Giuseppe Lanzino and Jacques Morcos
January 16, 2014
- Friends and colleagues, thank you for joining us for another session of the Double S Operative Grand Rounds. Today, we have two distinguished speakers Dr. Giuseppe Lanzino from Mayo Clinic in Rochester, Minnesota, and Dr. Jacques Morcos from University of Miami. They'll be talking to us about the emerging technology, of Flow Diversion for cerebral aneurysms. They will each one talk, first Dr. Lanzino, and then at the end, we'll have about 10 to 15 minutes of discussions regarding controversial issues. Giuseppe and Jacques, thank you for joining us and Giuseppe just take it away.
- Thank you to the WNS for this opportunity, flow diversion has been utilized for the treatment of intracranial aneurysms now for five years. And I think it's important we should be able by now to put this in prospective. So what I'll try to do, I will try to define what is in my view, the role of flow diversion or intracranial Aneurysms based on some of the data available as well as on the personnel experience. And then also briefly touch upon some of the most important complications of this technology. These are my disclosures, and just to briefly elaborate on the concept of flow diversion, the idea is that if we are able to place a device, which has a high mental ratio across the neck of the aneurysm, we are able to modify flow dynamics so that flow is redirected into the parent artery away from the aneurysm and these same times will promote some stasis and eventually progressive thrombosis of aneurysm over time. And I think that we can say that flow diversion is the treatment of choice for a complex proximal internal carotid artery. And which is also the type of aneurysm for which this technology has been approved by the FDA. So the concept actually works very well in these cases. This is a patient that was treated because of refractory retro orbital pain for several months, we thought this could have been related to this fusiform carbon or sinus aneurysm. You can see here with the placement of three telescoping device, the reconstruction of the profile of the siphon and the classic delayed intra aneurysmal stasis that often you see, and this immediately after placement of the device, disruption of flow, and again delayed stays into the more saccular portion of the aneurysm and this is the six month follow up. And you can see on the AP really the beautiful reconstruction of the profile of the internal carotid artery. This is another idea case of middle-aged lady with an incidental finding of this very large carotid* artery aneurysm. This was also treated with flow diversion, and this is a six month follow up in this patient . Now, I think also flow... So those are the definitely what you might do, are ideal cases for this type of technology. It has been a nice for me to see over the years how the animal studies co-related with the clinical situation. This is from studies in rabbit that were done by the accounts here at the Mayo clinic, showing that basically after the placement of flow diverter in the rabbit aneurysm mode you have formation of a clot and eventually the clot acts like a scar and so it retracts and the saccular actually shrinks. And again, this a nice correlation with the clinical situation, patient that with the intermediate of term operasis from a giant coronary sinus aneurysm treated agan with flow diversion six months follow-up. There is still a very small residual feeling of the annulus. And more importantly, here is the pre-treatment and you can see there is the worst displacement of the tutory stalk and that six months there has been the shrinkage of the aneurysm with the improvement of the massive effect. Of course, this is a phenomenon of trinket joke aneurysm that we see as long as the aneurysm is completely obliterated. And also as long as there is not significant calcification of the vessel wall, and this isn't the same patient is the one year follow up showing the resolution of that small receivable. This has also been corroborated by early clinical experience where symptoms of massive factor actually can improve after treatment that reduce modality. at the beginning, of course, there were concerns in treating patients with the mass effect because as we will see as the aneurysmal thrombosis, there is a relative volumetric expansion and some inflammation, which in theory could make symptoms of mass effect worse. But so far it's does not seem to be confirmed by clinical experience in the majority of patients. Now like any technology, especially when we start treating very complex injuries, there are complications. And I think that for full diversion, the major issues are some unforeseen complications related to delay the initial rupture and to these intraparenchymal hemorrhage, which are a way from the annulus, not related to rupture of the annulus, usually occur on the same side of the treatment, but there have been also cases reported on the other side because of these complications, that was a recent multicenter registry. That was conducted, those were participating the same test. And this is a retrospective multicenter registry involving sites with the large experience with flow diversion. And the criteria for enrollment in the registry is that the operator are said to accept to include all of the cases done that were for the diversion was used, So the idea behind this study was to get some sense about what the incidents of these complications in a large number of patients. And you can see that by definitions, measured events were considered that complications with the symptoms that persisted after seven days, minor were considered those transient complications causing the transient deficits. Again, it was a large number of patients with over 900 aneurysm. So with the relatively longer followup, and this is the painters besides, and they think that it's important when we discuss about this numbers to consider that the denominator, only the minority of aneurysms were a true giant aneurysms. That was a large portion that were large, and like it happens in a clinical practice once you have a device. And we know it's been utilized also for small aneurysm and small aneurysm in this study were about more than 50% of the cases. And here is again, distribution of annulus by location, mostly in the anterior circulation promoting the internal carotid artery, but also other locations were represented. So I think this is one of the most important point of the studies to try to understand that what is the incidents of delayed, the rupture of the aneurysm, and if we can see their own commerce, the incidence is relatively low and it's in the low single digits. But again, I like to stress for fairness, that the number of giant aneurysm in this study, was small only about 7%. In this particular complication seems to be almost exclusively confined to giant symptomatic painters, which we know are very unstable analysts and are often very difficult and risky to treat with different therapeutic modalities. So we can discuss what is the reason for this complication? I personally think that this is related to both the modification of ammo dynamics flowing to an unstable annulus, as well as the formation of a large clot burden. And we know very well that the clot triggers some degree of inflammation, which in an unstable very thin wall aneurysm can precipitate the growth. The other point is that most of these complications, most of these delayed ruptures tend to occur within the first week or first ten days after the treatment.
- Joseph, may I ask you how many of the cases had coils put in as well as the flow divert in the study, do you know?
- Right, I don't know about, that's a very important point because I will show it now where experience we have not seen this complication. And again, I think it's a result of two factors. Number one, the number of truly unstable giant symptomatic aneurysm and our experience was relatively low. And also we started using the coiling in addition to a flow diversion very early on when we start hearing about these complications, the idea of the coiling there is to decrease the clot burden by a filing portion of the aneurysm with coils, and also somehow buffer the hemodynamic changes into it and then completely treated anulus until the flow diverting effect takes place. And that you can see that in these studies, some of these events were considered, these delayed raptures were considered the relatively minor because resulted in a director CCCfs that were treated with endovascular treatment. And then again, that most of these complications were seeing within the first month after treatment. Now, I think we have a fairly good idea about delaying the aneurysm rapture Again, it seems to be limited to those a giant daily unstable symptomatic aneurysms. But I think that the major weakness at this point of this technology to which prevents a wider application, it's the issue really of the intraparenchymal hemorrhage. This was something that we did not predict. And I think this is a still a fairly, poorly understood that phenomenon. We unfortunately heard that one of these cases, this is a 42 year old patient who presented with the subarachnoid hemorrhage, flow diversion is still in my opinion, contract route is a relative contraindication in a patients with raptured hemostasis. In this case, we thought it was a reasonable option because the patient was in a poor neurological condition to start with and then underline quagga law. But, and also the MRH was related to a blood blister liking the super glenoid internal carotid artery. This was treated with flow diversion. The procedure was uneventfuL, unfortunately, the following day, the patient had that deterioration and you can see there was a discolor hemorrhage that was not changing the amount of subretinal hemorrhage, suggesting that this was distant from the target aneurysm suggesting that indeed, this was one of these distolar intraparenchymal hemorrhage that we still don't understand very well. And more importantly, this is a random complications. We cannot really pinpoint a specific aneurysms that are more at risk. In the intrepid, the registry, and these are data that have been already presented in abstract format meetings. The incidents of important distant intracranial hemorrhage was 2.4%. And again, this is not a negligible number, especially if we consider that more than 50% of the aneurysms were small. And I think this complication is one of the main factors limiting the use of this technology only to those aneurysm that we discussing that I will discuss in the course of the remaining part of the presentation. And you can see that most of these distant hemorrhage tends to be intraparenchymal hemorrhage. There was a very small number that were subarachnoid or intraventricular hemorrhage. Now, my impression is that ischemic thromboembolic complications are not a major issue when these technologies used the for on label application, there were some concerns in placing a high metal device where they make a ratio across a small perforators, but again, we have nice correlation now between the clinical experience and the animal studies. In the animal studies, what we observed is that placing a flow their diverter across the intercostal arteries in their rabbit tower, and the intercostal arteries can the air the diameter in the rabbit that can approximate the diameter of their anterior choroidal in some of the small anterior circulation perforators, these perforators, these small vessels, they do tend to stay open because there is a pressure gradient, which will keep them open and where we see with flow diversion occlusion of that source. It's usually in those vessels that have significant collateral supply, like the a anterior cerebral artery. If the patient has a good, a one on the other side, the posterior communicating artery or the automic artery and territory vessels, like the anterior carotid artery, lenticulostriate artery some of the ICA perforators, usually they stay patent and again, these patients are always on dual antiplatelet therapy. So in my opinion, thromboembolic complications, of course they do occur. But the main issue with this technology, some of the hemorrhagic complications I discussed because thromboembolic complications, usually if they are purely procedural, we see during the procedure we can counteract with the pharmacological interventions. They don't seem to be a major issue. And when we see even major vessel occlusion with this technology is usually although not always, but it is usually asymptomatic. Now I'll briefly go through some of our cases, we looked that our first a hundred consecutive patients, that we were early adopters of this technology, we have lost any patient to follow up. And we were looking primarily at complications. It gained this, some of the details that they were, again, 14 were giant aneurysm, there was a large number of very large aneurysm. And the light could in the Intrepid study about 50% were smaller aneurysm. All of these patients are pretreated for five days with dual antiplatelet therapy. And I think that this is also an important point is that we don't test the, for response to Plavix. I suspect that some of the MRR complications might be related to the fact that we tend in some centers, they do follow closely plate elect response to antiplatelet therapy, and they might, if they increase the dosage in there is really not good evidence to suggest that testing patients for response to Plavix decrease the incidence of thromboembolic complications while he might indeed increase the incidence of hemorrhagic complications. And usually patients are on Plavix for three months, after three months Plavix is discontinued and they continue aspirin. And we do like the first follow-up angiogram at six months. Again, this is a therapy that a strategy that works over time. So there is not much sense in doing that earlier follow up angiograms. The majority of the aneurysm that we treated there were, in the proximal ICA, but with increasing experience. And that will show some cases we treated aneurysm you know, their locations as well. Now, if we look at the permanent morbidity and mortality, we had very good experience with a very low morbidity and mortality. I showed that normally mortality was the patient with the distant intracranial hemorrhage or wherever these procedures, many of these procedures are quite complicated. And I think that this is a point that is very important to stress. And when we looked specifically at technical complications that did not necessarily result in permanent complications, technical issues were and they are not that uncommon with this technology, unfortunately, despite this has been around for more than five years, we're still working with first generation devices. When we look at technical issues, migration of these devices is not uncommon. This usually happens very procedurally during deployment, but there are now several cases report that even have delayed the migration of the device. The device might not expand completely and in some case, angioplasty is required. I apologize for this slide here. But these are often a middle age females with a very reactive vessel. So catheter induced vasospasm are common, and you can see, we had also had a host of different technical issues, which usually do not solve the permanent complications, but it's important that when approaching these procedures to be extremely careful and nowadays, we don't push the procedure if we encountered unexpected problems or difficulty, we rather stop rethink the strategy, consider alternatives or go back on a different day. So in conclusion, what is the current role of flow direction? I think, you know, after five years, we are obliged to be able to say exactly what is the role of this strategy. I think that flow diversion, it represents a paradigm shift. It's here to stay, and it is the treatment of choice for complex product glenoid, ICA aneurysm, especially for those large, very large aneurysms for a truly giant symptomatic aneurysm. I think it's ne of the potential treatments with the caveat that the incidence in the risk of delayed aneurysm, rapture it's higher in those patients. But I also think that a flow diversion is another tool in our armamentarium, and it allows us to be creative when we are dealing with with complex and unusual problems. This is one of these problems, a 63 year old man presented with right face pain and we're setting. This was related to mostly thrombosis, that giant pack annulus with the brainstem distortion edema. We treated this patient with the combination, and this is the portion of the anulus that was still feeling that the arrest was thrombosed. We treated this with the strategy of partial coiling, followed by pipeline placement, and this is the follow up MRI after three months showing partial reduction in size of the annulus solution of the brainstem edema with the resolution of symptoms. This patient is well, three years later, it's just refusing to come back for a catheter angiogram. These and other cases, 16 year old teenager was a presented with seizure was treater elsewhere with the excellent clip reconstruction along with the bypass. But as it often happens in these, you know, sort of blocked to the aneurysm, say in pediatric age, there was a asymptomatic recurrence one year later because of the prior surgery, we felt that a redo surgery was associate a special in the dominant hemisphere with is mythical risks. And we thought that a placement of a flow diverter was a reasonable choice. This is immediately after placement of the device. And this is a one year later with some degree of stenosis inside the device, but the resolution of the aneurysm and adequate the stock flow. And this is the final construct with the pre-existing clips. And these are the telescoping device placed in the involved into branch. These are in other cases, they even available. This strategy has really changed the way we treat that these a very large or giant a rupture annulus but he's a 37 year old man who presented with the headache and this very large ICF bifurcation aneurysm and the dominant hemisphere This was treated with partial calling of the dome to protect the patient from bleeding and this is the follow up a month later showing as expected a significant recurrence. And this was treated with a pipeline authorization, you can see the 10 month-follow-up with resolution of the aneurysm. And you can notice that we have lost one on this side, but as I mentioned before, this happened because the patient has an excellent and robust collateralization from the other side. In other case, it more and more, we are faced with these cases that are very difficult for which we don't have a good alternative. This is a 80 year old, I saw first with new onset of third nerve palsy. I manage this conservatively patient comes back, symptoms are getting worse. Aneurysm is growing this is a resecting the P 1, 2 junction aneurysm. By that time, we had enough experience that we felt comfortable treating these with the flow diversion. And you can see, we have changed quite a bit, the angle of the bifurcation, but six months later there was resolution of the pseudo annulus and on actual imaging study, partial involution of the aneurysm itself for which debilitation of symptoms. So I think flow diversion is an excellent therapeutic strategy for complex proximal, internal carotid artery aneurysm. It is an additional option when we are faced with a uncommon and a difficult situation. Technical and clinical issues are not uncommon after flow diversion, but I think with careful patient selection, compulsive perioperative care, the incidence of a paramedic important complications is very low. There are still limitations related primarily to the issue of delay. The annulus rupture mostly limited to giant symptomatic unstable aneurysms. And the main limitation is related to this issue of distal intraparenchymal hemorrhage, which unfortunately it's a poorly understood and it's a random complications, but likely seems to be very uncommon in the low single digits, thanks.
- Well, good evening. And thank you, Anne. And thank you WNS for the opportunity to have this debate with my good friend, Jacques Lanzino. So obviously I am going to take a little bit the contrarian viewpoint and try to critique flow diverters for aneurysms. I have a disclosure, I'm a consultant with Codman J and J. So I'd like to go very quickly over these five categories, the science, the technology, the experience, the lessons that we've learned, and at least my personal final verdict. So before we get into that, it is of course an exciting, an exciting development to have flow diverters. And let's remember to quote this wonderful thinker from France "Tradition's greatest calling is to give progress the courtesy it deserves by allowing it to erupt from tradition, like tradition erupted from progress." So I really do not want to be misinterpreted as one thing to stifle progress. That is absolutely not my goal, as you will hopefully see. What is the science of flow diverters? Very exciting, very complicated engineering concepts, which we will not get into here today. We have the issue of porosity index, which needs to be 65 to 70%. We have the issue of pore density, obviously it is ideal to be of this configuration rather than this. We know a little bit about the technology by now and briefly, there is a first the silk and then the pipeline, the details of their engineering is not really too important for this presentation. What do we know about the clinical experience with those devices? The early promising reports came from Buernos Aires, Budapest, and some other centers subsequently. We obviously don't have very long term outcome. It's very fresh technology. The first signs of trouble started at, that I'm aware of in 2010, with this report showing an early fatal hemorrhage after a use of a silk device for an aneurysm and the title included this sentence, "Do we need to rethink our concepts?" Well, let's show you what we know about silk, silk regarding a multicenter study that looked at delayed aneurysm rupture with the senior author being Ben Rufinag from Switzerland, looked at some numbers collected cases, and I'll show you some cases from that publication pre treatment here immediately post-treatment, patient does well for five days, and then previously unruptured aneurysm ruptures at day five as you can see here leading to death. Another case in a basil or trunk, similar fate, this is autopsy findings subsequently, and you can see evidence of war degradation. The third case, again, this carotid aneurysm suffered the same fate with autopsy findings here. The issue is, and the thinking is, is there a persistence of inertia driven flow, as opposed to the sheer driven flow, which has been reduced by the flow diverter? It is obviously dependent on individual parent and vessel anatomy and aneurysm morphology. That is an issue of continuous thrombus renewal and autolysis and weakening of the aneurysm wall. So the paradox we find ourselves in there is a race between healing and between world degradation, whichever one wins the race first will result in the outcome. It would be an excellent outcome if the healing wins, it will be a disastrous outcome if all degradation wins. And as Joscque alluded to in his talk, these are the four factors that seem to correlate with the rupture of the aneurysm. After flow divert are large and giant aneurysms, symptomatic aneurysm, an elevated aspect ratio of 1.6 and a morphology that favors inertia driven flow as opposed to sheer driven flow. Unfortunately, these factors are also the factors that make surgery open surgery, more complicated. The another study from three centers review of silk also showed similar results with overall complications, 38% mortality, 4% morbidity, 15%. The author's conclusions of that paper were that the concept of silk is promising, but there are major limitations. My personal conclusions would have been my goodness, these are really not very good results at all. And I would put a moratorium on this device until we figured out really what's going on and use it only when there are no qualified, experienced surgeons available to treat the aneurysm within that referral circle. Subsequent meeting in 2010 at valley desire, by the end of vascular gurus of this planet, looked at these issues, discuss the unanticipated problems and the company placed field safety notice saying that silk should be used only with corals or part of a randomized study. Let's talk about pipeline. Yes, very promising early series from Pedro Linux group in Buenos Iris subsequently also from Budapest and then the PETA trial, including the pipeline device came out. And the idea was to include next of aneurysms with two or more than four millimeter and a dome to neck ratio, less than 1.5 and exclude subarachnoid hemorrhage and other factors. However they need that is not what happened as you can see from my notations in blue only essentially a third were large or giant aneurysms as high as 29% had small necks. There were no AECOM, no distal aneurysm, only one MCA, no basilar and more than 50% needed additional coils with the pipeline. So when you select cases favorably like this, you will indeed have good results. 98% of the cases were feasible. Still there were technical difficulties in about a quarter that was major stroke in 6.4%. The annual results at six months were excellent. 93% obliteration of the aneurysm at six months. These are some of the cases from that trial. Very, very impressive results. You take an aneurysm like this, you place a flow diverter and similar to many of cases that this is a beautiful angiographic result. That certainly would be very hard to achieve with open clipping. But my conclusions about this study is that there is serious cherry picking happening, but that's fine. As long as we recognize it, we are including small aneurysms. We are including not on X we have only stable patients neurologically, and of course, no reason subarachnoid hemorrhage. And we have short follow up. And in spite of all this, there are indeed very procedural difficulties and strokes not to be dismissed. Then came the puffs trial, which led to FDA approval in this country. And I'm going to skip some of the details of the trial, but to show you that 98% of the cases needed more than one pipeline device used to be used. They were overlapping, this was the number of complications as mandated by the FDA. Ipsilateral major stroke without death with death, death without stroke, which was below the target number, which led to the approval. However, when you look at other complications and you add things up and you can see them here on the left, it adds up to a total irrelevant number of complications of 17%. And if you include every possible, I'm sorry, this doesn't show, but if you include every possible adverse outcome, you will get a total number of about 41%, but it was effective in obliterating 82% of the aneurysms. The FDA approved it indeed for use above age 22, but for large and giant aneurysms with white necks and four aneurysms below the superior hypophyseal artery level below, I'm sorry, below the peak com level on the carotid artery, every other use is considered off-label. And the warning was that, yes, aneurysms may thrombose and thrombose the parent artery and multiple devices may increase the risk of ischemia and that long-term followup at five years is needed. So the interesting thing about complications of flow diverters is there are two groups that are the technical procedural complications that do get better the more experienced the operator is, and hear that these two line items are there, but these four complications really have nothing to do with the operator experience, vessel thrombosis, peri aneurysm, inflammation, aneurysm, rupture, and ipsilateral intracerebral hemorrhage. And even sometimes contralateral. So that's the black box that seems to limit what should be a limitation of the wide applicability of the technology. The incidence of delayed ipsilateral intracerebral hemorrhage can be as high as 8.5% in the series was quoted as low as 0% in the PETA trial. And you've heard the Jacques is number as well. Mechanisms of ICH, nobody really knows. Is it a loss of elasticity of the large capacitance artery? The so-called compliance theory? Is it the bleeding in an embolic infarct? It also happens Contra laterally. So it is tough to think that these are the only mechanisms parent artery stenosis happens in about 6.6% of the cases at one year in the puffs, the trial. More pipeline stories of problems have been reported. This is just a selection of few abstracts. This is the first case in the U S that led eventually to death from basilar artery thrombosis, after an encouraging early results. Therefore overlapping pipelines in areas of perforators has been discouraged by the company, EV3, Covidien. This fascinating, very impressive report from the Buffalo group, talking about vertebrobasilar, large giant aneurysms essentially says we're nowhere near curing those cases. Look at the dismal outcomes with using flow diverters, death 57%, severe disability 14%. As this same situation with the open surgery for those as well. As well, flow diverters, once you put the temporary clip on them, you will deform them irreversibly. And Joscque has reported of telomere artery patency rates there is a patency of forward flow. When you cross ophthalmic artery of about 68%, however clinical outcome is not affected and patients don't seem to lose vision. An early post-market analysis showed that only 68% of aneurysms were occluded completely at final follow up with the pipeline. And when you summarize the series the last year, you can look at the column of complications and death with the use of flow diverters. You can see that here and here, and there is an issue of, should we use them in blister like aneurysms, the blood blister aneurysm. There was a recent publication comparing open versus endo with the use of flow diverters, showing that the re-growth and re-treatment rates are much higher with the use of flow diverters compared to open surgery. Again, further reports of delayed intracerebral hemorrhages in this publication. This was such a case from this paper that required surgery and meta analysis carried out by Dr. Lanzino and his group at the Mayo clinic published recently showed these numbers as complications, subarachnoid hemorrhage 4%, ICH 3%, Ischia 6%, perforator injury 3%, and total obliteration of the aneurism 76%, with these being the correlative factors. There is now second generation flow diverters, very preliminary, of course, Fred is one system, surpass is another system. And I saw an in vitro use of a new device called Admedes Nitinol Closed loop device. This is a picture of it, of course, all of these devices too early to comment on, I'll show you a couple of cases from our center. Just this past year, subarachnoid hemorrhage from a superior hypophyseal artery aneurysm, treated by my endovascular colleague. Here is the aneurysm a pipeline and coils were placed. No difficulties with doing that. Here is the immediate for... I'm sorry, this is a two week post treatment angiogram, patient is doing well upon discharge home. Three weeks later is readmitted with a contralateral ICH that led to death. Another case of this blister dorsal wall, blister aneurysm, again done recently with subarachnoid hemorrhage. One pipeline placed complete immediate disappearance of the aneurysm. Notice a few hits on the MRI. Ipsilateral to the device, early recanalization of the aneurysm at post bleed day six and post bleed day 12, almost full recanalization of the aneurysm. So again, we cannot celebrate too early with these cases because we do need some long-term followup. And there were a couple of small embolic infarct scene. And the last example I will give you would be this subarachnoid hemorrhage patient with this blister aneurysm treated with the pipeline device at two months, follow up it grew, at four months, it grew further, and he was referred to me and I operated on the patient. And this is how pipelines look at least through the vessel wall. The aneurysm had grown and it was actually not too difficult to place two clips on it and obtain this angiogram here with complete disappears. Why do aneurysms fail and rapture, why do aneurysm rupture in a delayed manner? It is unclear. The study from Buernos Aries seems to suggest that three aneurysmal stenosis of the parent artery is to blame in many cases because it results in paradoxical increase in the pressure gradient once the device is placed. And as you can see of their hemodynamic data, it's not a universally accepted concept, but it's an appealing theory. The lessons to learn in my opinion are the following. Let's face it as expected from a first generation device there are problems technical difficulty placing the device. Some issues with navigating the arteries problem two, uncertainty, whether the aneurysm will be obliterated over time. Number three, if it is operated, it probably will be in a delayed manner and problems can happen in the interim. Number four, the hemodynamics that lead to obliteration of the aneurysm may also lead toward the gradation and premature rupture. Number five, very important one. If the treatment does not work, you've closed the door to further endovascular treatment, at least because you cannot place a microcatheter through the straps of the device because of the high metal ratio, the prediction that the device, these devices will take over 25% of the aneurysm market have not materialized at all really isn't it the greatest shame that wild fanatics have abundant Z, the Y's completely lacking. That is a very true statement by Voltaire. I clearly do not have time to discuss clipping bypass, Ontarian sacrifice, which are alternatives. We certainly all, every one of us does have suffered from the hammer and nail syndrome. And we do tend to be wedded to the procedures that we do best. Finally, my verdict is that this is very exciting technology, but it is still in its infancy. Even today in 2013 mechanism of action is double edge sword. Success may be short-lived, but you also may have spectacular successes. As you have seen from the previous presentation. It does not solve the problems that cannot be dealt with with open surgery, such as vertebrobasilar dolichoectasia, aneurysms, the complications are way under reported. You take each one of those things. They are generally from single center under reported. You remember you have lifelong dependence on Plavix and aspirin. Failure with the use of the device compounds the problem. If you have to operate on those patients, the complication rates will go up. You'll shut down on options of temporary tapping with the aneurysm clips and so forth. This is definitely not in the category of minimally invasive. Unlike Joscque, I do feel that they should be used in about 5% of aneurysms today. And I do think these categories are definitely excellent candidates. Notice none of them are small paraclinoid, large paraclinoid, I'm perfectly fine with particularly fusiform as long as they're not really thrombosed. These are the patients who are on label and who should do best. Shall we reach consensus today? I'm not sure. I actually, Josecque and I are excellent friends. And because we always end up despising, those who agree with us too easily. So I really do not want him to agree with me too easily. And I hope I have not spoken too long and become an example of what Montesquieu wrote here. Thank you again very much for listening to us this evening.
- So Giuseppe and Jacques, I really appreciate your very thoughtful comments. Let's go ahead and do three cases relatively controversial and bring up nuances in terms of decision-making using microsurgical clip ligation versus endovascular flow diversion. The first case that Giuseppe, or one of the cases that Giuseppe discussed is a good one to start. A 37 year old female with this aneurysm, which is lot ruptured. And here is the angiogram demonstrated this internal carotid bifurcation aneurysm temporizing effect using coiling seems to be effective. And the patient is brought back and underwent pipeline placement with a relatively, with a very good result. Jacque, if I may ask you first, would you have used flow diversion here? Would you have used microsurgical clip ligation?
- No, I would not have used flow diversion. Of course you can never argue with the success, but with the retro scope, but, you know, I wish we knew that aneurysm re bleeds from their dome all the time. Clearly large aneurysm can re bleed from their necks. So as you show the angiogram recanalization at the base, patient could have re bled from that recanalized neck and we wouldn't be showing it as a success. So I'm not sure that that strategy is wise in general and exceptional case maybe, but I would not do that in general terms.
- You know, you can't argue with success, the catch here is that I do microsurgical obligation only as well. And maybe everything looks a nail to me because I own a hammer, but no one can argue that this is gonna be relatively risky operation in a left dominant hemisphere. So if the patient does well with endovascular techniques, he or she really has, you know, they want a jackpot. Giuseppe, do you want to comment on that?
- No, I think that actually this is one of the places where flow diversion has been very helpful in a situation like this, where we have patients with a very large or giant ruptured ICN haemorrage, I think they're temporizing with the partial coiling. And as soon as this patient is stabilized, the next three, four, six weeks go with the floor diversion has been a very helpful strategy with patients like this that eventually recovered with no evidence of any cognitive deficits whatsoever. So I think it is a very valid strategy, which is quite against our more traditional thinking that this would not have been an endovascular annulus.
- Jacques, what would you risk? What'd you say, estimate the risk of clip ligation of this aneurysm. Remember there are perforators attached, as we all know, medial to this aneurysm wall, it is very large and no matter how careful you are, you're not gonna be able to see the entire medial wall of this aneurysm when you place the clip.
- It's true, but if I remember correctly, when Giuseppe presents the case, this patient only had a headache, or he's in good shape. It's not a massive subarachnoid hemorrhage. There is some blood I think in the superficial cell side and maybe in the Sylvian fissure. So, you know, with the suction decompression or even adenosine arrests, this aneurysm is pointing straight up. Certainly if the neck is not calcified, I probably would quote the patient between five and 10% chance of a problem, but then it's a permanent cure. So that would be my approach to this.
- Okay, I think in my hands, the risk would be higher. I would code the patient about 10 to maybe 15%, but that's my impression. And I also have my doubts, if flow diversion is a permanent solution in a 37 year old woman, at this time, I would say most likely not and only time will tell. let's talk about another case, a 42 year old female with a six millimeter incidentally found unruptured of phallic organ aneurysm, Giuseppe, what would be your recommendation, observation flow diversion or clip ligation?
- I think a young patient with the six millimeter would most likely recommend the treatment. Our approach would be if the analysts can be treated with coiling only, I would prefer endovascular coiling, 15 aneurysm requires more complex endovascular technique then decide between a surgery versus a flow diversion.
- There's no question in my mind that unless there is, there are morphological reasons in this aneurysm that would make surgery significantly a complex that in a young patient who I don't want to be on Plavix and aspirin, the rest of her life, that I would clip it. If the neck has a morphology that can be clipped. Small aneurysms do very well. Where we get into trouble is in large aneurysms and we, yes, visual loss, visual vascular injuries to the optic apparatus during open surgery, large, giant aneurysm, very off dynamic region. Yes is an issue. Not particularly with the small ones. So I would not hesitate recommending open surgery or maybe observation. It's six millimeter it's so near the so-called seven millimeter threshold, is something I'll discussed with the patient.
- Let me ask you joke. How about if this aneurysm is clipable with a stent and you don't need to be on Plavix and aspirin, the rest of your life?
- Young patient, I think we'll do better with the permanent clip. If it's a "easy surgical aneurysm" I feel strongly about that.
- I think there is a point that needs to be made is that nowadays we don't think when we think about complications, we are not thinking all about blindness or any plegia, but we're also thinking about persistent headaches that some of these patients are left with. So I think minimally invasive approaches definitely I've done dangerous in many of these situations, especially when we deal. I think patients, many patients we've done ruptured incident anulus that we treat nowadays, we found the annulus for specific reasons. These are often patients that tend to have depression. They're very careful about relatively minor symptoms. So they tend to, they might be predisposed to what I would consider a less than ideal outcome after surgery, not because of major complications, but because of psychological and relatively minor issues like postal, persistent headaches.
- But Giuseppe you'd agree with me that really, we call it minimally invasive, but it really isn't. It's probably should be called minimal access surgery and is as invasive as open surgeries. I mean, you know, invasiveness, as you well know, is proportionate to the potential number of complications that can exist, whether we do it with a catheter or with a clip device. So, you know, I don't like that labeling as you know, regarding that.
- You know, Jacques, as much as I agree with you, I have to say that the market and the patients are gonna drive this. And no matter how we want to argue against the durability of coils and stents, the market will drive this and the patients and the consumers are going to demand a minimize access approach. Unless stenting and coiling are flow diversion that somehow in a long run, who's a significant inferiority to clip ligation on portray the market is going to drive us to consider a minimum access approach. That doesn't mean it's the right thing to do. It just means that it will happen. Let's talk about the next case. And that's a young patient, let's say 40 year old female with a blister dorsal carotid aneurysm who is in a very good shape. Would you do coiling and flow diversion? Would you do only flow diversion? Let's discuss if there is subretinal hemorrhage versus if it is incidental, which is relatively rare. Jacques, would you start first please?
- Yeah, Well, if it's incidental then as you said, I'm not sure I would call it a blister per se, but they are rare indeed. And I don't have, I won't hesitate too much in recommending open surgery for those now the ruptured blister, you will find publications and I didn't have time to expand it in my talk favoring, either favoring, both. However, one of the most recent ones suggested as is intuitive, that there is much higher incidents of re-growth and re-treatment, if you did it endovascularly. And it's certainly not simple as Giuseppe episode, to me knows dual anti-platelets in the presence of a blister depositing, the pipeline there, and often there isn't enough volume to put coils if you try to put corals the whole thing disintegrates. So I still would favor the clip wrapping technique in general. Yes, it is challenging with the perforators on the backside and having to fashion the sling in a way that would allow perforators and branches to go through. But that is probably the best long term plan.
- Go ahead Gossiper, please.
- I think that's a very difficult situation where my decision making, unfortunately probably will be influenced by my last case. And today my treatment of choice would be surgery. And of course it will depend a little bit on the morphology of the blister itself, while a lot of big ideas and also in relation to the picalm. But I think that what we have had good experiences with the sun clique graft that you are approximately to pick up quite often, you're able to place it and deal with this, but I agree It's a very difficult problem. We tend to use the latest technology that we have because often we are desperate and we don't have great solutions. And I don't think it's a coincidence that Jacques and I, when we illustrate that some of the complications of flow diversion, we used actually cases of glisten like aneurysms.
- Yeah, I agree. I think these aneurysms are challenging cases. No matter how you approach it, probably approaching the problem we never know what's the right thing to do. At least personally, I have given a chance to our endovascular colleagues to give it a shot first, just because there can be daunting cases. And usually they are pseudo aneurysms, there is no wall. If it fails, we just go ahead and right away into a high flow bypass and feel that that segment of the vessel is diseased and has to be tracked. I want to thank both of you guys for a very, very worthwhile discussion and wish all our viewers, a happy holiday season Giuseppe and Jacques, thanks again.
- Thank you.
- Thank you.
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