Key Points Question Can continuous cardiac rhythm monitoring beyond hospital discharge enhance atrial fibrillation (AF) detection among cardiac surgical patients? Findings In this randomized clinical trial of 336 cardiac surgical patients with risk factors for stroke, use of continuous cardiac rhythm monitoring with wearable sensors increased the rate of AF detection by 17.9% within 30 days of hospital discharge compared with usual care. Meaning Among cardiac surgical patients with risk factors for stroke and AF lasting less than 24 hours postoperatively, continuous cardiac rhythm monitoring significantly improved the rate of AF detection during the first 30 days after hospital discharge compared with usual care. This randomized clinical trial examines whether continuous cardiac rhythm monitoring enhances detection of postoperative atrial fibrillation (AF) among cardiac surgical patients during the first 30 days after hospital discharge compared with usual care. Importance Postoperative atrial fibrillation (POAF) occurring after cardiac surgery is associated with adverse outcomes. Whether POAF persists beyond discharge is not well defined. Objective To determine whether continuous cardiac rhythm monitoring enhances detection of POAF among cardiac surgical patients during the first 30 days after hospital discharge compared with usual care. Design, Setting, and Participants This study is an investigator-initiated, open-label, multicenter, randomized clinical trial conducted at 10 Canadian centers. Enrollment spanned from March 2017 to March 2020, with follow-up through September 11, 2020. As a result of the COVID-19 pandemic, enrollment stopped on July 17, 2020, at which point 85% of the proposed sample size was enrolled. Cardiac surgical patients with CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes, prior stroke or transient ischemic attack, vascular disease, age 65-74 years, female sex) score greater than or equal to 4 or greater than or equal to 2 with risk factors for POAF, no history of preoperative AF, and POAF lasting less than 24 hours during hospitalization were enrolled. Interventions The intervention group underwent continuous cardiac rhythm monitoring with wearable, patch-based monitors for 30 days after randomization. Monitoring was not mandated in the usual care group within 30 days after randomization. Main Outcomes and Measures The primary outcome was cumulative AF and/or atrial flutter lasting 6 minutes or longer detected by continuous cardiac rhythm monitoring or by a 12-lead electrocardiogram within 30 days of randomization. Prespecified secondary outcomes included cumulative AF lasting 6 hours or longer and 24 hours or longer within 30 days of randomization, death, myocardial infarction, ischemic stroke, non–central nervous system thromboembolism, major bleeding, and oral anticoagulation prescription. Results Of the 336 patients randomized (163 patients in the intervention group and 173 patients in the usual care group; mean [SD] age, 67.4 [8.1] years; 73 women [21.7%]; median [interquartile range] CHA 2 DS 2 -VASc score, 4.0 [3.0-4.0] points), 307 (91.4%) completed the trial. In the intent-to-treat analysis, the primary end point occurred in 32 patients (19.6%) in the intervention group vs 3 patients (1.7%) in the usual care group (absolute difference, 17.9%; 95% CI, 11.5%-24.3%; P < .001). AF lasting 6 hours or longer was detected in 14 patients (8.6%) in the intervention group vs 0 patients in the usual care group (absolute difference, 8.6%; 95% CI, 4.3%-12.9%; P < .001). Conclusions and Relevance In post–cardiac surgical patients at high risk of stroke, no preoperative AF history, and AF lasting less than 24 hours during hospitalization, continuous monitoring revealed a significant increase in the rate of POAF after discharge that would otherwise not be detected by usual care. Studies are needed to examine whether these patients will benefit from oral anticoagulation therapy. Trial Registration ClinicalTrials.gov Identifier: NCT02793895
【초록키워드】 randomized clinical trial, therapy, Trial, anticoagulation, Open-label, randomization, Hospitalization, stroke, COVID-19 pandemic, Sex, surgical, diabetes, risk factor, hypertension, discharge, adverse outcomes, continuous monitoring, Registration, Atrial fibrillation, female, Patient, Thromboembolism, death, nervous system, age, monitoring, Follow-up, congestive heart failure, women, Myocardial infarction, multicenter, cardiac, Analysis, high risk, vascular disease, Enrollment, Sample size, Primary outcome, intervention group, 95% CI, usual care, significant increase, hospital discharge, measure, participant, secondary outcome, primary end point, usual care group, absolute difference, finding, cumulative, MONITOR, major bleeding, 12-lead electrocardiogram, objective, benefit, setting, ENhance, Result, greater, enrolled, defined, occurred, significantly, conducted, median, less, determine, postoperative, Importance, Can, 24 hour, 6 hour, after cardiac surgery, intent-to-treat, investigator-initiated, patients randomized, persist, Point, Relevance, 【제목키워드】 surgery, detection, electrocardiogram, clinical, monitoring, cardiac, fibrillation, Effect, Continuous,