scholarly journals Midterm Outcomes After Infrapopliteal Interventions in Patients With Critical Limb Ischemia Based on the TASC II Classification of Below-the-Knee Arteries

2017 ◽  
Vol 24 (3) ◽  
pp. 321-330 ◽  
Author(s):  
Gagan D. Singh ◽  
Ellen K. Brinza ◽  
Justin Hildebrand ◽  
Stephen W. Waldo ◽  
T. Raymond Foley ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Tissue Loss ◽  
Success Rates ◽  
Chronic Total Occlusions

Purpose: To analyze the relationship between the new TransAtlantic Inter-Society Consensus (TASC II) infrapopliteal classification and limb outcomes among patients with critical limb ischemia (CLI). Methods: A single-center retrospective study was performed on 166 consecutive CLI patients (mean age 71 years; 113 men) undergoing endovascular treatment of 244 infrapopliteal lesions from 2006 to 2013. Patient, procedural, angiographic, and limb outcomes were compared for the new TASC A/B vs C/D classification for infrapopliteal lesions. Binary restenosis was determined by a peak systolic velocity ratio >2.0 by duplex ultrasound on follow-up at 1, 3, 6, and 12 months. Results: Seventy-two (43.4%) patients had TASC A/B lesions, while 94 (56.6%) had TASC C/D patterns of infrapopliteal disease. Baseline demographics and tissue loss (93% vs 94%, p=0.59) were similar between the groups. TASC A/B lesions were shorter (53±35 vs 170±83 mm, p<0.001), less severely stenosed (77%±24% vs 93%±14%, p<0.001), had a larger target vessel diameter (2.9±0.5 vs 2.6±0.5 mm, p<0.001), and were less frequently chronic total occlusions (24% vs 64%, p<0.001) compared with the TASC C/D group. Three-year freedom from both amputation (85% vs 67%, p=0.02) and major adverse limb events (79% vs 61%, p=0.02) were significantly higher in the TASC A/B group. Technical success rates (95% vs 80%, p<0.001) and 1-year primary patency (58% vs 51%, p=0.04) were higher in the A/B group. Overall 3-year survival was similar between the groups (96% A/B vs 88% C/D, p=0.2). Conclusion: TASC C/D infrapopliteal lesions are associated with higher amputation and major adverse limb events rates and lower primary patency compared with TASC A/B infrapopliteal lesions. Further studies are needed to assess the association between TASC C/D infrapopliteal lesions and clinical outcomes in patients with CLI.

Comparison of Results in Endovascular Interventions for Infrainguinal Lesions: Claudication versus Critical Limb Ischemia

2005 ◽  
Vol 71 (6) ◽  
pp. 474-480 ◽  
Author(s):  
Susan M. Trocciola ◽  
Rabih Chaer ◽  
Rajeev Dayal ◽  
Stephanie C. Lin ◽  
Naveen Kumar ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Clinical Success ◽  
Ankle Brachial Index ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Endovascular Interventions

This study analyzed clinical success, patency, and limb salvage after endovascular repair in patients treated for chronic limb ischemia presenting with claudication versus critical limb ischemia. Between October 2001 and August 2004, 115 patients (mean age 71) underwent endovascular treatment for infrainguinal arterial disease. Techniques included subintimal angioplasty and transluminal angioplasty with or without stents. Lesions were classified according to Transatlantic InterSociety Consensus. Follow-up (mean 11 months) included physical exam, ankle-brachial index, and duplex ultrasound. Patency rates were determined using Kaplan-Meier and compared by log-rank analysis. One hundred ninety-nine lesions were treated in 121 limbs using percutaneous techniques. Comorbidities were similar except higher rates of diabetes mellitus (67% vs 41%, P < 0.001) and chronic renal insufficiency (22% vs 7%, P < 0.05) were found in critical limb ischemia patients. Primary patency for claudicants was 100 per cent, 98 per cent, and 85 per cent at 3, 6, and 12 months and 89 per cent, 80 per cent, and 72 per cent for critical limb ischemia, respectively ( P = 0.06). Limb salvage was 91 per cent at 12 months for critical limb ischemia patients. Morbidity was similar between groups, and there was no perioperative mortality. Percutaneous intervention for both claudication and critical limb ischemia provides acceptable 12-month patency with limited morbidity.

scholarly journals Below-knee endovascular interventions have better outcomes compared to open bypass for patients with critical limb ischemia

2016 ◽  
Vol 22 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Caitlin W Hicks ◽  
Alireza Najafian ◽  
Alik Farber ◽  
Matthew T Menard ◽  
Mahmoud B Malas ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Multivariable Analysis ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Primary Patency ◽  
Tissue Loss ◽  
Vascular Intervention ◽  
Below The Knee ◽  
Endovascular Interventions ◽  
One Year

Both open surgery and endovascular peripheral interventions have been shown to effectively improve outcomes in patients with peripheral artery disease, but minimal data exist comparing outcomes performed at and below the knee. The purpose of this study was to compare outcomes following infrageniculate lower extremity open bypass (LEB) versus peripheral vascular intervention (PVI) in patients with critical limb ischemia. Using data from the 2008–2014 Vascular Quality Initiative, 1-year primary patency, major amputation, and mortality were compared among all patients undergoing LEB versus PVI at or below the knee for rest pain or tissue loss. Overall, 2566 patients were included (LEB=500, PVI=2066). One-year primary patency was significantly worse following LEB (73% vs 81%; p<0.001). One-year major amputation (14% vs 12%; p=0.18) and mortality (4% vs 6%; p=0.15) were similar regardless of revascularization approach. Multivariable analysis adjusting for baseline differences between groups confirmed inferior primary patency following LEB versus PVI (HR 0.74; 95% CI, 0.60–0.90; p=0.004), but no significant differences in 1-year major amputation (HR 1.06; 95% CI, 0.80–1.40; p=0.67) or mortality (HR 0.71; 95% CI, 0.44–1.14; p=0.16). Based on these data, we conclude that endovascular revascularization is a viable treatment approach for critical limb ischemia resulting from infrageniculate arterial occlusive disease.

scholarly journals One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia

2017 ◽  
Vol 24 (3) ◽  
pp. 311-316 ◽  
Author(s):  
Marc Bosiers ◽  
Joren Callaert ◽  
Koen Keirse ◽  
Jeroen M. H. Hendriks ◽  
Patrick Peeters ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Primary Patency ◽  
Drug Eluting Stent ◽  
Lesion Length ◽  
Imaging Data ◽  
Stent System

Purpose: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. Methods: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0–58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). Results: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. Conclusion: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

scholarly journals Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

2020 ◽  
Vol 27 (2) ◽  
pp. 296-303 ◽  
Author(s):  
Jaafer Golzar ◽  
Yoshimitsu Soga ◽  
Anvar Babaev ◽  
Osamu Iida ◽  
Daizo Kawasaki ◽  
...  
Keyword(s):  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Target Lesion Revascularization ◽  
Drug Eluting Stent ◽  
Kaplan Meier ◽  
Drug Eluting

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

Predictors of non-healing in patients with critical limb ischemia and tissue loss following successful endovascular therapy

2014 ◽  
Vol 85 (5) ◽  
pp. 850-858 ◽  
Author(s):  
Norihiro Kobayashi ◽  
Keisuke Hirano ◽  
Masatsugu Nakano ◽  
Toshiya Muramatsu ◽  
Reiko Tsukahara ◽  
...  
Keyword(s):  
Endovascular Therapy ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Tissue Loss

Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial

2019 ◽  
Vol 26 (2) ◽  
pp. 158-167 ◽  
Author(s):  
Osamu Iida ◽  
Kazushi Urasawa ◽  
Yasuo Komura ◽  
Yoshimitsu Soga ◽  
Naoto Inoue ◽  
...  
Keyword(s):  
Percutaneous Transluminal Angioplasty ◽  
Patency Rate ◽  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Stent Group ◽  
Primary Patency Rate ◽  
Multicenter Randomized Controlled Trial ◽  
Percutaneous Transluminal

Purpose: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. Materials and Methods: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. Results: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. Conclusion: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.

scholarly journals Cell Therapy in Patients with Critical Limb Ischemia

2015 ◽  
Vol 2015 ◽  
pp. 1-13 ◽  
Author(s):  
Rita Compagna ◽  
Bruno Amato ◽  
Salvatore Massa ◽  
Maurizio Amato ◽  
Raffaele Grande ◽  
...  
Keyword(s):  
Cell Therapy ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Tissue Loss ◽  
Systematic Analysis ◽  
Peripheral Arterial Obstructive Disease ◽  
Peripheral Arterial ◽  
Cellular Components

Critical limb ischemia (CLI) represents the most advanced stage of peripheral arterial obstructive disease (PAOD) with a severe obstruction of the arteries which markedly reduces blood flow to the extremities and has progressed to the point of severe rest pain and/or even tissue loss. Recent therapeutic strategies have focused on restoring this balance in favor of tissue survival using exogenous molecular and cellular agents to promote regeneration of the vasculature. These are based on stimulation of angiogenesis by extracellular and cellular components. This review article carries out a systematic analysis of the most recent scientific literature on the application of stem cells in patients with CLI. The results obtained from the detailed analysis of the recent literature data have confirmed the beneficial role of cell therapy in reducing the rate of major amputations in patients with CLI and improving their quality of life.

scholarly journals PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries

2018 ◽  
Vol 26 (1) ◽  
pp. 18-25 ◽  
Author(s):  
Andrew Holden ◽  
Andrew Hill ◽  
Andrew Walker ◽  
Brendan Buckley ◽  
Stephen Merrilees ◽  
...  
Keyword(s):  
De Novo ◽  
Balloon Catheter ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Chronic Total Occlusions ◽  
The Core ◽  
Safety Endpoint ◽  
Exciting Potential ◽  
Primary Safety Endpoint

Purpose: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory–adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

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