Elsevier

American Heart Journal

Volume 207, January 2019, Pages 76-82
American Heart Journal

Clinical Investigation
Real-world comparison of in-hospital Reveal LINQ insertable cardiac monitor insertion inside and outside of the cardiac catheterization or electrophysiology laboratory

https://doi.org/10.1016/j.ahj.2018.10.002Get rights and content

Background

Traditionally, insertable cardiac monitor (ICM) procedures have been performed in the cardiac catheterization (CATH) or electrophysiology (EP) laboratory. The introduction of the miniaturized Reveal LINQ ICM has led to simplified and less invasive procedures, affording hospitals flexibility in planning where these procedures occur without compromising patient safety or outcomes.

Methods

The present analysis of the ongoing, prospective, observational, multicenter Reveal LINQ Registry sought to provide real-world feasibility and safety data regarding the ICM procedure performed in the CATH/EP lab or operating room and to compare it with insertions performed outside of these traditional hospital settings. Patients included had at least a 30-day period after the procedure to account for any adverse events.

Results

We analyzed 1222 patients (58.1% male, age 61.0 ± 17.1 years) enrolled at 18 centers in the US, 17 centers in Middle East/Asia, and 15 centers in Europe. Patients were categorized into 2 cohorts according to the location of the procedure: in-lab (CATH lab, EP lab, or operating room) (n = 820, 67.1%) and out-of-lab (n = 402, 32.9%). Several differences were observed regarding baseline and procedure characteristics. However, no significant differences in the occurrence of procedure-related adverse events (AEs) were found; of 19 ICM/procedure-related AEs reported in 17 patients (1.4%), 11 occurred in the in-lab group (1.3%) and 6 in the out-of-lab group (1.5%) (P = .80).

Conclusions

This real-world analysis demonstrates the feasibility of performing Reveal LINQ ICM insertion procedures outside of the traditional hospital settings without increasing the risk of infection or other adverse events.

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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      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.

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