title: Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification: Results From the First Multicenter Global Registry.
abstract: This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry.
  
  
  
  The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population.
  
  
  
  We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR.
  
  
  
  From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm(2). SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25).
  
  
  
  TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.
authors.affiliation: Department of Medicine, Division of Cardiology, Evanston Hospital, Evanston, Illinois. Electronic address: mguerrero@northshore.org.
authors.forename: Mayra
authors.initials: M
authors.lastname: Guerrero
authors.affiliation: Center for Heart Valve Innovation, St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Danny
authors.initials: D
authors.lastname: Dvir
authors.affiliation: Cardiology Department, Bichat-Claude Bernard Hospital, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Himbert
authors.affiliation: Cardiology Department, Bichat-Claude Bernard Hospital, Paris, France.
authors.forename: Marina
authors.initials: M
authors.lastname: Urena
authors.affiliation: Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
authors.forename: Mackram
authors.initials: M
authors.lastname: Eleid
authors.affiliation: Department of Medicine, Division of Cardiology, Henry Ford Hospital, Detroit, Michigan.
authors.forename: Dee Dee
authors.initials: DD
authors.lastname: Wang
authors.affiliation: Department of Medicine, Division of Cardiology, Henry Ford Hospital, Detroit, Michigan.
authors.forename: Adam
authors.initials: A
authors.lastname: Greenbaum
authors.affiliation: Department of Medicine, Division of Cardiology, University of California San Francisco, San Francisco, California.
authors.forename: Vaikom S
authors.initials: VS
authors.lastname: Mahadevan
authors.affiliation: Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany.
authors.forename: David
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authors.lastname: Holzhey
authors.affiliation: Department of Surgery, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin.
authors.forename: Daniel
authors.initials: D
authors.lastname: O'Hair
authors.affiliation: Department of Cardiology, Rangueil University Hospital, Toulouse, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Dumonteil
authors.affiliation: Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
authors.affiliation: Department of Interventional Cardiology, McGill University Health Centre, Montreal, Quebec, Canada.
authors.forename: Nicolo
authors.initials: N
authors.lastname: Piazza
authors.affiliation: Department of Cardiovascular Surgery, Escola Paulista de Medicina, São Paolo, Brazil.
authors.forename: Jose H
authors.initials: JH
authors.lastname: Palma
authors.affiliation: Department of Medicine, Division of Cardiology, Albany Medical Center Hospital, Albany, New York.
authors.forename: Augustin
authors.initials: A
authors.lastname: DeLago
authors.affiliation: Cardiac Surgery Unit, Cardiocentro Ticino Foundation, Lugano, Switzerland.
authors.forename: Enrico
authors.initials: E
authors.lastname: Ferrari
authors.affiliation: Department of Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Witkowski
authors.affiliation: Department of Surgery, King's College Hospital, London, United Kingdom.
authors.forename: Olaf
authors.initials: O
authors.lastname: Wendler
authors.affiliation: Department of Medicine, Division of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.affiliation: Department of Medicine, Division of Cardiology, Angiografía de Occidente, Cali, Colombia.
authors.forename: Pedro
authors.initials: P
authors.lastname: Martinez-Clark
authors.affiliation: Department of Surgery, Saint Francis Medical Center, Peoria, Illinois.
authors.forename: Daniel
authors.initials: D
authors.lastname: Ciaburri
authors.affiliation: Department of Surgery, UCLA Medical Center, Los Angeles, California.
authors.forename: Richard
authors.initials: R
authors.lastname: Shemin
authors.affiliation: Department of Medicine, Division of Cardiology, St. Michael's Hospital, Toronto, Canada.
authors.forename: Sami
authors.initials: S
authors.lastname: Alnasser
authors.affiliation: Department of Medicine, Division of Cardiology, The Iowa Heart Center, Des Moines, Iowa.
authors.forename: David
authors.initials: D
authors.lastname: McAllister
authors.affiliation: Department of Cardiac Surgery, National Institute of Cardiovascular Diseases, Bratislava, Slovakia.
authors.forename: Martin
authors.initials: M
authors.lastname: Bena
authors.affiliation: Department of Surgery, Heart Hospital of Austin, Austin, Texas.
authors.forename: Faraz
authors.initials: F
authors.lastname: Kerendi
authors.affiliation: Department of Medicine, Division of Cardiology, The Nebraska Medical Center, Omaha, Nebraska.
authors.forename: Gregory
authors.initials: G
authors.lastname: Pavlides
authors.affiliation: Department of Surgery, Complexo Hospitalar de Niteroi, Niteroi, Brasil.
authors.forename: Jose J
authors.initials: JJ
authors.lastname: Sobrinho
authors.affiliation: The Valve and Structural Heart Interventional Center, University Hospitals Case Medical Center, Cleveland, Ohio.
authors.forename: Guilherme F
authors.initials: GF
authors.lastname: Attizzani
authors.affiliation: Columbia Heart Valve Center, New York Presbyterian Hospital-Columbia University Medical Center, New York, New York.
authors.forename: Isaac
authors.initials: I
authors.lastname: George
authors.affiliation: Heart Center, University of Bonn, Bonn, Germany.
authors.forename: George
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Department of Medicine, Division of Cardiology, Hôpital de La Tour, Geneva, Switzerland.
authors.forename: Amir-Ali
authors.initials: AA
authors.lastname: Fassa
authors.affiliation: Department of Cardiology, University of Rouen's Charles Nicolle Hospital, Rouen, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Cribier
authors.affiliation: Department of Cardiology and Cardiac Surgery, St. Thomas' Hospital, London, United Kingdom.
authors.forename: Vinnie
authors.initials: V
authors.lastname: Bapat
authors.affiliation: Department of Medicine, Division of Cardiology, Evanston Hospital, Evanston, Illinois.
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.affiliation: Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
authors.forename: Charanjit
authors.initials: C
authors.lastname: Rihal
authors.affiliation: Cardiology Department, Bichat-Claude Bernard Hospital, Paris, France.
authors.forename: Alec
authors.initials: A
authors.lastname: Vahanian
authors.affiliation: Center for Heart Valve Innovation, St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Webb
authors.affiliation: Department of Medicine, Division of Cardiology, Henry Ford Hospital, Detroit, Michigan.
authors.forename: William
authors.initials: W
authors.lastname: O'Neill
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D063126:Balloon Valvuloplasty; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D005060:Europe; D005260:Female; D006349:Heart Valve Diseases / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D009656:North America; D018579:Patient Selection; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013020:South America; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: calcific mitral stenosis; mitral annular calcification; mitral valve disease; mitral valve replacement; transcatheter valve replacement