Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups. Issue 3 (9th February 2023)

• Record Type: Journal Article
• Authors: Boveda, Serge; Higuera, Lucas; Longacre, Colleen; Wolff, Claudia; Wherry, Kael; Stromberg, Kurt; El-Chami, Mikhael F
• Is Part Of: Europace. Volume 25:Issue 3(2023)
• Page Start: 1041
• Page End: 1050
• Publication Date: 2023-02-09
• Subjects: Leadless pacemakers -- Transvenous pacemakers -- System reintervention -- Complications -- High-risk patients; Arrhythmia -- Treatment -- Periodicals; Cardiac pacing -- Periodicals; Catheter ablation -- Periodicals; Heart -- Physiology -- Periodicals; Electrophysiology -- Periodicals; 617.4120645
• DOI: 10.1093/europace/euad016
• Languages: English
• ISSNs: 1099-5129

Abstract

Abstract: Aims: 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 and results: This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study 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 Registration: ClinicalTrials.gov ID NCT03039712 Graphical Abstract: Graphical Abstract