Abstract Body:
Background
Leadless pacemakers offer potential advantages over transvenous systems, including reduced device-related complications. However, national patterns of adoption, patient selection, and comparative in-hospital outcomes remain incompletely defined, particularly across hospital capability strata.
Methods
We performed a retrospective cohort study using the National Inpatient Sample. Adult hospitalizations undergoing pacemaker implantation were identified, with leadless pacemaker implantation as the exposure and transvenous pacemakers as the reference. The primary outcome was in-hospital mortality. Secondary outcomes included complications, organ support, and resource utilization. Survey-weighted multivariable logistic and generalized linear models were used, adjusting for demographics, Elixhauser comorbidity score, hospital characteristics, and calendar year (linear). Temporal trends were assessed using survey-weighted logistic regression.
Results
Among 100,747 hospitalizations, leadless pacemaker implantation was associated with higher in-hospital mortality (aOR 1.47, 95% CI 1.28–1.68, p 6.22e-8), vascular complications (aOR 1.87, 95% CI 1.49–2.35, p 6.33e-8), invasive ventilation (aOR 1.41, 95% CI 1.28–1.54, p 1.70e-13), and dialysis (aOR 1.66, 95% CI 1.44–1.90, p 1.22e-12). Resource utilization was greater, including 14.6% longer length of stay (95% CI 12.2%–17.0%, p 6.32e-34) and 29.0% higher total charges (95% CI 23.9%–34.3%, p 7.53e-30). Leadless implantation was associated with lower device complications (aOR 0.60, 95% CI 0.52–0.70, p 8.73e-11). No significant differences were observed for perforation/tamponade (aOR 1.01, p 0.913), hemopericardium (aOR 1.02, p 0.948), or ECMO (aOR 1.15, p 0.555).
Leadless use increased over time (OR 1.18 per year, 95% CI 1.16–1.20, p 3.05e-112), including in non-capable hospitals (OR 1.32, p 4.91e-154) and high-tier hospitals (OR 1.14, p 5.35e-15), but remained markedly lower in non-capable hospitals (OR 0.07, 95% CI 0.064–0.073, p <1e-300).
Conclusions
Leadless pacemaker implantation was associated with lower device complications (aOR 0.60) but higher mortality (aOR 1.47), greater procedural intensity, and increased healthcare utilization. Despite rapid adoption (OR 1.18 per year), substantial disparities across hospital capability persist, likely reflecting selection of higher-risk patients and differential access.