Pericardial Effusion Requiring Intervention in Patients Undergoing Leadless Pacemaker Implantation: A Real-World Analysis from the National Inpatient Sample Database

Background Pericardial effusion requiring percutaneous or surgical based intervention remains an important complication of a leadless pacemaker implantation. Objective To determine real-world prevalence, risk factors and associated outcomes of pericardial effusion requiring intervention in leadless pacemaker implantations. Methods National Inpatient Sample and International Classification of Diseases, Tenth Revision codes were used to identify patients who underwent leadless pacemaker implantations during the years 2016−2020. The outcomes assessed in our study included prevalence of pericardial effusion requiring intervention, other procedural complications and in-hospital outcomes. Predictors of pericardial effusion were also analyzed. Result Pericardial effusion requiring intervention occurred in a total of 325 (1.1%) leadless pacemaker implantations. Patient-level characteristics that predicted development of a serious pericardial effusion included age > 75 years (OR 1.38, 95% CI 1.08-1.75), women (OR 2.03, 95% CI 1.62-2.55), coagulopathy (OR 1.50, 95% CI 1.12-1.99), chronic pulmonary disease (OR 1.36, 95% CI 1.07-1.74), chronic kidney disease (OR 1.53, 95% CI 1.22-1.94) and connective tissue disorders (OR 2.98, 95% CI 2.02-4.39). Pericardial effusion requiring intervention was independently associated with mortality (OR 5.66, 95% CI 4.24-7.56), prolonged length of stay (OR 1.36, 95% CI 1.07-1.73) and increased cost of hospitalization (OR 2.49, 95% CI 1.92-3.21) after leadless pacemaker implantation. Conclusion In a large, contemporary, real-world cohort of leadless pacemaker implantations in the US, the prevalence of pericardial effusion requiring intervention was 1.1%. Certain important patient-level characteristics predicted development of a significant pericardial effusion and such effusions were associated with adverse outcomes after leadless pacemaker implantations.