Applicability and clinical results of percutaneous transluminal angioplasty with a novel, long, conically shaped balloon dedicated for below-the knee interventions

Aim. The aim of this study was to assess the feasibility, safety and efficacy of percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia (CLI) using a novel balloon designed for below-the-knee (BTK) indications. Methods. The authors have prospectively collected baseline, periprocedural and mid-term data of all consecutive patients with CLI due to BTK disease in which PTA was attempted using a long (210 mm), conically-shaped balloon (0.5 mm tapering from proximal to distal balloon edges). The primary objective was the assessment of acute success (composite of technical, angiographic and procedural success). The secondary assessments included limb salvage rate, major (above the ankle) and minor (below the ankle) amputation, change in Rutherford class and cutaneous oxygen tension, reocclusion/ restenosis, rehospitalization, and repeat revascularization after one year. Results. A total of 31 patients were treated with 36 long tapered balloons. Ten patients presented with ischemic tissue loss. Target lesions were mostly occlusive and diffuse, commonly involving the tibial arteries as well as the in-flow and out-flow vessels. Acute success was achieved in 100% of the cases without periprocedural complications. Clinical improvement in functional status was obtained and maintained after an average of 12 months, with a significant (P<0.001) decrease in Rutherford class, 100% limb salvage, no major amputation and five (16.1%) minor amputations. Duplex ultrasound control showed Department of Diagnostic and Molecular Imaging Interventional Radiology, Nuclear Medicine and Radiation Therapy “Tor Vergata” University, Rome, Italy restenosis/reocclusion in two (6.5%) cases, whereas a total of seven (22.6%) patients underwent repeat revascularization (2 [6.5%] target lesion re-PTA). Conclusion. Infra-popliteal PTA with this new, BTK dedicated, long tapered balloon in patients with CLI was feasible and safe, and was associated favorable clinical results at both acute and mid-term follow-up. KEY WORDS: Ischemia - Limb salvage - Peripheral arterial disease.