Abstract
RationaleThe impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown.ObjectiveWe aimed to identify the effect of primary ICD implantation on quality of life (QoL), mood and dispositional optimism in patients undergoing dialysis.Methods and resultsWe 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.ConclusionsIn our population of patients on dialysis, ICD implantation did not affect QoL, mood or dispositional optimism significantly during 1-year follow-up.Clinical Trial RegistrationUnique identifier: ISRCTN20479861. http://www.controlled-trials.com.
Highlights
We found that in patients on dialysis, implantation of an implantable cardioverter-defibrillator (ICD), which is a device that can detect and treat life-threatening heart rhythm disturbances, did not affect quality of life, mood or dispositional optimism significantly in the first year after implantation
In this report we prospectively evaluated the impact of ICD implantation on quality of life (QOL), mood and dispositional optimism of patients participating in the Implantable Cardioverter-Defibrillator in Dialysis Patients (ICD2) trial [14]
171 patients were included in the current per-protocol analysis, of which 80 patients were allocated to the ICD group and 91 patients to the standard care group (Fig. 1)
Summary
We found that in patients on dialysis, implantation of an implantable cardioverter-defibrillator (ICD), which is a device that can detect and treat life-threatening heart rhythm disturbances, did not affect quality of life, mood or dispositional optimism significantly in the first year after implantation. This new data is important because it can help physicians to decide what the best, possibly life-saving, treatment is for the approximately 2 million patients suffering from endstage kidney disease worldwide. The physical and psychological impact of preventive ICD implantation in these vulnerable patients is unknown. The purpose of the current prespecified substudy of the randomized controlled ICD2 trial was to prospectively evaluate the impact of ICD implantation on QOL, mood or dispositional optimism in patients on maintenance dialysis
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