Is neuro-interventional dying?

[danielmd06]

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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[soulofmpatel]

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:

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

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.

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.

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

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

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.

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.

 

[soulofmpatel]

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.

 

[Jackofknives]

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.

 

[Jackofknives]

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.

 

[BlackFrancis33]

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.

 

[AlternateSome1]

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.

 

[dhavalp]

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.

 

[neglect]

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.

 

[neglect]

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.

 

[danielmd06]

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.

 

[Strokeguy]

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.

 

[danielmd06]

.

 

[soulofmpatel]

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.

The following is the composite primary end point quoted verbatim from the article: "stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke within 4 years."

There were increased MI s in the surgical group, negating the superior stroke benefit of carotid endarterectomy. Carotid endarterectomy was superior in symptomatic patients in the periprocedural period:

"the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic patients (6.1% vs 1.3%; P = .01)"

I do understand that this was not the primary endpoint, and many people do not seriously consider secondary analyses. Nonetheless, I think it is abundantly clear that CEA is the better procedure for preventing stroke, safety concerns aside

 

[AlternateSome1]

That interpretation just means that CEA is better . . . if you ignore all of the heart attacks. I believe the primary endpoint is more meaningful in this case. Now, that secondary outcome would suggest that a new trial of awake CEA vs CES may have some merit.

 

[startoverat40]

What about image guided delivery and monitoring of stem cell therapies?

 

[Strokeguy]

What about image guided delivery and monitoring of stem cell therapies?

Very much in basic science research at present. Not at all close to clinical trials. You may not even need to deliver stem cells directly to the brain to influence outcome. Stem cells converting into neurons is more of a fantasy, the mechanisms behind these potential therapies are multiple and largely systemic.

 

[burs0028]

Very much in basic science research at present. Not at all close to clinical trials.

I am aware of at least 1 multi-center phase II clinical trial...would be surprised if this ends up "saving" NIR, but wanted to point out that they are looking closely at stem-cell therapies for stroke and it definitely has gotten off the bench and into human trials.

clinicaltrials.gov/ct2/show/NCT01273337

 

[Strokeguy]

I am aware of at least 1 multi-center phase II clinical trial...would be surprised if this ends up "saving" NIR, but wanted to point out that they are looking closely at stem-cell therapies for stroke and it definitely has gotten off the bench and into human trials.

clinicaltrials.gov/ct2/show/NCT01273337

I meant 'monitoring' of stem cells. There is no image guided monitoring of stem cell delivery in clinical trials. Additionally there are trials investigating surgical as well as IV delivery.

 

[neglect]

There is only one reason for a conventional angiogram in a traumatic subdural: money, particularly in light of ARUBA. So upsetting to see overutilization at the expense of patient care.

 

[neglect]

MR Clean is reporting + results.

 

[TUGM]

MR Clean is reporting + results.

Where are you seeing the preliminary data? Tried to find something on it, but not seeing any results. Thanks!

 

[neglect]

Where are you seeing the preliminary data? Tried to find something on it, but not seeing any results. Thanks!

I'm not seeing anything either. Pm me and I'll send you what I have.

 

[typhoonegator]

I've only heard a brief overview myself. My group is going over some of it tomorrow at a staff meeting which I'll miss, sadly. Anxious to look over the results.

 

[Hank Rearden]

MR-CLEAN press release from world stroke congress

http://www.medscape.com/viewarticle/834064

 

[TUGM]

Well, I would like to see more positive trial results in the future before jumping to conclusions, but overall, really well conducted study, and obviously, I'm overjoyed at the results. I think SWIFT-PRIME is projected to finish recruitment in 2016, so that will be interesting as well. From what I hear from my mentors involved in the research, "results look favorable."

What an exciting time to be a neurologist-in-training!

 

[neglect]

And now even more good news for endovascular.

Looks like early M1 occlusions, and basilar occlusions, will be medical and surgical. All else medical.

It has taken a decade to learn to whom to offer these interventions: when, where, how. We're still finding out new things, but 10 years is ridiculous. Clearly fact that these interventions were approved before being shown to affect outcomes is to blame, but equal are those who took these patients to the cath lab outside trials. Shame on American sites for allowing the Dutch to have the first + trial. They did it right: no patients outside trials. Shame on us for failing to enroll IMSIII promptly, for pretending that registration trials are trials, for allowing ourselves to be hoodwinked by device manufactures.

Many things to reflect on, including a bit of a blow against a specialty who can treat, max, what, about 10-20% of all strokes (the percent of ICA, M1, or dual M2 artery occlusions). But, more excitingly, many things to be happy about. We now have two stroke therapies, one medical, one surgical.

 

[Jim Manderin]

Just heard word that ESCAPE (http://clinicaltrials.gov/show/NCT01778335) has officially stopped enrolling and is positive as well. An exciting time for stroke neurology, indeed.

 

[soulofmpatel]

Does anyone have further data on the results of the trials?

Looking at the press release, the mean time to groin puncture was 4 hours and 20 minutes, but was the result positive for all subgroups including the 4.5-6 hour subgroup? It seems that the dutch are very good at giving tPA quickly

I don't care too much about the open label design since they have MRI final infarct volume corroboration.

Does anyone have any data on the ESCAPE trial?

Neglect: we can probably prevent 80+% of strokes with lifestyle modification alone. In the next century, proper diet with save 100 times more neurons than microcatheters.

"Shame on American sites for allowing the Dutch to have the first + trial. They did it right: no patients outside trials. Shame on us for failing to enroll IMSIII promptly, for pretending that registration trials are trials, for allowing ourselves to be hoodwinked by device manufactures."

-completely agree with this.

-soul

 

[danielmd06]

Well, well, well.

 

[oopsy]

Full results out today:
http://www.nejm.org/doi/full/10.1056/NEJMoa1411587#t=article

It's pretty impressive that they were able to get the government to not reimburse IA treatment unless they were enrolled in a trial. Makes you wonder how much more insight we could generate here if there was a way to incorporate that.

How have people received these results amongst their groups?

 

[neglect]

Love the editorial:

"Readers may wonder how the trialists from a country with only 16.8 million inhabitants succeeded in enrolling 500 patients in just over 3 years, whereas other trials from much larger regions with similarly advanced medical systems struggled with recruitment. "

Just to put that in context: NYC, plus surrounding suburbs has 20 million, LA has 18. US failure, all due to the government deciding that these procedures worked before they were shown to work. Meanwhile, for a medication to be approved, it has to jump through regulatory hoops designed by Dali and Kafka. For all the **** the FDA gets, much of it unwarranted, this stands out as a massive regulatory failure. And yet no-one is calling them out on it.

And they also can't shut Oz the hell up about his amazing weight loss berries.