In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study.
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.



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.



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.



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).



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.
Scripps Green Hospital, La Jolla, California. Electronic address: rogers.john@scrippshealth.org.
John D
JD
Rogers
Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia; Department of Cardiology, Royal Adelaide Hospital, Adelaide, Australia.
Prashanthan
P
Sanders
Herzzentrum Dresden- Abteilung für Invasive Elektrophysiologie, Dresden, Germany.
Christopher
C
Piorkowski
Mayo Clinic College of Medicine, Rochester, Minnesota.
M Rizwan
MR
Sohail
Holy Cross Hospital, Fort Lauderdale, Florida.
Rishi
R
Anand
Cardiology Associates of North Mississippi, Tupelo, Mississippi.
Karl
K
Crossen
Tallahassee Research Institute, Inc., Tallahassee, Florida.
Farhat S
FS
Khairallah
Diagnostics, Cardiac Rhythm and Heart Failure, Medtronic, Inc., Mounds View, Minnesota.
Rachelle E
RE
Kaplon
Diagnostics, Cardiac Rhythm and Heart Failure, Medtronic, Inc., Mounds View, Minnesota.
Kurt
K
Stromberg
Baylor University Medical Center, Dallas, Texas.
Robert C
RC
Kowal
D000368:Aged; D000556:Ambulatory Surgical Procedures / Q000295:instrumentation / Q000379:methods; D001145:Arrhythmias, Cardiac / Q000175:diagnosis*; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation / Q000379:methods; D004777:Environment; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008904:Miniaturization / Q000379:methods*; D010043:Outcome and Process Assessment, Health Care; D057240:Patient Preference / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology*; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D014481:United States
Adverse event; Complication; Insertable cardiac monitor; Office; Reveal LINQ; Safety