title: Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement- a model-based longitudinal data analysis.
abstract: BACKGROUND
  Quality of life (QoL) measurements reported in observational studies are often biased, since patients who failed to improve are more likely to be unable to respond due to death or impairment. In order to observe the development of QoL in patients close to death, we analyzed a set of monthly QoL measurements for a cohort of elderly patients treated for aortic valve stenosis (AS) with special consideration of the effect of distance to death.
  
  
  METHODS
  QoL in 169 elderly patients (age ≥ 75 years), treated either with transcatheter aortic valve replacement (TAVR; n = 92), surgical aortic-valve replacement (n = 70), or drug-based therapy (n = 7), was evaluated using the standardized EQ-5D questionnaire. Over a two-year period, patients were consulted using monthly telephone interviews or outpatient visits, leading to a total of 2463 time points at which QoL values, New York Heart Association (NYHA) Functional Classification and their status of assistance were assessed. Furthermore, post-procedural clinical events and complications were monitored. Linear and ordered logistic regression analyses with random intercept were carried out, taking into account overall trends and distance to death.
  
  
  RESULTS
  QoL measures decreased slightly over time, were temporarily impaired at month 1 after the initial episode of hospitalization and decreased substantially at the end of life with a measurable effect starting at the sixth from last follow-up (month) before death. Many clinical complications (bleeding complications, stroke, acute kidney injury) showed an impairment of QoL measurements, but the inclusion of lagged variables demonstrated medium term (three months) QoL impairments for access site bleeding only. All other complications are associated with event-related impairments that decreased dramatically at the second and third follow-up interviews (month) after event.
  
  
  CONCLUSIONS
  Distance to death shows clear effects on QoL and should be taken into account when analyzing QoL measures in the elderly patients treated for aortic valve stenosis.
  
  
  BACKGROUND
  German Clinical Trial Register Nr. DRKS00000797.
authors.affiliation: Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Stefan-Meier-Str. 26, D-79104, Freiburg, Germany. kaier@imbi.uni-freiburg.de.|Department of Cardiology, Heart Center Freiburg University, Freiburg, Germany. kaier@imbi.uni-freiburg.de.
authors.forename: Klaus
authors.identifier: http://orcid.org/0000-0003-0837-6945
authors.initials: K
authors.lastname: Kaier
authors.affiliation: Department of Cardiology, Heart Center Freiburg University, Freiburg, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Gutmann
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, Heart Center Freiburg University, Freiburg, Germany.
authors.forename: Constantin
authors.initials: C
authors.lastname: von Zur Mühlen
authors.affiliation: Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Stefan-Meier-Str. 26, D-79104, Freiburg, Germany.
authors.forename: Philip
authors.initials: P
authors.lastname: Hehn
authors.affiliation: Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Stefan-Meier-Str. 26, D-79104, Freiburg, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Vach
authors.affiliation: Department of Cardiovascular Surgery, Heart Center Freiburg University, Freiburg, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: Department of Cardiology, Heart Center Freiburg University, Freiburg, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Zehender
authors.affiliation: Department of Cardiology, Heart Center Freiburg University, Freiburg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.affiliation: Department of Cardiology, Heart Center Freiburg University, Freiburg, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Reinöhl
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis / Q000523:psychology*; D019918:Heart Valve Prosthesis Implantation / Q000523:psychology*; D006801:Humans; D008297:Male; D010361:Patients / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*; D012307:Risk Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: AVR; Aortic valve replacement; EQ-5D; Quality of life; TAVI; TAVR; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement