Article Archive
Stroke Treatment Window Opens at Good Samaritan Hospital
Issue: September 2008
By: Juliet Farmer
Each year, almost 25,000 Bay Area residents suffer a stroke. Of those, very few will receive the type of treatment that saves brain function, thus offering positive quality of life.
That’s why in the stroke treatment community there’s a saying: “Time is brain.”
At Good Samaritan Hospital in San Jose, time is taken very seriously.
Good Samaritan Hospital (Good Sam), a leading acute care and tertiary service hospital, is one of the first five hospitals in the United States, and the first Hospital Corporation of America hospital, to undergo the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Survey on Stroke Care and Code Brain Attack Program, with certification effective December 2003.
Good Samaritan Hospital, the fourth largest hospital in Silicon Valley, opened in 1965 as a general acute care hospital. Not only is the hospital a designated Primary Stroke Center (PSC), their stroke team is also working to expand the stroke treatment window to provide better outcomes for stroke patients.
Two stroke team members, Dr. Harmeet Sachdev and Dr. Reza Malek, are involved in cutting-edge stroke treatments that could very well make the difference between life in a vegetative state and full stroke recovery.
Explaining the Window
Dr. Sachdev is a Board-certified neurologist and completed his neurology residency at Stanford University. When discussing strokes, he is quick to stress the importance of recognizing stroke symptoms in overall stroke recovery.
“The most important thing is the early and immediate recognition of stroke symptoms,” he explains. “With the heart, symptoms are different. But with the brain, there might be confusion, slurred speech, word usage problems, and/or numbness or weakness on one side of the body (i.e. arm or leg). The patient may even think he or she slept wrong. But it’s important not to ignore these symptoms and to speak to a healthcare professional right away. The window to save brain tissues is up to three hours, and in some cases six or eight, maybe up to 12 hours, but it’s definitely not a day. The sooner the better.”
Unfortunately, many stroke patients aren’t aware of a time issue. Studies show that the average person waits 13 hours after experiencing the first symptoms of a stroke before seeking medical care, and 42% of patients wait as long as 24 hours.
In July 1996, Dr. Sachdev was the first community neurologist and one of the first, if not the first California-based physician in a community hospital to offer intravenous tissue plasminogen activator (t-PA) treatment, a thrombolytic agent that works by dissolving the clot that is blocking the blood vessel in the stroke patient’s brain. He says that t-PA yields 90-100% recovery in approximately 40% of patients, but that not all patients receiving t-PA respond to this treatment, depending on the cause of the stroke.
According to Dr. Sachdev, treating strokes is a very fast-paced, complicated decision-making process. That’s why he pushed for a designated stroke team at Good Sam, which today is a model he presents to various hospitals all over the country.
The dedicated stroke team, which is available 24/7, includes a medical director, stroke neurologists, ICU physicians, and two stroke nurse coordinators, along with neuroradiologists and specially-trained stroke nurses, all of whom oversee the stroke patient’s care from entry into the emergency department through discharge.
Even with a stroke team in place, the numbers are still daunting.
“There are 500 to 600 strokes per year at Good Samaritan Hospital” Dr. Sachdev notes. “At Good Sam, 55% of patients have shown complete recovery, where I used to have to send paralyzed patients to nursing homes…from 1996 to 1999, 4.8-5.6% of stroke patients received t-PA, but now that awareness is so high and the window has been extended to eight hours, our rate is 11-13%, one of the highest in the Bay Area.”
Access to Primary Stroke Centers is another key in stroke recovery. Even after treatment centers started offering t-PA, patients would often end up in hospitals without stroke teams and therefore didn’t receive treatment in time. Now, certain criteria are required to achieve Primary Stroke Center certification, such as having a rapid response team in place, as well as the availability of two CT scanners 24/7 (one is used as a backup).
Expanding the Window
The three-hour stroke treatment window has been expanded dramatically in some cases with the use of devices that mechanically remove clots—devices such as Merci that have the potential to extend the treatment window eight to 12 hours, depending on the location of the stroke-causing clot.
The Merci Retrieval System™ is comprised of three products: the Merci Retriever®, the Merci® Balloon Guide and the Merci® Microcatheter. The Merci Retriever is a shaped wire constructed of nitinol, a "memory wire," which allows delivery of the Retriever in linear form through blood vessels via the Microcatheter. The Retriever returns to its coiled shape when deployed in and around the blood clot in the brain. This design is intended to help reduce potential damage to the delicate artery walls in the brain, which can lead to dissection, perforation and sometimes to hemorrhage and/or death, some of the risks among interventional devices.
The Merci Balloon Guide is used to facilitate the insertion and guidance of other catheters into the selected vessels in the brain. When the Retriever captures the blood clot, the balloon at the far end of the Balloon Guide is inflated in order to impede blood flow in the treatment area during the procedure, assisting with retraction of the blood clot. In a successful procedure, the Merci Retriever and the blood clot are withdrawn together into the Balloon Guide.
The Merci Microcatheter is a single lumen catheter designed to navigate and deliver the Retriever under x-ray guidance to the affected portion of the brain. Because the Retriever needs to be held in its linear form during delivery, the Microcatheter is designed specifically to be strong enough to keep the Retriever straight yet delicate and flexible enough to be safely and easily delivered into the brain. The outer shaft of the Microcatheter also has a hydrophilic coating designed to assist in navigating through the often narrow and winding vessels in the brain.
In addition to Merci, other research is working to take the window up to 14 hours using a balloon, according to Dr. Sachdev. So far, he says the results look promising, and they are in Phase 3 of the efficacy study. Good Sam is a participating hospital.
Another recent development in stroke treatment is the WingSpan Stent System, the first and only stent that’s made and approved for opening blood vessels in the brain. The stent delivery is much further and can reach vessels inside the brain as small as 2.5 mm.
The device, which is typically used in patients who are failing medical management, helps restore blood flow for patients with intracranial atherosclerotic disease (ICAD). Surgeons insert the stent up the leg arteries, guide it to the brain, then let its wire mesh expand, propping open a clogged blood vessel.
In the case of Transient Ischemic Attacks (TIAs) or "mini-strokes," up to 35% of those who experience one will have a full-blown stroke if left untreated. Instead of putting a TIA patient on aspirin or Plavix, the stent can be used to prevent future strokes.
Dr. Reza Malek, who specializes in Diagnostic Radiology, Neuroradiology, and Vascular and Interventional Radiology, graduated from Jefferson Medical School and spent his cardiovascular and interventional radiology fellowship at Brigham & Women’s Hospital, Harvard Medical School. He later completed a neurointerventional fellowship at UCSF Medical Center. He has been involved with Merci since the beginning, but says it will only help so long at the patient is “within the treatment window, at the correct hospital.”
“There is a bottleneck for the treatment of strokes,” he adds. “Only 300 physicians can do this [treatment]. In California, there are less than 30, with only 12 in private practice, so less than one percent of stroke patients receive the treatment.”
According to Dr. Malek, the reason for the physician shortage is that, due to the complex anatomy of the brain, training is long—an additional seven to nine years after medical school. It’s also a new specialty to medicine.
Then there’s a question of volume.
“Physicians can’t make livings only treating strokes,” he explains, “so they also treat brain aneurysms and other vascular diseases of the brain.”
Regarding treatment protocol, the current emphasis is on creating a two-tiered system where, where within two and a half hours of onset of symptoms, a patient goes directly to a PSC, and if it’s between two and a half and six hours within onset of symptoms, the patient is taken immediately to a comprehensive stroke center, in some cases bypassing the PSC all together.
Preventing the Need for a Window
According to physicians, technology will only take you so far, and the best form of stroke prevention is education and awareness.
That’s why Dr. Sachdev is involved in the Stroke Awareness Foundation, which was formed by three prominent local residents—retired businessman Charles E. Hoffman; President and CEO of the San Jose Silicon Valley Chamber of Commerce Pat Dando; and contractor/developer Charles J. Toeniskoetter—who each suffered but fully recovered from strokes.
All three discovered that there was a lack of knowledge among both the public and healthcare professionals about stroke identification and treatment, so they formed an organization that would not only educate the public about stroke warning signs, but also assure that people get transported by emergency medical vehicles to a JCAHO accredited stroke center for the most effective and efficient treatment. The Stroke Awareness Foundation’s mission is to improve community awareness of stroke, its treatment and related health issues through research, education, outreach and communications programs and activities in the community. (For more information, go to www.strokeinfo.org.)
Dr. Malek also advocates a proactive approach to treatment, adding, “I think still the majority of primary care physicians only prescribe aspirin or Plavix for TIAs, but treatment has moved way beyond that. I think every patient who has TIAs needs to find out why they are having them.”
“The most effective treatment is to not have a stroke at all,” he adds. “If patients drop their blood pressure by 10 points, their risk drops by 50%.”
Dr. Sachdev echoes the sentiment.
“Prevention is most important. Know the risk factors. Hypertension, the most undiagnosed and under-treated disease in the world, increases the risk of stroke by 17%. Diabetes increases the risk by 9%. Smoking by 6%. Family physicians need to become more aggressive as primary educators,” he concludes.
It’s precisely that proactive approach, along with swift medical response, specialized treatment devices, and community education and awareness, that is enabling Good Samaritan Hospital to turn the narrow treatment window into an open door for time-sensitive stroke treatment.
