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 Therapy with Interwoven Nitinol Stent Placement after Predilation for Heavily Calcified Femoropopliteal Artery Disease: Results of the BURDOCK Study.

PURPOSE: To investigate the 1-year and 2-year clinical outcomes of interwoven stent (IWS) implantation for symptomatic femoropopliteal arterial disease with calcification. MATERIAL AND METHODS: This prospective multicenter study evaluated 308 limbs (63% with the peripheral arterial calcium scoring system 3 and 4 severe calcification and 87% with ≥180° calcification on intravascular ultrasound) of 299 patients (diabetes in 66.9%, chronic renal failure in 52.8%, and dialysis in 49.2%) who underwent IWS (Supera; Abbott, Abbott Park, Illinois) implantation after sufficient predilation (residual stenosis < 30%) for calcified femoropopliteal lesions. The primary outcome measure was primary patency (freedom from restenosis) at 1 and 2 years, whereas the secondary outcome measure included freedom from clinically driven target lesion revascularization (CD-TLR). Clinical parameters associated with loss of patency were explored. RESULTS: Kaplan-Meier analysis showed that primary patency was 88.2% (95% confidence interval [CI], 84.5%-92.1%) at 1 year and 80.8% (95% CI, 76.1%-85.8%) at 2 years. The CD-TLR-free rate was 96.5% and 94.8% at 1 and 2 years, respectively. The characteristics associated with loss of patency were restenotic lesion with and without stent implantation (adjusted hazard ratio, 1.96 and 2.40; P = .047 and .041, respectively), chronic total occlusion (adjusted hazard ratio, 1.88; P = .022), and popliteal involvement (adjusted hazard ratio, 2.60; P = .002). CONCLUSIONS: The implantation of IWS after sufficient predilation for calcified femoropopliteal atherosclerotic disease demonstrated clinically acceptable primary patency.

Percutaneous deep venous arterialization with balloon angioplasty salvaged a life-threatening critical limb in a hemodialysis patient after repeated pedal angioplasty failed: A case report.

Chronic limb-threatening ischemia (CLTI) with severe below-the-ankle (BTA) lesions is often difficult to revascularize with endovascular treatment (EVT) and surgical treatment. We present a case of successful limb salvage using percutaneous deep venous arterialization (pDVA) in a patient with CLTI whose BTA lesion reconstruction failed. A 57-year-old man with diabetes mellitus and end-stage renal failure on maintenance hemodialysis was referred to our hospital because of gangrene in the second and third toes of his left foot. EVT was repeated for the anterior tibial artery, posterior tibial artery (PTA), dorsal foot artery, and plantar artery lesions; however, revascularization below the ankle was unsuccessful. As the infection had spread to the sole of the foot, below-the-knee amputation was indicated, but the patient refused. Therefore, we performed pDVA on the left PTA simultaneously with a Lisfranc amputation. An arteriovenous fistula was created at the ankle joint using a Venous Arterialization Simplified Technique and a guidewire was inserted into the plantar vein. Balloon dilatation from PTA to the plantar vein was performed to complete the pDVA. Although repeated EVT was required to maintain blood flow in the pDVA, skin grafting was performed 3 months after the pDVA, the wound completely healed, and he was discharged 6 months after the DVA. The pDVA can be an option for limb salvage in patients with no-option CLTI who are confronted by imminent amputation.

A novel technique of percutaneous intraluminal cracking using a puncture needle for severe calcified lesions of below-the-knee and below-the-ankle arteries.

PURPOSE: Endovascular therapy has recently become acceptable for the reconstruction of below-the-knee (BTK) and below-the-ankle (BTA) arterial lesions. However, we have sometimes experienced BTK or BTA lesions with calcifications that are too severe for balloon catheters to cross or expand despite successful guidewire passage. In this study, we assessed the feasibility and safety of the novel inner PIERCE technique for breaking down the calcium burden of BTK and BTA arterial lesions. METHODS: We retrospectively reviewed the records of patients who had undergone endovascular therapy between August 2018 and December 2019. The inner PIERCE technique was performed in those cases where low-profile balloon catheters were unable to pass through the target lesions or balloon indentation did not disappear beyond the rated burst pressure. An externalized guidewire system was established in 8 cases via bidirectional approaches, and a 20-gauge needle was directly inserted through the guidewires from the distal puncture site. In 10 cases of successful antegrade wiring, the tibial or pedal arteries distal to the lesion site were punctured for a retrograde guidewire approach to the lesion. The needle was slowly rotated and advanced across the lesion. RESULTS: We found that all lesions were severely calcified and 83.3% had chronic total occlusion. The inner PIERCE procedure allowed successful passage of the needle and subsequent low-profile balloon catheters in all cases. Optimal balloon dilatation was achieved in 94.4% of the cases using this technique. No procedure-related adverse events were observed. CONCLUSION: The novel inner PIERCE technique is a safe and feasible method for disrupting calcified BTK and BTA lesions.