Two new abstracts bolster CardioNet's (Conshohocken, Pennsylvania) CardioNet System's use to be expanded for the detection of atrial fibrillation (AF).
According to the studies, the system has the ability to detect clinically significant events in patients following ischemic stroke or surgical AF ablation procedures.
CardioNet reported the release of its new AF reporting package to enhance its current AF Management Program last year (Medical Device Daily, Oct. 6, 2008). The system offers a tool to the physician for the diagnosis, treatment and management of their AF patients. It also additionally provides physicians with a monitoring program to evaluate the clinical efficacy of catheter and surgical ablation procedures allowing improved management of these post surgical patients.
The first iteration of the device was given FDA clearance back in 2002. The company said that the system hasn't received CE Mark approval.
The two studies are Cryo-Maze for Concomitant Atrial Fibrillation: Mid-Term Results using CardioNet Home Monitoring Testing by Evelio Rodriguez, MD, of the division of cardiothoracic and vascular surgery at the Brody School of Medicine, East Carolina University (Greenville, North Carolina), and "Atrial Fibrillation Detected by Mobile Cardiac Outpatient Telemetry in Cryptogenic TIA or Stroke," by A.H. Tayal, MD, of the Comprehensive Stroke Center at Allegheny General Hospital (Pittsburgh).
"There have now been 19 publications or abstracts related to the system," Aaron Goldmuntz, director of business development at CardioNet, told Medical Device Daily. "This is just further validation of the clinical utility of this technology."
The study first utilized the CardioNet System for home monitoring of patients that underwent concomitant AF ablation to determine the efficacy of the procedure. The authors of the study noted that rhythm assessment after ablation with electrocardiogram (ECG) and/or Holter monitors has been shown to overestimate success, which led to their selection of the CardioNet System for the study. The study concluded that home monitoring with the CardioNet System should become standard of care after interventions performed to restore sinus rhythm in patients with AF.
The second demonstrates the feasibility of detecting AF in patients with stroke of undetermined etiology through prolonged monitoring. The study concluded that the CardioNet System detected a high rate of AF (23%) in patients that have experienced a transient ischemic attack or stroke for which the etiology was indeterminable through standard diagnostic evaluation methods.
Tayal, senior author of the study, commented: "Our study showed that mobile cardiac outpatient telemetry had a high rate of AF detection, including asymptomatic and short events, which may be a biomarker of prolonged and clinically significant AF. Such patients may benefit from anticoagulation and may not have been diagnosed with AF through standard methods."
Two additional studies utilized the CardioNet System for post-operative management and follow-up of patients that underwent surgical procedures to treat AF:
"Toward a Definitive, Totally Thoracoscopic Procedure for Atrial Fibrillation" – authored by John Sirak, MD, Ohio State University Department of Surgery, Division of Cardiothoracic Surgery (Columbus) and published in the Dec. 8, 2008 issue of The Annals of Thoracic Surgery.
"Surgical Correction Of Atrial Fibrillation With The Cryomaze Procedure: Long-term Outcomes Assessed With Continuous Outpatient Telemetry" –abstract presented by James Gammie, MD, University of Maryland Medical Center (Baltimore), at the Southern Thoracic Surgical Association (Chicago) 55th annual meeting on Nov. 6, 2008.
With nearly 20 published clinical papers and abstracts on the capabilities and efficacy of the CardioNet System, the company said it feels as if the system has been given a push in the right direction. One of the most important studies by far demonstrated the CardioNet System to be nearly three times superior in diagnosing clinically significant arrhythmias as compared to loop event monitoring, according to the company.
CardioNet says it provides ambulatory, continuous, real-time outpatient management solutions for monitoring relevant and timely clinical information regarding an individual's health.