Technical Success and Clinical Outcomes of Pedal Serration Angioplasty for Chronic Limb-Threatening Ischemia

Abstract

Purpose:

Patients with pedal artery occlusive disease have limited options when presenting with chronic limb-threatening ischemia (CLTI). Serration angioplasty (SA) has demonstrated less recoil and improved freedom from reintervention compared with plain old balloon angioplasty within the tibial vessels. We aimed to identify the technical feasibility and clinical outcomes of SA within the pedal (inframalleolar) vasculature in patients with CLTI.

Materials and Methods:

Patient with SA of the pedal vasculature for CLTI from January 01, 2021 to March 31, 2023 were included in this multicenter retrospective study. Pedal vessels were defined as any inframalleolar vessel distal to the talocrural joint. Patient demographics, anatomic and technical details, acute procedural outcomes, and outcomes at the most recent follow-up were collected for analysis. The primary endpoint was technical success, defined as SA with <50% residual target vessel stenosis. Secondary endpoints included freedom from vessel injury, amputation-free survival, clinically-driven target lesion revascularization (CD-TLR), composite major adverse limb events (MALEs), wound healing rate, and improvement in wound, ischemia, and foot infection (WIfI) clinical stage at the most recent follow-up.

Results:

Of the identified 45 patients managed with pedal SA, median pre-intervention Rutherford classification was 5, and 91.9% of patients had concomitant below-the-knee tibial artery intervention. The most commonly treated artery was the dorsalis pedis (59.2%), with a median diameter SA of 2.5 mm. Residual stenosis was <50% in 93.3% of cases and <30% in 82.2%. Freedom from vessel injury was 93.3% (1 immediate occlusion and 2 bail-out stents). Six-month freedom from major amputation was 93.3%, freedom from pedal CD-TLR was 93.3%, and freedom from MALE was 80.0%. At a median follow-up of 163 days, 48.7% of patients had complete wound healing, with the total frequency of either healed or improving wounds of 79.5%.

Conclusion:

Serration angioplasty of the inframalleolar vasculature in patients with CLTI had high rates of technical success with a low incidence of vessel injury. At a median follow-up of 5.4 months, wound healing was ahead of previously published studies on inframalleolar intervention.

Clinical Impact

This represents the largest series of a specialty balloon used to treat pedal occlusive disease in chronic limb-threatening ischemia patients. As the rate of pedal intervention increases, using new technology to safely achieve luminal gain is crucial for both short- and long-term limb salvage.