Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease.

OBJECTIVES: To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. METHODS: This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. RESULTS: 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. CONCLUSIONS: At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease.

OBJECTIVES: To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. BACKGROUND: The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug-eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long-term inflammation. BVSs are biodegradable scaffolds that provide short-term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. METHODS: This single-center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly-L-lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD-TVF) at 12 months. RESULTS: Thirty-one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD-TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford-Becker classification. CONCLUSIONS: At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD-TVF.

Report of endoscopic cochlear implantation.

OBJECTIVES: To report patient outcomes after transcanal endoscopic cochlear implantation for sensorineural hearing loss. PATIENTS: Males and female subjects more than 7 years old with sensorineural hearing loss (confirmed with audiologic studies) were selected. CT imaging was used to rule out any anatomic anomalies of the temporal bone. Smaller pediatric patients whose canal might still be growing and who might have a higher incidence of otitis media and otitis externa were excluded. Obese adults whose canal skin was too thick to allow good access down the ear canal were also excluded. INTERVENTION(S): Surgical (therapeutic). Endoscopic cochlear implantation using a transcanal approach. MAIN OUTCOME MEASURE(S): Implant position and function. Postoperative complications specifically related to transcanal approach and use of the endoscope. RESULTS: Twenty-five endoscopic cochlear implantations were performed in 24 ears on 11 female and 10 male subjects aged 7-65 years. Eight patients were implanted in Brazil, and 13 patients (17 yr) were implanted in the United States. All implants were fully inserted into the scala tympani, and 24 functioned normally with appropriate thresholds. Mean time of follow-up was 16 months (SD, ±7.2). The chorda tympani was sacrificed in 2 of 25 procedures, 12 EAC/TM tears occurred which healed by the second follow-up visit. No injury to the facial nerve was observed. One postoperative wound infection and 1 otitis externa each resolved with 1 week of antibiotics. Implant array was visible through the EACs skin but not exposed in 6 of 24 ears. CONCLUSION: Endoscopic cochlear implantation may become a viable, safe, and feasible alternative to the standard open transmastoid approach.