scholarly journals Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis

2020 ◽  
Vol 27 (5) ◽  
pp. 728-736 ◽  
Author(s):  
Jean M. Panneton ◽  
Jean Bismuth ◽  
Bruce H. Gray ◽  
Andrew Holden
Keyword(s):  
Functional Status ◽  
Stent Graft ◽  
De Novo ◽  
Univariate Analysis ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Performance Goal ◽  
Aortoiliac Occlusive Disease

Purpose: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. Materials and Methods: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study ( ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. Results: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and primary assisted patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status. Conclusion: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

scholarly journals Meta-analysis of Individual Patient Data After Kissing Stent Treatment for Aortoiliac Occlusive Disease

2018 ◽  
Vol 26 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Erik Groot Jebbink ◽  
Suzanne Holewijn ◽  
Michel Versluis ◽  
Frederike Grimme ◽  
Jan Willem Hinnen ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Ankle Brachial Index ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Primary Study ◽  
Secondary Patency ◽  
Aortoiliac Occlusive Disease ◽  
Cox Regression Analysis ◽  
Stent Treatment ◽  
Kissing Stent

Purpose: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. Materials and Methods: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. Results: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p<0.005). Any previous endovascular intervention (HR 2.52, p=0.02) was the main predictor for loss of secondary patency; history of cardiovascular disease (HR 0.27, p=0.04) was the main predictor of sustained secondary patency. Conclusion: The kissing stent technique has a good safety profile and acceptable patency rates up to 2 years, even in TASC C and D lesions, supporting an endovascular-first approach for AIOD.

Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial

2020 ◽  
pp. 152660282098041
Author(s):  
Timothy M. Sullivan ◽  
Thomas Zeller ◽  
Masato Nakamura ◽  
Peter A. Gaines ◽  
Keyword(s):  
De Novo ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Lesion Length ◽  
Stent Fracture ◽  
Vascular Stent ◽  
Stent Patency ◽  
Kaplan Meier ◽  
Stent System

Purpose To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. Materials and Methods The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial ( ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. Results The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. Conclusion Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

scholarly journals Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease

2017 ◽  
Vol 24 (5) ◽  
pp. 629-637 ◽  
Author(s):  
Jean Bismuth ◽  
Bruce H. Gray ◽  
Andrew Holden ◽  
Christopher Metzger ◽  
Jean Panneton ◽  
...  
Keyword(s):  
Stent Graft ◽  
Primary Endpoint ◽  
De Novo ◽  
Target Lesion ◽  
Occlusive Disease ◽  
Next Generation ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Iliac Arteries ◽  
Safety And Efficacy

Purpose: To evaluate the safety and efficacy of a next-generation balloon-expandable stent-graft for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries. Methods: A prospective, multicenter, single-arm safety and efficacy study ( ClinicalTrials.gov identifier: NCT02080871) of the VBX Stent Graft for treatment of de novo or restenotic lesions in the iliac arteries was conducted under an Investigational Device Exemption at 26 US sites and 1 New Zealand center. The study eligibility criteria were established with the aim of enrolling more “real-world” patients compared with previous iliac stent studies supporting Food and Drug Administration approval. The study enrolled 134 patients (mean age 66±9.5 years; 79 men) with 213 iliac lesions. Three-quarters of the population (101, 75.4%) had Rutherford category 3 ischemia, and 43 (32.1%) patients presented with TASC II C/D lesions. The primary endpoint was a composite of device- or procedure-related death within 30 days, myocardial infarction within 30 days, target lesion revascularization (TLR) within 9 months, and amputation above the metatarsals in the treated leg within 9 months. Results: In all, 234 devices were implanted in 213 lesions with 100% technical success; 57 (42.5%) patients received kissing stents at the aortic bifurcation. No devices exhibited a discernable change in length after final deployment as determined by independent core laboratory quantitative angiographic analysis. At 9 months, 3 (2.3%) of 132 patients (1 lost to follow-up, 1 unrelated death) experienced a major adverse event (3 TLRs) related to the primary endpoint. At 9 months, there were no device-related serious adverse events or unanticipated adverse device effects. Conclusion: The next-generation balloon-expandable stent-graft demonstrated notable 9-month safety and efficacy in treating iliac occlusive disease in patients reflecting common clinical practice.

Edge Stenosis After Covered Stenting for Long Superficial Femoral Artery Occlusive Disease: Risk Factor Analysis and Prevention With Drug-Coated Balloon Angioplasty

2018 ◽  
Vol 25 (3) ◽  
pp. 313-319 ◽  
Author(s):  
Ting-Chao Lin ◽  
Chun-Yang Huang ◽  
Po-Lin Chen ◽  
Chiu-Yang Lee ◽  
Chun-Che Shih ◽  
...  
Keyword(s):  
Risk Factors ◽  
Stent Graft ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Disease Risk ◽  
Target Lesion ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Lesion Length ◽  
Distal Edge

Purpose: To report a retrospective analysis of risk factors for edge restenosis after Viabahn stent-graft treatment of superficial femoral artery (SFA) occlusive disease and determine any protective effect of drug-coated balloons (DCBs) used at the time of stent-graft implantation. Methods: Between October 2011 and July 2016, 110 patients (mean age 73.3±7.6 years; 78 men) were treated with the Viabahn stent-graft for long SFA occlusions. Thirty-eight (34.5%) patients had DCB reinforcement at the distal edge of the stent-graft. For analysis, the population was divided into groups of no edge stenosis patients (n=88; mean lesion length 22.4±4.2 cm) and edge stenosis patients (n=22; mean lesion length 23.5±5.7 cm). The clinical outcomes, ankle-brachial indices, computed tomography angiography findings, and patency were compared at a minimum of 12 months. Logistic regression analysis was employed to determine risk factors for edge stenosis; the results are presented as the odds ratio (OR) and 95% confidence interval. Results: No differences in clinical or procedural characteristics were identified except the higher incidence of diabetes (p=0.008) and greater need for retrograde access (p=0.033) in the edge stenosis group. DCB reinforcement reduced the incidence of edge stenosis (p=0.021) and target lesion revascularization (TLR; p=0.010) and resulted in a significantly higher 1-year primary patency rate (92.1% vs 76.4%, p=0.042). However, multivariate analysis revealed only poor distal runoff (OR 0.31, 95% CI 0.11 to 0.83, p=0.020) as a predictor of edge stenosis. Conclusion: The risk of edge stenosis after Viabahn implantation was higher in patients with poor distal runoff. DCB reinforcement over the distal edge reduced edge stenosis, decreased 1-year TLR, and improved 1-year primary patency.

scholarly journals First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease

2016 ◽  
Vol 24 (1) ◽  
pp. 11-18 ◽  
Author(s):  
Andrew Holden ◽  
Stephen Merrilees ◽  
Brendan Buckley ◽  
Brigid Connor ◽  
Frances Colgan ◽  
...  
Keyword(s):  
Iliac Artery ◽  
De Novo ◽  
Ankle Brachial Index ◽  
Human Experience ◽  
Performance Outcomes ◽  
Occlusive Disease ◽  
Secondary Patency ◽  
Aortoiliac Occlusive Disease ◽  
Safety Endpoint

Purpose: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis. Methods: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated. Results: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months. Conclusion: This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.

Endovascular stent-graft treatment for graft-vein anastomotic stenosis in haemodialysis patients with arteriovenous grafts

VASA ◽  
2015 ◽  
Vol 44 (6) ◽  
pp. 466-472 ◽  
Author(s):  
Chia-Hsun Lin ◽  
Yen-Yang Chen ◽  
Chai-Hock Chua ◽  
Ming-Jen Lu
Keyword(s):  
Risk Factors ◽  
Stent Graft ◽  
Target Lesion ◽  
Primary Patency ◽  
Anastomotic Stenosis ◽  
Secondary Patency ◽  
Endovascular Stent ◽  
Stent Grafts ◽  
Venous Anastomosis ◽  
Arteriovenous Grafts

Abstract. Background: In this study, we investigated the patency of endovascular stent grafts in haemodialysis patients with arteriovenous grafts, the modes of patency loss, and the risk factors for re-intervention. Patients and methods: Haemodialysis patients with graft-vein anastomotic stenosis of their arteriovenous grafts who were treated with endovascular stent-grafts between 2008 and 2013 were entered into this retrospective study. Primary and secondary patency, modes of patency loss, and risk factors for intervention were recorded. Results: Cumulative circuit primary patency rates decreased from 40.0 % at 6 months to 7.3 % at 24 months. Cumulative target lesion primary patency rates decreased from 72.1 % at 6 months to 22.0 % at 24 months. Cumulative secondary patency rates decreased from 81.3 % at 12 months to 31.6 % at 36 months. Patients with a history of cerebrovascular accident had a significantly higher risk of secondary patency loss, and graft puncture site stenosis jeopardised the results of stent-graft treatment. Conclusions: Our data can help to improve outcomes in haemodialysis patients treated with stent-grafts for venous anastomosis of an arteriovenous graft.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC)

VASA ◽  
2021 ◽  
pp. 1-7
Author(s):  
Tanja Böhme ◽  
Elias Noory ◽  
Ulrich Beschorner ◽  
Frederik Lerke ◽  
Andrej Schmidt ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Small Sample ◽  
Adverse Event Rate ◽  
Control Cohort ◽  
Procedural Success ◽  
Laser Atherectomy

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

The Results of Superficial Femoral, Popliteal, and Tibial Artery Stenting for Peripheral Vascular Occlusive Disease

2005 ◽  
Vol 71 (11) ◽  
pp. 905-910 ◽  
Author(s):  
Joe H. Morgan ◽  
Charles E. Wall ◽  
D. Benjamin Christie ◽  
Richard L. Harvey ◽  
Maurice M. Solis
Keyword(s):  
Limb Salvage ◽  
Ankle Brachial Index ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Primary Therapy ◽  
Peripheral Vascular Occlusive Disease ◽  
Stage Renal Disease ◽  
End Stage ◽  
Angioplasty And Stenting ◽  
Vascular Occlusive Disease

The purpose of this study was to evaluate the patentcy rates and physiological effectiveness of angioplasty and stenting as a primary therapy for superficial femoral (SFA), popliteal (POP), and tibial (TIB) arterial occlusive disease. Seventy-eight patients had stents placed in the infra-inguinal vessels between January 1, 2001, and July 31, 2004. We collected data on patient demographics, symptoms, as well as pre- and postprocedure ankle-brachial index (ABI) and angio-graphic findings. Patency rates at 6 months, 12 months, and 24 months were analyzed by life table methods. Thirty-one men and 47 women had a mean age of 68 years (range 36–94 years). Risk factors included diabetes in 50 per cent, hypertension in 79 per cent, smoking in 41 per cent, and end-stage renal disease in 10 per cent. The indications for intervention were claudication in 52 per cent and limb salvage in 48 per cent of patients. Stents were placed in the SFA in 54 patients (69%), in the POP in 15 patients (18%), and in the TIB artery in 6 patients (8%). Average follow-up was 11.2 months. The mean postprocedural increase in ABI was 0.29. The 6-month, 1-year, and 2-year primary patency rates were 83 per cent, 58 per cent, and 47 per cent, respectively. Limb salvage was achieved in 66 per cent of patients treated for limb-threatening ischemia. There was one major and three minor complications. Stenting of the infra-inguinal vessels has a low morbidity, high success rate, and acceptable patency and limb-salvage rates.

Use of Extraperitoneal Iliac Artery Endarterectomy in the Endovascular Era

Vascular ◽  
2008 ◽  
Vol 16 (6) ◽  
pp. 310-315
Author(s):  
Matthew J. Metcalfe ◽  
Ravi Natarajan ◽  
Selva Selvakumar
Keyword(s):  
Iliac Artery ◽  
Common Femoral Artery ◽  
Major Amputation ◽  
Primary Patency ◽  
Technical Note ◽  
Occlusive Disease ◽  
Aortofemoral Bypass ◽  
Aortoiliac Occlusive Disease ◽  
Clinical Series ◽  
Societal Consensus

Although iliac artery (IA) endarterectomy has largely been replaced by bypass and endovascular options, open endarterectomy continues to play an important role in selected patterns of occlusive disease. The objective of this report is to present a contemporary clinical series of patients having undergone IA endarterectomy. Specifically, we define patterns of disease amenable to open endarterectomy and provide an updated technical note of this procedure. A retrospective study on 23 patients with IA occlusions unsuitable for radiologic intervention (TransAtlantic Inter-Societal Consensus [TASC] C and D lesions) underwent extraperitoneal IA endarterectomy. Twenty-five primary IA endarterectomies were performed. Of these, five required more extensive endarterectomy, three of the distal aorta and two of the contralateral IA. Sixteen of the 25 endarterectomies required common femoral artery endarterectomy and 6 required iliofemoral bypass. The average follow-up was 26 months. Procedure-related mortality occurred in one patient (4.3%). Within 4 months, one patient underwent an aortofemoral bypass and two patients required major amputation. Primary patency rates were 96% at 3 months and 88% at 1, 2, and 3 years. This series shows that in selected patterns of aortoiliac occlusive disease, endarterectomy remains an important alternative to consider.

Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial

2017 ◽  
Vol 25 (1) ◽  
pp. 68-78 ◽  
Author(s):  
John R. Laird ◽  
Thomas Zeller ◽  
Christian Loewe ◽  
Jack Chamberlin ◽  
Richard Begg ◽  
...  
Keyword(s):  
Clinical Success ◽  
Randomized Study ◽  
Ankle Brachial Index ◽  
The United States ◽  
Target Lesion ◽  
Primary Patency ◽  
Lesion Length ◽  
Stent Fracture ◽  
Fracture Rate ◽  
High Flexibility

Purpose: To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA). Methods: This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed. Results: Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p<0.001). Conclusion: The TIGRIS stent and LifeStent were similarly effective for the treatment of lesions in the SFA and PPA. The high flexibility and zero fracture rate associated with the TIGRIS stent make this device favorable for use in high-flexion arteries.

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