Motion, Articular; Reoperation; Retrospective Studies; Severity of Illness Index; Spinal Cord Compression; Surveys and Questionnaires; Total Disc Replacement; Treatment Outcome

The aim of this paper was to report our preliminary experience in outcome, safety and mid-term results in the treatment of thoracoabdominal aortic aneurysms (TAAA) with a novel multibranchstentgraft (E-xtra DESIGN ENGINEERING, JOTEC, Germany).. Eight patients (mean age 66 years, 2 female) with TAAA (Crawford type I: 2 cases, type III: 3 cases, type IV: 3 cases), mean aneurysm diameter 61 mm, growth over 5 mm per year were treated. Implantation was performed under general anesthesia and surgical exposition of the common femoral artery. Brachial access was percutaneous in 5/8 patients. Balloon-expandable (Advanta V12) bridging stent-grafts were employed and lined with self-expanding nitinol stents. All patients except type IV TAAA received a spinal drainage catheter.. The device was successfully deployed in 8/8 patients. 29/32 visceral branches were engaged. One stenosed celiac trunk was left untreated without further consequences, two renal arteries which could not be cannulated were revascularized with iliorenal bypass. One patient needed surgical revision of groin hematoma, one patient suffered from permanent protopathic sensory deficit. No renal complications occurred. Since the primary implantation was deliberately kept short and amount of contrast agent was minimised, four patients needed a secondary percutaneous procedure (Palmaz stent implantation for type I endoleak, re-PTA or additional bridging stent-graft implantation for type III endoleak). The assisted primary success rate was 8/8. Mean follow-up was 18 months. Success was stable in 7/8 patients, one patient shows type V endoleak with 5mm sac expansion. No mortality or complication occurred during follow-up.. The JOTEC E-xtra DESIGN ENGINEERING multibranch stent-graft is a promising new candidate for endovascular TAAA treatment with sufficient safety and efficacy. Its short delivery time suggests its use in patients with rapid aneurysm growth or high anxiety.

Topics: Aged; Alloys; Aortic Aneurysm, Thoracic; Aortography; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Female; Humans; Male; Middle Aged; Postoperative Complications; Prosthesis Design; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vascular Patency

Primary patency (PP) in trials assessing superficial femoral artery (SFA) stenting is defined as a combination of vessel patency assessed by duplex ultrasound (DUS) at the 12-month follow-up exam and freedom from revascularization of the index vessel through 12 months of follow-up. Loss of PP is thus more likely to be identified during the mandated DUS assessment. Moreover, DUS is performed within a prespecified allowed window of time for the visit that exceeds 12 months (typically by 30 days). Therefore, the time frame for detecting patency with DUS exceeds the time frame in which revascularization is captured. Survival analyses are often applied to present estimates of freedom from loss of PP, but there are no clear guidelines as to the correct method for presenting these analyses in reports from clinical trials. We aimed to analyze the implications of applying different methods in assessing freedom from loss of PP in studies assessing stenting for diseased SFA.. Data were simulated based on existing available results from SFA bare-metal nitinol stent trials published between 2009 and 2013 and summarized in a previous analysis (STROLL, SUPERB, RESILIENT, DURABILITY I, DURABILTY II, COMPLETE SFA). Six different approaches to Kaplan Meier (KM) analyses were applied based on entry criteria into and time frame of the KM model.. Six KM estimates of PP were generated for each of the 10,000 simulated datasets. The average exact PP rate was 70.6%, while the average estimated KM rates using the six different methods ranged between 68.0% and 81.9%.. KM estimates of PP vary substantially according to the methods employed. These may lead to misrepresentation of results from clinical trials. The development of a unified approach is advocated.

Topics: Alloys; Arterial Occlusive Diseases; Bias; Clinical Trials as Topic; Equipment Failure; Femoral Artery; Follow-Up Studies; Humans; Postoperative Complications; Recurrence; Stents; Survival Analysis; Treatment Failure; Vascular Patency

To evaluate the differential effects of endograft fabric types on pulse wave velocity (PWV), a valid, clinically feasible marker of arterial stiffness, in patients undergoing endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs).. As part of a registered study (ClinicalTrials.gov identifier NCT00636766), 118 consecutive men (mean age 71 ± 8 years) with AAA undergoing elective EVAR were divided into groups according to the type of fabric in the implanted endografts: 46 had polytetrafluoroethylene (PTFE)-covered stent-grafts and 72 received stent-grafts covered with polyester fabric. Patients with Marfan syndrome, collagen-related disorders, and end-stage renal failure were excluded. PWV, clinical characteristics (comorbidities, body mass index, blood pressure, lipids, and glucose profile), novel biomarkers [interleukin (IL)-6, IL-8, IL-10, and osteoprotegerin (OPG)] were determined at baseline and prospectively after 12 months.. At baseline, standard multiple regression analysis revealed the independent association of mean blood pressure, OPG, and AAA diameter with PWV after adjustment for age (R(2)=0.729, p=0.036). At follow-up, serum levels of both IL-8 and IL-10 were significantly increased, while OPG decreased in both groups (p<0.05). However, between-group comparison revealed a more adverse effect of polyester covered endografts on serum IL-8 (p<0.001) and OPG (p=0.048) levels. At the same time, PWV was considerably increased in both polyester (+4.12±0.33 m/s, p<0.001) and PTFE (+2.82 ± 0.25 m/s, p=0.003) groups; the effect was more pronounced in the former group (p=0.033). In multivariate analysis, the polyester endograft type emerged as an independent determinant of PWV change after EVAR (R(2)=0.460, p=0.040).. Both endograft types increased PWV, while recipients of polyester covered stent-grafts showed greater PWV elevation. Further investigation will clarify the inflammatory response and the differential clinical impact of endograft types.

Topics: Aged; Alloys; Aortic Aneurysm, Abdominal; Aortography; Biomarkers; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Elective Surgical Procedures; Endovascular Procedures; Female; Greece; Humans; Interleukin-10; Male; Middle Aged; Osteoprotegerin; Polyesters; Polytetrafluoroethylene; Postoperative Complications; Prospective Studies; Prosthesis Design; Pulse Wave Analysis; Risk Factors; Stents; Tomography, X-Ray Computed; Treatment Outcome; Vascular Stiffness

Topics: Alloys; Cholestasis; Colonic Diseases; Constriction, Pathologic; Duodenal Obstruction; Equipment Design; Esophageal Stenosis; Foreign-Body Migration; Humans; Intestinal Atresia; Postoperative Complications; Stents

Atrial septal defect (ASD) is a common congenital heart disease in adults. Amplatzer septal occluder is one of the most common devices used for transcatheter closure due to its high success rate and ease to implant. Cocoon atrial septal occluder is a new nitinol-based device, its shape resembles Amplatzer septal occluder but coated with platinum to prevent nickel release. Little is known about clinical outcomes of large ASD closure using Cocoon atrial septal occluder. To review our experience in closure of secundum ASD in adults by Cocoon septal occluder and to compare the clinical outcomes and results of the patients who had ASD closure with a device greater than or equal to 30 mm and less than 30 mm.. Between November 2005 and October 2008, 63 consecutive patients underwent transesophageal echocardiography (TEE)--guided transcatheter closure of secundum ASD. The patients were divided into two groups (Groups' 1 and 2) according to device diameter that is greater than or equal to 30 mm (n = 31) and less than 30 mm (n = 32), respectively. Clinical outcomes, complications, and transthoracic echocardiography (TTE) before hospital discharge, one to three months, and one-year were analyzed.. Device implantations were successful in 27 patients (87.1%) in group 1 and 31 patients (96.9%) in group 2 (p = 0.196). The maximum size of secundum ASD in group 1 determined by TTE, TEE, and balloon sizing diameter (BSD) were 22.6 +/- 5.0 mm (range 15-32), 28.1 +/- 4.8 mm (range 19-39), and 31 +/- 3.5 mm (range 23-38) respectively. The maximum size of secundum ASD in group 2 determined by TTE, TEE, and BSD were 19.7 +/- 4.4 mm (range 12-31), 20.4 +/- 3.4 mm (range 13-26), and 23.1 +/- 2.9 mm (range 15-30) respectively. The mean device size in groups 1 and 2 were 33.5 +/- 3.1 mm and 24.6 +/- 3.3 mm, respectively. Four patients (12.9%) in group 1 had unsuccessful implantations. All of them were in the first 15 cases of using large device and two of them had device embolization requiring surgical removal. One patient (3.1%) in group 2 had an unsuccessful implantation and had device embolization requiring surgical removal. The patients in both groups gradually improved in clinical symptoms with decreased RVsystolic pressure and decreased RV size with complete ASD closure at one year. Transcatheter closure of large secundum ASD by Cocoon septal occluder is feasible with hemodynamic benefit. However complication rates are higher with large ASD closure with device size greater than or equal to 30 mm especially during the early "learning curve" period. With experience, the complication rate declines and the success rate is no different from the group with smaller device size.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Cardiac Catheterization; Echocardiography, Transesophageal; Feasibility Studies; Female; Heart Septal Defects, Atrial; Humans; Male; Middle Aged; Postoperative Complications; Prosthesis Design; Septal Occluder Device; Treatment Outcome

This retrospective study estimated the efficacy and safety of the WallFlex duodenal stent for malignant gastric outlet obstruction (GOO) in Japan.. Forty-two consecutive patients with symptomatic malignant GOO were treated using WallFlex duodenal stents between January 2010 and October 2010.. The technical and clinical success rates were 100% and 83.3%, respectively.The median gastric outlet obstruction scoring system increased significantly, from 0 to 2, after stent placement (P < 0.01).The median survival time was 3.3 months (95% confidence interval (CI), 1.8-6.0 months), and the median eating period was 3.0 months (95% CI, 1.1-4.3 months). Re-intervention was required in 11 patients (26.2%). The complication rate was 26.2%. The major complication was stent occlusion (23.8%) by tumor ingrowth, which occurred in nine (21.4%) patients, and tumor overgrowth, which occurred in one (2.4%) patient. Stentmigration, perforation, and food impaction without stent occlusion were not observed.The median survival time of the patients with stent occlusion was 11.7 months (95% CI, 2.2 months - not reached), and the median stent patency of these patients was 4.0 months (95% CI, 0.8-4.7 months).These patients were successfully treated with additional stent insertion using a stent-in-stent procedure.. Duodenal stent placement using a WallFlex duodenal stent was safe and effective for managing malignant GOO.This stent is an uncovered metallic stent, and the major problem was stent occlusion due to tumor ingrowth. However, the occluded stent could be corrected by inserting an additional duodenal stent.

Topics: Aged; Aged, 80 and over; Alloys; Cholangiopancreatography, Endoscopic Retrograde; Contrast Media; Duodenum; Female; Fluoroscopy; Gastric Outlet Obstruction; Gastroscopy; Humans; Japan; Male; Middle Aged; Postoperative Complications; Prosthesis Design; Retrospective Studies; Statistics, Nonparametric; Stents; Stomach Neoplasms; Survival Rate; Treatment Outcome

Carotid artery stenting (CAS) has grown as a possible alternative for the treatment of extracranial cerebrovascular disease in the past decade. A preexisting contralateral carotid artery occlusion has been described as a risk factor for inferior outcomes after carotid endarterectomy, but its impact on CAS outcomes is less understood.. A retrospective review of 417 CAS procedures performed between May 2001 and July 2010 at a single center using self-expanding nitinol stents and mechanical embolic protection devices was conducted. Patients were divided into two groups, those with a preexisting contralateral carotid occlusion (group A, n = 39) versus those without a contralateral occlusion (group B, n = 378). Patient demographics and comorbidities as well as 30-day and late death, stroke, and myocardial infarction (MI) rates were analyzed. Mean follow-up was 4 years (range: 0-9.4 years).. Overall, mean age of the 314 men and 103 women was 70.5 years. In group A, there were two (5.1%) octogenarians and nine patients (23.1%) with symptomatic disease as compared with group B with 53 (14%) octogenarians and 121 (32%) patients with symptomatic disease. The overall 30-day death, stroke, and MI rates were 0.5%, 1.9%, and 0.7%, respectively. When comparing group A with group B, these results were not significantly different: death (0% vs. 0.5%), stroke (2.6% vs. 1.9%), and MI (0% vs. 0.8%). Long-term outcomes for groups A and B were also not significantly different: death (25.6% vs. 22.2%), stroke (5.3% vs. 3.4%), and MI (15.4% vs. 14%) (p = nonsignificant).. A preexisting contralateral carotid artery occlusion does not seem to adversely impact CAS outcomes.

Topics: Aged; Alloys; Angiography; Blood Vessel Prosthesis Implantation; Carotid Stenosis; Female; Follow-Up Studies; Humans; Male; Neural Tube Defects; Postoperative Complications; Retrospective Studies; Risk Factors; Stents; Stroke; Survival Rate; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States

To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self-expanding aortic bioprosthesis.. TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post-procedural conduction abnormalities and frequent need for PPM.. Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12-lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge.. Patients exhibited high-risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32-0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03-1.83).. Conduction abnormalities are frequently observed after TAVI with self-expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness.

Topics: Aged; Aged, 80 and over; Alloys; Analysis of Variance; Aortic Valve Stenosis; Bioprosthesis; Cardiac Catheterization; Cardiac Pacing, Artificial; Cohort Studies; Echocardiography, Doppler; Electrocardiography; Female; Follow-Up Studies; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Italy; Logistic Models; Male; Minimally Invasive Surgical Procedures; Multivariate Analysis; Postoperative Complications; Predictive Value of Tests; Preoperative Care; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Survival Rate; Time Factors; Treatment Outcome

Although endovascular stent treatment is increasingly used in infrainguinal atherosclerotic occlusive disease, outcome with focus on gender differences has not been reported in detail.. One hundred and twelve consecutive patients (67 [60%]) women, undergoing endovascular nitinol stent treatment of atherosclerotic lesions in the femoropopliteal segment were analysed concerning improvement in ankle brachial index (ABI), reinterventions, complications, amputation and survival rates up to 12 months after intervention. Risk factors for amputation and death were analyzed with logistic regression.. At presentation, women showed critical limb ischemia (CLI) more often than men (87% vs. 58 %; P = 0.001). After 12 months ABI had improved (from 0.40 ± 0.26 at baseline to 0.86 ± 0.22 after 12 months, P < 0.001), but 16 patients (15%) had been amputated and 27 patients (24 %) had died. After adjustment for age, diabetes mellitus and smoking, female gender was an independent risk factor for amputation (OR 9.0; 95% CI 1.1-76.5; P = 0.045).. Stent treatment of lesions in the femoropopliteal segment had favourable effects on ABI and limb salvage. Treated women more often had CLI and ran a higher risk for amputation within 12 months than men. This might reflect failure of clinicians to adequately appreciate symptoms of atherosclerotic leg artery disease in women.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty; Ankle Brachial Index; Female; Femoral Artery; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Postoperative Complications; Reoperation; Risk Factors; Sex Factors; Stents; Survival Rate; Treatment Outcome

Topics: Alloys; Anastomosis, Surgical; Esophageal Fistula; Esophagus; Gastroscopy; Humans; Male; Middle Aged; Postoperative Complications; Prostheses and Implants; Reoperation; Stents; Stomach; Stomach Neoplasms; Surgical Instruments; Sutures

We investigated the safety, feasibility and efficacy of the Occlutech devices for patent foramen ovale (PFO) and atrial septal defect (ASD) closure in a prospective trial.. The retention discs of the PFO device (23 x 25 mm, 27 x 30 mm) are connected by a 3 mm waist in the center with only one right atrial side central pin. The left atrial disc is produced either with a single or double flat layer, which allows a significant reduction of meshwork material. The ASD occluder (6-40 mm, 3 mm increments) has only one central pin on the right atrial side. Indications for closure included cryptogenic stroke with evidence of a PFO on transesophageal echocardiography (TEE) or an ASD II. The devices were implanted in 29 patients with PFO and in 12 patients with ASD II (fluoroscopy and TEE). An echocardiographic follow-up examination was performed after 1, 2 and 6 months.. The devices were successfully implanted in all 41 patients. There were no periprocedural complications. One patient with ASD II died of recurrent myocardial infarction without evidence of cardioembolic origin. TEE studies showed a residual shunt in 11.2% after 60 days in patients with PFO and a left-to-right shunt in 9.1% of the remaining patients with ASD II. After 180 days only 1 patient with PFO had a right-to-left shunt (3.7%). A residual shunt in the patients with ASD was not observed.. The novel Occlutech devices appear to be safe, feasible and effective for PFO and ASD closure, with a significant reduction of the meshwork and absence of left atrial central pin.

Topics: Adult; Aged; Alloys; Animals; Echocardiography; Echocardiography, Transesophageal; Equipment Failure Analysis; Equipment Safety; Feasibility Studies; Female; Foramen Ovale, Patent; Foreign-Body Reaction; Heart Septal Defects, Atrial; Humans; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Prosthesis Design; Septal Occluder Device; Swine; Swine, Miniature

Topics: Aged; Alloys; Echocardiography; Equipment Failure Analysis; Equipment Safety; Female; Foramen Ovale, Patent; Foreign-Body Reaction; Heart Septal Defects, Atrial; Humans; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Prosthesis Design; Septal Occluder Device

The recently released Amplatzer Ductal Occluder 2 (ADO2) was designed specifically for use in small children with moderate-sized shunts and larger children with small patent ductus arterioses (PDA). We report our initial experience with this device.. Patients referred with PDA underwent occlusion using the ADO2. This is a fabric-free nitinol wire 3-lobed device. All cases underwent pre-, intra- and post-procedural echocardiography, with follow up at 1 day and one month. Device sizing for device waist diameter and width was based on aortography.. Seven patients with a median age of 3 years and 4 months (range 7 months-23 years) and a median weight of 12 kg (range 7-56 kg) underwent successful PDA closure. The median ductal diameter was 1.5 mm (range 0.4-4 mm). Both transpulmonary (6/7) and transaortic approaches (1/7) were used. Recurrent patency at 24 hours with complete occlusion at 1 month was noted in a single case. A specific device-based length assessment applied resulted in shorter than recommended device selection.. The ADO2 broadens the spectrum of PDAs that can be simply and safely treated with devices. The flexibility of the articulations, coupled with the alternative deployment techniques, allow for increased ease of treatment in a range of small patients and specific ductal anatomies. An alternative device-specific length measurement of the duct length may result in less retaining disc protrusion. Broader experience is required to further delineate device and patient selection as well as to document its long-term efficacy and safety.

Topics: Alloys; Child; Child, Preschool; Ductus Arteriosus, Patent; Equipment Failure; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Postoperative Complications; Prosthesis Design; Prosthesis Fitting; Recurrence; Retreatment; Septal Occluder Device; Ultrasonography; Young Adult

Gastrointestinal anastomosis is a crucial step in many operative procedures, and responsible for a major portion of early and late post-operative complications. In order to improve on the results of current tools to perform an anastomosis, such as sutures and staplers, new concepts are being developed. One of these concepts is compression anastomosis. Compression anastomosis has been tried in the past but did not become popular mostly because of technical reasons. Recently, trials to accomplish compression anastomosis using Nitinol devices were conducted. Two devices were made and tested in the past three years: a side-to-side device and an end-to-end device. The common principle in both devices is the compression of two bowel loops through the constant pressure of a Nitinol device, thus producing a dual process of necrosis and healing until the lumens of both bowels fuse, and the device falls into the lumen and is excreted. Both devices have been tested in animals and humans, with encouraging results. In animals, the anastomoses were shown to demonstrate minimal inflammation and no foreign body reaction, with perfect healing of the mucosa. The side-to-side device was tested in over 500 human patients, and the end-to-end device is currently used in a large, multi-centric human trial.

Topics: Alloys; Anastomosis, Surgical; Animals; Clinical Trials as Topic; Digestive System Surgical Procedures; Elasticity; Equipment Design; Foreign-Body Reaction; Humans; Inflammation; Postoperative Complications; Pressure; Suture Techniques

Topics: Adult; Aged; Alloys; Audiometry, Pure-Tone; Auditory Threshold; Bone Conduction; Equipment Design; Female; Follow-Up Studies; Humans; Lasers, Solid-State; Male; Middle Aged; Ossicular Prosthesis; Otosclerosis; Otoscopes; Postoperative Complications; Prosthesis Design; Prosthesis Fitting; Stapes Surgery

Malignant biliary obstruction may be caused by cholangiocarcinoma and other nonbiliary carcinomas. At the time of diagnosis, 90% of patients with malignant obstructive jaundice may benefit from palliative treatment only. The objective of palliation is to relieve jaundice-related symptoms, prevent cholangitis, prolong survival, and improve quality of life. Percutaneous transhepatic biliary stenting is a well-established procedure used in patients with malignant obstruction of intra- and extrahepatic bile ducts. Twelve patients (9 women, 3 men; mean age, 68 years; range, 44-88 years) with inoperable malignant biliary obstruction were selected for percutaneous transhepatic biliary stenting with metallic stents in the period from January to December 2007. Technical and clinical success rate in this patient series was 83% and 80%, respectively. Minor and major complications occurred in 17% and 8% of cases, respectively, which is in the range reported by the others. This is our first experience of percutaneous transhepatic biliary stenting at the Hospital of Kaunas University of Medicine and, to our knowledge, the first reported patient series in Lithuania. These first results encourage expanding effective palliation by the employment of the percutaneous transhepatic biliary stenting in patients with nonresectable malignant biliary obstruction or in case of a recurrent disease after curative surgery. The cost effectiveness of percutaneous transhepatic biliary stenting against percutaneous transhepatic biliary drainage has yet to be evaluated in a prospective manner. However, immediate clinical benefits and positive short-term outcomes are unequivocal.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Bile Duct Neoplasms; Bile Ducts, Intrahepatic; Cholangiocarcinoma; Cholestasis; Drainage; Endoscopy; Female; Follow-Up Studies; Gallbladder Neoplasms; Humans; Jaundice, Obstructive; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Patient Selection; Postoperative Complications; Quality of Life; Radiography; Stainless Steel; Stents; Time Factors; Treatment Outcome

To evaluate the efficacy and safety of an expanded polytetrafluoroethylene-fluorinated ethylene-propylene (ePTFE/FEP)-covered metallic stent in the management of malignant biliary obstruction. Eighty consecutive patients with malignant common bile duct strictures were treated by placement of 83 covered metallic stents. The stent-graft consists of an inner ePTFE/FEP lining and an outer supporting structure of nitinol wire. Clinical evaluation, assessment of serum bilirubin and liver enzyme levels were analyzed before biliary drainage, before stent-graft placement and during the follow-up period at 1, 3, 6, 9 and 12 months. Technical success was obtained in all cases. After a mean follow-up of 6.9+/-4.63 months, the 30-day mortality rate was 14.2%. Survival rates were 40% and 20.2% at 6 and 12 months, respectively. Stent-graft patency rates were 95.5%, 92.6% and 85.7% at 3, 6 and 12 months, respectively. Complications occurred in five patients (6.4%); among these, acute cholecystitis was observed in three patients (3.8%). A stent-graft occlusion rate of 9% was observed. The percentage of patients undergoing lifetime palliation (91%) and the midterm patency rate suggest that placement of this ePTFE/FEP-covered stent-graft is safe and highly effective in achieving biliary drainage in patients with malignant strictures of the common bile duct.

Topics: Aged; Aged, 80 and over; Alloys; Antibiotic Prophylaxis; Cholangiography; Cholestasis; Coated Materials, Biocompatible; Common Bile Duct Neoplasms; Constriction, Pathologic; Female; Humans; Liver Function Tests; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Polytetrafluoroethylene; Postoperative Complications; Prosthesis Design; Stents; Survival Rate

Topics: Aged; Alloys; Balloon Occlusion; Female; Heart Septal Defects, Atrial; Humans; Mitral Valve Insufficiency; Platelet Aggregation Inhibitors; Postoperative Complications; Surgical Mesh; Treatment Outcome; Wound Healing

Topics: Adult; Aged; Alloys; Bronchial Fistula; Bronchoscopy; Empyema, Pleural; Female; Humans; Male; Middle Aged; Pleural Diseases; Pneumonectomy; Postoperative Complications; Prosthesis Design; Respiratory Tract Fistula; Treatment Outcome

The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent.. This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions > or = 4.0 mm and < or = 7.0 mm in diameter, and > or = 40 mm and < or = 200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents.. Mean target lesion length was 108 +/- 44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6 +/- 0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9 +/- 15.5 % (range 41.3 to 100) to 19.0 +/- 8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a > or = 30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63 +/- 0.20 to 0.94 +/- 0.17 and from 0.44 +/- 0.23 to 0.85 +/- 0.21, respectively (P<0.001 each).. The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions:

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Alloys; Angiography; Arterial Occlusive Diseases; Confidence Intervals; Europe; Female; Femoral Artery; Humans; Male; Middle Aged; Popliteal Artery; Postoperative Complications; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome

To assess the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents in the palliative treatment of malignant esophageal and tracheobronchial strictures.. Under fluoroscopic guidance, parallel stents were placed in 12 symptomatic patients with both malignant esophageal and tracheobronchial strictures. Seven of these 12 patients also had an esophagorespiratory fistula (ERF) and one patient had an esophagocutaneous fistula. Technical success, clinical improvement, complications, and survival rates were evaluated.. A total of 28 esophageal and airway stents were successfully placed. The grade of dysphagia and dyspnea score significantly decreased after stent placement (P=0.002 and 0.003, respectively). ERF and esophagocutaneous fistula were sealed off in all eight patients after esophageal stent placement; however, the esophagocutaneous fistula reopened 1 month later. Complications included stent migration or expectoration (n=3), tracheal compression by the esophageal stent (n=3), new fistula development due to covering membrane degradation of the esophageal stent (n=1), and symptomatic sputum retention (n=1). Stent removal was easily performed for two stents; one migrated stent and the other with covering membrane degradation. All 12 patients died within the mean survival period of 72.50 days (range 7-375 days).. Parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures.

Topics: Adult; Aged; Alloys; Bronchial Diseases; Constriction, Pathologic; Esophageal Fistula; Esophageal Stenosis; Esophagus; Female; Follow-Up Studies; Head and Neck Neoplasms; Humans; Lung Neoplasms; Male; Middle Aged; Palliative Care; Postoperative Complications; Radiography; Retrospective Studies; Stents; Survival Rate; Trachea; Tracheal Stenosis; Treatment Outcome

To present a patient in whom severe external carotid artery (ECA) stenosis causing ocular ischemia was treated with a drug-eluting stent.. A 55-year-old woman with severe, diffuse atherosclerosis presented with impaired left ocular perfusion and amaurosis fugax. Duplex ultrasonography and angiography documented bilateral occlusion at the origin of the internal carotid arteries, bilateral subtotal ECA stenoses, and subtotal distal left common carotid artery (CCA) restenosis following endarterectomy. Percutaneous revascularization of the left ECA and CCA stenoses was performed using a short coronary balloon-expandable sirolimus-eluting stent and a self-expanding nitinol stent, respectively. The procedure was uneventful, and the ocular symptoms resolved. At 6 months, the patient remained asymptomatic, with angiographically patent stents.. Drug-eluting stenting may be a novel option to treat symptomatic ECA stenosis.

Topics: Alloys; Amaurosis Fugax; Angiography, Digital Subtraction; Blood Vessel Prosthesis Implantation; Carotid Artery, Common; Carotid Stenosis; Coated Materials, Biocompatible; Endarterectomy, Carotid; Eye; Female; Humans; Immunosuppressive Agents; Ischemia; Middle Aged; Postoperative Complications; Reoperation; Sirolimus; Stents; Vascular Patency

Clinical results following stent implantation in the superficial femoral artery (SFA) are limited due to restenosis, often caused by stent fractures. Therefore new stent devices are desirable. The present study details our initial experience with the routine use of the novel Protégé EverFlex long self-expanding nitinol stent for treatment of long SFA total occlusions or stenoses.. Between February and March 2006 a total of 15 EverFlex nitinol stents were implanted in 12 patients with either total SFA occlusions (n = 9) or long stenoses (n = 3), mean lesion length 14.9 cm (+/- 10.4 cm). All patients presented with claudication stage Fontaine IIb (Rutherford category 3). Stent lengths were 10 cm (n = 6), 12 cm (n = 1), or 15 cm (n = 8), stent diameters were 6 mm (n = 14) and 7 mm (n = 1). Access was gained either by the crossover (n = 9), antegrade (n = 2), or popliteal approach (n = 1). After predilatation, stent placement and postdilatation were performed with 100% technical success. Clinical and apparative follow-up after 6-8 weeks indicated the absence of restenosis or reocclusion in all cases.. The novel long self-expanding EverFlex nitinol stent (10 cm/12 cm/15 cm in length) exhibits excellent technical handling characteristics with good short-term clinical results. Mid-term and long-term clinical results as well as potential stent fractures need to be further examined.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Male; Postoperative Complications; Stents; Treatment Outcome; Vascular Surgical Procedures

To assess the clinical effectiveness of temporary metallic stent placement with concurrent radiation therapy in patients with esophageal carcinoma by comparing it with permanent stent placement with concurrent radiation therapy.. Covered retrievable expandable nitinol stents were placed in 47 patients with esophageal carcinoma 1 week before starting radiation therapy; the stents were electively removed 4 weeks after placement in 24 patients (group A), while not electively removed in the other 23 patients (group B). In cases of complications, the stents were also removed from patients in groups A and B. The dysphagia score, complications (severe pain, granulation tissue formation, stent migration, esophagorespiratory fistula, and hematemesis), tumor overgrowth/regrowth, reintervention rates, and dysphagia-progression-free and overall survival rates were compared in the two groups.. Stent placement or removal was technically successful and well tolerated in all patients. The dysphagia score was significantly improved in both groups after stent placement (P < .01). Each of the stent-related complications was less in group A than in group B but there was no significant difference. However, the total number of patients with one or more than one complications and who needed related reinterventions was significantly less in group A than in group B (P = .042 and .030, respectively). Tumor overgrowth/regrowth and the total number of patients who required related reinterventions was not significantly different (P = 1.00 and .517, respectively). Dysphagia-progression-free and overall survival rates were significantly longer in group A than in group B (P = .005 and .001, respectively).. Temporary placement of a covered retrievable expandable metallic stent with concurrent radiation therapy for patients with esophageal carcinoma is beneficial for reducing complications and related reinterventions and for increasing resultant survival rates compared with permanent esophageal stent placement.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Carcinoma, Squamous Cell; Case-Control Studies; Coated Materials, Biocompatible; Deglutition Disorders; Esophageal Neoplasms; Esophageal Stenosis; Female; Humans; Korea; Male; Middle Aged; Polyurethanes; Postoperative Complications; Prospective Studies; Retrospective Studies; Stents; Survival Analysis

Manual piston malcrimping in stapedotomy may be the major cause of the occurrence of the significant, interindividual variations of postoperative air-bone gap (ABG), air-bone gap closures (ABGC), and postoperative recurrences of conductive hearing loss. To eliminate the effects of manual crimping on stapedotomy outcomes, the self-crimping, shape memory alloy Nitinol stapes piston was investigated and hearing evaluated.. Prospective, preliminary case-control study in a tertiary care referral center.. Sixteen patients with otosclerosis undergoing reversed stapedotomy using the Nitinol stapes piston were matched to reference patients out of our conventional titanium piston database. The effects of the self-crimping Nitinol piston on the postoperative ABGC, the postoperative air-bone gap (ABG) variations, and the postoperative short-term hearing results were investigated 3, 6 and 9 months postoperatively. These data were statistically compared with the results of the control patients in our titanium stapes piston database.. The mean postoperative ABG and the interindividual variations of the postoperative ABG were significantly smaller in the Nitinol group, the extent of ABGC greater in the Nitinol piston group, but not significant. The postoperative short-term stability of ABGC was similar in both groups. No infections or adverse reactions occurred during follow-up.. Our preliminary results suggest that the self-crimping shape memory alloy Nitinol stapes piston eliminates the limitations of manual malcrimping in stapedotomy, thus optimising the surgical procedure. This allows reliable, safe, and consistent air-bone-gap closure in patients with otosclerosis up to 1 year after surgery.

Topics: Adult; Aged; Alloys; Humans; Middle Aged; Postoperative Complications; Stapes Surgery

The purpose of this study is to evaluate fixation methods for polytetrafluoroethylene (ePTFE) mesh with an in vivo model of laparoscopic ventral hernia repair.. In 40 New Zealand white rabbits, a 4 x 4-cm ePTFE mesh (n = 80, two per animal) was attached to an intact peritoneum with polyglactin 910 (PG 910) (n = 20) or polypropylene (PP) (n = 20) suture, titanium spiral tacks (TS) (n = 20), or nitinol anchors (NA) (n = 20). Mesh was harvested at 8 and 16 weeks for fixation strength testing, adhesion assessment, and collagen (hydroxyproline) content. Fixation strength on day 0 was determined with mesh attached to harvested abdominal wall. Statistical significance was determined as p < 0.05.. There was no difference in fixation strength between PP (39.1 N) and PG 910 (40.0 N) sutures at time zero. At week 8, PP (25.7 N) was significantly stronger (p < 0.05) than PG 910 (11.4 N) suture, but not at week 16. The fixation strength of TS and NA (day 0, 15.4 vs 7.4 N; week 8, 17.5 vs 15.3 N; week 16, 19.1 vs 13.8 N) was not significantly different. Fixation with PP suture was significantly (p < 0.05) stronger than that with TS and NA at day 0 (39.1, 15.4, and 7.4 N, respectively) but not at weeks 8 or 16. The fixation strength of suture decreased significantly (p < 0.05) from day 0 to week 16 (PP: day 0 = 39.1 N, week 8 = 25.7 N, week 16 = 21.4 N; PG 910: day 0 = 40.0 N, week 8 = 11.4 N, week 16 = 12.8 N). The fixation strength of NA and TS did not change significantly (NA: day 0 = 7.4 N, week 8 = 15.3 N, week 16 = 13.8 N; TS: week 0 = 15.4 N, week 8 = 17.5 N, week 16 = 19.1 N). There were no differences in adhesion area based on fixation device used; however, there were more (p < 0.05) mesh samples using NA with adhesions compared to TS and adhesion tenacity was greater (p < 0.05) compared to that of TS, PP, and PG. Hydroxyproline content at weeks 8 and 16 was similar for all fixation devices.. The initial fixation strength for nonabsorbable suture is significantly greater than that of the metallic fixation devices, but after 8 weeks there is no difference. Laparoscopic ventral hernia repair without transabdominal suture fixation may be predisposed to acute failure. The metallic devices have similar fixation strength, although the incidence of adhesions and tenacity of adhesions appear to be greater with the nitinol anchors. Since these devices have similar fixation strengths and most likely provide adequate supplementation to transabdominal sutures for mesh fixation after laparoscopic ventral hernia repair, their use should be based on other factors, such as their propensity for adhesions, ease of application, and cost.

Topics: Alloys; Animals; Equipment Design; Hernia, Ventral; Hydroxyproline; Laparoscopy; Polyglactin 910; Polypropylenes; Polytetrafluoroethylene; Postoperative Complications; Rabbits; Surgical Mesh; Sutures; Tissue Adhesions; Titanium

To report endovascular occlusion of an internal iliac artery (IIA) aneurysm with an Amplatz nitinol vascular occlusion plug.. A 71-year-old asymptomatic man who had previously undergone open aortic aneurysm repair presented for annual follow-up. A bifurcated Dacron graft had been inserted 12 years ago from the infrarenal aorta to the left common femoral artery and the right common iliac artery. The left common iliac artery was ligated proximally, and the left external iliac artery (EIA) provided retrograde flow into the IIA. Magnetic resonance imaging (MRI) revealed a 7.4-cm aneurysm of the left IIA. After transfemoral calibrated catheter angiography was performed, the proximal EIA was occluded with an Amplatz nitinol vascular occlusion plug. In addition, microcoils were placed distal to the vascular plug to achieve complete thrombosis of the vessel. One day after treatment, the patient was discharged free of symptoms after MRI had shown complete obliteration of the IIA aneurysm. At 6 months, the patient was free from symptoms, and angiography confirmed exclusion of the IIA aneurysm.. This case illustrates the technical feasibility and successful short-term follow-up of a novel embolization approach to IIA aneurysms in patients with an aortofemoral graft.

Topics: Aged; Alloys; Aortic Aneurysm, Abdominal; Coated Materials, Biocompatible; Embolization, Therapeutic; Humans; Iliac Aneurysm; Magnetic Resonance Imaging; Male; Postoperative Complications; Radiography; Reoperation; Vascular Surgical Procedures

The objective of our study was to investigate the diagnostic accuracy of MRI and helical CT for endoleak detection.. Fifty-two patients underwent endovascular aneurysm repair with nitinol stent-grafts. Follow-up data sets included contrast-enhanced biphasic CT and MRI within 48 hr after the intervention; at 3, 6, and 12 months; and yearly thereafter. The endoleak size was categorized as < or = 3%, > 3% < or = 10%, > 10% < or = 30%, or > 30% of the maximum cross-sectional aneurysm area. A consensus interpretation of CT and MRI was defined as the standard of reference.. Of 252 data sets, 141 showed evidence for endoleaks. The incidence of types I, II, and III endoleaks and complex endoleaks was 3.2%, 40.1%, 8.7%, and 4.0%, respectively. The sensitivity for endoleak detection was 92.9%, 44.0%, 34.8%, and 38.3% for MRI, biphasic CT, uniphasic arterial CT, and uniphasic late CT, respectively. The corresponding negative predictive values were 91.7%, 58.4%, 54.7%, and 56.1%, respectively. The overall accuracy of endoleak detection and correct sizing was 95.2%, 58.3%, 55.6%, and 57.1% for MRI, biphasic CT, uniphasic arterial CT, and uniphasic late CT, respectively.. MRI is significantly superior to biphasic CT for endoleak detection and rating of endoleak size, followed by uniphasic late and uniphasic arterial CT scans. MRI shows a significant number of endoleaks in cases with negative CT findings and may help illuminate the phenomenon of endotension. Endoleak rates reported after endovascular aneurysm repair substantially depend on the imaging techniques used.

Topics: Aged; Aged, 80 and over; Alloys; Aneurysm; Female; Follow-Up Studies; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Postoperative Complications; Predictive Value of Tests; Prospective Studies; Sensitivity and Specificity; Statistics, Nonparametric; Stents; Tomography, Spiral Computed

We report our early experience with the Symmetry Aortic Connector (St. Jude Medical, St. Paul, MN) used for sutureless proximal aortosaphenous vein graft anastomoses without any cross clamp during coronary bypass procedures.. Between November 2001 and August 2002, 206 saphenous vein to aorta proximal anastomoses were created in 132 patients using the Symmetry device. All procedures were performed as part of off-pump coronary artery bypass surgery without any aortic clamping. Intraoperative variables and postoperative data were collected and analyzed retrospectively.. All 206 anastomoses (100%) were successfully completed with the connector. Severe atherosclerotic disease of the aorta was documented in 16 patients (12%). Four anastomoses (2%) required additional suture placement. Predeployment problems occurred with 3 grafts (2.5%) during loading of the connector. Average number of distal bypasses was 3.2 per patient. One patient (0.7%) required reoperation for bleeding from a proximal anastomosis. Six patients (4.5%) had perioperative myocardial infarction documented by electrocardiographic changes. Thirty-day operative mortality was 3% (4 patients). Intraoperative transit time flow measurement was performed in all cases (100%). Postoperative angiography in 43 patients at a median 3 months postoperatively revealed occlusion of 9 of the 81 saphenous vein grafts (11%).. The initial experience with a proximal saphenous vein graft to aorta anastomosis using the Symmetry connector demonstrates safety and ease of use. There is however some concern with early graft closure. A prospective randomized study is needed to clarify these concerns.

Topics: Aged; Alloys; Anastomosis, Surgical; Aorta, Thoracic; Coronary Angiography; Coronary Artery Bypass; Equipment Design; Evaluation Studies as Topic; Female; Humans; Male; Middle Aged; Postoperative Complications; Retrospective Studies; Stents; Surgical Instruments; Suture Techniques; Veins

The JoStent SelfX is a new biliary uncovered self-expanding nitinol stent. The main advantage of this stent in comparison with the "gold standard" Wallstent is the minimal shortening (< 10 %) that occurs during stent deployment. A prospective feasibility study was conducted to evaluate the method of stent implantation and the stent's short-term efficacy.. Between April 2001 and December 2002, the JoStent SelfX was implanted in 20 patients with inoperable malignant biliary obstructions, mainly caused by pancreatic cancer (12 of 20). All patients underwent sphincterotomy prior to stent insertion. After implantation, laboratory parameters for cholestasis and expansion of the stent were checked over a period of several days. All patients were followed for 8 weeks after implantation to document early stent dysfunction.. Stent implantation was easily managed and successful in all patients, with no technical problems. Prior bougienage was required in only one patient, who had a filiform stenosis. No stent retraction was observed during stent release. All stents showed full expansion within 5 days. No acute complications occurred. Adequate reduction in the elevated laboratory parameters for cholestasis was observed. Two patients had recurrent cholestasis and fever due to cholangitis, or stent occlusion caused by biliary sludge within 4 weeks.. This new biliary metal stent is easily inserted and does not shorten during stent release, allowing precise positioning. No acute complications occurred, but there were two cases of early stent dysfunction. The role of the JoStent SelfX in comparison with other biliary stents will need to be evaluated in a multicenter trial with a larger number of patients, to investigate the long-term results.

Topics: Aged; Aged, 80 and over; Alloys; Biliary Tract Neoplasms; Biliary Tract Surgical Procedures; Female; Humans; Male; Middle Aged; Palliative Care; Pilot Projects; Postoperative Complications; Stents; Treatment Outcome

The use of self-expanding metallic stents (SEMS) as esophageal endoprosthesis represents an advancement in the palliation of dysphagia from unresectable esophageal carcinoma. However, the problem of stent migration persists. Although most migrated stents have a benign outcome, complications do occur. Rare reports of intestinal obstruction have been confined to the stiff plastic and stainless-steel stents. We report the first case of intestinal obstruction secondary to the pliable Nitinol SEMS (Ultraflex) migration.

Topics: Adenocarcinoma; Aged; Alloys; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Deglutition Disorders; Device Removal; Epirubicin; Equipment Design; Esophageal Neoplasms; Fluorouracil; Foreign-Body Migration; Humans; Ileal Diseases; Intestinal Obstruction; Laparotomy; Liver Neoplasms; Male; Postoperative Complications; Stents

Reducing the negative side effects associated with extracorporeal circulation is the major advantage of off-pump revascularization. However, side clamping of a calcified aorta for proximal anastomoses can cause emboli, resulting in neurologic damage. This problem has been addressed by introducing a mechanical anastomosis device (Symmetry, St Jude Medical) that allows vein-to-aorta anastomosis without manipulating the aorta. This report describes our experience with this device.. Between June 2001 and April 2002, 77 connectors (1.3 per patient) were deployed in 61 patients (51 men and 10 women; mean age, 68 +/- 8.6 years) undergoing off-pump coronary artery bypass grafting or beating-heart revascularization. Intraoperative quality assessment included transit-time flow measurement (Medistim) and indocyanine green-based angiography (Spy, Novadaq).. The surgeons were meticulously trained in loading of the device. No postoperative neurologic deficits were detected. Fifty-three patients had an uneventful course. However, 8 (13.1%) patients with 12 implanted connectors were symptomatic within 8 months (1 day to 8 months). Angiography revealed significant (95%) stenosis or even occlusion of the proximal vein-to-aorta anastomosis at the level of all connectors. Four patients underwent reoperation (2 dilated-stented and 2 treated with drugs).. On the basis of these observations, the routine use of the connector was halted at our institution. At the moment, the use of this therapy is reserved for patients with severely calcified aortas with no technical alternative. Further investigations appear necessary to evaluate the clinical patterns of this otherwise promising technology.

Topics: Aged; Alloys; Anastomosis, Surgical; Aorta; Aortic Diseases; Calcinosis; Coronary Angiography; Coronary Artery Bypass; Equipment Failure; Female; Graft Occlusion, Vascular; Humans; Male; Postoperative Complications; Veins

A 5-year-old castrated male Pomeranian was evaluated because of severe dyspnea and coughing, and a diagnosis of complete, static collapse of the trachea at the thoracic inlet was made. After failure to improve with medical management alone, an endoluminal tracheal stent was placed, which resulted in resolution of signs. Ten weeks after stent placement, the dog underwent tracheal resection and anastomosis because the stent had fractured at the level of the thoracic inlet. One year after surgery, the dog was doing well and required treatment with hydrocodone infrequently. Compared with other surgical treatment options, placement of an endoluminal tracheal stent is a relatively noninvasive intervention that can provide effective relief from the clinical signs associated with tracheal collapse in dogs. Implantation of endoluminal tracheal stents may be associated with complications; therefore, the procedure may best be regarded as a salvage procedure for dogs with end-stage disease that are refractory to appropriate medical management, have extensive collapse of the intrathoracic portion of the trachea, or are poor candidates for surgery.

Topics: Alloys; Animals; Dog Diseases; Dogs; Male; Postoperative Complications; Prosthesis Implantation; Reoperation; Stents; Tracheal Stenosis; Treatment Outcome

A 7-month-old miniature horse was referred for respiratory distress. Tracheal collapse at the level of the thoracic inlet was diagnosed. An intraluminal nitinol stent was placed with endoscopic guidance. Respiratory function was restored immediately after stent placement. The main complication observed during a 14-month follow-up period was growth of granulation tissue through the stent, which was controlled satisfactorily by electrocautery performed during endoscopy with the horse standing. Treatment of tracheal collapse with an intraluminal stent is an effective, practical, and minimally invasive procedure in miniature and young equids and ponies.

Topics: Alloys; Animals; Electrocoagulation; Endoscopy; Granulation Tissue; Horse Diseases; Horses; Minimally Invasive Surgical Procedures; Postoperative Complications; Prosthesis Implantation; Stents; Tracheal Diseases; Treatment Outcome

To evaluate the clinical efficacy of a curved nitinol stent-graft for repair of thoracic aortic aneurysms.. The Matsui-Kitamura stent-graft (MKSG), composed of a self-expanding nitinol stent and polyester fabric, was shaped to match the aortic curvature of 11 patients (6 men; mean age 72.6 years, range 33-90) with 6 true and 5 false aneurysms of the distal arch or proximal descending aorta. The delivery system was an 18 or 20-F J-shaped sheath combined with a preloader-type introducer. The original mean proximal neck length was 16.4 mm, but 4 patients received an axilloaxillary bypass to lengthen the neck. Although the mean corrected proximal neck length was 21.9 mm (overall), 5 cases still had proximal necks <15 mm long.. All curved MKSGs were successfully deployed in the correct position and fitted to the curvature of the aortic arch, achieving complete aneurysm exclusion in 8 (73%) cases. The other 3 repairs displayed early endoleaks; 1 received an additional MKSG, but the other 2 are being observed. Thirty-day mortality was 0%. One patient developed transient renal failure requiring hemodialysis; no neurological complications were observed.. Endovascular repair of thoracic aortic aneurysms using curved MKSGs appears to be feasible and clinically effective. A tighter fit of the device to the curvature of the aortic arch may exclude distal arch aneurysms despite a short proximal neck.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Aortic Aneurysm, Thoracic; Blood Vessel Prosthesis Implantation; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polyesters; Postoperative Complications; Prosthesis Design; Stents; Treatment Outcome

The Symmetry Bypass System Aortic Connector (St Jude Medical, Inc) is a novel device for the construction of sutureless proximal anastomoses. The connector allows attachment of saphenous vein grafts to the aorta without requiring aortic clamping. We report our initial clinical experience with this device.. In a 2-month period from May to July 2001, a total of 139 consecutive proximal anastomoses were performed in 67 patients using the connector. All procedures were performed on a beating heart without cardiopulmonary bypass or any aortic clamping. Intraoperative variables and postoperative results were prospectively collected and retrospectively analyzed.. Of 139 consecutive proximal anastomoses 138 (99.3%) were successfully completed with the device. One anastomosis required suture revision because of misdeployment. Six anastomoses (4.3%) required an additional suture for leak. Predeployment problems included connector loading/preparation malfunction in 10 grafts (7.2%), five because of human error and five technical failure. There was no operative mortality, perioperative myocardial infarction, or stroke. Vessels bypassed included the circumflex system (n = 59), right coronary artery and branches (n = 48), diagonal branch (n = 26), and left anterior descending coronary artery (n = 6). At a mean follow-up of 7 months, survival was 94.1% and survival free of major adverse cardiac and cerebrovascular events (MACCE) was 88.1%.. Initial clinical experience with a sutureless proximal saphenous vein graft to aorta anastomosis performed with a mechanical connector demonstrates safety, reliability, and ease of use. Surmounting a brief learning curve improves the subtleties of device loading and deployment. Further benefits will be determined in an ongoing randomized study.

Topics: Adult; Aged; Alloys; Anastomosis, Surgical; Aorta, Thoracic; Aortography; Coronary Artery Bypass; Equipment Design; Female; Humans; Imaging, Three-Dimensional; Intraoperative Complications; Male; Middle Aged; Postoperative Complications; Prospective Studies; Suture Techniques; Veins

Significant morbidity and mortality offset the benefits of lung volume reduction surgery (LVRS) for emphysema. By contributing to distal lung collapse, bronchoscopic placement of valved prostheses has the potential to noninvasively replicate the beneficial effects of LVRS. The purpose of this study was to investigate the safety and feasibility of placing valves in segmental airways of patients with emphysema.. Case series.. Tertiary hospital, severe airways disease clinic.. Ten patients aged 51 to 69 years with apical emphysema and hyperinflation, otherwise suitable for standard LVRS. Mean preoperative FEV(1) was 0.72 L (19 to 46% predicted), and 6-min walk distance was 340 m (range, 245 to 425 m).. Apical, bronchoscopic, segmental airway placement of one-way valves (silicone-based Nitinol bronchial stent; Emphasys Medical; Redwood City, CA) under general anesthesia. Placement was over a guidewire under bronchoscopic and fluoroscopic control.. Four to 11 prostheses per patient took 52 to 137 min to obstruct upper-lobe segments bilaterally. Inpatient stay was 1 to 8 days. No major complications were seen in the 30-day study period. Minor complications included exacerbation of COPD (n = 3), asymptomatic localized pneumothorax (n = 1), and lower-lobe pneumonia (day 37; n = 1). Symptomatic improvement was noted in four patients. No major change in radiologic findings, lung function, or 6-min walk distance was evident at 1 month, although gas transfer improved from 7.47 +/- 2.0 to 8.26 +/- 2.6 mL/min/mm Hg (p = 0.04) and nuclear upper-lobe perfusion fell from 32 +/- 10 to 27 +/- 9% (mean +/- SD) [p = 0.02].. Bronchoscopic prostheses can be safely and reliably placed into the human lung. Further study is needed to explore patient characteristics that determine symptomatic efficacy in a larger patient cohort.

Topics: Aged; Alloys; Animals; Bronchi; Bronchoscopy; Feasibility Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pilot Projects; Plethysmography; Pneumonectomy; Postoperative Complications; Prostheses and Implants; Prosthesis Design; Pulmonary Emphysema; Sheep; Silicones; Stents

Several types of metal stents are available for the treatment of tracheobronchial stenosis. They can be self-expanding, balloon expandable, covered with a silicone membrane or uncovered. We have used a new self-expanding tracheobronchial nitinol wire stent since 1998, and our results are presented below.. Over a period of two years, 25 patients had a stent in the trachea or bronchus. The stents were inserted while the patients were under general anaesthesia, and flexible bronchoscopy was used. Respiratory function, histopathology, stent data, complications, and mortality were prospectively recorded.. Eighteen patients had a malignant stenosis. Bronchial stenosis following a single lung transplantation (3) was the most frequent reason for a benign stenosis (7). Most of the patients had the stent placed in the trachea (14). All the stent insertions were performed without complications, and respiratory function was immediately improved in all patients except for two. The postoperative complications were inflammatory granuloma (5), stent dislocation (3), delayed expansion (2), stent rupture (1), and stent occlusion caused by retained secretions (1).. The tracheobronchial ultraflex nitinol stent was easy to handle and was troublesome for only a few patients. Nitinol stents are considered to have a good biocompatibility, but 12% of the patients developed inflammatory granulations requiring electroresection.

Topics: Adult; Aged; Alloys; Bronchial Diseases; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Follow-Up Studies; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Stents; Tracheal Stenosis; Treatment Outcome

Sternomy represents the standard approach to the heart and great vessels in most cardiothoracic procedures. Closure of this incision is simple; however, healing complications such as dehiscence, osteomyelitis, mediastinitis, and superficial wound infection or fistula may occur. We describe an alternative technique for sternal closure using semirigid fixation with thermoreactive clips.

Topics: Alloys; Humans; Postoperative Complications; Sternum; Surgical Instruments; Suture Techniques; Wound Healing

Nitinol, a nickel-titanium alloy, is a valuable material in the construction of interventional endoluminal devices because of its biocompatibility, super elasticity, high resiliency and shape memory. The possibility of nickel toxicity has been raised with devices constructed of Nitinol. Our investigation examines the long-term corrosive behavior of this alloy in experimental and biological environments.. We performed three levels of study. Microscopic examination was made of 64 devices of various sizes, randomly selected from 240 Amplatzer Septal Occluders that had been exposed to saline solution at 37 degrees C for fourteen months. All samples were studied by electron microscopy ranging from 50 to 5000 times magnification. We also studied microscopically 3 Amplatzer devices explanted 18-36 months after implantation in dogs, and 2 Amplatzer Septal Occluders removed from patients 18 months (cardiac transplant) and 19 months (died of causes unrelated to device placement) after implantation, which were examined grossly and by electron microscopy up to 5000 times magnification. We then measured the levels of nickel in the blood using inductive plasma mass spectroscopy in 19 patients with implanted Amplatzer devices, making measurements before and 6 months after implantation.. Electron microscopy showed an intact titanium oxide layer with no evidence of corrosion in vitro and in vivo. One explanted device in direct contact with the platinum leads of a pacemaker for eighteen months showed minor pitting of the titanium oxide layer believed to be galvanic in nature. No wire fractures were found in vitro after cycle testing with 400 million cycles, nor in devices taken from the animals and humans. Biochemical studies showed no significant elevation of levels of nickel levels after implantation.. Nitinol wire of Amplatzer septal occlusion devices is resistant to corrosion when exposed to physiologic saline solution, and in experimental animals as well as humans. A device in contact with a platinum pacemaker electrode developed minimal pitting of the titanium oxide layer, believed to be galvanic in nature and of no structural or clinical significance. There is no increase of concentrations of nickel in the blood of patients who have received Amplatzer nitinol devices. These favorable testing results reveal that nickel-titanium is an inert, corrosion resistant alloy.

Topics: Adolescent; Adult; Alloys; Animals; Balloon Occlusion; Child; Child, Preschool; Corrosion; Disease Models, Animal; Dogs; Equipment Failure; Humans; Male; Models, Biological; Postoperative Complications; Time Factors; Vascular Diseases

Tracheal collapse is a common problem that is typically observed in middle-aged and older small-breed dogs. It is a structural, obstructive airway disease with a dynamic component that can affect the intra- and extrathoracic portions of the trachea and mainstem bronchi. Many methods of treatment have been suggested, including medical management and provision of extraluminal and intraluminal support. All techniques used to treat intrathoracic and mainstem bronchial collapse have been associated with major complications or limitations. This report describes the implantation of intraluminal nitinol stents to successfully treat intrathoracic as well as extrathoracic tracheal collapse in a dog. The stents are composed of material that has characteristics similar to those of the trachea; nitinol stents may provide a method of supporting intrathoracic tracheal and mainstem bronchial collapse in dogs.

Topics: Alloys; Animals; Bronchography; Bronchoscopy; Dog Diseases; Dogs; Male; Postoperative Complications; Reoperation; Stents; Trachea; Tracheal Stenosis; Treatment Outcome

Angioplasty and stenting are becoming increasingly accepted techniques for the treatment of carotid stenosis. However, the optimal stent for carotid intervention is not known.. We compared the short- and intermediate-term results of carotid stenting using either nitinol or stainless-steel self-expanding stents in 178 high surgical risk patients undergoing carotid stenting at our institution. Of these 178 patients, eighty-nine received stainless-steel stents and 89 received nitinol stents. The groups were similar with respect to age, gender, diabetes, hypertension, left ventricular function, and symptom status. There were more patients with contralateral carotid occlusion in the nitinol stent group. Independent neurological evaluation was performed in all patients pre- and post-carotid stenting.. At 6 months, there was a similar incidence of stroke (3.3% versus 2.2%) in the stainless-steel group and nitinol stent group, respectively. There was higher 6-month mortality noted in the stainless-steel stent group, but there were no neurological deaths in either group.. In a single-center patient cohort with similar baseline characteristics, patients receiving nitinol stents and stainless-steel stents had similar neurological outcomes.

Topics: Aged; Aged, 80 and over; Alloys; Carotid Artery, Common; Carotid Artery, External; Carotid Stenosis; Equipment Safety; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Incidence; Male; Middle Aged; Ohio; Postoperative Complications; Radiography; Stents; Stroke; Survival Analysis; Time Factors; Treatment Outcome

Topics: Alloys; Carotid Artery, Common; Carotid Artery, External; Carotid Stenosis; Equipment Safety; Graft Occlusion, Vascular; Humans; Postoperative Complications; Stents; Stroke; Treatment Outcome

To evaluate the short-term patency and healing characteristics of the Cragg EndoPro covered stent in an atherosclerotic model as one of the Food and Drug Administration requirements before possible approval of the device for human use in the United States.. Seventeen self-expanding stent-grafts were placed in the aorta and right and left iliac arteries of six Yucatan microswine exposed to a regimen of accelerated atherosclerosis. The stent-grafts were constructed from nitinol wire formed into a tubular zigzag configuration. The stent frame was covered by a thin woven polyester fabric tube, with medium permeability, available in multiple diameters and lengths. The animals were killed at 24 hours, 3 months, and 6 months. Assessment was done by angiography and histology.. All stents were patent immediately after deployment. Two stents were occluded at follow-up, indicating an 88% patency rate. Minor lumen narrowing was found at the follow-up intervals. Histologic examination revealed a mixture of mature and immature endothelial cells lining both the native and stented regions in all vessels examined. The new endoluminal surface was composed primarily of fibrocollagen and elastic fibers and smooth muscle cells. Intimal thickness was inversely correlated to medial thickness. Medial compression with atrophy was observed routinely with rare necrosis. Complete tissue ingrowth was seen by 3 months. The degree of vascular inflammation increased over time, as well as the foreign body giant cell reaction to the polyester fabric.. The patency rate does not appear to be better than that with angioplasty or noncovered stent placement in the studied time frame. The progressive vascular inflammatory changes noted should be further investigated in longer-term animal trials to ensure its safety in humans because this device is meant to be permanent.

Topics: Alloys; Animals; Arteriosclerosis; Disease Models, Animal; Female; Postoperative Complications; Stents; Swine

To document a preliminary study to assess the deployment and outcomes of endoluminal stent grafting in the superficial femoral artery (SFA) with use of a prototype device.. Twenty patients with lifestyle-limiting intermittent claudication were selected for treatment with a balloon-mounted expansive polytetrafluoroethylene graft. All patients had angiographically proven SFA disease (median length, 17 cm) with normal arterial inflow and at least two calf vessels patent to the ankle. Follow-up was by means of ankle brachial pressure index (ABPI), duplex ultrasound, and angiography.. Fourteen patients were successfully treated. Six patients were excluded: five by the study protocol and one because the procedure was a technical failure. ABPI rose from 0.6 before treatment to 1.0. The treated limbs became asymptomatic. Twelve-month primary, primary assisted, and secondary patency rates of treated patients were 29%, 50%, and 64%.. Endovascular stent grafting of SFA lesions is technically feasible, but the patency rates obtained with this design are inferior to those obtained with conventional surgical bypass.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Biocompatible Materials; Blood Vessel Prosthesis Implantation; Female; Femoral Artery; Follow-Up Studies; Humans; Intermittent Claudication; Male; Middle Aged; Polytetrafluoroethylene; Postoperative Complications; Prosthesis Design; Secondary Prevention; Stents; Treatment Outcome; Ultrasonography, Interventional

Topics: Alloys; Bile Duct Neoplasms; Bile Ducts, Intrahepatic; Biliary Fistula; Cholangiocarcinoma; Common Bile Duct Diseases; Humans; Male; Middle Aged; Postoperative Complications; Stents

To assess heating- and 3D MRA imaging characteristics of a commonly used aortic stent graft in a 1.5T MR-environment.. A bifurcated stent graft (Vanguard; Boston Scientific, Oakland, N. J.) was evaluated in vitro regarding localized heating effects as well as imaging appearance using fast 3D GRE sequences. To quantitate stent related artifacts, stent wall thickness and luminal diameters were measured. Subsequently eight patients were imaged three months following placement of an aortic stentgraft with 3D MRA. Images were assessed for the presence of stent leaks, luminal patency, and stent configuration.. There were no temperature changes associated with the stent during scanning. Wall thickness measurements overestimated true stent thickness, resulting in minimal underestimation of luminal diameters on 3D MRA images. In vivo imaging confirmed these results. Stent patency was confirmed in all 8 patients.. Contrast-enhanced 3D MRA appears well suited for the evaluation of the abdominal and pelvic vasculature following aortic implantation of a Vanguard stent.

Topics: Aged; Alloys; Aorta, Abdominal; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Contrast Media; Gadolinium DTPA; Heating; Humans; Injections, Intravenous; Magnetic Resonance Angiography; Male; Phantoms, Imaging; Postoperative Complications; Reproducibility of Results; Stents

We report on a 72-year old male with a large aneurysm of descending thoracic aorta which was treated by implantation of a Dacron-covered self-expanding Nitinol stent graft (Talent, HOSMED). The patient was unfit for surgical aneurysm resection because of generalised atherosclerosis and cardiomyopathy. We think that stent implantation for descending thoracic aortic aneurysms is an attractive alternative to surgical aneurysm resection, especially in patients with enhanced operative risk. However, further experience, and especially long term-results, are required before more widespread application of intra-luminal stent implantation in the management of thoracic aortic aneurysms can be recommended.

Topics: Aged; Alloys; Aortic Aneurysm, Abdominal; Aortography; Follow-Up Studies; Humans; Image Processing, Computer-Assisted; Male; Polyethylene Terephthalates; Postoperative Complications; Stents; Treatment Outcome

To evaluate the success rates of the implantation of stent grafts in the treatment of peripheral aneurysms.. In 13 patients with 15 aneurysms at the common iliac artery (n = 6), external iliac artery (n = 1), hypogastric artery (n = 2), femoral artery (n = 2) or popliteal artery (n = 4), implantation of dacron-covered nitinol stents was performed. The patients were followed up for three to 20 months (mean, 8.8 months) with intravenous digital subtraction angiography, CT or colour-coded Doppler sonography.. In all cases, the aneurysm was successfully occluded after stent implantation. In one case with a popliteal aneurysm, kinking of the vessel caused thrombosis of the stent. The stent was successfully reopened. The aneurysm however, had to be surgically treated 9 months later. The primary and secondary patency rates at 6 months were 93% and 100%, respectively.. The method described might be an alternative therapy to surgery. There are some limitations in respect of treatment of popliteal aneurysms.

Topics: Adult; Aged; Alloys; Aneurysm; Equipment Design; Female; Femoral Artery; Follow-Up Studies; Humans; Iliac Artery; Male; Middle Aged; Polyethylene Terephthalates; Popliteal Artery; Postoperative Complications; Radiography; Stents; Time Factors

Our purpose was to evaluate a new prosthesis for percutaneous closure of secundum atrial septal defects (ASDs).. Percutaneous closure of surgically created fossa ovalis ASD was attempted in 15 minipigs. The mean balloon-stretched ASD diameter was 12.3+/-2.3 mm (range, 10 to 16 mm). The self-expanding prosthesis was braided from 0.005-in Nitinol wires in the shape of two flat buttons with a short connecting waist with a diameter corresponding to that of the defect to be closed. Polyester filling was added to enhance thrombogenicity. Pulmonary arteriography with levo-phase was obtained before placement; immediately after placement; and at 1-week, 1-month, and 3-month follow-ups. Four animals were killed at 1 week, 1 month, and 3 months for histopathological correlation. Three deaths resulted from ventricular fibrillation (one during anesthesia and two during the placement procedure). Successful placement of the prosthesis was achieved in the remaining 12 animals. Overall immediate ASD closure on angiography occurred in 7 of 12 animals (all polyester-filled prostheses). Absent or trace shunt by angiography was present in 11 of 12 devices at 1 week, with the remaining one demonstrating a small shunt. All septal defects were completely closed at 1 month with the exception of one case in which delayed partial dislodgment of an undersized prosthesis into the right atrium had developed. Closure rate at 3 months was 100%. Neoendothelialization and fibrous incorporation of the prosthesis were completed within 1 to 3 months.. Effective and permanent occlusion of secundum ASDs is feasible with a device that offers the advantages of easy placement, self-centering, and repositionability.

Topics: Alloys; Animals; Cardiac Catheterization; Endocardium; Femoral Vein; Foreign-Body Migration; Heart Septal Defects, Atrial; Jugular Veins; Postoperative Complications; Prostheses and Implants; Prosthesis Design; Swine; Swine, Miniature; Ventricular Fibrillation; Wound Healing

To evaluate treatment of infrarenal abdominal aortic aneurysm (AAA) with a new endoluminal stent-graft.. In 26 male patients, straight or bifurcated nitinol stents covered with woven Dacron graft material were implanted to treat eccentric saccular AAA (n = 3) or AAA involving the bifurcation and common iliac arteries (n = 23), with follow-up from 8 days to 8 1/2 months.. Implantation was technically successful in all but one of the 26 (96%) patients (leak of the stent-graft for more than 3 months necessitated implantation of an additional covered stent). In seven of the 26 patients, minor residual perfusion persisted immediately after implantation, but complete thrombosis occurred within 7 days. Five procedure-related complications occurred: distal embolization (n = 2); local hematoma, which necessitated surgery (n = 1); acute hepatic failure due to gastric bleeding, in a patient with liver cirrhosis (n = 1); and stent-graft occlusion due to emboli originating from the left atrium (n = 1).. Exclusion of AAA from circulation was feasible, safe, and clinically effective with the new stent-graft.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Aortic Aneurysm, Abdominal; Aortography; Blood Vessel Prosthesis; Humans; Male; Methods; Middle Aged; Polyethylene Terephthalates; Postoperative Complications; Radiography, Interventional; Stents

With a series of 31 transluminal stent-graft procedures, we assessed the feasibility and clinical effectiveness of a new stent-graft for the treatment of infrarenal abdominal aortic aneurysms (AAAs).. We treated the patients (male; mean age 71 years) with straight or bifurcated nitinol stents covered with woven dacron graft material for infrarenal eccentric saccular AAA (n = 4) or AAA involving the bifurcation and the common iliac arteries (n = 27). The 18-F delivery system was advanced via a surgical arteriotomy and the stent-graft was placed under fluoroscopic control. Follow-up period ranged from 8 days to 9 months.. The implantation of the stent-grafts was technically successful in 30/31 cases. Procedure-related complications were acute hepatic failure due to gastric bleeding in a patient with liver cirrhosis, graft occlusion due to emboli originating from the left atrium (n = 1), macro-embolisation (n = 3), local haematoma (n = 1) and av-fistula (n = 1) requiring surgery. A post-implantation syndrome with leukocytosis and elevated C-reactive protein was observed in all patients.. Endoluminal repair of infrarenal AAA with use of dacron covered nitinol stent-grafts is feasible, safe and clinically effective. However, careful long-term evaluation is necessary.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis; Follow-Up Studies; Humans; Male; Middle Aged; Polyethylene Terephthalates; Postoperative Complications; Stents; Time Factors; Tomography, X-Ray Computed

The aim of this report is to describe our experience with the Stentor device for endovascular treatment of the abdominal aortic infrarenal aneurysms also extending to the bifurcation and the common iliac arteries. Stentor is a thermal memory (Nitinol) self-expanding graft, covered by an external 0.1 mm Dacron material.. Between December 1994 and July 1995 endoluminal repair of infrarenal aneurysmal disease was undertaken in 6 patients at high surgical risk. The lesions include 2 infrarenal abdominal aorto-aortic aneurysms, 2 infrarenal abdominal aortic aneurysms extended to the common iliac arteries and 2 false aortic aneurysms in patients with previous aorto-bifemoral graft. Straight grafts were implanted in 4 patients and bifurcated in 2. Repair was done in the operating room using general anesthesia. The endograft was placed through remote arteriotomies and advanced under fluoroscopic guidance to his predetermined site. Three-dimensionally reconstructed spiral CT scan and arteriography were performed before the procedure for a preoperative accurate measurement for endograft preprocedural adaptation in length and diameter.. All endografts were successfully deployed. Intraoperative arteriography at the end of the procedure revealed a distal "leak" into an aneurysmal common iliac artery, due to diameter mismatch, in a bifurcated device. There was no instance of embolism or graft migration. No patient required conversion to an open operation. There were no instances of embolism or graft migration. No patient required conversion to an open operation. There were no coagulative disorders. Minor complications were: groin haematoma (1), fever (1), intestinal paralysis (1), pelvic pain (1). Follow-up with spiral CT-scan and echo color-Doppler confirmed normal blood flow through the graft in 5 patients and persistence of distal leak in 1 patient.. These preliminary results demonstrate the accuracy of implantation and device's adaptability to the particular anatomy of the aneurysmal aorta and iliac arteries. Proximal fixation to the aortic wall, secure seal at the proximal and distal fixation point present the critical aspects of this new surgical technique. More detailed preoperative measurements of aneurysmal disease are required rather than for traditional surgery. Presently we prefer to treat the no operable patients with this endovascular technique in relation with shortness of the follow-up.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Aortic Aneurysm, Abdominal; Evaluation Studies as Topic; Humans; Male; Middle Aged; Postoperative Complications; Stents; Tomography, X-Ray Computed; Ultrasonography

With a series of 34 transluminal stent-graft procedures, we assessed the feasibility and clinical effectiveness of a new stent-graft for the treatment of infrarenal abdominal aortic aneurysms (AAAs). We treated 34 male patients (mean age 71 years) with straight of bifurcated nitinol stents covered with woven Dacron graft material for infrarenal excentric saccular AAA (n = 3) or AAA involving the bifurcation and the common iliac arteries (n = 31). The 18-F delivery system was advanced via a surgical arteriotomy and the stent-graft was placed under fluoroscopic control. Follow-up period ranged from 8 days to 13 months. The implantation of the stent-grafts was technically successful with exclusion of AAA in 31/34 cases (91%). In 2 patients, there was a persisting leak at the distal end of the endoprosthesis after treatment; in another, marked coiling of the external iliac artery impeded the delivery system to be advanced and consecutive rupture resulted in conversion to surgical repair. Other procedure-related complications were acute hepatic failure due to gastric bleeding in a patient with liver cirrhosis, graft occlusion due to emboli originating from the left atrium (n = 1), local hematoma (n = 1), and AV-fistula (n = 1) requiring surgery. A post-implantation syndrome with leucocytosis and elevated C-reactive protein was observed in all patients. Endoluminal repair of infrarenal AAA with use of Dacron covered nitinol stent-grafts is feasible, safe and clinically effective. However, careful long-term evaluation is necessary before it will become clinical practice.

Topics: Aged; Alloys; Aortic Aneurysm, Abdominal; Aortography; Blood Vessel Prosthesis; Feasibility Studies; Follow-Up Studies; Humans; Iliac Artery; Male; Polyethylene Terephthalates; Postoperative Complications; Prosthesis Design; Prosthesis Failure; Stents; Tomography, X-Ray Computed

The paper is concerned with the description of the first experience in a new method of roentgen endoprosthetics of the cervical canal of the uterus using a nitinol spiral prosthesis. The spiral has a shape memory effect. Prostheses were implanted to 13 patients with strictures or atresia of the cervical canal after bougienage for a period of 193 days. A new canal was formed with further epithelialization within this period. Recurrences after prosthesis removal were unnoticed.

Topics: Adult; Alloys; Carcinoma in Situ; Cervix Uteri; Constriction, Pathologic; Dilatation; Female; Humans; Laser Therapy; Postoperative Complications; Prostheses and Implants; Prosthesis Design; Radiography; Time Factors; Uterine Cervical Neoplasms