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

Publication ,  Journal Article
Piccini, JP; El-Chami, M; Wherry, K; Crossley, GH; Kowal, RC; Stromberg, K; Longacre, C; Hinnenthal, J; Bockstedt, L
Published in: JAMA Cardiol
October 1, 2021

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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Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

October 1, 2021

Volume

6

Issue

10

Start / End Page

1187 / 1195

Location

United States

Related Subject Headings

  • United States
  • Time Factors
  • Survival Rate
  • Retrospective Studies
  • Pacemaker, Artificial
  • Male
  • Humans
  • Heart Ventricles
  • Follow-Up Studies
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Piccini, J. P., El-Chami, M., Wherry, K., Crossley, G. H., Kowal, R. C., Stromberg, K., … Bockstedt, L. (2021). Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker. JAMA Cardiol, 6(10), 1187–1195. https://doi.org/10.1001/jamacardio.2021.2621
Piccini, Jonathan P., Mikhael El-Chami, Kael Wherry, George H. Crossley, Robert C. Kowal, Kurt Stromberg, Colleen Longacre, Jennifer Hinnenthal, and Lindsay Bockstedt. “Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker.JAMA Cardiol 6, no. 10 (October 1, 2021): 1187–95. https://doi.org/10.1001/jamacardio.2021.2621.
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 Oct 1;6(10):1187–95.
Piccini, Jonathan P., et al. “Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker.JAMA Cardiol, vol. 6, no. 10, Oct. 2021, pp. 1187–95. Pubmed, doi:10.1001/jamacardio.2021.2621.
Piccini JP, El-Chami M, Wherry K, Crossley GH, Kowal RC, Stromberg K, Longacre C, Hinnenthal J, Bockstedt L. Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker. JAMA Cardiol. 2021 Oct 1;6(10):1187–1195.

Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

October 1, 2021

Volume

6

Issue

10

Start / End Page

1187 / 1195

Location

United States

Related Subject Headings

  • United States
  • Time Factors
  • Survival Rate
  • Retrospective Studies
  • Pacemaker, Artificial
  • Male
  • Humans
  • Heart Ventricles
  • Follow-Up Studies
  • Female