Abstract
Infants requiring permanent pacemakers (PMs) must receive epicardial leads and abdominal generators due to their small size. Few studies have explored the prevalence and predictors of device-related adverse events (DRAE) in this population. To explore associations between patient and device characteristics with DRAE in infants requiring permanent PM implantation. This multicenter retrospective cohort study included patients who received a permanent epicardial PM at ≤12 months between 1/1/2015- 8/1/2021. The primary outcome was time to DRAE, defined as a composite of: (1) lead fracture or insulation break; (2) lead exit block; (3) coronary compression; or (4) surgical site infection. The secondary outcome was time to death or heart transplant. Time-to-event analysis was performed using a univariate and multivariate Cox proportional hazards regression model. 178 infants underwent PM implantation (109 postoperative heart block, 65 congenital heart block, and 4 symptomatic bradycardia) at a median age and weight of 93.5 days (range 0-365) and 4.5 kg (1.9-9.3). Median cohort follow-up time was 747 days (1-4559). DRAE occurred in 26 (15%) patients at a median 199.5 days (0-2673). Patients with DRAE were younger (median 15.5 days vs 106 days, p=0.002), smaller (3.6 kg vs 4.7 kg, p=0.03), had less frequent congenital heart disease (62% vs 81%, p=0.04), and had higher generator volume-to-weight ratios (2.9 cc/kg vs 2.3 cc/kg, p=-.02) compared to those without DRAE. The relationships of age, weight, and generator volume-to-weight ratio with DRAE were non-linear, with risk inflections observed at ≤90 days, <4.5 kg, and ≥2.5 cc/kg, respectively. Only age ≤90 days at PM implantation (OR 6.99, 95% CI 2.57-19.0, p<0.001) and female sex (OR 0.39, 95% 0.17-0.88, p=0.024) retained significance on multivariate modeling. Death/transplant occurred in 34 (19%) patients at a median 89.5 days (1-809) with only a pacing indication of symptomatic bradycardia (OR 5.37, 95% CI 1.63-17.70, p=0.006) demonstrating significance on multivariate analysis. Congenital heart disease (OR 1.62, 95% CI 0.63-4.19, p=0.32) was not associated with death/transplant. Permanent PM implantation in infants carries substantial risk of device-related morbidity, predominantly driven by patient age at PM implantation and sex. Sex-specific risk for DRAE requires further investigation. All-cause mortality is strikingly high in infants with permanent PMs and is independent of congenital heart disease.
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