PFO Research Foundation Responds to Clinical Trial Data


…patients are more than a P-value and in the case of PFO the quality of life can be very different between a patient who is tolerating medical therapy well and one who is not. ”  -Bray Patrick-Lake | President and CEO of the PFO Research Foundation

PO Box 20849, Boulder, CO 80308

Telephone O:1.888.736.2477

Press Release from earlier today at www.pforesearch.org

Patients with PFO Say Clinical Trial Data Doesn’t Tell the Whole Story

For David Dansereau, an avid ice hockey player and marathoner, being on blood thinners for the rest of his life after his second cryptogenic stroke wasn’t a treatment he was willing to settle for so he chose to have his patent foramen ovale (PFO) closed with a device in 2007.  PFO is commonly referred to as a “hole in the heart” condition, describing a tunnel-like remnant of fetal circulation between the atrial chambers of the heart.  PFO may be found in 20-25% of the population and has been linked to conditions such as cryptogenic stroke (stroke of unknown origin), migraine, decompression illness and hypoxemia (low blood oxygen), although not everyone with a PFO will have complications with the condition.

For the unlucky patients like Dansereau, suffering a stroke can be a life altering experience with lifelong consequences.  Standard medical therapy typically involves taking daily oral anti-coagulants that thin the patients’ blood to prevent clotting.  Dansereau said he felt punched in the gut when he learned about the medical therapy for his condition.  He noted that blood thinners carry a number of risks like hemorrhages, often require patients to get frequent blood tests, radically modify their diets, and abstain from beloved activities.  The 44 year-old father of 3 with a busy physical therapy practice said he carefully considered the risks of being on blood thinners versus having a device placed in his heart and opted for the PFO closure procedure.  He was home from the hospital 24 hours later and when he finished a brief course of blood thinning medications following the procedure he resumed his normal activities, ever grateful to rejoin his kids on the ice.  The data being published from the CLOSURE 1 clinical trial may show no statistical difference between the effectiveness of the two therapies, but Dansereau said in his case one therapy clearly offered him a much higher quality of life when he considered all of the risks and benefits.

Dansereau is not alone in his experience.  After suffering a stroke at the age of 42 and discovering she had a PFO, Peggy Mahrt was initially prescribed aspirin therapy.  Two months later she suffered a transient ischemic attack (TIA), or loss of blood flow to the brain, and was switched to a stronger blood thinner before enrolling in the RESPECT Trial at UCLA, which was investigating the effect of PFO closure on recurrent cryptogenic stroke.  Mahrt was randomized to the medical therapy arm of the trial, meaning she stayed on blood thinners instead of receiving device closure, so researchers could compare the number of strokes and TIA’s between the two groups.  Yet what they studied seemed to leave a huge gap in knowledge of interest to patients who are making treatment decisions, said Mahrt.   She is frustrated that the quality of life issues between the two therapies weren’t emphasized when she was being treated.

Mahrt remained on warfarin for over a year while in the study.  During that time she says she had difficulty tolerating the drug.  She had no energy, her hair fell out, her skin changed for the worse and black circles that she’d never before had appeared under her eyes.  She experienced episodes of dizziness that caused her to fall and split her head open twice, and left her bleeding profusely in front of her children.  Both incidents required trips to the ER and were upsetting to her family members.  Her injuries also required multiple MRI and CT scans to make sure that no hemorrhages happened for the two weeks after her injuries.  Mahrt says, “my life became limited and filled with fear of another injury.  The daily diet restrictions of not eating too many greens, broccoli or cranberry juice and weekly blood draws became draining and depressing.  This was not something I looked forward to doing for the rest of my life … I was only in my early 40’s!   I did not have the freedom to do the things I used to do; water skiing, hiking, white water rafting/kayaking, and running, all in fear of that I would fall or hit my head.  This was also extremely stressful on my children and husband.  It was a daily source of concern and anxiety in our lives.”

Mahrt sought out PFO experts and held open discussions with her family.  She came to the decision that this was not the way she wanted to live for the rest of her life and her family agreed.  She then researched device closure, traditional open heart surgery and robotic closure for PFO.  In September 2010, she chose to close her PFO with a device percutaneously in hopes of reclaiming her life.  The effects were overwhelmingly positive and Mahrt says she has been amazed with the improvement in her life.  She says she didn’t realize how limited her life had been due to PFO.  She was unsure of device closure at first and the thought of having a device in her heart was overwhelming at times.  But after being on warfarin and seeing her lifestyle change for the worse, she is grateful for the improved quality of life device closure offered her.  To Mahrt the fact there is no statistical difference between the two therapies means researchers left the most important part of the equation out:  the patient.

Bray Patrick-Lake serves as the President and CEO of the PFO Research Foundation, an organization founded by patients with PFO for patients with PFO with the goals of providing patients with unbiased scientific information and improving patient care.  She has long been concerned with the issues raised by Mahrt and Dansereau.  She co-authored a commentary with PFO expert, Dr. John Carroll of the University of Colorado Hospital, entitled “Design of patent foramen ovale trials: the importance of patient reported outcomes,” which appeared in the September 2011 issue of Clinical Investigation.  Patrick-Lake does not doubt the data from CLOSURE 1.  However, she emphasizes that patients are more than a P-value and in the case of PFO the quality of life can be very different between a patient who is tolerating medical therapy well and one who is not.

According to Patrick-Lake, the announcement of the CLOSURE 1 trial results at the American Heart Association meeting has affected the informed consent process and increased insurance denials for PFO patients seeking device closure.  She said the foundation has seen a sizeable increase in correspondence from concerned patients who felt their doctors or insurers forced them into a treatment that is not right for them, as well as a rise in increased concern from young women in their childbearing years for whom some medical therapy may not be appropriate.  “The knee jerk reaction to the CLOSURE 1 data can prove to be dangerous to patients like Peggy who aren’t doing well on blood thinners by denying them access to device closure through reimbursement restriction and failing to inform them of other treatment options,” said Patrick-Lake.  She went on to say that in order for true shared decision making to take place patients must be able to evaluate the risks and benefits of each therapy in combination with their values and preferences through unbiased dialogue with their physicians, and to accurately do that quality of life measures have to be made available to patients.  “Unfortunately the conversation about PFO has become one of cost containment for now rather than patient quality of life, which is ironic in light of what was spent mopping up Peggy’s blood thinner complications.  For the patients who do well on medical therapy it is a non-issue and the foundation supports the standard medical therapy protocol, but we also believe patients like Peggy deserve to have options that give patients a decent quality of life,” said Patrick-Lake.

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“Balance” Wristbands,Bracelets and Sports Necklaces are a Scam


Save Your Money!

The only “magical properties” behind the technologies they use are in the marketing and in the way they get you to plunk down $40-$100 or more to promise pain relief, better balance or improved recovery and performance.

By David Dansereau  for know-stroke.org

balance-necklace-scam
Save Your Money

Although this is not a new product, I needed to drop you a line about how this scam may now be used on stroke survivors.  I received a call last week from a stroke survivor who had been “pitched” one of these bracelets to help improve his balance.  He was apparently at a golf expo and the salesman promised him he could prove it would work for him.  See the test and the scam unveiled below, but first, what is in these things?

A look at the” Magic ” healing potion inside the bracelet shown:

The scientific power in question and shown in this picture is called the Phiten necklace. It is a fabric-covered PVC rubber cord that apparently contains powdered titanium. The purported effects of wearing the necklace are increased energy, better balance and blood flow, reduced muscle pain, and improved  joint mobility. I went to the vendors website and couldn’t find a single scientific study to back these claims, but with a little digging I did find a class action lawsuit against the company.

Here’s the test :

They have a brown paper carrier bag or enclosed container that contains a brick shaped object concealed inside.  They ask you to stand, extend your arm and then they place the bag in your hand, causing you to quickly respond to the weight and essentially “setting you up” to fall off balance.  You then put the bag down, and they drape the “magic” necklace or wristband across your arm and place the bag in your hand again.  It’s supposed to be easier with the necklace on your body.   The real reason the victim may feel a difference however, has more to to with something called “the order effect” which I’ll try to explain here:  
When a person tries to pick up an object the brain makes a rough guess as to how much strength it’s going to require. With an unrecognizable object concealed in a bag, we have no idea how much it’s going to weigh. The contents of the bag are actually quite heavy, and most people are likely to underestimate the effort required. The test with the necklace draped over the arm is always the second attempt, by which time our brain has recalculated and knows exactly how much effort is required. Hence it seems much easier to lift and the connection is made that the necklace gave you new powers, or improved strength and balance.

With further investigation, here’s three things which may logically explain why people were “stronger” in post-tests after putting on the magic bracelets or necklaces:

  • Order effect (explained above and reviewed here with another example)
  • Placebo effect
  • Applied Kinesiology
Order Effect

Research explains that the “Order Effect” may in part be the reason why some people become stronger or more flexible. The Order Effect claims that on the second or latter attempts, people get more familiar with an activity. People therefore can prepare better and can learn how to surpass the previous feat. Note that  tests almost always start without the “magic” wrist band, necklace or pendant. The “magic” product is given to you only on the second try, but since you already know what you’re supposed to do, you tend to outdo your previous performance.

Another example: you’ve probably done the exercise where you bend your body forward and you try to touch the floor with your fingers without your knees bending. At first you won’t be able to reach the floor, but after trying it for the second or third time, you’ll be closer and even be able to touch the floor- that’s the Order Effect.

Placebo Effect

The second reason why the body tests seem to be successful may be due to the Placebo Effect, defined by Wikipedia as “the tendency of any medication or treatment to exhibit results simply because the recipient believes that it will work.” That’s regardless whether the medicine or treatment has already been proven scientifically to be effective.  Want to believe in “magic” or just have a lucky (expensive) charm?  Then these  wrist bands and necklaces can produce the same thing. As long as people believe they are real, the placebo can take effect.

Applied Kinesiology

The most plausible explanation why the scam “proof” body tests appear “amazingly” successful is simply the use of Applied Kinesiology, or the use of manual muscle-strength testing for medical diagnosis.

Watch the video below for an example of how this  “magic” is done:

In the Endurance body test, a person is asked to stand with one leg up and arms fully stretched sidewards. In the first test (without the magic wrist band in this case), the pressure applied to the arm is directed outside the person’s center of gravity, as if the person is being pulled away. Naturally, the person falls off balance.

On the second attempt of the same test — now with the person holding the “magic” wrist band — the arm is being pressed down towards the body, meaning, the direction of the pressure is towards the person’s center of gravity. Now, even without any special gadget or anything, the person won’t fall even though more pressure is applied.

Bottom Line:

Always look at the science to explain why things work.  Even though these “magic” products are no more than perhaps lucky charms, they are expensive.  I take particular offense when a snake oil salesman looks on a stroke survivor, observes a deficit, and promises and “instant” cure.  I looked at only one product here, but there are others all with their own “magic powers”. Power Balance wrist bands, EFX bracelets, and Scalar Pendants are some of the other names, and I would only venture to guess that they all make similar claims, with the same bottom line, they do not work.

[Personal Sidebar] Many pro athletes that our kids all admire and want to copy are donning these bands and “cool” necklaces, and the NBA, MLB and other pro teams are now endorsing them to match their team colors.  So despite the pseudo science,   all these brands continue to sell their expensive products even though some have even admitted that real science does not come into play in any of their claims.

by David Dansereau for know-stroke.org

Here’s a video to watch on YouTube  that shows the “magic” :

References:

http://www.classaction.org/phiten-necklaces-and-bracelets.html

P90X vs. P2X1: Which is better for stroke prevention?


I know you’ve heard of P90x, the  popular DVD / infomercial pitch to get you fit, right?  But what about P2X1??

P2X1 is the lesser known, (newly discovered) but soon to be heavily pitched  ‘biochemical switch’, which is associated with strokes and heart disease when it is ‘turned on’.   According to new research reported today the Big Pharma scientists will soon be working on drugs to block these P2X1 receptors in an effort to potentially reduce “dangerous” blood clotting that leads to strokes and heart attacks.  Get ready survivors, because there will soon be another pill coming down the pipeline (fast tracked, I am sure) to help you….

So what’s best?  Popping another pill or start moving (yes, exercise) to prevent blood clots, heart disease and strokes??  If you haven’t heard, my new book looks at just this issue.  I even give you a practical approach for stroke survivors to adapt some of those hip P90X moves everyone is talking about.

David Dansereau's Home Stroke Recovery Guide

David Dansereau

Know-Stroke.org

References:

http://www.medicalnewstoday.com/articles/242615.php

http://www.my-physical-therapy-coach.com/stroke-recovery-journal.html

Super Bowl Poll Results:Muscle Memory and Stroke Recovery


The winner of the “Muscle Memory Poll from my last post is NOT Madonna, although she did get 20% of the vote.

MuscleMemoryPoll
Results of our Muscle Memory Poll on Know-Stroke.org

The winning Super Bowl vote(s) for best display of muscle memory* during the big game were split evenly between the Manningham catch (40%) and the Bradshaw touchdown run (40%). Unfortunately, NFL Films pulled the videos off of YouTube shortly after posting this poll so you can’t go back to the last post to review each play but we can get inside the huddle and replay what was happening on the field courtesy of interviews conducted after the game by reporters for Giants.com

According to the an interview with Eli Manning, here’s what went on in the huddle and what he was yelling to Ahmad Bradshaw on the final scoring play: “I just yelled, ‘Don’t score! Don’t score!’ Obviously, he heard me (because) he thought about it. I know it’s tough for a running back. They see a big hole right there going for a touchdown (and muscle memory almost drives them on autopilot to get in the end zone*). I think something almost had to pop into his head like something was up. This is a little bit too good to be true. I am yelling, and he obviously had heard me. He thought about kind of going down, but I think he didn’t quite know what to do. He said, ‘Hey, I have a touchdown, I am going to take it.’ I am glad he did.”

Eli Manning also commented on the great catch by Manningham and if he thought his pass late in the fourth quarter was one of the best throws of his career. Here’s what Giants.com reports Eli said: “I’m not good at ranking my throws. Obviously, it was a Super Bowl and a tight throw, but I didn’t have any questions. I felt the safety was inside. I wasn’t worried about whether it would be an interception or a dangerous throw when the ball was released. I saw a window. I felt confident about it. I didn’t think much about it. I just saw where Mario (Manningham) was and knew the timing. A lot of those throws are muscle memory. You don’t think about how far to throw it or what to do. You see your receiver, you step, you make the throw and hopefully you put it in a good spot where he can catch it. He made a great play.”

What the heck does this have to do with stroke recovery?

Successful stroke recovery requires an adequate stimulus or volume of “work in” to drive change. This input or training effect restores or retrains that same muscle memory and makes tasks more fluid or automatic. In a previous post I described how stroke patients must develop a new mindset to be successful.  They must think of their rehab as preparing with the same mindset as an athlete would before going to 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 Coach 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

[*Sidebar] Because I write this column I get to cast the tie breaking deciding vote.  I vote for the Touchdown.  Bradshaw had every muscle fiber trained to go for the end zone ever since the day he started practicing as a youth.  With all those years of practice, it was entirely unnatural to stop and fall at the goal line despite Eli yelling at him to get down.  Survivors take note, Fall or Walk – your choice- now go practice!

David Dansereau

Know-stroke.org

Definitions:
*Muscle memory as defined in Wikipedia has been used synonymously with motor learning, which is a form of procedural memory that involves consolidating a specific motor task into memory through repetition. When a movement is repeated over time, a long-term muscle memory is created for that task, eventually allowing it to be performed without conscious effort. This process decreases the need for attention and creates maximum efficiency within the motor and memory systems.

References:
http://www.giants.com/news-and-blogs/article-1/Super-Bowl-Eli-Manning-Quotes/0502f743-cc15-45b1-8d7d-4728c70f072f

http://knowstrokeblog.my-physical-therapy-coach.com/2008/10/29/recruit-the-right-physical-therapist-as-your-stroke-coach/