Special Access program in Canada

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Special Access program in Canada

Postby Cece » Mon Jan 30, 2012 6:19 pm

http://www.wireservice.ca/index.php?mod ... y&sid=7442
The procedure is described as minimally invasive and is used to reduce high blood pressure in patients who cannot be effectively treated by drugs. The Peter Munk Cardiac Centre received approval from Health Canada to perform the procedure under the Special Access Program. This program allows physicians to request access to drugs or procedures that are currently not approved in Canada. Health Canada’s website notes that the Special Access program “… is limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable or are unavailable.”

Renal denervation was discussed at ISET two weeks ago. It isn't the greatest procedure to have. There are equal chances of it helping, doing nothing, or directly causing the patient's condition to worsen. But for the patients it helps, it can really help.

Renal denervation is being performed on patients under the Special Access program in Canada.

I see no reason why jugular venoplasty is not being performed on patients with outflow obstructions under the same Special Access program.
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Re: Special Access program in Canada

Postby jackiejay » Mon Jan 30, 2012 7:31 pm

has anybody tried to get it done under this "special access" program?....
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Re: Special Access program in Canada

Postby eric593 » Tue Jan 31, 2012 12:11 am

Cece wrote:
I see no reason why jugular venoplasty is not being performed on patients with outflow obstructions under the same Special Access program.


*sigh...

Because venous obstructions that cause a new condition now described by some as CCSVI are also found in healthy people and there is no evidence that they cause any "serious or life threatening illness", or any illness of any significance or insignificance at all. As Dr. Sclafani emphasizes, he treats "CCSVI NOT MS".
The obvious difference is that hypertension has well documented ill effects if not controlled. That, and renal denervation has studies done elsewhere documenting its impact on high blood pressure. Something else that venoplasty for CCSVI lacks as well.

It seems pretty clear to me why these situations are not comparable and why this could not be used as an example to argue for coverage of venoplasty for CCSVI under Canadian healthcare on a compassionate basis. You are comparing two circumstances that are vastly dissimilar.
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Re: Special Access program in Canada

Postby DougL » Tue Jan 31, 2012 4:53 am

eric593 wrote:Because venous obstructions that cause a new condition now described by some as CCSVI are also found in healthy people and there is no evidence that they cause any "serious or life threatening illness", or any illness of any significance or insignificance at all.


i have seen the affect of the treatment on an unhealthy person. speaking as a relatively healthy person, if i was ever to discover i too had the condition some people call CCSVI, i would book the treatment with Dr S the same day.

you are correct, there is no evidence yet. but in my opinion, we are talking about a major flaw in blood flow. there is no way i could be convinced that it is something "i can live a normal life with".

i did not witness the event but had it described to me. when Dr. S put the scope in my partner's right jug and blocked it, her face lit up like a tomato. this was caused by the doctor but what if it happened because of a clot or something. i see strokes and heart attacks in her future.

you are correct, there is no evidence. i wonder how many healthy people who suddenly died of a heart attack had this condition some people call CCSVI. how many healthy people who have CCSVI today will also have MS in 10 years.

you are correct, there is no evidence that CCSVI causes "serious or life threatening illness". i think the misunderstanding is that CCSVI is the "serious and life threatening illness".

again, just my humble opinion.

i wonder what would happen if i went to my doctor and complained that i think i had a stroke. the specialists find nothing but i keep pointing to my CCSVI. i wonder if it would be treated. hmmm. all it would take is one person who does not have MS to get treated in Canada and then ....
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Re: Special Access program in Canada

Postby eric593 » Tue Jan 31, 2012 6:23 am

A case study of one will not be sufficient to allow "special access" to the treatment. So long as healthy patients are found with CCSVI, a randomized blinded trial will be needed. One where patients are randomized, data assessors are blinded and patients aren't paying themselves. As doctors are known to say, the venous system is repetitive and collaterals can form as well to allow blood to bypass obstructions. At the moment, we have no reliable, reproducible data showing that the alleviation of CCSVI has any health benefit nor that CCSVI has any deleterious effect on health. Not when many, many healthy people are walking around with it in the absence of any symptoms. We will need proper studies done to control variables.

I'm not sure the significance of your partner's face becoming red when total blood flow was interrupted on one side by the inflation of the balloon. Obviously those with CCSVI are not walking around with red faces, nor is it a symptom of MS, so I'm not sure what that means except specific to your partner's particular anatomy. Besides, I was under the impression that the external jugular veins controlled facial colour?

Healthy people with CCSVI are not "rushing" to have this diagnosis, one that has had no effect on their health, fixed. There has never been any intimation that I've read or heard that untreated CCSVI increases a risk of clots, heart attack or stroke.
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Re: Special Access program in Canada

Postby 1eye » Tue Jan 31, 2012 7:33 am

It is not always the red faces that are the obvious sign. In fact I have heard it said that if a person has had the procedure, their colour will be better, redder and less pale. People have said they could tell I had had it, immediately, before being told, just by the colour of my face. The results of venous hypertension are not something I would bank on being clearly marked, or recognizable even by those with the intensive training that TiMS provides. The consequences are more known, and can be found on Wikepedia. This also applies to venous reflux. If a person is having that problem I would expect that someone in the medical profession would be prepared to refer them to an appropriate specialist. It may be a problem for the patient if they too obviously have a nervous disorder, even if that may have been caused by the venous problem, because of the irresponsible behaviour of a few neurologists. Their continued willingness to see Canadians suffer and die, rather than allow them to try to obtain professional treatment locally, is medieval and unChristian, at best. The consequences of a heart valve causing venous reflux are known, similar to the symptoms of MS, and asymptomatic in a large number of people. Does that mean the ones who do have symptoms should not be treated by a cardiologist, including angioplasty, because it might also be "MS"? I would certainly hope not.

I don't think people should be advising the government or individuals on an Internet forum, or taking advice from there only, or even relying on it . No offense meant to anyone here. In my old business that might have been called a sole-sourcing problem. If there isn't already one, there should be a warning label that is unmistakeable, against this sort of thing. If, on the other hand, someone finds out a doctor's address or phone number, well, that's what it's there for. By all means, get a second opinion. And not from someone anonymous.

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Re: Special Access program in Canada

Postby Cece » Tue Jan 31, 2012 9:15 am

DougL wrote:i did not witness the event but had it described to me. when Dr. S put the scope in my partner's right jug and blocked it, her face lit up like a tomato. this was caused by the doctor but what if it happened because of a clot or something. i see strokes and heart attacks in her future.

That happened to me too, DougL. Even before he'd seen the other vein, he said that reaction was an indicator of a severe blockage on the other side. Sure enough, the other side was 99% blocked.

Perhaps when the only working internal jugular is suddenly completely blocked, a portion of the displaced blood flow exits through the external jugulars, causing a back-up there, causing the very red face? I am not sure.

Good memories! It hurt when that first jugular was ballooned, and I felt light-headed and was holding on and enduring it, and then it was done and my head cleared and the first thing was that it felt like the Fentanyl, which had made me woozy, was cleared away and I felt sharper, and I noticed the music, and I realized that I had changed, that quickly.
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Re: Special Access program in Canada

Postby DougL » Tue Jan 31, 2012 10:36 am

eric593 wrote:There has never been any intimation that I've read or heard that untreated CCSVI increases a risk of clots, heart attack or stroke.


i may be misinformed, but i read that Dr. Zamboni did the procedure on his wife because he was concerned with a stroke in her future. Not because of any association to her MS.
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Re: Special Access program in Canada

Postby 1eye » Tue Jan 31, 2012 11:20 am

eric593 wrote:A case study of one will not be sufficient to allow "special access" to the treatment.... ...We will need proper studies done to control variables...

...Healthy people with CCSVI are not "rushing" to have this diagnosis, one that has had no effect on their health, fixed. There has never been any intimation that I've read or heard that untreated CCSVI increases a risk of clots, heart attack or stroke.


Who might this "we" be of which you speak, who will need "proper" studies done? You sound like you have some decision-making power here, when all I can see is a cryptic nom-de-keyboard. If people are not rushing to have it fixed, maybe it's because they are currently asymptomatic, as I was for 17 years after my first "attack". Perhaps if they knew what was going to happen to them in the long run, they might be thinking about it. Perhaps if there had ever been any long-term studies done on these people, they might have a clue.

Need I repeat that there were studies on angioplasty being done only long after it was accepted practice, that it continued to be done during the studies? That it was only assumed that it would have efficacy?
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Re: Special Access program in Canada

Postby drsclafani » Tue Jan 31, 2012 8:30 pm

eric593 wrote:
Cece wrote:
I see no reason why jugular venoplasty is not being performed on patients with outflow obstructions under the same Special Access program.


*sigh...

Because venous obstructions that cause a new condition now described by some as CCSVI are also found in healthy people and there is no evidence that they cause any "serious or life threatening illness", or any illness of any significance or insignificance at all. As Dr. Sclafani emphasizes, he treats "CCSVI NOT MS".
The obvious difference is that hypertension has well documented ill effects if not controlled. That, and renal denervation has studies done elsewhere documenting its impact on high blood pressure. Something else that venoplasty for CCSVI lacks as well.

It seems pretty clear to me why these situations are not comparable and why this could not be used as an example to argue for coverage of venoplasty for CCSVI under Canadian healthcare on a compassionate basis. You are comparing two circumstances that are vastly dissimilar.


I am a PI for SUNY Downstate on the Symplicity trial. This trial is the third study being done by the owners of the patent.

the first trial was by the start up company Ardian. and published by Krum
Catheter-based renal sympathetic denervation for resistant
hypertension: a multicentre safety and proof-of-principle
cohort study
Henry Krum, Markus Schlaich, Rob Whitbourn, Paul A Sobotka, Jerzy Sadowski, Krzysztof Bartus, Boguslaw Kapelak, Anthony Walton,
Horst Sievert, Suku Thambar, William T Abraham, Murray Esler
Summary
Background Renal sympathetic hyperactivity is associated with hypertension and its progression, chronic kidney
disease, and heart failure. We did a proof-of-principle trial of therapeutic renal sympathetic denervation in patients
with resistant hypertension (ie, systolic blood pressure ≥160 mm Hg on three or more antihypertensive medications,
including a diuretic) to assess safety and blood-pressure reduction eff ectiveness.
Methods We enrolled 50 patients at fi ve Australian and European centres; 5 patients were excluded for anatomical
reasons (mainly on the basis of dual renal artery systems). Patients received percutaneous radiofrequency
catheter-based treatment between June, 2007, and November, 2008, with subsequent follow-up to 1 year. We assessed
the eff ectiveness of renal sympathetic denervation with renal noradrenaline spillover in a subgroup of patients.
Primary endpoints were offi ce blood pressure and safety data before and at 1, 3, 6, 9, and 12 months after procedure.
Renal angiography was done before, immediately after, and 14–30 days after procedure, and magnetic resonance
angiogram 6 months after procedure. We assessed blood-pressure lowering eff ectiveness by repeated measures
ANOVA. This study is registered in Australia and Europe with ClinicalTrials.gov, numbers NCT 00483808 and NCT
00664638.
Findings In treated patients, baseline mean offi ce blood pressure was 177/101 mm Hg (SD 20/15), (mean 4·7 antihypertensive
medications); estimated glomerular fi ltration rate was 81 mL/min/1·73m² (SD 23); and mean reduction
in renal noradrenaline spillover was 47% (95% CI 28–65%). Offi ce blood pressures after procedure were reduced by
–14/–10, –21/–10, –22/–11, –24/–11, and –27/–17 mm Hg at 1, 3, 6, 9, and 12 months, respectively. In the fi ve
non-treated patients, mean rise in offi ce blood pressure was +3/–2, +2/+3, +14/+9, and +26/+17 mm Hg at 1, 3, 6, and
9 months, respectively. One intraprocedural renal artery dissection occurred before radiofrequency energy delivery,
without further sequelae. There were no other renovascular complications.
Interpretation Catheter-based renal denervation causes substantial and sustained blood-pressure reduction, without
serious adverse events, in patients with resistant hypertension. Prospective randomised clinical trials are needed to
investigate the usefulness of this procedure in the management of this condition.
Funding Ardian Inc.

This was the basis for a randomized trial in Europe and Australia that showed efficacy in treatment by reducing blood pressure. They did not have to show a reduction in stroke, heart attacks, kidney failure. I cannot find a paper on that randomized prospective trial, but several short papers by various groups in italy, netherlands, spain to same a few.

becoming The device was then released by Ardian in Europe and is now becoming a mainstream therapy for patients who fail drug therapy (that is, remain hypertensive despite three or more medications including a diuretic.

The Device and the company were bought by Medtronic, a large conglomerate in cardiovascular instrumentation for treatments and diagnostics.Now FDA has approved a trial of the device in the united states. It is a well designed study.


That trial is a double blinded trial, comparing optimized medical therapy against RF ablation of the renal sympathetic nerves in a 1:2 ratio.


i think that the letter is on target, not however, in any way disparaging the sympathectomy work

while there are three times as many papers in the literature since 2009 on sympathectomy than on ccsvi. However there are more randomized papers in ccsvi. many papers in the european experience of hypertension are small short series.

I think that the letter was dead on
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Re: Special Access program in Canada

Postby drsclafani » Tue Jan 31, 2012 8:38 pm

eric593 wrote:A case study of one will not be sufficient to allow "special access" to the treatment. So long as healthy patients are found with CCSVI, a randomized blinded trial will be needed. One where patients are randomized, data assessors are blinded and patients aren't paying themselves. As doctors are known to say, the venous system is repetitive and collaterals can form as well to allow blood to bypass obstructions. At the moment, we have no reliable, reproducible data showing that the alleviation of CCSVI has any health benefit nor that CCSVI has any deleterious effect on health. Not when many, many healthy people are walking around with it in the absence of any symptoms. We will need proper studies done to control variables.

I'm not sure the significance of your partner's face becoming red when total blood flow was interrupted on one side by the inflation of the balloon. Obviously those with CCSVI are not walking around with red faces, nor is it a symptom of MS, so I'm not sure what that means except specific to your partner's particular anatomy. Besides, I was under the impression that the external jugular veins controlled facial colour?

Healthy people with CCSVI are not "rushing" to have this diagnosis, one that has had no effect on their health, fixed. There has never been any intimation that I've read or heard that untreated CCSVI increases a risk of clots, heart attack or stroke.

eric,
i recall that it costs a lot of money to have this procedure done. Perhaps some patients are not having this done because they cannot afford the fees, travel, etc.
It is a common phenomenon that inflating the balloon on the first jugular vein causes the face to become beet red. Clearly there is transfer of blood to external branches. Why? because the other jugular uis usually also blocked. This is a significant finding. It is highly reliable in predicting obstruction on the other side.


I am not sure why you say that there are many people walking around with ccsvi without symptoms. CCSVI is a symptom complex. I do not recall seeing jugular veins that look like these in normal patients, of which i have angiogramed hundreds

But this is silly. Don't accept the concept. Enjoy yourself
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Re: Special Access program in Canada

Postby DrCumming » Fri Feb 03, 2012 5:57 am

Sal, this is off topic from the thread title ....

At ISET, a member of the audience suggested that part of the improvement seen post jugular vein dilation could be related to injury of the vagus nerve causing a transient sympathectomy similar to renal denervation... interesting thought.
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