Baptist Jacksonville first to enroll patients in global study to treat brain aneurysms
September 15, 2014 | Jacksonville, FL
Baptist Medical Center Jacksonville is the first hospital in the world to enroll a patient in an international study that is assessing a new way to treat brain aneurysms.
Baptist Jacksonville is one of 20 sites globally that will be studying a device that has traditionally been used for larger aneurysms in the brain. A cerebral aneurysm is an area where a blood vessel in the brain weakens, resulting in a bulging or ballooning of part of the vessel wall.
The study hopes to expand the use of the Pipeline™ Embolization Device, a braided cylindrical mesh also called a flow diverter, which slows the flow of blood into the aneurysm and allows the diseased vessel to heal. The study will evaluate the device in the treatment of small and medium unruptured brain aneurysms. The device is inserted through a microcatheter into an artery in the groin and threaded through the body to the brain.
Baptist Jacksonville is playing a leadership role in the PREMIER Prospective study sponsored by Covidien and providing advanced training for many visiting physicians on the device using elaborate simulators.
“Being the first to enroll a patient in this trial demonstrates the commitment of Baptist and Lyerly Neurosurgery to clinical research and expanding options for brain aneurysm treatment in the region,” said Ricardo Hanel, MD, PhD, director of the Stroke & Cerebrovascular Center at Baptist Jacksonville and neurovascular surgeon with Lyerly Neurosurgery.
Baptist Jacksonville treated the first patient at the end of July. Baptist is the lead enrolling center with three patients treated in Jacksonville, including Dana Bean, 52, of Fernandina Beach. She had the procedure after having her small aneurysm monitored the past six years.
“I was sitting on a time bomb of not knowing. That is the scary thing about it,” Bean said, whose mother and grandfather died from an aneurysm. “The question of when and if it was going to happen was always there. It’s one of those things where you wake up in the middle of the night and think ‘what if’ and you start thinking about the people you love.”
The study looks at using the pipeline technique for aneurysms 12 mm and smaller and in various locations of the brain.
“This study will show the benefit of this breakthrough technology for smaller aneurysms and that patients can do well with these treatments,” Dr. Hanel said. “This will make it widely available for use by more patients.”
The pipeline procedure is more efficient, Dr. Hanel added, compared to other techniques such as coiling because, once the aneurysm is closed off, the possibility of the aneurysm reoccurring with the pipeline is close to zero.
The Baptist Stroke & Cerebrovascular Center hopes to enroll 20 to 25 people during the next six months, ages 22 to 80, and will continue to enroll patients for two years. Patients will be followed for a five-year period.
“Baptist Jacksonville is at the forefront in the assessment of newer technologies to improve the care of patients with brain aneurysms and strokes,” said neurovascular surgeon Eric Sauvageau, MD, who directs the Stroke & Cerebrovascular Center with Dr. Hanel.
For Bean, who is married and a sales manager for a dairy, she said, “There is a huge weight lifted off.” She’ll be monitored during the coming months and in six months, the aneurysm is expected to be gone.
“It’s an amazing thing they are doing. I think of how many people this could save,” Bean said.
Every year, an estimated 40,000 people in the United States experience a ruptured cerebral aneurysm and about 4 percent of the population may be living with an unruptured aneurysm.