Key result
Patients without guideline indications at ICD generator replacement had a significantly lower rate of appropriate therapies compared to those maintaining indications (3% vs 33%, P<0.01).
Why the study?
Does LVEF recovery and lack of prior therapies predict freedom from appropriate ICD therapies after generator replacement in primary prevention patients?
Observational (n=141)
Does LVEF recovery and lack of prior therapies predict freedom from appropriate ICD therapies after generator replacement in primary prevention patients?
Effect estimate: OR 12.0
Absolute Event Rate: 3% vs 33%
p-value: p=< 0.01
At the time of ICD generator replacement, nearly a third of primary prevention patients no longer meet guideline indications and have a significantly reduced risk of requiring appropriate therapies, driven primarily by LVEF recovery.
LVEF recovery may identify low-risk patients for generator replacement decisions; leaves open need for RCTs before practice change.
Background Implantable cardioverter‐defibrillator (ICD) is associated with reduction in arrhythmic mortality. However, at the time of generator replacement (GR) some patients had not experienced therapies and had a different clinical profile. Therefore, the risk‐benefit ratio of ICD may have changed. Our aim was to determine the proportion of patients with ICD implanted in primary prevention that maintain guideline‐derived indications at the time of GR and assess predictors of therapies in the postreplacement period. We evaluate the long‐term benefit of ICD after GR in nonischemic cardiomyopathy (NICM) versus ischemic cardiomyopathy (ICM). Methods We included 141 patients undergoing GR from 11/2009 to 7/2015. Patients were divided into: G1 – guideline congruent indication for ICD at the time of GR (left ventricular ejection fraction [LVEF] ≤ 35% or appropriate therapies) and G2 – guideline incongruent indication (patients without appropriate therapies and LVEF >35%). We also compared ICD benefit between ICM and NICM patients. Results Maintenance of guideline‐driven indications for ICD (G1) was present in 68% of patients and 32% had recovery of LVEF and no ICD therapies at the time of GR (G2). After GR, G2 patients showed a lower rate of appropriate therapies (3% vs 33%, P < 0.01). LVEF ≤ 35% was the only independent predictor of appropriate therapies (OR 12.0, P < 0.01). In multivariate analysis, etiology of heart failure did not predict the arrhythmic risk. Conclusion At the time of GR, a significant proportion of patients no longer met guideline indications for ICD and their need for therapies is reduced. The etiology of heart failure did not predict freedom from therapies.
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Madeira et al. (2017) conducted an observational in Implantable cardioverter-defibrillator (ICD) primary prevention (n=141). Guideline incongruent indication (LVEF >35% and no prior therapies) vs. Guideline congruent indication (LVEF ≤35% or prior appropriate therapies) was evaluated on Appropriate therapies in the postreplacement period (OR 12.0, p=< 0.01). Patients without guideline indications at ICD generator replacement had a significantly lower rate of appropriate therapies compared to those maintaining indications (3% vs 33%, P<0.01).
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