Implant Evaluation of an Insertable Cardiac Monitor Outside the Electrophysiology Lab Setting

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

PLOS ONE, 2013, vol. 8, issue 8, 1-6

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.

Date: 2013
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0071544

DOI: 10.1371/journal.pone.0071544

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