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Heart Rhythm. 2017 May;14(5):702-709. doi: 10.1016/j.hrthm.2017.01.035. Epub 2017 Feb 10.

Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study.

Author information

1
Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. Electronic address: gduray@yahoo.com.
2
Department of Cardiac Pacing and Electrophysiology, CHU/Université de Bordeaux, Pessac, France.
3
Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, Georgia.
4
CARE Hospitals, CARE Foundation, Hyderabad, India.
5
Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia.
6
Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.
7
Fuwai Hospital, Beijing, China.
8
Department of Cardiology, Kyorin University Hospital, Tokyo, Japan.
9
Department of Cardiology, Kepler University Hospital, Linz, Austria; Paracelsus Medical University Salzburg, Salzburg, Austria.
10
Medtronic, plc, Mounds View, Minnesota.
11
Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, Oklahoma.

Abstract

BACKGROUND:

Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months.

OBJECTIVE:

The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months.

METHODS:

The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates.

RESULTS:

The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years.

CONCLUSION:

Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.

KEYWORDS:

Leadless transcatheter pacing; Long-term performance; Transcatheter pacemaker

PMID:
28192207
DOI:
10.1016/j.hrthm.2017.01.035
[Indexed for MEDLINE]
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