Spontaneous bleeding in the brain, known as intracerebral hemorrhage (ICH), remains the least treatable and most devastating form of stroke. While it accounts for only 15 percent of all strokes, it is a leading cause of mortality, morbidity, and disability worldwide, and few effective treatment options exist. Over recent months, however, Mount Sinai physicians have taken a leading national role in creating and implementing a new minimally invasive technique that is showing promise.
ICH occurs when a small artery in the brain leaks blood directly into surrounding tissue and forms a localized hematoma (clot), which continues to destroy neurons and causes life-threatening pressure on the brain. Loss of balance, blurry vision, and difficulty speaking are among the common symptoms, as well as headache and vomiting, which increase gradually over minutes to hours.
The effort is being led by J Mocco, MD, MS, Director of the Cerebrovascular Center at the Mount Sinai Health System, and Professor and Vice Chair for Education in the Department of Neurosurgery at the Icahn School of Medicine at Mount Sinai, and Christopher Kellner, MD, Director of the Intracerebral Hemorrhage Program at Mount Sinai and Assistant Professor of Neurosurgery.
Over the course of 15 months, they have treated nearly 50 patients with a novel strategy to evacuate blood clots using ultrasound imaging, paired with intraoperative CT
scanning and MRI-guided navigation, to precisely locate the blood clot within the brain. Through a tiny hole in the skull, a sheath containing a camera and an experimental suction device, known as the Apollo™ System, is navigated to the clot. The physicians then aspirate the clot with the Apollo device, normalizing the brain pressure.
In 2016, Dr. Mocco was named co-principal investigator of a Phase I clinical trial that will enroll approximately 50 patients at 10 sites across the United States to test the feasibility, safety, and efficacy of this procedure when compared to previously published standards. The trial, called the INVEST trial, is funded by Penumbra, Inc., the company that developed the Apollo System, and is scheduled to commence in May.
“We have just completed a six-month follow-up for the first 28 patients treated with this device, and although the data are preliminary, it appears that patients overall are doing very well with this procedure,” says Dr. Mocco.
One recent patient—an extremely active 86-year-old classical pianist—presented to Mount Sinai Beth Israel in February. “He came in with left arm and leg paralysis, slurred speech, and lethargy,” says Dr. Kellner. A CT scan revealed a very large 85 cc hemorrhage, and he was transferred to the Intracerebral Hemorrhage center at Mount Sinai West. Given his age, and the size and the location of the hemorrhage, he scored a ‘4’ on the ICH Score, which predicts a 97 percent chance of mortality within 30 days.The physicians removed the clot within 24 hours of the hemorrhage.
“He has made a remarkable recovery,” says Dr. Kellner. “He was discharged to the rehabilitation unit at The Mount Sinai Hospital after only 10 days. Currently, he is cognitively almost back to normal, can walk with a walker, and is back to playing the piano.”
Dr. Mocco has received research grants from Penumbra, Stryker, Microvention, Medtronic, and Codman.