Implant evaluation of an insertable cardiac monitor outside the electrophysiology lab setting

Roman Pachulski, James Cockrell, Hemant Solomon, Fang Yang, John Rogers, Roman Pachulski, James Cockrell, Hemant Solomon, Fang Yang, John Rogers

Abstract

Background: To date, insertable cardiac monitors (ICM) have been implanted in the hospital without critical evaluation of other potential settings. Providing alternatives to in-hospital insertion may increase access to ICM, decrease waiting times for patients awaiting diagnosis, and reduce hospital resources.

Methods: This was a prospective, non-randomized, clinical trial involving nine clinical sites throughout the United States designed to assess the feasibility of ICM implants in a non-hospital setting. Other than the Reveal® ICM, implant supplies and techniques were left to physician discretion in patients who met indications. Patients were followed up to 90 days post-implant. The primary objective was to characterize the number of procedure-related adverse events that required surgical intervention within 90 days.

Results: Sixty-five patients were implanted at nine out-of-hospital sites. The insertion procedure was well tolerated by all patients. There were no deaths, systemic infections or endocarditis. There were two (3%) procedure-related adverse events requiring device explant and four (6%) adverse events not requiring explant. ICM use led to 16 diagnoses (24.6%) with 9 patients proceeding to alternate cardiac device implants during the course of the 90-day follow up.

Conclusion: Out-of-hospital ICM insertion can be accomplished with comparable procedural safety and represents a reasonable alternative to the in-hospital setting. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT01168427.

Conflict of interest statement

Competing Interests: FY was an employee of Medtronic, Inc., whose company funded this study. JC is an employee of Cardiovascular Consultants PA. HS is an employee of Southeastern Heart and Vascular Center. In addition, Dr. James Cockrell acts on the Regional Advisory Panel and is a speaker for Medtronic. Dr. John Rogers is also a speaker and consultant for Medtronic as well as receives research support and acts as a speaker and consultant for St. Jude Medical. Reveal® ICM is a product of Medtronic. There are no further patents, products in development or marketed products to declare. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1. Patient Flow Chart: Enrolled patient…
Figure 1. Patient Flow Chart: Enrolled patient outcomes.

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