BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study

• Main Authors: Khaled Awad, Raul Weiss, Asim Yunus, Jon M. Bittrick, Rajasekhar Nekkanti, Mahmoud Houmsse, Toshimasa Okabe, Teagan Adamson, Crystal Miller, Abdul K. Alawwa
• Format: Article
• Language: English
• Published: BMC 2020-04-01
• Series: BMC Cardiovascular Disorders
• Subjects: Insertable cardiac monitor; Office procedure; Safety; Feasibility; BioMonitor 2; Adverse event
• Online Access: http://link.springer.com/article/10.1186/s12872-020-01439-8

Abstract Background Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of in-office insertion of the BioMonitor 2 and better understand in-office procedures, including patient selection, pre-insertion protocols, resource availability, and staff support. Methods Patients meeting an indication for a rhythm monitor were prospectively enrolled into this single-arm, non-randomized trial. All patients underwent insertion in an office setting. Two follow-up visits at days 7 and 90 were required. Information on adverse events, device performance, office site preparations, and resource utilization were collected. Results Eighty-two patients were enrolled at six sites. Insertion was successful in all 77 patients with an attempt. Oral anticoagulation was stopped in 20.8% of patients and continued through insertion in 23.4%, while prophylactic antibiotics were infrequently utilized (37.7% of study participants). On average, the procedure required a surgeon plus two support staff and 35 min in an office room to complete the 8.4 min insertion procedure. The mean R-wave amplitude was 0.77 mV at insertion and 0.67 mV at 90-days with low noise burden (2.7%). There were no procedure related complications. Two adverse events were reported (event rate 2.7% [95% CI 0.3, 9.5%]). Conclusions In-office insertion of the BioMonitor 2 is safe and feasible. Devices performed well with high R-wave amplitudes and low noise burden. These results further support shifting cardiac monitor insertions to office-based locations. Trial registration clinicaltrials.gov, NCT02756338 . Registered 29 April 2016.