Volume-outcome analysis of in-hospital complications after cardiac implantable electronic device implantation: a 250 000-case study‡.

AIMS: Although implantation volume of cardiac implantable electronic device (CIED) is widely considered a prognostic factor, Germany continues to show a wide distribution of hospitals performing CIED procedures, with annual volumes ranging from fewer than 10 to over 500 cases. Using a new statistical volume-outcome model, we examined the existence and shape of the relationship between complication rates and hospital volume. METHODS AND RESULTS: The analysis is based on data from all first inpatient CIED implantations performed between 1 January 2010 and 31 December 2020, in hospitals across North Rhine-Westphalia. All peri- and post-operative complications documented in mandatory quality assurance were included. A possible association between implantation volume and quality was assessed using a flexible generalized additive mixed model. Out of 249 118 cases, the overall complication rate was 2.4%, with lead-related issues being the most common (1.5%). Forest plot analysis identified American Society of Anaesthesiologists Class 4-5, New York Heart Association Class IV, subclavian vein access, and dual-chamber pacemaker systems as the strongest predictors of complications. Volume-outcome analysis revealed a significant association between implantation volume and complications, particularly among pacemaker patients [P < 0.001, area under the curve (AUC) 0.7], and showed a relevant reduction in hospital stays and healthcare costs. Modelling suggested that a 50-case annual cut-off could prevent ∼16% of complications, requiring ∼16% of patients to be redirected to other hospitals. CONCLUSION: This study demonstrates a statistically significant association between implantation volume and complication rates across all CIED procedures, with the effect being particularly pronounced among pacemaker patients.