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

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• 作者：John D. Rogers ; MD^⁎ ; ^{rogers.john@scrippshealth.org} ; Prashanthan Sanders ; MBBS ; PhD ; FHRS^&dagger ; ; ^&Dagger ; ; Christopher Piorkowski ; MD ; PhD^&Dagger ; &Dagger ; ; M. Rizwan Sohail ; MD^§ ; ; Rishi Anand ; MD^║ ; Karl Crossen ; MD^&para ; ; Farhat S. Khairallah ; MD^# ; Rachelle E. Kaplon ; PhD^⁎⁎ ; Kurt Stromberg ; MS^⁎⁎ ; Robert C. Kowal ; MD ; PhD ; FHRS^&dagger ; &dagger ;
• 关键词：Insertable cardiac monitor ; Office ; Reveal LINQ ; Safety ; Complication ; Adverse event
• 刊名：Heart Rhythm
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：14
• 期：2
• 页码：218-224
• 全文大小：703 K
• 卷排序：14

文摘

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.ObjectivesThe 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.MethodsFive 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.ResultsICM 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).ConclusionThe 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.