Case study focused on favorable CRT optimization of cardiomyopathy patient with limited exertion tolerance; new FDA-approved medical device that provides objective cardiopulmonary gas exchange measurements and real-time physiological assessment to enable CRT optimization during low level exercise easily and quickly without undue strain on the patient
Minneapolis-St. Paul, MN (October 14, 2009) – Presenting to a group of leading physicians and nurses from the heart failure programs in Greater Chicago, Dr. Abraham Kocheril, Professor of Medicine and Director of Clinical Electrophysiology at the University of Illinois at Chicago, together with Dr. Thomas Stamos, Director of Heart Failure at the University of Illinois Medical Center, presented a heart failure patient case study in which the Shape-HF™ Cardiopulmonary Exercise Testing System was used to optimize cardiac resynchronization therapy (CRT). The patient had long-standing cardiomyopathy and had received a pacemaker for heart block. She was later upgraded to a CRT-D because of symptomatic heart failure and poor left ventricular function. The patient’s exertion tolerance was limited by dyspnea. Dr. Kocheril used the Shape-HF device to optimize the patient’s cardiac resynchronization therapy with favorable results.
Developed by Shape Medical Systems, Inc., the Shape-HF is a non-invasive medical device that assesses heart-lung interaction and ventilation in patients with chronic heart failure and other cardiopulmonary disease. It is the first gas exchange testing device specifically designed for cardiology and uses low intensity, sub-maximal or steady state testing protocols to allow testing of even high-risk patients with little or no discomfort. It is designed to quantify the severity of dyspnea on exertion and fatigue and evaluate the physiological interaction between the heart, lungs, and other organ systems. This makes it possible for the physician to assess therapy options for the individual patient and track patient progress. In addition to being the first and only device that objectively measures cardiopulmonary gas exchange easily and quickly without undue strain on the patient, Shape-HF provides real-time physiological assessment to enable CRT optimization during exercise and is cost-effective and easy to use.
According to Dr. Kocheril, “The CRT response rate in heart failure patients is about 70%. The Shape-HF System is likely to help us get the remaining 30% feeling better—those we call non-responders—because it lets us objectively measure response to CRT and optimize timing between the atrium and the two ventricles of the heart in real time while the patient is exercising.”
Shape Medical Systems President and COO Clarence Johnson says, “Cost, logistics and the complexity of testing and data interpretation, as well as the significant level of patient discomfort associated with cardiopulmonary exercise testing has limited its utility and deprived physicians and their patients of much needed physiological information. Shape-HF overcomes these limitations. It provides objective data to the cardiologist right in the office or clinic. The test is easy on patients and the equipment is intuitive and easy to use.”
Dr. Kocheril is certified by the American Board of Internal Medicine in Cardiovascular Disease and Clinical Cardiac Electrophysiology. He has published extensively, serves as a reviewer for several journals, and is on the editorial board of one journal. He has spoken internationally and takes an active role as faculty in the annual scientific sessions of the Heart Rhythm Society.
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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