Author + information
- Received September 5, 2018
- Revision received December 13, 2018
- Accepted December 16, 2018
- Published online January 30, 2019.
- Mikhael F. El-Chami, MDa,∗ (, )
- Nicolas Clementy, MDb,
- Christophe Garweg, MDc,
- Razali Omar, MDd,
- Gabor Z. Duray, MDe,
- Charles C. Gornick, MDf,
- Francisco Leyva, MDg,
- Venkata Sagi, MDh,
- Jonathan P. Piccini, MDi,
- Kyoko Soejima, MDj,
- Kurt Stromberg, MSk and
- Paul R. Roberts, MDl
- aDivision of Cardiology, Section of Electrophysiology, Emory University Hospital, Atlanta, Georgia
- bCentre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours, France
- cUniversitaire Ziekenhuizen Leuven–Campus Gasthuisberg, Leuven, Belgium
- dCardiac Vascular Sentral, Kuala Lumpur, Malaysia
- eClinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary
- fMinneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota
- gAston Medical Research Institute, Aston Medical School, Aston University, Birmingham, United Kingdom
- hSouthern Heart Group, Jacksonville, Florida
- iDuke University Medical Center, Durham, North Carolina
- jKyorin University Hospital, Tokyo, Japan
- kMedtronic, Mounds View, Minnesota
- lUniversity Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom
- ↵∗Address for correspondence:
Dr. Mikhael El-Chami, Division of Cardiology-Section of Electrophysiology, Emory University, 550 Peachtree Street Northeast, Atlanta, Georgia 30308.
Objectives This study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation.
Background Leadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis.
Methods Patients on hemodialysis at the time of Micra implantation attempt (n = 201 of 2,819; 7%) from the Micra Transcatheter Pacing Study investigational device exemption trial, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post-Approval Registry were included in the analysis. Baseline characteristics, periprocedural outcomes, and intermediate-term follow-up were summarized.
Results Patients on hemodialysis at the time of Micra implantation attempt were on average 70.5 ± 13.5 years of age and 59.2% were male. The dialysis patients commonly had hypertension (80%), diabetes (61%), coronary artery disease (39%), and congestive heart failure (27%), and 72% had a condition that the implanting physician felt precluded the use of a transvenous pacemaker. Micra was successfully implanted in 197 patients (98.0%). Reasons for unsuccessful implantation included inadequate thresholds (n = 2) and pericardial effusion (n = 2). The median implantation time was 27 min (interquartile range: 20 to 39 min). There were 3 procedure-related deaths: 1 due to metabolic acidosis following a prolonged procedure duration in a patient undergoing concomitant atrioventricular nodal ablation and 2 deaths occurred in patients who needed surgical repair after perforation. Average follow-up was 6.2 months (range 0 to 26.7 months). No patients had a device-related infection or required device removal because of bacteremia.
Conclusions Leadless pacemakers represent an effective pacing option in this challenging patient population on chronic hemodialysis. The risk of infection appears low with an acceptable safety profile. (Micra Transcatheter Pacing Study; NCT02004873; Micra Transcatheter Pacing System Continued Access Study Protocol; NCT02488681; Micra Transcatheter Pacing System Post-Approval Registry; NCT02536118)
The Micra Transcatheter Pacing Study, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post Approval Registry are funded by Medtronic. Dr. El-Chami is a consultant for Medtronic and Boston Scientific. Dr. Clementy has received consulting fees from Medtronic. Dr. Garweg has received consulting fees from Medtronic and Biotronic. Dr. Omar has received honoraria for speaking engagements on behalf of the Speakers Bureaus of Boehringer Ingelheim, Boston Scientific, and Medtronic. Dr. Duray has received research grants from Boston Scientific, Biotronik, and Medtronic; has received consulting fees from Bayer/Schering Pharma, Biotronik, Boehringer Ingelheim, Medtronic, Abbott, and St. Jude Medical; and is a member of the Micra Study steering committee. Dr. Gornick owns stock in Medtronic. Dr. Leyva has received consulting fees from Medtronic, Boston Scientific, LivaNova, St. Jude Medical; and has received research grants from Boston Scientific, LivaNova, Medtronic, Abbott, Microport, and St. Jude Medical. Dr. Piccini has received consulting fees from ARCA Biopharma, Allergan, Biotronik, Boston Scientific, Gilead, Johnson & Johnson, Medtronic, Philips, Sanofi, GlaxoSmithKline, and Motif Bio. Dr. Soejima has received funding from Medtronic. Mr. Stromberg is an employee of and owns stock in Medtronic. Dr. Roberts has received consulting fees from Boston Scientific and Medtronic. Dr. Sagi has reported that he has no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received September 5, 2018.
- Revision received December 13, 2018.
- Accepted December 16, 2018.
- 2019 American College of Cardiology Foundation
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