AHA Press release on PFO: More patients needed in clinical trials to find treatment for heart condition linked to certain strokes

 Article source: American Heart Association media room

 

News Releases
More patients needed in clinical trials to find treatment for heart condition linked to certain strokes
Statement Highlights:

Patent foramen ovale (PFO), an opening between the two chambers of the heart, has been associated with some strokes for which there has been no identifiable cause.
Due to a lack of solid research and clinical evidence, there is no established ideal way to treat PFO.
This statement identifies a number of ongoing trials for PFO and calls for doctors to enroll appropriate patients in these trials that could one day lead to a definitive treatment for this condition.

DALLAS, May 11, 2009 — The American Heart Association and the American College of Cardiology are calling on doctors to enroll more patients in clinical trials for catheter-based closure of patent foramen ovale (PFO), a condition caused when an opening between the two chambers of the heart fails to close at birth. Due to a lack of conclusive research on the management of PFO after stroke or transient ischemic attack, there is currently no clearly established treatment for this condition.

View the full science advisory here

This “call to action” advisory is published in Circulation: Journal of the American Heart Association and the Journal of the American College of Cardiology. The American Academy of Neurology has affirmed the value of this science advisory.

The advisory writing group notes there are a number of ongoing clinical trials looking at patients with PFO and cryptogenic strokes, which are strokes with no identifiable cause after an extensive search.

Enrollment in the trials has lagged and the off-label use of PFO closure devices has accelerated, jeopardizing the funding of some studies and the scientific validity of others. “Off-label” indicates when a device or drug is used to treat a condition not listed on its label. This is a common practice, especially for older drugs or devices that perhaps have found new uses but not been put through the rigors of FDA testing and approval for the new use.

“We must have enough patients followed for an adequate time in these trials to make the data valid and the findings strong,” said Patrick O’Gara, M.D., chair of the writing group and director of Clinical Cardiology at Brigham and Women’s Hospital in Boston. “The completion and peer review of these trials are critical to establishing the evidence base needed to help us make informed decisions regarding the best care for patients with this condition.”

Potential treatments for PFO are important for reducing stroke risk. The advisory cites research that shows PFO present in 33.8 percent to 43.9 percent of patients with cryptogenic stroke. A PFO is usually detected by echocardiography during evaluations after a stroke.

Although “optimal” treatment for PFO isn’t established, current options for treatment include drug therapy with either anti-platelet agents like aspirin or vitamin K antagonists such as warfarin, surgical repair, or closing the opening with catheter-based (percutaneous) devices. Surgical repair is not usually recommended unless a patient is already undergoing surgery for another reason.

Current American Heart Association/American Stroke Association guidelines recommend anti-platelet medication as the first-line therapy for PFO. Warfarin should be considered if there is an additional indication for anticoagulation. They say that there isn’t enough evidence to recommend closing a PFO after a first stroke, but that closure may be considered for patients with recurrent cryptogenic stroke despite optimal medical therapy.

The choice between drug therapy and catheter-based repair has been intensely debated. To date, adequately powered, randomized, prospective clinical trials comparing drug therapy with catheter-based repair have yet to be completed.

Three Food and Drug Administration (FDA) advisory committee meetings (1997, 2002 & 2007) have affirmed the need for completing appropriately sized randomized controlled clinical trials to compare drug therapy with percutaneous device closure. As yet, no device for PFO closure is approved by the FDA.

In addition to the call for doctors to refer more patients to the ongoing trials, the advisory group recommends the data from these trials should be pooled where appropriate and that the “off-label” use of closure devices should be curtailed.

More information on the ongoing trials for patients with PFO can be found at http://www.clinicaltrials.gov and http://www.strokecenter.org/trials.

Co-authors include Gloria Catha, Steven R. Messe, M.D.; John C. Ring and E. Murat Tuzcu, M.D. Author disclosures are available on the manuscript.

###

The American Heart Association receives funding primarily from individuals, foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are disclosed at http://www.americanheart.org/corporatefunding.

NR09-1051 (Circ/O’Gara)

About the American College of Cardiology (ACC):
The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 37,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. For more information, visit http://www.acc.org.

About the American Heart Association (AHA):
The American Heart Association is the nation’s oldest and largest voluntary health organization dedicated to building healthier lives, free of heart disease and stroke. These diseases, America’s No. 1 and No. 3 killers, with all other cardiovascular diseases claim nearly 870,000 lives a year. In fiscal year 2006-07 the association invested more than $554 million in research, professional and public education, advocacy and community service programs to help all Americans live longer, healthier lives. To learn more, call 1-800-AHA-USA1 or visit http://www.americanheart.org

TodayinPT.com – Heart of the Matter

Barbara Marquand interviewed me recently for an article which appeared in this month’s Today in PT Magazine. Here’s the link for more info on understanding the PFO-Stroke link.  Read the full article

Making progress towards The Oprah Show

by David Dansereau

Article from Today in PT magazine

Last month I reported to you that I was picking up the pace trying to spread the word on stroke awareness, even getting interviewed by the NY Times for an article on PFO/stroke. This is just a quick post to show you that I’m still spreading the word trying to get to the big show, that being The Oprah Show with my message.

I was interviewed by a writer from Today in PT magazine and that article appears in their March issue. You can read it online here: Read the full article

Recruit the right Physical Therapist as Your Stroke Coach

The multidimensional impact of a stroke requires physical therapists to be flexible and versatile with their treatment approaches, yet they should also be strong in communicating the reality of the training that will be required of their stroke patients.

I tell my stroke patients that they must think of their rehab as preparing for the Olympics. Just as an athlete would use an expert coach to design and oversee an appropriate training protocol, the stroke survivor should team up with a PT that has developed an arsenal of therapy skill sets. The therapist also should have a working knowledge of the new research in training intensity and frequency as it relates to neuroplasticity. The PT should also be up to date on new EMG, FES and combined biofeedback and gaming technologies to maximize their patients home training program and to help provide enough stimulus and volume of work required to rewire the brain.

“Performing 2 sets of 10 reps once per day is not going to get you to the Olympics and it certainly is not going to prepare you for your return to the best possible outcome post stroke!”

David Dansereau, Stroke Survivor and Physical Therapist

Stroke researchers now know that the brain has a much greater capacity for change in response to imposed demands than earlier believed. This capacity for change is known as neuroplasticity. A good PT coach should understand that to induce neuroplastic changes and reorganize the brain post stroke they must intervene with intense, task-specific repetitions that require a challenge in rehabilitation much to the same level as an Olympian in training for a gold medal performance. Effective rehabilitation therefore involves constant practice and repetition to perfect post stroke performance, and the stroke survivor must understand the workout plan designed by their PT and be consistent with their home exercise regimen to maximize their return.

I am still researching for a follow-up on several new technologies available to stroke survivors and therapists for an upcoming post. A recent conversation I had with a stroke survivor at a Tedy’s Team meeting got me thinking of this topic of the way PT’s should coach their stroke patients. I wanted to comment here on why it is so important for stroke survivors to rethink the way they approach their rehabilitation.

I certainly hope your physical therapist has already conveyed this vital message to you. If not, you might want to start recruiting a new PT as your stroke coach!

Bloggers abuzz about sex and stroke

WOW!- I know, I used the word sex and “the other “s” word” together- I can explain…

I mentioned in my last post I’d be following up with more information on the emerging technologies available to enhance stroke rehabilitation outcomes. Well, this post as you can tell from the title is not about stroke rehab directly, (although many stroke survivors might argue that sex would be the most enjoyable and welcomed component to any therapy plan of care).

Anyway, my point in including this post here is that it confirms my suspicion when you add those three little letters together to form the word “sex” it certainly pulls readers in to any headline and grabs attention.

The proof: I’ve never seen more bloggers post on any one single stroke related topic in a given week, than this past one, EVER.

Here’s only a few of the recent headlines:

“Holy ^@#~ ! “ A stroke from Sex

35yr Old Woman has Orgasm Related Stroke

When Sex Leads To Stroke

That’s enough- I think you get my point….

Unfortunately, the rise in attention recently for stroke awareness came at the expense of a 35-year old Illinois woman. She, too, at the time probably didn’t realize that sex with her boyfriend could trigger a life threatening stroke that temporarily left one side of her face numb, slurred speech and weakness in her left arm. While her physician treated her, it is reported he was puzzled to find that his patient did not “fit the profile of a typical stroke sufferer”. This stroke survivor is a young, healthy, non-smoking woman with no known cardiovascular risk factors.

Her doctor acted FAST…

Her physician found it too late to inject her with tPA, a clot-busting drug that must be administered within three hours of a stroke. In what was reported as a risky decision, he ran a catheter from an artery in the groin to her brain, applying tPA directly to the clot. Her symptoms improved almost immediately and within an hour she was out of danger and is reported to be well on her way to a full recovery.

Why did I add my first post on sex and stroke?

Well, I can assure you it was not to grab headlines, Sarah Palin is still leading that category these days. This unfortunate incident did remind me of a topic that wasn’t discussed much during the management of my PFO or during my own stroke rehab. Yes, sex. Is it safe when you have a PFO or other similar known heart defect?

So, to get to the answer (maybe) let’s look at what was the reason for the recent headline grabbing “stroke after sex” which perpetuated a blogging frenzy As a rule, sex and orgasm triggered strokes are rare in young men and women, though not unheard of. For such a stroke to occur in a relatively young person, experts still argue that it perhaps requires a combination of factors and events, not unusual in themselves, but extremely unlikely to occur at the same time. One variable that seems to be consistent in the cases that have been reported involving young people who (were brave enough to tell the truth) had suffered similar sex related strokes, is that they all had a small opening in the wall between the two upper chambers of the heart, as was in the case of this young Illinois woman. This minor heart defect or opening, called Patent Foramen Ovale (PFO), as you can read more about throughout my blog, is found by many reports to be seen as frequently as in one in four adults. Such an opening allows some blood to flow from the right to the left side of the heart, bypassing lungs only to go straight to the brain. As there are no symptoms, most people with PFO do not know they have this heart defect. It has been reported that 40% of people suffering a cryptogenic stroke ( i.e.) a stroke with no known cause, have been found to have PFO.

Is sex the culprit?

It is well reported that strain can cause increased blood flow through a PFO. For example, the strain of bearing down during a bowel movement, strain of breathing out of a shut mouth or holding a breath, and strain during sex, particularly during orgasm,. Experts will mostly agree strokes are not caused by PFO’s alone, there must be a small blood clot present, which must break free and enter the heart, then cross over and bypass the body’s normal “pulmonary filter” instead traveling through the PFO then up to the brain. Normally, the rule of thumb is that small blood clots stuck in the lungs dissolve, but a blood clot that passes through a PFO lodges itself in the brain and causes a stroke.

Again, with the Illinois woman serving as our own case study here, this young patient suffered a headline grabbing “sex-related stroke” because of her PFO. It was also reported she had a small blood clot in her leg, the possible side effect of oral contraceptives taken for birth control. Doctors generally still report that a vast majority of people with PFOs, often go through life without any problems, and while the risk of stroke during sex must be kept in perspective, the risk is low if you consider the chain of events needed and presented in this post. Fortunately, according to stroke experts, sexual intercourse, in itself, is not likely to trigger a stroke without accompanying risk factors.

So, now l can get back to writing and researching for my next post of emerging stroke technologies and hope to have that available soon. In the meantime, please use the recent sex and stroke buzz to be reminded that strokes occur all year long, just not during Stroke Awareness Month in May. In fact, here are the stats:

• 700,000 Americans suffer a stroke each year
• Approximately 160,000 die of stroke each year

The most common risk factors for stroke in young people are those linked to migraines, drug use, coagulation diseases, or athletic injuries that cause trauma or injury in the blood vessels, especially in the neck. Even with these risk factors, the chances of a young person suffering from stroke are extremely small but that is no reason to be ignorant of the warning signs. As I’ve been saying all along, there are young faces of stroke and you should know what they look like. Be prepared and get help fast. Know-Stroke!

As one stroke campaign says well, “Time Lost is Brain Lost”

Until next time-

Written by David Dansereau

My new video demo shows you how to boost your nutrition for better health

Free-Video-Demo

---

Be sure to visit my nutrition website.  I’ve just added a new video demo so you can have access to a new multimedia demonstration of my powerful nutrition coaching program. Learn how to quickly and easily balance your nutrition and create healthy customized meal plans that target your goals in three easy steps!

---

See the POWER of our nutrition coaching program in Action!

Redeem your coupon

Free health resources to boost your Brain and Heart IQ

• Want the latest tips for healthy living after a stroke or heart attack?
• Want to learn more about the latest research in stroke or heart attack recovery for survivors and caregivers?

Two of the best subscriptions, in my opinion, you can get free for the asking that answer these questions and much more are listed below. They are Stroke Smart, a publication of the National Stroke Association and Heart Insight, a publication of the American Heart Association.

Of course you can always stop by my office and pick up a free copy, but if you follow these links you can view archived issues on their websites or even order a copy to be mailed right to your door-free too!

Hockey Tribute to Jamie Coyle a Big Success

A tribute hockey tournament for Jamie Coyle took place at the Smithfield Ice Rink in RI over the weekend. Her coaches Henry Sherman, Charlie Stimson and Jim Hopgood talk of her recovery in this video. Click on the video to link to play the Providence Journal story by Glenn Osmundson.  On a personal note, it was an honor to take part in this great event to raise funds for Jamie.  I’ll update you on the fundraising totals as soon as I know more, but it looks like her coaches were closing in on $11,000 towards the end of the tournament!

• Thanks to Jamie’s coaches for inviting me to drop the first puck to open the tournament
• Thanks to the American Stroke Association in RI for donating the great gift baskets and educational items

Hockey Tournament for Jamie Coyle

Fight For Seven

Here’s the latest update on young stroke survivor Jamie Coyle. According to the latest website post, Jamie had a good weekend and has made some great progress already. She is scheduled to begin rehabilitation at Spaulding Rehab in Boston this week. Follow this new link http://www.fightfor7.com/ to read about Jamie and see how you can help “Fight for Seven”.

Please help young stroke survivor Jaime Coyle

While I was reading through the Valley Breeze newspaper earlier today, the story of 13 year old Jaime Coyle jumped out at me. I learned from the article Jaime is one of the top young female hockey players in Rhode Island and just like Tedy Bruschi and myself, she apparently suffered a stroke from a PFO while playing in a hockey tournament this past weekend. Don’t ask me why, but even before I turned the page from the headline “Young skater Coyle suffers stroke during tournament” my gut told me it was related to her heart. Please read her story here and help if you can. She is currently battling to recover in a Massachusetts hospital and her coaches are planning a fund raiser to help in her recovery.

For additional updates regarding Jamie, and any upcoming events planned, please visit http://www.RIGirlsHockey.com. A message center has been established so Jamie can stay in touch with her friends and family as she recovers. Please contact the coaches through this website if you would like to assist in any way.

http://rigirlshockey.com/

Jaime’s story in the Valley Breeze can be viewed here:
http://www.valleybreeze.com/Free/MAIN-8-14-ALL-Jaime-Coyle-stroke-victim
The Valley Breeze article was written by Paul Dubois-Sports Editor

Prov. Journal picked up my story

I learned from the American Stroke Association, Boston Affiliate that the The Providence Journal ran my story in yesterday’s Sunday paper.  I did not see the actual article, but here’s the link they sent me from the print. Below is the link – check it out>

http://www.beloblog.com/ProJo_Blogs/running/2008/07/stroke-survivor.html

Not Oprah yet, but perhaps this will help gain some more momentum:)