SEATTLE, Feb. 25, 2010 – David Newell, M.D., co-executive director of the Swedish Neuroscience Institute (SNI) in Seattle today presented results of a groundbreaking study of 33 patients with spontaneous intracerebral hemorrhage who were screened for inclusion in a SNI clinical study known as ‘SLEUTH’ (Safety of Lysis with Ultrasound in the Treatment of Intracerebral and Intraventricular Hemorrhage). The presentation took place at the American Heart Association’s International Stroke Conference in San Antonio, Texas. Co-authors of the study include Mohsin Shah, M.D., (SNI); Daniel F. Hanley, M.D., Johns Hopkins University Medical School (Baltimore, MD); Douglas Hansmann, Ph.D., and Robert Wilcox (Bothell, WA).
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 hemorrhage, in addition to the thrombolytic (strong blood thinner) drug tissue plasminogen activator (rt-PA) for 24 hours.
Intracerebral hemorrhage is a devastating form of stroke. Half of all patients die within one month of the event, and those who survive typically suffer dramatic loss of brain function and motor skills. Often, they 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 more quickly a clot can be removed the better, and hours count. A minimally invasive treatment approach that combines catheter-delivered ultrasound in conjunction with a clot-busting drug was used,” said Dr. Newell. “This new therapy has shown promising and encouraging results.”
The most surprising thing we discovered was how rapidly the hemorrhage disappeared with ultrasound,” said Dr. Newell. “And there were virtually no side effects, such as site infections or bleeding, during or after treatment.” Dr. Newell emphasized that a multi-center trial for safety and efficacy with a redesigned catheter is warranted. “If this technique is proven to work on several hundred patients in a controlled study, it will provide huge benefits. Two million people worldwide experience intracerebral hemorrhage each year and there is no effective treatment available now. This has great potential to address the problem without cranial surgery.”
The Washington State Life Sciences Discovery Fund – funded through money that Governor Christine Gregoire successfully helped appropriate for Washington state through the tobacco settlement –provided a $170,000 grant, which allowed SNI to team with Bothell, Wash.-based EKOS Corporation to evaluate 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.
Background on Intracerebral hemorrhage
Intracerebral hemorrhage (ICH) occurs in more than 100,000 Americans each year and has no effective treatment. It is fatal in 30 percent to 50 percent of all occurrences and the majority of survivors have significant motor and cognitive disability. The severity of brain injury is related to the volume of blood clot and the exposure time. ICH is easily and rapidly identified. It occurs in younger patients, and it initially produces a smaller injury to the cerebral tissues, suggesting that improvement is possible with the right intervention that promotes effective blood-clot removal.
ICH is frequently complicated by intraventricular hemorrhage (IVH). IVH increases mortality to as high as 80 percent. IVH obstructs cerebrospinal fluid (CSF) flow and leads to hydrocephalus. Re-establishing CSF flow is considered a neurosurgical emergency requiring ventricular catheter placement. These catheters control ICP, but do not enhance blood removal. Research demonstrating the value of blood removal suggests that rapid and complete removal is desirable, but rarely achieved rapidly with current technology. It has been recently demonstrated that ultrasound markedly increases the rate of blood-clot lysis (break down) produced by the thrombolytic substance recombinant tissue plasminogen activator (rt-PA).
Current surgical care for ICH 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. This innovative approach combines local delivery of rt-PA with ultrasound enhancement to provide effective blood-clot removal.
Swedish is the largest, most comprehensive non-profit health provider in the Greater Seattle area. It is comprised of three hospital campuses – First Hill, Cherry Hill and Ballard – a freestanding emergency department and ambulatory care center in Issaquah, Swedish Visiting Nurse Services, and the Swedish Physician Division – a network of more than 40 primary-care and specialty clinics located throughout the Puget Sound area. In the fall of 2009, Swedish broke ground on a new medical office building and hospital in the Issaquah Highlands, as well as a medical office building and ambulatory center in Ballard. 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 www.swedish.org
About Swedish Neuroscience Institute
In 2004, Swedish expanded its neuroscience services by establishing the Swedish Neuroscience Institute. The team of leading neurosurgeons and other specialists are building a world-class institute dedicated solely to the treatment and advancement of neurological disorders for patients in the Pacific Northwest and around the world. Swedish/Cherry Hill has been designated as the hub for the Institute and has been upgraded with four state-of-the-art operating rooms featuring intra-operative MRI, CT scanning and neuro-interventional radiology capabilities; a renovated neuro intensive-care unit; and a CyberKnife® facility for radiosurgical treatment of tumors throughout the body. SNI specializes in the research for and treatment of stroke; cerebral aneurysms and arteriovenous malformations; movement disorders such as Parkinson’s disease and tremors; brain tumors (including both malignant tumors and benign tumors such as meningiomas); neuro-endocrine disorders including pituitary tumors; epilepsy; child neurological disorders; neuro-ophthalmology; headaches; multiple sclerosis and many other neurological conditions and diseases. In each category, physicians from different specialties are brought together to provide a multi-disciplinary approach centered on providing top-notch patient care. For more information, visit www.swedish.org
Drs. David Newell and Moshin Shah do not report any conflict-of-interest concerning the materials or methods used in the study.
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