Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups

Abstract

This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications. Methods This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study and results were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4–5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [malignancy, HR 0.68 (0.48–0.95); diabetes, HR 0.69 (0.53–0.89); TVD, HR 0.60 (0.44–0.82); COPD, HR 0.73 (0.55–0.98)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37–0.89); TVD, HR 0.46 (0.28–0.76); COPD, HR 0.51 (0.29–0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32–0.83); diabetes, HR 0.52 (0.35–0.77); TVD, HR 0.44 (0.28–0.70); COPD, HR 0.55 (0.34–0.89)] had lower rates of the combined outcome. Conclusion In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups. Trial ClinicalTrials.gov ID NCT03039712 Registration