Real-World Outcomes of Dedicated Leaflet Modification for Bioprosthetic Valve-In-Valve TAVR

Abstract

Background Coronary obstruction during valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) is infrequent but catastrophic. Mechanical splitting of bioprosthetic leaflets may mitigate this risk, but real-world experience remains limited. Objectives The aim of this is to evaluate procedural performance and in-hospital outcomes of a dedicated mechanical leaflet-splitting device in ViV TAVR. Methods Consecutive postapproval cases were performed at 28 centers from February to November 2025. Patients were selected for elevated risk based on preprocedural computed tomography criteria, including virtual valve-to-coronary distance ≤4 mm and/or virtual valve-to-sinotubular junction distance ≤3 mm. Procedural outcomes were assessed among patients in whom splitting was attempted; safety outcomes were assessed among all patients in whom the device was introduced. Events were adjudicated using Valve Academic Research Consortium-3 definitions. Results Among 150 patients (age 78.9 ± 8.5 years; 60.0% female), 95 of 150 (63.3%) underwent ViV TAVR for failed surgical and 55 of 150 (36.7%) for failed transcatheter valves. Computed tomography analysis showed predicted acute coronary obstruction risk in 131 of 150 (87.3%) patients, including combined sinus sequestration and direct ostial obstruction in 76 of 150 (50.7%). Leaflet splitting was attempted in 145 patients and was successful in 144 of 145 (99.3%); dual-leaflet splitting was performed in 83 of 145 (57.2%). Coronary obstruction occurred in 3 of 150 (2.0%; 95% CI: 0.7-5.7). All-cause mortality occurred in 3 of 150 (2.0%; 95% CI: 0.7-5.7), including 2 deaths from left ventricular perforation and 1 after stroke. Conversion to surgery occurred in 2 of 150 (1.3%; 95% CI: 0.4-4.7). Conclusions In this early U.S. commercial experience, mechanical leaflet splitting demonstrated high procedural success in an anatomically high-risk ViV TAVR cohort. Serious complications occurred, and longer-term systematic follow-up remains important.