Appropriateness of Primary Prevention Implantable Cardioverter Defibrillators at Time of Generator Replacement: Are Indications Still Met?
Vinay Kini, MD Mohamad Khaled Soufi, MD Rajat Deo, MD, MTR Andrew E. Epstein, MD, FACC Rupa Bala, MD Michael Riley, MD, PhD Peter W. Groeneveld, MD, MS Alaa Shalaby, MD, FACC Sanjay Dixit, MD, FACC
OBJECTIVES: We sought to determine how often patients with primary prevention ICDs meet
guideline-derived indications at time of generator replacement.
BACKGROUND: Professional societies have developed guideline criteria for the appropriate
implantation of an ICD for the primary prevention of SCD. It is unknown whether patients
continue to meet criteria when their devices need replacement for battery depletion.
METHODS: We performed a retrospective chart review of patients undergoing replacement of
primary prevention ICDs at two tertiary VA Medical Centers. Indications for continued ICD
therapy at time of generator replacement included LVEF < 35% or receipt of appropriate device
RESULTS: In our cohort of 231 patients, 59 subjects (26%) no longer met guideline-driven
indications for an ICD at time of generator replacement. An additional 79 patients (34%) had not
received any appropriate ICD therapies and had not undergone reassessment of their LVEF.
Patients with an initial LVEF of 30-35% were less likely to meet indications for ICD therapy at
time of replacement (OR 0.52, 95% CI 0.30-0.88; p=0.01). Patients without ICD indications
subsequently received appropriate ICD therapies at a significantly lower rate than patients who
did (2.8% vs. 10.7% annually, p < .001). If ICD generator explants were performed instead of
replacements in the patients without ICD indications, the cost savings would be $1.6 million.
CONCLUSIONS: Approximately 25% of patients who receive primary prevention ICDs may no
longer meet guideline indications for ICD use at time of generator replacement, and these
patients receive subsequent ICD therapies at a significantly lower rate.
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