Porter Health System was recently selected by The Center for Medicare and Medicaid (CMS) and Abbott Vascular as a site for CHOICE – a post market clinical trial investigating the use of carotid stents in high surgical-risk patients. One of only two hospitals in Northwest Indiana approved for participation in the clinical study, it was necessary for Porter to demonstrate positive outcomes and a high level of skill in performing the delicate procedure according to Interventional Cardiologist Sandeep Sehgal, MD, the primary investigator for the CHOICE study.
“To gain approval as one of the study sites in the United States and Europe, was a painstaking process,” said Dr. Sehgal. “Dr. (Keith) Atassi and I worked very closely with CMS and Abbott to bring this study to Porter.” Dr. Atassi is the study’s co-investigator. Dr. Sehgal continued by saying, “I think being selected says a great deal about Porter’s commitment to excellence and to the quality of care we offer our patients.”
One of the goals of the study is to gather data about the benefits of performing carotid artery stenting in patients who are at high risk for stroke, are not having symptoms, yet are considered high risk for undergoing carotid endarterectomy.
“Carotid artery stenosis is a narrowing of the aortic valve of the heart, and it is a significant contributing factor for stroke,” explained Dr. Sehgal. He went on to share that carotid endarterectomy (the surgical removal of the inner lining of the carotid artery) is the gold standard for treating carotid artery stenosis however not every patient can undergo the surgery. “We are unable to perform carotid endarterectomies on patients with severe COPD, advanced chronic heart failure or those who have previous radiation or surgery to the head because they cannot tolerate the anesthesia. Inserting a stent to open the narrowed carotid artery does not require general anesthesia.”
Currently CMS only approves carotid artery stenting for high-risk patients who have had a stroke or a transient ischemic attack. Clinical evidence gathered through the CHOICE trial will be reviewed by CMS to see if stenting for high-risk patients who are having no symptoms proves to be a valid treatment method. If the results are positive, CMS may reconsider its policy.
According to the American Heart Association, stroke is the third leading cause of death in the United States and the number one cause of disability in adults, and approximately 25 percent of strokes are caused by coronary artery disease. “Obviously, if we can successfully treat high-risk patients before they have a stroke, it will greatly improve their chances of living a healthier life,” said Dr. Sehgal.