Five-Year Experience of Interwoven Self-Expanding Stent Implantation in Stenotic Kinking of Below the Knee Prosthetic Bypasses.

PURPOSE: The purpose of this study was to evaluate the 5-year real-world results of Supera stent implantation in below the knee prosthetic bypasses (BKPBs). All the procedures were performed because of a history of recurrent thrombosis of the graft and significant stenotic kinking of the prosthesis during knee flexion. A Supera stent was implanted to prevent the next potential BKPB thrombosis. MATERIALS AND METHODS: Fourteen patients were included in this single-center, retrospective observational cohort study. All patients underwent Supera stent implantation in infrainguinal prosthetic bypass between 2012 and 2017, due to a history of recurrent thrombosis and kinking of the prosthetic bypass. RESULTS: Prior to Supera stent implantation procedure, all the patients had more than one episode of acute limb ischemia caused by thrombosis of the BKPB. The median number of BKPB thromboses prior to Supera stent implantation was 3 and ranged from 2 to 6. Technical success was achieved in all cases. Primary patency rates at 12, 24, 36 and 60 months were 71.4%, 57.1%, 57.1% and 14.3%, respectively. Secondary patency rates at 12, 24, 36 and 60 months were 78.6%, 64.3%, 64.3% and 35.7%, respectively. One stent fracture was reported during 60-month follow-up. Major amputation was performed in 6 patients in 5-year follow-up. CONCLUSION: Supera stent in treatment of recurrent thrombosis of BKBP is a safe procedure with acceptable mid-term results. However, larger and comparable prospective studies are needed for broader analysis of this procedure.

A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

Directional Atherectomy With Antirestenotic Therapy Versus PTA/Supera Stenting for Popliteal Artery Lesions: A Propensity-Matched Analysis.

PURPOSE: This study examines the use and impact of directional atherectomy with antirestenotic therapy (DAART) versus angioplasty plus Supera stent implantation on the outcomes during endovascular treatment of popliteal lesions in clinical practice. METHODS: Overall 143 consecutive patients (mean age 75.0±12.2 years, 72% male), with isolated atherosclerotic disease of the popliteal artery who underwent endovascular treatment using DAART therapy or percutaneous transluminal angioplasty (PTA)/Supera stenting of the popliteal artery between January 2016 and December 2021 were identified from a retrospectively database. Patient and plaque characteristics were collected. A propensity-score matched, case-control analysis was conducted to balance covariates between the group of patients who underwent DAART and the one treated by PTA/Supera stenting. RESULTS: A total of 51 patients (35.7%) showed severe claudication and 92 (64.3%) critical limb ischemia. There was a trend toward longer treated lesions (90.4±81 vs 72.5±5.3 mm, p=0.089) and more chronic total occlusions (60.5% vs 46.8%, p=0.058) in the PTA/Supera stenting group, although not reaching statistically significance. Moderate-to-severe calcification was present in most lesions treated (75.8% of DAART group, 80.2% of PTA/Supera stenting group, and 78.3% of total cohort). Among the 53 case-matched pairs of patients treated with DAART or PTA/Supera stenting, there were no significant differences in short-term outcomes, including rate of technical success (96.2% vs 98.1%, p=0.232), procedural success (88.7% vs 90.1%, p=0.251), distal embolization (1.9% vs 1.9%, p=0.178), dissection (5.7% vs 1.9%, p=0.268), perforation (3.8% vs 5.6%, p=0.163), hospital discharge (1.2±0.1 vs 1.0±0.1, p=0.325), 30 day minor (28.3% vs 32.1%, p=0.264) or major amputation rates (7.5% vs 3.8%, p=0.107), and 30 day mortality (1.9% vs 1.9%, p=0.173). At 1 year, there was no difference in primary patency (73.6% vs 77.4%, p=0.233), primary assisted patency (81.3% vs 84.9%, p=0.167), secondary patency (86.8% vs 92.5%, p=0.094), ipsilateral minor (35.8% vs 39.6%, p=0.472) or major amputation (9.4% vs 7.5%, p=0.186), ankle brachial index improvement (0.32±0.12 vs 0.37±0.37, p=0.401), or mortality (5.7% vs 5.7%, p=0.121) rate between patients who underwent DAART or PTA/Supera stenting for popliteal lesions. CONCLUSION: Twelve-month results following DAART technique or PTA/Supera stenting of atherosclerotic lesions of the popliteal artery are not different, regardless of patient and plaque characteristics. CLINICAL IMPACT: The DAART technique for the treatment of popliteal artery atherosclerotic disease is presented as a "leave nothing behind" strategy with on-year clinical outcomes similar to ATP/Supera stenting.

Three-Year Real-World Outcomes of Interwoven Nitinol Supera Stent Implantation in Long and Complex Femoropopliteal Lesions.

BACKGROUND: Peripheral artery disease (PAD) remains a major issue in modern societies and affects more than 200 million people around the world. Endovascular methods have been evaluated to be safe and effective in limb salvage. The Supera is able to withstand increased compression, biomechanical stress and to have higher radial force. The objective of this study is to evaluate performance, durability and 3-year patency of Supera stent implantation in severe femoropopliteal disease. METHODS: A retrospective real-world analysis was performed with consideration of 77 patients that had a Supera stent implanted with femoropopliteal atherosclerotic disease at a single center. Among the 77 individuals, 92 Supera stents were implanted. Analysis of patients' demographics, lesions characteristics, reintervention rates and patency rates was performed. RESULTS: The median follow-up was 33 months and ranged from 0 to 84 months. Chronic limb-threatening ischemia was observed among 43 patients. Mean lesion length was 152.8 ± 94.6 mm. Chronic total occlusions were observed in a majority of lesions. Overall, primary patency rates at 6, 12, 24 and 36 months were 85.0%, 73.6%, 59.2% and 53.2%, respectively. CONCLUSIONS: The Supera stent is effective in the management of long and complex lesions. The results of patency rates were evaluated to be worse among lesions extending to the popliteal artery.

SUPERA stent placement for salvaging early recurrent arteriovenous graft thrombosis after percutaneous transluminal angioplasty: A single-center study.

BACKGROUND: The aim of this study was to evaluate the patency of the helical interwoven SUPERA stent for salvaging prosthetic arteriovenous (AV) grafts with rapidly recurrent thrombotic occlusion developed within a short time period after successful percutaneous transluminal angioplasty. METHODS: From December 2019 to September 2021, the data of 20 patients with AV graft who had the SUPERA stent inserted satisfying the following conditions were consecutively collected. (1) More than 1 year has passed since the AV access operation; (2) Thrombotic re-occlusion of AV graft occurred within 3 months after previous successful endovascular treatment; (3) Residual stenosis is greater than 30% after full effacement of balloon angioplasty in the primary lesion. Post-interventional target lesion primary patency (TLPP), access circuit primary patency (ACPP), and secondary patency (SP) were calculated. RESULTS: Primary lesions of early recurrent arteriovenous graft thrombosis were found in 13 patients with graft-vein anastomosis, six patients with intra-graft stenosis, and one patient with outflow vein complications. The lesions showed residual stenosis in 47.4% (interquartile range: 44.1%-55.3%) of patients despite full-effacement balloon angioplasty. Clinical success was achieved in all patients with full-expansion of the stents at the 1-month follow-up. The TLPP was 70.7% and 32% at 6 and 12 months, respectively, and ACPP was 47.5% and 6.8% at 6 and 12 months, respectively. The SP was 76.1% and 57.1% at 6 and 12 months, respectively. No cannulation complications occurred in the six patients with installation inside the graft. No hemodialysis or stent fracture occurred in any patient during the follow-up period. CONCLUSIONS: The SUPERA stent may have a role in salvaging AV grafts with early recurrent thrombosis due to its greater radial force and its conformability and can be useful in treating stenosis involving the elbow or axilla, with fair patency and low complication rates.

Sheathless use of Supera stent minimizes access complications in antegrade femoral puncture: Technical note with case series.

Antegrade femoral puncture (AFP) is the preferred strategy to treat lower limb obstructive disease. However, the presence of vascular calcification may be associated with procedure related adverse events, impairing endovascular device strategies. We describe a case series of superficial femoral and popliteal artery treatments by Supera stent implantation using a simple technique to significantly minimize the dimension of the antegrade femoral puncture from 6 to 4 French (Fr). All antegrade femoral punctures, crossing femoro-popliteal lesion and predilation were made with 4 Fr introducer. After preparation the Supera stent was navigated in sheathless fashion via 0.018-inch guidewire. Postdilation and final control were made replacing the 4 Fr introducer via the same guidewire. A good final result was achieved. Patients were discharged early without any complications. This minimally invasive technique in cases of infrainguinal peripheral artery disease could be feasible and effective for minimizing the risk of complications in patients with critical limb ischemia.

Superficial Femoral Artery Rupture "Bailed Out" Using Novel Design of Supera Stent.

Peripheral artery disease is a condition that occurs due to narrowing or occlusion of arterial lumen usually secondary to atherosclerosis. Endovascular treatments are minimally invasive procedures that have become popular for recanalization of such calcified/sclerosed arteries. However, heavily calcified arteries make these procedures challenging and are more prone to complications like balloon rupture and bleeding. Herein, we report a novel case of rupture of superficial femoral artery and its management using self-expanding Supera stent.

Endovascular retrieval of an elongated Supera stent.

Stenting is used to achieve artery patency, and the Supera stent, a self-expanding interwoven nitinol stent, has produced good clinical outcomes. A 70-year-old woman with peripheral artery disease had experienced intermittent claudication (Fontaine stage IIb). Endovascular treatment was performed for a chronic total occlusion TransAtlantic InterSociety Consensus class II type B lesion. A Supera stent (Abbott Vascular, Santa Clara, CA) was used. However, it had become severely elongated to the proximal end in the superficial femoral artery and was removed using a balloon inserted from the side and trapped to the guide sheath with the distal end of the stent outside the sheath. After this bailout, an alternate stent could be placed through an antegrade approach to the contralateral common femoral artery.

Supera stent implantation for the treatment of isolated popliteal artery disease systematic review and evaluation of current endovascular strategies.

<b>Introduction:</b> The anatomical location of the popliteal artery is one of the greatest challenges for percutaneous interventions. The biomechanical attributes of the vessel lead to higher rates of restenosis, stent fracture, and occlusion. Some surgeons consider the popliteal artery as a no stenting zone. Many specialists favor percutaneous transluminal angioplasty to be the first line of endovascular treatment in the popliteal artery with bail-out stent implantation if the results are suboptimal. The Supera peripheral stent system is a novel stent that has been manufactured with a high degree of flexibility and supposedly might be appropriate for implantation in the popliteal artery. </br></br> <b>Aim:</b> Evaluation of the performance of Supera stent in isolated popliteal artery disease in comparison to other methods of treatment. </br></br> <b>Methods:</b> As many as 92 articles were found in the databases and after full-text review, 4 studies matched the inclusion criteria and were evaluated. </br></br> <b>Results:</b> Primary patency rates of Supera implantation in an isolated popliteal artery at 12 months ranged from 68% to 90%. In all four studies, no stent fractures were observed. Only one study provided longer follow-up than 12 months and evaluated the performance of the Supera stent 36 months after implantation. </br></br> <b>Conclusion:</b> In conclusion, mentioned studies show promising and superior to other stent patency rates of the Supera stent regarding popliteal artery lesions. What is more, no stent fracture is promising regarding longer follow-up. However, more studies with longer follow-ups and direct comparison to other methods are required to fully evaluate Supera's performance in the popliteal artery.

Analysis of Interwoven Nitinol Stenting for the Treatment of Critical Limb Ischemia: Outcomes From an Average 3-Year Follow-up Period.

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.

Tratamiento endovascular de trombosis de arteria poplítea mediante stent supera / Endovascular treatment of popliteal artery thrombosis with supera stent

La enfermedad arterial periférica es una patología muy prevalente en la sociedad, y se está desarrollando nuevas técnicas para tratarla mediante cirugía endovascular, mucho menos agresiva que las utilizadas hasta el momento. El sector Poplíteo por las fuerzas de elongación y torsión a las que está sometido, era hasta la aparición del stent Supera®, territorio de la cirugía abierta, pero gracias a las características de estos stents, nos permite realizar una cirugía menos invasiva en ese territorio. (AU)

The peripheral arterial disease is a very common pathology, and there are developments in new techniques to treat it by endovascular surgery, less aggressive than those used so far. The popliteal sector due to the elongation and torsion forces which is subjected, until the appear of Supera® stent, was only treated by open surgery, but thanks to this type of stent, allow us to treat that territory with less invasive surgeries

Endovascular Treatment of Simultaneous Iliac and Superficial Femoral Arterial Pseudoaneurysms After Stenting Procedure Complications.

PURPOSE:: To report on the endovascular management of a patient affected by concomitant left common iliac artery and right superficial femoral artery (SFA) pseudoaneurysms after stent positioning. CASE REPORT:: A 77-year-old man affected by severe lower limb atherosclerosis was previously treated with iliac and femoropopliteal Supera stenting procedures; he presented to our emergency department because of bilateral severe claudication recurrence, back pain, and right groin region swelling. Angio-computed tomography (CT) depicted 2 pseudoaneurysms of the left common iliac artery and right SFA, due to stent fracture and stent intussusception, respectively. A 2-step endovascular treatment was planned using bilaterally covered stent-grafts to exclude vascular lesions from blood flow. The devices were successfully deployed without any complication. At 1 month, angio-CT confirmed patency of the implanted stent-grafts showing complete pseudoaneurysm exclusion without leaks. CONCLUSION:: Endovascular approach can be a valid option in the treatment of pseudoaneurysms due to stenting procedure complications.