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Observational Study
. 2021 Oct 1;6(10):1187-1195.
doi: 10.1001/jamacardio.2021.2621.

Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker

Jonathan P Piccini  1 , Mikhael El-Chami  2 , Kael Wherry  3 , George H Crossley  4 , Robert C Kowal  3 , Kurt Stromberg  3 , Colleen Longacre  3 , Jennifer Hinnenthal  3 , Lindsay Bockstedt  3
Affiliations
Observational Study

Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker

Jonathan P Piccini et al. JAMA Cardiol. .

Erratum in

  • Change to Open Access Status.
    [No authors listed] [No authors listed] JAMA Cardiol. 2021 Nov 1;6(11):1344. doi: 10.1001/jamacardio.2021.3756. JAMA Cardiol. 2021. PMID: 34495292 Free PMC article. No abstract available.

Abstract

Importance: The safety and efficacy of leadless VVI pacemakers have been demonstrated in multiple clinical trials, but the comparative performance of the device in a large, real-world population has not been examined.

Objective: To compare patient characteristics and complications among patients implanted with leadless VVI and transvenous VVI pacemakers.

Design, setting, participants: The Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (Micra CED) is a continuously enrolling observational cohort study evaluating complications, utilization, and outcomes of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted between March 9, 2017, and December 1, 2018, were identified and included. All Medicare patients implanted with leadless VVI and transvenous VVI pacemakers during the study period were enrolled. Patients with less than 12 months of continuous enrollment in Medicare prior to leadless VVI or transvenous VVI implant and with evidence of a prior cardiovascular implantable electronic device were excluded, leaving 5746 patients with leadless VVI pacemakers and 9662 patients with transvenous VVI pacemakers. Data were analyzed from May 2018 to April 2021.

Exposures: Medicare patients implanted with leadless VVI pacemakers or transvenous VVI pacemakers.

Main outcomes and measures: The main outcomes were acute (30-day) complications and 6-month complications.

Results: Of 15 408 patients, 6701 (43.5%) were female, and the mean (SD) age was 81.0 (8.7) years. Compared with patients with transvenous VVI pacemakers, patients with leadless VVI pacemakers were more likely to have end-stage kidney disease (690 [12.0%] vs 226 [2.3%]; P < .001) and a higher mean (SD) Charlson Comorbidity Index score (5.1 [3.4] vs 4.6 [3.0]; P < .001). The unadjusted acute complication rate was higher in patients with leadless VVI pacemakers relative to transvenous VVI pacemakers (484 of 5746 [8.4%] vs 707 of 9662 [7.3%]; P = .02). However, there was no significant difference in overall acute complication rates following adjustment for patient characteristics (7.7% vs 7.4%; risk difference, 0.3; 95% CI, -0.6 to 1.3; P = .49). Pericardial effusion and/or perforation within 30 days was significantly higher among patients with leadless VVI pacemakers compared with patients with transvenous VVI pacemakers in both unadjusted and adjusted models (unadjusted, 47 of 5746 [0.8%] vs 38 of 9662 [0.4%]; P < .001; adjusted, 0.8% vs 0.4%; risk difference, 0.4; 95% CI, 0.1 to 0.7; P = .004). Patients implanted with leadless VVI pacemakers had a lower rate of 6-month complications compared with patients implanted with transvenous VVI pacemakers (unadjusted hazard ratio, 0.84; 95% CI, 0.68-1.03; P = .10; adjusted hazard ratio, 0.77; 95% CI, 0.62-0.96; P = .02).

Conclusions and relevance: In this study, despite significant differences in patient characteristics, patients in whom a leadless pacemaker was implanted were observed to have higher rates of pericardial effusion and/or perforation but lower rates of other device-related complications and requirements for device revision at 6 months. Understanding the benefits and risks associated with leadless VVI pacemakers compared with transvenous VVI pacemakers can help clinicians and patients make informed treatment decisions.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Piccini is supported by grant R01HL128595 from the National Heart, Lung, and Blood Institute; has received grants for clinical research from Abbott Laboratories, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips; and serves as a consultant to Abbott Laboratories, AbbVie, AltaThera, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone Pharmaceuticals, MyoKardia, Sanofi, Electrophysiology Frontiers, Pfizer, Respicardia, Philips, and UptoDate. Dr El-Chami is a consultant for Medtronic, Boston Scientific, and Biotronik, and serves on the advisory boards for Medtronic and Biotronik. Drs Wherry, Kowal, Longacre, and Bockstedt, Mr Stromberg, and Ms Hinnenthal hold equity in Medtronic. Dr Crossley is a consultant for Medtronic and Boston Scientific, and serves on the speakers bureau for Medtronic and Spectranetics.

Figures

Figure 1.
Figure 1.. Cohort Formation Flowchart
Patient selection and exclusion criteria and the numbers of patients excluded/included at each step. CIED indicates cardiac implantable electronic device; TVPM, transvenous pacemaker.
Figure 2.
Figure 2.. Time-to-Event Plots for Complications, Device Revision, and Mortality Out to 6-Month Follow-up in Patients Treated With Leadless VVI vs Transvenous VVI Pacing
A, Hazard ratio (HR) and cumulative incidence function for 6-month complication based on the Fine-Gray competing risk model. B, HR and cumulative incidence function for 6-month device revision based on the Fine-Gray competing risk model. C, HR and patient mortality rates based on the Cox proportional hazards model. The comparisons of 6-month device revision and patient mortality were not significantly different between groups.
See this image and copyright information in PMC

Comment in

References

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