The new FDA-approved Shape-HF™ Cardiopulmonary Testing System “can make a dramatic difference in treating CRT patients.” Dr. Abraham Kocheril, Professor of Medicine and Director of Clinical Electrophysiology at the University of Illinois at Chicago
Minneapolis-St. Paul, MN (May 26, 2009) – Speaking to a group of approximately 300 top electrophysiologists, Dean MacCarter, Ph.D., Vice President Clinical Affairs for Shape Medical Systems, Inc., introduced a new, patented method for optimizing therapy in patients with implanted cardiac resynchronization pacemakers at the Heart Rhythm Society’s 30th Annual Scientific Meeting May 13-16 in Boston, MA. This new method involves using the Shape-HF™ Cardiopulmonary Testing System to measure changes in patient breathing efficiency as cardiac resynchronization therapy (CRT) settings are adjusted. In this way, physicians are able to assess the physiological effect of therapy in real time while the patient is exercising at a level consistent with normal daily activity.
CRT is used in severe cases of heart failure to restore synchrony between the heart chambers—the atria and two ventricles—during the heart beat. In patients with advanced heart failure the heart may not beat strongly enough to supply adequate oxygen to peripheral tissues, and poor blood flow to the lungs disrupts the process of exchanging needed oxygen for carbon dioxide, a waste product of normal metabolism. Combined, these effects lower the amount of oxygen in the blood, which decreases the patient’s ability to exercise and causes inefficient, labored breathing.“Shortness of breath on even mild exertion is a key symptom in heart failure,” says Dr. MacCarter. “We know that a positive response to CRT therapy improves breathing efficiency during exercise, so it makes sense that parameters that can measure patient breathing efficiency can be used to determine the proper CRT settings.”
A “Cake Walk” of a Test
The test involves measuring ventilation parameters while the patient exercises on a treadmill at a very low intensity of one mile per hour with the treadmill set at a 2% grade. “This is a level of exercise that is consistent with normal daily activity in this patient population,” noted MacCarter. “Patients I have worked with in the clinic call it a ‘cake walk’ because it is quite an easy test for them to do.” As the patient exercises at a steady state heart rate, the physician adjusts therapy settings every two minutes, enough time for the adjustments to be reflected in breathing physiology. At the end of the test, during which four to five therapy settings are tested, the Shape-HF™ System uses a proprietary computer algorithm to rank the physiological response to exercise at each setting. The physician then reviews the results and chooses the therapy setting he or she believes is most appropriate for the patient.
UIC Electrophysiology Expert Expects Device to Help Non-Responders
CRT is a widely used method for treating patients with severe heart failure when alternative treatment options have been exhausted. According to Dr. Abraham Kocheril, Professor of Medicine and Director of Clinical Electrophysiology at the University of Illinois at Chicago (where the Shape-HF™ System has already been installed), “The CRT response rate in heart failure patients is about 70%. The Shape-HF™ System is likely to help us get the remaining 30%—those we call non-responders—feeling better.” Clarence Johnson, President and COO of Shape Medical Systems adds, “Because patient breathing efficiency is so sensitive to changes in CRT settings, using gas exchange parameters to assess these changes provides a completely objective method for defining response to CRT therapy.”
Only Device to Objectively Measure CRT Response in Real Time
The Shape-HF System is the only device that objectively measures CRT response in real time while the patient is exercising. The System is cost-effective, easy to use, and the test is easy on the patient. “Most CRT patients are forced to spend most of their time in bed or lying on the couch,” said Dr. MacCarter. “Our objective is to get them off the couch, back on their feet and enjoying life again.”
About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards. Formerly known as the North American Society for Pacing and Electrophysiology (NASPE), the Society was founded in 1979 to address the scarcity of information about the diagnosis and treatment of cardiac arrhythmias. The Heart Rhythm Society is now the preeminent professional group representing more than 5,100 specialists in cardiac pacing and electrophysiology from more than 70 countries.
About Shape Medical Systems, Inc.
Shape Medical Systems Inc. is a privately held, St. Paul, Minnesota-based medical device company whose core technology lies in the development and commercialization of products for assessing heart/lung interaction and ventilation in chronic heart failure and other cardiopulmonary disease. Shape's clear mission is to develop products that increase the quality of patients' lives by helping doctors quantify shortness of breath, assess patient functional capacity, optimize drug, device and rehabilitation therapy, and monitor patient progress. Shape Medical Systems was founded in 2004 and received FDA market clearance for the Shape-HF™ Cardiopulmonary Testing System in April 2009. The Shape-HF™ System, testing protocols and applications are protected by patent 7,225,022 and other U.S. and foreign patents issued and pending.
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