NCDR Study Identifies Predictors of Outcome After ICD Generator Changes
A left ventricular ejection fraction (LVEF) >35% alone or in combination with a proportional risk of arrhythmic death (PRAD) <43% in patients at the time of a generator change in an ICD implanted for primary prevention of sudden cardiac arrest was associated with worse survival compared with patients without ICDs, according to a study published recently in the Journal of the American Heart Association.
Kenneth C. Bilchick, MD, FACC, et al., used data from 40,933 patients (age, 67.7 years; 24.5% women; 34.1% with LVEF >35%) in ACC's EP Device Implant Registry, formerly the ICD Registry, who underwent a generator change between 2012 and 2016 to identify predictors of survival, including the Seattle Heart Failure Model (SHFM) to predict annual mortality, LVEF >35% alone, and LVEF >35% plus PRAD.
Compared with 23,472 patients with heart failure without an ICD, patients with an LVEF >35% at the time the generator was changed had a lower SHFM-adjusted survival (model interaction hazard ratio, 1.21; 95% CI, 1.11-1.31). Among patients with an LVEF ≤35% at the time of the generator change, survival was worse, vs. controls, in the 21% of patients with a PRAD <43% while it was improved in the 10% with a PRAD >65%. The model indicated the association of the PRAD with survival benefit or harm was similar in patients who did and did not have ICD therapies before the generator change.
Bilchick, et al., write, "Our findings could have an important impact on decision making among patients and providers, as well as future clinical trial designs by highlighting key factors associated with prognosis and survival benefit with replacement ICDs." Furthermore, "these findings also provide key data that could be the basis for a randomized clinical trial to evaluate the effectiveness of a risk model-based intervention to determine the best candidates for replacement ICDs."
Keywords: National Cardiovascular Data Registries, EP Device Implant Registry, Stroke Volume, Ventricular Function, Left, American Heart Association, Heart Failure, Primary Prevention, Death, Sudden, Cardiac, Registries, Decision Making, Prognosis
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