title: A Comparison of the Quality of Life of Patients With an Entirely Subcutaneous Implantable Defibrillator System Versus a Transvenous System (from the EFFORTLESS S-ICD Quality of Life Substudy).
abstract: The first clinical results from the Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the subcutaneous implantable cardioverter defibrillator (EFFORTLESS S-ICD) Registry on the entirely S-ICD system are promising, but the impact of the S-ICD system on patients' quality of life (QoL) is not known. We evaluated the QoL of patients with an S-ICD against an unrelated cohort with a transvenous (TV)-ICD system during 6 months of follow-up. Consecutively implanted patients with an S-ICD system were matched with patients with a TV-ICD system on a priori selected variables including baseline QoL. QoL was measured with the Short-Form Health Survey at baseline, 3, and 6 months after implant and compared using multivariable modeling with repeated measures. Patients with an S-ICD (n = 167) versus a TV-ICD system (n = 167) did not differ significantly on physical (p = 0.8157) and mental QoL scores (p = 0.9080) across baseline, 3, and 6 months after implantation in adjusted analyses. The evolution in physical (p = 0.0503) and mental scores (p = 0.3772) during follow-up was similar for both cohorts, as indicated by the nonsignificant interaction effect for ICD system by time. Both patients with an S-ICD system and a TV-ICD system experienced significant improvements in physical and mental QoL between time of implant and 3 months (both p's <0.0001) and between time of implant and 6 months (both p's <0.0001) but not between 3 and 6 months (both p's >0.05). In conclusion, these first results show that the QoL of patients with an S-ICD versus TV-ICD system is similar and that patients with either system experience improvements in QoL on the short term.
authors.affiliation: Department of Psychology, University of Southern Denmark, Odense, Denmark; Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Cardiology, Thorax Center, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: sspedersen@health.sdu.dk.
authors.forename: Susanne S
authors.initials: SS
authors.lastname: Pedersen
authors.affiliation: Department of Cardiology, University Medical Center, Utrecht, the Netherlands.
authors.forename: Mirjam H
authors.initials: MH
authors.lastname: Mastenbroek
authors.affiliation: Boston Scientific Corporation, St Paul, Minnesota.
authors.forename: Nathan
authors.initials: N
authors.lastname: Carter
authors.affiliation: Cardiology Department, Russels Hall Hospital, Dudley, United Kingdom.
authors.forename: Craig
authors.initials: C
authors.lastname: Barr
authors.affiliation: Department of Cardiology, Homnolka Hospital, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
authors.affiliation: Department of Cardiology, Thorax Center Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
authors.forename: Marcoen
authors.initials: M
authors.lastname: Scholten
authors.affiliation: Cardiology Department, The Heart Hospital, Institute of Cardiovascular Science, University College London, London, United Kingdom.
authors.forename: Pier D
authors.initials: PD
authors.lastname: Lambiase
authors.affiliation: Department of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.
authors.forename: Lucas
authors.initials: L
authors.lastname: Boersma
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Jens B
authors.initials: JB
authors.lastname: Johansen
authors.affiliation: Department of Cardiology, Thorax Center, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Dominic A M J
authors.initials: DA
authors.lastname: Theuns
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000379:methods; D011788:Quality of Life; D012042:Registries; D017180:Tachycardia, Ventricular / Q000150:complications / Q000628:therapy*; D014693:Ventricular Fibrillation / Q000150:complications / Q000628:therapy*