Heart patients on anticoagulants benefit from home self-testing using Raytel's INR@Home system

Windsor 26 January 2005St. Jude Medical Inc. has recently launched an exclusive marketing alliance with Raytel Cardiac Services to promote Raytel's new INR@Home anticoagulation blood monitoring system, which could benefit millions of mechanical heart valve patients using the blood-thinning medication warfarin. St. Jude Medical is a major mechanical heart valve company and recently implanted its 1,5 millionth mechanical heart valve. All mechanical heart valve patients must take blood-thinning medication to reduce the risk of thrombosis and, as a result, must regularly monitor their anticoagulation. Raytel's INR@Home system allows patients to self-test their anticoagulation levels at home rather than visiting a clinic or a laboratory.


Heart patients on anticoagulation therapy who self-test their blood levels stay "in range" and have fewer complications compared to patients who don't self-test, according to a new European study published in the United States by the Annals of Internal Medicine, January 2005, Vol. 142, Issue 1, pages 1-10. Using a home meter, similar to blood sugar monitors commonly used by diabetics, the self-testing heart valve patients maintained their optimal therapeutic blood levels and had fewer major complications compared to patients following conventional testing methods. In-home self-testing is provided in the United States through services like INR@Home anticoagulation blood monitoring, offered by Raytel Cardiac Services, an expert in remote cardiac monitoring services in the USA.

Dr. Heinrich Kortke, M.D., from Bad Oeynhausen, Germany, discussed findings from the Early self-controlled anticoagulation trial (ESCAT) study, a randomized and prospective study that examined the viability of patient self-testing immediately after mechanical heart valve replacement at the 41st annual Society of Thoracic Surgeons (STS) meeting, January 24-26, in Tampa, Florida.

"Patient self-testing should become the standard of care for mechanical heart valve patients", stated Richard J. Shemin, M.D., Professor and Chairman, Department of Cardiothoracic Surgery, Boston Medical Center. "Self-testing encourages patients to be more active participants in their anticoagulation management, while reducing complications such as haemorrhage and thrombo-embolism. The Raytel system provides reliable technology and enhanced ease of use, with excellent tracking and reporting, clearly solving many of the logistical problems that hampered previous self-testing efforts."

More than 2,7 million heart patients nationwide - those at highest risk, including mechanical heart valve recipients - take the anticoagulant warfarin (Coumadin) daily to prevent blood clots from forming. Warfarin must be managed closely because it has a "narrow therapeutic range", where too much can cause bleeding, and too little can cause a stroke. Maintaining the proper range is difficult for most people and requires monthly testing at a laboratory or clinic. INR, which stands for "International Normalization Ratio", is the accepted measurement of the patient's clotting time, and is used to adjust warfarin dosage. With Raytel's INR@Home monitoring system, patients can easily test their INR levels more frequently on a weekly basis in the comfort and convenience of their own home, instead of the traditional appointments every four weeks at a laboratory or clinic.

In 2002, Centers for Medicare and Medicaid (CMS) approved weekly self-testing for patients with mechanical heart valves. This decision was based on studies, which demonstrated that weekly self-testing helps patients remain in their therapeutic range, thereby reducing the risk of bleeding or stroke.

The most recently published study was conducted in Spain using 737 heart patients on anticoagulant treatment who were randomly assigned to test monthly at hospital clinics or self-test their blood levels at home every week. "Heart patients with mechanical valves can safely undergo weekly self-testing at home. With self-testing through Raytel's INR@Home monitoring service, patients who begin to drift out of range can quickly have their warfarin dose adjusted, since the system tracks the results and immediately sends them to the patient's physician", stated Dr. Richard J. Shemin. "Since anticoagulated patients generally have no warning signs to alert them to trouble, physicians can now have advance warning and can intervene before complications, such as haemorrhage or thrombo-embolism set in. With such a precise and reliable system as INR@Home self-testing, patients can begin to take control of their anticoagulation management."

Once a physician prescribes the service, Raytel provides the patient with a portable home testing meter and testing supplies, as well as personalized instruction on how to use the equipment. Self-testing is easy for patients to learn and use. A drop or two of blood from a fingerstick is placed on a specially designed test strip, which is then inserted into the self-testing meter. Built-in on-board controls help ensure reliable results on each and every test.

The patient calls in the results to Raytel's 24-hour, toll-free remote monitoring centre, where highly skilled, knowledgeable technicians compare the INR test results to the patient's prescribed therapeutic range. The results are plotted on an INR trend report that is transmitted to the physician's office, and Raytel immediately alerts the physician to any INR values found to be out of the prescribed range so dosage adjustments can be made with a quick phone call.

"INR@Home self-testing offers peace of mind to patients, since they know their weekly test results will be immediately transmitted to their physician, rather than the delays that often occur with traditional monthly testing in a lab", stated Richard Albrecht, vice president of marketing, Raytel Cardiac Services. "Patients and their physicians share a close relationship with Raytel's skilled technicians who are always available to assist them in any way they can."

Besides offering timely and critical patient information to physicians and health care providers, Raytel's INR@Home monitoring of mechanical heart valve patients is rapidly becoming recognized by insurance plans as a cost-effective application of medical technology. "The expense associated with medical care for mechanical heart valve patients on anticoagulants is dramatically reduced with the use of INR patient self-testing. Hospital costs to treat a haemorrhagic complication from warfarin can be as high as $10.000, so this fills an important need in helping to reduce the spiraling cost of health care in the United States", explained Richard Albrecht. "It improves patients' lives through more frequent monitoring, and it's economically advantageous for physicians and insurers as well."

Raytel Cardiac Services is a division of Raytel Medical Corporation, a wholly owned subsidiary of SHL-Telemedicine Ltd., world expert in developing and marketing advanced telemedicine systems, and call centre services to subscribers. Raytel Cardiac Services is a provider of remote pacemaker monitoring and cardiac diagnostic testing in the United States, serving more than 200.000 patients and 15.000 physicians annually. Raytel's highly trained health care professionals use telephone and Internet technology 24-hours, seven days a week, to monitor patients with pacemakers, suspected arrhythmia, implanted defibrillators (ICDs) and other cardiac-related conditions. Patient reports are generated with each monitoring session and forwarded to their physician for review.

Leslie Versweyveld

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