nitinol and Chronic-Disease

To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions.. The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months.. All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months.. MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months.

Topics: Aged; Alloys; Ankle Brachial Index; Australia; Blood Flow Velocity; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; New Zealand; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Regional Blood Flow; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).. Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging.. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure.. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74).. The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chronic Disease; Combined Modality Therapy; Constriction, Pathologic; Female; Femoral Artery; Humans; Laser Therapy; Lasers, Excimer; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency

To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).. The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7±10.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions.. A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (<30% residual stenosis) was achieved in 90.0%. There were no in-hospital major adverse events. Primary patency (defined as a peak systolic velocity ratio <2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months.. In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Blood Flow Velocity; Chronic Disease; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recovery of Function; Stents; Time Factors; Treatment Outcome; United States; Vascular Calcification; Vascular Patency

To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL).. One hundred four patients (55 men; mean age 66+/-19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention.. QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting.. Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Female; Femoral Artery; Health Status Indicators; Humans; Ischemia; Male; Middle Aged; Prospective Studies; Prosthesis Design; Quality of Life; Recovery of Function; Recurrence; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Surgical Procedures; Walking

Topics: Aged; Alloys; Basement Membrane; Chronic Disease; Coloring Agents; Endotamponade; Female; Fluorescein Angiography; Humans; Indocyanine Green; Middle Aged; Recurrence; Retinal Perforations; Stents; Surgical Flaps; Vitrectomy

Topics: Alloys; Chronic Disease; Female; Femoral Vein; Humans; Iliac Vein; Male; Postthrombotic Syndrome; Registries; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions.. A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter.. Recanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%.. Findings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.

Topics: Adolescent; Adult; Aged; Alloys; Chronic Disease; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Iliac Vein; Male; Middle Aged; Retrospective Studies; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Diseases; Vascular Patency; Vena Cava, Inferior; Young Adult

Endovascular treatment is indicated for the treatment of symptomatic thoracic central vein obstruction (TCVO) but is limited by high rates of restenosis and the need for re-intervention. The aim was to assess the safety and mid-term patency of a novel dedicated venous stent for the treatment of TCVO of benign aetiology.. This was a prospective single centre observational study of 20 patients (median age 65 years, 50% male) referred for the treatment of symptomatic chronic (>three months duration) TCVO between May 2016 and January 2018. Balloon angioplasty with implantation of a self expanding nitinol stent (Vici, Boston Scientific, Marlborough, MA, USA) was performed in all patients. Clinical records including demographics, aetiologies and types of TCVO, and procedural details were recorded. Patients were followed up clinically at one, six, and 12 months. Primary and assisted primary patency were reported.. All 20 lesions were total occlusions, of which 55% (n = 11) were de novo, 10% (n = 2) peri-stent restenosis, and 35% (n = 7) in-stent re-occlusion. The aetiology of TCVO was predominantly (95%) because of multiple or prolonged central venous line insertion. The procedural success rate was 90% (18/20) with no procedural complications. The median follow up was 13.5 months. Primary patency was 100% at 6 months. One patient required re-intervention for stent in segment restenosis at 7 months. The assisted primary patency rate was 100% at 12 months.. Endovascular treatment of benign TCVO with the novel dedicated venous stent was safe and effective in relieving obstructive symptoms with excellent one year patency rates.

Topics: Aged; Alloys; Chronic Disease; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Male; Middle Aged; Phlebography; Prospective Studies; Registries; Risk Factors; Self Expandable Metallic Stents; Thorax; Time Factors; Treatment Outcome; Vascular Diseases; Vascular Patency; Veins

Our goal was to assess the viability of an alternative anchoring design for a transcatheter aortic valve based on a form-fitting principle with a self-expanding nitinol frame to reduce issues related to excess radial force.. A 26-mm outer diameter prototype of a self-expanding nitinol frame was developed to reduce the amount of necessary radial force by utilizing additional anchoring via protruding arms in each aortic sinus, thus allowing for a form-fitting principle as well as the coaxial self-alignment of the valve inside the native anatomy. The prototype valve was implanted via a transapical approach in the orthotopic position in 2 sheep. Follow-up examinations were performed at regular intervals during a 3-month period to confirm adequate function and anchoring.. Observation demonstrated secure, facilitated positioning with perfect alignment of the stent in the aortic sinuses. Repeated transthoracic echocardiography showed adequate valve function over the entire period with no change in the valve position, gradients or regurgitation. The animals remained in sinus rhythm during the entire period.. The prototype frame with its form-fitting properties has the potential to resolve issues related to malpositioning and excess radial force for transcatheter aortic valves as well as to extend the treatment possibilities to pure aortic insufficiencies. The stent is presently being tested in vitro for its long-term durability.

Topics: Alloys; Animals; Aortic Valve; Aortic Valve Insufficiency; Chronic Disease; Disease Models, Animal; Echocardiography; Feasibility Studies; Heart Valve Prosthesis; Prosthesis Design; Sheep; Stents; Transcatheter Aortic Valve Replacement

The aim of the study was to investigate venous patency and clinical outcomes for endovascular treatment of iliofemoral venous obstruction in patients with post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) with dedicated self-expanding nitinol stents.. Data were collected from the prospective Swiss Venous Stent Registry, enrolling consecutive patients with a standardized follow-up procedure since January 2008. Patency was evaluated by duplex sonography and clinical outcome by various scores including the Villalta score at baseline, three, six, and 12 months, and then annually after endovascular therapy.. Overall, 93 patients (64 PTS, 29 NIVL) were analysed. Mean follow-up time was 20 ± 16 (range 3-70) months. A total of 11 (12 %) patients had a stent occlusion, all of which occurred in the PTS group, and 13 (14 %) patients had a symptomatic stent stenosis. Primary patency was 79 % (95 % CI 68-87 %) at 12 months and 72 % (95 % CI 59-82 %) at 24 months. In PTS patients, primary patency at 12 months was 75 % (95 % CI 61-84 %) vs. 89 % (95 % CI 63-97 %) in NIVL patients (p = 0.10). Secondary patency at 24 months was 94 % (95 % CI 84-98 %) in PTS and 100 % in NIVL, p = 0.19). Overall, 62 (67 %) patients were free from PTS at the latest follow-up with a Villalta score < 5 points. Predictive factors for the loss of primary patency were stents placed below the inguinal ligament (OR 2.59, 95 % CI, 0.99-6.84, p = 0.05).. In symptomatic patients with chronic iliofemoral vein obstruction, endovascular therapy with self-expanding nitinol stents was associated with favourable patency rates and clinical improvement in the majority of patients.

Topics: Adult; Aged; Alloys; Chronic Disease; Endovascular Procedures; Female; Femoral Vein; Humans; Iliac Vein; Male; Middle Aged; Postthrombotic Syndrome; Prosthesis Design; Registries; Self Expandable Metallic Stents; Switzerland; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Venous Insufficiency

The aim was to compare outcomes of self expanding PTFE covered stents (CSs) with bare metal stents (BMSs) in the treatment of iliac artery occlusions (IAOs).. Between January 2009 and December 2015, 128 iliac arteries were stented for IAO. A CS was implanted in 78 iliac arteries (61%) and a BMS in 50 (49%). After propensity score matching, 94 limbs were selected and underwent stenting (47 for each group). Thirty day outcomes and midterm patency were compared; follow-up results were analysed with Kaplan-Meier curves.. Overall, iliac lesions were classified by limb as TASC B (19%), C (21%), and D (60%). Technical success was 98%. Comparing CS versus BMS, the early cumulative surgical complication rate (12% vs. 12%, p = 1.0) and 30 day mortality rate (2% vs. 2%, p = 1.0) were equivalent. At 36 months (average 23 ± 17), overall primary patency was similar between CS and BMS (87% vs. 66%, p = .06), and this finding was maintained after stratification by TASC B (p = .29) and C (p = .27), but for TASC D, CSs demonstrated a higher patency rate (CS, 88% vs. BMS, 54%; p = .03). In particular, patency was in favour of CSs for IAOs > 3.5 cm in length (p = .04), total lesion length > 6 cm (p = .04), and IAO with calcification > 75% of the arterial wall circumference (p = .01).. Overall, the use of self expanding CS for IAOs has similar early and midterm outcomes compared with BMS. Even if further confirmatory studies are needed, CSs seem to have higher midterm patency rates than BMSs for TASC D lesions, IAOs with a total lesion length > 6 cm, occlusion length > 3.5 cm, and calcification involving > 75% of the arterial wall circumference. These specific anatomical parameters may be useful to the operator when deciding between CS and BMS during endovascular planning.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Chi-Square Distribution; Chronic Disease; Coated Materials, Biocompatible; Computed Tomography Angiography; Constriction, Pathologic; Female; Humans; Iliac Artery; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Peripheral Arterial Disease; Polytetrafluoroethylene; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Objective This study aimed to evaluate the safety and the efficacy of primary stenting to treat Trans-Atlantic Inter-Society Consensus II (TASC) D femoropopliteal lesions. Background Advances in wire, balloon and stent design have been reported to improve the durability of stenting of longer femoropopliteal lesions. Methods A total of 57 limbs of 53 patients with Rutherford stage 3 to 6 due to TASC D femoropopliteal lesions were treated with a self-expanding nitinol stent in a prospective, single-centre, observational study. End points of interest included primary and secondary patency, target lesion revascularization, in-stent restenosis, major adverse cardiovascular events, Rutherford class improvement and change in walking capacity at 1 year. Results A total of 53 patients (57 lesions) were treated with a self-expanding nitinol stent and final procedural success was 91.2%. The median length of the treated segment was 330 ± 96 mm. The median stented segment was 366 ± 71 mm and the mean number of the stents was 2.1 ± 0.9. At 1 year, primary and secondary patency rates were 63.9% and 82.1%, respectively. Major adverse cardiovascular events occurred in 11 patients (22.9%), and[[strike_start]] [[strike_end]]significant benefits were observed in Rutherford class and walking distance (both P < 0.001). Conclusions Primary implantation of self-expanding nitinol stents for the treatment of TASC D femoropopliteal lesions appears to be safe and effective, especially in patients who have multiple co-morbidities and a high risk for surgical bypass. The risk of restenosis was higher when long stenting was extended to the popliteal artery.

Topics: Aged; Alloys; Angioplasty; Arterial Occlusive Diseases; Chronic Disease; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Popliteal Artery; Prospective Studies; Prosthesis Design; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex

To evaluate the long-term outcomes of self-expandable nitinol stent implantation with intraluminal angioplasty for chronic total occlusion (CTO) in the superficial femoral artery (SFA) of patients with TransAtlantic Inter-Society Consensus (TASC) D lesions.. From 2004 to 2011, self-expandable nitinol stent implantation in SFA was performed successfully in 72 consecutive limbs of 68 patients with TASC D lesions. These patients were assessed for an average of 38.8 ± 25.6 months. The procedure was performed using a 0.014" or 0.018" guidewire and intraluminal angioplasty.. Patients with hemodialysis constituted 20.6% of cases. The mean occlusion length was 244.6 ± 34.1 mm. A bidirectional approach was performed in 69.4% of cases. Primary patency rates were 77.9%, 71.9%, 67.2%, and 51.5% at 1 year, 2 years, 3 years, and 5 years, respectively. Secondary patency rates were 88.6%, 78.7%, 71.1%, and 56.0% at 1 year, 2 years, 3 years, and 5 years, respectively. Cox regression multivariate analysis for hemodialysis pertaining to loss of primary and secondary patency resulted in hazard ratio = 2.555 (95% confidence interval, 1.108-5.891; P=.03) for loss of primary patency and hazard ratio = 3.615 (95% confidence interval, 1.380-9.471; P=.01) for loss of secondary patency.. Long-term patency of self-expandable nitinol intraluminal stent implantation with intraluminal angioplasty to treat CTO (TASC D) in SFA is promising. Hemodialysis was the only independent predictor for loss of primary and secondary patency.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Consensus; Endovascular Procedures; Female; Femoral Artery; Follow-Up Studies; Humans; Leg; Male; Prosthesis Design; Retrospective Studies; Self Expandable Metallic Stents; Time Factors

Critical limb ischemia may be the consequence of chronic occlusion of an aneurysm of popliteal artery. Endovascular repairs have the potential to be less invasive than open surgery and to allow the treatment, during the same procedure, of occlusive infrapopliteal diseases achieving a better distal outflow. Eleven patients with occluded popliteal artery aneurysm (PAA) underwent an endovascular repair of PAA using a new technique, by positioning of a Viabahn graft inside a bare nitinol stent, deployed at the level of aneurysm with the intent to avoid distal embolization and to assure an external scaffold for the Viabahn graft. Immediate success rate was 100%. A peroneal artery embolization occurred in 1 patient (9%) and was successfully treated by stent implantation. Four (36.4%) patients needed a below-the-knee revascularization to achieve at least 1 vessel line to the foot. Mean postoperative hospital stay was 2.6 days. At 24-month follow-up, primary patency, target lesion revascularization, and major amputation rates were 82%, 9%, and 0%, respectively. All patients are still alive at last follow-up visit. The endovascular repair with the combined use of a bare metal stent and Viabahn graft resulted in a low incidence of distal embolization and major amputation rate, with an excellent 24-month patency rate, and may offer a safe alternative to open surgery for the treatment of occluded PAAs.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Disease; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Limb Salvage; Male; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Caval valve implantation has been suggested for transcatheter treatment of severe tricuspid regurgitation (TR). Combining the interventional technique with the promising surgical experience with decellularized valves, we sought to evaluate the functional and structural outcome of decellularized pericardial tissue valves (dTVs) in the low-pressure venous circulation in a chronic model of TR.. Sixteen pericardial tissue valves were heterotopically implanted in the inferior and superior vena cava in a sheep model (54-98 kg; median 74.5 kg, n = 8) of severe TR. The devices were assembled using self-expanding nitinol stents and bovine pericardia decellularized by a detergent-based protocol (group dTV; n = 8). Glutaraldehyde-fixed pericardial tissue valves served as control (GaTV, n = 8). After 6 months, device function and structural maturation were analyzed using echocardiographic, histologic, immunohistologic, and electron microscopic approaches. After implantation, cardiac output increased significantly from 3.7 ± 1.1 l/min to 4.8 ± 1.1 l/min (P < 0.05) and competent valve function was verified by angiography. At 6 months, angiographic and echocardiographic evaluation revealed moderate to severe regurgitation in all GaTV. In contrast, five of the eight dTVs functioned well with only minor regurgitation. In these animals, autopsy revealed preserved valve structure with tender leaflets without signs of thrombosis or calcification. Conversely, GaTV showed severe degeneration with large calcification areas. Microscopic and histologic analysis confirmed endothelial repopulation in both valve types. However, additional interstitial reseeding was observed in decellularized valves.. In the venous circulation in severe TR, decellularized valves show superior functional performance compared to Ga-fixed tissue valves. Macroscopic and microscopic analyses suggest preserved structural integrity and advanced endothelial and interstitial repopulation with evidence of less degradation in dTV. © 2014 Wiley Periodicals, Inc.

Topics: Alloys; Animals; Bioprosthesis; Cardiac Catheterization; Chronic Disease; Disease Models, Animal; Female; Gene Expression Regulation; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemodynamics; Prosthesis Design; Recovery of Function; Severity of Illness Index; Sheep; Stents; Time Factors; Tricuspid Valve; Tricuspid Valve Insufficiency; Ultrasonography; Vena Cava, Inferior; Vena Cava, Superior

Deep venous stenting has become the primary treatment option for chronic venous obstructive disease, both for iliac vein compression and post-thrombotic venous lesions. Until recently, only stents aimed at arterial pathology were used, because no dedicated venous stents were available. However, three such stents have now become available. These venous stents are characterized by increased length, diameter, flexibility, and radial force. This study reports an early experience with one of these devices; the sinus Venous stent (OptiMed GmbH, Ettlingen, Germany).. Between March 2012 and July 2014, 75 patients were treated with the sinus Venous stent: 35 cases of iliac vein compression syndrome and 40 cases of unilateral chronic obstruction in post-thrombotic syndrome (PTS). Diagnosis of relevant obstruction was made using clinical evaluation, duplex ultrasound, and magnetic resonance venography. Patency during follow up was assessed with duplex ultrasound. Clinical improvement was assessed by VCSS, Villalta score, rate of ulcer healing, and improvement of venous claudication.. The cumulative patency rates at 3, 6, and 12 months were 99%, 96%, and 92%, respectively. The cumulative assisted primary patency rates were 99% at 3, 6, and 12 months. The cumulative secondary patency rate at 12 months was 100%. Differences exist in patency rate between the subgroups of non-thrombotic and post-thrombotic, with the first showing no re-occlusions. All re-thromboses in the PTS group were treated by ancillary treatment modalities. VCSS and Villalta score decreased significantly after stenting, as did venous claudication. Morbidity was low without clinically relevant pulmonary embolism, and mortality was nil. Although two out of seven ulcers healed temporarily, no ulcer remained healed at 12 months follow up.. Short-term clinical results using the sinus Venous stent are excellent, with significant symptom reduction, low morbidity rates, and no mortality. Loss of stent patency is seen less often compared with arterial stents described in the literature.

Topics: Adolescent; Adult; Aged; Alloys; Angioplasty, Balloon; Chronic Disease; Female; Humans; Iliac Vein; Intermittent Claudication; Kaplan-Meier Estimate; Leg Ulcer; Magnetic Resonance Angiography; Male; May-Thurner Syndrome; Middle Aged; Netherlands; Phlebography; Postthrombotic Syndrome; Prosthesis Design; Recurrence; Stents; Tertiary Care Centers; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Wound Healing; Young Adult

Persistent retrograde false lumen perfusion is a common mode of failure after thoracic endovascular aortic repair (TEVAR) for chronic dissection. Objectives were to describe a novel endovascular approach for false lumen occlusion and assess outcomes.. From 2009 to 2013, 21 patients (mean age, 64 ± 11 years) with chronic thoracoabdominal dissection underwent adjunctive false lumen embolization using covered stent devices for persistent retrograde perfusion. Eight patients had type B dissection, 13 had residual dissection after prior type A repair, and all were deemed high risk for open operation. False lumen embolization in 17 patients was an adjunct at the initial TEVAR or extension, including two as elephant trunk completion. In the other four, this was done as an isolated procedure, and three had previously undergone TEVAR sparing the celiac artery. Covered stent devices included iliac plugs in 18, nitinol embolization plugs in two, and occluded stent graft in one. More than one device was used in 15 patients.. There was one hospital death due to left subclavian artery aneurysm rupture but no patient had stroke, paraplegia, myocardial infarction, or renal failure. Mean follow-up was 25 ± 19 months. During surveillance computed tomography imaging, false lumen thrombosis was noted in all patients, but four required further embolization because the thrombosis was incomplete. Mean maximum aortic diameter decreased from 64 ± 14 to 59 ± 15 mm. There was one late death from intracranial hemorrhage and no aortic ruptures.. Adjunctive false lumen embolization with a covered stent device promotes thrombosis and remodeling after stent grafting the true lumen for chronic dissection. Further study of this strategy is warranted.

Topics: Aged; Alloys; Aortic Aneurysm, Thoracic; Aortic Dissection; Aortography; Chronic Disease; Embolization, Therapeutic; Endovascular Procedures; Female; Humans; Male; Middle Aged; Prosthesis Design; Stents; Thrombosis; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vascular Remodeling

To investigate the 5-year patency rates and predictors of restenosis after self-expanding nitinol stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions.. Outcomes and long-term patency rates after self-expanding nitinol stent for CTO in the SFPA lesions have not been clarified.. From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding nitinol stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding nitinol stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis.. Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total stent length was 198 ± 7 mm, and mean stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis.. Women and patients requiring small stents failed to maintain primary patency when treated with self-expanding nitinol stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Constriction, Pathologic; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Sex Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI).. Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR<2.5) and respectively no target lesion revascularization performed within 12 months. The average lesion length of the treated femoro-popliteal segment was 315 mm. Performing spot stenting average stent length in all patients was 245 mm (minimal 215 mm, maximal 315 mm).. Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%.. Endovascular intervention of long SFA occlusions using subintimal or intraluminal recanalization technique with implantation of the Pulsar-18 SE nitinol stent in CLI patients is safe and clinically effective with a primary patency rate after 12 months of 77% and a freedom from target lesion revascularization rate of 86%.

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Chronic Disease; Constriction, Pathologic; Critical Illness; Exercise Test; Exercise Tolerance; Female; Femoral Artery; Germany; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Recovery of Function; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Wound Healing

Interventional closure of patent arterial duct has become an accepted alternative to surgical closure. Clinical trial with "Nit-Occlud® PDA-R".. To assess the safety and efficacy of the device, we performed a prospective clinical study between June, 2009 and December, 2010 in La Paz, Bolivia. In all, 29 - 22 female patients and 7 male patients - out of 59 patients were selected on the basis of inclusion criteria. The procedures were performed under sedation at an age and weight of 5.7 years and 22.7 kilograms, respectively, with 4-6 French arterial sheaths and 5-7 French venous sheaths. The minimal diameter of the duct was 3.5 millimetres. The procedure, fluoroscopy, and hospitalisation times were 96.4 minutes (55 to 145), 13.1 minutes (3 to 25.2), and 24 hours, respectively. The "Nit-Occlud® PDA-R" was successfully deployed in all patients. Immediate, 24-hour, 1-, 3-, and 6-month closure rates were 65.5%, 79.3%, 96.5%, and 100%, respectively. The systolic pulmonary pressure diminished from 37 millimetres of mercury (21 to 57) before the intervention to 31 millimetres of mercury (21 to 45) after the intervention. No early or late embolisation, haemolysis, left pulmonary artery, or descending aorta obstruction occurred.. We conclude that the "Nit-Occlud® PDA-R" device is safe and effective in closing patent arterial duct up to a diameter of 8 millimetres.

Topics: Adolescent; Adult; Alloys; Bolivia; Cardiac Catheterization; Child; Child, Preschool; Chronic Disease; Ductus Arteriosus, Patent; Female; Fluoroscopy; Humans; Hypoxia; Infant; Male; Middle Aged; Prospective Studies; Prostheses and Implants; Treatment Outcome; Young Adult

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

To evaluate the prevalence, factors, and clinical impact of self-expanding stent fracture following iliac artery stenting.. A review of the endovascular registry database for our department showed 353 patients with occlusive diseases of the iliac artery who underwent stenting between 1997 and 2007. While clinical data and images were retrospectively reviewed for all patients, 165 patients who underwent self-expanding stenting and plain radiograph with >or=6-months follow-up were analyzed. Mean follow-up was 43 months for 305 stents (elgiloy, n = 83; nitinol, n = 222) implanted in 216 iliac arteries. The mean duration until the last imaging study was 38 months. Items concerning prevalence of stent fracture, factors associated with fracture, and outcomes for patients with stent fracture were analyzed.. Stent fracture was detected in 11 of 216 iliac arteries (5.1%). In stent-based analysis, 11 of 305 stents (3.6%) showed stent fracture, classified as type I in 2 stents, type II in 3 stents, type III in 4 stents, type IV in 1 stent, and type V in 1 stent. Stent fracture was detected in 11 of 222 nitinol stents (5.0%), but no Elgiloy stents. Cox proportional hazards regression model indicated stenting for chronic occlusion as a risk factor associated with nitinol stent fracture (hazard ratio [HR] = 6.09, P = 0.008, 95% confidence interval [CI] 1.59-23.3). Cumulative primary patency rates in iliac arteries with and without fractured stents were 90% and 91% at 8 years (P = .80), respectively.. Fracture of self-expanding stents is rare in iliac arteries, but stenting for chronic occlusion represents a risk factor for fracture. Fractures of stents placed in iliac arteries rarely affect patency.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Equipment Failure Analysis; Female; Humans; Iliac Artery; Male; Middle Aged; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Radiography; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Failure; Vascular Patency

It has been reported that nitinol stents provide higher patency in chronic phase than stainless steel stents after intervention to superficial femoral artery (SFA). However, there are few reports about stent patency for chronic total occlusion of SFA (SFA CTO).. To compare clinical outcomes of self-expanding nitinol stents and stainless steel stents after percutaneous peripheral intervention (PPI) for SFA CTO.. Between April 2004 and August 2007, a total of 25 SFA CTO lesions (nitinol stent group, 13; stainless steel stent group, 12) in 21 patients were treated with PPI, all patients were followed clinically, and 21 lesions (nitinol, 9; stainless steel, 12) received follow-up angiography. There was no significant difference in baseline characteristics, mean stent diameter (7.3+/-0.7 mm vs. 6.9+/-1.2 mm, p=0.32), pre-ankle-brachial index (ABI), and Fontaine stage between groups. Mean occlusion length and stent length were significantly longer (129.5+/-54.9 mm vs. 39.0+/-20.6 mm, 250.8+/-90.0 mm vs. 145.2+/-64.6 mm, respectively, p<0.01) and number of stents was significantly larger (2.8+/-0.9 vs. 1.6+/-0.5, p<0.01) in the nitinol stent group. At follow-up, ABI was significantly lower (0.73+/-0.20 vs. 0.95+/-0.13, p=0.04), restenosis rate and target lesion revascularization was significantly higher (58.3% vs. 15.4%, p=0.03; 50.0% vs. 7.7%, p=0.02, respectively) in the stainless steel stent group.. Our study demonstrates the superiority of nitinol stent implantation compared with stainless steel stent implantation for SFA CTO.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Chronic Disease; Drug-Eluting Stents; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Radiography; Stainless Steel; Treatment Outcome

This registry aims at evaluating the use and efficacy of the EndoFit stent graft (LeMaitre Vascular, Burlington MA, USA) for the treatment of acute and chronic aortic type B dissections.. Indications for treatment are: recurrent pain, persistent hypertension, serious organ malperfusion in patients with acute or subacute type B aortic dissection and progression of aneurysm size despite maximal medical therapy in patient with chronic type B dissection. Exclusion criteria are: age under 18 years old, pregnancy, coagulopathy or bleeding disorders, connective tissue disease. Straight or tapered EndoFit stent graft will be used in acute or chronical dissection respectively.. The primary endpoint is the assessment of the safety and the efficacy of the EndoFit Thoracic Endoluminal Stent Graft in the exclusion of the thoracic aortic false lumen in acute and chronic type B aortic dissections. The assessment includes: technical success, thrombosis of the thoracic false lumen at 6 months, rate of aorto-enteric, aorto-esophageal and aorto-bronchial fistula, serious adverse events including death, stroke, paraplegia, myocardial infarction, multi-organ failure and renal insufficiency. Secondary endpoints are: the technical feasibility of device implantation in 2 different shapes (straight for acute dissection and tapered for chronic dissection), the technical feasibility of endovascular placement of tapered grafts in vessels of different size and shape, the integrity of the device fabric and wire structure, the occurrence of device migration, the patient's neurological, cardiac and cardiovascular status, the blood flow supply to abdominal and visceral organs arteries and any secondary intervention including stentgraft extension, coiling or surgical conversion. One hundred patients enrolled have been defined to allow reliable findings and results.. The DEDICATED is the first prospective data collection registry focusing on the role of tapered stentgrafts in chronic aortic dissection and their efficacy in excluding the dissected thoracic false lumen.

Topics: Acute Disease; Alloys; Aortic Aneurysm, Thoracic; Aortic Dissection; Blood Vessel Prosthesis; Chronic Disease; Disease Progression; Europe; Humans; Pilot Projects; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Registries; Safety; Stents; Treatment Outcome

The purpose of this study was to evaluate the safety and efficacy of self-expanding SMART nitinol stents in patients with chronic limb ischemia (CLI) demonstrating Type B or C TransAtlantic Inter-Society Consensus (TASC) lesions in the femoropopliteal (FP) arterial segment. There were 137 lower limbs in 122 patients with chronic limb ischemia, secondary to TASC A (n = 12) or TASC B,C (n = 125) lesions in the FP artery were treated with Cordis SMART self-expanding nitinol stents. Hemodynamic stent failure occurred with the presence of a greater than 50% stenosis within the stented segment, measured by standard Duplex velocity criteria, obtained at various postintervention intervals. The hemodynamic primary stent patency was calculated by life-table methods from the time of intervention, uninterrupted by hemodynamic stent failure. The mean lesion length was 12.2 cm (range, 4 to 28 cm). The technical success was 98%. Within the follow-up period (mean, 302 days), 24 limbs were diagnosed with hemodynamic stent failure. The hemodynamic primary stent patency rates were 92%, 76%, 66%, and 60% at 6, 12, 18, and 24-months, respectively. These data provide objective evidence that endovascular treatment of FP TASC A, B and C lesions using self-expanding nitinol SMART stents in patients with chronic limb ischemia provides favorable safety and durability outcomes. Further investigation is warranted.

Topics: Aged; Alloys; Angioplasty, Balloon; Catheterization, Peripheral; Chronic Disease; Female; Femoral Artery; Humans; Ischemia; Leg; Male; Popliteal Artery; Radiography, Interventional; Stents; Treatment Failure; Vascular Patency

Topics: Aged; Alloys; Chronic Disease; Cough; Female; Humans; Stents; Tracheal Diseases