EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
Procedural and one-year outcomes of the BASILICA technique in Europe: the multicentre EURO-BASILICA registry.
Многоцентровое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Abdel-Wahab Mohamed, Richter Ines, Taramasso Maurizio, Unbehaun Axel, Rudolph Tanja, Ribichini Flavio L, Binder Ronald, Schofer Joachim, Mangner Norman, Dambrink Jan-Henk, Trejo-Velasco Blanca, Thiele Holger, Kitamura Mitsunobu, Lanz Jonas
Аннотация
BACKGROUND: The real-world outcomes of the use of the BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction) transcatheter technique in Europe have not been described.
AIMS: We sought to evaluate the procedural and one-year outcomes of BASILICA in patients at high risk for coronary artery obstruction (CAO) undergoing transcatheter aortic valve implantation (TAVI) in a multicentre European registry (EURO-BASILICA).
METHODS: Seventy-six patients undergoing BASILICA and TAVI at ten European centres were included. Eighty-five leaflets were identified as targets for BASILICA due to high risk for CAO. The updated Valve Academic Research Consortium 3 (VARC-3) definitions were used to determine prespecified endpoints of technical and procedural success and adverse events up to one year.
RESULTS: Treated aortic valves included native (5.3%), surgical bioprosthetic (92.1%) and transcatheter valves (2.6%). Double BASILICA (for both left and right coronary cusps) was performed in 11.8% of patients. Technical success with BASILICA was achieved in 97.7% and resulted in freedom from any target leaflet-related CAO in 90.6% with a low rate of complete CAO (2.4%). Target leaflet-related CAO occurred significantly more often in older and stentless bioprosthetic valves and with higher implantation levels of transcatheter heart valves. Procedural success was 88.2%, and freedom from VARC-3-defined early safety endpoints was 79.0%. One-year survival was 84.2%; 90.5% of patients were in New York Heart Association Functional Class I/II.
CONCLUSIONS: EURO-BASILICA is the first multicentre study evaluating the BASILICA technique in Europe. The technique appeared feasible and effective in preventing TAVI-induced CAO, and one-year clinical outcomes were favourable. The residual risk for CAO requires further study.
AIMS: We sought to evaluate the procedural and one-year outcomes of BASILICA in patients at high risk for coronary artery obstruction (CAO) undergoing transcatheter aortic valve implantation (TAVI) in a multicentre European registry (EURO-BASILICA).
METHODS: Seventy-six patients undergoing BASILICA and TAVI at ten European centres were included. Eighty-five leaflets were identified as targets for BASILICA due to high risk for CAO. The updated Valve Academic Research Consortium 3 (VARC-3) definitions were used to determine prespecified endpoints of technical and procedural success and adverse events up to one year.
RESULTS: Treated aortic valves included native (5.3%), surgical bioprosthetic (92.1%) and transcatheter valves (2.6%). Double BASILICA (for both left and right coronary cusps) was performed in 11.8% of patients. Technical success with BASILICA was achieved in 97.7% and resulted in freedom from any target leaflet-related CAO in 90.6% with a low rate of complete CAO (2.4%). Target leaflet-related CAO occurred significantly more often in older and stentless bioprosthetic valves and with higher implantation levels of transcatheter heart valves. Procedural success was 88.2%, and freedom from VARC-3-defined early safety endpoints was 79.0%. One-year survival was 84.2%; 90.5% of patients were in New York Heart Association Functional Class I/II.
CONCLUSIONS: EURO-BASILICA is the first multicentre study evaluating the BASILICA technique in Europe. The technique appeared feasible and effective in preventing TAVI-induced CAO, and one-year clinical outcomes were favourable. The residual risk for CAO requires further study.