Patients who received non-evidence-based implantable cardioverter-defibrillators (ICDs) for primary prevention had an increased risk of mortality and hospitalization, according to a study published recently in the American Journal of Cardiology. Researchers observed the greatest increase in risk occurred within the first year of device implantation.

The retrospective analysis evaluated data from 71,555 ICD implantations identified in ACC's EP Device Implant Registry, formerly the ICD Registry, and linked to Medicare fee-for-service administrative claims data between April 2010 and December 2013. Of these, 9,609 (13.4%) were categorized as non-evidenced based, defined as primary prevention-based implantation in patients with recent myocardial infarction (MI) or coronary revascularization and those with newly diagnosed or severe heart failure (HF). Usama A. Daimee, MD, et al., used multivariable time-to-even analyses to compare longitudinal outcomes, including all-cause mortality and all-cause hospital readmissions, over an average of 4.75 years following ICD implantation.

Overall results found that patients receiving non-evidence-based ICDs had greater mortality risk at 90 days and at one year compared with those receiving evidence-based ICDs. Mortality risk was similar across both groups at three years. Similarly, patients in the non-evidence-based ICD group had a greater risk of all-cause hospital readmissions at 90 days; however, researchers noted the difference in readmission risk between the evidence-based and non-evidence-based groups decreased at one year and three years.

"The increased risk of mortality and hospitalization in patients with non-evidence-based ICDs was observed early in follow-up and largely in patients with NYHA Class IV symptoms and those with MI within 40 days," said Daimee and colleagues. "These findings may help guide shared decision-making for ICD implantations, particularly for severe HF patients and those recovering from a recent MI."

Clinical Topics: Arrhythmias and Clinical EP, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Acute Heart Failure

Keywords: National Cardiovascular Data Registries, EP Device Implant Registry, Patient Readmission, Defibrillators, Implantable, Fee-for-Service Plans, Retrospective Studies, Medicare, Heart Failure, Primary Prevention, Myocardial Infarction, Cardiology

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