Canadian media reporting on death from CCSVI complications

[concerned]

"The problem with all of this is that there has not been a good randomized, controlled, double-blinded study that says it's either effective or ineffective. Nor has there been a trial done that assesses what the risks are or aren't," McDonald explained.

[concerned]

So, is this not what Zamboni's procedure is or whatever Dr. McDonald said, because a stent was used?

[CCSVIhusband]

Again, you're relating it to MS ...

Looks like we're back in the circle ... the vortex (or whirlpool) where some people want to argue one way, but have it another way.

EVERYONE agrees, we want randomized controlled trials. How come nobody is doing them?

The death is tragic. It makes me sad. But this man made a decision - hopefully knowing what the minimum and maximum risks were. I don't think anyone doesn't know those risks, and it seems everyone going to have this done knows the risks ... There isn't a person on this board that doesn't know the risks going in.

But ...

If the man had been able to have this procedure done in Canada is it likely he'd be alive today? (yes, most likely - I think that's fair to reason) because he would have had follow-up and his doctors in Canada would have known what was done.

...

[concerned]

I've heard people say "If I knew that it could make me worse, I wouldn't have gotten the procedure done."

Did they know the risks going in?


ALSO I'm relating it to MS because we are on a forum called ThisisMS, and also, my mother has had MS for 30 years, which is why we've been paying attention to this whole thing in the first place.

[Cece]

EVERYONE agrees, we want randomized controlled trials. How come nobody is doing them?

Dr. Dake is (fully funded, which takes millions!), Dr. Mehta is, Dr. Siskin is. Dr. Sclafani disagrees, says we do not want RCTs until they're further along in the discovery process of how to do the procedure right.

I struggled to report this death on Facebook (and did so here on TIMS) 5 days after it happened, but people didn't want to hear it. We couldn't release his name because his widow did not consent, but now apparently she is talking. Even without his name, I felt the news had to be released because people were not always pursuing follow up ultrasounds, even when advised to do so by their angioplasty doctors.

Thank you for sharing it originally, you were right to do so. I don't think this is a follow-up ultrasound issue, because he had that. If he had gone untreated the second time, he would have still had the 80% narrowing from clotting but he'd have been ok. The death came as a complication from the blood thinners after the second procedure. I again say we need to know what blood thinners those were if we are to assess what risk we are all at.

He was reported earlier as being severely disabled, but from the article it said he was able to use a wheelchair and had only been in it 18 months. I'm not sure at what EDSS a person is no longer able to use a wheelchair, but I think this man was within the EDSS range that doctors are comfortable doing the procedure. (Once it is an EDSS of 8 or above, there can be some hesitancy or exclusion from ccsvi trials or extreme difficulty with traveling. But this man was not in that category.) And the picture with the baby breaks my heart.

[PCakes]

I've heard people say "If I knew that it could make me worse, I wouldn't have gotten the procedure done."

Did they know the risks going in?

The challenge is to embrace that in these, the early days, there are no guarantees.

Dr. Zamboni speculates that there may exist different types of MS that have slightly different origins leading to the similar disease outcome, of which only a proportion, although a large proportion in his view, may stem from these intraluminal abnormalities.

Cece, yes, mine too.

[CCSVIhusband]

I've heard people say "If I knew that it could make me worse, I wouldn't have gotten the procedure done."

Did they know the risks going in?

Dr. Zamboni speculates that there may exist different types of MS that have slightly different origins leading to the similar disease outcome, of which only a proportion, although a large proportion in his view, may stem from these intraluminal abnormalities.

See if people would read all the research, they would know things like this. You don't hear any of us saying, go have this done, don't research it, pay us $10,000. NOT a single person has said this.

It's not my fault, nor anyone's fault really, if they choose to leap blindly into something. That's just silly. I don't run into the ocean without first surveying the scene, and seeing how far out people are, where the lifeguards and flags are, etc. But when I do there are still risks, a risk that a horseshoe crab is there to puncture my foot, or that I'll step on a shell and really cut myself, or I'll get stung by a jellyfish, or that a shark just happens to be in the spot I run into. They're all risks I know about, but ones I'm willing to take. (heck, I might run in and stumble and break my leg on a chest of some pirate gold - another risk, and potentially great reward) I can't imagine anyone doing that with their body and health and not weighing the risks and rewards (though I agree with you some probably did, and quite stupidly in my opinion). But I AGAIN FROM PERSONAL EXPERIENCE, know when we went to the doctor, we were warned of the negative potential outcomes before the procedure as well ... so claiming ignorance is admitting to being ignorant.

That said, since you brought her into this, has your mother read the research, or does she just read this site (if she does then she knows the risks, but does she know the research into the WHY)?
Does she still want to have it done knowing this?
Or are you going to point to this one death to dissuade her when there are so many other cases of good things happening? What if you (or she) personally knew Rose2, or Magoo, or others treated by Dr. Dake who had stents and great successes (sorry to name-drop those folks, I hope they don't mind for the sake of argument).
Or are you just generally concerned? (I agree these two incidents with stents make me very leery ... and the stories of people who may have gotten worse *it's all anecdotal right* ... but at the same time, did they read the research, communicate ENTIRELY with their doctors what they wanted looked at, what Dr. Zamboni really saw and why ... and things like that?)

My wife and I spent months and months and months reading the research, talking to doctors, discussing with Dr. Sclafani ... before we decided on a doctor we were comfortable with and actually went through with this. We told him about webs (found), about entering through the left femoral vein (done - and may thurner found), about valve issues and things like that ...

Can you say anyone going abroad has done the same? Nope, but I'll bet a lot of people who have taken the time to go to doctors in the US (or if they could in Canada) and have a lot of appointments with those doctors WOULD have done that ... and that's what patients and doctors need to do. Not this fly half-way around the world stuff.

As cheer has always said, GO LOCAL. A doctor/patient relationship is very important. Nobody argues that.

But your turn to take a spin in the circle now ... (and here we go)

[LR1234]

.......

[CCSVIhusband]

See, LR makes a good point. That she was able to be treated in her home country after returning (I'm not sure I remember, but I don't believe she had her CCSVI procedure in her country).

But the man in Canada wasn't allowed to have anything done in his country so he had to travel ... with a clot, and on meds to medical tourism.

To me, that's a recipe for disaster.

Unfortunately in this case, one with a tragic ending ...

But what if he'd have been treated in Canada when he first tried ... well hindsight is 20/20 for a reason.

Sad story though.

LR, have they RE-checked your (99.9% sure clotted vein)?

How did they remove the clot by open vein surgery? (sorry if I missed the story elsewhere)

[youbetcha]

Very sad to hear and yes it's very important to make an informed decison and to be comfortable with that decision before doing anything. My thoughts and prayers are with that family today.

[Cece]

I could have died from the thrombosis in my left jugular which clotted with NO stent.
I got on a plane unable to see properly, unable to breathe, feeling exhausted. My heart was racing and I honestly thought I was not going to make it. (sorry for the drama but its the truth I was seriously ill)

Your doctor should not have let you go in that condition, it is appalling.

How much longer do you think the medical tourism will be going on? I think years. Someone - Pcakes, was it you? - told me that even when Canada approves the CCSVI treatment, the line for it will go forever.

We need to accept the reality that medical tourism is part of this so it needs to be as safe as possible for those who go. If Bulgaria is not safe, we need to say so. Same with Costa Rica. How do we assess these things?

It's not my fault, nor anyone's fault really, if they choose to leap blindly into something.

But it is our responsibility, if we see these dangers, to warn those around us who don't. PwMS are a vulnerable population, I know from my own head stuff & cogfog & judgement errors, I can't imagine how much harder it would be if my MS weren't stable if I didn't feel I had the time to sort this out.

[PCakes]

.. Pcakes, was it you? - told me that even when Canada approves the CCSVI treatment, the line for it will go forever.

Yes, that was me. I also explained that as part of my initial diagnosis I was told that the wait list for an mri was 6 months. I 'chose' to go to a private imaging clinic and had my results in 48 hours.
Canadians have supported the 'medical tourism' industry for years. Joint, hip & knee, replacements are a very good example. The wait lists up here for many types of surgery are long. The pain often overtakes the ability to wait.
We also see other reasons for travel. Not long ago the Newfoundland Premiere, Danny Williams, travelled to the U.S.A. for heart surgery. http://www.nationalpost.com/news/story.html?id=2510700 This set off all kinds of controversy but he was 'making a choice' that he was fortunate enough to have.

[garyak]

I go for my second procedure in 2 weeks back in san diego. I have decided that I probably will not opt for a stent. I also strongly feel that what happened to this poor unfortunate soul was medical neglect and malpractice in the highest form. That canadian doctor needs to have his ass involved in malpractice litigation for sure.

[elliberato]

Any type of surgery or procedure will have some deaths...it is a risk factor even with simple
appendicitis or tonsils. Very Sad though...and I fault the Canadian docs for not treating him. I don't care
where he had his procedure!
HB

[thornyrose76]

Is there a fund set up for this man's family? When this story first came to light, it was said that they were trying to raise the money to transport the body home.

The Costa Rican doctor's assessment was that it was the blood thinners that caused this. We should find out what blood thinners those were, if any one of us is ever to be put on them and if it's not the same as what standard of care would be here or in Canada. The fatality at Stanford was also attributed to the blood thinners.

I wish this had turned out to not be true.

Thornyrose, in two provinces there have now been official statements that they will provide care as needed for complications for CCSVI treatments done out of country. I think they are catching up. There was a telling statement, I forget which doctor or official it was from, but it was that they could not do a redo or repeat of the experimental procedure. I think that shows a lack of knowledge. There may be times when the vein recoils to what it had been and the patient wants a do-over, but that is not to be confused with a clotting or complication or emergency care situation.

And manitoba, ontario, and the rest of the maratimes can follow suit. The gov't here needs to step up and start listening to those that are ill instead of resting on the laurels of the long dead Tommy Douglas, the father of free health care. It's horrible what happened to this young man, a disgrace. I am so angry right now, I wish, long to be state side.