nitinol and Aneurysm--False

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

We report the case of a 36-year-old male, admitted in the emergency room with a nonruptured brachial pseudoaneurysm after buprenorphine injection, with no signs of distal acute ischemia. After endovascular treatment with a nitinol covered stent associated with adapted antibiotherapy and 35 days of hospitalizations, the patient was discharged with good short results but stent need to be removed at 6 months for thrombosis and partial exposure through the wound.

Topics: Adult; Alloys; Aneurysm, False; Aneurysm, Infected; Anti-Bacterial Agents; Brachial Artery; Device Removal; Drug Users; Endovascular Procedures; Humans; Male; Prosthesis Design; Stents; Substance Abuse, Intravenous; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

Formation of a femoral artery pseudoaneurysm is not infrequent after femoral arterial access. We successfully treated a pseudoaneurysm of the femoral artery using the StarClose vascular closure system. Closing device can be an alternative option for the treatment of pseudoaneurysm.

Topics: Alloys; Aneurysm, False; Catheterization, Peripheral; Endovascular Procedures; Equipment Design; Femoral Artery; Hemostatic Techniques; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Punctures; Surgical Instruments; Tomography, X-Ray Computed; Treatment Outcome

Topics: Aged; Alloys; Aneurysm, False; Angiography, Digital Subtraction; Arterial Occlusive Diseases; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Male; Prosthesis Design; Stents; Treatment Outcome

Stent fracture with pseudoaneurysm formation in the femoropopliteal artery has uncommonly been reported. We present the case of a 72-year-old man with a fracture of self-expanding nitinol stent and a pseudoaneurysm formation in the suprageniculate popliteal artery. The popliteal artery was successfully reconstructed with a small saphenous vein graft interposition.

Topics: Aged; Alloys; Aneurysm, False; Angioplasty; Arterial Occlusive Diseases; Humans; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Saphenous Vein; Stents; Tomography, X-Ray Computed; Treatment Outcome; Vascular System Injuries

A 66-year-old man was treated for disabling right leg calf claudication with angioplasty and stenting of a chronically occluded superficial femoral artery. During attempted subintimal passage, the guidewire tracked extralumenally, which was not recognized, but it was successfully redirected into the true lumen distal to the occlusion with the use of the Outback (Cordis Endovascular, Miami Lakes, Fla) re-entry device. A bare metal nitinol stent was initially deployed extralumenally in the perivascular soft tissue. The patient returned for reintervention 9 days later complaining of pain and discoloration of the popliteal space. Duplex evaluation of the superficial femoral artery revealed a pseudoaneurysm, and Viabahn stent grafts (W. L. Gore & Assoc, Flagstaff, Ariz) were successfully deployed to produce an endovascular percutaneous prosthetic bypass.

Topics: Aged; Alloys; Aneurysm, False; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Disease; Constriction, Pathologic; Femoral Artery; Humans; Intermittent Claudication; Male; Prosthesis Design; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex

With the advancement of technology and manufacturing of prosthetic grafts, non- anastomotic pseudoaneurysm arising from a graft is now uncommon. Here we report a case of non-anastomotic pseudo aneurysm occurring 21 years after implantation of ePTFE femoro-femoral crossover graft. An 80 year old female with a previous history of a femoro- femoral cross-over bypass surgery performed using a10 mm reinforced polytetrafluoroethylene graft presented with a pulsatile lump in her right groin. CT angiography showed a fusiform type non-ruptured false aneurysm of 6.4 cm maximum diameter and was arising directly from the graft. Because of the risk of rupture, the patient was treated endovascularly with 13 mm * 8 cm Viabahn self-expanding covered stent across the pseudo aneurysm. The final angiographic results were excellent and showed resolution of the aneurysm with good flow through the graft and distal vessel. This type of complication is easily diagnosed by clinical examination and imaging studies, which display an aneurysm of the graft remote from the anastomosis. Percutaneous intervention with covered stent may offer an easy and safe way to treat this type of aneurysm.

Topics: Aged, 80 and over; Alloys; Aneurysm, False; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Endovascular Procedures; Female; Femoral Artery; Femoral Vein; Humans; Polytetrafluoroethylene; Prosthesis Design; Reoperation; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler, Duplex

Blunt trauma-induced aortic injury traditionally has been treated with early open surgical repair. However, recently endovascular stent-graft technology is considered a less-invasive therapeutic alternative, and flexible stent-grafts, such as the Matsui-Kitamura stent-graft (MKSG), are being used widely. We report our experience with the curved MKSG in treating thoracic aortic injuries.. Nine patients with traumatic thoracic aortic injury underwent endovascular surgery (8, emergency; 1, elective) with curved MKSG. The study variables were Injury Severity Score, endovascular surgery duration, aortic and stent-graft diameter, stay in the intensive care unit, follow-up period, and mortality. An MKSG was constructed using the Matsui-Kitamura stent and a polyester fabric graft. The stent-graft was placed using the transfemoral approach and the wire-tug technique.. The mean Injury Severity Score was 42.3; 5 patients required 6 emergency procedures before the endovascular procedure (pneumothorax or hemothorax drainage, 5; transarterial embolization, 1). In 8 patients (88.9%), we achieved complete pseudoaneurysm exclusion or hemostasis in the injured portion. There were no postoperative complications; blood loss was minimal, and the intensive care unit stay was 13.4 days. The overall hospital mortality was 22.2% (n = 2; causes of death were unrelated to MKSG placement). Neither intervention-related mortality during follow-up (mean, 237.7 days) nor late endovascular graft-related complications (endoleak or graft migration) were noted.. Although this study is limited by a small sample size and short follow-up period, no collapse or stent-graft fractures were noted. Thus, MKSG placement for traumatic thoracic aortic injury appears a safe and effective therapy.

Topics: Adult; Aged; Alloys; Aneurysm, False; Aorta, Thoracic; Blood Vessel Prosthesis; Elective Surgical Procedures; Emergencies; Equipment Design; Hemostasis, Endoscopic; Humans; Middle Aged; Prosthesis Design; Stents; Wounds, Nonpenetrating

The use of vascular plug devices for the occlusion of high-flow lesions is a relatively new and successful procedure in peripheral and cardiopulmonary interventions. We report on the use and efficiency of the Amplatzer vascular plug in a small clinical series and discuss its potential for occlusion of large vessels and high-flow lesions in neurointerventions.. Between 2005 and 2007 four patients (mean age 38.5 years, range 16-62 years) were treated with the device, in three patients to achieve parent artery occlusion of the internal carotid artery, in one patient to occlude a high-flow arteriovenous fistula of the neck. The application, time to occlusion, and angiographic and clinical results and the follow-up were evaluated.. Navigation, positioning and detachment of the device were satisfactory in all cases. No flow-related migration of the plug was seen. The cessation of flow was delayed by a mean of 10.5 min after deployment of the first device. In the procedures involving vessel sacrifice, two devices had to be deployed to achieve total occlusion. No patient experienced new neurological deficits; the 3-month follow-up revealed stable results.. The Amplatzer vascular plug can be adapted for the treatment of high-flow lesions and parent artery occlusions in the head and neck. In this small series the use of the devices was uncomplicated and safe. The rigid and large delivery device and the delayed cessation of flow currently limit the device's use in neurointerventions.

Topics: Adolescent; Alloys; Aneurysm, False; Balloon Occlusion; Carotid-Cavernous Sinus Fistula; Embolization, Therapeutic; Equipment Design; Female; Humans; Intracranial Aneurysm; Male; Middle Aged; Radiography

An iatrogenic fistula and consequent pseudoaneurysm developed between the right subclavian artery and right pulmonary artery as a result of misplacement of a hemodialysis access catheter. The patient, who was considered to be at high risk for surgical repair, successfully underwent endovascular treatment that involved insertion of two nitinol stents covered with expanded polytetrafluoroethylene (stent-grafts), one into the right subclavian artery and the other into a right upper lobe pulmonary artery. Multi-detector row computed tomographic angiography played an integral role in the evaluation of the patient's vascular injury and treatment planning.

Topics: Aged; Alloys; Aneurysm, False; Arterio-Arterial Fistula; Blood Vessel Prosthesis Implantation; Catheterization; Female; Humans; Iatrogenic Disease; Polytetrafluoroethylene; Prosthesis Design; Pulmonary Artery; Radiography, Interventional; Renal Dialysis; Stents; Subclavian Artery; Tomography, X-Ray Computed; Treatment Outcome

A 77-year-old man was transferred to the hospital with swelling of his neck and oropharynx after a stab injury to his oral cavity with pruning shears. Findings at complete neurologic examination were normal. Contrast-enhanced computed tomography (CT) and angiography revealed a pseudoaneurysm at the pharyngeal portion of the right internal carotid artery. Endovascular treatment was undertaken by using the double bare stent technique. The pseudoaneurysm was completely occluded immediately after the procedure. There were no complications. There were no further symptoms or evidence of recurrence of the aneurysm during the 18-month follow-up period. The double bare stent technique is safe and effective for the treatment of zone III carotid artery stab injuries.

Topics: Aged; Alloys; Aneurysm, False; Angiography, Digital Subtraction; Carotid Artery Injuries; Carotid Artery, Internal; Humans; Male; Prosthesis Design; Stents; Tomography, X-Ray Computed; Treatment Outcome; Vascular Surgical Procedures; Wounds, Stab

This report describes an unusual complication related to inferior vena cava (IVC) filter placement. A 50-year-old woman undergoing long-term anticoagulation presented to her primary care physician with abdominal pain after a motor vehicle accident. An IVC filter had been placed 7 years earlier. Computed tomography of the abdomen demonstrated a moderate perisplenic hematoma and a fragmented IVC filter penetrating the aorta. A small infrarenal aortic pseudoaneurysm had developed at the penetration site. Wallgraft placement successfully sealed the aneurysm.

Topics: Abdominal Pain; Accidents, Traffic; Alloys; Aneurysm, False; Aorta, Abdominal; Aortic Aneurysm, Abdominal; Blood Vessel Prosthesis Implantation; Female; Hematoma; Humans; Middle Aged; Spleen; Stents; Vena Cava Filters

Topics: Aged; Alloys; Anastomosis, Surgical; Aneurysm, False; Blood Vessel Prosthesis; Catheterization, Central Venous; Coated Materials, Biocompatible; Humans; Iatrogenic Disease; Male; Polytetrafluoroethylene; Stents; Subclavian Artery; Vertebral Artery

Treatment of dissecting pseudoaneurysms of the distal cervical internal carotid artery with preservation of the parent artery by using stents or coils has become routine. Tortuosity remains a significant obstacle to successful endovascular treatment in some cases. We report the use of a stent-coil technique to treat a nonhealing dissecting pseudoaneurysm and associated stenosis with anatomic preservation of a redundant loop involving the stented arterial segment. This was accomplished by using a Neuroform dedicated intracranial stent.

Topics: Adult; Alloys; Aneurysm, False; Aspirin; Carotid Artery, Internal, Dissection; Carotid Stenosis; Combined Modality Therapy; Dominance, Cerebral; Embolization, Therapeutic; Female; Follow-Up Studies; Humans; Ischemic Attack, Transient; Platelet Aggregation Inhibitors; Radiography; Stents