Risk factors associated with clinically relevant pericardial effusion after primary cardiac implantable electronic device implantation

Introduction: Pericardial effusion, a known complication to implantation of cardiac implantable electronic devices (CIED), may cause life-threatening cardiac tamponade. Limited knowledge is available about risk factors for clinically relevant procedural pericardial effusion. The aim is to identify the patient- and procedure-related risk factors associated with clinically relevant procedural pericardial effusion. Method: A nationwide observational cohort study based on data on 55 121 patients from the Danish Pacemaker Register between 2000 and 2018. We defined a clinically relevant procedural pericardial effusion related to the implantation if it occurred within 90 days after the primary CIED-procedure. Prespecified risk factors were analysed by multivariable logistic regression models to estimate the association with pericardial effusion. Results: There were 115 (0.21%) patients diagnosed with clinically relevant procedural pericardial effusion, with a median age of 75 years and 38.3% were females. Of these, 80.9% lead to a subsequent pericardiocentesis procedure. In adjusted logistic regression analysis, an increased risk of clinically relevant pericardial effusion was associated with female sex (OR:1.49 [95%CI: 1.03-2.16]), heart failure (OR:1.54 [95%CI: 1.06-2.23]), previous cardiac surgery (OR:1.63 [95%CI: 1.05-2.55]), CRT-device (OR:2.05 [95%CI: 1.23-3.41]), tertiary-centres (OR:1.8 [95%CI: 1.18-2.73]), increased procedural volume per year (>1000) (OR:1.85 [95%CI: 1.03-3.30]), indication of device-implantation (atrioventricular block) (OR:2.37 [95CI: 1.45-3.87]), and increasing number of leads implanted (two leads (OR:2.39 [95%CI: 1.43-4.00]), three leads (OR:4.77 [95%CI: 2.50-9.10])). Conclusion: Clinically relevant procedural pericardial effusion is a rare complication after CIED-implantation in Denmark. This study reveals important patient- and procedure-related risk factors associated with clinically relevant procedural pericardial effusion.