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Observational Study
. 2024 Nov 1;26(11):euae273.
doi: 10.1093/europace/euae273.

Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study

Mikhael F El-Chami  1 , Lucas Higuera  2 , Colleen Longacre  2 , Kurt Stromberg  2 , George Crossley  3 , Jonathan P Piccini  4
Affiliations
Observational Study

Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study

Mikhael F El-Chami et al. Europace. .

Abstract

Aims: Leadless pacing is a safe and effective alternative to transvenous pacing for bradycardia. Micra AV is a leadless, single-device solution that provides atrioventricular synchronous ventricular pacing therapy. Early results from the Micra AV CED study showed reductions in short-term complications associated with the Micra AV leadless pacemaker among US Medicare patients. The objective of this study is to compare chronic complications, re-interventions, and all-cause mortality at 2 years between patients implanted with a Micra AV leadless pacemaker and a traditional dual-chamber transvenous (DC-TV) pacemaker.

Methods and results: Patients implanted with a Micra AV leadless pacemaker (n = 7552) or a DC-TV pacemaker (n = 110 558) in 2020 and 2021 were identified using device registration-linked Medicare administrative claims data. Competing risk models compared the unadjusted and propensity score overlap weight-adjusted complication, re-intervention, and all-cause mortality rates of Micra AV and DC-TV patients at 2 years. Micra AV patients had significantly more comorbidities (end-stage renal disease 14.9 vs. 2.0%, P < 0.0001; renal dysfunction 47.9 vs. 34.2%, P < 0.0001; diabetes 46.2 vs. 38.3%, P < 0.001; congestive heart failure 41.4 vs. 30.6%, P < 0.0001). Two years post-implant, Micra AV patients had lower complication rates [adjusted 5.3 vs. 9.6%, hazard ratio (HR): 0.54, 95% confidence interval (CI) 0.49-0.61, P < 0.0001] and lower re-intervention rates (adjusted 3.5 vs. 5.6%, HR: 0.62, 95% CI 0.54-0.72, P < 0.0001) than DC-TV patients. Upgrades to cardiac resynchronization therapy were low in both groups (adjusted 1.6 vs. 1.7%, P = 0.40), as were Micra AV upgrades to a dual-chamber system (adjusted 1.4%). All-cause mortality rates remained higher in Micra AV than in DC-TV patients (unadjusted HR: 2.48, 95% CI 2.35-2.62, P < 0.0001; adjusted HR: 1.53, 95% CI 1.44-1.62, P < 0.0001).

Conclusion: Patients implanted with Micra AV had lower complications and re-intervention rates at 2 years than patients implanted with a traditional DC-TV pacemaker. All-cause mortality remained higher in Micra AV patients, likely due to their higher comorbidity burden and other differences in baseline characteristics.

Clinical trial registration: ClinicalTrials.gov ID NCT04235491.

Keywords: Complications; Leadless pacemakers; Survival; System re-intervention; Transvenous pacemakers.

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Conflict of interest statement

Conflict of interest: M.F.E.-C. consults for Medtronic and Boston Scientific. G.C. is supported by CTSA award no. UL1 TR002243 from the National Center for Advancing Translational Sciences and consults for Medtronic and Boston Scientific and on the Speakers Bureau for Medtronic and Spectranetics. J.P.P. is supported by R01HL128595 from the National Heart, Lung, and Blood Institute, receives research grants from Abbott, American Heart Association, Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips, and consults for Abbott, AbbVie, Ablacon, AltaThera, ARCA Biopharma, Biotronik, Boston Scientific, Bristol Myers Squibb, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, Itamar, Pfizer, Sanofi, Philips, ResMed, and Up-to-Date. L.H., C.L., and K.S. are Medtronic employees and minority stockholders.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Cumulative incidence functions of chronic complications and device-related re-interventions at 2 years in Micra AV vs. dual-chamber transvenous patients. Adjusted HRs, 95% CIs, and cumulative incidence functions for 2-year chronic complications (A) and device-related re-interventions (B) based on Fine–Gray competing risk models. CI, confidence interval; DC, dual-chamber; HR, hazard ratio.
Figure 2
Figure 2
Cumulative incidence functions of all-cause mortality at 2 years in Micra AV vs. dual-chamber transvenous patients. Unadjusted (A) and adjusted (B) HRs, 95% CIs, and cumulative incidence functions for 2-year all-cause mortality based on Fine–Gray competing risk models. CI, confidence interval; DC, dual-chamber; HR, hazard ratio.
See this image and copyright information in PMC

References

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    1. El-Chami MF, Bockstedt L, Longacre C, Higuera L, Stromberg K, Crossley G et al. Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. Eur Heart J 2021;43:1207–15. - PMC - PubMed
    1. Piccini JP, El-Chami M, Wherry K, Crossley GH, Kowal RC, Stromberg K et al. Contemporaneous comparison of outcomes among patients implanted with a leadless vs transvenous single-chamber ventricular pacemaker. JAMA Cardiol 2021;6:1187–95. - PMC - PubMed
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