Lead complications after cardiac surgery in danish patients with cardiac implantable electronic devices: a nationwide nested case-control study

Abstract

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Karen Elise Jensen’s Foundation Manipulation of the heart during cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) may result in lead damage or -displacement, but whether cardiac surgery truly infers an excess risk of lead failure is not known. The objective of this study was to examine risk of lead complications as a result of cardiac surgery in CIED patients. We conducted a nationwide nested case-control study. Our source population comprised all patients ≥18 of age who underwent a de novo CIED implantation in Denmark between 1998 and 2017. Only patients who were alive and event-free at six months after implantation were eligible for inclusion in the case-control study. Cases were defined as incident lead complications resulting in a revision procedure, and were matched 1:30 to controls using risk set sampling. We used conditional logistic regression to estimate incidence rate ratios (IRRs) for the association between cardiac surgery and lead complications. Our population consisted of 61,869 de novo CIED patient. We identified 1324 incident cases of lead complications and 39,708 time-matched controls. 1036 cases and controls underwent cardiac surgery during follow-up; 61 cases (4.5%) and 975 controls (2.5%). Risk of lead-related reoperation was highest within the first six months of cardiac surgery (IRR 10.1, 95% CI 6.5-15.6, adjusted IRR 11.0, 95% CI 7-17.4). At one year, we observed no association between cardiac surgery and lead complications (IRR: 1.0, 95% CI 0.7-1.5 and adjusted IRR: 1.1, 95% CI 0.7-1.6). Cardiac surgery was associated with a substantial risk of lead complications in patients with de novo CIEDs. Manipulation of the heart including cannulation of the right atrium is a likely explanation for the subsequent lead problems.