Prophylactic Use of Implantable Cardioverter-Defibrillators in the Prevention of Sudden Cardiac Death in Dialysis Patients

Abstract

Background: Patients with end-stage renal disease who are undergoing dialysis are reported to be at high risk of sudden cardiac death (SCD), and to date, no therapy has been shown to be effective in reducing this risk. The feasibility and value of prophylactic implantable cardioverter-defibrillator (ICD) implantation to prevent SCD is uncertain. Methods: We conducted the ICD2 trial (Implantable Cardioverter-Defibrillator in Dialysis Patients), a prospective, randomized, controlled study investigating the value and safety of ICD implantation to prevent SCD in 200 patients on dialysis with a left ventricular ejection fraction ≥35%, after adequate screening and optimization of other treatments. The primary end point was SCD. Secondary end points were all-cause mortality and ICD-related complications. Results: The trial was stopped as per the recommendation of the data and safety monitoring board for futility reasons after inclusion of 188 patients, 97 in the ICD group and 91 in the control group. The median duration of follow-up was 6.8 years (interquartile range, 3.8–8.8 years). SCD occurred in 19 of 188 cases (10.1%), 11 of 97 in the ICD group and 8 of 91 in the control group. The cumulative SCD incidence at 5 years was 9.7% (95% CI, 3.3%–16.2%) in the ICD group and 7.9% (95% CI, 1.7–14.0%) in the control group, resulting in a hazard ratio of 1.32 (95% CI, 0.53–3.29; P =0.55). Overall, 99 of 188 patients died (52.7%), 52 in the ICD group and 47 in the control group. Five-year survival probability was 50.6% (95% CI, 39.8%–61.5%) in the ICD group and 54.5% (95% CI, 43.0–66.0%) in the control group, resulting in a hazard ratio of 1.02 (95% CI, 0.69–1.52; P =0.92). Among 80 patients who received an ICD, 25 adverse events related to ICD implantation occurred. Conclusions: In a well-screened and well-treated population undergoing dialysis, prophylactic ICD therapy did not reduce the rate of SCD or all-cause mortality, which remained high. Clinical Trial Registration: URL: http://www.controlled-trials.com . Unique identifier: ISRCTN20479861.

Cardiovascular Mortality Can Be Predicted by Heart Rate Turbulence in Hemodialysis Patients

“…In our cohort, 35% (n = 7) of those who succumbed to cardiovascular causes suffered from sudden cardiac death which might be attributed to an arrhythmogenic event and is thus potentially preventable by the implantation of a cardioverter defibrillator (ICD) (Di Lullo et al, 2016). However, a recent randomized controlled trial including dialysis patients with a LVEF ≥ 35% showed no advantage of prophylactic ICD implantation (Jukema et al, 2019). One explanation for this result might be provided by recent studies showing that fatal arrhythmias are more frequently related to bradyarrhythmias than to tachyarrhythmias.…”

“…At the same time, cardiovascular and sudden cardiac death risk stratification of end-stage renal patients is presently an important unmet clinical need. Blanket prophylaxis by implantable defibrillators does not improve survival in these patients (Jukema et al, 2019).…”

Heart failure management in dialysis patients: Many treatment options with no clear evidence

“…For example, a propensity‐matched retrospective study of 303 hemodialysis patients with HFrEF, showed no mortality benefit associated with receiving an ICD for primary prevention, with one‐year mortality rates of 43% in the ICD group as compared with 40% in the non‐ICD group 89 . The only RCT to date was stopped prematurely when the effect size calculated in an interim analysis suggested it would be futile to continue 90 . Furthermore, there are additional risks with ICD therapy in dialysis patients that are important to consider.…”

Implantable Defibrillators for Primary Prevention of Sudden Death in Patients on Dialysis

“…8,9 Even among patients with non-dialysis-dependent chronic kidney disease, the benefits of ICDs are unclear. 10,11 The recently published Implantable Cardioverter-Defibrillator in Dialysis Patients (ICD2) Study 12 is the first randomized controlled trial specifically designed to examine the efficacy of prophylactic ICD implantation in dialysis patients.…”