BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment:...

Area of Science:

• Cardiology
• Medical Devices
• Clinical Procedures

Background:

• Insertable cardiac monitors (ICMs) are crucial for diagnosing arrhythmias.
• Traditionally, ICM insertions occurred in hospitals, but recent updates allow office-based reimbursement.
• Limited data exists on the resources and processes for in-office ICM insertions.

Purpose of the Study:

• To evaluate the safety and feasibility of in-office insertion of the BioMonitor 2 ICM.
• To understand the necessary in-office procedures, including patient selection, pre-insertion protocols, and resource requirements.

Main Methods:

• Prospective enrollment of patients indicated for a rhythm monitor.
• All patients underwent BioMonitor 2 insertion in an office setting.
• Data collection included adverse events, device performance, site preparation, and resource utilization.

Main Results:

• Successful insertion in 77 out of 82 enrolled patients across six sites.
• Procedure averaged 35 minutes in an office room, with an 8.4-minute insertion time, requiring a surgeon and two staff.
• Device performance showed high R-wave amplitude and low noise burden (2.7%), with no procedure-related complications.

Conclusions:

• In-office BioMonitor 2 insertion is a safe and feasible procedure.
• The device demonstrated excellent performance in the office setting.
• Findings support the transition of cardiac monitor insertions to office-based locations.