result from a weakened area in an artery of the brain that fills with blood and causes outward bulging or ballooning.

The Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial () focuses on the safety and effectiveness of the SEAL system, which can be used to treat patients with ruptured and unruptured brain aneurysms in a range of sizes.

“I’m excited to be a part of groundbreaking aneurysm treatment research, and for the opportunity to bring patients in Louisville and the surrounding region a novel treatment option not yet widely available,” said  a neurosurgeon with Brain & Spine Institute and assistant professor in the UofL Department of Neurological Surgery. “The device is small enough that we can use a minimally invasive technique via an artery in the groin to deliver the device and disrupt the blood flow to the aneurysm, causing it to clot and heal, while decreasing the need for more invasive procedures like a craniotomy.”

Patients with brain aneurysms are usually asymptomatic until their aneurysm ruptures. A ruptured aneurysm is a form of stroke and a potentially life-threatening condition that can result in brain damage or death.

“As an academic health care system affiliated with the University of Louisville, we are committed to providing our patients with the latest innovative treatments, including those offered through clinical trials,” said Joshua Beardsley, system vice president of neurosciences and spine. “I’m proud of our providers for helping to pioneer the next generation of aneurysm care.”

About SEAL IT

SEAL IT is a prospective, U.S. and international single-arm, multicenter, interventional study. The clinical trial seeks to establish the safety and effectiveness of the system in treating patients with wide neck unruptured or ruptured intracranial aneurysms that are less than or equal to 19 millimeters in widest diameter. Data such as imaging and patient presentation will be collected from participants immediately after their procedure in addition to three, six and 12 months after their procedure. Participants will receive follow-ups annually for five years.

Doctors found she had not one, but three. Robert James, MD, a neurosurgeon at , treated two of her aneurysms with minimally invasive stents, but the location of the third, at a juncture of arteries, was not conducive to stent treatment.

In January, the U.S. Food and Drug Administration approved the WEB Aneurysm Embolization System for treating this type of aneurysm, and on Feb. 13, Steinhilber was one of the first three patients in Kentucky to be treated with the device at .

An aneurysm is an enlarged, weakened area of an artery that results in a bulging or ballooned area in the artery. Untreated, an aneurysm in the brain may rupture, causing severe disability, cognitive loss or death. The WEB system, James said, provides a new, minimally invasive option for treating wide-necked bifurcation aneurysms, which occur at the juncture of two arteries. In the procedure, a mesh basket is placed inside the aneurysm, allowing blood to bypass the opening, which seals itself off over time, creating a permanent cure.

“If we can fix the aneurysm before it bursts and cure it, then the threat of this aneurysm bursting and the patient dying from it essentially goes away,” James said. “The WEB device is a game changer for the minimally invasive treatment of aneurysms.”

Steinhilber is grateful to have more advanced options for treating her condition. Two of her sisters were treated for aneurysms in the past. One required re-treatment and another was unable to be treated for one aneurysm due to its location. A third sister died suddenly from what may have been a ruptured aneurysm.

“Seeing the history of my sisters, I feel very good about what the UofL doctors are doing here,” Steinhilber said. “It’s wonderful to see the progress made in treating aneurysms.”

As many as 6 million people in the United States are estimated to have an unruptured brain aneurysm. Coils and stents have provided minimally invasive options for some types of aneurysms, but James explained those options have limitations in their use, and may have negative features.

The WEB (an acronym for Woven Endo-Bridge) device is approved for treating wide-neck bifurcation aneurysms, which may account for 35 percent of all brain aneurysms. James completed the first three procedures in Kentucky with the device since it received FDA pre-market approval on Jan. 7. He had previous experience in performing the procedure, having participated in the device’s clinical trials.

During the WEB system procedure, a small catheter is threaded from the groin area through the patient’s artery to the aneurysm site. Using fluoroscopy imaging, the surgeon deploys the WEB device into the “sack” of the aneurysm, where its flexible mesh conforms to the aneurysm walls, minimizing blood flow inside the aneurysm. In most cases, over time, the body seals off or occludes the neck of the aneurysm, essentially curing it.

In clinical testing, the WEB system was shown to be highly effective and safer than other options. In addition, the minimally invasive nature of the procedure means most patients, including Steinhilber, are able to go home the next day.

In addition to unruptured aneurysms, the WEB system may be used in some cases in which the aneurysm has already ruptured, providing more desirable options for treatment.

“This device also gives us the ability to use flow diversion in already ruptured bifurcation (branch point) aneurysms to prevent them from re-rupturing, which we have never been able to do before,” James said.

The WEB system, marketed by MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, has been used safely in more than 6,000 cases outside the United States as well as clinical studies here and abroad.

Re-certification as a CSC, the highest designation of care for stroke patients awarded by The Joint Commission, the primary independent accrediting body for health-care systems in the United States, assures patients that the physicians, nurses and other providers at UofL Hospital are fully prepared to quickly assess and treat patients suffering from all types of strokes using the most advanced treatments available. The Joint Commission re-certified the UofL program for two years, the maximum time period allowed for certification.

“We are proud to serve the citizens of our region with the highest level of integrated stroke care. We will continue to set the bar in Kentucky and Southern Indiana when it comes to stroke prevention and treatment,” said Kerri Remmel, MD, PhD, chair of the Department of Neurology at the UofL School of Medicine and director of the University of Louisville Stroke Program.

Patients are treated by the highly trained and specialized physician faculty members of the UofL School of Medicine, including neurologists, neurosurgeons, cardiologists, emergency medicine providers, neuro-radiologists, vascular surgeons, hospitalists and neuro critical care providers. The multidisciplinary team also includes advance practice nurses, social workers, rehabilitation specialists, case managers and dietitians.

Comprehensive stroke centers such as UofL have the ability to care for patients suffering a stroke, 24-hours a day, 7 days a week, and perform procedures that may not be available elsewhere. When a patient arrives in the emergency department at UofL Hospital, examination, laboratory studies, cardiac tests and state-of-the-art imaging studies can be performed within minutes of a patient’s arrival.

Highlights of the UofL Stroke Program include:

• Rapid delivery of clot-busting drug – The UofL Stroke Program achieved the highest award status from the American Heart Association/American Stroke Association, Target: Stroke Elite Plus Honor Roll, in 2016 for prompt IV administration of the clot-busting drug ). UofL met the standard of administering the drug to more than 75 percent of patients who qualify within 60 minutes of arrival to the hospital, and to more than 50 percent of eligible patients within 45 minutes of arrival.
• Clot-removal techniques – UofL neurointerventional specialists can rapidly open blocked blood vessels by removing blood clots and quickly restoring neurological function to patients.
• Aneurysm treatment – UofL neurosurgeons and interventional specialists are experts with the latest treatments for brain aneurysms, whether with surgery or minimally invasive endovascular coiling techniques.
• Tele-stroke consultations – UofL neurologists provide their expertise to hospitals in outlying communities in Kentucky and Southern Indiana in real time via tele-stroke services. Using a 5-foot, 6-inch-tall robot, physician specialists in Louisville can interact and converse with a patient, the patient’s family, and on-site physicians and nurses through a live, two-way audio and video feed. The remote connection allows neurologists at UofL to more quickly determine the best treatment protocol for patients in their home hospitals and allow them to be treated with IV t-PA or other treatments quickly when appropriate.
• Post-stroke support – In addition to inpatient care, the UofL Stroke Program provides stroke survivor and caregiver support to improve patients’ wellbeing as they resume their daily lives.
• Community education – UofL Stroke Program team members reach out to educate community members about reducing the risk of stroke by monitoring their blood pressure and maintaining healthy habits.

Even prior to its designation as Kentucky’s first certified Comprehensive Stroke Center in 2012, the UofL Stroke Program achieved the highest recognition with the American Heart Association/American Stroke Association, receiving the Get with the Guidelines Stroke Gold Plus Award for the last 11 years. The recognition is awarded for meeting performance guidelines for the treatment and management of stroke patients from hospital admission to discharge.