To retrieve, or not to retrieve: System revisions with the Micra transcatheter pacemaker
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
PubMed
28713024
DOI
10.1016/j.hrthm.2017.07.015
PII: S1547-5271(17)30857-3
Knihovny.cz E-zdroje
- Klíčová slova
- Leadless pacemaker, Pacemaker, Pacemaker revision, Retrievals, Transcatheter pacemaker,
- MeSH
- časové faktory MeSH
- design vybavení MeSH
- dospělí MeSH
- kardiostimulátor škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- miniaturizace MeSH
- míra přežití trendy MeSH
- následné studie MeSH
- odstranění implantátu přístrojové vybavení MeSH
- prospektivní studie MeSH
- rozhodování * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční arytmie mortalita terapie MeSH
- srdeční katétry * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- Geografické názvy
- Spojené státy americké epidemiologie MeSH
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.
Emory University Hospital Atlanta Georgia
Hôpital Cardiologique du Haut Lévêque CHU Bordeaux Université Bordeaux IHU LIRYC Bordeaux France
Medtronic plc Mounds View Minnesota
Michigan Heart Ypsilanti Michigan
Na Homolce Hospital Prague Czech Republic
Section of Cardiovascular Medicine Yale University School of Medicine New Haven Connecticut
St Luke's Mid American Heart Institute Kansas City Missouri
The Ohio State University Wexner Medical Center Columbus Ohio
Citace poskytuje Crossref.org
Transcatheter non-acute retrieval of the tine-based leadless ventricular pacemaker
Retrieval and replacement feasibility of 7-year-old implanted leadless pacemaker with tines fixation
