scholarly journals One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial

2017 ◽  
Vol 25 (1) ◽  
pp. 100-108 ◽  
Author(s):  
Aljoscha Rastan ◽  
James F. McKinsey ◽  
Lawrence A. Garcia ◽  
Krishna J. Rocha-Singh ◽  
Michael R. Jaff ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Clinical Results ◽  
Major Amputation ◽  
Primary Outcome Measure ◽  
Primary Patency ◽  
Walking Distance ◽  
Lesion Length ◽  
Directional Atherectomy

Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound–defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients.

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 The role of directional atherectomy in critical-limb ischemia

2021 ◽  
Vol 135 ◽  
pp. 175394472110469
Author(s):  
Prakash Krishnan ◽  
Arthur Tarricone ◽  
Simon Chen ◽  
Samin Sharma
Keyword(s):  
Lower Extremity ◽  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Relevant Literature ◽  
Limb Ischemia ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Directional Atherectomy ◽  
Procedural Success

Background: Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia. Methods: A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded. Results: Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm. Conclusions: DA may be a useful tool in the treatment of lower extremity critical-limb ischemia.

scholarly journals Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions

2016 ◽  
Vol 24 (2) ◽  
pp. 181-188 ◽  
Author(s):  
Konstantinos Stavroulakis ◽  
Arne Schwindt ◽  
Giovanni Torsello ◽  
Arne Stachmann ◽  
Christiane Hericks ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
Patency Rate ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Technical Success ◽  
Primary Patency Rate ◽  
Technical Success Rate ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

2017 ◽  
Vol 51 (2) ◽  
pp. 60-66 ◽  
Author(s):  
Alessia Giaquinta ◽  
Ardita Vincenzo ◽  
Ester De Marco ◽  
Massimiliano Veroux ◽  
Pierfrancesco Veroux
Keyword(s):  
Wound Healing ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Lesion Length ◽  
Free Survival ◽  
Tibial Arteries

Background: Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions. Objectives: This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm. Methods: All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis >70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1- and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates. Results: Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1- and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency ( P = .022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing. Conclusions: The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.

scholarly journals Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions

2014 ◽  
Vol 8s2 ◽  
pp. CMC.S15224
Author(s):  
Michael Lichtenberg ◽  
Birgit Hailer ◽  
Matthias Kaeunicke ◽  
Wilhelm-Friedrich Stahlhoff ◽  
Dirk Boese ◽  
...  
Keyword(s):  
Renal Insufficiency ◽  
Patency Rate ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Walking Distance ◽  
Lesion Length ◽  
Nitinol Stent

Purpose To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. Methods This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) <2.5) and no target lesion revascularization was performed within 12 months' follow-up. No drug-eluting devices were allowed in this registry. Results Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I–III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly ( P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes ( P = 0.18) and renal insufficiency ( P = 0.3) was not significantly lower as compared to the overall primary patency. Conclusions In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

Isolated femoral artery revascularisation with or without iliac inflow improvement – a less invasive surgical option in critical limb ischemia

VASA ◽  
2021 ◽  
pp. 1-7
Author(s):  
Andreas S. Peters ◽  
Katrin Meisenbacher ◽  
Dorothea Weber ◽  
Theodosios Bisdas ◽  
Giovanni Torsello ◽  
...  
Keyword(s):  
Risk Factors ◽  
Femoral Artery ◽  
Critical Limb Ischemia ◽  
Negative Impact ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Lesion Length ◽  
Vascular Intervention ◽  
Selection Of Variables ◽  
Surgical Option

Summary: Background: Isolated femoral artery revascularisation (iFAR) represents a well-established surgical method in the treatment of peripheral arterial disease (PAD) involving common femoral artery disease. Data for iFAR in multilevel PAD are inconsistent, particularly in patients with critical limb ischemia (CLI). The aim of the study was to evaluate the outcome of iFAR in CLI regarding major amputation and reintervention and to identify associated risk factors for this outcome. Patients and methods: The data used have been derived from the German Registry of Firstline Treatment in Critical Limb Ischemia (CRITISCH). A total of 1200 patients were enrolled in 27 vascular centres. This sub-analysis included patients, which were treated with iFAR with/without concomitant iliac intervention. For detection of risk factors for the combined endpoint of major amputation and/or reintervention, selection of variables for multiple regression was conducted using stepwise forward/backward selection by Akaike’s information criterion. Results: 95 patients were included (mean age: 72 years ± 10.82; 64.2% male). Of those, 32 (33.7%) participants reached the combined endpoint. Risk factor analysis revealed continued tobacco use (odds ratio [OR] 2.316, confidence interval [CI] 0.832–6.674), TASC D-lesion (OR: 2.293, CI: 0.869–6.261) and previous vascular intervention in the trial leg (OR: 2.720, CI: 1.037–7.381) to be associated with reaching the combined endpoint. Conclusions: iFAR provides a reasonable, surgical option to treat CLI. Lesion length (TASC D) seems to have a negative impact on outcome. Further research is required to better define the future role of iFAR for combined femoro-popliteal lesions in CLI – best in terms of a randomised controlled trial.

Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Aljoscha Rastan ◽  
Marianne Brodmann ◽  
Tanja Böhme ◽  
Roland Macharzina ◽  
Elias Noory ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Primary Study ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Infrapopliteal Artery ◽  
Directional Atherectomy ◽  
Drug Coated Balloon

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the TLR rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

2021 ◽  
pp. 152660282110348
Author(s):  
Grzegorz Halena ◽  
Dainis K. Krievins ◽  
Dierk Scheinert ◽  
Janis Savlovskis ◽  
Piotr Szopiński ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Major Amputation ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Femoropopliteal Bypass ◽  
Chronic Total Occlusions ◽  
Target Vessel Revascularization ◽  
Kaplan Meier

Purpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. Results: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan–Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. Conclusions: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.

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.

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