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Implanting insertable cardiac monitors (ICMs) in a hospital holding area is feasible and safe. This study found no procedure-related adverse events in most patients when using a standardized protocol, demonstrating a viable alternative to traditional settings.

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Area of Science:

  • Cardiology
  • Medical Devices
  • Clinical Trials

Background:

  • Insertable cardiac monitors (ICMs) can be implanted outside traditional operating rooms.
  • Research is exploring standardized, alternative locations for ICM implantation.
  • Feasibility studies aim to move beyond operating rooms or cardiac labs for ICM procedures.

Purpose of the Study:

  • To assess the feasibility of implanting ICMs in a hospital holding area.
  • To evaluate procedure-related adverse events associated with ICM implantation in a non-traditional setting.
  • To observe patient outcomes following ICM implantation in a standardized holding area.

Main Methods:

  • Prospective, non-randomized, single-center post-market clinical trial.
  • Medtronic Reveal LINQ ICM implanted in a hospital operating room holding area.
  • Patients followed for 90 days to monitor for adverse events.

Main Results:

  • Twenty patients underwent ICM implantation in a holding room.
  • One patient required ICM removal and biventricular ICD insertion due to diagnosis.
  • Eighteen patients experienced no serious complications or procedure-related adverse events.

Conclusions:

  • ICM implantation in a holding area is feasible following a standardized protocol.
  • Adherence to sterile technique is crucial for safe implantation in alternative locations.
  • No procedure-related adverse events were observed in the majority of patients.