Sex-Related Outcomes of Transcatheter Aortic Valve Implantation with Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry

• DOI: 10.1101/2023.09.05.23295098
• Publication Date: 2023-09-07T15:25:14Z
• Authors: Marianna Adamo; Luca Branca; Elisa Pezzola; Francesco Saia; Thomas Pilgrim; Mohamed Abdel-Wahab; Philippe Garot; Caterina Gandolfo; Claudia Fiorina; Sofia Sammartino; Azeem Latib; Ignacio Amat Santos; Darren Mylotte; Federico De Marco; Ole De Backer; Luis Nombela Franco; Mariama Akodad; Flavio Luciano Ri...; Francesco Bedogni; Giulia Laterra; Alessandro Mazzap...; Daijiro Tomii; Pietro Laforgia; Stefano Cannata; Andrea Scotti; Simone Fezzi; Enrico Criscione; Enrico Poletti; Mattia Mazzucca; Mattia Lunardi; Andrea Mainardi; Stefano Andreaggi; Angelo Quagliana; Nicholas Montarello; Breda Hennessey; Matias Mon-Noboa; David Meier; Carmelo Sgroi; Claudia Maria Red...; Orazio Strazzieri; Silvia Crescenzia...; Valentina Frittitta; Elena Dipietro; Alessandro Comis; Chiara Melfa; Mariachiara Calì; Holger Thiele; John G. Webb; Lars Sondergaard; Corrado Tamburino; Marco Metra; Giuliano Costa; Marco Barbanti
• Keywords: Stroke

ABSTRACT Background Evidence regarding sex-related differences in response to transcatheter aortic valve implantation according the type is lacking. This study sought evaluate impact of sex on treatment effect Evolut-PRO/PRO+ (PRO) or Sapien 3 Ultra (ULTRA) devices clinical outcomes. Methods Comparative Analysis Evolut PRO vs Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) a multicenter multinational registry including patients undergoing latest-iteration ULTRA implantation. Overall, 1174 out 1897 were matched based and compared sex, while 470 males 630 females type. Thirty-day 1-year outcomes evaluated. Results In both group, had higher comorbidity burden, smaller root. Both 30-day (device success [DS], early safety outcome, permanent pacemaker [PPI], patient-prosthesis mismatch [PPM], paravalvular regurgitation [PVR], bleedings, vascular complications, all-cause death) (all-cause death, stroke heart failure hospitalization) did not differ groups. However, male decreased likelihood DS with versus (p interaction 0.047). A risk PPI stroke, lower PPM was observed ULTRA, regardless sex. No other noted. Conclusions Sex modify outcomes, exception that (versus females) receiving PRO).