Data presented as a Hot Line session at the EUROPACE 2009 congress on the XPECT clinical trial, sponsored by Medtronic, Inc. showed that the Medtronic Reveal XT Insertable Cardiac Monitor (ICM) reliably identifies patients with AF (sensitivity of 96.1 percent) and correctly confirms the absence of AF in patients (negative predictive value of 97.4 percent).
It is widely known that AF is an independent risk factor for stroke, increasing risk approximately five-fold. Several recent studies have indicated that the correlation between AF episodes and symptoms is poor, meaning that patients may be symptom-free during AF, or experience AF-like symptoms not related to AF.
Current methods for detecting AF, such as Holter monitors and 24-hour event monitors, have limited effectiveness, even if performed repeatedly, given the transitory nature of the monitoring. XPECT (Reveal XT Performance Trial), involving 247 patients at 20 sites, was conducted to quantify the accuracy of continuous monitoring, achieved via the Reveal XT insertable cardiac monitor, for detecting and documenting AF through continuous monitoring.
Professor Gerhard Hindricks of the Heart Center at the Universitätsklinikum in Leipzig, Germany, serves as principal investigator for the XPECT trial and presented data. “The XPECT results show that continuous monitoring by the Reveal XT device enables reliable detection of AF with high sensitivity and specificity, along with accurate recordings of AF episode duration,” said Prof. Hindricks. “Additionally, this trial demonstrated that the Reveal device correctly rules out AF in patients who do not have significant AF burden. Continuous monitoring can be an essential tool for physicians to successfully manage AF or subsequently take action to prevent negative outcomes such as stroke resulting from AF. Physicians can best optimize the use of antiarrhythmic and anticoagulation medicines only if they can precisely and correctly diagnose a patient’s atrial fibrillation.”