Deans' stroke musings

Changing stroke rehab and research worldwide now.Time is Brain!Just think of all the trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 493 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It's quite disgusting that this information is not available from every stroke association and doctors group.
My back ground story is here:http://oc1dean.blogspot.com/2010/11/my-background-story_8.html

Saturday, October 29, 2016

FDA Approves PFO Closure Device Amplatzer device

So this seems to implicitly argue that closing a PFO is better that medical drug treatment. Challenging all these previous studies.

Stroke Rounds: PFO Closure Works Long-Term Only for Some

 

Landmark Study Finds Expensive Catheter Procedure to Close Hole in Heart No More Effective Than Medical Therapy to Prevent Strokes

 

AAN Nixes Routine PFO Closure

The latest here:

http://www.medpagetoday.com/Cardiology/Strokes/61096?xid=nl_mpt_DHE_2016-10-29&eun=g424561d0r&pos=1 
 
The FDA approved the Amplatzer PFO Occluder device to reduce stroke risk for patients with prior cryptogenic stroke believed to be caused by a patent foramen ovale (PFO)-related blood clot.
The move marks a return to market after being withdrawn in 2006, when the FDA determined it no longer qualified for a humanitarian device exemption as the target population for this device was greater than 4,000 patients. "For the past 10 years, no FDA-approved heart occluder devices have been on the market specifically indicated to close PFOs to reduce the risk of a recurrent stroke in patients with a prior cryptogenic stroke," the FDA announcement of the approval noted.
The panel advising the FDA on the Amplatzer device in May had voted overwhelmingly in favor of its safety, although adverse effects can include injury to the heart; atrial fibrillation; blood clots in the heart, leg, or lung; bleeding; and stroke.
But the panel was fairly split on efficacy (9-7 vote), citing problems with the RESPECT trial, which was the basis for approval but had failed to find superiority of the device over medical management alone for prevention of recurrent cryptogenic strokes. Subsequent analyses, however, showed fewer PFO-related second strokes.
Earlier this year, the American Academy of Neurology recommended against routine PFO closure for cryptogenic ischemic strokes.
"The Amplatzer PFO Occluder provides a nonsurgical method for doctors to close a PFO," Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health, said in a press release. "But as the device labeling clearly states, patients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke and help ensure that PFO closure with the device is likely to assist in reducing the risk of a recurrent stroke."
The Amplatzer device is contraindicated for patients with a heart valve infection or other untreated infections, a heart tumor or blood clot at the implant site, other abnormal connections between the heart chambers, or if cardiovascular anatomy or blood clots would interfere with catheter mobility.

 

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