Author + information
- Received March 14, 2017
- Revision received May 1, 2017
- Accepted May 19, 2017
- Published online August 21, 2017.
- Ander Regueiro, MD, MSca,
- Jian Ye, MD, MScb,
- Neil Fam, MDc,
- Vinayak N. Bapat, MDd,
- François Dagenais, MDa,
- Mark D. Peterson, MD, PhDc,
- Stephan Windecker, MDe,
- John G. Webb, MDb and
- Josep Rodés-Cabau, MDa,∗ ()
- aDepartment of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada
- bDivisions of Cardiology and Cardiac Surgery, St Paul’s Hospital, Vancouver, Canada
- cDepartment of Interventional Cardiology and Cardiac Surgery, St Michael’s Hospital, Toronto, Canada
- dDepartment of Cardiothoracic Surgery, St Thomas’ Hospital, London, United Kingdom
- eDepartment of Cardiology, University Hospital of Bern, Bern, Switzerland
- ↵∗Address for correspondence:
Dr. Josep Rodés-Cabau, Québec Heart & Lung Institute, Laval University, 2725, Chemin Ste-Foy, G1V 4G5, Québec City, Québec, Canada.
Objectives This study sought to determine late (2-year) outcomes following transcatheter mitral valve replacement (TMVR) with the FORTIS valve (Edwards Lifesciences, Irvine, California).
Background No data exist on long-term clinical outcomes following TMVR in patients with severe native mitral regurgitation (MR).
Methods This multicenter registry included consecutive patients with severe MR who underwent TMVR with the FORTIS valve under a compassionate clinical use program. Clinical and echocardiographic data were collected at baseline, 30-day, and 1- and 2-year follow-up.
Results Thirteen patients (71 ± 8 years, 10 men, logistic European System for Cardiac Operative Risk Evaluation score = 23.7 ± 12.1%) with severe MR were included. MR was of ischemic origin in most (76.9%) patients, and the mean left ventricular ejection fraction was 34 ± 9%. Technical success was achieved in 10 patients (76.9%), and 5 patients (38.5%) died within the 30 days following the procedure. At 30-day follow-up, mean transmitral gradient was 3 ± 1 mm Hg, and there were no cases of moderate-severe residual MR or left ventricular outflow tract obstruction. Two patients died during the follow-up period due to terminal heart failure, leading to an all-cause mortality rate of 54% at 2-year follow-up. At 2-year follow-up, all patients but 1 were in New York Heart Association functional class II, and there were no cases of valve malfunction (increasing gradients or MR recurrence). Computed tomography exams performed at 2-year follow-up in 3 patients showed no valve prosthesis fractures or displacement.
Conclusions TMVR with the FORTIS valve was feasible. MR reduction after TMVR was maintained at 2-year follow-up and no late device-related events were observed.
Dr. Regueiro was supported by a grant from the Fundacion Alfonso Martin Escudero (Madrid, Spain). Drs. Ye and Webb have served as consultants for Edwards Lifesciences. Dr. Bapat has served as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific. Drs. Bapat, Windecker, Webb, and Rodés-Cabau have received research grant support from Edwards Lifesciences. Dr. Peterson has served as a proctor for Edwards Lifesciences and LivaNova. Dr. Windecker has received institutional research grant support from Bracco, Boston Scientific, and Terumo. Dr. Rodés-Cabau holds the Canadian Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 14, 2017.
- Revision received May 1, 2017.
- Accepted May 19, 2017.
- 2017 American College of Cardiology Foundation