Key result
Mechanical leaflet splitting may mitigate coronary obstruction risk during valve-in-valve TAVR despite limited data.
Why the study?
Coronary obstruction during ViV TAVR is catastrophic, and although mechanical splitting of bioprosthetic leaflets may mitigate this risk, real-world experience remains limited.
Does a dedicated mechanical leaflet-splitting device provide procedural success and safety in patients at high risk for coronary obstruction undergoing valve-in-valve TAVR?
Observational (n=150)
Yes
Does a dedicated mechanical leaflet-splitting device provide procedural success and safety in patients at high risk for coronary obstruction undergoing valve-in-valve TAVR?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“These findings suggest that dedicated mechanical leaflet modification in a contemporary U.S. real-world practice is feasible and facilitates ViV TAVR in a cohort that is at high risk of coronary obstruction.”
In high-risk valve-in-valve TAVR patients, mechanical leaflet splitting demonstrated high procedural success (99.3%) and a low rate of coronary obstruction (2.0%), though serious complications like LV perforation occurred.
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: This study sought 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.
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Makkar et al. (2026) conducted an observational in Failed bioprosthetic valves requiring valve-in-valve TAVR at high risk for coronary obstruction (n=150). Dedicated mechanical leaflet-splitting device was evaluated on Procedural success of leaflet splitting. Mechanical leaflet splitting during valve-in-valve TAVR achieved 99.3% procedural success, with coronary obstruction occurring in 2.0% (95% CI 0.7-5.7) of patients.
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