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Old 06-08-2013, 07:01 AM   #51
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Originally Posted by danielmd06 View Post
I don't understand why this thread suddenly became a bit sharp.

To restate my original points:

(1) NIR is not "dying" due to the extant potential of alternative (ie non-ischemic stroke) work.
(2) NIR has not (yet) been definitively ruled out (based on RCT's) for acute stroke therapy. And likely will never be (my anecdotal $0.02). We'll see.
(3) The need for NIR is not as ubiquitous as was once thought four years ago...based upon a lack of promising trials and despite (1) above.

And something that meant alot to me once upon a time:

(4) The odds of doing 100% NIR are waaaay long. One must be ready to step into the breach and perform neurosurgery, run a stroke program, run a stroke clinic, run a NICU, or read rads studies. Pressing respective need and overall reimbursements will play a huge role in what private groups and hospitals will think on when considering candidates from different backgrounds for NIR, too.

So the job will continue thrive...albiet not on every street corner and the need is less than was once calculated.
Well, #1, 3, and 4 still seem okay statements. But I was sure wrong on #2. C'est la vie.
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Old 06-10-2013, 12:13 PM   #52
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Once again, I see eye to eye with neglect who is always realistic and clear-thinking. As far as I am concerned, I have absolutely no confidence the stroke community. I am completely cynical. They will not respond to negative data. They are just like cardiologists. The negative data will continue to roll in, and the number of procedures will continue to increase. I actually disagree with neglect about INR being a dying field because people will continue to do off-label and essentially contraindicated procedures out of desperation. It is the same psychology of not giving up on an elderly, irreversibly ill and suffering relative or giving chemotherapy to an 85 year old with multiple comorbidities. We are men of action. Action implies strength. Inaction implies ineptitude and apathy.

I don't care if strokeguy has 30 years of experience and 100 publications. These procedures are failing misreably. Your proceduralists are not better than those in these clinical trials. Your clinical judgment is not significantly better than the neurologists in these trials. Get over yourself.

In some of these trials, the deck was stacked heavily in favor of intervention. Think about IMS3 and how much better these patients were as candidates for intervention compared to the typical patient getting off -label thrombectomy (i.e 6.5 hours out, a lot of abnormalities on NC CT)

I actually would credit stroke guy for making very reasonable statements later in this thread, espcially this:

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In my opinion this should at least make physicians think that unless something gets proven in well designed clinical trials it is a falacy to make it a pseudo-standard of care.
Here are some of my responses to statements made earlier in this thread

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Originally Posted by Strokeguy View Post
Unlike medical therapies, devices are extremely technology dependent.
stenting went head to head against nothing and was utterly destroyed.



Future clinically trials should be in patients with strokes despite maximum medical therapy and done with extreme caution and pessimism.

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Lets say, we don’t want to stent, then also there is always a safer option of balloon angioplasty alone.
Prove it in a clinical trial first.

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Many people are not aware of the results of SENTIS.
Interesting. Perhaps this would be especially beneficial in patients with low blood pressure and/or heart failure

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Let me also clarify – CREST did NOT show that surgery is better than stenting. CREST demonstrated NON-INFERIORITY of stenting compared to surgery.
Oh really?



check out the article if you questions the statistical significance: http://www.ncbi.nlm.nih.gov/pubmed/23265585

The article says "When performed by surgeons, CAS and CEA have similar net outcomes, although the periprocedural risks vary (lower stroke with CEA and lower MI with CAS). These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke." However, CEA was clearly better in preventing stroke, though CAS in this study did not entirely have modern protection devices

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If you all remember that prior trials (including European) showed stenting inferior to surgery. This again has to do with evolution of ‘technology’; newer generation devices were used in CREST. This should be kept in mind with regards to intracranial stenting as well.
All wishful thinking. Prove it in a clinical trial.


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The more acute stroke cases that go to interventional, the more M&M.’ This could not have been further from the truth.
You've lost your mind. Interventional treatment causes M&M cases. I've seen so many. I've also seen some younger pts with M1 syndromes do surprising well when they weren't treated because they didn't develop reperfusion injury, massive cerebral edema, prolonged hospital stays, complications et cetera.
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Old 06-10-2013, 12:18 PM   #53
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I should say one more thing.

I am not against continued clinical trials in stroke-intervention, even if they are ill-conceived and doomed to failure.

I do believe that thrombectomy may be beneficial in some patients (i.e. recanalization time < 3 hours from onset, stone cold negative NC CT head)

I am opposed to performing these expensive high risk unproven procedures outside of the setting of a clinical trial.
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Old 06-10-2013, 12:43 PM   #54
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And by the way, embolic protection device (EPD) is not magic that prevents stroke from happening. A lot of the dislodged debris from stenting are actually the result of passing the catheter through the stenosis rubbing on the plaque. What EPD does essentially is to occupy more space in your catheter, i.e. a bigger tube that you jam into the plaque, embolize the plaque material and then deploy the parachute.

If you ask people that have worked with EPD whether they have ever seen clots in the parachute, I bet 100% will honestly say no. I highly doubt this would ever work.
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Old 06-12-2013, 01:19 AM   #55
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Also the CREST trial has never taken into account that CEA can be done awake in high cardiac risk patients (or anybody) which essentially reduces MI risk to equivalent of stenting.
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Old 06-12-2013, 06:43 PM   #56
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I have heard an argument similar to the following repeatedly over the past few years, and the argument seems to recycle with each new device that comes out:

'The 'newer device' is better than the 'older device'. Trial X stinks because they used the older device.' This is usually followed by a statement about how the individual has seen great outcomes with the 'newer device'. The problem of course is that the now apparently substandard older device (e.g. Merci) was being used for years as the pseudo-standard by this same individual.

I want interventional neurology to be solvent for many reasons, friends in the field, the future of our specialty etc. But the above scenario cannot play out continuously (especially in acute stroke trials). This isn't the fault of interventionalists, as the means by which a device can become approved, or at least widely available, is questionable (on its best day). None of us has all the answers. But I don't think it is wrong to ask for well designed trials before a device is available for widespread use.
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Old 06-12-2013, 09:23 PM   #57
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Quote:
Originally Posted by soulofmpatel View Post
Oh really?



check out the article if you questions the statistical significance: http://www.ncbi.nlm.nih.gov/pubmed/23265585

The article says "When performed by surgeons, CAS and CEA have similar net outcomes, although the periprocedural risks vary (lower stroke with CEA and lower MI with CAS). These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke." However, CEA was clearly better in preventing stroke, though CAS in this study did not entirely have modern protection devices
My understanding is that CREST was designed as a superiority trial with the null hypothesis being that the two procedures were equivalent.

"Analyses were aimed at testing for superiority. The
null hypothesis was that the two study treatments
are equivalent; the alternative hypothesis was that
the treatments differ."

If you look at Table 2, the comparison of the Primary end point between the CEA and CAS groups demonstrated a p-value of 0.38, which is not significant. Thus the hypothesis should be rejected, and no superiority was demonstrated.

Please correct me if I have misunderstood.
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Old 06-12-2013, 09:36 PM   #58
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Quote:
Originally Posted by AlternateSome1 View Post
My understanding is that CREST was designed as a superiority trial with the null hypothesis being that the two procedures were equivalent.

"Analyses were aimed at testing for superiority. The
null hypothesis was that the two study treatments
are equivalent; the alternative hypothesis was that
the treatments differ."

If you look at Table 2, the comparison of the Primary end point between the CEA and CAS groups demonstrated a p-value of 0.38, which is not significant. Thus the hypothesis should be rejected, and no superiority was demonstrated.

Please correct me if I have misunderstood.
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Old 06-14-2013, 11:38 AM   #59
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Quote:
Originally Posted by soulofmpatel View Post
Once again, I see eye to eye with neglect who is always realistic and clear-thinking. As far as I am concerned, I have absolutely no confidence the stroke community. I am completely cynical. They will not respond to negative data. They are just like cardiologists. The negative data will continue to roll in, and the number of procedures will continue to increase. I actually disagree with neglect about INR being a dying field because people will continue to do off-label and essentially contraindicated procedures out of desperation. It is the same psychology of not giving up on an elderly, irreversibly ill and suffering relative or giving chemotherapy to an 85 year old with multiple comorbidities. We are men of action. Action implies strength. Inaction implies ineptitude and apathy.
Well, I take this as a compliment and I'd like to return it. It is clear that you're deeply passionate about stroke care. Your "cynicism" can only occur to someone who loves but gets jilted or finds an unexpected fault. So stay as you are, please don't get old and tired like all the leaders in the field. The attitude among most of the >50 seems to be this: shrug and roll eyes, as the endovascular team takes another 80 yo nursing home patient with early CT changes up to cath and as Medicare continues to pay for it. The Ivy Towers are letting us down - they don't keep their house in order, and their children learn and the neighborhood is going to hell.

But I disagree with you. Neurointerventional is dying. The insurance companies are the ones who are actually paying for these useless procedures. How long do you think they are going to keep doing this? They're going to have to be very foolish to pay for both IV tPA and the procedure that doesn't affect outcomes that follows. And once that happens, as Medicare wises up, the swamp will start to drain. I'm hopeful this day will come.
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Old 06-15-2013, 07:49 AM   #60
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Originally Posted by danielmd06 View Post
Well, #1, 3, and 4 still seem okay statements. But I was sure wrong on #2. C'est la vie.
Yeah, you were wrong. Even I didn't think IMS III would show so much IA fail. Although there is no direct comparison, one could say that IV tPA beats nothing, and IV tPA is about the same as IA treatments, so IA treatments might beat nothing.

But you saw how wrong this logic can be with the anti-platelet trials.
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Old 06-16-2013, 07:54 AM   #61
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Yeah, you were wrong. Even I didn't think IMS III would show so much IA fail.
Yep. But that's why we do trials.

I will admit I was surprised and honestly...disappointed. Maybe others thought the studies would turn out this way all along.

I was someone drawn to neurology by NIR. I think it is a Good Thing for our specialty to have procedural-oriented fellowship options, and I do think residents should still consider NIR. I certainly don't think one can realistically expect to be in the angio suite all day long. But the ability to do diagnostic neuroradiological work, and practice the remaining scope of NIR (beyond just acute therapy for ishcemic stroke) still keeps the field interesting. To me at least.
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Old 06-16-2013, 12:47 PM   #62
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NIR can be / is interesting, but I would advice neurology residents to not build an endovascular career (even part time endovascular work) for several reasons. There are too many neurointerventionalists around. The expectation was that stroke intervention will dramatically increase procedural volumes; and now it will not. Neurologists would have brought strokes to the 'INR plate' but with sammpris and acute trials showing futility, it will be hard for neurologists to 'share' endovasc work with neurosurgeons and radiologists. Neurosurgeons will by far 'control' intervention since majority pts come from them and to some extent most will agree that they are best suited to make treatment decisions on clip or coil. This puts interventional neurologists in a difficult spot; there are huge political turf wars to deal with more so when there are too many operators. Eventually there is pressure from employers to generate enough revenue to be able to pay for their malpractice. Too many operators in INR are already resulting in less case volumes for current practitioners to sustain their technical skills. Carotid stents are still not reimbursible (outside of registries as SAPPHIRE or unless CEA is not an option due to specific reasons). CAS is also performed by almost all endovasc operators incl cardiologists, vasc surgeons, IR... Several editorials in AJNR, Stroke etc have already higlighted the oversupply of neurointerventionalists.
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Old 06-16-2013, 05:51 PM   #63
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