Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. (11th November 2021)

• Record Type: Journal Article
• Authors: El-Chami, Mikhael F; Bockstedt, Lindsay; Longacre, Colleen; Higuera, Lucas; Stromberg, Kurt; Crossley, George; Kowal, Robert C; Piccini, Jonathan P
• Is Part Of: European heart journal. Volume 43:Number 12(2022)
• Page Start: 1207
• Page End: 1215
• Publication Date: 2021-11-11
• Subjects: Leadless pacemakers -- Transvenous pacemakers -- System reintervention -- Complications -- Survival; Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.12005
• DOI: 10.1093/eurheartj/ehab767
• Languages: English
• ISSNs: 0195-668X

Abstract

Abstract: Aims : Clinical trials have demonstrated the safety and efficacy of the Micra leadless VVI pacemaker; however, longer-term outcomes in a large, real-world population with a contemporaneous comparison to transvenous VVI pacemakers have not been examined. We compared reinterventions, chronic complications, and all-cause mortality at 2 years between leadless VVI and transvenous VVI implanted patients. Methods and results : The Micra Coverage with Evidence Development study is a continuously enrolling, observational, cohort study of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted with a leadless VVI pacemaker between March 9, 2017, and December 31, 2018, were identified using Medicare claims data linked to manufacturer device registration data ( n = 6219). All transvenous VVI patients from facilities with leadless VVI implants during the study period were obtained directly from Medicare claims ( n = 10 212). Cox models were used to compare 2-year outcomes between groups. Compared to transvenous VVI, patients with leadless VVI had more end-stage renal disease (12.0% vs. 2.3%) and a higher Charlson comorbidity index (5.1 vs. 4.6). Leadless VVI patients had significantly fewer reinterventions [adjusted hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.45–0.85, P = 0.003] and chronic complications (adjusted HR 0.69, 95% CI 0.60–0.81, P < 0.0001) compared with transvenous VVI patients. Adjusted all-cause mortality at 2 years was not different between the two groups (adjusted HR 0.97, 95% CI 0.91–1.04, P = 0.37). Conclusion : In a real-world study of US Medicare patients, the Micra leadless VVI pacemaker was associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of chronic complications compared with transvenous VVI pacing. There was no difference in adjusted all-cause mortality at 2 years. Graphical Abstract: