Wireless Healthcare Innovator CardioNet Provides Cardiac Industry’s Only Comprehensive Suite of Arrhythmia Monitoring Solutions

Current diagnostic solutions for detecting cardiac arrhythmias, include Holter monitoring, typically worn for 24-48 hours, event monitoring, worn for 30 days, and Mobile Cardiac Outpatient Telemetry (MCOT), worn for up to 21 days. Only CardioNet offers physicians a comprehensive suite of these solutions for diagnosing patients and monitoring the efficacy of treatment plans. These include Mobile Cardiac Outpatient Telemetry (MCOT), AF auto-trigger and auto-trigger event monitoring, looping and non-looping event monitoring, Holter monitoring, and pacemaker check services. Furthermore, CardioNet provides this turnkey set of services at no cost to healthcare providers, and supports these solutions with unparalleled service and education departments focused on ease of use for both physicians and patients.

Proven in use in over 100,000 patients since FDA-clearance in 2002, CardioNet’s premier product and service, Mobile Cardiac Outpatient Telemetry (MCOT), provides real-time, beat-to-beat analysis, and automatic detection and transmission of ECG data.
CardioNet monitors patients continuously for up to 21 days, utilizes a rate, rhythm, and morphology algorithm that recognizes clinically significant arrhythmias, and automatically transmits two channels of ECG data via wireless cellular technology to the CardioNet Monitoring Center. Highly-skilled CCT-certified monitoring technicians analyze the data, and when notification criteria are met, contact physicians with the pertinent information. Clinically significant heart information is delivered to physicians on daily reports, including heart rate information in an easy-to-use Heart Rate Trend Graph, atrial fibrillation burden (if applicable) in an AF Burden Graph, and two-channel ECG rhythm strips. Only CardioNet provides physicians with both Heart Rate Trend and AF Burden graphs, and two channels of ECG information, enabling physicians to more easily diagnose their patients.

Once prescribed, CardioNet MCOT is easy to use by patients. Highly skilled patient educators instruct patients on the use and care of the small, portable sensor and monitor. Most importantly, once the patient transmits the initial ECG baseline, there is no further need for patient interaction. Patients go about their normal daily activities with the knowledge that their heart is being monitored, and the confidence that if an arrhythmic event occurs, CardioNet MCOT will automatically provide the necessary information to their physician. If patients experience symptoms during their monitoring period, they can easily input their symptoms and activities using the user-friendly touch screen on the CardioNet MCOT monitor. The patients’ symptoms, activities, and the underlying ECG data are automatically transmitted to the CardioNet Monitoring Center for analysis and reporting.

Clinical Support for CardioNet MCOT

In March 2007, a first of its kind study, published in the Journal of Cardiovascular Electrophysiology, compared the effectiveness of two ambulatory electrocardiographic monitoring systems in detecting arrhythmias. Three hundred patients presenting with symptoms suggestive of a cardiac arrhythmia and with previous negative or inconclusive 24-hour Holter monitoring or 24-hours of telemetry, were enrolled in the study by 17 cardiology practices. Patients were randomized to either Mobile Cardiac Outpatient Telemetry (MCOT) or to a cardiac loop event recorder. The results of the study showed that CardioNet MCOT was almost three times more effective detecting and diagnosing clinically significant arrhythmias compared to the frequently prescribed cardiac loop event recorder 4.

CardioNet MCOT detected clinically significant arrhythmias in 41 percent of patients, compared to the cardiac loop event recorder, which detected arrhythmias in just 15 percent of patients (p<0.001). Furthermore, CardioNet MCOT detected clinically significant atrial fibrillation in 23 percent of patients, compared to 8 percent by cardiac loop event recorders (p<0.001). In patients that experienced no symptoms (asymptomatic patients) during the study, the cardiac loop event recorders detected no (0%) clinically significant atrial fibrillation, compared to MCOT, which detected clinically significant atrial fibrillation in 17 percent of patients (p<0.001).

Other notable findings of the study:

• In patients with syncope (fainting, passing out) or presyncope (dizziness), MCOT detected clinically significant arrhythmias in 52 percent of patients, compared to 16 percent of cardiac loop event patients (p<0.001).
• In patients with syncope or presyncope, MCOT detected clinically significant atrial fibrillation in 24 percent of patients compared to 2 percent of cardiac loop event patients (p<0.001). In the same group of patients, MCOT detected asymptomatic atrial fibrillation in 19 percent of patients compared to no (0%) cardiac loop event patients (p<0.001).
• In a sub-group of sites using the auto-detect/auto-trigger cardiac loop event recorders, an arrhythmia was confirmed or excluded as the cause of symptoms in 88 percent of MCOT patients, compared to only 46 percent of cardiac loop event patients (p=0.002).

In response to the findings, lead investigator Steven A Rothman, M.D., Mainline Arrhythmia and Cardiology Consultants, Wynnewood, PA, stated, “These are very compelling findings that for the first time clinically validate the importance and superiority of MCOT – particularly when you consider that a meaningful percentage of patients may not experience easily detectable symptoms. Clearly, physicians need to more carefully consider the value of prescribing MCOT as the first-line diagnostic tool when monitoring patients for clinically significant arrhythmias.”

Post-Diagnosis Treatment and Treatment Monitoring

Today, physicians have several options for treating cardiac arrhythmias once they’ve determined the arrhythmia to be cardiogenic in nature. These options may include medicinal management, use of implanted devices known as Implantable Cardiac Defibrillators (ICDs) or pacemakers, ablations, and other surgical procedures. Only CardioNet MCOT has the ability to provide physicians with daily report tools demonstrating the efficacy of some of these treatment options.

Medicinal Management
When using drugs to medicinally manage patients with Atrial Fibrillation, physicians can use the CardioNet Heart Rate Trend and AF Burden Graphs at the top of patient daily reports to measure the incidence and duration of AF. These graphs enable physicians to determine the effectiveness of their medicinal management strategy by determining if AF is still present, and if the patient’s heart rate is controlled. Based on their findings, physicians can remotely titrate medicine dosages, to reach optimal dosage levels and maximize safety.

Post-procedure Monitoring
Post-procedure monitoring is important for physicians and patients to determine if the procedure was effective. Monitoring patients post-cardiac ablation is one area gaining popularity. In a recent study performed at Johns Hopkins University, results showed that relying on patients’ symptoms alone to determine the effectiveness of the procedure – whether or not atrial fibrillation is still present – is not an accurate measure. Utilizing CardioNet MCOT and the Atrial Fibrillation Burden Graph on the daily patient reports, regardless of patient symptoms, physicians can see the incidence and duration of AF each day, and determine whether or not the procedure was effective.

Contacts:
Derek Lucchese
227 Washington Street #300
Conshohocken, PA 19428
Telephone 610-729-7021
Fax 610.828.8048
derek.lucchese@cardionet.com

i Mayo Clinic website
ii American Heart Association website
iii Heart Rhythm Society website
iv “Utility of Mobile Cardiac Outpatient Telemetry.” The Journal of Cardiovascular Electrophysiology. Vol.18, No.3, March 2007, p 1-7.