SEATTLE, June 10, 2011 – David Newell, M.D., co-executive director of the Swedish Neuroscience Institute (SNI), had a peer-reviewed journal article published today about a study that is the first to report successful use of ultrasound technology to treat hemorrhagic stroke within the brain. The article, “Minimally invasive evacuation of spontaneous intracerebral hemorrhage using sonothrombolysis,” was published by the Journal of Neurosurgery in the JNSPGOnline section. The Journal is an international, peer-reviewed neurosurgical journal published by the American Association of Neurological Surgeons.
The groundbreaking study shows 33 patients presenting to the Swedish Neuroscience Institute in Seattle with spontaneous intracerebral hemorrhage (stroke). A small series of nine patients, who met the entry criteria, were entered into the initial trial. The patients were screened for inclusion in the SNI clinical study known as ‘SLEUTH’ (Safety of Lysis with Ultrasound in the Treatment of Intracerebral and Intraventricular Hemorrhage). The study occurred between Nov. 21, 2008 and July 13, 2009.
Using Ultrasound to treat Hemorrhagic Brain Stroke
Treatment was conducted in the operating room and included placement of a burr hole, as well as navigation of the ultrasound and drainage catheter into the hemorrhage using a GPS-like system (STEALTH) for optimal catheter placement. Ultrasound was then delivered to the brain blood clot, in addition to the thrombolytic (strong blood thinner) drug tissue plasminogen activator (rt-PA) for 24 hours.
“The faster you can remove a clot in the brain, the better. Time is of the essence when you are dealing with clot issues in the brain. In this procedure, we used a minimally invasive treatment approach that combines catheter-delivered ultrasound combined with a clot-busting drug,” said Dr. Newell. “The rapid removal of hemorrhage from the brain using this minimally invasive method is significant enough to warrant further study. Hemorrhagic stroke is the most serious type of stroke, but an effective and timely treatment can make the difference between life and death.”
Intracerebral hemorrhage is a devastating form of stroke. More than 2 million people experience intracerebral hemorrhage each year and there is no effective treatment available now. About half of all patients die within one month of the event from the extreme complications and lack of effective treatment. This stroke is particularly dangerous because of the inability of current, highly invasive techniques to drain the excess blood. Often, those who survive typically suffer dramatic loss of brain function and motor skills. Most patients are unable to resume normal activities such as caring for themselves, straining family members or requiring more extensive, expensive, ongoing, professional care further burdening the health-care system.
The study in the Journal shows that all patients had significant volume reductions in the treated hemorrhage and virtually no side effects, such as site infections or bleeding, during or after treatment.
“While we’re in the early stages of this research, it has the potential to provide huge benefits to people around the world. We’re excited about this procedure,” said Dr. Newell. “Catheter redesigns are taking place which promise to enable the technology to move it into further clinical studies.”
Current surgical care for patients presenting with these stroke symptoms is open craniotomy, with a small, 4-percent benefit that remains controversial. Craniotomy can be associated with poor patient stability, substantial brain tissue injury, and frequent re-bleeding. In IVH a ventriculostomy (ventricular drain) is placed into the contra lateral ventricle to drain cerebrospinal fluid which can build up pressure.
In contrast, data from human and animal models demonstrate that minimally invasive surgery (MIS) techniques and thrombolytics can substantially reduce blood-clot size and the area of brain tissue in direct contact with blood – resulting in better patient stability, substantially decreased tissue injury, and minimal bleeding or infection. The long-term goal of this research is to change the way ICH and IVH are treated, reducing brain injury with catheter-based surgical and clinical management.
One patient who took part in this study was a 38-year-old Port of Seattle cop who showed up to a local community hospital with signs of a hemorrhagic stroke. Doctors there told him that a lemon-sized blood clot was causing the stroke but it was inoperable due to the location of it. After some quick research he and his fiancé found Dr. Newell at SNI. In the end, the procedure successfully eliminated the blood clots.
The Washington State Life Sciences Discovery Fund, funded through money owing from Governor Christine Gregoire’s leadership in negotiating through the tobacco settlement for Washington state, provided a $170,000 grant, which allowed the SNI to team with Bothell, Wash.-based EKOS Corporation to conduct initial studies of this innovative treatment. EKOS, which has been working with Dr. Newell since 2007, is now well positioned to pursue the commercial viability of this breakthrough therapy. In 2010, the company won a $2.7 million grant from the National Institutes of Health to develop a device specifically designed to treat intracerebral hemorrhagic stroke.
Co-authors of the study include M. Mohsin Shah, M.D. (SNI); Robert Wilcox (Voyage Medical, Redwood City, CA); Douglas Hansmann, Ph.D. (EKOS Corporation, Bothell, WA); as well as Drs. Eric Melnychuk, John Muschekki and Daniel Hanley (Brain Injury Outcomes Center, The Johns Hopkins University School of Medicine).
Drs. David Newell and Moshin Shah do not report any conflict-of-interest concerning the materials or methods used in the study.
Swedish has grown over the last 101 years to become the largest, most comprehensive non-profit health provider in the Greater Seattle area with 8,500 employees, 3,000-physicians and 1,200-volunteers. It is comprised of four hospital campuses (First Hill, Cherry Hill, Ballard and Edmonds); emergency departments and ambulatory care centers in Issaquah, Redmond and Mill Creek; Swedish Visiting Nurse Services; and Swedish Medical Group – a network of more than 70 primary-care and specialty clinics located throughout the Greater Puget Sound area. Swedish recently opened a new emergency department and medical office building (MOB) on its Ballard campus and will open a new MOB and hospital in the Issaquah Highlands in the summer/fall 2011. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatric specialties, organ transplantation and clinical research. For more information, visit Swedish online at www.swedish.org, www.facebook.com/swedishmedicalcenter or www.twitter.com/swedish.
In 2007, Swedish embarked upon an ambitious $100 million fundraising campaign. Campaign investments are used to support a wide-variety of initiatives throughout the health-care system, including cancer, heart and vascular, women and children, neurosciences, and orthopedics as well as programs to support underserved populations. To date, the campaign has secured gifts totaling more than $74 million. For more information or to support the campaign, visit www.campaignforswedish.org.