Safety of in-hospital insertable cardiac monitor procedures performed outside the traditional settings: results from the Reveal LINQ in-office 2 international study

Abstract

Background Historically, the majority of insertable cardiac monitor (ICM) procedures were performed in the cardiac catheterization (cath) lab, electrophysiology (EP) lab, or operating room (OR). The miniaturization of ICMs allows the procedure to be relocated within the hospital without compromising patient safety. We sought to estimate the rate of untoward events associated with procedures performed within the hospital but outside the traditional settings and to characterize resource utilization, procedure time intervals, and physician experience. Methods The Reveal LINQ in-Office 2 (RIO 2) International study was a single arm, multicenter, prospective study. Patients indicated for an ICM and willing to undergo device insertion outside the cath/EP lab or OR were eligible and followed for 90 days after insertion. Results A total of 191 patients (45.5% female aged 63.8 ± 26.9 years) underwent successful Reveal LINQ ICM insertion at 17 centers in Europe, Canada and Australia. The median total visit duration was 106 min (interquartile range [IQR]: 55–61). Patient preparation and patient education accounted for 10 min (IQR: 5–20) and 10 min (IQR: 8–15) of total visit duration, respectively. Preparation and education occurred in the procedure room for 90.6 and 60.2% of patients, respectively. There were no untoward events (0.0, 95% CI: 0.0–2.1%) though four patients presented with procedure-related adverse events that did not require invasive intervention. Physicians rated procedure location as convenient or very convenient. Conclusions The Reveal LINQ™ ICM insertion can be safely and efficiently performed in the hospital outside the cath/EP lab or OR. Trial registration ClinicalTrials.gov identifier NCT02412488 ; registered on April 9, 2015. Electronic supplementary material The online version of this article (10.1186/s12872-019-1106-3) contains supplementary material, which is available to authorized users.

Preliminary results from the LUX‐Dx insertable cardiac monitor remote programming and performance (LUX‐Dx PERFORM) study

“…Two infections resolved with oral antibiotic treatment, and one resulted in explant of the ICM. This low rate of infection is consistent with other reports of low infection rates (0%–1.6%) 11 , 12 , 13 , 14 , 15 …”

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

“…The median time from incision to closure was 4.0 minutes (IQR, 2.3–6.2 minutes) as compared to 4.0 minutes (IQR, 3.0–6.0 minutes) reported in another state-of-the-art ICM with a similar cross-sectional profile (Reveal LINQ; Medtronic Inc, Minneapolis, MN). 10 In 18.5% of our patients, the ICM was inserted in a consultation room instead of a catheterization lab or operation theatre. Miniaturization of ICMs enables the procedure to be relocated to this new environment, giving hospitals flexibility in planning the use of their facilities without compromising patient safety or outcomes.…”

“…Miniaturization of ICMs enables the procedure to be relocated to this new environment, giving hospitals flexibility in planning the use of their facilities without J o u r n a l P r e -p r o o f compromising patient safety or outcomes. [9][10][11][12] From the patients' perspective in a large-cohort study described by Rogers et al, 11 far more patients perceived the procedure location to be "very convenient" when it was performed in-office (85%) than when it was performed in hospital (29%).…”

"ILRs- Implantable Loop Recorders, Insertion Guidance and After Care Precautions- A Review and Reflection of the Literature and Our Experience"

“…In our practice of a 1000 bed tertiary care facility and EP lab which implants approximately 250 loop recorder devices per year [9], we have a very low side effect profile, much as is seen nationally. As in previous loop recorder studies [10] our side effect profile includes localized bleeding (small hematoma), localized skin changes (irritation and or rash) and localized infection or mild pain at the insertion pocket site [11]. These side effects are limited to a less than1-2% chance of occurrence and are easily managed with short term compression, skin care and acetaminophen or ibuprofen.…”

“…This literature review examined advantages of an ILR, evolving ILR technology, possible skin changes or rashes, increased pain at the insertion site, migration of the loop recorder and dislodgement of the loop recorder. This search proved to be challenging as the LINQ loop recorder insertion is associated with such a low complication rate and considered a smooth and relatively troublefree procedure [10]. The literature review revealed cases which included the term "pain" but did not directly relate to the pocket site pain.…”