Author + information
- Prashanthan Sanders,
- Rishi Anand,
- Robert Kowal,
- Christopher Piorkowski,
- M. Rizwan Sohail,
- Hans Kragten,
- Angel Moya,
- Kurt Stromberg and
- John D. Rogers
Background: The vast majority of current insertable cardiac monitor (ICM) procedures are performed in a cardiac catheterization (cath)/EP lab. Miniaturization of ICMs may allow device insertion to be moved from these traditional hospital setting to other “out-of-lab” less resource intensive locations within the hospital, such as holding areas or procedure rooms.
Methods: The Reveal LINQTM in-Office 2 (RIO 2) International study is a single arm, multicenter, prospective study designed to assess the safety of Reveal LINQTM ICM insertion procedures performed outside the traditional hospital setting within the hospital. Patients indicated for an ICM and willing to undergo device insertion outside the cath/EP lab or operating room were eligible. The protocol required maintaining an appropriate sterile technique during the days after insertion, with visits 30 and 90 days post-procedure. The primary objective was to estimate the rate of untoward events (a composite of unsuccessful ICM insertion and complication related to ICM procedure) associated with out-of-lab procedures. A complication was a adverse even requiring invasive intervention such as system revision or intravenous drug administration.
Results: A total of 191 patients (45.5% female aged 63.8 + 26.9 years) underwent an ICM insertion attempt between September 2015 and May 2016, at 17 centers in Europe, Canada and Australia. All procedures took place within the hospital but in out-of-lab settings and were successful. The median visit duration was 106 min. Among the 191 patients, the rate of untoward events was 0.0% (95% CI: 0.0% – 2.1%). Four patients presented with procedure related adverse events that did not require invasive intervention (1 patient had insertion site pain, 2 had an incision site hemorrhage, and 1 had vasovagal syncope following the procedure). Non of the patients developed infections despite the fact that 56% of procedures were conducted without antibiotic prophylaxis.
Conclusions: The Reveal LINQTM ICM insertion procedure can be safely performed outside of the traditional hospital settings.
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Arrhythmias and Clinical EP: Devices 1
Abstract Category: 5. Arrhythmias and Clinical EP: Devices
Presentation Number: 1109-086
- 2017 American College of Cardiology Foundation