Strong Memorial offers newly OK’d carotid stenting procedure
Clinical innovation lessens risk of stroke, complications for high-risk patients
Tuesday, October 26, 2004
A new carotid stenting procedure that holds great promise for thousands of patients at risk for stroke is being performed by physicians at Strong Memorial Hospital of the University of Rochester Medical Center.
A team of Strong Memorial cardiologists, vascular surgeons and interventional radiologists last month was the first in New York state to perform the procedure, which treats life-threatening plaque blockages in neck arteries leading to the brain, since its approval by the U.S. Food and Drug Administration in August.
Olive Hockey, 82, of Batavia underwent the stenting procedure on Sept. 7. It was performed by interventional cardiologist Craig Narins, M.D., and vascular surgeon Cynthia Shortell, M.D., both of the Strong Heart and Vascular Center.
Hockey had experienced scarring in the carotid vessel after having traditional surgery two years ago and needed the new blockage treated, although another surgery was considered dangerous in her case. She did well during and after her carotid stenting procedure and was discharged the next day.
The traditional surgical procedure, called carotid endarterectomy, is done in an operating room and requires an incision in the neck to remove plaque blocking the vessel that takes blood to the brain. While surgery is effective, there is a risk of stroke or death, a result of plaque that may escape during the procedure, reaching the brain and triggering a stroke.
The carotid stenting procedure is typically performed in a catheterization laboratory or surgical endovascular suite where a catheter is inserted in a small incision and used to clear blockage in the vessel. A stent is then placed at the blockage site to reinforce the vessel wall, in a manner similar to the common procedure done in heart or leg arteries. The technique was shown in the study done by Guidant to be as safe or safer than the traditional procedure in patients who are at high risk for surgery.
The reduced risk offered by the stenting procedure is due in part to built-in safety features such as a tiny, umbrella-shaped filter that extends into the artery above the blockage, Narins says. When opened, the filter prevents any plaque that may escape during the procedure from reaching the brain and triggering a stroke.
Strong Memorial has been involved in several studies that consider the stent technology for carotid arteries, including Guidant’s Archer study, the clinical trial of the stent manufactured by Guidant Corp. that considered how stents worked in patients at higher risk, and the ongoing CREST trial, a larger, NIH-funded study that compares stent therapy with traditional methods of removing plaque from the artery. Strong Memorial is the only area hospital involved in the CREST study.
And just last week, at the request of the FDA, Guidant Corp. asked 60 medical centers to collect additional data this winter about the carotid stenting procedure. Strong Memorial will be the only Rochester hospital participating in this next phase of data collection, which will increase the size of the volunteer pool by 500 to further test the procedure, Narins says.
Narins is a leading expert on carotid stents. He came to Rochester three years ago, after completing interventional cardiology training at Cleveland Clinic. He has served as the principal investigator leading Strong Memorial’s participation in the Archer study. He also currently serves as Strong Memorial’s principal investigator for the CREST trial.
Through his participation in these studies, Narins has performed more than 100 procedures since 1998, and his colleagues in vascular surgery and interventional radiology have performed about 50.
“In several national trials of carotid stents, all have shown reduced complication rates compared with traditional surgery in high-risk patients,” Narins says. For instance, Narins points out that for lower risk patients there is about a 2-percent risk of stroke when undergoing either surgery or stent implant. However, studies have demonstrated that for high-risk patients, the chances of suffering a stroke, heart attack or death are lower in those who underwent the stenting procedure.
It is estimated that thousands of people annually could benefit from carotid stenting in the U.S., and hospitals may soon face rising patient demand for the procedure.
“As with any new technology or medical device, it’s critical to make certain physicians have appropriate training and experience,” Narins says. “Properly used, carotid stents may make clearing plaque safer for certain patients.”
Narins stresses that carotid surgery remains an effective and proven procedure for non-high-risk patients, and the decision to utilize stenting or surgery needs to be made on an individual basis.