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The impact of transvenous cardioverter-defibrillator implantation on quality of life,depression and optimism in dialysis patients: report on the secondary outcome of QOL in the randomized controlled ICD2 trial
Authors:Timal  Rohit J.  de Gucht  Veronique  Rotmans  Joris I.  Hensen  Liselotte C. R.  Buiten  Maurits S.  de Bie  Mihaly K.  Putter  Hein  Schalij  Martin J.  Rabelink  Ton J.  Jukema  J. Wouter
Affiliation:1.Department of Cardiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands
;2.Department of Health and Medical Psychology, Leiden University, Leiden, The Netherlands
;3.Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
;4.Department of Cardiology, Treant Zorggroep, Hoogeveen, The Netherlands
;5.Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands
;
Abstract:Rationale

The impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown.

Objective

We aimed to identify the effect of primary ICD implantation on quality of life (QoL), mood and dispositional optimism in patients undergoing dialysis.

Methods and results

We performed a prespecified subanalysis of the randomized controlled ICD2 trial. In total, 177 patients on chronic dialysis, with an age of 55–81 years, and a left ventricular ejection fraction of?≥?35%, were included in the per-protocol analysis. Eighty patients received an ICD for primary prevention, and 91 patients received standard care. The Short Form-36 (SF-36), Geriatric Depression Scale-15 (GDS-15), Revised Life Orientation Test (LOT-R) questionnaires were administered prior to ICD implantation (T0), and at 1-year follow-up (T1) to assess QoL, depression and optimism, respectively. The patients were predominantly male (76.0%), with a median age of 67 years. Hemodialysis was the predominant mode of dialysis (70.2%). The GDS-15 score difference (T1 ? T0) was 0.5 (2.1) in the ICD group compared with 0.3 (2.2) in the control group (mean difference ? 0.3; 95% CI ? 1.1 to 0.6; P?=?0.58). The LOT-R score difference was ? 0.2 (4.1) in the ICD group compared with ? 1.5 (4.0) in the control group (mean difference ? 1.1 (0.8); 95% CI ? 2.6 to 0.4; P?=?0.17). The mean difference scores of all subscales of the SF-36 were not significantly different between randomization groups.

Conclusions

In our population of patients on dialysis, ICD implantation did not affect QoL, mood or dispositional optimism significantly during 1-year follow-up.

Clinical Trial Registration

Unique identifier: ISRCTN20479861. http://www.controlled-trials.com.

Keywords:
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