some details on adverse events listed by FDA

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some details on adverse events listed by FDA

Postby Cece » Fri May 11, 2012 6:41 pm

http://www.ocmetro.com/t-Hoag-doctor-cr ... -2012.aspx
In the second documented case, a man, experienced complications immediately following the procedure, including difficulty communicating, a facial droop and double vision. He was taken directly to Hoag’s emergency department, where an MRI scan revealed that an acute obstruction of blood to the brain stem had caused a severe stroke. After five days in Hoag’s stroke management care unit, his condition stabilized and the patient was transferred.

The FDA letter talked about different adverse events. I had heard about a stroke but hadn't heard the details until now. What a terrible thing to have happened. I am not sure how venoplasty of the jugulars could contribute to a stroke. Could the balloon have been inflated large enough that it pressed against the carotid artery and somehow diminished flow? Heparin is administered during the procedure but could a clot have formed and travelled? Or if both jugulars were severely blocked, could cutting off flow through the one jugular have caused a complete outflow obstruction leading to a stroke? It's hard to weigh the risk of a stroke when it is unclear how it could follow venoplasty of the jugulars at the base of the neck.

The FDA also included abdominal bleeding as one of its adverse events, and it took me awhile to connect that to Mr. Mostic, who passed away in Costa Rica after being turned away for clot treatment in his native Canada. Abdominal bleeding was a complication of the drug taken to dissolve the clot, which was itself a complication of the stent. Very sad.

www.thisisms.com/forum/chronic-cerebros ... tml#p65185
What happened to Holly was also an arterial bleed in the brainstem.
Last edited by Cece on Fri May 11, 2012 7:07 pm, edited 1 time in total.
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Re: some details on adverse events listed by FDA

Postby 1eye » Fri May 11, 2012 7:07 pm

I think you can get strokes from aneurysms or embolisms in either veins or arteries. If an embolism goes from vein to artery, it can cause stroke, I think. I have no clue how this one happened. I think a stroke is a variable length of time with no oxygen getting to part of your brain. I have a family history of stroke, and now also CCSVI.
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Re: some details on adverse events listed by FDA

Postby Cece » Fri May 11, 2012 7:25 pm

Can an embolism travel upstream like that? Or can massive reflux and pressure caused by the balloon blocking flow? I know some doctors keep the ballooning times very short, which would minimize even the possibility. Everything we've heard is that venoplasty of the jugulars is very safe and these are very rare adverse events.

The previously linked article also included information on Maralyn Clarke, who suffered a subdural hematoma after the procedure.
In the Journal article, Brant-Zawadzki reports two cases of two MS patients who underwent differing forms of the liberation treatment at a “local outpatient facility.” The first patient, a woman, developed a headache and high blood pressure following the procedure but was still allowed to return to her hotel. After vomiting and losing consciousness, she was rushed to Hoag’s emergency room, where it was discovered that a subdural hematoma, bleeding in the brain, developed following the treatment. After five days, the family decided to discontinue treatment, and the patient died in the hospital.
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Re: some details on adverse events listed by FDA

Postby 1eye » Fri May 11, 2012 8:36 pm

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Re: some details on adverse events listed by FDA

Postby 1eye » Sat May 12, 2012 12:54 pm

These are rare events. Even if there were 10, which I doubt, 10 on 25,000 is not exactly as risky as say, Tysabri, which the FDA has no problem with and does not call experimental. Whose side are they on? Caveat emptor.
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Re: some details on adverse events listed by FDA

Postby drsclafani » Sun May 20, 2012 11:24 pm

1eye wrote:These are rare events. Even if there were 10, which I doubt, 10 on 25,000 is not exactly as risky as say, Tysabri, which the FDA has no problem with and does not call experimental. Whose side are they on? Caveat emptor.


The FDA is empowered to safeguard the public. Many years before CCSVI was even mentioned, angioplasty balloon catheters were defined as potentially life-threatening devices Such devices REQUIRE an Investigational Device Exemption ( IDE) from the FDA when they are used in an investigational trial where effectiveness and safety in that trial has not been established. If one performed angioplasty of any blood vessel not originally approved for their use, one should get an IDE.
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Re: some details on adverse events listed by FDA

Postby MarkW » Tue May 22, 2012 2:55 am

drsclafani wrote:The FDA is empowered to safeguard the public. Many years before CCSVI was even mentioned, angioplasty balloon catheters were defined as potentially life-threatening devices. Such devices REQUIRE an Investigational Device Exemption (IDE) from the FDA when they are used in an investigational trial where effectiveness and safety in that trial has not been established. If one performed angioplasty of any blood vessel not originally approved for their use, one should get an IDE.

Thanks for the explanation Dr S. I always put stents into the 'potentially life-threatening device' camp. Now, I appreciate that if one mis-uses a balloon catheter (designed for arteries) in a vein, then rupture of a major vein could occur and death would result.
An interesing comparison between 'off label prescribing' and 'novel use of a surgical device' may be more mis-leading than enlightening but the FDA has powers in both areas.
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Re: some details on adverse events listed by FDA

Postby drsclafani » Tue May 22, 2012 4:26 am

MarkW wrote:
drsclafani wrote:The FDA is empowered to safeguard the public. Many years before CCSVI was even mentioned, angioplasty balloon catheters were defined as potentially life-threatening devices. Such devices REQUIRE an Investigational Device Exemption (IDE) from the FDA when they are used in an investigational trial where effectiveness and safety in that trial has not been established. If one performed angioplasty of any blood vessel not originally approved for their use, one should get an IDE.

Thanks for the explanation Dr S. I always put stents into the 'potentially life-threatening device' camp. Now, I appreciate that if one mis-uses a balloon catheter (designed for arteries) in a vein, then rupture of a major vein could occur and death would result.
An interesing comparison between 'off label prescribing' and 'novel use of a surgical device' may be more mis-leading than enlightening but the FDA has powers in both areas.
MarkW

Mark
the FDA makes no distinction about the location of an angioplasty. I cant speak historically, but i can speculate that much of the use of balloons early on was in angioplasty of the coronary arteries. use in that location is surely associated with risk of death.

I do not think that even "mis-use" of an angioplasty catheter in the jugular vein is life threatening per se. It is the device that is considered potentially life threatening. The venous pressure is too low and the surrounding tissue provides too much resistance to lead to exsanguination. use of these devices in the central veins of the chest is more risky because resistance is low if blood leaks out of the vein into the chest or mediastinum.

nonetheless, oversite of the off label useof such devices in investigations is a right and proper function of the FDA. The rub is the apparent the lack of thorough research of the topic by the FDA before issuing the warning. There may be no consensus, but the only paper of which I am aware that speaks about the risk of the procedure is the Canadian retrospective review from vancouver that discussed patients coming back from foreign countries with complications. Much less valuable than the data from the mandato, simka and petrov papers.
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Re: some details on adverse events listed by FDA

Postby 1eye » Tue May 22, 2012 6:02 am

drsclafani wrote:The FDA is empowered to safeguard the public. Many years before CCSVI was even mentioned, angioplasty balloon catheters were defined as potentially life-threatening devices Such devices REQUIRE an Investigational Device Exemption ( IDE) from the FDA when they are used in an investigational trial where effectiveness and safety in that trial has not been established. If one performed angioplasty of any blood vessel not originally approved for their use, one should get an IDE.


You could argue that safety had been established, on at least two continents. If agreement between three independent studies is not consensus, I think you may never get there.

I have seen the results of the exercise of those powers when I met someone with facial paralysis resulting from PML.
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Re: some details on adverse events listed by FDA

Postby drsclafani » Tue May 22, 2012 8:44 am

1eye wrote:
drsclafani wrote:The FDA is empowered to safeguard the public. Many years before CCSVI was even mentioned, angioplasty balloon catheters were defined as potentially life-threatening devices Such devices REQUIRE an Investigational Device Exemption ( IDE) from the FDA when they are used in an investigational trial where effectiveness and safety in that trial has not been established. If one performed angioplasty of any blood vessel not originally approved for their use, one should get an IDE.


You could argue that safety had been established, on at least two continents. If agreement between three independent studies is not consensus, I think you may never get there.

I have seen the results of the exercise of those powers when I met someone with facial paralysis resulting from PML.


i would agree with you
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Re: some details on adverse events listed by FDA

Postby Endovasc » Wed May 23, 2012 11:09 am

FDA oversight is limited to clinical trials not retrospective studies. Balloon catheters are class II devices. Efficacy is not required only demonstration of safety. Despite these points, and I could list others, they suggest consulting with a neurologist. Is there another example of the FDA suggesting to the public that they ask a neurologist about a vascular issue?
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Re: some details on adverse events listed by FDA

Postby Cece » Wed May 23, 2012 11:20 am

Endovasc wrote:Is there another example of the FDA suggesting to the public that they ask a neurologist about a vascular issue?

I can't imagine that there is. Good point.
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Re: some details on adverse events listed by FDA

Postby drsclafani » Wed May 23, 2012 11:42 am

Endovasc wrote:FDA oversight is limited to clinical trials not retrospective studies. Balloon catheters are class II devices. Efficacy is not required only demonstration of safety. Despite these points, and I could list others, they suggest consulting with a neurologist. Is there another example of the FDA suggesting to the public that they ask a neurologist about a vascular issue?


I certainly cannot imagine them suggesting that patients ask a vascular specialist about a neurological problem.
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Re: some details on adverse events listed by FDA

Postby cheerleader » Wed May 23, 2012 12:53 pm

Endovasc wrote:FDA oversight is limited to clinical trials not retrospective studies. Balloon catheters are class II devices. Efficacy is not required only demonstration of safety. Despite these points, and I could list others, they suggest consulting with a neurologist. Is there another example of the FDA suggesting to the public that they ask a neurologist about a vascular issue?


Actually, there is another situation where this is being played out. I believe we are seeing the same situation of neurological insistance of oversight in one procedure which was done for decades without them, and was later put thru clinical trials because of them---Carotid endarterectomy (CEA)

Some history for those who might not know--. Endarterectomy is the removal of material on the inside of an artery. This is open surgery, and began in the 1940s and 50s, later became an interventional radiological procedure, as well. This surgical procedure has been used to prevent stroke by correcting stenosis in the common carotid artery. Due to pressures put on the vascular community by the pharmaceutical industry (who have drugs created to lower stroke risk) there have been clinical trials and much debate in the last decade. Many conflicting study results. Some show the new drugs are better, some show surgery. The ones where drugs prevail are published in neurological journals. Vascular intervention in vascular journals.
Here is the AAN recommendation published in Neurology. No surprise--they like statins! http://www.aan.com/professionals/practi ... ectomy.pdf

Blood to and from the brain is going to be a tremendous issue in the coming years. Whether neurodegeneration, stroke and dementia can be prevented or repaired by mechanical procedures, lifestyle intervention and pharma will be debated in medical journals. And neurologists will want a piece of this, because even though the brain is connected to the heart via blood vessels....their flag is placed on our craniums, and their research is funded by pharma.
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Re: some details on adverse events listed by FDA

Postby 1eye » Wed May 23, 2012 1:16 pm

cheerleader wrote:their flag is placed on our craniums.
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Nice to know of this, but I believe both my cranium and circulation belong to me.
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