1 in 38 ICD patients experience major complications to lead revisions

Surgery to revise implantable cardioverter-defibrillator (ICD) leads had the highest overall incidence of major complications compared to initial implantation or procedures that did not involve the leads.

In a study published Aug. 1 in the American Journal of Cardiology, researchers comparing outcomes from different types of ICD surgeries found major complications occurred in 3.2 percent of patients requiring surgery that involved ICD leads. Comparatively, major complications occurred in 2.6 percent of initial patients and 0.6 percent of patients who were undergoing revision of their pocket-only device that left the leads in place.

The research team reviewed the National Cardiovascular Data Registry’s ICD registry for procedures performed between April 2010 and June 2011. Of the 174,499 procedures performed in that span, 92,751 were initial ICD implants, 31,057 involved ICD lead movement or replacement and 50,691 were pocket-only procedures.

When reviewing the frequency of major complications against the number of patients in the study, David A. Steckman, MD, of the University of Colorado’s cardiac electrophysiology section in Aurora, and colleagues found that the cohort who experienced lead revisions stood out with a 1 in 38 chance of complications.

Among the major reasons for lead involvement, replacement of recalled parts occurred in 1.6 percent of cases and 28.1 percent involved the end of expected battery life on the device. Lead revision, infection and device malfunction occurred in 12.9 percent, 5.5 percent and 3.2 percent of cases. Device upgrades accounted for 35 percent of lead-involved reimplants.

When leads were not involved, 95.7 percent of reimplantation occurred due to battery life in the pocket-only group. With an overall risk of 0.6 percent, few patients comparatively had complications in surgeries where leads were left alone.

Of concern to the research team was the failure rate of one particular ICD lead, the Riata (St. Jude Medical), involved in a recall during the reviewed time period. Steckman et al noted high risks with lead involvement, particularly in mortality and the risk of infection requiring antibiotic use.

Complications also cost patients and insurers in other ways. Patients who experienced complications on average stayed 3.4 days longer and cost $7,251 more per hospital stay. ICD reimplantation-related infections cost $18,477 more per stay and stayed an extra 9.6 days.

Steckman et al recommended consideration of higher complication rates in repeat ICD procedures with lead implantation or revision when evaluating and counseling patients on upgrading devices.