Early outcomes of redo-TAVI with the SAPIEN 3 platform: the prospective, multicentre ReTAVI registry.
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Tarantini Giuseppe, Fovino Luca Nai, Alvarez Covarrubias Héctor Alfonso, Wolny Rafał, Fabris Tommaso, Skipirzepa Joanna Nawara, Eden Matthias, Zamorano Jose Luis, Joner Michael, Cuisset Thomas, Delgado Victoria, Rodés-Cabau Josep, Saia Francesco, Bieliauskas Gintautas, Van Belle Eric, Modine Thomas, Rheude Tobias, Garot Philippe, Jung Christian, Rudolph Tanja K, Leroux Lionel, Rottbauer Wolfgang, Nestelberger Thomas, Lhermusier Thibault, Nejjari Mohammed, Regueiro Ander, Meier David, Fraccaro Chiara, Hartikainen Tau, Karam Nicole, Swaans Martin, Rodrigues Alberto, Dreger Henryk, Hengstenberg Christian, Schmitz Thomas, Mauler-Wittwer Sarah, Piazza Nicolo, Combaret Nicolas, Letocart Vincent, Auffret Vincent, Durand Eric, Urena-Alcázar Marina, Del Valle-Fernández Raquel, Drago Andrea, De Carlo Marco, Jimenez Diaz Victor Alfonso, Dąbrowski Maciej, Mascherbauer Julia, Sudre Arnaud, Ong Peter, Gonska Birgid, Mancone Massimo, Fabris Enrico, Teles Rui Campante, Nombela-Franco Luis, Asmarats Lluis, Vilalta Victoria, Protasiewicz Marcin, Webb John Graydon, Tóth-Gayor Gábor, Zierer Andreas, Rioufol Gilles, Seiffert Moritz, Adamo Marianna, Meucci Francesco, Ielasi Alfonso, Burzotta Francesco, Lopez Benito Maria, Loewenstein Itamar, Kralisz Paweł, Legutko Jacek, Huczek Zenon, Pavei Andrea, Raková Radka, Wesselink Wilbert, Zielinski Marie, Trushina Nataliya, Bramlage Peter, Parma Radoslaw
Аннотация
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: â¨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.