title: Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial.
abstract: BACKGROUND
  Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR.
  
  
  OBJECTIVE
  This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery.
  
  
  METHODS
  Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes.
  
  
  RESULTS
  Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2at baseline vs. 72.1 ± 19.3 ml/m2at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%.
  
  
  CONCLUSIONS
  TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514).
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, St. Vincent's Hospital, Sydney, Australia. Electronic address: dmuller@stvincents.com.au.
authors.forename: David W M
authors.initials: DWM
authors.lastname: Muller
authors.affiliation: Center for Valve and Structural Heart Disease and Cardiothoracic Surgery Service, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Robert Saeid
authors.initials: RS
authors.lastname: Farivar
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, St. Vincent's Hospital, Sydney, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Jansz
authors.affiliation: Center for Valve and Structural Heart Disease and Cardiothoracic Surgery Service, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Richard
authors.initials: R
authors.lastname: Bae
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, Prince Charles Hospital, Brisbane, Australia.
authors.forename: Darren
authors.initials: D
authors.lastname: Walters
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, Prince Charles Hospital, Brisbane, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Clarke
authors.affiliation: Divisions of Cardiology and Cardiothoracic Surgery, Baylor University Medical Center, Dallas, Texas.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Grayburn
authors.affiliation: Divisions of Cardiology and Cardiothoracic Surgery, Baylor University Medical Center, Dallas, Texas.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Stoler
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway.
authors.forename: Gry
authors.initials: G
authors.lastname: Dahle
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway.
authors.forename: Kjell A
authors.initials: KA
authors.lastname: Rein
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, St. Vincent's Hospital, Sydney, Australia.
authors.forename: Marty
authors.initials: M
authors.lastname: Shaw
authors.affiliation: Departments of Cardiology and Cardiothoracic Surgery, Prince Charles Hospital, Brisbane, Australia.
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Scalia
authors.affiliation: Divisions of Cardiology and Cardiothoracic Surgery, Evanston Hospital, Evanston, Illinois.
authors.forename: Mayra
authors.initials: M
authors.lastname: Guerrero
authors.affiliation: Divisions of Cardiology and Cardiothoracic Surgery, Evanston Hospital, Evanston, Illinois.
authors.forename: Paul
authors.initials: P
authors.lastname: Pearson
authors.affiliation: Departments of Cardiovascular Medicine and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: Departments of Cardiovascular Medicine and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Marc
authors.initials: M
authors.lastname: Gillinov
authors.affiliation: Division of Cardiology and Department of Cardiothoracic Surgery, Medstar Washington Hospital Center, Washington DC.
authors.forename: Augusto
authors.initials: A
authors.lastname: Pichard
authors.affiliation: Division of Cardiology and Department of Cardiothoracic Surgery, Medstar Washington Hospital Center, Washington DC.
authors.forename: Paul
authors.initials: P
authors.lastname: Corso
authors.affiliation: Beth Israel Deaconness Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Popma
authors.affiliation: Beth Israel Deaconness Medical Center, Boston, Massachusetts.
authors.forename: Michael
authors.initials: M
authors.lastname: Chuang
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Philipp
authors.initials: P
authors.lastname: Blanke
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.affiliation: Center for Valve and Structural Heart Disease and Cardiothoracic Surgery Service, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Paul
authors.initials: P
authors.lastname: Sorajja
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization; D004452:Echocardiography; D005240:Feasibility Studies; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: heart failure; mitral prosthesis; mitral regurgitation; mitral valve implantation; transcatheter