November 7, 2019 — Ultrasoundplasty before angioplasty for below-the-knee lesions (BTK) lesions may improve clinical outcomes without the need for a drug-eluting device, acceding to data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting.
The Ulysse registry is a retrospective, nonrandomized, single-center study evaluating the safety and the efficacy of ultrasoundplasty before angioplasty to treat BTK in 22 critical limb ischemia (CLI) patients (35 BTK lesions). All patients were Rutherford category 4 to 6 and had moderate-severe calcification. Ultrasoundplasty was performed using the Kapani catheter (Apani Corp.), which delivers a local, low-frequency, high-intensity ultrasound energy to the lesion.
The objective of the study was to demonstrate that locally delivered ultrasound energy may modify plaque structure using microcavitational effects and change plaque compliance without risk of vessel dissection and rupture. Modifications of plaque structure may potentially improve the outcome of a simple balloon angioplasty, said presenter Costantino Del Giudice, M.D., University Paris Descartes, Hopital Europeen George Pompidou, Paris, France.
The primary safety outcomes were the major adverse events at 30 days, recurrence of CLI, and surgical or endovascular revascularization at 6 months. The primary efficacy endpoint was angiographic restenosis and target lesion revascularization at six months. Immediate outcomes showed good results, with 100% technical success and no major adverse events. At six-month angiographic control, primary patency was 97.1%, with 100% ulcer healing and no target lesion revascularization and no CLI recurrence. At 24 months, freedom from restenosis was 91.4% as evaluated by Doppler ultrasound control, with no target lesion revascularization and no CLI recurrence. No major adverse events were reported.
A larger randomized study is needed to confirm these results.