A Leadless Ventricular Pacemaker Providing Atrioventricular Synchronous Pacing in the Real-World Setting: 12-Month Results from the Micra AV Post-Approval Registry.

Garweg, Christophe; Chinitz, Jason S; Marijon, Eloi; Haeberlin, Andreas; Winter, Stefan; Iacopino, Saverio; Curnis, Antonio; Breitenstein, Alexander; Hussin, Azlan; Mela, Theofanie; El-Chami, Mikhael F; Roberts, Paul R; Piccini, Jonathan P; Stromberg, Kurt; Fagan, Dedra H; Clementy, Nicolas (2024). A Leadless Ventricular Pacemaker Providing Atrioventricular Synchronous Pacing in the Real-World Setting: 12-Month Results from the Micra AV Post-Approval Registry. Heart rhythm, 21(10), pp. 1939-1947. Elsevier 10.1016/j.hrthm.2024.06.008

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BACKGROUND

Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction.

OBJECTIVES

To report performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12-months.

METHODS

The Micra AV PAR is a prospective single-arm observational registry designed to assess safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12-months were summarized and compared to a historical cohort of 2,667 transvenous dual-chamber pacing patients.

RESULTS

The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 vs. 71.1 years, P<0.0001) with a higher incidence of renal disease (22.3% vs. 9.8%, P<0.0001) compared to transvenous dual-chamber patients. Through 12-months, the major complication rate was 3.7% in Micra AV patients compared to 8.8% in transvenous dual-chamber patients (hazard ratio [HR]: 0.42, 95% confidence interval [CI]: 0.28-0.61; P<0.001). The system revision rate was 1.5% in Micra AV patients compared to 5.5% for transvenous dual-chamber patients (HR: 0.25, 95% CI: 0.13-0.47; P<0.001); this reduction was largely driven by the absence of lead dislodgements requiring revision. Median AV synchrony index was 79.4% (IQR:65.2%-86.4%) among patients paced >90%.

CONCLUSIONS

The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple co-morbidities, with a significantly lower rate of complications and system revisions through 12-months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Häberlin, Andreas David Heinrich

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1556-3871

Publisher:

Elsevier

Language:

English

Submitter:

Pubmed Import

Date Deposited:

20 Jun 2024 10:00

Last Modified:

04 Oct 2024 00:13

Publisher DOI:

10.1016/j.hrthm.2024.06.008

PubMed ID:

38878939

Uncontrolled Keywords:

atrioventricular block atrioventricular synchronous pacing bradycardia clinical trial leadless pacing

BORIS DOI:

10.48350/197866

URI:

https://boris.unibe.ch/id/eprint/197866

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