Proximal Protection Alternative for Use During Carotid Artery Stenting
Carotid artery revascularization historically has been achieved by an open surgical technique called carotid endarterectomy. In this approach, the vessel is opened to remove the plaque while the patient is under general anesthesia. Carotid artery stenting is an alternative carotid artery stenosis treatment in which a stent is placed via a catheter inserted through a tiny incision in the groin. During carotid artery stenting there is some risk of embolization of the carotid artery plaque to the brain causing a stroke or mini-stroke. Distal embolization protection filters are deployed downstream from the lesion to capture emboli during the procedure. The filter is then retrieved and removed from the body after stenting is completed to safely remove the debris.
Although this approach has been shown to have a similar efficacy and safety compared to carotid endarterectomy, there are some carotid artery stenoses that are still too high risk for either carotid surgery or carotid stenting with distal filter protection. These stenotic lesions include 99% occlusions that pose a challenge for filter advancement as well as lesions with fresh, mobile thrombus often found in patients with recent stroke or mini-stroke. Other complex lesions in tortuous carotid arteries too tortuous for distal filter placement were felt to be excessively high risk in the past. In these subsets of patients who were previously deemed both too high risk for carotid endarterectomy and extremely complex for carotid artery stenting with distal protection there has been no other revascularization option until a few years ago.
The Mo.Ma device is a proximal protection tool that protects the brain during a carotid artery stenting procedure. The Mo.Ma device includes balloons that are inflated inside the common carotid artery and external carotid artery to act like surgical clamps, preventing any plaque debris that might break off and migrate upstream in the carotid artery to the brain. The stenting procedure is performed while the balloons remain inflated. Distal embolic protection is not required since the inflated balloons prevent flow of debris to the cerebral arteries. After the stenting is completed, the suspended blood is aspirated to filter out any debris, and the balloons are then deflated and removed. The entire procedure takes less than an hour.
Using the Mo.Ma proximal protection device, several patients have been successfully treated by interventional cardiologist Dr. Amir Haghighat at Bay Medical Center in Panama City, FL. Dr. Haghighat treated the first patient in the region in the early part of 2011 after the patient presented with an acute stroke during a heart attack. This patient had multiple underlying illnesses that made him too high risk for surgery. Initially, there was reluctance to offer the patient anything other than medical therapy, especially considering the dense thrombus burden in the carotid arterial lesion. However, the patient continued to have mini-strokes on medical therapy, and this prompted the decision to use the Mo.Ma device when a distal filter would have been too high a risk. Fortunately, the patient did well, and his carotid artery lesion was reduced from 99% occlusion to no residual stenosis and no recurrent strokes or mini-strokes.
Since this patient was treated, several additional patients have been successfully treated with this proximal protection device technique at Bay Medical Center without any periprocedural strokes, mini-strokes or major adverse events.