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

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.

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.

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.