Intravascular lithotripsy enables safe and effective transfemoral aortic valve replacement

Area of Science:

• Cardiovascular Interventions
• Interventional Cardiology
• Vascular Medicine

Background:

• Transfemoral transcatheter aortic valve replacement (TAVR) is often not feasible in patients with severe peripheral artery disease (PAD).
• Iliofemoral calcification poses a significant barrier to transfemoral access for TAVR.
• Modifying iliofemoral calcium may be a strategy to enable transfemoral access in PAD patients.

Purpose of the Study:

• To evaluate the feasibility and safety of using intravascular lithotripsy (IVL) to modify iliofemoral calcium, thereby enabling transfemoral access for TAVR in patients with severe PAD.
• To assess the efficacy of the TREATABLE classification system in identifying patients who would benefit from IVL-assisted transfemoral TAVR.
• To compare complication rates in high-risk transfemoral TAVR patients with and without IVL use.

Main Methods:

• Prospective screening of consecutive TAVR patients (June 2022-February 2024) using the TREATABLE classification to identify candidates for IVL-supported transfemoral TAVR.
• Retrospective analysis of TAVR patients (February 2020-June 2022) evaluated with the TREATABLE classification to determine complication rates without IVL.
• Endpoints included successful TAVR, safety, and three-month outcomes.

Main Results:

• 11.4% of prospective patients (26/229) received IVL-supported transfemoral TAVR, with significantly higher iliofemoral calcification severity in this group.
• In a retrospective analysis of 1000 patients, 154 transfemoral TAVR patients were classified as high-risk.
• High-risk transfemoral patients without IVL had a significantly higher rate of post-interventional stenosis or occlusion (12.3% vs. 0%, p=0.049) compared to the prospective IVL group.

Conclusions:

• IVL-supported transfemoral TAVR demonstrates favorable success and safety in patients with severe PAD, as identified by the TREATABLE classification.
• The TREATABLE classification is a valuable tool for selecting patients who can benefit from IVL to facilitate transfemoral TAVR.
• IVL effectively modifies iliofemoral calcification, enabling successful transfemoral access in challenging PAD cases.