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Heart Rhythm. 2017 Dec;14(12):1801-1806. doi: 10.1016/j.hrthm.2017.07.015. Epub 2017 Jul 14.

To retrieve, or not to retrieve: System revisions with the Micra transcatheter pacemaker.

Author information

1
Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: eric.grubman@yale.edu.
2
Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
3
Vanderbilt University Medical Center, Nashville, Tennessee.
4
St. Luke's Mid-American Heart Institute, Kansas City, Missouri.
5
The Ohio State University Wexner Medical Center, Columbus, Ohio.
6
Na Homolce Hospital, Prague, Czech Republic.
7
Michigan Heart, Ypsilanti, Michigan.
8
Emory University Hospital, Atlanta, Georgia.
9
Medtronic, plc, Mounds View, Minnesota.
10
Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, Oklahoma.

Abstract

BACKGROUND:

Early experience with leadless pacemakers has shown a low rate of complications. However, little is known about system revision in patients with these devices.

OBJECTIVE:

The purpose of this study was to describe the system revision experience with the Micra Transcatheter Pacing System (TPS).

METHODS:

Patients with implants from the Pre-market Micra Transcatheter Pacing Study and the Micra Transcatheter Pacing System Continued Access Study (N = 989) were analyzed and compared with 2667 patients with transvenous pacemakers (TVPs). Revisions included TPS retrieval/explant, repositioning, replacement, or electrical deactivation (with or without prior attempt at retrieval, generally followed by TVP implant) for any reason. Kaplan-Meier revision rates were calculated to account for varying follow-up duration and were compared using a Fine-Gray competing risk model.

RESULTS:

The actuarial rate for revision at 24 months postimplant was 1.4% for the TPS group (11 revisions in 10 patients), 75% (95% confidence interval 53%-87%; P < .001) lower than the 5.3% for the TVP group (123 revisions in 117 patients). TPS revisions occurred 5-430 days postimplant for elevated pacing thresholds, need for alternate therapy, pacemaker syndrome, and prosthetic valve endocarditis; none were due to device dislodgment or device-related infection. TPS was disabled and left in situ in 7 cases, 3 were retrieved percutaneously (range 9-406 days postimplant), and 1 was surgically removed during aortic valve surgery.

CONCLUSION:

The overall system revision rate for patients with TPS at 24 months was 1.4%, 75% lower than that for patients with TVPs. TPS was disabled and left in situ in 64% of revisions, and percutaneous retrieval was successful as late as 14 months postimplant.

KEYWORDS:

Leadless pacemaker; Pacemaker; Pacemaker revision; Retrievals; Transcatheter pacemaker

PMID:
28713024
DOI:
10.1016/j.hrthm.2017.07.015
[Indexed for MEDLINE]
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