Why the study?
Previous studies on leadless pacemakers reported conflicting mortality and complication rates, often relying on claims data with limitations, necessitating detailed clinical factor analysis including Charlson comorbidity index to identify mortality risk factors.
Does a higher Charlson comorbidity index predict increased mortality in patients receiving a leadless pacemaker?
Cohort (n=574)
No
Does a higher Charlson comorbidity index predict increased mortality in patients receiving a leadless pacemaker?
Hazard Ratio: 3.04 (95% CI 1.7–5.42)
p-value: p=<0.001
A preprocedural Charlson comorbidity index >4, along with age ≥80 years, LVEF ≤35%, and hemoglobin ≤12 g/dL, are significant independent predictors of early mortality after leadless pacemaker implantation.
May inform preprocedural risk stratification in leadless pacemaker recipients; extends transvenous data but hypothesis-generating and requires prospective validation.
Background: In certain high-risk subgroups, leadless pacemakers (LPs) have lower 2-year complications and reintervention rates than transvenous-VVI pacing. Despite this, other studies have reported higher all-cause in-hospital mortality and complications in the LP group. Many of these studies are based on claims data, which have inherent limitations. We conducted a single-center, detailed, retrospective study to examine clinical factors, including the Charlson comorbidity index (CCI), associated with higher mortality among patients receiving an LP. Objective: This study aimed to examine clinical factors, including the CCI, associated with higher mortality among patients receiving an LP. Methods: A retrospective analysis was conducted among 574 patients who received an LP between 2018 and 2022 at a quaternary care hospital. CCI was generated for each patient, and a multivariable Cox regression analysis was performed to obtain associated hazard ratios. Furthermore, we conducted logistic regression analyses to identify unique factors that affect the odds of 30-day mortality. Results: The mean CCI score in the study population was 5.30 (standard deviation 2.03). The total mortality in the study population was 26.6% (n = 146). Patients who had a CCI of >4 points had a 3-fold increase in risk of mortality compared with those who had a CCI of ≤4 points (hazard ratio 3.04; 95% confidence interval [CI] 1.70-5.42). Moreover, there was a decreased odds of survival within the first 30 days among those with a CCI of >4. Low left ventricular ejection fraction (odds ratio [OR] 2.62; 95% CI 1.05-6.56), hemoglobin (OR 2.29; 95% CI 1.10-4.77), and advanced age (OR 2.28; 95% CI 1.20-4.34) were identified as independent risk factors of early mortality. Conclusion: CCI has previously been demonstrated to be a significant predictor of mortality in patients receiving pacemakers or implantable defibrillators. In our study, we found that a CCI of >4 was independently associated with mortality. In addition, our study highlights that low left ventricular ejection fraction, hemoglobin, and advanced age are key risk factors that may predict early mortality among LP patients.
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Patel et al. (2025) conducted a cohort in Symptomatic bradycardia requiring leadless pacemaker (n=574). Charlson comorbidity index (CCI) >4 vs. Charlson comorbidity index (CCI) ≤4 was evaluated on Hazard of all-cause mortality (HR 3.04, 95% CI 1.70-5.42, p=<0.001).
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