Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

TLDR

Complications after cardiac implantable electronic device treatment are associated with increased morbidity, healthcare costs, and possibly mortality. The study aims to quantify the incidence of complications and identify patient- and procedure-related risk factors in a nationwide Danish cohort. A population-based cohort of 5,918 patients who underwent CIED procedures from May 2010 to April 2011 was examined through chart review and registry data, with adjusted risk ratios calculated using binary regression. Nine point five percent of patients experienced at least one complication, with higher risk in females, underweight individuals, low-volume centers, dual‑chamber ICD or CRT‑D recipients, those undergoing upgrades or revisions, low-volume operators, and emergency procedures, indicating that complications are more frequent than generally acknowledged and that identified predictors can inform patient care and system planning.

Abstract

Aims Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality. Methods and results Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1-1.6), underweight (aRR 1.5; 1.1-2.3), implanted in a centre with an annual volume <750 procedures (0-249 procedures: aRR 1.6; 1.1-2.2, 250-499: aRR 2.0; 1.6-2.7, 500-749: aRR 1.5; 1.2-1.8), received a dual-chamber ICD (aRR 2.0; 1.4-2.7) or CRT-D (aRR 2.6; 1.9-3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0-1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4-2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0-2.3). Conclusion CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment.