Kardia Pro algorithm Evaluation.

<div><p>Atrial fibrillation (AF) is a prevalent and clinically significant cardiac arrhythmia, with a growing incidence. The primary objectives in AF management are symptom relief, stroke risk reduction, and prevention of tachycardia-induced cardiomyopathy. Two key strategies for rhythm control include antiarrhythmic drug therapy and pulmonary vein isolation (PVI), with PVI being recommended for selected patients. Even though PVI is effective, post procedural health care utilization is high, contributing to emergency department (ED) overcrowding, which is a global healthcare concern. The use of remote rhythm diagnostics, such as a 1-lead ECG device (KM), may mitigate this issue by reducing ED visits and facilitating more plannable AF care. <i>Objective</i>: This study aimed to assess whether providing AF patients with a 1-lead ECG device for 1 year after PVI would reduce ED utilization compared to standard care. Additionally, the study assessed whether this intervention would render AF care more plannable by reducing the incidence of unplanned cardioversions. <i>Methods</i>: A historically controlled, prospective clinical trial was conducted. The intervention group were patients undergoing PVI for AF between September 2018 and August 2020, all patients in this group received a 1-lead ECG device for 1 year for remote rhythm monitoring. The historical control group were patients undergoing PVI between January 2016 and December 2017; these patients did not receive a 1-lead ECG device. Data on ED visits, planned and unplanned cardioversions, and outpatient contacts in the year after the PVI were collected for both groups. <i>Results</i>: The study included 204 patients, 123 in the 1-lead ECG group and 81 in the standard care group. There was no statistically significant difference in the number of all-cause ED visits (63 vs 68 per 100 pts, respectively, p = 0.72), ED visits for possible rhythm disorders, or ED visits for definite rhythm disorders between the two groups. However, the 1-lead ECG group demonstrated a higher proportion of planned cardioversions compared to unplanned ones (odds ratio 4.9 [1.57–15.85], p = 0.007). <i>Conclusion</i>: Providing patients with AF following PVI with a 1-lead ECG device did not result in a statistically significant reduction in ED visits during the first year. However, it did improve the management of recurrent AF episodes by substituting unplanned cardioversions with scheduled ones.</p><p>Clinical Trials Registration Number <a href="https://clinicaltrials.gov/ct2/show/NCT06283654" target="_blank">NCT06283654</a>.</p></div>