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

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.

Keywords: Adverse event; BioMonitor 2; Feasibility; Insertable cardiac monitor; Office procedure; Safety.

Conflict of interest statement

KA: Consultant honoraria from BIOTRONIK, Inc.; Research support from BioSense Webster. RW: Research support from Boston Scientific, Medtronic, Abbott, BIOTRONIK, Inc., and Biosense Webster; Consultant honoraria from Boston Scientific, BIOTRONIK, Inc., Biosense Webster, and Merit Medical; Advisory board for Boston Scientific and Biosense Webster. AY: Consulting honoraria from BIOTRONIK, Inc.. JMB, RN, MH, and TO: No conflicts of interest to declare. TA and CM: Employed by BIOTRONIK, Inc.. AKA: Consultant honoraria from St. Jude Medical/Abbott, Boston Scientific, and Medtronic; Research support from St. Jude Medical/Abbott, Boston Scientific, and BIOTRONIK, Inc.; Speaking fees from Boston Scientific.

Figures

Fig. 1

Flowchart of Patient Enrollment and Study Participation

Fig. 2

Standard Insertion Positions of the BioMonitor 2. Position A: 45°relative to the sternum over the fourth intercostal space. Position B: parallel to the sternum over the fourth intercostal space. Position C: perpendicular to the sternum, sub-mammary

Fig. 3

Long Term Amplitude and Noise Trends. The mean and 95% CI for long term (a) R-wave amplitude and (b) noise burden trends extrapolated from all study partcipants using BIOTRONIK Home Monitoring® data are presented