Risk of pericardiac effusion after cardiac implantable electronic device implantation a nationwide study

Funding Acknowledgements Type of funding sources: None. Background Procedural pericardiac effusion (PE) is considered a major complication to implantation of cardiac implantable electronic devices (CIED), including permanent pacemakers (PM), cardiac resynchronization therapy devices with defibrillators (CRT-D) or without (CRT-P), and implantable cardioverter defibrillators (ICD), as it can cause life threatening cardiac tamponade. Very little is known about risk factors for procedural PE. Aim To identify the patient- and procedure related risk factors associated with clinically relevant procedural PE. Methods & Results This is a nationwide retrospective observational cohort study based on data on 51.599 patients from the Danish Pacemaker Register. Included were all Danish patients who received their first PM, CRT or ICD from 2000 – 2018. Procedural PE was defined related to the invasive procedure if it occurred within 1 months after the invasive procedure and no cancer was diagnosed before the procedure. Pre-specified risk factors, including sex, age, year, implantation center-type and device type were analyzed by multivariable logistic regression models to estimate the association with PE. A total of 78 (0.2%) patients were diagnosed with procedural PE, with a median age of 73 years and 43% were females. In adjusted logistic regression analysis age > 70, heart failure [aOR 1.64 (1.01;2.67)], ischemic heart disease [aOR 1.84 (1.13;2.99)], direct oral anticoagulation [aOR 1.77 (1.13–2.77.)], amiodarone use [aOR 3.03 (1.75–5.22)], beta blocking agent [aOR 2.26 (1.23 –4.14)], university hospitals [aOR 2.59 (1.18 –5.67)] and PM implantation [aOR 3.38 (1.77;6.45)], were associated with PE. Conclusion Procedural PE is a rare complication after CIED implantation in Denmark. Importantly most of the risk factors for PE are modifiable. Optimizing the modifiable risk factors may reduce the risk of complication.