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.

Biodegradable, Biocompatible, and Implantable Multifunctional Sensing Platform for Cardiac Monitoring

“…In addition, the methods and materials used for fabrication are simple and cost-effective, providing an advantage over currently used devices that are complicated, expensive, and made of rigid materials with complex procedures. The fact that the suggested device is biodegradable and does not require additional surgeries for removal also lowers the procedure costs of operations. − The estimated costs of our device compared to current solutions in the market are summarized in Table S1.…”

Implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke: a systematic review and economic evaluation

“…The observational studies represent a wide sample of patients who have received an ICM in practice (n = 3414) and provide evidence for the Reveal LINQ and for additional outcomes that were not available from the CRYSTAL-AF trial. l In total, one study 65 for Confirm Rx (of an older model, the Confirm DM2102), five studies of the BioMonitor 2-AF [77][78][79][80][81][82][83][84] (all BioMonitor 2 but only one 80 of which we can be certain was of the '-AF' model) and five studies 34,50,[85][86][87] of the Reveal LINQ [three studies 34,85,87 of the Reveal LINQ and three 50,86 studies of the Reveal XT (one study 34 included both devices)] in mixed populations were included based on the recommendations of the companies. All of these mixed population studies are either single-arm observational studies or they provide DTA data for the ICM using Holter monitoring as the reference standard.…”

“…However, (confidential information has been removed) were deemed to meet the inclusion criteria for a discussion of non-CS or mixed population data. The key characteristics of the five included studies (two publications and six personal communications) [77][78][79][80][81][82][83][84] are summarised in Table 15 and their results are discussed in the paragraphs below. The EAG notes that only (confidential information has been removed) and that the primary indication for the ICM is CS (confidential information has been removed) of the study participants for each of the included studies.…”

“…Clinician time taken to insert the BioMonitor 2 was reported in five studies. [77][78][79][80][81][82][83][84] Reinsch et al 80 reported that all devices were successfully implanted in a cath lab with a median time from skin cut to last suture of 8 minutes (IQR 7-10 minutes) and Ooi et al 78 reported that all implantations were successfully performed in cath labs on the first attempt, with a median time from incision to last suture of 9 minutes (IQR 5-14 minutes). (Confidential information has been removed.)…”

Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety

“…The impact of body composition on sensing amplitude detected by the ICM was among the secondary endpoints of several previous studies. Although data from short-sensing-vector devices (Reveal LINQ) suggested an inverse relationship between R-wave amplitude and BMI ( 17 ), studies with long-sensing-vector ICMs were less conclusive ( 8 , 10 , 18 – 22 ) ( Table 5 ). Lacour et al ( 18 ) did not observe such relationship in a small cohort of 19 patients implanted with a previous device version (BioMonitor 2).…”