Percutaneous intervention of a giant native coronary artery aneurysm using self-expanding stents.

In the absence of standardized management guidelines, coronary artery aneurysms (CAAs) present therapeutic challenges. Percutaneous coronary intervention (PCI) is rarely explored, especially in giant aneurysms with persistent angina, where surgery might be presumed as a preferred option. We describe the technical aspects and feasibility of PCI using Gore Viabahn expanded polytetrafluoroethylene (ePTFE)-covered nitinol self-expanding stents in a 66-year-old woman with a complex medical history and an enlarging, symptomatic right coronary artery aneurysm. The case was complicated by endoleak after the first stent, but intravascular ultrasound guidance enabled the precise deployment of additional stents, resulting in the successful exclusion of the aneurysm. This case demonstrates steps to successful CAA PCI with Gore Viabahn ePTFE-covered nitinol self-expanding stents and emphasizes that in unsuitable surgical candidates, PCI might be a potential alternative for symptomatic CAAs.

Results of Palliative Stenting in Malignant Superior Vena Cava Syndrome Analyzing Self-Expanding Stainless Steel and Nitinol Venous Bare Metal Stents.

PURPOSE: The purpose was to analyze the technical, clinical, and survival outcomes of our patients with malignant superior cava vein syndrome (SVCS) treated with endovascular approach and analyze the efficacy of different stent types used. MATERIAL AND METHODS: It is an observational, retrospective, single-center study. From 2006 to 2023, 42 patients (32 male, 10 female, mean age 62 years, age range, 41-87 years) underwent percutaneous stent placement for malignant SVCS. One stainless steel stent (Wallstent) and 2 venous nitinol stent type (Sinus-XL, Venovo) were used. Follow-up mean was 276 days. RESULTS: A total of 53 stents were deployed. Clinical success was 97.6% in less 24 hours. Technical success was achieved in 97.6%. No complications were found except 1 patient died during the procedure due to stent migration and atrial dissociation (2.3%). Overall intraprocedural stent migration rate was 11.9% (18.8% stainless steel stent, 9.6% nitinol stent, p>0.05). Overall survival rates were 87.8%, 41.99%, and 34.12%, and overall primary patency rates were 100%, 93.3%, 91.6% at 1, 6, and 12 months, respectively. CONCLUSIONS: Endovascular treatment is a safe and effective therapeutic option for SVCS with high technical and clinical success rates and low complication and recurrence rates. CLINICAL IMPACT: The malignant superior cava vein syndrome is a rare clinical entity treated classically with radiation and chemotherapy with a slower response, or surgical bypass, which is an aggressive surgical technique. Endovascular treatment offers a low-invasive technique with quick clinical resolution and good permeability results. However, further studies are lacking to deal with procedure technical characteristics, stent type used, technical complications, and medium- and long-term patency studies. This study aims to evaluate all these items, analysing self-expanding stainless steel and nitinol venous bare metal stents, and add value to endovascular treatment, confirming the good results of this technique.

Multicenter Registry of Common Femoral Artery Disease Treated With Endovascular Revascularization Using Interwoven Nitinol Stents: An Observational Retrospective Study.

PURPOSE: Surgical thromboendarterectomy has been the gold standard treatment for common femoral artery (CFA) disease. However, endovascular therapy (EVT) is conducted in certain patients with CFA lesions because of multiple comorbidities. The interwoven nitinol stent (IWS) has been developed to prevent stent fracture. Thus, this study aimed to evaluate the feasibility of EVT using IWS for CFA lesions in clinical practice. MATERIALS AND METHODS: This retrospective multicenter registry analyzed patients who had symptomatic lower-extremity artery disease due to CFA lesions and underwent EVT using IWS between 2019 and 2021. The primary endpoint was restenosis 2 years after EVT. RESULTS: This study enrolled a total of 177 patients with 196 CFA lesions. The 2-year estimate of freedom from restenosis was 88.0%. The 2-year freedom rates from the target-lesion revascularization, major amputation, and all-cause death were 92.9%, 99.0%, and 75.2%, respectively. The clinical features significantly associated with restenosis risk were the reference vessel diameter (RVD, per 1.0 mm, hazard ratio [HR], 0.24 [0.08-0.70]; p=0.009), external iliac artery (EIA) involvement (HR=4.03 [1.56-10.4]; p=0.004), superficial femoral artery (SFA) involvement (HR=3.05 [1.00-9.25]; p=0.049), body mass index (BMI; per 1.0, HR=0.85 [0.73-0.99]; p=0.032), occlusion of deep femoral arteries (DFAs) at baseline (HR=7.89 [2.04-30.5]; p=0.003), and chronic limb-threatening ischemia (CLTI, HR=2.63 [1.02-6.78]; p=0.045). Their significant association was also confirmed by the random survival forest analysis. During a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases (37.2%), and no patients had cannulation-related complications, such as failed hemostasis, fracture of IWS, and stent occlusion. CONCLUSIONS: Endovascular therapy using IWS in CFA lesions showed acceptable 2-year patency rates at 88.0% and might preserve the arterial access via the ipsilateral CFAs. Small RVD, involving EIA and SFA lesions, emaciation, occluded DFA, and CLTI are associated with poor 2-year patency rates following EVT, thus, IWS implantation in CFA lesions may be an option for patients unsuitable for surgical revascularization. CLINICAL IMPACT: This retrospective multicenter registry enrolled 177 patients with 199 CFA lesions treated with EVT using interwoven nitinol stents, because surgical thromboendarterectomy was difficult due to their multiple comorbidities. The 2-year estimate of freedom from restenosis was acceptable at 88.0%. The 2-year freedom rate from major amputation was also high at 99.0%. Moreover, during a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases, and no patients had cannulation-related complications such as failed hemostasis, fracture of IWS, and stent occlusion.

Endovascular treatment with interwoven nitinol stent for common femoral artery lesions: 2-year outcomes of a single center experience.

OBJECTIVE: The study aimed was to report 2-year outcomes of endovascular treatment with interwoven nitinol (Supera™) stent for common femoral artery (CFA) lesions. METHODS: We reviewed the clinical data of 20 patients who presented with CFA stenosis or occlusion and underwent balloon angioplasty followed by Supera™ stenting in CFA between February 2016 and January 2022. The outcomes were evaluated in these patients in terms of technical success, post-intervention complications, reintervention, and cumulative patency (1 year, and 2 years). RESULTS: The study included 20 patients (22 lesions) who presented with isolated CFA lesions (3), iliac lesions involving CFA (6), superficial femoral artery (SFA) lesions involving CFA (8), and extensive lesions from the iliac artery to SFA (5). There were 16 men (80%) with a mean age of 69.7 years (range, 34-83). Hypertension, smoking, and diabetes were found in 15 (75%), 7 (35%), and 7 patients (35%), respectively. Clinical presentations were Rutherford stage 5 (9, 45%), Rutherford stage 4 (5, 25%), Rutherford stage 6 (4, 20%), and Rutherford stage 3 (2, 10%). Technical success was achieved in all patients (100%). The procedures for treatment were isolated CFA Supera™ stenting (1, 4.5%), CFA plus DFA Supera™ stenting (jailed SFA) (2, 9.1%), CFA plus SFA Supera™ stenting (jailed DFA) (8, 36.4%), CFA Supera™ stenting plus bare iliac stenting (Astron) (6, 27.3%), CFA plus SFA Supera™ stenting (jailed DFA) plus bare iliac stenting (Astron) (5, 22.7%), and additional DFA angioplasty (7, 31.8%). The rate of in-hospital mortality and morbidity were 0% and 10%, respectively. Distal embolization after pre-dilatation occurred in 1 patient, and cerebral infarction occurred 12 h after the procedure in 1 patient. The mean follow-up time was 23 months (range, 2-64). During the follow-up period, in-stent occlusion occurred in 2 patients at 9 and 46 months. Re-intervention was performed in 1 patient due to recurrent symptom of claudication. The cumulative primary patency at 1 year and 2 years were 93.3% and 93.3%, respectively. CONCLUSION: Endovascular treatment with interwoven nitinol (Supera™) stent for CFA lesions was associated with acceptable outcomes at 2 years.

Double-wire woven nitinol stent for treating dogs with refractory tracheal collapse: A case series.

This retrospective case series describes the signalments, clinical signs, diagnostic test results, and postoperative complications obtained from the medical records of 10 client-owned dogs that underwent treatment for grade IV tracheal collapse using double-wire woven nitinol stents between October 2017 and September 2021. Respiratory signs resolved in all dogs immediately after tracheal stent placement. Mild to moderate stent fractures were identified in five dogs, of which two showed concurrent respiratory distress necessitating re-stenting after several months. Minor complications, such as stent migration, were absent. The double-wire woven nitinol stent optimised for the canine trachea showed favourable outcomes and minimal complications.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial.

PURPOSE: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). METHODS: The STELLA SUPERA (STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2-6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. RESULTS: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. CONCLUSION: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Treatment of Long Femoropopliteal Occlusive Lesions With Self-expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial.

PURPOSE: The efficacy and safety of the Supera stent in superficial femoral artery (SFA) have been reported mostly in shorter lesions with relatively low proportion of occlusions. There are little data on the effectiveness of the Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal occlusive lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral artery disease. MATERIALS AND METHODS: The STELLA-SUPERA-SIBERIA is a prospective, single-center, single-arm study. Patients with symptomatic (Rutherford stages 3-6) de novo and TASC C/D occlusive lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the 12 month rate of primary sustained clinical improvement (upward shift on the Rutherford classification to a one level without the need for repeated target lesion revascularization (TLR) in surviving patients without the need for unplanned amputation). Secondary endpoints were the 24 month of primary sustained clinical improvement, MALE, limb salvage, the primary patency, the secondary patency, 24 month MACE. Follow-up included clinical examination, duplex scan, and biplane x-ray up to 24 months. RESULTS: Between April 2019 and January 2020, 52 symptomatic patients with 55 long femoropopliteal occlusive lesions (52.7% TASC D lesions and 47.3% TASC C lesions) were treated. The mean target lesion length was 205±72 mm. All patients had total occlusions. The mean lesion length of the implanted Supera stents was 198±82 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 80.2% and 63.6%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). The primary patency rate at 12 and 24 months was 78.1% and 60.0%, respectively. At 12 and 24 months, freedom from TLR was 83.5% and 81.8%, respectively. There were no stent fractures at 24 months. CONCLUSION: Supera Stent implantation for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Head-to-head studies are mandatory to establish Supera Stent as an alternative tool to open surgery for long femoropopliteal lesions. CLINICAL IMPACT: Our study indicated, that using self-expanding interwoven nitinol stent for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Although bypass grafting is recommended for prolonged femoropopliteal lesions, open surgery is more traumatic and is associated with greater risks than endovascular procedures. Our findings suggest that the use of interwoven nitinol stents can overcome the disadvantages of traditional stents in such cases, which may help to improve patients' outcomes and reduce the risk of adverse events.

Novel Self-Expanding Interwoven Nitinol Stent for Treating Femoropopliteal Artery Disease: 12-Month Results of Single-Center First-in-Man Study.

PURPOSE: To evaluate the safety and efficacy of Innospring® stent, a novel self-expanding interwoven nitinol stent, in treating femoropopliteal atherosclerotic lesions. METHODS: A prospective, single-center, single-arm, first-in-human study enrolled 15 patients (mean age 73.1 years; 13 men) to evaluate the safety and efficacy of the Innospring® stent monitored by core laboratories. The inclusion criteria were claudication or ischemic rest pain, de novo lesions or nonstented restenosis, >70% stenosis, lesion length <20 cm, and a reference vessel diameter of 4-7 mm. The primary safety endpoint was 30-day major adverse events. The primary efficacy end point was stent patency at 12 months. Follow-up evaluations were conducted at 30 days, 6 months, and 12 months. RESULTS: The lesion length was 6.1 ± 3.5 mm. Fourteen (93.3%) patients had lesions of the superficial femoral artery and 3 (20.0%) patients had lesions of the popliteal artery. Nine (60.0%) patients had moderate-to-severe calcified lesion. Technical and procedural success was 100%. No patients experienced major adverse events in the first 30 days. The Rutherford category showed significant and sustained improvement at 6 and 12 months. The 12-month follow-up radiographs obtained in 13 patients confirmed the absence of stent fractures in 100% of examinations. The cumulative primary stent patency rate at 6 and 12 months were 93.3% and 84.6%, respectively. CONCLUSION: Stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide superior stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress. CLINICAL IMPACT: Endovascular recanalization is a widely accepted and recommended treatment for symptomatic peripheral artery diseases. The Innospring® stent is a novel self-expanding interwoven stent containing eight nitinol wires with additional radial force, fracture-resistance, and visibility under fluoroscopy. This first-in-human study using the Innospring® stent in patients with femoropopliteal occlusive disease reported that stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide an impressive stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress.

Multicenter, retrospective registry of isolated atherosclerotic popliteal arteries treated with endovascular revascularization.

Isolated atherosclerotic popliteal lesions (IAPLs) have been considered challenging. This study aimed to investigate the efficacy of endovascular therapy (EVT) using the newer devices for IAPLs. This retrospective multicenter registry analyzed patients with lower extremity artery disease having IAPLs who underwent EVT using the newer devices between 2018 and 2021. The primary outcome was primary patency 1 year after EVT. A total of 392 consecutive patients undergoing EVT for IAPLs were enrolled. The Kaplan-Meier analysis showed that the primary patency and the freedom from target lesion revascularization were 80.9% and 87.8% 1 year after EVT, respectively. The multivariate Cox proportional hazards regression analysis showed that the clinical features that were independently associated with restenosis risk were drug-coated balloon (DCB) use for younger age (< 75 years old; adjusted hazard ratio, 3.08 [95% confidence interval 1.08-8.74]; P = 0.035), non-ambulatory status (2.74 [95% confidence interval 1.56-4.81]; P < 0.001), cilostazol use (0.51 [95% confidence interval 0.29-0.88]; P = 0.015), severe calcification (1.86 [95% confidence interval 1.18-2.94]; P = 0.007), and small external elastic membrane (EEM) area measured by intravascular ultrasound (IVUS) (< 30 mm2) (2.07 [95% confidence interval 1.19-3.60]; P = 0.010). From the univariate analysis, among patients treated with DCB, younger patients (n = 141) were associated with more comorbidities including smoking (P < 0.001), diabetes mellitus (P < 0.001), end-stage renal disease (P < 0.001), history of revascularization (P = 0.046) and small EEM area (P = 0.036), compared to older patients (n = 140). Moreover, smaller post-procedural minimum lumen area measured by IVUS after DCB dilatation was observed in younger patients (12 ± 4 vs. 14 ± 4 mm2, P = 0.033). This retrospective study demonstrated that the current EVT provided an acceptable 1-year primary patency rate in patients with IAPLs. The primary patency was lower following DCB in younger patients, likely due to the higher rates of comorbidities in this patient population.

A Systematic Review and Meta-Analysis of 12-Month Patency After Intervention for Iliofemoral Obstruction Using Dedicated or Non-Dedicated Venous Stents.

BACKGROUND: Endovascular stenting of the deep venous system has been proposed as a method to treat patients with symptomatic iliofemoral outflow obstruction. The purpose of this systematic review and meta-analysis was to compare the effectiveness of this treatment at 1-year following the development of dedicated venous stents. METHOD AND RESULTS: We searched MEDLINE and EMBASE for studies evaluating the effectiveness of venous stent placement. Data were extracted by disease pathogenesis: non-thrombotic iliac vein lesions (NIVL), acute thrombotic (DVT), or post-thrombotic syndrome (PTS). Main outcomes included technical success, stent patency at 1 year and symptom relief. A total of 49 studies reporting outcomes in 5154 patients (NIVL, 1431; DVT, 950; PTS, 2773) were included in the meta-analysis. Technical success rates were comparable among groups (97%-100%). There were no periprocedural deaths. Minor bleeding was reported in up to 5% of patients and major bleeding in 0.5% upon intervention. Transient back pain was noted in 55% of PTS patients following intervention. There was significant heterogeneity between studies reporting outcomes in PTS patients. Primary and cumulative patency at 1 year was: NIVL-96% and 100%; DVT-91% and 97%; PTS (stents above the ligament)-77% and 94%, and; PTS (stents across the ligament)-78% and 94%. There were insufficient data to compare patency outcomes of dedicated and nondedicated venous stents in patients with acute DVT. In NIVL and PTS patients, stent patency was comparable at 1 year. There was inconsistency in the use of validated tools for the measurement of symptoms before and after intervention. When reported, venous claudication, improved in 83% of PTS patients and 90% of NIVL patients, and ulcer healing occurred in 80% of PTS patients and 32% of NIVL patients. CONCLUSIONS: The first generation of dedicated venous stents perform comparably in terms of patency and clinical outcomes to non-dedicated technologies at 1 year for the treatment of patients with NIVL and PTS. However, significant heterogeneity exists between studies and standardized criteria are urgently needed to report outcomes in patients undergoing deep venous stenting.

Removal of Partially Deployed Supera Stents: Case-Based Review and Technical Considerations.

PURPOSE: Maldeployment of the Supera stent system can result in primary technical failure, inferior primary patency, and poorer patient outcomes. The purpose of this article is to present a case series illustrating the conditions required to perform optimal stent deployment, and if necessary, undertake successful stent removal following maldeployment. TECHNIQUE: Two key failures of effective Supera deployment are elongation and invagination. Several technical factors should be considered to reduce the risk of maldeployment: aggressive target vessel predilation, the use of multiple fluoroscopic views, slow deployment with controlled forward pressure applied on the delivery device, "sandwich packing" of the stent above and below target lesions, and the "pulling back" of invagination. To successfully retrieve a partially deployed stent, 3 factors should be considered: the percentage of the stent already deployed, the distance from the distal tip of the introducing sheath to the proximal extent of the deployed stent, and the severity of proximal vessel disease. The higher these factors, the greater the risk of stent detachment and failed retrieval. CONCLUSION: In this series of 6 cases of maldeployment, the removal of a partially deployed Supera stent appeared to be feasible and safe, with success dependent on selected technical and anatomical considerations.

Directional atherectomy and drug-coated balloon angioplasty vs. bare nitinol stent angioplasty for femoropopliteal artery lesions.

Background: The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare nitinol stent (BNS). Patients and methods: This retrospective cohort study included patients with femoropopliteal artery lesions who underwent percutaneous endovascular surgery between January 2016 and June 2019. The primary outcome was the primary patency rate after 12, 24, and 36 months; the secondary outcomes comprised incidence of flow-limiting dissections, technical success, limb salvage, and all-cause death. Results: During the study period, 110 (44%) patients underwent DA+DCB, and 140 (56%) patients underwent bare nitinol stent (BNS). There were no differences in the 12- and 24-month patency rates of the two groups (98.2% vs. 93.6% and 68.2% vs. 60.0%, both p>.05). The 36-month primary patency rate in the DA+DCB group was significantly higher than that of the BNS group (27.3% vs. 15.7%, p=.003). The technical success rate and all-cause death were similar between groups (p>.05). Flow-limiting dissections occurred more frequently in the BNS group than in the DA+DCB group (27.9% vs. 10.9%, p=.033). After adjustment for potential confounders, such as sex, smoking, hypertension, hyperlipidemia, ABI after surgery, TASC II B, lesion length ≥15 cm, two-vessel runoff, and three-vessel runoff, the HR for primary patency rate comparing BNS to DA+DCB was 2.61 (95%CI: 1.61-4.25). Conclusions: In this retrospective cohort study, DA+DCB was associated with a higher 30-month primary patency rate and a lower flow-limiting dissection incidence than BNS.

Long-Term Results of Endovascular Treatment with Nitinol Stents for Femoropopliteal TASC II C and D Lesions.

Background and Objectives: The feasibility of endovascular treatment (EVT) for Trans-Atlantic Inter-Society Consensus (TASC) II C and D femoropopliteal artery lesions has been described, but no prospective study has performed a long-term follow-up. The aim of this study was to report the long-term results of nitinol stents (NS) for the treatment of long femoropopliteal lesions. Materials and Methods: A single-center prospective, randomized controlled trial (RCT) comparing EVT with NS and vein bypass surgery was previously performed. The EVT group's follow-up was extended and separately analyzed with primary patency as the primary endpoint. The secondary endpoints were technical success, secondary patency, reinterventions, limb salvage, survival, complications, and clinical improvement. Results: Between 2016 and 2020, 109 limbs in 103 patients were included. A total of 48 TASC II C and 61 TASC II D lesions with a mean lesion length of 264 mm were reported. In 53% of limbs, the indication for treatment was chronic limb-threatening ischemia. The median follow-up was 45 months. Technical success was achieved in 88% of cases, despite 23% of the lesions being longer than 30 cm (retrograde popliteal access in 22%). At four-year follow-up, primary patency, secondary patency, and freedom from target lesion revascularizations were 35%, 48%, and 58%, respectively. Limb salvage and survival were 90% and 80% at 4 years. Clinical improvement of at least one Rutherford category at the end of follow-up was achieved in 83% of limbs. Conclusions: This study reports the longest follow-up of endovascular treatment with nitinol stents in femoropopliteal TASC II C and D lesions. The results emphasize the feasibility of an endovascular-first strategy, even in lesions beyond 30 cm in length, and clarify its acceptable long-term durability and good clinical outcomes. Large multicenter RCTs with mid- and long-term follow-up are needed to investigate the role of different endovascular techniques in long femoropopliteal lesions.

Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results.

OBJECTIVE: To examine the efficacy and durability of an interwoven self-expanding nitinol stent for the treatment of superficial femoral and popliteal arteries. METHOD: Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA® stents were retrospectively identified.The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class and ankle-brachial index. RESULTS: From July 2012 to May 2014, 42 limbs in 36 patients (mean age, 61.5 ± 7.5 years; 75% male) were treated with angioplasty and primary stenting. Total occlusions were present in 14 limbs, and 63.8% had either moderate or severe calcification. The mean (±SD) lesion length was 105 mm (±28). Primary patency was 91.4% at 6 months and 85.7% at 12 months. The ankle brachial index increased from 0.57 ± 0.19 preoperative to 0.91 ± 0.12 postoperative. There was no procedural or device-related morbidity or mortality after revascularization and only one major amputation was observed on follow-up. CONCLUSIONS: Our experience shows that, Supera stents are safe and effective in our cohort of patients, with acceptable patency rates. There were no stent fractures so far even with stenting of the femoropopliteal segments. Stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.

A midterm analysis of patients who received femoropopliteal helical interwoven nitinol stents.

BACKGROUND: The aim of this study was to report midterm outcomes (up to 72 months) of patients who received femoropopliteal helical interwoven nitinol stents (Supera Peripheral Stent System, Abbott Laboratories, Inc, Webster, Tex). METHODS: Prospectively collected data on patients treated with femoropopliteal non-drug-eluting angioplasty and helical interwoven nitinol stents were retrospectively analyzed. Patients were followed up with 6, 12, 18, 24, 36, 48, 60, and 72 months clinical, duplex, and radiographic assessments. Restenosis is defined as 50% or greater restenosis of the target lesion on duplex ultrasound imaging. RESULTS: From October 2011 to September 2018, 315 patients (198 males) with 360 legs and a median age of 78 years (range, 46-100 years) were included. Symptoms of claudication, rest pain, and tissue loss were found in 212 (58.9%), 53 (14.7%), and 150 (41.7%) legs, respectively. In 176 (48.9%) legs, stents were placed in the popliteal segments. The mean stented lesion length was 119.0 mm (range, 40-450 mm). The overall primary patency rates at 6, 12, 24, 36, 48, 60, and 72 months were 90.6%, 80.5%, 73.8%, 68.9%, 65.3%, 63.1%, and 63.1%, respectively. The ankle-brachial pressure index increased from 0.58 ± 0.18 preoperatively to 0.87 ± 0.16 postoperatively. There were no stent fractures on follow-up. Patency rate was not statistically affected by indication of treatment, lesion calcification, or diabetes, but the length of stents and involvement of popliteal arteries were statistically significantly worse (log-rank test, P = .011 and P = .005). Stents with inner diameters of 4-mm had an initial lower patency compared with 5-mm stents, but the patency rates merged and crossed over at 46 months (log-rank test, P = .131). There was no procedural- or device-related morbidity or mortality, and there were nine major amputations after revascularization. CONCLUSIONS: This study provides long-term clinical data demonstrating that Supera stents are effective and durable.

Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry.

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry (ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

Sequential coronary bifurcation revascularization with the Xposition S™ self-apposing stent: a comparative fractal bench study.

Coronary bifurcation revascularization needs to take account of the diameter differential between vessels and to limit side-branch obstruction (SBO). The self-apposing properties of the Xposition S™ stent (STENTYS, France) seem interesting in this regard. The present experimental fractal bench study determined the best provisional stenting technique using Xposition S™. Three sequential strategies were compared (n = 5/group): implantation alone, side-branch inflation (SBI), and re-POT (initial proximal optimization technique (POT) + SBI + final POT). 2D- and 3D-OCT analyses and micro-CT scan were performed to quantify the main mechanical results at each step. Of the three groups, SBI and re-POT provided better final results than implantation alone in terms of residual SBO (respectively, 24.6 ± 5.6% and 24.8 ± 5.0% vs. 46.5 ± 10.3%, p < 0.05) and malapposition (respectively, 0.9 ± 0.6% and 0.8 ± 0.4% vs. 3.8 ± 1.9%, p < 0.05). Unlike SBI, the two POTs of the re-POT sequence did not improve the final result. SBI, alone or as part of re-POT, systematically led to one connector breakage, whereas implantation alone maintained complete stent integrity (p < 0.05). In Xposition S™ implantation, SBI should be systematic, but not post-dilatation specifically dedicated to bifurcation stenting (i.e., POTs). However, global post-dilatation is still mandatory to prevent stent underexpansion due to untreated stenosis.

Combination therapy of heparin-bonded covered stent and bare-nitinol stent assessed by intravascular ultrasound.

To examine clinical outcomes for combination therapy of heparin-bonded covered stent [VIABAHN™ stent (VIA)] and bare-nitinol stent (BNS), and to determine independent predictors of restenosis after VIA implantation assessed by intravascular ultrasound (IVUS). A retrospective analysis was conducted on VIA use in the femoropopliteal artery of 71 patients (81 lesions) treated between June 2012 and November 2018. We divided the treated lesions into two groups; that is, whether BNS was added at the proximal site of the VIA or not (combination of VIA and BNS group [COM; n = 21] vs. VIA group [n = 60]). The median follow-up duration was 21.6 months (interquartile range, 13.2-28.8 months). Restenosis at 2 years was observed in 5 lesions (33%) in COM group and 17 lesions (38%) in VIA group (log-rank, P = 0.74). In VIA group, 14 lesions developed restenosis within 12 months. Multivariate logistic regression analysis of VIA group revealed that the proximal plaque burden was an independent predictor of restenosis within 12 months after VIA implantation (odds ratio 1.15, 95% confidence interval 1.01-1.30, P = 0.01), with the optimal cutoff value of 43% (area under the receiver operator characteristic curve 0.79, sensitivity 91%, specificity 69%). A remaining plaque of > 43% at the proximal reference segment was an independent predictor of restenosis after VIA implantation. When residual stenosis is observed at the proximal site of SFA after VIA implantation, combination therapy of VIA and BNS would be an optimal management.

[Self-expanding nitinol stents for bleeding from esophageal varices in patients with portal hypertension]. / Lechenie krovotecheniya iz varikozno rasshirennykh ven pishchevoda nitinolovym stentom u bol'nykh portal'noi gipertenziei.

Blakemore probe-obturator was previously preferable for primary hemostasis in patients with bleeding from esophageal varices. Currently, Danis self-expanding nitinol stent became an effective alternative. According to some manufacturers, Danis stent has some advantages over balloon tamponade. We report implantation of nitinol stent for hemostasis in a patient with multiple recurrent bleeding and ineffective endoscopic manipulations. A method of stent fixation for prevention of distal migration as the most common complication is described.

[Endoscopic treatment of gastroduodenal perforations]. / Endoskopicheskoe lechenie gastroduodenal'nykh perforatsii.

A 93-year-old patient underwent endoscopic treatment of perforated duodenal ulcer after previous laparoscopic suturing complicated by failure of sutured defect. A self-expanding nitinol stent with partial polyurethane coating was used. Positive effect of the treatment was noted. Further study of this method and its clinical introduction in case of favorable results can significantly reduce the incidence of complications and mortality in patients with perforated gastroduodenal ulcers.