title: Analysis of the additional costs of clinical complications in patients undergoing transcatheter aortic valve replacement in the German Health Care System.
abstract: BACKGROUND
  This study aims at analyzing complication-induced additional costs of patients undergoing transcatheter aortic valve replacement (TAVR).
  
  
  METHODS
  In a prospective observational study, a total of 163 consecutive patients received either transfemoral (TF-, n=97) or transapical (TA-) TAVR (n=66) between February 2009 and December 2012. Clinical endpoints were categorized according to VARC-2 definitions and in-hospital costs were determined from the hospital perspective. Finally, the additional costs of complications were estimated using multiple linear regression models.
  
  
  RESULTS
  TF-TAVR patients experienced significantly more minor access site bleeding, major non-access site bleeding, minor vascular complications, stage 2 acute kidney injury (AKI) and permanent pacemaker implantation. Total in-hospital costs did not differ between groups and were on average €40,348 (SD 15,851) per patient. The average incremental cost component of a single complication was €3438 (p<0.01) and the estimated cost of a TF-TAVR without complications was €34,351. The complications associated with the highest additional costs were life-threatening non-access site bleeding (€47,494; p<0.05), stage 3 AKI (€20,468; p<0.01), implantation of a second valve (€16,767; p<0.01) and other severe cardiac dysrhythmia (€10,611 p<0.05). Overall, the presence of complication-related in-hospital mortality increased costs.
  
  
  CONCLUSIONS
  Bleeding complications, severe kidney failure, and implantation of a second valve were the most important cost drivers in our TAVR patients. Strategies and advances in device design aimed at reducing these complications have the potential to generate significant in-hospital cost reductions for the German Health Care System.
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Gutmann
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany; Center for Medical Biometry and Medical Informatics, Medical Center, University of Freiburg, Germany. Electronic address: kaier@imbi.uni-freiburg.de.
authors.forename: Klaus
authors.initials: K
authors.lastname: Kaier
authors.affiliation: Department of Cardiovascular Surgery, Heart Center Freiburg University, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Sorg
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Constantin
authors.initials: C
authors.lastname: von Zur Mühlen
authors.affiliation: Department of Cardiovascular Surgery, Heart Center Freiburg University, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Siepe
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Moser
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Geibel
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Zirlik
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Ahrens
authors.affiliation: Department of Cardiovascular Surgery, Robert-Bosch-Krankenhaus Stuttgart, Germany.
authors.forename: Hardy
authors.initials: H
authors.lastname: Baumbach
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: Center for Medical Biometry and Medical Informatics, Medical Center, University of Freiburg, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Vach
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Zehender
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.affiliation: Department of Cardiology and Angiology I, Heart Center Freiburg University, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Reinöhl
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003695:Delivery of Health Care / Q000191:economics* / Q000639:trends; D005260:Female; D005858:Germany / Q000453:epidemiology; D017721:Hospital Costs / Q000639:trends; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000175:diagnosis / Q000191:economics* / Q000453:epidemiology*; D011446:Prospective Studies; D012042:Registries; D065467:Transcatheter Aortic Valve Replacement / Q000191:economics* / Q000639:trends; D016896:Treatment Outcome
keywords: Cost analysis; Resource utilization; TAVI; TAVR; VARC complication