In-office insertion of a miniaturized insertable cardiac monitor: results from the Reveal LINQ In-Office 2 randomized study
Date
2017
Authors
Rogers, J.
Sanders, P.
Piorkowski, C.
Sohail, M.
Anand, R.
Crossen, K.
Khairallah, F.
Kaplon, R.
Stromberg, K.
Kowal, R.
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Journal article
Citation
Heart Rhythm, 2017; 14(2):218-224
Statement of Responsibility
John D. Rogers, Prashanthan Sanders, Christopher Piorkowski, M. Rizwan Sohail, Rishi Anand, Karl Crossen, Farhat S. Khairallah, Rachelle E. Kaplon, Kurt Stromberg, Robert C. Kowal
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Abstract
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.
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