ULYSSE Registry Data Suggest Ultrasoundplasty Before Angioplasty for BTK Lesions May Improve Outcomes

 

November 6, 2019—Costantino Del Giudice, MD, presented data from the ULYSSE registry during a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada. Dr. Del Giudice is an interventional radiologist at the Hôpital Européen Georges Pompidou in Paris, France.

The ULYSSE registry, a retrospective, nonrandomized, single-center study, evaluated the safety and efficacy of ultrasoundplasty before angioplasty to treat below-the-knee (BTK) lesions in 22 patients with critical limb ischemia (CLI). In all, 35 BTK lesions were assessed. All patients in the registry were Rutherford category 4 to 6 with moderate-severe calcification.

All ultrasoundplasty was performed using the Kapani catheter (Apani Corporation), which delivers a local, low-frequency, high-intensity ultrasound energy to the lesion.

According to the late-breaking trial summary, the registry objective was to demonstrate that locally delivered ultrasound energy may modify plaque structure using microcavitational effects and change plaque compliance without the risk of vessel dissection and rupture. Modifications of plaque structure may potentially improve the outcome of simple balloon angioplasty.

The ULYSSE registry’s primary safety outcomes were 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 (TLR) at 6 months.

The data showed good results for immediate outcomes, with 100% technical success and no major adverse events. On 6-month angiographic control, primary patency was 97.1%, with 100% ulcer healing and no TLR and no CLI recurrence. At 24 months, freedom from restenosis was 91.4%, as evaluated by Doppler ultrasound control, with no TLR and no CLI recurrence. No major adverse events were reported.

Researchers concluded that ultrasoundplasty before angioplasty for BTK lesions may improve clinical outcomes without the need for a drug-eluting device. However, a larger randomized study is needed to confirm these results.

 

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