BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly performed in younger and lower-risk patients. Since many of these patients will outlive their transcatheter heart valve (THV), redo-TAVI procedures are expected to rise in number. Yet, real-world evidence on the procedural safety and efficacy of redo-TAVI remains limited. AIMS: We aimed to evaluate the 30-day procedural and clinical outcomes of redo-TAVI using the balloon-expandable SAPIEN 3 platform. METHODS: The ReTAVI registry is a prospective, international study enrolling consecutive patients with a failed aortic THV undergoing redo-TAVI with a balloon-expandable SAPIEN 3 THV. Data were collected across 59 international centres. All imaging was centrally analysed, and major clinical events were adjudicated by an independent committee. RESULTS: 
A total of 143 patients (median age 84 years; 40.6% female; median Society of Thoracic Surgeons risk score 7.0%) were enrolled. The predominant failing THVs were balloon-expandable SAPIEN 3 (30.1%), self-expanding CoreValve/Evolut (53.1%), and ACURATE (14.0%) platforms. The most common failure mode was isolated regurgitation (48.6%), followed by stenosis (35.2%) and a mixed pathology (16.2%). The replacement valve was successfully implanted in 95.1% of patients, with a 30-day mortality rate of 3.5%. The 30-day stroke and pacemaker implantation rates were 0.7% and 6.3%, respectively. Redo-TAVI significantly improved valve haemodynamics, with mean gradients decreasing overall (Δ=–12.0 mmHg), and a more pronounced reduction in stenotic failures (Δ=–29.0 mmHg). Coronary obstruction was observed in 1.4% of cases. CONCLUSIONS: Redo-TAVI with a balloon-expandable SAPIEN 3 THV platform is a safe and effective reintervention strategy across diverse failed THV types, when guided by the Heart Team, standardised procedural planning, and comprehensive imaging. ClinicalTrials.gov: NCT05601453.
Tarantini, G., Fovino, L. N., Alvarez Covarrubias, H. A., Wolny, R., Fabris, T., Skipirzepa, J. N., Eden, M., Zamorano, J. L., Joner, M., Cuisset, T., Delgado, V., Rodés-Cabau, J., Saia, F., Bieliauskas, G., Van Belle, E., Modine, T., Rheude, T., Garot, P., Jung, C., Rudolph, T. K., Leroux, L., Rottbauer, W., Nestelberger, T., Lhermusier, T., Nejjari, M., Regueiro, A., Meier, D., Fraccaro, C., Hartikainen, T., Karam, N., Swaans, M., Rodrigues, A., Dreger, H., Hengstenberg, C., Schmitz, T., Mauler-Wittwer, S., Piazza, N., Combaret, N., Letocart, V., Auffret, V., Durand, E., Urena-Alcázar, M., Del Valle-Fernández, R., Drago, A., De Carlo, M., Jimenez Diaz, V. A., Dąbrowski, M., Mascherbauer, J., Sudre, A., Ong, P., Gonska, B., Mancone, M., Fabris, E., Teles, R. C., Nombela-Franco, L., Asmarats, L., Vilalta, V., Protasiewicz, M., Webb, J. G., Tóth-Gayor, G., Zierer, A., Rioufol, G., Seiffert, M., Adamo, M., Meucci, F., Ielasi, A., Burzotta, F., Lopez Benito, M., Loewenstein, I., Kralisz, P., Legutko, J., Huczek, Z., Pavei, A., Raková, R., Wesselink, W., Zielinski, M., Trushina, N., Bramlage, P., Parma, R., Early outcomes of redo-TAVI with the SAPIEN 3 platform: the prospective, multicentre ReTAVI registry, <<EUROINTERVENTION>>, 2026; 22 (11): e629-e641. [doi:10.4244/EIJ-D-25-01268] [https://hdl.handle.net/10807/338799]
Early outcomes of redo-TAVI with the SAPIEN 3 platform: the prospective, multicentre ReTAVI registry
Tarantini, Giuseppe;Saia, Francesco;Meucci, Francesco;Burzotta, Francesco;
2026
Abstract
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly performed in younger and lower-risk patients. Since many of these patients will outlive their transcatheter heart valve (THV), redo-TAVI procedures are expected to rise in number. Yet, real-world evidence on the procedural safety and efficacy of redo-TAVI remains limited. AIMS: We aimed to evaluate the 30-day procedural and clinical outcomes of redo-TAVI using the balloon-expandable SAPIEN 3 platform. METHODS: The ReTAVI registry is a prospective, international study enrolling consecutive patients with a failed aortic THV undergoing redo-TAVI with a balloon-expandable SAPIEN 3 THV. Data were collected across 59 international centres. All imaging was centrally analysed, and major clinical events were adjudicated by an independent committee. RESULTS: 
A total of 143 patients (median age 84 years; 40.6% female; median Society of Thoracic Surgeons risk score 7.0%) were enrolled. The predominant failing THVs were balloon-expandable SAPIEN 3 (30.1%), self-expanding CoreValve/Evolut (53.1%), and ACURATE (14.0%) platforms. The most common failure mode was isolated regurgitation (48.6%), followed by stenosis (35.2%) and a mixed pathology (16.2%). The replacement valve was successfully implanted in 95.1% of patients, with a 30-day mortality rate of 3.5%. The 30-day stroke and pacemaker implantation rates were 0.7% and 6.3%, respectively. Redo-TAVI significantly improved valve haemodynamics, with mean gradients decreasing overall (Δ=–12.0 mmHg), and a more pronounced reduction in stenotic failures (Δ=–29.0 mmHg). Coronary obstruction was observed in 1.4% of cases. CONCLUSIONS: Redo-TAVI with a balloon-expandable SAPIEN 3 THV platform is a safe and effective reintervention strategy across diverse failed THV types, when guided by the Heart Team, standardised procedural planning, and comprehensive imaging. ClinicalTrials.gov: NCT05601453.
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
