07
Apr
15

Swedish Medical Center Testing New Brain Aneurysm Treatment Technology

Joe Niekro Foundation Medical Advisory Board Member, Dr. Donald Frei of Swedish Medical Center, is leading the study of an investigation device called WEB to treat brain aneurysms. Swedish is one of the 20 sites across the country doing trials on this new technology.

The device is already approved in Europe, and doctors just put it into the first patient in Colorado.

“Brain Aneurysms are deadly, and if we can come up with better and safer and more effective ways of treating brain aneurysms, we absolutely should do that,” said Dr. Don Frei with Radiology Imaging Associates.

The new technology is a tiny metal mesh sphere that expands inside the artery to seal of the aneurysm. It  is a revolutionary treatment for challenging ruptured and unruptured aneurysms. The initiation of the WEB study represents an important milestone for this exciting technology platform and a critical step towards improving outcomes in a patient population with significant unmet needs.

The idea — if blood can’t get in, it can’t rupture.

“We have no idea if this device is going to be better than what’s out there already and that’s what the study is going to try to find out,” said Frei.

The study will enroll 139 patients at hospitals across the United States and in Canada and Europe.

22
Mar
15

How Do You Know if You are Suffering from Depression?

By: Kimberly Chapman – Patient Advocacy Director/Support Group Coordinator

Recently, I had the honor of speaking with a well-known neuropsychologist. I asked him how he can tell if his patients are truly suffering from depression as opposed to the normal sad feelings a survivor might typically experience. He described the exact test he gives his patients to help determine if depression has set in:

1. You call your financial planner and tell him to invest $20,000 into a high risk investment. A week later your financial planner calls you and states all $20,000 was lost in a bad investment.
How do you feel?

2. A couple of hours later the financial planner calls back exclaiming, “Woops, I made a mistake. I meant to say you lost $5,000. You still have $15,000 left of your initial investment.”
Now, how do you feel?

The point of this experiment is to see if your emotions and feelings change between scenario #1 and #2. The depressed survivor will not find any joy or the smallest amount of relief in scenario #2. Instead, it might compound the depression even further.

Depression after having a brain aneurysm/AVM is the most common mental health disorder. In fact, I suffered from depression immediately following my ruptures. Unfortunately, my depression eventually turned into rage. Not only was this time in my life lonely but it was scary. I’ve never felt so alone and disconnected as I did when the depression took hold of me. At the time of my ruptures, there was scarcely any information or educational materials for survivors to inform themselves. No one told me that depression is a side effect from experiencing a brain aneurysm.

For those survivors that feel depression might have a hold of them, understand there is absolutely no shame in having this disorder. Please know you have the right to be upset or even mad about what has happen in your life, but it should never go beyond this. Life is not about suffering. Depression has a high cure rate and can be treated by a medical professional relatively quickly.

Anyone can give up and bury their head in the sand, it’s the easiest thing in the world to do. But to hold it together when everyone else would understand if you fell apart, that’s true strength.

Although the world is full of suffering, it is also full of the overcoming of it. ~ Helen Keller

To read more on depression and coping, please click here.

14
Mar
15

NEW TREATMENT EVIDENCE FOR THE MOST SEVERE STROKES

Written by JNF Medical Advisory Board Member – Dr. Michael Chen of Rush University

More common than ruptured brain aneurysms, and still involving brain blood vessels, is ischemic stroke.  A blockage of a major blood vessel in the brain can cause a range of neurological problems and disabilities depending on what part of the brain is deprived of blood. The severity of the stroke and disability depends on the size and location of the blockage. Fortunately, new evidence from multiple stroke studies published in the New England Journal of Medicine, from the US, Canada, the Netherlands and Australia show convincing, statistically robust evidence that those patients who have these emergent large vessel occlusions (ELVO) within the first few hours after symptom onset, do much better if they undergo an interventional procedure to remove the clot.

Much like the procedure involved with placing endovascular coils or flow-diverters for brain aneurysms, there are also devices that are used within a patient’s arteries that can remove clots. These devices have been in use for over 10 years, and the most recent design iterations such as the stent-triever have shown favorable performance. Performance is measured in how complete blood flow restoration to the previously affected brain region can be achieved.

This treatment is not for every stroke patient. Patients with less severe neurologic deficits such as slight face and arm numbness and weakness without additional symptoms, likely have only a small blood vessel affected and should make a favorable recovery spontaneously. Those patients who do have large blood vessel occlusions sometimes have poor brain vascular reserve and the affected brain undergoes irreversible injury very rapidly (within minutes) would also not benefit from interventional blood flow restoration. It is really those patients who have severe deficits who still have brain tissue that is “holding its breath.” The brain tissue is stunned, but not irreversibly injured yet. Flow restoration in these cases can prevent progression to irreversible injury and restore the function that brain region was responsible for.

Much of our focus now is how to effectively deliver this proven treatment for a population of patients that are in real need for an effective therapy. It’s no use to have a proven therapy but no effective system in which to deliver it. Because time is so critical, well-designed and highly dedicated teams and systems are required to achieve favorable clinical outcomes. Many comprehensive stroke centers are investing resources in creating efficient internal workflows that can coordinate multiple services to function nearly simultaneously. Just as important is shortening the times by which a patient develops a symptom and arrives to the hospital. Stroke awareness, particularly how to recognize severe strokes caused by an ELVO, by first responders may hopefully lead to preferential triage of these patients to comprehensive stroke centers, saving hours that might be spent at a hospital that doesn’t provide these types of therapies.

12
Feb
15

GROUNDBREAKING STUDIES FIND THAT NEUROINTERVENTIONAL SURGERY REDUCES STROKE MORTALITY

WASHINGTON, DC – February 11, 2015 – Two new clinical trials on the treatment of stroke (ESCAPE and EXTEND IA) demonstrate that neurointerventional surgery significantly increases the number of patients who are able to live independently without major neurological disabilities. The ESCAPE study, published today in the New England Journal of Medicine, also shows that neurointerventional surgery reduces stroke mortality by 50 percent.

ESCAPE (Endovascular treatment for Small Core and Anterior circulation Proximal occasion with Emphasis on minimizing CT to recanalization times) and EXTEND IA (Extending the Time for Thrombolysis in Emergency Neurological Deficits – Intra-Arterial) are two of three studies (together with SWIFT PRIME) that confirm the MR CLEAN study published in the New England Journal of Medicine late last year—which showed that the addition of inside-the-artery clot removal is more effective than IV-administered “clot-busting” tissue plasminogen activator (IV-tPA) treatment alone for the treatment of stroke.

“All three of these studies confirm what we are seeing in everyday practice. In many cases, instead of suffering major neurological disability, patients are able to go home to resume their lives,” said Dr. Peter Rasmussen, director of the Cerebrovascular Center, Cleveland Clinic in Cleveland, Ohio, and president of the Society of NeuroInterventional Surgery (SNIS). “Within-the-artery procedures, which are performed by neurointerventional surgeons, are not the appropriate treatment for every patient suffering from stroke, but for those patients experiencing the most severe types of ischemic strokes, they are life-saving, viable and effective therapies that offer many benefits over traditional treatments, including shorter recovery times and a better chance to return to normal activities.”

ESCAPE is the first study to show that the overall stroke mortality rate was reduced by 50 percent with neurointerventional surgery, from two in 10 patients for standard-of-care treatment to one in 10. ESCAPE and EXTEND IA showed better outcomes for those patients treated with neurointerventional surgery. In ESCAPE, nearly 30 percent of patients treated with IV-tPA treatment alone were able to live independently without major neurological disabilities. For patients receiving neurointerventional surgery, that number increased to 53 percent. EXTEND IA showed even better results, with 71 percent of patients who received neurointerventional surgery returning to independent living, compared with 40 percent in the standard treatment group.

According to Dr. Peter Mitchell, co-principal investigator of EXTEND IA and the director of neurointervention at the Royal Melbourne Hospital, two of the key differences in better outcomes for stroke patients were the use of more advanced brain imaging to select patients most likely to benefit and earlier treatment. The Royal Melbourne Hospital, where the EXTEND IA study was conducted, treats approximately 500 ischemic stroke patients a year and is one of the few stroke centers in the world to treat patients within 20 minutes of arriving in the emergency department.

According to Dr. Donald Frei, a neurointerventional surgeon at Radiology Imaging Associates in Denver, Colo., and president-elect of SNIS, treatment time is critical. While ESCAPE showed that neurointerventional surgery can be performed up to 12 hours from the onset of stroke, the success of the trial can be credited to fast treatment and the use of brain and blood vessel imaging. In ESCAPE, researchers were on average two hours faster in opening the blocked blood vessels than in previously reported trials.

“These positive studies are important milestones in the transformation of care for stroke patients, but it’s also important to understand that the comprehensive stroke centers that participated excel in providing this type care,” said Dr. Frei. “The results may not be replicable in every hospital. It’s important that when stroke occurs, the disease is identified quickly and patients are transported to facilities that are equipped to provide the best evidence-based interventions for ischemic and hemorrhagic stroke management.”

ESCAPE included 22 sites worldwide and patients in the U.S., U.K., Ireland and South Korea and evaluated the effect of endovascular treatment for patients with acute ischemic stroke caused by a clot obstructing one of the major intracranial arteries. The study was ended early because it crossed the pre-specified boundary for efficacy. The study included 316 patients who fit the criteria for neurointerventional surgery and arrived for treatment within 12 hours of their stroke who were randomized to standard medical care (which included the IV-tPA where appropriate) or standard medical care plus neurointerventional surgery.

The EXTEND IA trial compared IV-tPA to IV-tPA and neurointerventional surgery in patients with acute ischemic stroke receiving IV therapy within 4.5 hours of stroke onset. Patients were selected using CTA and CTP to identify those with large vessel occlusion and small core infarct with significant volume of “threatened” tissue. The trial was stopped early because of efficacy when 70 of the intended 100 patients had been randomized (35 to each arm) after the presentation of the MR CLEAN results prompted the DSMB to perform a pre-specified analysis.

Of 695,000 people who suffer acute ischemic stroke in the U.S., 40 percent have a large-vessel blockage, which often leads to death or permanent disability. These neurointerventional procedures have potential life-saving benefits for almost 300,000 people in the U.S. who suffer a stroke with a large vessel blockage. Stroke is the leading cause of disability and the fourth cause of death in U.S. In 2010, stroke cost the U.S. an estimated $54 billion, including the cost of health care services, medications and missed days of work. Strokes cost $74 billion in health care expenditures annually for treatment due to disability.

Neurointerventional surgery is a critical piece of a system of stroke care that has helped reduce death rates from stroke by more than 35 percent from 2000 to 2010. This includes public education to reduce risk factors and recognize the symptoms of stroke, emergency medical services processes and protocols to appropriately assess patients and emergency transport guidelines that immediately deliver stroke patients to a comprehensive stroke center. SNIS works to develop general standards to define principles of practice that will produce high-quality care and provides guidance on standardized techniques, procedures and practices in the neurointerventional field, not only to improve health care outcomes but also to define the core practice from which this specialty can build and grow.

02
Feb
15

Best Friends Together Again

Today, the world lost a wonderful man and heaven gained a true angel.  Dave Bergman, former Chairman of the Board of The Joe Niekro Foundation and best friend of the late Joe Niekro, passed away this morning after a fearlessness battle with cancer.  There aren’t words to describe what this man meant to the entire Niekro family and the Joe Niekro Foundation and the incredible human he was.  As we watched Dave fight this dreaded disease for nearly three years, we all can say we learned a valuable lesson in heroism and courage.  Not once did we hear Dave complain, question why, give up or lose hope.  Instead, we saw a man who met the cancer demon head on and gave it a fight it had never imagined.  Today, Dave joined his best friend in heaven, leaving a legacy that will forever live on.

There aren’t many memories the Niekro family has without Dave in them.  From 1978 when he approached Joe in the Houston Astros locker room, calling him “Mr. Niekro”, to just this year when Dave spoke to me about how impressed he was on the progress of the foundation.  When I decided to start the foundation, Dave was the first person I called to ask if he would participate on the board.  I knew he would share the same passion that I did for the man he called his best friend.  Dave has been like my second Dad from the time I could walk and my heart is broken for the hole his passing leaves with us all.

I will never forget Dave stepping out of the elevator at St. Joseph’s Hospital in Tampa, FL after hearing the news of Dad’s aneurysm.  He had a look on his face that will stay with me forever.  Dave was the first one there when Dad died, and I can guarantee that Dad was the first one to meet Dave at the pearly gates today, with a fishing pole in one hand and a baseball glove in the other.  As most of you know, fishing was their passion and not a story they told didn’t have something about “snook fishing” in it.  Best friends, together again!

Dave, you will forever be missed and we are all so thankful for the service, love, compassion and support you gave to us all.

everglades IMG_0291

18
Jan
15

JNF Awards $90,000 in Research Grants

The Joe Niekro Foundation has announced the 2014 Joe Niekro Research Grant recipients.  A total of $90,000 has been awarded by the foundation, which is committed to supporting patients and families, research, treatment and awareness of brain aneurysmsAVMs and hemorrhagic strokes.  “We are thrilled to award these recipients with this critical funding needed to help support the advancements of neurological research,” states JNF Founder, Natalie Niekro.

The first awardee, Barrow Neurological Institute, has received a seed grant in the amount of $50,000 for the study Deconstructing the vascular tangle-A molecular biopsy of cerebral arteriovenous malformations by Dr. Joseph Zabramski and Dr. Yashar Kalani.  This groundbreaking study will aim to understand the pathogenesis of AVM formation and identify signaling pathways involved in vascular development and AVM formation.

JNF Founder Natalie Niekro along with Board of Directors Members (from left to right) Bill Michels, Kimberly Chapman, Gary Simms and Linda Michels present a $50,000 research grant to Drs. Yashar Kalani and Joseph Zabramski.

JNF Founder Natalie Niekro along with Board of Directors Members (from left to right) Bill Michels, Kimberly Chapman, Gary Simms and Linda Michels present a $50,000 research grant to Drs. Yashar Kalani and Joseph Zabramski.

A $20,000 grant will go to the University of Michigan for the project, Intraventrical injection of noncellular fluid from subarachnoid hemorrhage patient leads to ventricular enlargement and periventricular injury, by Dr. Aditya Pandey.  This current project aims to understand the role of human subarachnoid hemorrhage (SAH) non-cellular cerebral spinal fluid (CSF) in causing hydrocephalus and periventricular cellular injury.

The final recipient, the SNIS Foundation who received a $20,000 award for the Joe Niekro Research Grant. This annual grant enables investigators to conduct pilot projects related to brain aneurysms, AVMs or stroke. It is the intention of the grant that the seed data from these projects will indicate feasibility and appropriateness of the research prior to applying for further funding; therefore, emphasis will be placed on research deemed to have the most potential for future funding.

Since inception, the Joe Niekro Foundation has awarded over $500,000 in research funding and has built a patient advocacy network that expands across the globe. The foundation provides education on the causes, risk factorsand treatments of these conditions, while funding the advancement of neurological research.

Click here to view the list of previously funded projects.

For more information about funding opportunities including program guidelines and contacts, visit http://www.joeniekrofoundation.com/research-grants/grant-guidelines/.

29
Dec
14

Groundbreaking Study Confirms That Neurointerventional Surgery Provides Significant Clinical Benefit

Study is most significant stroke treatment clinical trial since NINDS-2 says Society of NeuroInterventional Surgery

WASHINGTON, DC – December 17, 2014 – A new study published in the New England Journal of Medicine confirms that the addition of inside-the-artery clot removal is more effective than IV-administered “clot-busting” tissue plasminogen activator (IV-tPA) therapy alone for the treatment of stroke. These endovascular (or neurointerventional) procedures have potential life-saving benefits for almost 300,000 people in the United States who suffer a stroke with a large vessel blockage, says the Society of NeuroInterventional Surgery (SNIS).

Of 695,000 people who suffer acute ischemic stroke in the U.S., 40 percent have a large-vessel blockage, which often leads to death or permanent disability. MR CLEAN (Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands) evaluated the effect of endovascular treatment for patients with acute ischemic stroke caused by a clot obstructing one of the major intracranial arteries. The study showed that inside-the-artery clot removal during early treatment nearly doubled the likelihood of a good neurological outcome and that it worked well for patients who had received IV-tPA and for those who had contra-indications for IV-tPA.

“The MR CLEAN Study confirms what we are seeing in everyday practice,” said Peter Rasmussen, MD, director of the Cerebrovascular Center, Cleveland Clinic in Cleveland, Ohio, and president of SNIS, “Within-the-artery procedures, which are performed by neurointerventional surgeons, are not the appropriate treatment for every patient suffering from stroke, but for many patients they are life-saving, viable and effective therapies that offer many benefits over traditional treatments, including shorter recovery times and a better chance to return to normal activities.”

According to Dr. Donald Frei, a neurointerventional surgeon at Radiology Imaging Associates in Denver, Colo., and president-elect of SNIS, MR CLEAN is the most significant randomized, controlled stroke treatment study since the NINDS-2 trial in 1995 and subsequent FDA approval of IV-tPA. While IV-tPA revolutionized stroke care, it must be administered within 4.5 hours. Neurointerventional surgery can be performed up to 6 hours from the onset of stroke, significantly expanding the treatment window.

“MR CLEAN is an important milestone in the transformation of care for stroke patients, but it is not the end of the story,” said Dr. Frei. “Neurointerventional surgery is a relatively young and rapidly changing field that typically outpaces clinical research, and we need to ensure that these treatments—their success evident in thousands of lives saved—continue to be evaluated in clinical trials. We are confident that when designed and implemented correctly, clinical studies will continue to show positive results.”

Frei also said that neurointerventional surgery is a critical piece of a system of stroke care that has helped reduce death rates from stroke by more than 35 percent from 2000 to 2010. This includes public education to reduce risk factors and recognize the symptoms of stroke, emergency medical services processes and protocols to appropriately assess patients and emergency transport guidelines that immediately get stroke patients to a hospital that is equipped to provide the best evidence-based interventions for ischemic and hemorrhagic stroke management.

SNIS works to develop general standards to define principles of practice that will produce high quality care and provides guidance on standardized techniques, procedures and practices in the neurointerventional field, not only to improve health care outcomes but also to define the core practice from which this specialty can build and grow.

Stroke is the leading cause of disability and the fourth cause of death in U.S. In 2010, stroke cost the U.S. an estimated $54 billion, including the cost of healthcare services, medications and missed days of work. Strokes cost $74 billion in healthcare expenditures annually for treatment due to disability.

For complete article, click here.




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