Elena Dipietro, Giuliano Costa, Mariachiara Calì, Orazio Strazzieri, Silvia Crescenzia Motta, Valentina Frittitta, Alessandro Comis, Sofia Sammartino, Luigi La Rosa, Carmelo Sgroi, Wanda Deste, Pierfrancesco Veroux, Salvatore Lentini, Maria Cristina Inserra, Maria Teresa Cannizzaro, Valeria Garretto, Corrado Tamburino, Marco Barbanti
{"title":"Long-term clinical efficacy of transfemoral transcatheter aortic valve implantation with three different platforms.","authors":"Elena Dipietro, Giuliano Costa, Mariachiara Calì, Orazio Strazzieri, Silvia Crescenzia Motta, Valentina Frittitta, Alessandro Comis, Sofia Sammartino, Luigi La Rosa, Carmelo Sgroi, Wanda Deste, Pierfrancesco Veroux, Salvatore Lentini, Maria Cristina Inserra, Maria Teresa Cannizzaro, Valeria Garretto, Corrado Tamburino, Marco Barbanti","doi":"10.1016/j.carrev.2025.01.014","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Long-term durability and outcomes of transcatheter aortic valve implantation (TAVI) have been reported only with first generation devices.</p><p><strong>Objectives: </strong>To compare clinical efficacy of TAVI with Sapien 3 (Edwards Lifesciences), Evolut R/PRO (Medtronic) or Acurate Neo (Boston Scientific) transcatheter heart valves (THVs) at long-term.</p><p><strong>Methods: </strong>Consecutive TAVI patients treated with Sapien 3, Evolut R/PRO and Acurate Neo THVs at Policlinico G. Rodolico of Catania with at least 5 years follow-up were included in this analysis. Patients were divided into three different groups according to the TAVI device used. Outcomes were compared after inverse probability of treatment weighting adjustment. The primary endpoint was the composite of all-cause death, disabling stroke and heart failure (HF) re-hospitalization at 7 years. The co-primary endpoint was valve-related clinical efficacy according to Valve Academic Research Consortium 3 (VARC-3) definition, at 7 years.</p><p><strong>Results: </strong>From September 2014 to December 2018, 383 tranfemoral TAVI patients receiving Sapien 3 (n = 131, 34.2 %), Evolut R/PRO (n = 134, 34.9 %), or Acurate Neo (n = 118, 30.8 %) devices were compared. At 7 years, the composite primary endpoint did not differ among study groups (60.2 % vs. 51.6 % vs. 62.1 % for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, p<sub>log-rank</sub> = 0.50). The co-primary endpoint was also similar (2.2 % vs. 1.2 % vs. 4.2 %, for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, p<sub>log-rank</sub> = 0.86).</p><p><strong>Conclusions: </strong>Clinical efficacy of TAVI with Sapien 3, Evolut R/PRO and Acurate Neo devices was sustained and comparable up to 7 years. Low and similar rates of valve degeneration were reported among the three devices. Randomized clinical trials are necessary to corroborate these findings and to assess the impact of specific hemodynamic differences among the three THV platforms in the context of long-term clinical efficacy.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6000,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiovascular Revascularization Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.carrev.2025.01.014","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Long-term durability and outcomes of transcatheter aortic valve implantation (TAVI) have been reported only with first generation devices.
Objectives: To compare clinical efficacy of TAVI with Sapien 3 (Edwards Lifesciences), Evolut R/PRO (Medtronic) or Acurate Neo (Boston Scientific) transcatheter heart valves (THVs) at long-term.
Methods: Consecutive TAVI patients treated with Sapien 3, Evolut R/PRO and Acurate Neo THVs at Policlinico G. Rodolico of Catania with at least 5 years follow-up were included in this analysis. Patients were divided into three different groups according to the TAVI device used. Outcomes were compared after inverse probability of treatment weighting adjustment. The primary endpoint was the composite of all-cause death, disabling stroke and heart failure (HF) re-hospitalization at 7 years. The co-primary endpoint was valve-related clinical efficacy according to Valve Academic Research Consortium 3 (VARC-3) definition, at 7 years.
Results: From September 2014 to December 2018, 383 tranfemoral TAVI patients receiving Sapien 3 (n = 131, 34.2 %), Evolut R/PRO (n = 134, 34.9 %), or Acurate Neo (n = 118, 30.8 %) devices were compared. At 7 years, the composite primary endpoint did not differ among study groups (60.2 % vs. 51.6 % vs. 62.1 % for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, plog-rank = 0.50). The co-primary endpoint was also similar (2.2 % vs. 1.2 % vs. 4.2 %, for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, plog-rank = 0.86).
Conclusions: Clinical efficacy of TAVI with Sapien 3, Evolut R/PRO and Acurate Neo devices was sustained and comparable up to 7 years. Low and similar rates of valve degeneration were reported among the three devices. Randomized clinical trials are necessary to corroborate these findings and to assess the impact of specific hemodynamic differences among the three THV platforms in the context of long-term clinical efficacy.
期刊介绍:
Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. Cardiovascular Revascularization Medicine publishes articles related to preclinical work and molecular interventions, including angiogenesis, cell therapy, pharmacological interventions, restenosis management, and prevention, including experiments conducted in human subjects, in laboratory animals, and in vitro. Specific areas of interest include percutaneous angioplasty in coronary and peripheral arteries, intervention in structural heart disease, cardiovascular surgery, etc.