Clinical InvestigationReal-world comparison of in-hospital Reveal LINQ insertable cardiac monitor insertion inside and outside of the cardiac catheterization or electrophysiology laboratory
Section snippets
Study overview
The Reveal LINQ Registry is an ongoing, non-randomized, observational, multi-center, global study (ClinicalTrials.gov, NCT02746471). Its purpose is to generate reliable long-term “real-world” data of product performance, economic valuation, site-of-service procedural information and to identify the value of the Reveal LINQ ICM (Medtronic Inc., Minneapolis, USA) in the care pathway. In total, 1613 patients monitored with the ICM have been enrolled and will be followed prospectively from
Study population
As of October 2017, 1222 patients fulfilled the inclusion criteria for this analysis. Patients were enrolled at 18 centers in the United States (58% of patients), 17 centers in Middle East/Asia (Israel, Saudi Arabia, Japan) (15%) and 15 centers in Europe (Belgium, Germany, Greece, Italy, Netherlands, Portugal, Spain, UK) (27%). The mean age was 61.0 ± 17.1 years and 58.1% were male. The most common primary indications for an ICM were syncope (30.3%), cryptogenic stroke (18.3%), suspected AF
Discussion
We provide real-world evidence that Reveal LINQ ICM insertions performed outside the traditional settings within the hospital are feasible, safe and comparable with insertions performed in the traditional settings. Of the 17 patients with ICM/procedure-related adverse events (1.4%), 11 (1.3%) were observed in the in-lab group (EP/CATH lab/operating room or in-lab) and 6 (1.5%) occurred in the out-of-lab group (procedure/clean room or EP lab holding area). There was no statistically significant
Limitations
One of the limitations of this registry is that it does not collect detailed information on procedural aspects related to sterility, namely prepping, draping, use of surgical mask, gown, and gloves. However, the low infection rate reported supports the assumption that conventional best practices were followed regardless of the site of service. Another limitation encountered has been collecting data for the type of anesthetic used. Although it was possible to select multiple options in the case
Conclusion
In summary, this analysis shows that performing the ICM procedure outside of the CATH/EP lab or operating room within the hospital is possible without increasing the risk of infection or complications. However, it is of great importance that the implanting physicians use best surgical practices, regardless of the site of service.
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New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population
2022, Heart Rhythm O2Citation Excerpt :In the BIO|STREAM-ICM study, no follow-up visits were mandatory, but in-office and remote follow-ups were reported as conducted. Adverse events related to the insertion procedure or study device were reported during the study and are presented according to the categories and severity definition used in a large study of an alternative ICM model, to allow for comparisons.9 During the insertion of ICM devices, investigators recorded procedure location; insertion position; wound closure method; duration from skin incision to tool removal, wound closure, and wound cleaned; antibiotic prophylaxis; and the need for ICM repositioning.
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RCT# NCT02746471
Declaration of Interest
S. Beinart: Consultancy fees and Honoraria from Medtronic, Abbott, Janssen, Bristol Myers Squibb, Pfizer, Daiichi-Sankyo, and Zoll.
A. Natale: Consultancy fees and honoraria: Medtronic, BWI, Boston Scientific, Abbott, and Janssen.
A. Verma: Grant support and advisory board fees: Medtronic, Bayer, Boehringer Ingelheim, Biosense Webster, and Abbott.
A. Amin: Consultancy fees from Medtronic.
S. Kasner: Consulting/honoraria: Medtronic, AstraZeneca, Bayer, Bristol Meyers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Johnson&Johnson, Novartis, Merck; Research grant: WL Gore, AstraZeneca.
H.-C. Diener: Honoraria: Medtronic, Abbott, Allergan, AstraZeneca, Bayer Vital, BMS, Boehringer Ingelheim, CoAxia, Corimmun, Covidien, Daiichi-Sankyo, D-Pharm, Fresenius, GlaxoSmithKline, Janssen-Cilag, Johnson & Johnson, Knoll, Lilly, MSD, MindFrame, Neurobiological Technologies, Novartis, Novo-Nordisk, Paion, Parke-Davis, Pfizer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, Syngis, Talecris, Thrombogenics, WebMD Global, Wyeth and Yamanouchi. Financial support for research: AstraZeneca, GSK, Boehringer Ingelheim, Lundbeck, Novartis, Janssen-Cilag, Sanofi-Aventis, Syngis and Talecris.
M. Del Greco: Nothing to declare.
B. Wilkoff: Consultancy fees from Medtronic, Abbott, Phillips.
E. Pouliot: Medtronic employee and shareholder.
N. Franco: Medtronic employee and shareholder.
S. Mittal: Consultancy fees from Medtronic.