title: Implant evaluation of an insertable cardiac monitor outside the electrophysiology lab setting.
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.
  
  
  CONCLUSIONS
  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.
authors: South Texas Heartbeat, San Antonio, Texas, United States of America.
authors: Roman
authors: R
authors: Pachulski
authors: James
authors: J
authors: Cockrell
authors: Hemant
authors: H
authors: Solomon
authors: Fang
authors: F
authors: Yang
authors: John
authors: J
authors: Rogers
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003710:Demography; D004567:Electrodes, Implanted; D055724:Electrophysiological Phenomena; D004594:Electrophysiology / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
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