title: Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings.
abstract: BACKGROUND
  To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT).
  
  
  METHODS
  Cost-utility analysis using a combination of a decision tree and Markov process was performed. The clinical effectiveness was determined based on the results of the Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) trial. The mean age of the target population was 62 years, 77% of the patients were males, 64% of the patients had severe FMR and all patients had New York Heart Association functional class III. The epidemiological, cost and utility data were derived from the literature. The analysis was performed from the German statutory health insurance perspective over 10-year time horizon.
  
  
  RESULTS
  Over 10 years, the total cost was €36,785 in the PMVR arm and €18,944 in the OMT arm. However, PMVR provided additional benefits to patients with an 1.15 incremental quality-adjusted life years (QALY) and an 1.41 incremental life years. The percutaneous procedure was cost-effective in comparison to OMT with an incremental cost-effectiveness ratio of €15,533/QALY. Results were robust in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis with a willingness-to-pay threshold of €35,000/QALY, PMVR had a 84 % probability of being cost-effective.
  
  
  CONCLUSIONS
  Percutaneous mitral valve repair may be cost-effective in inoperable patients with FMR due to heart failure.
authors.affiliation: Synergus AB, Svardvagen 19, 182 33, Danderyd, Sweden. oleg.borisenko@synergus.com.
authors.forename: Oleg
authors.initials: O
authors.lastname: Borisenko
authors.affiliation: Medical Clinic I, Neuss City Clinic, Lukas Krankenhaus GmbH, Preußenstraße 84, 41464, Neuss, Germany. michael.haude@uni-due.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.affiliation: Department of Internal Medicine II, Paracelsus Medical University Salzburg, Müllner Hauptstr. 48, A-5020, Salzburg, Austria. uta.hoppe@uni-koeln.de.
authors.forename: Uta C
authors.initials: UC
authors.lastname: Hoppe
authors.affiliation: Department of Cardiology, Interventional Cardiology, HCP Medical Center, Poznan University of Medical Sciences, ul. 28 czerwca 1956 Nr 194, 61-485, Poznan, Poland. tsiminia@umed.poznan.pl.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Siminiak
authors.affiliation: Pole Sante Republique, 105 Avenue de la République, 63050, Clermont-Ferrand, France. janusz.lipiecki@hotmail.fr.
authors.forename: Janusz
authors.initials: J
authors.lastname: Lipiecki
authors.affiliation: Department of Cardiology, University of Washington, Seattle, WA, USA. stevegold@cardiacdimensions.com.
authors.forename: Steve L
authors.initials: SL
authors.lastname: Goldberg
authors.affiliation: Cardiac Dimensions Incorporated, 5540 Lake Washington Blvd NE, Kirkland, WA, 98033, USA. nmehta@cardiacdimensions.com.
authors.forename: Nawzer
authors.initials: N
authors.lastname: Mehta
authors.affiliation: Cardiac Dimensions Incorporated, 5540 Lake Washington Blvd NE, Kirkland, WA, 98033, USA. obouknight@cardiacdimensions.com.
authors.forename: Omari V
authors.initials: OV
authors.lastname: Bouknight
authors.affiliation: Synergus AB, Svardvagen 19, 182 33, Danderyd, Sweden. staffan.bjessmo@synergus.com.|Department of Learning Informatics, Medical Management Centre, Management and Ethics, Karolinska Institutet, Solnavägen 1, 171 77, Solna, Sweden. staffan.bjessmo@synergus.com.
authors.forename: Staffan
authors.initials: S
authors.lastname: Bjessmo
authors.affiliation: Division of Pediatric Emergency Medicine, Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA, 98105, USA. dreuter@cardiacdimensions.com.
authors.forename: David G
authors.initials: DG
authors.lastname: Reuter
mesh_terms: D003362:Cost-Benefit Analysis; D003663:Decision Trees; D005260:Female; D005858:Germany; D006333:Heart Failure / Q000150:complications; D019918:Heart Valve Prosthesis Implantation / Q000191:economics* / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D058386:Mitral Valve Annuloplasty / Q000191:economics* / Q000379:methods*; D008944:Mitral Valve Insufficiency / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D019057:Quality-Adjusted Life Years; D012680:Sensitivity and Specificity