Guilherme F Attizzani1, Luis Augusto P Dallan2, Alan Markowitz2, Steven J Yakubov3, G Michael Deeb4, Michael J Reardon5, John K Forrest6, Abeel A Mangi6, Jian Huang7, Jeffrey J Popma8. 1. Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio. Electronic address: guilherme.attizzani@uhhospitals.org. 2. Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio. 3. Department of Interventional Cardiology, OhioHealth Riverside Methodist, Columbus, Ohio. 4. Departments of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor, Michigan. 5. Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas. 6. Departments of Internal Medicine (Cardiology) and Cardiac Surgery, Yale University School of Medicine, New Haven, Connecticut. 7. Department of Biostatistics, Medtronic Statistical Services, Minneapolis, Minnesota. 8. Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Abstract
OBJECTIVES: This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group). BACKGROUND: The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear. METHODS: Patients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2. RESULTS: The Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively). CONCLUSIONS: The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).
OBJECTIVES: This study sought to compare outcomes following transcatheter aortic valve replacement when valve repositioning was performed (repositioned group) versus procedures without repositioning (nonrepositioned group). BACKGROUND: The Evolut R and Evolut PRO valves were designed to allow repositioning during deployment, yet the effect of repositioning on clinical outcomes remains unclear. METHODS:Patients implanted with the Evolut R or PRO valve from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial continued access study and the Evolut Low Risk Trial between June 2016 and November 2018 were combined. Baseline multidetector computed tomography data were analyzed for the Evolut Low Risk Trial patients. The primary outcomes were the rate of all-cause mortality and the rate of disabling stroke 30 days. Secondary outcomes were per Valve Academic Research Consortium-2. RESULTS: The Evolut R or PRO valve was implanted in 946 patients, and repositioning was performed in 318 (33.6%). Compared with patients in the nonrepositioned group, patients in the repositioned group had lower Society of Thoracic Surgeons score (2.3 ± 1.3% vs. 2.6 ± 1.4%; p < 0.001) and fewer prior percutaneous coronary interventions (11.9% vs. 19.7%; p = 0.003). There were no differences in baseline multidetector computed tomography parameters between groups. There were no differences in the primary outcome of death (0.3% vs. 0.3%; p = 0.99) or disabling stroke (0.3% vs. 0.5%; p = 0.71) at 30 days or 1 year (1.9% vs. 2.9%; p = 0.44; and 0.8% vs. 0.9%%; p = 0.79, respectively). CONCLUSIONS: The utilization of the repositioning feature of the Evolut valves was safe, and no differences in death or disabling stroke were observed at 30 days or 1 year between groups. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283; Safety and Efficacy Study of the Medtronic CoreValve® System In the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).
Authors: Francesco Moroni; Lorenzo Azzalini; Lars Sondergaard; Guilherme F Attizzani; Santiago García; Hani Jneid; Mamas A Mamas; Rodrigo Bagur Journal: J Am Heart Assoc Date: 2022-06-14 Impact factor: 6.106
Authors: Fernando L M Bernardi; Josep Rodés-Cabau; Gabriela Tirado-Conte; Ignacio J Amat Santos; Claudia Plachtzik; Fernando Cura; Matias Sztejfman; Fernanda M Mangione; Rogério Tumeleiro; Vinicius Borges Cardozo Esteves; Eduardo França Pessoa de Melo; Alejandro Alcocer Chauvet; Felipe Fuchs; Rogerio Sarmento-Leite; Estêvão Carvalho de Campos Martins; Luis Nombela-Franco; José Raul Delgado-Arana; Wolfgang Bocksch; Pablo Lamelas; Carlos Giuliani; Diego Carter Campanha-Borges; Jose A Mangione; Fábio Sandoli de Brito; Alexandre C Abizaid; Henrique B Ribeiro Journal: J Am Heart Assoc Date: 2021-09-03 Impact factor: 5.501
Authors: Oliver Maier; Kerstin Piayda; Stephan Binnebößel; Nora Berisha; Shazia Afzal; Amin Polzin; Kathrin Klein; Ralf Westenfeld; Patrick Horn; Christian Jung; Malte Kelm; Verena Veulemans; Tobias Zeus Journal: Front Cardiovasc Med Date: 2022-08-31