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Prophylactic Use of Implantable Cardioverter-Defibrillators in the Prevention of Sudden Cardiac Death in Dialysis
J Wouter Jukema1, Rohit J Timal1, Joris I Rotmans2
1Department of Cardiology (J.W.J., R.J.T., L.C.R.H., M.S.B., M.K.d.B., L.v.E., M.J.S.), Leiden University Medical Center, The Netherlands.
Insights
Prophylactic implantable cardioverter-defibrillator (ICD) therapy did not reduce sudden cardiac death (SCD) or mortality in dialysis patients. The high risk of SCD and death persists despite ICD implantation in this population.
Area of Science:
- Cardiology
- Nephrology
- Medical Devices
Background:
- Patients undergoing dialysis for end-stage renal disease face a high risk of sudden cardiac death (SCD).
- Existing therapies have not proven effective in mitigating this elevated SCD risk.
- The efficacy and safety of prophylactic implantable cardioverter-defibrillators (ICDs) in this population remain uncertain.
Purpose of the Study:
- To investigate the value and safety of prophylactic ICD implantation in preventing SCD among dialysis patients.
- To assess the impact of ICDs on all-cause mortality and device-related complications in this high-risk group.
Main Methods:
- The ICD2 trial was a prospective, randomized, controlled study involving 200 dialysis patients with left ventricular ejection fraction ≥35%.
- Patients were screened and optimized for other treatments before randomization to ICD implantation or a control group.
- The primary endpoint was SCD, with secondary endpoints including all-cause mortality and ICD-related complications.
Main Results:
- The trial was halted early for futility after enrolling 188 patients.
- No significant difference in SCD rates was observed between the ICD and control groups (5-year incidence: 9.7% vs. 7.9%; HR 1.32, P=0.55).
- All-cause mortality was also similar between groups (5-year survival: 50.6% vs. 54.5%; HR 1.02, P=0.92), with 25 adverse events reported in 80 patients receiving an ICD.
Conclusions:
- Prophylactic ICD therapy does not reduce SCD or all-cause mortality in well-screened and well-treated dialysis patients.
- Sudden cardiac death and overall mortality remain high in this patient population.
- The prophylactic use of ICDs is not recommended for preventing SCD in dialysis patients based on these findings.
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.
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