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https://hdl.handle.net/2440/105103
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Type: | Journal article |
Title: | In-office insertion of a miniaturized insertable cardiac monitor: results from the Reveal LINQ In-Office 2 randomized study |
Author: | Rogers, J. Sanders, P. Piorkowski, C. Sohail, M. Anand, R. Crossen, K. Khairallah, F. Kaplon, R. Stromberg, K. Kowal, R. |
Citation: | Heart Rhythm, 2017; 14(2):218-224 |
Publisher: | Elsevier |
Issue Date: | 2017 |
ISSN: | 1547-5271 1556-3871 |
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 |
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. |
Keywords: | Insertable cardiac monitor; office; Reveal LINQ; safety; complication; adverse event |
Rights: | © 2016 Heart Rhythm Society. All rights reserved. |
DOI: | 10.1016/j.hrthm.2016.11.001 |
Grant ID: | NHMRC |
Published version: | http://dx.doi.org/10.1016/j.hrthm.2016.11.001 |
Appears in Collections: | Aurora harvest 3 Medicine publications |
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