Intravascular lithotripsy enables safe and effective transfemoral aortic valve replacement

In patients with severe peripheral artery disease (PAD), transfemoral transcatheter aortic valve replacement (TAVR) is often not feasible.

Iliofemoral calcium modification by intravascular lithotripsy (IVL) may enable transfemoral access in PAD patients.

Between June 2022 and February 2024, all consecutive TAVR patients at our institution were prospectively screened for use of IVL according to the predefined TREATABLE classification, involving parameters such as calcification, vessel kinking and stenosis. Endpoints comprised successful TAVR, safety, and three-month outcomes (DRKS00034681). In an independent retrospective approach, all TAVR patients treated between February 2020 and June 2022 were evaluated with the TREATABLE classification towards complication rates without use of IVL (DRKS00029242).

Two hundred twenty-nine prospective patients were included and after application of the TREATABLE classification, 26 patients (11.4%) received IVL-supported transfemoral TAVR. According to the TREATABLE classification, there was a similar extent of kinking (p = 0.468), but a significantly higher severity of calcification in the IVL-treated group (p < 0.001). In the retrospective analysis of the additional 1000 patients, 966 (96.6%) received transfemoral and 34 alternative access TAVR. 154 transfemoral and all alternative access TAVR were identified as high-risk according to the TREATABLE classification. Comparing the retrospective and prospective TREATABEL cohorts, transfemoral high-risk patients in the retrospective cohort without IVL showed a higher rate of post-interventional stenosis or occlusion (12.3% vs. 0%, p = 0.049).

This observational study shows a favourable success and safety level of IVL-supported transfemoral TAVR despite severe PAD, based on the TREATABLE classification. Therefore, the newly developed classification provides a suitable tool for identifying patients who would benefit from facilitating transfemoral TAVR by IVL.