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      Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry

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          Abstract

          Introduction

          Leadless pacemakers may provide a safe and attractive pacing option to patients with cardiac implantable electronic device (CIED) infection. We describe the characteristics and outcomes of patients with a recent CIED infection undergoing Micra implant attempt.

          Methods and Results

          Patients with prior CIED infection and device explant with Micra implant within 30 days, were identified from the Micra post approval registry. Procedure characteristics and outcomes were summarized. A total of 105 patients with prior CIED infection underwent Micra implant attempt ≤30 days from prior system explant (84 [80%] pacemakers and 13 [12%] ICD/CRT‐D). All system components were explanted in 93% of patients and explant occurred a median of 6 days before Micra implant, with 37% occurring on the day of Micra implant. Micra was successfully implanted in 99% patients, mean follow‐up duration was 8.5 ± 7.1 months (range 0‐28.5). The majority of patients (91%) received IV antibiotics preimplant, while 42% of patients received IV antibiotics postprocedure. The median length of hospitalization following Micra implant was 2 days (IQR, 1‐7). During follow‐up, two patients died from sepsis and four patients required system upgrade, of which two patients received Micra to provide temporary pacing support. There were no Micra devices explanted due to infection.

          Conclusion

          Implantation of the Micra transcatheter pacemaker is safe and feasible in patients with a recent CIED infection. No recurrent infections that required Micra device removal were seen. Leadless pacemakers appear to be a safe pacing alternative for patients with CIED infection who undergo extraction.

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          Most cited references12

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          2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction

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            Continued rise in rates of cardiovascular implantable electronic device infections in the United States: temporal trends and causative insights.

            Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted, based on data available through 2003. We investigated recent trends and possible causes of the increasing numbers of CIED infections. We analyzed the occurrence of CIED infections and the associated changes in characteristics of CIED recipients, using the National Hospital Discharge Survey database from 1996 through 2006. The number of CIED implantations continued to increase after 2003 from 199,516 in 2004 to 222,940 in 2006, representing a 12% increment. In the same period, the number of CIED infections increased from 8,273 in 2004 to 12,979 in 2006, representing a 57% increment. From 1996 to 2006, comorbid illnesses in recipients of new CIED devices became more prevalent with an increasing percentage of patients with end-organ failures (6.5% in 1996 vs 8.0% in 2006, P < 0.001) and diabetes mellitus (14.5% in 1996 vs 16.5% in 2006, P = 0.005). The proportion of Caucasian recipients also decreased (65.6% in 1996 vs 57.6% in 2006, P < 0.001). During that same period, the number of implanted cardiac resynchronization devices increased dramatically while the age of CIED recipients did not change. The number of patients with CIED-related infections in the United States continues to increase out of proportion to the increase in implantation rates. Possible causes for this on-going epidemic include sicker patients with varying racial backgrounds, and more complex procedures. These insights may help improve our ability to best select patients for CIED implantation in "real-life" settings. (PACE 2010; 414-419).
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              A Leadless Pacemaker in the Real-World Setting: The Micra Transcatheter Pacing System Post-Approval Registry.

              First-in-man studies of leadless pacemakers have demonstrated high implant success rates, and safety and efficacy objectives were achieved. Outside of the investigational setting, there are particular concerns over cardiac effusion/perforation, device dislodgement, infection, telemetry, and battery issues.
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                Author and article information

                Contributors
                melcham@emory.edu
                Journal
                J Cardiovasc Electrophysiol
                J. Cardiovasc. Electrophysiol
                10.1111/(ISSN)1540-8167
                JCE
                Journal of Cardiovascular Electrophysiology
                John Wiley and Sons Inc. (Hoboken )
                1045-3873
                1540-8167
                28 January 2019
                April 2019
                : 30
                : 4 ( doiID: 10.1111/jce.2019.30.issue-4 )
                : 569-574
                Affiliations
                [ 1 ] Division of Cardiology Section of Electrophysiology, Emory University Atlanta Georgia
                [ 2 ] Department of Cardiology Odense University Hospital Odense Denmark
                [ 3 ] Division of Cardiology, Central Manchester University Hospitals, NHS Foundation Trust Manchester United Kingdom
                [ 4 ] Department of Heart Disease Haukeland University Hospital
                [ 5 ] Department of Clinical Science University of Bergen Bergen Norway
                [ 6 ] Division of Cardiology, University Clinical Hospital of Santiago de Compostela, Santiago de Compostela Spain
                [ 7 ] Division of Cardiology, Service de cardiologie, CHU de Brest Brest France
                [ 8 ] Division of Cardiology, University of Montpellier, CHRU Montpellier, PHYMEDEXP, CNRS, INSERM Montpellier France
                [ 9 ] Division of Cardiology, University of Alabama at Birmingham Birmingham Alabama
                [ 10 ] Division of Cardiology, University Hospital Southampton NHS Foundation Trust Southampton United Kingdom
                [ 11 ] Division of Cardiology, Kyorin University Hospital Tokyo Japan
                [ 12 ] Medtronic, plc Mounds View Minnesota
                [ 13 ] Division of Cardiology, Duke University Medical Center and Duke Clinical Research Institute Durham North Carolina
                Author notes
                [*] [* ] Correspondence Mikhael F. El‐Chami, MD, Division of Cardiology, Section of Electrophysiology, Emory University, 550 Peachtree Street NE, Atlanta 30308, Georgia. Email: melcham@ 123456emory.edu

                Author information
                http://orcid.org/0000-0003-4978-7177
                http://orcid.org/0000-0002-0685-4563
                http://orcid.org/0000-0003-0772-2404
                Article
                JCE13851
                10.1111/jce.13851
                6850680
                30661279
                410c3db2-0ee3-4b45-8e84-a247a8e6059e
                © 2019 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 03 December 2018
                : 20 December 2018
                : 09 January 2019
                Page count
                Figures: 1, Tables: 3, Pages: 6, Words: 3906
                Funding
                Funded by: Medtronic , open-funder-registry 10.13039/100004374;
                Award ID: This manuscript is from the Micra post approval re
                Categories
                Original Article
                Original Articles
                Clinical
                Custom metadata
                2.0
                April 2019
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.1 mode:remove_FC converted:12.11.2019

                Cardiovascular Medicine
                cardiac implantable electronic device infection,leadless pacemakers,micra,permanent pacing,transcatheter pacemaker

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