title: Initial Experience of Transcatheter Mitral Valve Replacement With a Novel Transcatheter Mitral Valve: Procedural and 6-Month Follow-Up Results.
abstract: BACKGROUND
  There are scarce data available on transcatheter mitral valve replacement (TMVR), and these have been limited to procedural results, with no follow-up status reported.
  
  
  OBJECTIVE
  The goal of this study was to evaluate the feasibility, procedural results, and 6-month follow-up outcomes after TMVR with a mitral transcatheter heart valve (Fortis, Edwards Lifesciences, Irvine, California).
  
  
  METHODS
  We report a series of 3 patients (mean age 71 ± 9 years, 2 men) who had TMVR under a compassionate clinical use program. All patients treated had functional mitral regurgitation (MR) secondary to ischemic cardiomyopathy (prior bypass surgery in all cases; left ventricular ejection fraction between 25% and 30%) and were considered to be at very high surgical risk (mean Society of Thoracic Surgeons score: 9.3).
  
  
  RESULTS
  The procedure was performed through the transapical approach, and the valve was successfully implanted in all cases, with no major complications. At hospital discharge, echocardiographic evaluation revealed trace residual MR in 2 patients and no MR in 1 patient. The mean transvalvular mitral gradient was ≤4 mm Hg in all patients. At the 3-month follow-up, the valve function remained unchanged, and transesophageal echocardiography and computed tomography showed no structural failures. All patients had improvements in functional status, in exercise capacity as evaluated by 6-min walk test, and in quality of life. At 6-month follow-up, all patients remain alive, without hospital readmission for heart failure and with New York Heart Association functional class ≤II.
  
  
  CONCLUSIONS
  TMVR with this valve is feasible and is associated with good outcomes. Optimal valve functional results were obtained acutely and were sustained at 6-month follow-up in all patients. Further studies with a larger number of patients and longer follow-up are warranted.
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Omar
authors: O
authors: Abdul-Jawad Altisent
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Eric
authors: E
authors: Dumont
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: François
authors: F
authors: Dagenais
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Mario
authors: M
authors: Sénéchal
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Mathieu
authors: M
authors: Bernier
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Kim
authors: K
authors: O'Connor
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Silvie
authors: S
authors: Bilodeau
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Jean Michel
authors: JM
authors: Paradis
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Francisco
authors: F
authors: Campelo-Parada
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Rishi
authors: R
authors: Puri
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors: Maria
authors: M
authors: Del Trigo
authors: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca.
authors: Josep
authors: J
authors: Rodés-Cabau
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000379:methods; D018618:Echocardiography, Doppler, Color / Q000379:methods; D017548:Echocardiography, Transesophageal / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D016330:Frail Elderly; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D007902:Length of Stay; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging* / Q000401:mortality / Q000601:surgery*; D011182:Postoperative Care / Q000379:methods; D012494:Sampling Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: heart failure; mitral regurgitation; mitral valve surgery; transcatheter cardiac therapeutics