Leaflet Modification to Mitigate Coronary Obstruction Risk During TAVR

Abstract

Background Coronary obstruction (CO) is a rare but life-threatening complication of transcatheter aortic valve replacement (TAVR). Leaflet modification techniques have been developed to mitigate this risk; however, real-world evidence remains scarce. Objectives The aim of this study was to report procedural and 30-day outcomes of patients at high risk for CO undergoing leaflet modification. Methods LOFTER-TAVR (Leaflet mOdiFication Techniques to prEvent coRonary obstruction risk during Transcatheter Aortic Valve Replacement) was an international, multicenter registry of consecutive patients undergoing leaflet modification before TAVR (September 2019 to January 2026). Coprimary endpoints were leaflet modification–directed technical success and Valve Academic Research Consortium 3 (VARC-3) technical success. Secondary endpoints included in-hospital and 30-day outcomes. Results A total of 293 patients underwent leaflet modification, including 202 (68.9%) through a leaflet-splitting approach and 91 (31.1%) through an intraleaflet disruption approach. Overall, 139 of 293 (47.4%) treated valves were natives. Successful leaflet traversal occurred in 310 of 318 leaflets (97.5%; 95% CI: 94.9%-98.9%) and successful leaflet modification in 306 of 318 leaflets (96.2%; 95% CI: 93.3%-97.9%). Leaflet modification–directed technical success was achieved in 251 of 293 patients (85.7%; 95% CI: 81.0%-89.4%) and VARC-3 technical success in 254 of 293 patients (86.7%; 95% CI: 82.1%-90.3%). Notably, 91.1% (95% CI: 87.1%-94.0%) of patients underwent TAVR without CO events. Delayed CO occurred in 3 of 293 patients (1.0%; 95% CI: 0.3%-3.0%). The median follow-up duration was 100 days (Q1-Q3: 30-443 days). At 30 days, freedom from VARC-3 early safety was achieved in 181 of 293 patients (61.8%; 95% CI: 56.5%-67.6%). Conclusions Leaflet modification techniques demonstrated high technical feasibility across a broad anatomical spectrum but carried considerable early clinical risk. These findings support its role as an adjunctive strategy for selected patients undergoing TAVR, although in the context of careful preprocedural planning and a structured multidisciplinary approach.