Journal
HEART RHYTHM
Volume 14, Issue 2, Pages 218-224Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.hrthm.2016.11.001
Keywords
Insertable cardiac monitor; Office; Reveal LINO; Safety; Complication; Adverse event
Categories
Funding
- Medtronic
- TYRX
- Spectranetics and Boston Scientific
- National Health and Medical Research Council
- National Heart Foundation of Australia
- St. Jude Medical
- Boston Scientific
- Biotronik
- Sorin
- Imricor
Ask authors/readers for more resources
BACKGROUND Recent miniaturization of an insertable cardiac monitor (ICM) may make it possible to move device insertion from a hospital to office setting. However, the safety of this strategy is unknown. OBJECTIVES The primary objective was to compare the safety of inserting the Reveal LINQ ICM in an office vs a hospital environment. Ancillary objectives included summarizing device- and procedure-related adverse events and responses to a physician questionnaire. METHODS Five hundred twenty-one patients indicated for an ICM were randomized (1:1 ratio) to undergo ICM insertion in a hospital or office environment at 26 centers in the United States in the Reveal LINQ In-Office 2 study (ClinicalTrials.gov identifier NCT02395536). Patients were followed for 90 days. RESULTS ICM insertion was successful in all 482 attempted patients (office: 251; hospital: 231). The untoward event rate (composite of unsuccessful insertion and ICM- or insertion related complications) was 0.8% (2 of 244) in the office and 0.9% (2 of 227) in the hospital (95% confidence interval, -3.0% to 2.9%; 5% noninferiority: P < .001). In addition, adverse events occurred during 2.5% (6 of 244) of office and 4.4% (10 of 227) of hospital insertions (95% confidence interval [office minus inhospital rates], -5.8% to 1.9%; 5% noninferiority: P < .001). Physicians indicated that for procedures performed in an office vs a hospital, there were fewer delays > 15 minutes (16% vs 35%; P < .001) and patient response was more often very positive. Physicians considered the office location very convenient more frequently than the hospital location (85% vs 27%; P < .001). CONCLUSION The safety profile for the insertion of the Reveal LINQ ICM is excellent irrespective of insertion environment. These results may expand site of service options for LINQ insertion.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available