Endovascular Treatment of Severely Calcified Femoropopliteal Lesions Using the “Pave-and-Crack” Technique: Technical Description and 12-Month Results

Purpose: To report midterm results of the “pave-and-crack” technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. Methods: Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to “pave” the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was “cracked” before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method. Results: Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%. Conclusion: Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal “pave-and-crack” technique.

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Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis

Journal of Endovascular Therapy ◽

10.1177/1526602817745668 ◽

2017 ◽

Vol 25 (1) ◽

pp. 81-88 ◽

Cited By ~ 21

Author(s):

Damianos G. Kokkinidis ◽

Prio Hossain ◽

Omar Jawaid ◽

Bejan Alvandi ◽

T. Raymond Foley ◽

...

Keyword(s):

Balloon Angioplasty ◽

Cox Regression ◽

Multivariable Analysis ◽

Limb Ischemia ◽

Target Lesion ◽

Lesion Length ◽

Stent Restenosis ◽

Kaplan Meier ◽

Laser Atherectomy ◽

In Stent Restenosis

Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

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

Journal of Endovascular Therapy ◽

10.1177/15266028211034862 ◽

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.

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Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

Journal of Endovascular Therapy ◽

10.1177/1526602819839044 ◽

2019 ◽

Vol 26 (3) ◽

pp. 305-315 ◽

Cited By ~ 7

Author(s):

Michel M. P. J. Reijnen ◽

Iris van Wijck ◽

Thomas Zeller ◽

Antonio Micari ◽

Pierfrancesco Veroux ◽

...

Keyword(s):

Critical Limb Ischemia ◽

Limb Ischemia ◽

Target Lesion ◽

Major Amputation ◽

Limb Amputation ◽

Post Hoc Analysis ◽

Kaplan Meier ◽

Global Study ◽

Post Hoc ◽

Drug Coated Balloon

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

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Endovascular first strategy for de novo TransAtlantic Inter-Society Consensus C and D femoro-popliteal disease: Mid-term outcomes from a single tertiary referral center

Vascular ◽

10.1177/1708538114529564 ◽

2014 ◽

Vol 23 (1) ◽

pp. 31-40 ◽

Cited By ~ 5

Author(s):

Jeffrey Lorne Grenville ◽

Kong Teng Tan ◽

Hadas Moshonov ◽

Dheeraj Kumar Rajan

Keyword(s):

De Novo ◽

Ankle Brachial Index ◽

Limb Ischemia ◽

Transluminal Angioplasty ◽

Study Patient ◽

Lesion Length ◽

Secondary Patency ◽

Tertiary Referral Center ◽

Patient Demographics ◽

The Mean

Purpose: Describe outcomes after endovascular intervention of TransAtlantic Inter-Society Consensus C and D femoro-popliteal disease. Materials and methods: Retrospective cohort study. Patient demographics, ankle-brachial indices, and lesion details were analyzed from a prospectively maintained database. In all, 980 limbs treated with percutaneous transluminal angioplasty ± stenting of the femoro-popliteal segment between 2005 and 2012 were reviewed. Seventy-six patients representing 83 limbs with de novo TransAtlantic Inter-Society Consensus C and D lesions measuring ≥15 cm continuously were identified (mean age 71.3 ± 12.1 years, 62% male). Results: Twenty-five (30.1%) limbs were treated for severe claudication and 58 (69.9%) for critical limb ischemia. The mean pre-procedural ankle-brachial index was 0.47 ± 0.19. The mean lesion length was 22.9 ± 4.82 cm. Seventy patients representing 77 limbs were available for a mean follow-up length of 19.5 months (range 0–79). The mean post-procedural ankle-brachial index was 0.71 ± 0.28. Primary, assisted-primary, and secondary patency rates were 68.1%, 72.7%, and 83.3% at 6 months, 55.3%, 63.6%, and 58.3% at 12 months, and 38.2%, unavailable, and 10.4% at 24 months, respectively. Conclusions: Angioplasty-first strategy for TransAtlantic Inter-Society Consensus C and D lesions of the femoro-popliteal artery can be safely performed. However, patency drastically decreases after 12 months suggesting further improvements are required to achieve longer-term clinical benefit.

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Prospective Single-Arm Trial of Endovascular Mechanical Debulking as Initial Therapy in Patients With Acute and Subacute Lower Limb Ischemia: One-Year Outcomes

Journal of Endovascular Therapy ◽

10.1177/1526602819840697 ◽

2019 ◽

Vol 26 (3) ◽

pp. 291-301 ◽

Cited By ~ 3

Author(s):

Miroslav Bulvas ◽

Zuzana Sommerová ◽

Ivan Vaněk ◽

Jiří Weiss

Keyword(s):

Limb Ischemia ◽

Initial Therapy ◽

Exclusion Criterion ◽

Secondary Patency ◽

Primary Therapy ◽

Technical Success ◽

Free Survival ◽

The Mean ◽

One Year

Purpose: To report the results of a prospective, single-arm study to establish whether the initial treatment of acute or subacute limb ischemia (ALI and SLI, respectively) can be accomplished successfully using endovascular mechanical debulking of the target vessels to avoid the risks associated with thrombolysis and/or open surgery. Materials and Methods: From April 2009 to April 2015, 316 consecutive patients (mean age 70.9±12 years; 184 men) with ALI (202, 63.9%) or SLI (114, 36.1%) were enrolled; the only exclusion criterion was irreversible ischemia. The ALI group included 146 (72.3%) participants with category IIb ischemia and 56 (27.7%) with category IIa. Critical limb ischemia was diagnosed in 74 (64.9%) of the 114 patients with SLI. Target occlusions of thrombotic (n=256) or embolic (n=60) origin were located in the femoropopliteal segment (n=231), prosthetic or venous femoropopliteal bypass grafts (n=75), and the aortoiliac segment (n=35). The mean occlusion length was 22.9±14.8 cm. Results: The overall technical success (residual stenosis ≤30%) was 100% after debulking and adjunctive techniques (aspiration, dilation, stenting) at the level of the target lesions. No open surgical or thrombolytic modalities were necessary to bypass or recanalize the target vessels, and no death occurred in association with target occlusion therapy. Additional infrapopliteal interventions were performed in 195 (61.7%) patients (adjunctive thrombolysis in 29) to treat acute, subacute, and chronic lesions. Minor complications directly related to the debulking procedure occurred in 26 (8.2%) patients. Serious complications occurred in 11 (3.5%) patients, including hemorrhage in 8 (2.5%) patients (associated with infrapopliteal thrombolysis in 5). At 30 days, primary and secondary patency rates were 94.3% and 97.2%, respectively; mortality was 0.3% (1 fatal intracranial hemorrhage after adjunctive thrombolysis). Of 229 patients eligible for 1-year follow-up, amputation-free survival was estimated to be 87.4% in 199 patients with available data. Conclusion: In this all-comers study, mechanical debulking with the Rotarex alone or with adjunctive techniques is feasible as a primary therapy for occluded supratibial vessels in patients with ALI or SLI.

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Rotational atherectomy with adjunctive balloon angioplasty in calcified chronic total occlusions of superficial femoral artery

Vascular ◽

10.1177/1708538120970817 ◽

2020 ◽

pp. 170853812097081

Author(s):

Aysen Y Engin ◽

Onur Saydam

Keyword(s):

Balloon Angioplasty ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Primary Patency ◽

Rotational Atherectomy ◽

Secondary Patency ◽

Technical Success ◽

Technical Success Rate ◽

The Mean ◽

Drug Coated Balloon

Objectives The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions. Methods Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned. Results Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan–Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up. Conclusions Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication.

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

Journal of Endovascular Therapy ◽

10.1177/1526602820980419 ◽

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.

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Midterm Results of Low-Profile Stents to Treat Atherosclerotic Iliac Artery Disease

Journal of Endovascular Therapy ◽

10.1177/1526602817704827 ◽

2017 ◽

Vol 24 (3) ◽

pp. 349-354 ◽

Cited By ~ 2

Author(s):

Nicola Troisi ◽

Leonardo Ercolini ◽

Emiliano Chisci ◽

Piefrancesco Frosini ◽

Enrico Barbanti ◽

...

Keyword(s):

Multivariate Analysis ◽

Iliac Artery ◽

Balloon Dilation ◽

Limb Ischemia ◽

Target Lesion ◽

Major Amputation ◽

Primary Patency ◽

Secondary Patency ◽

Related Complication ◽

Low Profile

Purpose: To evaluate the safety and effectiveness of low-profile 4-F stents for the treatment of atherosclerotic iliac artery lesions. Methods: Between January 2009 and December 2015, 63 patients (mean age 69.3 years; 42 men) received low-profile stents (Astron Pulsar or Pulsar-18) at the discretion of the operator to treat iliac artery occlusive disease. The majority of patients (40, 63.5%) had critical limb ischemia; 36 of 82 lesions were total occlusions. All procedures were performed with 4-F equipment. Outcomes evaluated included mortality, patency (primary, assisted primary, and secondary), absence of target lesion revascularization (TLR), and limb salvage. Associations of patient and procedure variables with patency and TLR outcomes were sought with univariate and multivariate analysis. Results: Via a brachial (n=46/63) or femoral (n=17/63) access, 82 stents were successfully deployed to treat the 82 lesions, with <30% residual stenosis. The overall access-related complication rate was 1.6% (brachial artery occlusion). Mean duration of follow-up was 24.1±22.3 months (range 1–72), during which 3 patients died and 1 major amputation occurred at 10 months. The 4-year Kaplan-Meier estimate of primary patency was 76.9% (95% CI 70.2% to 83.6%); the assisted primary and secondary patency estimates were 79.3% (95% CI 73% to 85.6%) and 91% (95% CI 84.5% to 97.5%). The 4-year freedom from TLR estimate was 73.8% (95% CI 67.4% to 80.2%). On multivariate analysis, the only associations confirmed involved Rutherford category 5/6 with primary patency (hazard ratio [HR] 5.7, 95% CI 4.4 to 7, p=0.02) and assisted primary patency (HR 6.1, 95% CI 4.9 to 7.3, p=0.01). Conclusion: Use of a low-profile 4-F stent in atherosclerotic iliac lesions was safe and effective. At 4 years, the overall patency and the absence of TLR were good. Midterm outcomes were poor in patients with Rutherford category 5/6 ischemia. Finally, the use of stents with a ≥6-mm diameter and postdeployment balloon dilation are recommended in all cases.

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

Vascular and Endovascular Surgery ◽

10.1177/1538574416689429 ◽

2017 ◽

Vol 51 (2) ◽

pp. 60-66 ◽

Cited By ~ 1

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.

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Clinical Experience with a New Nitinol Self-Expanding Stent in Peripheral Arteries

Journal of Endovascular Therapy ◽

10.1177/152660289600300403 ◽

1996 ◽

Vol 3 (4) ◽

pp. 369-379 ◽

Cited By ~ 6

Author(s):

Michel Henry ◽

Max Amor ◽

Rafael Beyar ◽

Isabelle Henry ◽

Jean-Marc Porte ◽

...

Keyword(s):

Long Term Results ◽

Lesion Length ◽

Secondary Patency ◽

Peripheral Arteries ◽

External Compression ◽

Nitinol Stent ◽

Nitinol Stents ◽

The Mean

Purpose: To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries. Methods: Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% ± 9.9% (range 75% to 100%), and mean lesion length was 45 ± 23 mm (range 20 to 120 mm). Results: Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%). Conclusions: This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.

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