Objectives: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. Background: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. Methods: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. Conclusions: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.
Bibliographical noteFunding Information:
Prof. Van Mieghem has received institutional research grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, PulseCath BV, Abiomed and Daiichi Sankyo; Prof. Windecker reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, Sinomed. Prof. Windecker serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V‐Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/excecutive committee group of several investigated‐initiated trials that receive funding by industry without impact on his personal remuneration. Stephan Windecker is an unpaid member of the Pfizer Research Award selection committee in Switzerland; Dr. Manoharan has served as a proctor for Boston Scientific, Medtronic and St. Jude Medical; Prof. Bosmans serves as a proctor for Medtronic; Prof. Bleiziffer has served as a consultant and proctor for Medtronic, a proctor for JenaValve, a proctor for Boston Scientific, and has received travel expenses from Medtronic; Dr. Modine serves as a proctor for Medtronic; Prof. Linke has received speaker honoraria or served as a consultant for the following companies: Medtronic, St. Jude Medical, Claret Medical Inc., Boston Scientific, Edwards Lifesciences, Symetis, and Bard, and holds stock options from Claret Medical Inc. In addition, he received grant support from Medtronic and Claret Medical Inc.; Dr. Scholtz has received honoraria and travel expense reimbursements from Medtronic; Dr. Tchétché has received honoraria or consultation fees from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic; Dr. Finkelstein serves as a proctor and consultant for Edwards Lifesciences and Medtronic; Dr. Ito has nothing to disclose; Ms. Eisenberg is an employee and shareholder of Medtronic, plc; Prof. Grube serves on an advisory board for Medtronic, Boston Scientific and High Life, and has an equity interest in CardioValve, Valve Medical, Shockwave, Millipede, Pie‐Cardia, Pipeline, Ancora and Laminar.
Jane Moore, MS, ELS drafted the methods and results, created all tables and figures, and formatted the paper for journal style. Maarten Hollander, MSc, and Linda Schepers, MSc from Medtronic Bakken Research Center (Maastricht, The Netherlands) were responsible for overall study management. All are employees of Medtronic, plc (Dublin, Ireland).
© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.