|
Chronic Migraines Caused by a Hole in the Heart? “Highly Likely,” New Research Says
New research unveiled at TCT 2008 by Dr. Stephen Silberstein (a leading neurologist) suggests that 66 percent of chronic migraine sufferers have abnormal blood flow caused by a hole in their heart or a right-to-left shunt that bypasses the filtration process of the lungs. Most of these defects are known as a PFO, a heart condition prior research shows is found in 25 percent of the population.
WASHINGTON, D.C., PHILADELPHIA, Pa. & SALT LAKE CITY – October 13, 2008 – New research presented this morning suggests that two-thirds of all chronic migraine sufferers have a hole in their heart or a right-to-left shunt. This leads to abnormal blood flow that bypasses the filtration process within the lungs and may be a significant contributor to chronic headache pain.
Dr. Stephen Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University Hospital and former president of the American Headache Society, presented these research findings this morning at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C. TCT is the largest annual gathering in the United States of interventional cardiologists, and Dr. Silberstein’s research was sponsored (in part) via a grant from Coherex Medical.
Dr. Silberstein’s presentation was titled “First Report of Clinical Trial Results: The Prevalence of PFO in Patients with Chronic Migraine.” In the study, 66 percent (86 of 131) of adult chronic migraine sufferers in the statistically valid research effort were found to have an abnormal right-to-left shunt of blood that travels to the left side of the heart without being properly filtered by the lungs. According to Dr. Silberstein, the most common form of RLS heart defects are patent foramen ovales (PFOs), a condition that previous research shows is typically found in 25 percent of all people.
According to Dr. Silberstein, not all PFOs cause clinical problems in patients; however, this new data may indicate that patients who suffer from chronic migraine have a higher prevalence on PFO versus the general population.
“Although the possible connection between PFO heart defects and migraines has been known for awhile, we believe this is the first time such a clear connection can be drawn between those suffering chronic migraines and RLS defects,” Dr. Silberstein said. “Since the vast majority of all RLS defects are PFOs and PFOs are found in roughly 25 percent of the population, we would expect roughly 25 percent of the participants in our study to have an RLS or a PFO – in other words, approximately 33 patients.
“Instead, we found a correlation more than 2.6 times the expected results (86 patients). This is a very significant difference. In other words, it’s highly likely there’s a strong connection between PFO/RLS heart defects and chronic migraines. If our results are borne out in future research, such studies will suggest a fairly simple way to eliminate or reduce chronic migraine pain – close PFO defects.”
Research Study Highlights
In the study directed by Dr. Silberstein and led by Dr. Stephanie Nahas, a team of Thomas Jefferson University Hospital researchers selected 277 consecutive chronic migraine patients at the hospital’s headache center as possible study participants. Of these
182 patients agreed to participate in the study,
140 entered the study, and
131 completed the study.
For the purpose of the study, chronic migraineurs were defined as those patients who experienced a migraine headache at least once every other day for three months or more (with or without “aura”), with each migraine lasting four hours or longer.
Finally, each participant was screened for the possibility of an RLS heart defect via a bubble Transcranial Doppler (TCD) sonographic procedure. In this test, a saline solution was pre-agitated so both the solution and microscopic air bubbles could be injected into each patient. Medical professionals then used the TCD to monitor the flow of blood to the head to see how many (if any) air bubbles streamed into the brain.
According to Silberstein, the study results were quite remarkable. Sixty-six percent of the study participants (86 out of 131) were found to have an abnormal right-to-left blow flow shunt, most likely a PFO heart defect. Additionally, 55 patients were classified as having a moderate to large amount of bubbles streaming into the brain (11-300 bubbles or more than 300 bubbles, respectively).
“We applaud Drs. Silberstein and Nahas and their team for the quality and significance of their research,” said Richard J. Linder, president and CEO of Coherex Medical. “To show such a correlation between chronic migraine headaches and a right-to-left shunt, likely through a PFO heart defect, is of high scientific value and significant news for the more than 100 million chronic migraine sufferers around the world.
“Interestingly enough, Dr. Silberstein’s research also found that migraine with aura was not a predictor of having a right-to-left shunt or PFO in chronic migraine populations. This finding may indeed impact future randomized controlled trials in treating chronic migraine in patients with PFO.”
Coherex Medical during TCT2008
Coherex Medical is exhibiting at TCT2008 in booth #1625.
Dr. Brian Whisenant, chairman and founder of Coherex Medical will deliver a presentation later today at 4:59 p.m. (EDT) titled “The Coherex ‘Intra-Tunnel’ PFO Closure Device: Early Clinical Experiences (Special Emphasis on Migraine Prevention).” Linder will also deliver a presentation at TCT 2008 on Wednesday, October 15 at 4:59 p.m. (EDT) titled “Industry Perspectives: The Challenge of Consensus Building.”
Coherex is sponsoring a breakfast symposium during TCT 2008 entitled “The Science of Headache: A New Collaboration Between Neurology and Cardiology.” This symposium will be held from 7 to 8 a.m. (EDT) tomorrow (Tuesday, October 14) in Room 144C in the Walter E. Washington Convention Center in Washington, D.C.
About Dr. Stephen D. Silberstein and Thomas Jefferson University Hospital
As the Director of the Jefferson Headache Center at Thomas Jefferson University Hospital, Dr. Silberstein is recognized as one of the foremost neurologists in the world on headache medicine. The former president of the American Headache Society, Dr. Silberstein currently serves on the editorial board or team of 11 publications, including Cephalagia and Headache. For more information about Thomas Jefferson University Hospital, its headache center and/or Dr. Silberstein’s research, please visit www.jeffersonhospital.org or call 215-955-6000.
About Patent Foramen Ovale (PFO) Heart Defects
A foramen ovale is a tunnel-like opening between the upper chambers of the heart that allows blood to bypass the lungs and is present in all fetuses. Normally, the foramen ovale closes soon after an infant is born. However, if this opening fails to close naturally after birth the opening is said to remain patent and the condition is called a patent foramen ovale (PFO).
PFO is a common heart defect that occurs in approximately 25 percent of the population. Under certain conditions, a PFO may allow blood to bypass the lungs and shunt directly from the right side of the heart to the left. Since the lungs normally filter all of blood flowing through the body, this shunt may allow unfiltered blood clots and other components to travel directly to the brain.
There are at least two medical conditions that may benefit from PFO closure: migraine and stroke. Migraine disease affects approximately 12 percent of adults. Multiple retrospective studies have demonstrated a marked reduction in migraine symptoms following PFO closure. As such, the worldwide market potential for PFO closure to treat migraine patients has been estimated to be more than $15 billion per year. According to the Stroke Council of the American Heart Association, approximately 500,000 strokes each year worldwide may be attributable to the presence of a PFO, which represents a potential annual market size of close to $2 billion.
About the Coherex FlatStent PFO Closure System
The Coherex FlatStent™ PFO Closure System is similar in use and function to self-expanding vascular stents which are widely used by interventional cardiologists. However, the patent-pending Coherex FlatStent PFO Closure System incorporates a unique fusion of PFO closure mechanisms and accepted medical practices in a design expected to naturally seal a PFO tunnel.
About Coherex Medical
Formed in 2003 by Brian Whisenant, M.D., Coherex Medical is focused on addressing structural heart disease and conditions through medical devices. For more information, please visit www.coherex.com or call 801-433-9900.
Aura: Approximately 15% of migraine sufferers have advance warning of a pending headache. Such an “aura” is typically a visual effect where the sufferer sees flashing lights or an arc of sparkling light surrounding objects.
Coherex Medical and Coherex FlatStent are trademarks of Coherex Medical, Inc. All other trademarks are the properties of their respective owners.
Media Contact for Dr. Silberstein and/or Thomas Jefferson University Hospital:
Ed Federico, 215-955-5507, ed.federico@jefferson.edu
Coherex Medical Contacts:
Trent Loveless, Coherex Medical, 801-433-9900, tloveless@coherex.com or
David Politis, Politis Communications, 801-523-3730(w)/801-556-8184(c), dpolitis@politis.com |
09/22/09
Coherex Medical Signs Exclusive Distribution Agreement with Abbott
09/22/09
Coherex Medical Announces Lunch Symposium during TCT 2009
(the Transcatheter Cardiovascular Therapeutics Conference) on Tues., Sept. 22, 2009
08/20/09
Coherex Medical Closes $16.5 Million Series B Preferred Stock Financing
07/08/09
Coherex Medical’s Coherex FlatStent EF PFO Closure System Granted CE Mark Clearance for Closing PFOs – a Common Heart Defect; Company to Begin Sales/Marketing Efforts in Europe
07/08/09
CE Mark Clearance for Coherex Medical’s Coherex FlatStent EF PFO Closure System
10/13/08
Chronic Migraines Caused by a Hole in the Heart? “Highly Likely,” New Research Says
10/12/08
Coherex Medical Announces Breakfast Symposium and Executive Presentations During This Week’s TCT 2008 (the Transcatheter Cardiovascular Techniques Conference)
10/21/07
First “Live Case” Transmission of a PFO Closure Procedure Using the Coherex FlatStent PFO Closure System to be Presented at TCT 2007
10/03/07
Coherex Medical Successfully Completes First Human Cases with its Coherex FlatStent PFO Closure System as Company Begins COHEREX-EU Study to Seek CE Mark Clearance
10/03/07
Utah company's new stent may help repair heart defects
10/02/07
Coherex Medical to Begin its COHEREX-EU Study to Pursue CE Mark Clearance for its Coherex FlatStent PFO Closure System
10/01/07
Coherex Medical has been invited to deliver a presentation at In3 East, Boston, one of the leading venture capital and strategic partnership conferences in the United States
05/10/07
2007 Utah Innovation Awards Winners
04/17/07
2007 Utah Innovation Awards Finalists
|
