title: 2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.
abstract: BACKGROUND
  The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services.
  
  
  OBJECTIVE
  This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States.
  
  
  METHODS
  We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry.
  
  
  RESULTS
  The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%.
  
  
  CONCLUSIONS
  The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.
authors.affiliation: Department of Surgery, School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado; Denver Department of Veterans Affairs Medical Center, Denver, Colorado. Electronic address: frederick.grover@ucdenver.edu.
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Grover
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Sreekanth
authors.initials: S
authors.lastname: Vemulapalli
authors.affiliation: School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.
authors.forename: John D
authors.initials: JD
authors.lastname: Carroll
authors.affiliation: University of Florida, Jacksonville, Florida.
authors.forename: Fred H
authors.initials: FH
authors.lastname: Edwards
authors.affiliation: Baylor Scott and White Health, Plano, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: Emory University, Atlanta, Georgia.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: University of California, San Francisco, California.
authors.forename: Ralph G
authors.initials: RG
authors.lastname: Brindis
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: David M
authors.initials: DM
authors.lastname: Shahian
authors.affiliation: Structural and Congenital Heart Center, Hackensack University Medical Center and The Joseph M. Sanzari Children's Hospital, Seton Hall Hackensack University-School of Medicine, Hackensack, New Jersey.
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ruiz
authors.affiliation: Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland; Division of Cardiovascular Surgery, Department of Surgery, Johns Hopkins All Children's Heart Institute, All Children's Hospital and Florida Hospital for Children, St. Petersburg, Tampa, and Orlando, Florida.
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Jacobs
authors.affiliation: Beaumont Hospital, Royal Oak, Michigan.
authors.forename: George
authors.initials: G
authors.lastname: Hanzel
authors.affiliation: Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.affiliation: Cleveland Clinic, Abu Dhabi, United Arab Emirates.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: American College of Cardiology, Washington, DC.
authors.forename: Susan
authors.initials: S
authors.lastname: Fitzgerald
authors.affiliation: The Society of Thoracic Surgeons, Chicago, Illinois.
authors.forename: Matina
authors.initials: M
authors.lastname: Kourtis
authors.affiliation: American College of Cardiology, Washington, DC.
authors.forename: Joan
authors.initials: J
authors.lastname: Michaels
authors.affiliation: American College of Cardiology, Washington, DC.
authors.forename: Barbara
authors.initials: B
authors.lastname: Christensen
authors.affiliation: The Society of Thoracic Surgeons, Chicago, Illinois.
authors.forename: William F
authors.initials: WF
authors.lastname: Seward
authors.affiliation: American College of Cardiology, Washington, DC.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Hewitt
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008946:Mitral Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D012042:Registries; D012189:Retrospective Studies; D012955:Societies, Medical; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000401:mortality / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014481:United States