Leaflet Modification to Mitigate Coronary Obstruction Risk During TAVR: Results From the LOFTER-TAVR Registry

Area of Science:

• Cardiology
• Interventional Cardiology
• Cardiac Surgery

Background:

• Coronary obstruction (CO) is a rare but serious complication following transcatheter aortic valve replacement (TAVR).
• Leaflet modification techniques aim to reduce the risk of CO during TAVR.
• Real-world data on the efficacy and safety of these techniques are limited.

Purpose of the Study:

• To evaluate the procedural and 30-day outcomes of patients undergoing leaflet modification prior to TAVR.
• To assess the effectiveness of leaflet modification in preventing coronary obstruction.
• To report on the technical success and early clinical safety of the leaflet modification procedure.

Main Methods:

• The LOFTER-TAVR registry included consecutive patients undergoing leaflet modification before TAVR across multiple international centers.
• Leaflet modification was performed using either a leaflet-splitting or intraleaflet disruption approach.
• Coprimary endpoints included leaflet modification-directed technical success and Valve Academic Research Consortium 3 (VARC-3) technical success.

Main Results:

• High technical success rates were observed for leaflet traversal (97.5%) and modification (96.2%).
• Leaflet modification-directed technical success was 85.7%, and VARC-3 technical success was 86.7%.
• A significant majority of patients (91.1%) underwent TAVR without CO events, with only a 1.0% rate of delayed CO.

Conclusions:

• Leaflet modification techniques are technically feasible for a wide range of anatomies and effectively reduce CO risk during TAVR.
• Despite high technical success, these procedures are associated with considerable early clinical risks.
• Leaflet modification should be considered an adjunctive strategy for select TAVR patients, emphasizing meticulous preprocedural planning and a multidisciplinary team approach.