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Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study.
Amat-Santos, Ignacio J; García-Gómez, Mario; de Marco, Federico; Won-Keun, Kim; Brito, Joao; Halim, Jonathan; Jose, John; Sengotuvelu, Gunasekaran; Seth, Ashok; Terkelsen, Christian; Protasiewicz, Marcin; Bonilla, Nelson; García, Bruno; Sánchez-Luna, Juan Pablo; Blasco-Turrión, Sara; González, José Carlos; González-Bartol, Esther; Ijsselmuiden, Alexander J J; Gómez-Salvador, Itziar; Carrasco Moraleja, Manuel; San Román, Alberto.
Afiliación
  • Amat-Santos IJ; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Spain. Electronic address: ijamat@gmail.com.
  • García-Gómez M; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Spain.
  • de Marco F; Cardiology Department, Policlinico San Donato, Milan, Italy.
  • Won-Keun K; Cardiology Department, Kerckhoff-Klinik, Bad Nauheim, Germany.
  • Brito J; Cardiology Department, Hospital Santa Cruz, Lisbon, Portugal.
  • Halim J; Cardiology Department, Amphia Hospital, Breda, The Netherlands.
  • Jose J; Cardiology Department, Christian Medical College Vellore, Tamil Nadu, India.
  • Sengotuvelu G; Cardiology Department, Apollo Hospital Chennai, Tamil Nadu, India.
  • Seth A; Cardiology Department, Fortis Escorts Heart Institute, New Delhi Hospital, Delhi, India.
  • Terkelsen C; Cardiology Department, Aarhus Universitetshospital, Aarhus, Denmark.
  • Protasiewicz M; Cardiology Department, Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
  • Bonilla N; Departamento de Cardiología, Hospital Médico Quirúrgico, Instituto Salvadoreño del Seguro Social, San Salvador, El Salvador.
  • García B; Departamento de Cardiología, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
  • Sánchez-Luna JP; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
  • Blasco-Turrión S; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
  • González JC; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
  • González-Bartol E; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
  • Ijsselmuiden AJJ; Cardiology Department, Amphia Hospital, Breda, The Netherlands.
  • Gómez-Salvador I; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Spain.
  • Carrasco Moraleja M; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Spain.
  • San Román A; Departamento de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Spain.
Rev Esp Cardiol (Engl Ed) ; 76(11): 872-880, 2023 Nov.
Article en En, Es | MEDLINE | ID: mdl-36898524
INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estenosis de la Válvula Aórtica / Prótesis Valvulares Cardíacas / Reemplazo de la Válvula Aórtica Transcatéter / Enfermedad de la Válvula Aórtica Bicúspide / Enfermedades de las Válvulas Cardíacas Tipo de estudio: Clinical_trials Límite: Aged / Aged80 / Female / Humans / Male Idioma: En / Es Revista: Rev Esp Cardiol (Engl Ed) Año: 2023 Tipo del documento: Article Pais de publicación: España
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estenosis de la Válvula Aórtica / Prótesis Valvulares Cardíacas / Reemplazo de la Válvula Aórtica Transcatéter / Enfermedad de la Válvula Aórtica Bicúspide / Enfermedades de las Válvulas Cardíacas Tipo de estudio: Clinical_trials Límite: Aged / Aged80 / Female / Humans / Male Idioma: En / Es Revista: Rev Esp Cardiol (Engl Ed) Año: 2023 Tipo del documento: Article Pais de publicación: España