NCDR Study Finds Dual-Chamber ICDs are Associated With Higher Rates of Complications

The use of dual-chamber implantable cardioverter-defibrillators (ICDs) compared with single-chamber ICDs are associated with a higher rates of device-related complications, according to a study published May 14 in the Journal of the American Medical Association.

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The retrospective cohort study used data from the NCDR's ICD Registry™ and looked at 32,034 patients from 1,270 hospitals who received an ICD for primary prevention without indications for pacing. Out of the cohort, 62 percent received a dual-chamber ICD, and 38 percent received a single-chamber ICD.

Results showed rates of complications were lower for single-chamber ICDs when compared to dual-chamber ICDs (3.51 percent vs. 4.72 percent; P<.001; risk difference, -1.20 [95 percent CI, - 1.72 to -0.69]), but device type was not significantly associated with 1-year mortality (unadjusted rate, 9.85 percent vs. 9.77 percent; hazard ratio [HR], 0.99 [95 percent CI, 0.91 to 1.07]; P=.79), 1-year all-cause hospitalization (un-adjusted rate, 43.86 percent vs. 44.83 percent; HR, 1.00 [95 percent CI, 0.97 – 1.04]; P=.82), or hospitalization for heart failure (unadjusted rate, 14.73 percent vs. 15.38 percent; HR, 1.05 [95 percent CI, 0.99 – 1.12]; P=.19).

The authors note that, "current guidelines do not specify whether a single- or dual-chamber ICD should be used among patients receiving an ICD for primary prevention who do not have pacing indications." Lead author Pamela N. Peterson, MD, MSPH, FACC, Department of Medicine, Denver Health Medical Center, Denver, also noted that "randomized trials demonstrating the efficacy of primary prevention ICDs used predominantly single-chamber devices, leaving an absence of evidence regarding the safety and outcomes of dual-chamber devices." However, the Centers for Medicare and Medicaid Services (CMS) National Coverage Decision for ICDs states that "providers must be able to justify the medical necessity of devices other than single lead devices."

Peterson adds that their results showed that, "more complex and more costly dual-chamber ICD did not result in improved mortality or hospitalizations outcomes, and in fact were associated with higher rates of complications among patients without a pacing indication who received a primary prevention ICD. These findings do not support the routine use of dual chamber ICDs for primary prevention," she adds. Moving forward, Peterson notes, "among patients who do not have an indication for pacing, use of a dual-chamber device should be considered carefully."

Keywords: Heart Failure, Centers for Medicare and Medicaid Services, U.S., Hospitalization, Defibrillators, Implantable, Primary Prevention, United States

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