FDA approves Amplatzer


News announcement from FDA you’ll be interested in if you’ve suffered a cryptogenic stroke from a suspected PFO and need more choice for treatment.


Update to Recent Post: Long Journey to Improve PFO Patient Voice and treatment Options for Cryptogenic Stroke

Wow, I have personally spent lots of time advocating for this important stroke/PFO patient matter over many, many years but hard work has now paid off.  The FDA announced last week the Amplatzer is now finally approved for recurrent cryptogenic stroke treatment in certain PFO patients!

Congrats and recognition for the commitment from the original team of PFO patients (formerly PFO Research Foundation in the US) that I began this important advocacy journey on with together so many years ago. Thank you!

Read the FDA Notice:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm527096.htm

Take look back at my FDA testimony and this PFO journey background here:

http://www.know-stroke.org/a-long-journey-to-improve-pfo-patients-voice-and-treatment-options-for-cryptogenic-stroke/

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What a Journey !
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New American Academy of Neurology (AAN) Guidelines on PFO Closure in Cryptogenic Stroke are Discouraging


David Dansereau
David Dansereau (Know-Stroke.org)

AAN Ruling Again on P values NOT Patient Values

[In my opinion this is very discouraging news and more evidence to show there is still a great divide in how neurologists and cardiologists treat cryptogenic stroke with known PFO.]

PFO Closure Tipping Point

Despite the hard work of PFO patients (like myself) to make a difference by providing testimony and  their real life perspectives to the FDA recently, it looks like the AAN is unmoved and keeping with their same position on how to best mangage and educate patients that have had a cryptogenic stroke with confirmed  PFO.

 

Read the post of this news from TCTMD

 

King Wilder, 57, never knew he had a hole in his heart until he had a stroke


 Listen to this 911 call and share Mr. Wilder’s  chilling experience of what it feels like to be having a stroke and not be able to communicate.  It was later determined that the cause of his stroke was probably caused from a PFO (patent foramen ovale), or hole in his heart.

 

As shared by The Desert Sun

 

stroke911knowstrokeorg

Is PFO closure now a black hole for medicine?


-by David Dansereau,MSPT  Know-Stroke.org

I admit, I was drifting in thought as I watched the movie Interstellar with my boys over the weekend. The 2014 movie stars Matthew McConaughey who plays Cooper, an ex-pilot who must leave his family on Earth behind to lead an expedition beyond our galaxy through a black hole to discover whether mankind has a future among the stars. My boys love space movies and usually I am guilty of falling fast asleep between the two of them by 30 minutes in, but this movie kept me awake for nearly 3 hours.  I was thinking if I could speed up time like in the movie, where will PFO closure be 7, 15, 30 years from now? Also, if I could go back in time, would I elect to have PFO closure again?? PFO closure at one time early in my treatment after my stroke was described to me by a treating physician as a condition stuck in a “grey” area of medicine.  Unfortunately, I believe PFO closure, along with research into this area is now changing colors and drifting more from grey to black.  I wonder, does PFO research still have a place in medicine?

pfoblackhole_knowstrokeorgThe black hole

Beyond the issue of reimbursement which has been pulled into the black hole years ago, patients simply looking for best practices on managing a possible pathological PFO  have been left behind too long in the mission to explore and treat PFO’s. The medical community has mostly failed us (patients) by not defining a clear patient pathway.  Patient’s have united together over time to try to make a difference.  For example, there have been groups of patient’s that started the PFO Research Foundation out of frustration and lack of united efforts by the medical community to hear patient’s voices. I disclose I was once part of this patient group at the beginning.  Currently, however,  many of these patient efforts remain “under construction” like the vessel being constructed in Intersteller  in attempt to bring humans to a better place. There have also been many smaller, all well intended, social media groups that have entered the PFO galaxy trying to fill the void left by medicine.  Several PFO debate and support groups surrounding the condition have spun off from migraine and stroke to other possible related disorders.  All either lack anything new to report, or the ability to gather new  funding resources to lead serious PFO patient directed research groups like this forward.    At the same time, most physicians that remain in the PFO space continue to argue and take sides over best practices for management.  Either way, the PFO closure debate slowly is making almost no measurable progress and patients are still left to look to the internet for best practices, like Cooper did to space, for answers.  While some patients along with their physicians await FDA ruling, many physicians caught in the controversies that surrounds PFO closure have already made up their mind and stopped doing PFO closure procedures as reimbursement has dried up.   Some have  simply dismissed the option from the start, others are waiting and holding their opinions silent adrift in a black hole of sorts.

While we all wait, there has been some new data and PFO research analysis conducted by pooling data.  There are also a few international studies and groups slowly trying to collect, analyze and report new data.  I wish, however, as do many PFO patients waiting on the launchpad here in the U.S.,  that we could somehow rocket this effort forward much faster so we are not looking back like Cooper at a lifetime that has passed him by trying to solve a problem.

New Report Released : Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack


PFO Closure vs. Medical Therapy


Published Sept. 8 2015
Cochrane.org

PFO-know-stroke-dot-orgThe authors of this report wanted to compare the safety and effectiveness of transcatheter device closure (TDC) versus medical therapy in people with a patent foramen ovale (PFO) who have suffered a stroke of unknown cause in order to prevent strokes or similar events occurring again.

Key results: The Cochrane Report  found that, “when compared with medical therapy, TDC failed to show any significant benefit in reducing the risk of recurrent stroke or similar events. However, there was a possible protective effect on recurrent strokes in those participants for whom an Amplatzer device was used compared with medical therapy. We did not find evidence that TDC increased the rate of serious adverse events overall. However, TDC increased the risk of new-onset atrial fibrillation (where there is a problem with the rate or rhythm of the heartbeat) and may be associated with the type of device used.”

Read the full Cochrane Report on PFO closure vs. medical therapy 

Authors: 
Li J, Liu J, Liu M, Zhang S, Hao Z, Zhang J, Zhang C

Chime in!  

Have You Had PFO Closure?  Take Our Quick Poll:


Many patient’s report improvement in symptoms and sometimes even complete resolution of symptoms after PFO closure, while other patients report mixed results.  If this applies to you, I hope you’ll chime in here how you feel after closure in this very unscientific anonymous poll:


 

See Our Previous PFO Poll:

Want to tell Us More about Your PFO Story?

A video guide to learn about patent foramen ovale (PFO) and learn about resources and related health topics.


Know about PFO (patent foramen ovale) and related heart and brain topics of interest to your health.

More videos just added:

Watch new videos to know about patent foramen ovale (PFO) and learn about resources and related health topics.

A Year in Review- Still No Closure on PFO Closure!!


 PFO Closure Progress:

Still in the Dark Ages?


These PFO posts still remain two of my most popular posts in 2014 according to WordPress site stats for “Year in Review” which makes me sad actually because it probably means folks are still looking for closure on PFO closure (2 years after the original PFO closure/”Dark Ages” post and 4 years after the PFO Exercise Guidelines post)!

Wish the medical community could do much better for PFO patients:(


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Source: Know-Stroke.org

 

 References:

http://knowstrokeblog.my-physical-therapy-coach.com/2010/10/07/exercise-guidelines-for-pfo-patients-needed/

http://knowstrokeblog.my-physical-therapy-coach.com/2012/07/30/is-pfo-closure-back-in-the-dark-ages/

Know-PFO.org

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