Providence Studies ICD Aimed at Warning Patients of Deadly Heart Problems
Providence Hospital: Southfield
Friday, March 15, 2013
Contact: Brian Taylor, 586-753-0726.
Southfield, Mich..- An experimental device designed to alert patients that they may be experiencing a heart attack or abnormal heart rhythm is being studied at Providence Hospital.
Led by Christian Machado, M.D., the hospital’s director of electrophysiology, the study will look at the safety and effectiveness of an implantable cardioverter defibrillator that has a feature that monitors changes in the ST segment, a specific section of the patient’s heartbeat. When it detects a change it’s designed to deliver a vibration that alerts the patient to seek emergency treatment.
“This is a very important study because this device has the potential to help us identify patients that may be having a deadly cardiac event and provide the potentially lifesaving treatment they need. The faster we can identify a problem and treat a patient the more lives we can save,” says Dr. Machado.
Known as the Analyze ST trial, the trial will study the safety and effectiveness of a new feature in the St. Jude Medical Fortify® ST implantable cardioverter defibrillator system. The ST monitoring feature in the Fortify ST ICD is designed to monitor changes in the ST segment.
A feature in the device makes it possible for physicians to automatically monitor the ST segment from inside the body and on a continual basis. The device can also alert the patient to a change in the ST segment, prompting them to seek medical attention. Changes in the ST segment have long been studied via surface electrocardiograms as a potential indicator of a heart attack.
More than half of patients experiencing a heart attack die before reaching a hospital. Even patients with stable coronary artery disease are at high risk of having a life-threatening or potentially fatal coronary event. Additionally, 15 to 20 percent of patients who have had an ischemic event have recurrent events. As a result, coronary artery disease needs to be managed on an ongoing basis to avoid a more unstable or life threatening heart problem.
Approximately two thirds of ICD patients have narrowing or blocked arteries responsible for significantly obstructing the flow of blood to a patient’s heart, with many more having risk factors for developing cardiovascular disease. The trial will determine if this diagnostic capability can provide detection of acute coronary syndrome events, and may provide important insights leading up to an event. The study will also provide key insights on the value of such a diagnostic feature in possibly reducing the event-to-treatment time and positively impacting patient outcomes.
The technology has been an available feature in St. Jude Medical ICDs in Europe since 2008, but this is the first trial to study the device’s use in the U.S. In all, more than 5,000 patients will participate in the study to evaluate the effectiveness and safety of the new ST monitoring feature.
Providence Hospital is a member of the St. John Providence Health System Heart & Vascular Care Network, a leading provider of heart care in Michigan. For 11 years, Providence has been ranked as one of top hospitals in the United States for heart care, according to an independent national study conducted by Truven Health Analytics, formerly the health care business of Thomson Reuters. Providence is also recognized as Blue Distinction Centers for Cardiac Care by Blue Cross Blue Shield of Michigan.