Is neuro-interventional dying?

[neglect]

The CREST study shows that surgery is better than stenting. The SAMMPRIS trial stops enrollment because there were too many strokes in the interventional wing. The more acute stroke cases that go to interventional, the more M&M.

This leaves diagnostics (but CTA gets better and better) aneurysms (pretty common), AVMs (rare), tumors (potentially common if IA therapy turns out to be beneficial), and nosebleeds.

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[Strokeguy]

The last few posts about interventional neurology likely created some confusion about the field. The subspeciality has a strong base regardless. Let me clarify and also inform.
First, about SAMMPRIS, it clearly shows that compared to current optimal medical therapy, angioplasty and stenting with the ‘Wingspan-Gateway system’ is more risky at 30 days. That being said, most stroke experts await the long term results as well as detailed analysis. The trial was stopped on recommendations from the DSMB. This does NOT mean intracranial angioplasty and stenting is dead. There are always those pts who ‘fail optimal medical therapy’; and these are the ones who do need endovascular treatment. SAMMPRIS clearly shows that Wingspan stent with the gateway balloon is more risky. Like all endovasc therapies, results to a large extent depend on how good/safe the device is (considering that all operators in a clinical trial are experts). This stent has a high outward radial force and may not be the best one available. There is another trial going on that uses a balloon mounted stent. Unlike medical therapies, devices are extremely technology dependent. A case in point is comparing the initial GDC coils and the ones currenty available.
Lets say, we don’t want to stent, then also there is always a safer option of balloon angioplasty alone. Till date, only med therapy failures were stented. Now we are not sure with wingspan. Had SAMMPRIS showed otherwise, we would be recommending stenting for all symptomatic intracranial stenosis, which now we wouldn’t and shouldn’t. Why use a more dangerous system. But for ‘med failures’ balloon angioplasty remains a viable option. There is better technology available and evolving.
Many people are not aware of the results of SENTIS. This trial used Neuroflo – a flow diversion device within 14 hours of stroke onset. This device diverted flow to the brain by reducing flow in the aorta by 70%. A balloon was inflated above the renal artery for 45 min and then below it again for 45 min. They also enrolled over 500 pts; and showed 30% decreased stroke mortality with this device. Patients did better with the device, but did not reach the primary end point of 90 day mrs0-1 (which the investigators felt was unrealistic, since all stroke trials use 0-2 for good outcomes). NO (or very few) stroke pts are expected to be absolutely normal in 90 days.
You can all do the math – how many pts can be eligible for therapy with this system versus how many ‘have been excluded from wingspan stenting’ with our current evidence. We have a large number of ischemic strokes with very few pts having intracranial stenosis in the US.

Let me also clarify – CREST did NOT show that surgery is better than stenting. CREST demonstrated NON-INFERIORITY of stenting compared to surgery. CREST also showed that stenting is better in younger pts and surgery better in older (if there was no risk for anesthesia). Data shows that carotid stenting for symptomatic disease has increased significantly following CREST. 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. We aren’t there yet with wingspan.
I feel relieved when SAMMPRIS showed that wingspan-gateway is not good enough; at least in the short term. So this remains a work in progress. We shouldn't use this device, and need further tech innovation.

‘The more acute stroke cases that go to interventional, the more M&M.’ This could not have been further from the truth. Patients that require endovasc treatment have severe strokes that have the worst natural history and large artery occlusions are known to have less recanalization with IV lytics. MRRESCUE and IMS-3 are still on; but we have a lot of data on utility of interventional therapy. Look at the editorial in the April 2011 edition of Stroke. There is also a prospective study - Bridging Intravenous–Intra-Arterial Rescue Strategy Increases Recanalization and the Likelihood of a Good Outcome in Nonresponder Intravenous Tissue Plasminogen Activator-Treated Patients: A Case–Control Study
Marta Rubiera, Marc Ribo, Jorge Pagola, Pilar Coscojuela, David Rodriguez-Luna, Olga Maisterra, Bernardo Ibarra, Socorro Piñeiro, Pilar Meler, Francisco J. Romero, Jose Alvarez-Sabin, and Carlos A. Molina
Stroke. 2011;42:993-997; published online before print March 3 2011, doi:10.1161/STROKEAHA.110.597104

There is a new retrievable stent device (Stentriever) which has by far the best recan rates and also opens the artery much earlier than Merci or Penumbra.
I think interventional neurology is a dynamic and futuristic field. There will always be procedures/devices that are undesirable (proven by clinical trials) and there will be many others that are useful. Technological advances also make a difference.

 

[neglect]

SAMMPRIS, it clearly shows that compared to current optimal medical therapy, angioplasty and stenting with the ‘Wingspan-Gateway system’ is more risky at 30 days.

Yes. And the people who fail med therapy are going to be few. It is an open question if they "need endovascular treatment." Patients with respiratory failure need intubation. I don't see the data showing this need, I see it as a risky option when you've got nothing. Again, rare.

Unlike medical therapies, devices don't need to affect outcomes, so as you know, they're on the market before they are properly studied. This was a case in point. Before we adopt further brain interventions for IC stenosis, perhaps we should be a little less gullible for the next best thing. Stroke neurologists remind me of those any enthusiast, "Oh gee, look at this one!"

Lets say, we don’t want to stent, then also there is always a safer option of balloon angioplasty alone. Till date, only med therapy failures were stented. Now we are not sure with wingspan. Had SAMMPRIS showed otherwise, we would be recommending stenting for all symptomatic intracranial stenosis, which now we wouldn’t and shouldn’t. Why use a more dangerous system. But for ‘med failures’ balloon angioplasty remains a viable option. There is better technology available and evolving.

I doubt this. There's only different technology. It sounds to me like your mind is made up, and you're just waiting for the next greatest unproven thing to come along - so then you can do the procedure under a veil of ignorance. Not sure how this squares with informed consent.

Personally, this study just shows that dangerous interventional procedures are very dangerous.

Many people are not aware of the results of SENTIS. This trial used Neuroflo – a flow diversion device within 14 hours of stroke onset. This device diverted flow to the brain by reducing flow in the aorta by 70%. A balloon was inflated above the renal artery for 45 min and then below it again for 45 min. They also enrolled over 500 pts; and showed 30% decreased stroke mortality with this device. Patients did better with the device, but did not reach the primary end point of 90 day mrs0-1 (which the investigators felt was unrealistic, since all stroke trials use 0-2 for good outcomes). NO (or very few) stroke pts are expected to be absolutely normal in 90 days.

I see study and clinic follow ups with Rankin 0-1 all the time.

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

Per the editorial that accompanied the paper, "Namely, carotid-artery stenting is associated with a higher periprocedural risk of stroke or death, a difference that was still significant at 4 years"

Sorry, that sounds worse to me. Here's a question, are patients being consented for this?

‘The more acute stroke cases that go to interventional, the more M&M.’ This could not have been further from the truth. Patients that require endovasc treatment have severe strokes that have the worst natural history and large artery occlusions are known to have less recanalization with IV lytics.

1. If I hear about another bull**** case control series I'll throw up. And if I hear about using recanalization as the outcome, it'll be projectile.
2. Yes, the more cases I see that go to interventional, the more horrible iatrogenic lesions I see. Those ones die and are quickly forgotten. They don't make the advertisements.
3. You say that you disagree with my experience, but you quickly back up and say that these patients have bad natural histories anyway. You disagree, what, you've never seen iatrogenic injury to these patients? Guess you haven't seen very much then.

In the future IA therapies in acute stroke might be useful, might not. If not, and there's no telling, then there are going to be a lot of people fighting over a few patients. You kept harping about technology, but medical therapies are moving forward as well.

Overall, these studies give initial enthusiasm for interventional serious pause.

 

[typhoonegator]

Wow, it's great to see informed individuals presenting sound arguments. Nice to have a break from "Cleveland Clinic vs. OHSU?"

One thing to remember (particularly given that this is a neurology forum) is that there is an awful lot more to neurointerventional radiology than acute stroke treatment, carotid stenting, and intra-cranial stent deployment. Those issues have been getting a lot of press lately (deservedly so) because of the explosion in methodologies and high-profile studies on these topics, and because of the large population of individuals that are affected by carotid stenosis, stroke, and intracranial athero.

NeuroIR docs do a lot of other things too. They coil aneurysms (both acutely and electively). They do pre-op tumor embo for meningiomas, pericytomas, and mets. They embolize and take-down AVMs. They embolize dural venous fistulas and spinal dAVFs. They do vertebroplasties. They stent across dissections. They stent venous sinuses and do venous embolectomies. They close CCFs. They treat vasospasm in a variety of ways.

Granted, there are fewer of these populations of patients than there are strokes and carotid disease, but there is work to be done. As an aside, there is precious little data for many of these therapies as well, particularly if you are a "splitter" rather than a "lumper".

Because it is an invasive field, we also have to remember that NeuroIR docs also have the capacity to cause RP bleeds, pseudoaneurysms, aortic and large vessel dissections, embolic strokes, vessel rupture, ICH, IVH, etc. People aspirate on the table, they fall off the table, they have allergic reactions, they suffer renal failure from the dye, they have reactions to the anesthesia, and they die. These things can all happen even if you were to design the absolute perfect intracranial stent and place it in the hands of the most experienced technician. So the bar needs to be set high for these therapies, and they have to be tested in a rigorous manner to make sure they are worth it compared to any non-invasive or alternative invasive measures, both financially and medically.

Does the field stand to benefit a ton from evidence that they have a role in management of chronic large and medium vessel disease of the extracranial and intracranial vasculature? Sure, and such evidence would support an awful lot more catheter jockeys than aneurysms and AVMs would, but it doesn't really make sense to say that the field would dry up completely.

 

[aaddnl]

NeuroIR docs do a lot of other things too. They coil aneurysms (both acutely and electively). They do pre-op tumor embo for meningiomas, pericytomas, and mets. They embolize and take-down AVMs. They embolize dural venous fistulas and spinal dAVFs. They do vertebroplasties. They stent across dissections. They stent venous sinuses and do venous embolectomies. They close CCFs. They treat vasospasm in a variety of ways.

INR will not be dead, and there will be plenty of jobs available. There may not be quite as many jobs tho, bc now, not every Stroke certified hospital is gonna aggressively recruite a Neuro-interventionalist for stents and acute stroke intervention. I do agree with the previous poster that mentioned that technology will improve and outcomes can be better, but until the data is demonstrated, there will be a lot of skeptical neurologists.

 

[aaddnl]

Personally, this study just shows that dangerous interventional procedures are very dangerous.

Yeah, SAMPRISS does kinda show that, but the big news is that it is a surprise. I think most felt that the stenting would show benefit, and it didnt, so what to do now? Better techniques and better technology will likely improve outcomes in the future, but currently optimizing medical therapy has been shown best in these patients.

 

[neglect]

INR will not be dead, and there will be plenty of jobs available. There may not be quite as many jobs tho, bc now, not every Stroke certified hospital is gonna aggressively recruite a Neuro-interventionalist for stents and acute stroke intervention. I do agree with the previous poster that mentioned that technology will improve and outcomes can be better, but until the data is demonstrated, there will be a lot of skeptical neurologists.

How many sinus thromboses that require IR are there? At a tertiary hospital I'd put that number at 1 in 2-3 years.

Not dead, but the more it gets studied, the more it gets wounded.

Yeah, SAMPRISS does kinda show that, but the big news is that it is a surprise. I think most felt that the stenting would show benefit, and it didnt, so what to do now? Better techniques and better technology will likely improve outcomes in the future, but currently optimizing medical therapy has been shown best in these patients.

I agree, what were people thinking? That these stents were benign!?

Even more scary, the people who find the results surprising are apparently BLIND to the 1/8 chance of harm. WHat else are they blind to? No surprise that these same people enthusiastically support the unstudied stroke interventions. They literally don't see what they don't want to.

The other factor I'd like to bring up is the difference between high level academic hospitals where residents and fellows train and the OSH that you guys loath so much. In the OSH, they need to keep the program running 100% based on patients coming in. So the marginal cases get sweeped up. The 85 year old demented NH home patient with a single stroke who's primary care doctor thinks he's doing a good job by getting an MRA? She gets cath/plasty/stent. (well, perhaps not anymore after recent trial, but you get the idea)

 

[Mattchiavelli]

Wow, it's great to see informed individuals presenting sound arguments. Nice to have a break from "Cleveland Clinic vs. OHSU?"

Very much agreed!

 

[danielmd06]

The CREST study shows that surgery is better than stenting. The SAMMPRIS trial stops enrollment because there were too many strokes in the interventional wing. The more acute stroke cases that go to interventional, the more M&M.

This leaves diagnostics (but CTA gets better and better) aneurysms (pretty common), AVMs (rare), tumors (potentially common if IA therapy turns out to be beneficial), and nosebleeds.

Wow. How did I miss this thread?

Great points you make. But the field isn't really "dying" is it? You mean (I'm guessing) that there isn't as great a need for a huge number of specialists in this field based on disheartening study results? In that case, I would agree with you.

But as far as acute stroke therapy, what of IMS-I and IMS-II? And the jury is still out on IMS-III, as Strokeguy pointed out.

Also, as you yourself mentioned, the non-stroke stuff will continue to require the attention of an interventionalist (I agree that these cases are not as prolific as acute ischemic stroke). Bottom line, hospitals and stroke programs need these people, albeit not one on every street corner...

Fun topic.

 

[Strokeguy]

Lets put it plain and simple, you do not send mild strokes to the angiosuite. These are always patients with bad deficits; more the ICA/M1 or basilar artery occlusions. These are more likely to have poor outcomes. It would be extremely uncommon for these strokes to have an mRS 0-1 at 90 days. If such a ‘miracle cure’ were possible then the Nobel prize would have been awarded by now. I do see a large volume of these apart from milder strokes as well as TPA responders and non-responders. In addition I do also see several pts with mortality and malignant conversion. No one is justifying sending a mild stroke or a pt who has improved significantly to the angiosuite just to clean an MCA branch.
Sure I do see complications, but they are not as frequent as they have been made out to be. The number of published ‘trials’ (registered in clinical trials.gov) also make this case. These trials are not hiding complications and have DSMBs. If this were the case, many of these trials would have been stopped by the NIH. I am talking of trials starting from PROACT, IMS 1&11, EMS bridging, Merci/Multi-Merci (and many others abroad) that have been completed and eventually led to current ongoing phase 3 trials as IMS-3 and MR-RESCUE (that are now ongoing for several yrs). INR trials have also been conducted in non-ischemic pathologies. It is quite clear that these therapies need to be performed at larger institutions either academic or non-academic. There is a reason why we are moving toward telemedicine stroke care – to be able to concentrate highly specialized care in ‘experienced hands’. These centers have neurovascular teams comprising neurologists, nsurgeons, radiologists, interventionalists, neurointensivists,… that treat a significant number of pts and have specialized roles. Tertiary neurologic care is moving away from the ‘OSH’ where a demented 85 yr old could get stented for all the wrong reasons’. It is very well known that complications are higher in low volume centers. The same is true for all critical fields incl trauma, cardiac, transplant… If you cannot score a home run, it doesn’t mean the bat is no good, just that you don’t know how to hit.

I do not blame neglect for being cautious/suspicious about iatrogenic injuries, but a lot depends on the pt volume and operator expertise (which also depends on how much you do). There are several articles in pubmed to prove this point. This happens to be the case in all invasive specialities, neurointervention is no different.
I am all for using evidence based medicine. NeuroIR procedures no doubt have an element of risk, but they are not used for patients with mild neurologic symptoms (if they are anywhere, then it is a shame).
Agree that very few venous thromboses go for endovasc treatment. These are very selective cases that continue to deteriorate despite anticoagulation. INR treatment is more of a last resort for these. But this doesn’t mean that these are the only procedures requiring venous sinus instrumentation. Neurointerventionalists do a lot more transvenous instrumentation for AVMs/fistulas/ trauma among other things. As a neurologist (who may not be an intensivist), you may not be aware of the wide variety of INR procedures.
Agree that with emerging technology, just like devices newer medical therapies also develop. The turn around time for these pharmacologic advances is much longer though. They also add a lot of complexity to pt care. Like we now have dabigatran, I have started seeing pts with ICH from dabigatran. We do not know how to reverse it (dialysis takes a long time) and pts continue to bleed. The package insert is not very helpful in this regard. Pradaxa (dabig) no doubt is an advancement over coumadin but adds to the complexity. How do we treat a pt on dabigatran presenting with acute stroke. There is now a talk of registries to explore this aspect and treat with IV TPA. Pharmacologic agents also have complications that can be difficult to treat due to systemic administration.
By no means is neuro IR dying. There is a large variety and number of procedures. Just like most invasive subspecialities, new therapies emerge and either phase out for lack of evidence or become standard of care. In addition, it is very difficult to design the perfect clinical trial for the perfect therapy. Neurologists, of all physicians should know this. This is how all our initial treatments for epilepsy, MS, movement disorders, etc emerged.

 

[typhoonegator]

Excellent post ^

Being at one of those telemedicine referral centers, and seeing a lot of nuanced and complicated stroke cases, I have some doubts that we will ever be able to get the final word on some of these therapies from an evidence-based standpoint. The subpopulations just get too small to give you any statistical power. All M1 occlusions at 3.5 hours are not created equal, and even as you sub-stratify these populations more potentially confounding variables emerge. What does their perfusion map look like? Do they have good collaterals? What does "good collaterals" even mean? Do they have early FLAIR change? Is there susceptibility artifact in the infarct zone already? Did they already get IV tPA? Or desmoteplase perhaps in the future?

Doing an RCT on acute M1 occlusions who have already received tPA with NIHSS > 12 at 3-6 hours with diffusion/perfusion mismatch > 1/3 of the MCA with low-grade collateralization (angio grade I-II) without early FLAIR change and without susceptibility artifact is going to give you some serious recruitment issues but that doesn't mean that this might not be the ideal patient to take for MERCI/Penumbra/Neuroflow/POBA/whatever.

Not saying that it is hopeless, or that we shouldn't try. And believe me, I try to be as evidence-based as possible (the ICU will destroy you if you aren't), but I do fear at times that we might throw out the baby with the bathwater in some of these studies by unfairly lumping patients or handing catheters to operators who don't meet very stringent training/experience requirements.

 

[Raygun77]

This is a fantastic discussion with some great to-and-fro!

The real niche of interventional neurology is stroke treatment. Aneurysms, tumours are primarily 'surgical' diseases, so I anticipate if data does irrefutably demonstrate an advantage to strokes from this kind of therapy, it'll become much easier for neurologists to enter interventional practices, and many more will!

I remember reading an editorial by a stroke doctor on how surgery/interventional innovations and devices has long not been put through the same rigorous 'evidence-based practice' requirements and need for clear mortality benefits vs. the gold standard for FDA approva as compared to drugs- he cited a paper from the 70s which opined this (can't find this editorial unfortunately!). It is interesting to me that surgeons are given a bit more 'free lease' to use their clinical acumen to decide if/when to intervene. But Typhoonegator, your post makes it pretty clear why this is the case- all patients are unique and sweeping broad strokes (e.g. on pts with a 70% symptomatic stenosis should get CEA performed) don't take into account any of the extra details- patients age, function, surgeons proficiency, etc. It's much easier to make sweeping guidelines with drugs that typically have a more 'population-wide' benefit rather than a direct life/death impact on the patient. Anyway, this has been an interesting epiphany to me, and makes me feel that perhaps im more suited to an interventional gig!

 

[neglect]

Great points you make. But the field isn't really "dying" is it? You mean (I'm guessing) that there isn't as great a need for a huge number of specialists in this field based on disheartening study results? In that case, I would agree with you.

Well, dying might be hyperbole. But outside a few certain things, the indications seem to be drying up.

I've been on call this week, and I've never obtained MRA/CTA's on first time strokes. Given recent data, when would you ever do it? I'm scratching my head.

But as far as acute stroke therapy, what of IMS-I and IMS-II? And the jury is still out on IMS-III, as Strokeguy pointed out.

I predict the numbers are going to be modest. Regardless, some get better, some die, CT perfusion is bull****. When we get cold hard numbers, it's going to look much less attractive for the 85 yo nursing home patients who are found face down in their porridge with a right HP and who's neurotic daughters are >500 miles away.

Lets put it plain and simple, you do not send mild strokes to the angiosuite. These are always patients with bad deficits; more the ICA/M1 or basilar artery occlusions. These are more likely to have poor outcomes. It would be extremely uncommon for these strokes to have an mRS 0-1 at 90 days. If such a ‘miracle cure’ were possible then the Nobel prize would have been awarded by now. I do see a large volume of these apart from milder strokes as well as TPA responders and non-responders. In addition I do also see several pts with mortality and malignant conversion. No one is justifying sending a mild stroke or a pt who has improved significantly to the angiosuite just to clean an MCA branch.

This is precisely the problem with interventionism. You speak with absolute certainty, "no one is justifying..." but you have no data to back up your assertions. In point of fact, because there is no data, people are doing just that.

Also, I have recently seen Rankin 1 at 3 months after whopper right MCA occlusion. I also have a guy who's the equivalent of a cop who presented with NIHSS 19, aphasic adn right HP. He was low 30's, given IV tPA only, and now works without dysfunction. And more.

The problem is that everyone has these stories. Stories are not data. They're just stories.

Sure I do see complications, but they are not as frequent as they have been made out to be. The number of published ‘trials’ (registered in clinical trials.gov) also make this case. These trials are not hiding complications and have DSMBs. If this were the case, many of these trials would have been stopped by the NIH. I am talking of trials starting from PROACT, IMS 1&11, EMS bridging, Merci/Multi-Merci (and many others abroad) that have been completed and eventually led to current ongoing phase 3 trials as IMS-3 and MR-RESCUE (that are now ongoing for several yrs). INR trials have also been conducted in non-ischemic pathologies. It is quite clear that these therapies need to be performed at larger institutions either academic or non-academic. There is a reason why we are moving toward telemedicine stroke care – to be able to concentrate highly specialized care in ‘experienced hands’. These centers have neurovascular teams comprising neurologists, nsurgeons, radiologists, interventionalists, neurointensivists,… that treat a significant number of pts and have specialized roles. Tertiary neurologic care is moving away from the ‘OSH’ where a demented 85 yr old could get stented for all the wrong reasons’. It is very well known that complications are higher in low volume centers. The same is true for all critical fields incl trauma, cardiac, transplant… If you cannot score a home run, it doesn’t mean the bat is no good, just that you don’t know how to hit.

You're human, so you're blind to small differences in outcomes. You're not blinded. You're biased. None of what you write means anything. You need to get blinded, placebo controlled numbers.

I do not blame neglect for being cautious/suspicious about iatrogenic injuries, but a lot depends on the pt volume and operator expertise (which also depends on how much you do).

Emotional bolstering. You don't "blame" me for caution? Are you joking? Could you possibly be any more condescending? It's OK, I don't blame you and your attendings for being gung ho about experimental procedures that are killing people. After all, I'm sure they have a mortgage and a nice car.

Also, you don't know me, so please don't pretend you do. I've made no secret that I'm not at a high level academic center - but I have been and frankly our volumes are higher.

Being at one of those telemedicine referral centers, and seeing a lot of nuanced and complicated stroke cases, I have some doubts that we will ever be able to get the final word on some of these therapies from an evidence-based standpoint.

Appeal to ignorance. A bit unbecoming.

 

[typhoonegator]

I guess we should just throw our hands up in the air then, admit all of our strokes to the ward service where they can get an ASA and a smile, and start searching for a SNF bed for all of them.

You want clinical trials? We're doing them. And it isn't "ignorance" to admit that we don't have all the answers. But sitting on our collective butts isn't going to render acute stroke care any clearer.

I'm not an interventionalist, and neither myself nor my attendings make any money by sending people to the angio suite. But it is hard for me to understand how the current lack of data on mechanical thrombectomy automatically leads to you decide that we're "killing people". You state yourself that we need trials, and rebuke Strokeguy for being "not blinded", but neither are you, and your assessment of the situation is based just as strongly in personal experience as his.

And finally, I thought this was a rational discussion, and I don't really see why anyone needs to resort to mean-spirited diatribes.

 

[neglect]

I guess we should just throw our hands up in the air then, admit all of our strokes to the ward service where they can get an ASA and a smile, and start searching for a SNF bed for all of them.

You want clinical trials? We're doing them. And it isn't "ignorance" to admit that we don't have all the answers. But sitting on our collective butts isn't going to render acute stroke care any clearer.

I'm not an interventionalist, and neither myself nor my attendings make any money by sending people to the angio suite. But it is hard for me to understand how the current lack of data on mechanical thrombectomy automatically leads to you decide that we're "killing people". You state yourself that we need trials, and rebuke Strokeguy for being "not blinded", but neither are you, and your assessment of the situation is based just as strongly in personal experience as his.

And finally, I thought this was a rational discussion, and I don't really see why anyone needs to resort to mean-spirited diatribes.

Diatribes? I'm the most concise by far.

Look, you can say things are too complex to be studied properly, or you can say that things aren't really all that complex, they can be studied, and clinical trials guide management. If the former, then you wallow in ignorance for eternity and start heparin on the people you're scared about (and you're usually scared, so you cover it up with false bravado and arrogant infallibility). If the former, then there's little to talk about. If the latter, then that's exactly what we have been talking about: Putting people into the cath lab and not into trials.

 

[Bonobo]

First of all, let's clarify that neglect's issue with neurointerventional is specific to treatment of stroke. There are good randomized trials demonstrating the utility of endovascular therapy for symptomatic aneurysms and the interventional will only grow in use when treating AVM's, AVF's, tumors, pseudoaneurysms, traumatic and non-traumatic head and neck bleeders, etc.

For stroke, however, so far the evidence hasn't established any utility for interventional neuroradiology. CREST and SAPPHIRE demonstrate that carotid stenting is a reasonable option, particularly in patients at high risk for surgical complications, or possibly in younger patients (reminding everyone that this particular CREST result has not been replicated yet). It is unclear to me what effect this will have on carotid stenting. SAMMPRIS was negative, but the number of patients treated for intracranial stenosis is relatively low compared to the number of cases done for other indications, in particular acute stroke.

As I have long said in previous posts, the fate of interventional stroke lies in IMS-3, and probably also MR-RESCUE. If positive, then neurologists will have a major role to play in neurointerventional. If negative, then a lot of practices dependent on stroke cases (including every practice run by a neurology-trained interventionalist) will need to find new work. Radiology and neurosurgery trained interventionalists will do just fine as they continue to treat vascular malformations and other classically "neurosurgical" diseases.

My bet, a crude one unfortunately, is that IMS-3 and MR-RESCUE will demonstrate a benefit in a subgroup of patients, most likely those with moderately severe strokes and proximal occlusions (which they must have to be enrolled), since this "clinical-angiographic" mismatch, in my opinion, will prove to be a better predictor of the utility of recanalization then anything else. The very severe strokes may also benefit, but only when the outcomes are adjusted to include MRS 0-3 (or 0-4), as the SENTIS trial should have done (those trial investigators bet poorly--I agree that you can see a patient achieve an MRS of 1 after a large MCA stroke and NIHSS > 12, but the rate is 15-20% based on several studies).

B

 

[typhoonegator]

There isn't a single patient who goes to the angio suite at my hospital unless they are a part of a clinical trial. There is no other way. There is no "compassionate use" because there is no supposition on our part that any group is more likely than not to benefit. Hence, there is no "bravado" in taking people to clot retrieval, although there is a lot of hand wringing, informed consent, and more hand wringing.

This is as it should be. Until more trial data comes out, I still have equipoise about whether we are helping or hurting people as a whole with these forms of treatment. Once that equipoise dies (in either direction), the research should stop.

I don't know when we started talking about heparin in acute stroke, but that seems to be off-topic. All fields of medicine have superstitious docs that do odd things in the name of teleologic explanations.

To Bonobo, the neurology-trained interventionalists at my institution to all forms of intervention, not just acute stroke and carotids. They treat aneurysms and AVMs, and they do kyphoplasties, etc. So regardless of the outcomes of trials for acute stroke interventional treatment, neurointerventionalists with a background in neurology will still be able to do all of the other procedures they have been trained to perform.

The point of my prior statement about these studies (being difficult because small subgroups that appear only a few times in a large study may benefit while the whole group does not) was not intended to be an acceptance of the current state of the field, or a comfort with "ignorance". I'm merely lamenting the challenges of this research, as well as voicing my concern that we'll eventually have to do away with a form of therapy that may work great for a super-selected population because we just can't reliably define conditions in which it can best be used. That doesn't mean I'm going to ignore the data and just keep doing it if that day comes.

I'm a co-investigator in 7 acute ischemic stroke studies at present, 5 of which are multi-center, randomized trials. I'm one of the guys doing the blinded research that will inform this issue. I'm not, as some would insinuate, wandering around the wards using heparin with false bravado while lining my attendings' pockets with the trappings of ill-gotten interventional procedures. I know those people exist, but I'm not your straw man.

 

[Bonobo]

To typhoonegator, your points are well taken. Indeed while I personally believe that even if IMS-3 etc. come negative, endovascular techniques are likely to be useful in a select population, but it will be difficult to prove that we can define that select population.

I disagree a bit about your perception of what will happen to neurology-trained neurointerventionalists. Certainly, those that are established at major academic institutions with large referral bases will continue to do well, but many interventionalists at smaller institutions or private practices depend more on stroke, particularly if they were neurology trained. Furthermore, I think the field will in general be less willing to take on a neurologist compared to a neurosurgeon or radiologist if stroke treatments are next to nil. Anecdoctally, institutions that do more endovascular stroke treatments tend to be much more willing to hire neurology trained fellows.

Nevertheless, I am hopeful, and even a bit optimitistic that IMS-3 and MR-RESCUE will demonstrate a significant benefit in at least a subgroup of patients. We will just have to wait and see...

 

[typhoonegator]

Good points, Bonobo. I don't have a great picture of community-based neurointerventional practice and hadn't considered that a lack of acute stroke interventional options might make a neurology-trained practitioner less attractive as a hiring option.

Of course, one would hope that there are enough neurology-trained interventionalists out there doing good work to prove to the world that they are just as capable aneurysm coilers as radiologists!

 

[neglect]

To typhoonegator, your points are well taken. Indeed while I personally believe that even if IMS-3 etc. come negative, endovascular techniques are likely to be useful in a select population, but it will be difficult to prove that we can define that select population.

I disagree a bit about your perception of what will happen to neurology-trained neurointerventionalists. Certainly, those that are established at major academic institutions with large referral bases will continue to do well, but many interventionalists at smaller institutions or private practices depend more on stroke, particularly if they were neurology trained. Furthermore, I think the field will in general be less willing to take on a neurologist compared to a neurosurgeon or radiologist if stroke treatments are next to nil. Anecdoctally, institutions that do more endovascular stroke treatments tend to be much more willing to hire neurology trained fellows.

Nevertheless, I am hopeful, and even a bit optimitistic that IMS-3 and MR-RESCUE will demonstrate a significant benefit in at least a subgroup of patients. We will just have to wait and see...

I think we'll see stenting dry up, so the future will hinge on IMS-3. And I honestly think the data will show the same sort of pattern we see with IV tPA, early = slightly better. Later = harmful.

 

[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.

 

[neglect]

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.

I think #4 is a great point. There are those who don't want to get their hands dirty or concern themselves with anything other than neuro-IR. That could happen, but it isn't likely.

I don't think the jobs are going to thrive. I think the market is going to be locked up and I agree that the need is going to be less in the future, not more.

 

[Strokeguy]

The INR requirement is unlikely to saturate anytime soon. A lot has to do with the low number of interventionalists who get trained every year. The other reason is a good number of groups (that include neurologists/nsurgeons and rads) want interventionalists with diversified practices. This is more to their benefit and helps in cross coverage. A purely INR practice can result in burnout. Secondly, the number of available interventionalists is still concentrated in specific geographic locations.
Ischemic stroke as everyone mentioned is only a part of INR. There are many more things practiced/evolving in pathologies like SAH, tumors (embo or targetted chemo), trama incl ENT/head and neck as well as spine.
Even with ichemic stroke, there is a lot in evolution. I know for example in Europe and Japan research is underway on hypothermia using endovasc tech; since we know systemic hypothermia doesn't necessarily cool the brain. There are concepts of flow diversion using devices that are being explored. SENTIS is just one example. You can never write off a field by a single trial alone.
Though I agree with all previous posts that INR specialists are not required in every hospital. This practice is feasible and successful in a larger group where the volume is concentrated. Just like other subspecialities like transplant surgery there will always be a requirement; though not as much as like in GI or body IR for example.

 

[neglect]

The INR requirement is unlikely to saturate anytime soon. A lot has to do with the low number of interventionalists who get trained every year. The other reason is a good number of groups (that include neurologists/nsurgeons and rads) want interventionalists with diversified practices. This is more to their benefit and helps in cross coverage. A purely INR practice can result in burnout. Secondly, the number of available interventionalists is still concentrated in specific geographic locations.
Ischemic stroke as everyone mentioned is only a part of INR. There are many more things practiced/evolving in pathologies like SAH, tumors (embo or targetted chemo), trama incl ENT/head and neck as well as spine.
Even with ichemic stroke, there is a lot in evolution. I know for example in Europe and Japan research is underway on hypothermia using endovasc tech; since we know systemic hypothermia doesn't necessarily cool the brain. There are concepts of flow diversion using devices that are being explored. SENTIS is just one example. You can never write off a field by a single trial alone.
Though I agree with all previous posts that INR specialists are not required in every hospital. This practice is feasible and successful in a larger group where the volume is concentrated. Just like other subspecialities like transplant surgery there will always be a requirement; though not as much as like in GI or body IR for example.

I think this is exactly right for an ideal world. Like transplant, there are a few centers that are really good and they engage other hospitals for referrals.

The problem is that we live in a world made imperfect by the pursuit of money. Ever wonder why Cleveland has two amazing hospitals and both do amazing cardiac care? Hint: it isn't about the people in Cleveland. It's about non-doctors, the marketers, the CEOs, the finance people who want to a slice of a well paying business.

Neuro-IR is the same. The hospitals don't give a **** if anything works or if it kills people (although that would weigh in on their 5 year plan). They aren't doctors. They are not at all beholden to patients. They're entirely beholden to the bottom line. And the bottom line is that there is money to be made.

Currently, as we've discussed, there are many medical unknowns in neuro-IR (making informed consent impossible to my mind). So if you're an administrator and optimist, then hire some IR people.

The problem might come later, as we've seen, with decreased indications for neuro-IR procedures.

 

[PETRAN]

Whats this new NIR fad lol? Ok, im not a doctor (i'm currently practicing as a psychologist in a neuro clinic though but im seriously thinking of going to med school) but its kinda strange seeing so many neuros wanting to go to interventional neuroradiology (in most - if not all- of Europe by the way neurologists are not allowed to do this kind of thing, only radiologists are). If you want to be that interventional why not go to rads or even neurosurgery right from the beginning? I thought that neurology was the more intellectual/superb-diagnostics/academic-research-type specialty with highly sophisticated doctors able to unveil the neuro underpinnings of the most complex zebra case (well, it may sound a bit funny but from what i saw it is partly true). I also see the pharmacotherapies getting better with the appearance of more neuroprotective agents, cognitive enhancers, better anti-epileptics and psychotropics and who knows, even neuro-regeneration promoting substances, the research on these topics is very hot at the moment. I think that there are some very interesting "traditional" neurological areas/fellowships to go like epilepsy, sleep, behavioral, movement, neurorehab.... and a little bit of research isn't bad- at the molecular/cellular, applied/clinical or systems/behavioral level, because there is nothing more interesting than the brain (ok maybe the universe...but it is at the same league).


If it is because of money, well, if i'm not mistaken you'll work more hours in NIR so you'll not have the time to enjoy them lol (and anyway, too much doesn't mean too happy no?). I actually envy you guys because i could be a behavioral neuro, epileptologist, sleep doctor or just a general neurologist and enjoy big medical doctor salaries whilst at the same time do very interesting stuff (clinically and maybe research-wise)and without having to sacrifice personal life (and for what? for doing stenting not impressed ) But these are just a non-neurologist's two cents so there is no need to take the post seriously

 

[typhoonegator]

If it is because of money, well, if i'm not mistaken you'll work more hours in NIR so you'll not have the time to enjoy them lol (and anyway, too much doesn't mean too happy no?). I actually envy you guys because i could be a behavioral neuro, epileptologist, sleep doctor or just a general neurologist and enjoy big medical doctor salaries whilst at the same time do very interesting stuff (clinically and maybe research-wise)and without having to sacrifice personal life (and for what? for doing stenting not impressed ) But these are just a non-neurologist's two cents so there is no need to take the post seriously

Oh lord. Why waste your time writing a long missive if you don't "need to take the post seriously" ?

We each make our own decisions about what is important in life. Your opinion on the matter is no more valuable than anyone else's. Personally, I agree with you, but dismissing any specialty on purely qualitative grounds is fundamentally invalid.

 

[neglect]

Oh lord. Why waste your time writing a long missive if you don't "need to take the post seriously" ?

We each make our own decisions about what is important in life. Your opinion on the matter is no more valuable than anyone else's. Personally, I agree with you, but dismissing any specialty on purely qualitative grounds is fundamentally invalid.

Actually, just to take this in a different direction, academics feel this pressure as well. That is another reason they start fellowship programs: to get the fellows to cover for them and decrease their work load. The system might be set up for failure. As more people go into neuro-IR, saturation occurs. There are only so many true indications for these procedures, and as I mentioned, two are in decline (ICA stents and intracerebral stents).

Many people have an interest in getting fellows through.

 

[Mattchiavelli]

to PETRAN
there is a big overrepresentation of people asking questions about NIR on these forums because
-a lot of people don't understand the whole multiple residencies to the same fellowship concept and how it pans out
-a number of premeds and med students end up thinking about NIR because they like the nervous system and they like procedures, but don't really have the resources to know that there are more procedures in neurology than LPs and the invasive vascular procedures of NIR

On the interview trail this year, I don't think I met anyone that said they were really gong-ho for NIR. Most of the people that came off like they were trying to follow the money were talking about/asking about neurology followed by interventional pain

 

[Strokeguy]

PETRAN,
The traditional neurology you speak of has evolved and essentially become outpatient for the most part. With significant therapeutic advancements, neurology has essentially dichotomized into predominantly inpatient and outpatient work. Most of the traditional neuro is now outpt. The vast majority of inpt neurology is neurovascular and critical care. Perhaps you are not aware of this since most referrals to neuropsych are from outpt neurology practices.
ICU care was also not the ‘traditional neurology’ work, but now we have the expanding subspeciality of neurocritical care. So the so called traditional notions of neurology are breaking.
I know that neurointensivists treat several pts who are traditionally not neuro-‘medical’; like SAH, neurotrauma and spinal cord injury. Similarly we are advancing towards stroke therapy as well as vasospasm and a lot of other pathologies with increasing roles in the angiosuite.
There is now much greater collaboration with neurosurgery than ever before; including in fields like epilepsy, movement disorders etc (which were ‘traditionally’ neurology domains alone).
In Europe neuroradiologists were controlling INR. Now, I have heard about as well as personally know of neurologists from Spain, Italy and Germany who trained or are training in INR in the US (Univ of Pittsburgh is one institution).
You will be surprised that in UK, a lot of acute stroke treatment is done by ‘geriatricians’ and some internists!! Neurologists entered this field very late.
There is an aggressive group of neurologists that are involving more and more into acute/critical care therapies.
Regarding INR, there is a lot under development, which I have mentioned in my prior posts . The reason a lot of INR academicians are so busy is because there IS work and this field is not saturating anytime soon. We do NOT however require few hundred INR trained every year. The training is long and hard and this ensures that check and balances in terms of work force and practice. A lot of people from nsurg/radiology/neurology start with wanting to train in INR and then change their mind later on.
Economics and economic politics affects all specialities everywhere (not just including Cleveland). Regarding intra/extracranial stenting, this is a work in progress. Now we know wingspan is dangerous, but by no means is this the end of intracranial stenting. VISSIT trial is still on. A lot of people who do not understand device design and technology will have different opinions. Carotid stenting has certainly become more prominent now. I do not want to get into ugly debates on this forum, but people need to attend conferences (ISC or CNS/AANS) to understand the pros and cons. I am not saying we do not do CEA; but now there is greater evidence for individualized decision making for stenting vs CEA. There was an hour long session at the International stroke conference purely for this discussion. Period. End result is that there has been an increase in carotid stenting nationwide, but CEA is still done in most pts.
Clinicaltrials.gov will give you all the trials in progress that look at INR therapies under development. This does involve targeted chemo in brain/spine malignancies, cell delivery, cooling…. (apart from all that has been mentioned previously)

How are INR practices evolving? Initially a lot of interventionalists worked alone, and with ‘burn out’, they have now moved into groups (where there are at least 2 if not more), just to share the work load. This has in many ways brought INR guys from different backgrounds together for ‘cross coverage’; and also led to a need for interventionalists. With this re-organization I do not think there would be saturation soon.
Reimbursements just like any field will go up and down. It does look like every medical speciality will have lesser incomes as time goes on, so it is important to choose and do what you like.

 

[PETRAN]

PETRAN,
The traditional neurology you speak of has evolved and essentially become outpatient for the most part. With significant therapeutic advancements, neurology has essentially dichotomized into predominantly inpatient and outpatient work. Most of the traditional neuro is now outpt. The vast majority of inpt neurology is neurovascular and critical care. Perhaps you are not aware of this since most referrals to neuropsych are from outpt neurology practices.
ICU care was also not the ‘traditional neurology’ work, but now we have the expanding subspeciality of neurocritical care. So the so called traditional notions of neurology are breaking.
I know that neurointensivists treat several pts who are traditionally not neuro-‘medical’; like SAH, neurotrauma and spinal cord injury. Similarly we are advancing towards stroke therapy as well as vasospasm and a lot of other pathologies with increasing roles in the angiosuite.
There is now much greater collaboration with neurosurgery than ever before; including in fields like epilepsy, movement disorders etc (which were ‘traditionally’ neurology domains alone).
In Europe neuroradiologists were controlling INR. Now, I have heard about as well as personally know of neurologists from Spain, Italy and Germany who trained or are training in INR in the US (Univ of Pittsburgh is one institution).
You will be surprised that in UK, a lot of acute stroke treatment is done by ‘geriatricians’ and some internists!! Neurologists entered this field very late.
There is an aggressive group of neurologists that are involving more and more into acute/critical care therapies.
Regarding INR, there is a lot under development, which I have mentioned in my prior posts . The reason a lot of INR academicians are so busy is because there IS work and this field is not saturating anytime soon. We do NOT however require few hundred INR trained every year. The training is long and hard and this ensures that check and balances in terms of work force and practice. A lot of people from nsurg/radiology/neurology start with wanting to train in INR and then change their mind later on.
Economics and economic politics affects all specialities everywhere (not just including Cleveland). Regarding intra/extracranial stenting, this is a work in progress. Now we know wingspan is dangerous, but by no means is this the end of intracranial stenting. VISSIT trial is still on. A lot of people who do not understand device design and technology will have different opinions. Carotid stenting has certainly become more prominent now. I do not want to get into ugly debates on this forum, but people need to attend conferences (ISC or CNS/AANS) to understand the pros and cons. I am not saying we do not do CEA; but now there is greater evidence for individualized decision making for stenting vs CEA. There was an hour long session at the International stroke conference purely for this discussion. Period. End result is that there has been an increase in carotid stenting nationwide, but CEA is still done in most pts.
Clinicaltrials.gov will give you all the trials in progress that look at INR therapies under development. This does involve targeted chemo in brain/spine malignancies, cell delivery, cooling…. (apart from all that has been mentioned previously)

How are INR practices evolving? Initially a lot of interventionalists worked alone, and with ‘burn out’, they have now moved into groups (where there are at least 2 if not more), just to share the work load. This has in many ways brought INR guys from different backgrounds together for ‘cross coverage’; and also led to a need for interventionalists. With this re-organization I do not think there would be saturation soon.
Reimbursements just like any field will go up and down. It does look like every medical speciality will have lesser incomes as time goes on, so it is important to choose and do what you like.

Thanks strokeguy, very informative post. I know that a few neurologists do the NIR thing in Europe but i'm not sure it is legal in most of European countries (!) I know that in many countries it is not. You are spot-on for the UK. Tha majority of neurological populations are examined (depending on the condition) by internists, geriatricians and psychiatrists. This is maybe because the total number of UK neurologists is 300 or something (true story). Neurophysiologists is also a different specialty altogether!


Yes you are right, the majority of neuropsych evaluations is from outpatient so maybe i had this in mind. I used to work in a neuro-inpatient though and they also had MS, movement, epilepsy and dementia units. So for someone who starts a neurology residency today is it obligatory to do a NIR post? (for neuro-critical i guess it is?) If the vast majority of in-patients is stroke patients, isn't there a substantial exposure to the other "traditional neurology" (e.g. epilepsy, sleep, migraine, parkinson's, huntington's, alzheimer's, MS, neurophysiology etc.)? Because i'am thinking of going to medical school as a mature student for this kind of thing and i would especially like working between neurology and psychiatry and the behavioral manifestations and underpinnings of neurological conditions (in many european countries the two specialties are still quite close). Maybe one day the harder "neurocritical" aspects of neurology become a different specialty whereas some of the "traditional" aspects of neurology get re-united with psychiatry in a single "brain-doctor" specialty? Who knows.

 

[Strokeguy]

I am not sure about the legalities, but I hear the ice is breaking in Europe as well.
In the US, you get ample exposure to all subspecialities during residency. There is mandatory 18 months of in-patient neurology and a lot of outpt exposure as well. What I meant is that in the US, most pts with epilepsy, MD, Neuromusc etc are managed as out-pt. They do present acutely, say with status, GB or myasthenic crisis and then get admitted to the ICU where the neurointensivists treat them. Some pts do get admitted with gen neuro problems including seizures, myelopathy, etc. But by and large cerebrovascular and neurocritical care is the predominant majority of in-pt neurology. This is how things have evolved in the US. In the old days, a lot of the 'traditional neuro' pts would be managed inpt, but now it is predominantly outpt.
Also, angiography historically was performed by neurologists and neurosurgeons. My mentors who trained in neurology during the 60s preformed angiographies by direct carotid puncture. This was before the transfemoral approach. You will find the same in Europe if you speak those who trained in the 60s. Angio was even used to diagnose tumors, mass effect, herniation etc.
In the US, vascular neurology and neurocritical care have evolved as well established fields. INR is pursued only after the above training and by no means mandatory. INR of course is shared with nsurg and radiology.

 

[typhoonegator]

Yeah, angiography was initially within the purview of neurology.

Neuro-radiology at my hospital was started because the neurologists needed someone to help out with their angiograms. In speaking with some of the extremely senior faculty, they would have a medical student stand beside the patient with a stack of X-ray plates, and then the neurologist would yell "go" while they injected dye into the carotid and started the X-ray exposure. The medical student would let plate after plate drop to the floor, shooting an X-ray with each one to give them a cine of the angiogram.

When all you had at your disposal was pneumocephalograms, plain films of the head and spine, and angiograms like this, you didn't really need full time neurorads! Ah, the days of giants.

 

[Famo]

yes

 

[gonogo]

The Neurointerventional Bubble. This article appeared last year on AJNR.

http://www.ajnr.org/cgi/content/full/31/7/1162

 

[neuroir]

...but many interventionalists at smaller institutions or private practices depend more on stroke, particularly if they were neurology trained...

That is not true. No neurointerventionalist, in academia or private world, can justify his salary performing solely intraarterial stroke treatments. The definition of a busy neurointerventional program is directly related to the number of aneurysms they coil, for that is where the strongest evidence supporting implementation of neuroendovascular treatment is coming from. If one accepts a job offer allowing him/her to treat only occluded MCAs, he/she will be one unhappy half-ass specialist. Any neurointerventionalist (irrespective of their specialty background) must possess adequate skills to perform the entire spectrum of neuroendovascular procedures. Unfortunately, there are TOO MANY "neurointerventional fellowships" around these days offering fragmented training in exchange for having a fellow carry the pager and be the first responder to various emergencies. The above-mentioned "Neurointerventional Bubble" article discusses this issue in detail.

SAMMPRIS was indeed a setback. But as typhoonegator has mentioned, most of interventional neurologists perform ALL kinds of procedures on the vessels above the aortic arch, and sometimes below it as well. We do petrosal sinus samplings for endocrinologists, embolize nosebleeds for ENT, coil Vein of Galen malformations for pediatricians, etc. etc. It will take much more than 1-2 failed clinical trials to kill the field or render us useless.

 

[neglect]

Ims3: something is going on! Futile? Or beneficial?

 

[DrTICI]

Ims3: something is going on! Futile? Or beneficial?

It is NOT GOOD news! Futile

Very disappointing

 

[burs0028]

I'm very interested to hear more about this...not sure how long we'll have to wait before anything is officially released.

 

[DrTICI]

I'm very interested to hear more about this...not sure how long we'll have to wait before anything is officially released.

We will all be eagerly awaiting the detailed results. We know for now that it was halted based on the DSMB finding that there was a very very low likelihood of any arm showing any benefit over the other going forward as far as the primary end point after an interim analysis of almost 600 patients.

 

[RAD345]

IMS-3 is on hold right now. but this trial originally designed in 2004. For IMS-3 patient enrollment was super difficult.

There are a lot of advances since then. everything from patients being transferred by EMS, to MRI techs and Angio staff and the non neurologist physicians. Everyone knows better and selections are much better. We have now Solitaire stent that has a high revascularization rate. There are a lot of new micro-catheter and -wires.

The Neurointerventional is NOT dying. There are good results in the stroke field. Other than stroke, patients with intracranial or facial vascular malformations, tumors (cerebral or facial), carotid tumors, spinal lesions are benefit from the hard-working physicians in this field.

No matter who does it, a Neuorlogist, a Neurosurgeon or a Radiologist, people love to have these specialists around for the most desperate moments!

 

[neglect]

IMS-3 is on hold right now. but this trial originally designed in 2004. For IMS-3 patient enrollment was super difficult.

There are a lot of advances since then. everything from patients being transferred by EMS, to MRI techs and Angio staff and the non neurologist physicians. Everyone knows better and selections are much better. We have now Solitaire stent that has a high revascularization rate. There are a lot of new micro-catheter and -wires.

The Neurointerventional is NOT dying. There are good results in the stroke field. Other than stroke, patients with intracranial or facial vascular malformations, tumors (cerebral or facial), carotid tumors, spinal lesions are benefit from the hard-working physicians in this field.

No matter who does it, a Neuorlogist, a Neurosurgeon or a Radiologist, people love to have these specialists around for the most desperate moments!

The point is that this trial was negative. In fact, it was so negative that it was halted early. That's pretty negative.

Furthermore, IMSIII did everything it could do to try to bolster the endovascular arm. It allowed each new "advance," but in the end it failed to find that they changed clinical outcomes. You simply can't say neurovasc has "good results in the stroke field" when the biggest and best trial in acute stroke showed futility when compared to IV tPA alone.

I think that even the most devoted advocate of IA stroke treatments now has to reconsider. At very least, this trial has a few lessons: 1. Biology is complex. 2. IA approaches have now been humbled. 3. Before rushing into new IA procedures and screenings, they must be shown to be effective within randomized trials.

And just to enlarge point #3. I'm not saying that it is impossible to select patients who might benefit from select endovascular therapies. But I'm saying that we can't do it at this time. Again, this trial has humbled a lot of people, and if hospital administrators are smart, then some have reconsidered their unabashed enthusiasm.

 

[neglect]

I think we'll see stenting dry up, so the future will hinge on IMS-3. And I honestly think the data will show the same sort of pattern we see with IV tPA, early = slightly better. Later = harmful.

Just wanted to post this unaddressed prediction here. Not to say I told you so...

 

[neglect]

Another blow.

At this point it is just a dismal and shallow medical backwater.

 

[Strokeguy]

Couldn't agree more. I had mentioned this in one of my prior messages about this trial. ARUBA even if it had shown benefit of invasive therapy would still have resulted in even more selected AVM cases getting these therapies (turns out these therapies are far more harmful). There was a higher incidence of crossover to the 'treated/intervention' group though (hearsay). In any case if you have 3 times more adverse events in that group then it certainly puts the writing on the wall.

 

[neglect]

Couldn't agree more. I had mentioned this in one of my prior messages about this trial. ARUBA even if it had shown benefit of invasive therapy would still have resulted in even more selected AVM cases getting these therapies (turns out these therapies are far more harmful). There was a higher incidence of crossover to the 'treated/intervention' group though (hearsay). In any case if you have 3 times more adverse events in that group then it certainly puts the writing on the wall.

Your point is very well taken. When you initially made it, I did not grasp how subtle it was. The field is in deep trouble.

 

[Acherona]

I'm sick of taking care of patients with iatrogenic strokes and other complications induced by the neurointerventionalists. Yea it's cool to be a cowboy and make bank by mucking around in people's brains without any evidence whatsoever, but at some point your conscience should kick in.

 

[badasshairday]

It looks like the only beneficialy intervention is coiling intracranial aneurysms. And cerebral angiograms, but that is just diagnostic.

 

[badasshairday]

It looks like the only beneficialy intervention is coiling intracranial aneurysms. And cerebral angiograms, but that is just diagnostic.

BTW, I was just trolling to keep this discussion going. Obviously didn't work.

Anyways, I think it will be interesting to see what the SWIFT trial shows with the new SOLITAIRE device. The Solitaire stent-retrieval device looks a heck of a lot more elegant than the Merci device. Also I've already seen some amazing outcomes with the Solitaire thus far.

 

[neglect]

It looks like the only beneficialy intervention is coiling intracranial aneurysms. And cerebral angiograms, but that is just diagnostic.

BTW, I was just trolling to keep this discussion going. Obviously didn't work.

I didn't think of this as trolling. I thought of this as an honest opinion. At this point, aneurysm coiling and diagnostic angiograms is the bedrock. Except that the diagnostic angiograms, if you're honest, are superseded by ever better MRA and CTA.

Anyways, I think it will be interesting to see what the SWIFT trial shows with the new SOLITAIRE device. The Solitaire stent-retrieval device looks a heck of a lot more elegant than the Merci device. Also I've already seen some amazing outcomes with the Solitaire thus far.

I have heard: "I've already seen some amazing outcomes..." with every failed device thus far. I've heard it with Merci, and we learned that Merci was associated with slightly more harm. All this shows is that doctors without a blind are heavily biased and simply can't be trusted with statistical analysis. In short, clinical experience is a poor compass in these cases.

The bottom line is that none of these intra-arterial options have been shown to work yet. When they do, it will be appropriate only for a slim minority of acute stroke cases.

 

[Strokeguy]

For all Solitaire and Trevo enthusiasts and also those who believe that stent-retrievers not being used in most IMS-3 cases is a reason why the trial failed to show benefit of endovasc therapy, you all must read the recent article in Stroke by Dr Broderick. He looked at the entire dataset of SWIFT, TREVO, IMS-3, MRRESCUE. There is detailed anaylsis of 'time to groin puncture' and recanalization rates as well as 90 day outcomes. He has also provided numbers and percentages of ICA occlusions with Merci as well as the new devices and also in pts who received IV TPA alone. There is no doubt that new devices have higher recan rates. Most importantly - 90 day outcomes were similar for all individual groups - whether they were treated with Merci, Solitaire, Trevo or whatever; and IV TPA alone. In fact IV TPA outcomes from IMS-3 were better than endovasc arms in other trials. In conclusion - IV TPA trumps all treatments, the rest still need evidence whether they work and if so then in which patients.
Those who are serious vascular guys must read this article-
What the SWIFT and TREVO II Trials Tell Us About the Role of Endovascular Therapy for Acute Stroke. Joseph P. Broderick and Gerhard Schroth. Stroke. published online May 16, 2013

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.
Point to note - the time to groin puncture was still the earliest in the endovasc arm of IMS-3, shorter than SWIFT and TREVO. So IMS-3 investigators and collaborators did an excellent job with enrolling, randomizing and taking pts to the angiosuite, still the results showed no benefit over IV TPA. So anyone who thinks that in SWIFT or TREVO, pts may have done better than in IMS-3 is mistaken.
In any case, the writing is on the wall. The manuscript (mentioned above) should at least clarify these misconceptions.