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Complication risks reported in CRT replacement surgeries
Poole J. Circulation. 2010;122:1553-1561.
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Complication risks with implantable cardioverter defibrillator generator replacements were higher than those experienced with pacemaker replacements, although both procedures, particularly those with lead additions, resulted in notable risks for the patient, study findings indicated.
The study included data from the REPLACE registry, which was a prospective, multicenter study created to compile complication data on patients for 6 months after replacement of a pacemaker or ICD generator. Major complications were defined as those placing the patient at significant risk, requiring an intervention, procedure or hospitalization for management.
The final study group included patients from two cohorts: those without (cohort 1, n=1,031) and those with (cohort 2, n=713) a planned transvenous lead addition for replacement or device upgrade for capacity of additional therapies.
According to study data, cohort 1 experienced a major complication rate of 4% (95% CI, 2.9-5.4), whereas the rate was 15.3% (95% CI, 12.7-18.1) in cohort 2 patients. Complication rates were highest in those with ICD vs. pacemaker generator replacements (OR=2.38; 95% CI, 1.30-4.38), with the highest overall rates reported in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% CI, 15.1-22.6).
These findings, researcher Jeanne E. Poole, MD, and colleagues wrote, highlight the overall risk and variety of complications that can occur with these procedures and provide systematically captured data that better approximate the true procedural risks.
“Recommendations for lifelong device therapy should include consideration of the risks associated with generator replacements and lead additions, especially in situations in which the benefit may be less certain,” they said. “These data emphasize the need for future efforts directed at extending battery longevity and minimizing lead-related complications.”
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