- [Physician] Nothing to disclose. Use of EVAR in patients with large aortic neck, in my presentation today, defined as above 31, is very controversial. However, a good number of patients undergoing EVAR for large aortic neck diameter in United States. We conducted a study to analyze short and long term outcome
in patient with a small aortic neck diameter, defined as below 28, and then some people consider large neck above 28, so we looked at both above 28 and above 31. There's a prospective collected data of 688 out of 741 EVAR done over roughly a decade.
Patient divided according to aortic neck, below 28, 28-31, and above 31. 592 were equal or below 28, 63 in the gray zone, 28-31, and 33 were purely above 31. Other aortic neck feature were recorded
and we previously recorded that and published it previously. Early and late outcome were analyzed using logistic regression analysis and Kaplan-Meier analysis. The devices used, if you notice, was a little more skewed toward Gore Excluder, 416, 115 Cook, 74 AneuRx, 33 Talent,
14 Endurant, 28 Powerlink, and so forth. If you look to the demographic and clinical characteristics otherwise, nothing except what you see in red, the mean age for above 31 were older, and also, for above 31, almost 94% have one aortic neck feature
which was outside the IFU. Perioperative complications and variable were not significant between any group. As you notice here, fluoroscopy, blood loss, transfusion, contrast used, length of stay was literally equivalent. Same thing with perioperative complication,
there was no significant difference when it come to perioperative complications. Now when we start comparing above 31, which, to me, is the most critical issue, above 31 versus equal or below 31, the early type I endoleak
three to one in favor of the below 31. The P value was not significant, it's feasible, the sample. However, still, you talk about almost three to one. Early intervention, 15 versus 9%. Late type I endoleak, 13.8 versus 3% with significant P value.
Similar significant rate was noticed in sac expansion, late intervention, and also survival. We'll look to logistic regression analysis and look into the above 31, look at the bottom one where the two groups, above 31 versus below 31,
the mortality odds ratio, five times more, sac expansion, four times more, late intervention, 5.3 more, and late type I endoleak 5.2. Somewhat, there was tendency for above 28 versus below 28, but definitely above 31 was impressively
significantly different. Even looking to multi-regression analysis, show the same significance of the outcome as noted here. Freedom from late type I endoleak, as noted here, at three years, 97% versus 88%, P value inching, but I presume it's only three years.
Looking for sac expansion, significant P value, 92% versus 81%, late intervention, 96 versus 91. However to me, that was misleading, since quite many of above 31 do not want anything done or they died during the follow-up.
Survival analysis was significantly, 90% versus 68%, at three years. One study I found which is comparable of ours, but looking to above 28 versus below 28, and using only one Talent device, so really it's not exactly the same,
but above 28 was associated for higher major adverse event rate, higher migration, lower freedom from all-cause mortality, and aneurysm-related death. In summary, I'm going to give you the question which Frank Veith want to be answered.
In our personal recommendation, after this observation over the past couple of years, my recommendation good surgical risk open repair or a fenestrated graft if you have, and we start doing this just in last three, four years, which mean available expertise on longevity
if you want to do fenestrated, but we still prefer open repair. High surgical risk, FEVAR or chimney, standard EVAR may be considered if the longevity was not very high. Thank you very much, Mr. Chairman.
- I'm going to give you an update on where we are with the Gore Retrograde Single Branched Endovascular devices. These are my disclosures. There are a number of things to consider when this device was first envisioned and it goes back to the question of
left subclavian artery coverage in TEVAR. As we know about 40% of TEVAR procedures result in coverage of the LSA to either zone two or more proximal. And this obviously can be for different reasons, most of the time it's to enable
a longer and straighter landing zone in the arch and potentially to mitigate against bird-beaking. So the current options we're all familiar with, LSA coverage without revascularization and the various ways to ensure that the
left subclavian artery is revascularized and now of course Chimney snorkel and Branch and Fenestration although less common than the open surgical approaches are beginning to come into favor, but there is limited available supporting data.
In terms of the risk of left subclavian artery without revascularization. We're familiar with those from posterior strokes, spinal cord ischemia, left arm ischemia type type II endoleak
and the risk of surgical LSA revascularization as you're familiar with from open surgical approaches. So it's really a balancing act between surgical and no revascularization. Obviously there's a range of treatment strategies for doing revascularization every patient,
to an every elective patient, to selective revascularization, or when only when anatomically indicated, and we're familiar with those. Rather absolute indications. And as again we balance out the potential risk as well.
Obviously a single side branch device can take up the challenge of this, by again addressing the left subclavian artery and eliminating the risk of any phrenic nerve injury. Again, it enables profusion and it reduces the surgical risk of an open procedure.
Some of the things that we've learned to mitigate against risk from single side branch involve, obviously, snaring the through and through wire in the descending thoracic aorta, staying out of the arch for any manipulations. I think that one thing about this particular device
that is beneficial, although possibly not unique, is that there is the side branch portal allows for flexible device positioning as you can see in this particular patient. Actually the lateral tortuosity in the arch is actually of a greater or shorter radius of curvature
that you can actually see in our normal looking at it rotational. And that again you can afford that some ability to have flexibility in terms of device positioning to still allow a seal and getting good patency. Another thing we've learned, of course,
to mitigate against the risk of embolization, perhaps through air, is back bleeding through this particular device. So this is now a prescribed technique of putting the device partially into the sheath and allow back bleeding
in an attempt to try and mitigate against any air gasping introduced. And this again is an effort to try and flush the delivery system. In terms of stroke impact, again we know again,
this is just one example from the literature left clavian artery covered with revascularization has a higher stroke rate than coverage with revascularization, and from the MOTHER Registry we know that whether it's done as a stage procedure,
not which it was done in 60% of cases. Of all cases it was done about 30%. That the stroke rate was lower with revascularization as opposed to no revascularization. And again, the single side branch allows that to happen and in the initial experience,
the stroke rate in zone two was 3.2%. Again, this is just an example of using an access from in the through and through wire, having a five French access in the arm certainly is less invasive. Here you can see ballooning of the entire side branch,
again to ensure patency throughout, in terms of the initial pivotal trial there was only one case that had a loss of side branch patency this was between one and six months the patient was at a patent side branch at one month
and was occluded although not clinically symptomatic on a CT at six months. And you can see that represents a 96.8% patency. So in conclusion, selective revascularization, whoops. There we go.
Is the standard of care in TEVAR patients to date. Some evidence shows that supports that revascularization may result in lower stroke and spinal cord ischemia rates but not statistically significant surgical procedure for revascularization carries risk and next generation TEVAR devices
intend to able LSA perfusion while reducing surgical risk. The feasibility arm of the GORE TAG device showed associated surgical revascularization without significant risk or complication. Thanks very much.
- Dear chairman, dear colleagues and friends, it's my pleasure to be again with you. Nothing to declare. In our experience of CCSVI and angioplasty we have more than 1,300 patients with different neurological disorders. Not only MS, but also migraine,
lateral amyotrophic sclerosis, Parkinson's disease, left sided amaurosis. We published our data with an emphasis on the safety of the procedure. We had virtually zero percent of serious complication. What about the clinical improvement?
In fact, we noticed function improvement in more than 62.5% of these patients. And in fact, the group of Pierfrancesco Veroux showed similar between 50 and 60% of the patients restoring the normal blood venous flow. In fact, in their work was shown that the type
of anatomic disturbance, anatomic feature is very important predictor if the flow will be restored by the simple PTA. And the most important into the brave dream trial was also that, in fact, the restoration of the flow was achieved in around 70% of the patients.
And exactly in these 70% of the patients with restored flow like Paulo emphasized already, there were lesion, 91% of them were lesion-free on the MRI, and 77% of them were lesion-free on the six-month. We performed a substudy regarding the hypercapnia
and hypoxaemia of the jugular veins in the CCSVI-positive patients. And what we have described in this 178 patients with CCSVI and 50 healthy control group. In fact, we established that the patients CCSVI-positive the venous sample by the jugular veins was typical
with hypercapnia and hypoxaemia in desaturation, huge desaturation with improvement after the balloon angioplasty in all three parameters. What was the reason for that? In fact, in nine patients of our group we examined, the perfusion, the nuclear perfusion of the brain
before and after the treatment. I'm here presenting non-positive for MS young patient without MRI demyelization. And but on the brain perfusion he had deep hyperperfusion on the left side, and the patient was complaining with deep fatigue.
And we saw practically full occlusion of the enominate vein. And after the recanalization using first coronary and after it peripheral balloons, and in this particular case we had to stent finally. And you see still persistence of a huge crossover collateral even after ballooning.
But after stenting we saw practically full restoration of the flow. You see in less than three to four seconds it was very interesting to see on the perfusion imaging, nuclear perfusion, full restoration of the flow of this gentleman.
So this is very important to emphasize that there is direct relationship between the blood gas disturbances on the brain level, and demyelinization process. What about the PTA? It's probably not the optimal treatment.
We have to establish reliable clinical and anatomical predictors for vascular and clinical success in order to answer the important questions: who will be vascular responders, or MRI responders, and finally the clinical responders in this group of patients?
And concluding, ladies and gentlemen, the CCSVI is a real vascular pathologic entity and is probably a trigger for more than one neurologic degenerative disorder. Endovascular treatment, balloon, PTA, and stenting of CCSVI is feasible and safe.
Methods and strategies improving the early and late patency rate have to be elaborated because the good clinical result is strongly dependent on the vascular patency and flow restoration. And thank you very much for your attention.
- [Michael] I have no disclosures. President Trump has said on many occasions, the best way to prevent leaks is to build a big wall. Well the corollary would be is the best way to prevent type one endoleaks is probably to build a big graft. So EVAR has become the preferred treatment method for aneurysmal repair, indications for use have expanded.
We've had progressive improvements with fixation, technology, delivery systems, and physician experience. But despite this, arguments exist for and against EVAR, in unfavorable anatomy as you've already heard. Endograft advancements that are pertinent today include the development of large diameter devices.
We have two 36 millimeter devices and a 35 millimeter device available in the US. Since obtaining approval, large devices have increasingly been used to treat hostile necks, not just large necks. Schanzer pointed out previously that 35% of patients undergoing EVAR have adverse anatomic neck characteristics.
Short necks, broad necks, angulations and irregularities. And thus, skepticism exists about the use of large or oversized devices placed in hostile necks. I think a critically important factor is not just the size, but the morphology of the neck itself. Without question we like to see
parallel necks on all of our EVARs. Unfortunately there are many cases for which we have a flared or barrel neck. In turn very likely adverse events are associated with this, because we're probably dealing with degeneration of the native aortic wall.
Ample evidence exists linking hostile necks to unfavorable EVAR outcomes. However, increased experience, improved technology, development of adjunctive devices, have changed some of these results. 2006, the FDA approved the Cook Zenith 36 millimeter device.
Data pulled from the Australian clinical study and also in the Cleveland Clinic. 41 implants, 12 month followup. The results were comparable to the smaller size endografts. Well let's jump forward, here we have data pulled from three high volume centers in the Netherlands, 2008, 2012.
Comparison of small necks versus large necks, greater than 30 millimeters in size. Endpoints, freedom from neck-related adverse events with Endurant, not Cook. Median follow-up 4.1 and 3.1 years respectively, and look at the neck range, 31 to 34 millimeters in size.
So this is one of the first studies to look at neck diameters beyond that 31 diameter range. Four year freedom from survival, 75% versus 95%. So a big difference comparing the small to the large, and multivariate regression analysis showing larger necks were independent risk factors
or adverse events down the line. Within that study, 26 patients had endograft oversizing of less than 10%. And when you look at the details, with univariate and multivariate analysis, you can clearly see, proximal neck-related adverse events,
endoleaks, and need for re-intervention were significantly higher than those individuals with a larger proximal neck. So a second study pulled data, three high volume European centers, 1300 EVARS, 118 patients were included in this sub-cohort
looking at large EVAR necks, greater than 20 millimeters. And what's interesting about this, they went big. The mean neck diameter, 29.7 with a range of 20 to 36, and 20% of the patients were treated outside of the IFU. Endpoint was the same, follow-up 37.9 months. And what did they learn, well they learned the following:
Type one endoleaks occurred frequently, 12%. Need for re-intervention, 7%. Aneurysm related mortality, 3%. And survival there's a significant drop-off. And this is all presumed to the fact that, quite likely, aortic wall degeneration and disease progression
occurred in these large EVARs. When you break down the data analysis of the 14 type one endoleaks, I'll take you to the last column. You'll see that eight out of the 14 patients had endograft oversizing of less than 10%.
So here's the question. Can large neck aneurysms greater than 35 millimeters be effectively and durably treated by EVAR, probably not. My tip for you, I'd avoid treating 35 millimeter necks with standard EVAR. My suggestion, as you heard previously,
I think FEVAR or branch devices are more appropriate. chEVAR if needed, or conventional open repair. Now if you do find yourself in that emergent situation, treating a large neck, these are my suggestions. Hope you have a long parallel infrarenal neck. Maximize your landing zone,
possibly encroach upon your renals. Make sure that you've got a normal pararenal aorta, utilizing a large 36 millimeter endograft, a suprarenal fixation, and complementing that quite likely, with endoanchors to juxtapose the endograft to the aortic wall.
There's a variety of adjunctive techniques that we can implement. Certainly the PERICLES registry has given us a lot of information, showing it's a valid off the shelf technique, immediately available and an appropriate alternative for complex EVAR.
And the ANCHOR registry as you've heard quite a bit about as well. Anchors are effective adjunct as prophylaxis against proximal neck complications. The last option, should you run into the situation with neither of those are available,
an EVAR with an external wrap is not unreasonable. So in conclusion, large necks represent advancing stage of aortic wall degeneration. Early follow-up suggests it's positive, but mid-term follow-up opposes the use of EVAR in large diameter necks.
And consider using standard EVAR to treat large necks only in an urgent or high risk surgical situation. Thank you.
- [Fabrizio Fanell] This is my disclosures. So I will a will show you a case where we did for the first time a kissing lithoplasty in case of a heavy calcified lesion in the common iliac. This was a male patient, 71 years old with hypertension, heavy smoker,
more than 30 cigarettes per day in the last 20 years, with hypercholesterolemia. And he came to us with a he underwent, a couple of one year before a stenting on the left common iliac artery. And the patient came back to our hospital with a bilateral buttock claudication
and also with some pain in the left leg. He underwent an ultrasound evaluation, and the report was of a severe stenosis or occlusion of the severe stenosis of both common iliac artery and occlusion of the distal portion of the left SFA. And also the
over chest report of the presence of calcium everywhere. So we did an OLA CT angio, this was the scan of the through the section you can see the huge amount of calcium at all into the abdominal aorta
but also in the iliacs and in the peripheral. Some excel images just to show you the circumferential distribution of the calcium into the lower portion of the abdominal aorta as well as in the iliac bifurcation and also in the distal portion of the common iliac artery.
They saw the images in the SFA, you can see that calcium is more less everywhere especially in the left side with this also in occlusion portion of the SFA. There are some plane image that we are acquired in the cath lab, you can see the huge amount of calcium and
also we have about wait I was the SFA, there was the circumferential distribution, you can see that I apologize for the not a better get quality of the image of the strength previously implanted, this was Smart 8*40 mm that was done in an other hospital.
So in the opinion with there the in ensure that confirm the severe stenosis on the left of radiology of left of common iliac artery. There was so another severe stenosis on the right side. We did the contralateral access where there the initially recanalization of the Lt SFA
and we start to think about how to manage the lesion, here the in the SFA and common iliac and what came to our mind was the use of the lithoplasty that you know is a this technology that seems to be very helpful in case of severe calcified lesions especially in combination with that of balloons,
because scan is not going to bark the lesion but can create some farction in plaque so we can have a better tar take and the tar can navigate so the calcium going to the smooth muscle cells. In times of a technique
video bilateral retrograde CFA access, you know using a 6Fr bladed introducer and then away put into the cut the 7mm balloon cut this from Shockwave Medical 7mm in the meter. Those are the plane images because at the beginning we were thinking how we can deploy
out where to put the cath access. Also because on the left side, there was the strength of leading place and we were not a thinking about the we don't need to do a lithoplasty, we did a stent because of to see no sense to perform this dilatation in area without calcium.
So put two devices, you can see that major to the vast swelling was to the abdominal aorta just to not to go far away into the common iliacs and we start doing inflate the first ballon on the left side, this was the first 7mm balloon and the technical problem
that we face at that point that we were not a this technique was not in our mind. So we were not able to do a contemporary dilatation of both ballon so we started to inflate the balloon to the beginning of 4 atm and we did the
initial activity of the system on the left side 60 pulses you know and then are increase the size up to 6mm. After the first inflation on the left side we did same on the right side and you can see the word like PTCB over the system stenosis on the right side. There was not able to be solve also one
we inflate the balloon up to 6 atm. So that point we move little bit the balloon to put deletion in just in the center of the device and we need the 4 inflations on right side, 4 treatments on the right side and just 3 treatments on the left side.
There was the final you know image that we acquire after the lithoplasty and the final treatment was done using the DCB-In.Pact Admiral, 8mm in meter * 40, you can see as no more waste on the right side one we inflate both balloon up to 8 atm. Obviously as a traditional we feel
DCB inflator for 3 mins just to increase the mechanical effect and then we did the final angio and this was pretty go in our opinion especially because we do not upset any dissection that obviously something that can create the program especially at the level of our team bifurcation.
At this definitely was after sure will lead to the use of the lithoplasty system. So the final evaluation was that the we observe a 15% of the severe stenosis, this obviously was something that we can see you know that can call success.
No dissection on both sides, ABI increase immediately you now up to 0.85. And we put patient on to double anti-platelet therapy for a month and then we have a 6 months follow up with ultrasound doppler show that patency of both vessels, you can see the ABI settle a little bit lower
on the right side and pretty go on the left side. So in conclusion we know a believe that lithoplasty can be use in the common iliac area, not only in case of single lesion but also in petition of patient candidate for even where we can have a some difficulties
in terms of heavy calcified lesions in the iliac fem region. Thank you for your attention!
- [Instructor] So, I have nothing to disclose. You know that peripheral-visceral aneurysms are relatively uncommon disease sometimes asymptomatic, symptomatic most of the time, it's an atheromatous disease. To treat peripheral-visceral aneurysms, you can propose surgery but you know that it is high risk morbidity/mortality
between four and 25% and you have now endovascular procedures, classical procedures with covered stents, stent grafts, bare stents and coils but all these techniques have a number of limitations, disadvantages, drawback, complication. So, we know these complications and as a reason,
we use now the multilayer flow modulator. You know this stent and for peripheral procedure, you have stenting diameter from five to 16 mm, length, 15 to 150 mm and different approach ways: femoral retrograde, femoral antegrade, contralateral, brachial and up to now,
more than 3500 MFM have been implanted worldwide. So, what is MFM Action? You have the problem of force on the wall. When MFM is implanted, one of its main effects is to reduce the force applied by arterial flow on the wall which cause the aneurysm growing.
And you can see that after MFM implantation, the force is almost zero and MFM removes the risk of expansion and rupture. And you have also the arterial flow action on arterial flow velocity and the sudden and key action on MFM is on the flow.
The MFM act reversing the degrading flow with vortex, you see its vortex here, to a physiological laminar flow aligned to the wall. This lead to gradual organized thrombus formation with lines of Zahn, and you have total thrombosis over time. So we have a personal series of 47 patients
and we treated different aneurysms in iliac, femoral, popliteal, renal, mesenteric, caeliac, carotid, subclavian and most of the time approach ways was femoral and once, right brachial artery. This patient was treated for celiac, huge celiac aneurysm and you can see, the force on the wall,
the reduction of the force applied by the flow on the wall is clearly confirmed via numerical simulation and you can see this simulation and the regulation of the force on the wall. And for the velocity.
Un-physiological reversed flow with recirculation regions in the aneurysm sac before the implantation on the left is instantly converted into a laminar flow. And you see the laminar flow leading with time to organized thrombus and you see this laminar flow here.
So we see very well. So you see after implantation of the stent force mounts later, the stent is totally well patent and this aneurysm is almost totally thrombosed if the stent is well patent.
We treated 23 iliac aneurysm. First case is seven years ago. A patient who had also a dissection we treated at the same setting. And you can see after implantation three weeks later, it's almost totally thrombosed and four years later,
we have a very good result for dissection and aneurysm. We treated also iliac aneurysm involving iliac internal artery and you can then replace a stent in front of this internal iliac artery and two years later, this artery is patent.
We treated also popliteal aneurysm, renal aneurysm, nine cases. The first case, I did nine, 10 years ago is a renal aneurysm, huge. We implanted a stent here and you can see the stent is well patent and the branches also with good result.
But unfortunately this patient died from cancer and you had a necropsy which confirmed the patency of the stent and the shrinking of the stent and renal aneurysm well treated with shrinkage and total thrombosis of this aneurysm. Also, we can treat supra aortic vessels
like this subclavian aneurysm and the carotid aneurysm also. So, we did meta analysis with our result and with literature data with 128 aneurysms and you can see that overall survival is 95%. We had complete aneurysm exclusion in 94% with significant shrinkage in 83% of the cases.
And in the follow-up, we observe a progressive thrombosis and shrinkage of this aneurysm which exclusion with MFM may take several weeks or months but the aneurysm wall is no longer subjected to local peak wall shear stress, thus preventing against rupture.
So to conclude, MFM represents an alternative to current device. Local pressure, aneurysm wallstress are immediately relieved once MFM is in place, which protects against a rupture. We preserve the collateral. We have a progressive sac thrombosis
and shrinkage depending on the importance of collateral, initial aneurysm size. Reduced diameter is a safe procedure with low complication and no 30 day mortality. Hard endpoints, severe guidelines must be respected to have good results.
MFM is a breakthrough. A hope, not a hoax. Thank you for your attention.
- [Presenter] I have nothing to disclose. The incidence of limb thrombosis after EVAR is reported with a percentage between three and 7% of cases. A narrow distal aorta is a well-recognized risk factor for this complication, especially if calcified, with possible limb kink and compression at the level of the bifurcation at subsequent thrombosis.
Historically, aorto-uniiliac reconstruction has been proposed as the treatment of choice to address this problem. Nevertheless, it should be, it is a more invasive approach and today should be considered the last-resort option. The unibody design stent graph
is an appealing concept in this scenario. We have a single-lumen main body stent graft with no iliac limbs at the level of the aortic bifurcation and a reported low rate of reintervention in the followup. Last but not least, a possible solution to address the problem of a small distal aorta
is to implant a standard modular stent graft and reinforce the radial strength of the stent graft limbs at the level of the bifurcation, implanting two high radial force kissing stents. And several papers have been published that confirm the effectiveness of an aggressive policy
of primary stenting to prevent limb complications in the presence of a small distal aorta. We reviewed our experience with endoluminal repair of triple As in the last four years, with 343 patients treated since January 2014. We approved five cases of reintervention
for limb complications that were all fixed by the secondary procedure. Considering only the anatomies with a real small distal aorta, we identified 17 patients with an aortic bifurcation equal or less than 16 millimeter in diameter.
Among these patients, seven were treated with a unibody bifurcated stent graft, and 10 received the modular stent graft with the adjunctive primary stenting. - Just repeat. - One out of seven patients in the unibody stent graft group was reoperated
two years after the first intervention and required the relining with kissing stents. In contrast, none of the patients who were treated with the modular stent graft with adjunctive primary stenting was reoperated, and all limbs are patent at mean followup of 14 months.
I'm going to show you some images from our experience. Here we have a male patient with an aneurysm of the distal portion of the aorta and then a real narrow aortic bifurcation. This patient was treated with a unibody Endologix AFX device with ballooning of the aortic bifurcation.
Had a nice final result that is maintained 30 months after the procedure at CT scan followup. This is the case that was reoperated in the unibody stent graft group. She was a lady with a large aortic aneurysm
and highly calcified aortic bifurcation. Her first treatment was the implant of an Endologix AFX device, but the patient was readmitted two years later for symptoms of the left side due to compression of the left main body prosthesis
at the level of the bifurcation. And the problems were fixed, implanting two kissing stent with a good final result. This is another case of triple A with a small distal aorta. In this patient, we used the standard modular stent graft.
At the end of the procedure, we implanted two kissing stents to reinforce the radial strength of the stent graft at aortic bifurcation, and you see that the post-operative CT scan confirms the good expansion of the stent graft limbs. This is the last case I'm going to show you,
a patient with a sacral aortic aneurysm along distal aortic neck and an aneurysm of both common iliac arteries. This patient was treated with a GORE EXCLUDER Device with adjunctive iliac branch device on both sides to preserve the epigastric arteries.
At in the end of the procedure, we implanted two kissing stent to reinforce the stent graft limbs. - [Man] It's back. (faint speaking) - Not to worry. - [Man] Yeah, there's nobody else.
- [Presenter] Okay. (faint speaking) (laughing) And this was the case I was showing to you. The patient with aneurysm of the abdominal aorta, both common iliac arteries,
the implant of a modular GORE EXCLUDER Device with iliac branch on both sides, and then the end of the procedure reinforce the strength of the iliac limbs implanting two kissing stents. And you see the nice final result
that is confirmed at the post-operative CT scan. In conclusion, ladies and gentlemen, a narrow distal aorta carries a high risk of limb complications after EVAR. The unibody design stent graft may be a good option in this anatomical setting.
Nevertheless, according to our experience, in the presence of a real small aorta, implant of a standard modular stent graft with adjunctive primary stenting is the most rational and effective approach. I thank you very much for your attention.
- Dear colleagues and friends, it's my privilege to present our data. On the same way, very exciting like you have seen up to now regarding this new technology. Aortic dissection, independently of way of treatment, surgical or hybrid, or any endovascular too, the mortality rate, the procedure mortality rate
is quite high. Mainly in the cases of malperfusion syndrome. The malperfusion syndrome is worsening significantly the results and because of that, in these cases of aortic dissection treatment, we need secondary procedures in more than 30% of the cases.
The guidelines say that endovascular option for secondary procedure is the preferred one. I will show a case illustrating this worse scenario. It's 15 years ago. 54 year male with type A aortic dissection. Quite a complex case.
He was operated on immediately, but unfortunately the clinical course was extremely bad. He was dying with the sign of malperfusion syndrome with extremely compressed true lumen and very impaired flow into the branches. In this case, we intuitively implanted two Wallstents,
one after the other. And the patient fortunately survived and he had a fantastic centralization of flow into the true lumen and restoration of the flow into the branches. He dropped off of the followup,
but 10 years later we called him for a CT scan and it was very nice to see that the false lumen totally disappeared, the centralization flow into the true lumen is excellent, and the branches flow, it's absolutely normal. Let's jump into the future.
Similar scenario. Two years ago a 71 year old gentleman, he was operated again for type A dissection. Unfortunately he had a huge compression that was in fact evolving during the time. Huge compression of the true lumen, expanding false lumen,
these are very bad predictors for the mortality. And because of that, we had already on the shelf the MFM technology allowing perfusion of the side branches. We decided in this case to implant MFM already. And it was successful. It was truly very compressed true lumen
and we had to post-dilate it with a ballon, even the MFM. But the final result was excellent with centralization flow into the true lumen, and restored side branches flow. Both six and one year and two year followup is excellent with very good centralization in all branches,
as you can see, completely patent. We published our results in the book of Professor Palombo. What is remarkable? It's very important to emphasize that not only the clinical, the primary success is 100%, but it's done practically by a totally endovascular approach
with 0% of ICU stay and 90% without general anesthesia. Regarding the late results, the aorta related to that is 0% and the patency rate of more than 120 branches covered is more than 90%. We had only three patients with a secondary procedure because of ischemic problem.
So it's another gentleman treated for type B dissection in the past with aneurysm formation. We overlap with the MFM device with excellent result. This is the gentleman that had in fact both aneurysm and dissection at the same time. For me, this is the same disease.
So the patient was included into the streamlined trial with very good result, but 20 days after, he's hunter, very active hunter, so during the hunting he had dissection on the proximal part and we did something like a reverse PETTICOAT,
implanted a stent graft within the MFM with excellent result more than one year after the procedure. This is a very young, 48, male patient in a critical condition with extreme true lumen compression. And we implanted in the middle of the night,
we didn't have enough time, he was in a critical condition. We implanted in this type A, critically ill patient, MFM starting from the coronary arteries with excellent patency, not only of the coronaries but also the brachiocephalic vessels and all the visceral vessels down there. So as a conclusion I will say
that the treatment of complex thoracoabdominal aortic pathology is a real challenge because of the high natural mortality and morbidity. The implantation of MFM in the treatment of complex aortic pathology is effective and safe. This treatment allows preservation of blood flow
into the branches arising from the stented area. The early and mid-term followup results are promising. We need more systematic procedural and clinical data in order to establish the exact indications of this novel technology. And thank you very much for your attention.
- [Presenter] Thank you very much, Mr. Chairman, and thank you to Frank for the kind invitation, and I'm going to be talking about the Nexus Single Arch Branch Endograft System for treating the aortic arch lesions. These are my disclosures. So we've all heard in this session,
and then in the one before, that treating lesions in zone two and zone one is particularly challenging when you're going to land in zone zero. And it doesn't matter whether you fix these things open, whether you do arch debranching,
or one of the specially designed grafts. There's a risk of stroke, paraplegia, and death, which is what we've heard. None of these grafts are approved, either in Canada or the United States. But let me introduce you
to the Nexus Single Branch Arch Graft. Here it is, a modular design, it's made of Nitinol, it's 20 French, there's a single branch here for the innominate, an opening for the arch module, and then this part, which goes into the
mid-arch and the descending thoracic aorta. You can see the ascending module, which fits in and locks on this tantalum ring, and is placed in the ascending aorta. Obviously this is done with rapid ventricular pacing. This system minimizes brain and limb ischemia.
There's very much reduced arch manipulation because you're not cannulating branches. But it does require arch debranching with a carotid-carotid and a carotid-subclavian bypass. This device is pulled up on a through-and-through wire from the brachial artery, which I'm going to show you.
This system has been used in 28 patients. First in man study, in 11 patients, and a compassionate use in 17, which is where our cases fit in in Toronto, and these are the people who've implanted them. This is an example of one of our initial cases,
two saccular aneurysms, one in the descending thoracic aorta, which was fixed initially, and then we came and fixed the arch aneurysm using the Nexus system. You can see that with a through-and-through wire through the brachial down to the femoral,
we've placed the device. We do an angiogram to mark the carotid and subclavian bifurcation, and then the device is beginning to be deployed here. Once you get the initial part of the branch deployed, it's advanced slightly, so that you can open
the opening for the arch, for the ascending aorta, and then the ascending module is then deployed with careful markers that allow you to deploy this right on this tantalum ring. You can see the final result here, with perfusion of the carotid-carotid, carotid-subclavian
in the 3D rendition. Now our Toronto results, you can see that our patients were relatively elderly, they were 75. They had large aneurysms, almost seven centimeters. The distance from the innominate to the origin of the aneurysm,
one is an average, just about one centimeter. And there was a significant length of stay associated with the debranch as well as the repair. Importantly, however, there were no strokes, no spinal cord ischemia, and no mortality. And we had no proximal endoleaks.
We did have one patient here, you can see, who had a hematoma in their ascending aorta, which evolved into a dissection, and that required removal of the ascending module with sewing a conventional surgical graft to the rest of the endograft.
There was a type III and a type II endoleak, as well. Now you've already heard that the results of doing this, whether it's through conventional surgery or through open repair, are associated with mortality. So if you look in the literature, you can see this systematic review
and the meta-analysis by Moulakakis, which shows results for open elephant trunks, arch hybrids, this is the most recent Cook publication, with their most recent series, and a systemic review from Piergiorgio Cao. Here are our results in the Global Nexus.
So there have been, with the Global Nexus, a 7% 30-day mortality, but we have not had any. But there is, that's very respectable compared to open elephant trunks at 9 1/2%, and almost 12% for hybrids. You can see that there's been a 7% stroke rate
with full recovery in the Global Nexus, but we had none. And there's 11% in the Cook and 6.2 in the open repair. There's been so spinal cord ischemia, but there has been some in the open and hybrid repairs. So in summary, Mr. Chairman, the Nexus Arch graft minimizes arch manipulation.
The favorable early results, I believe, with no strokes, is a result of this. This is applicable to arch aneurysms, with and without dissection, and clearly larger case series are going to define its role in the longterm.
- Thanks (mumbles) I have no disclosures. So when were talking about treating thoracoabdominal aortic aneurysms in patients with chronic aortic dissections, these are some of the most difficult patients to treat. I thought it would be interesting
to just show you a case that we did. This is a patient, you can see the CT scrolling through, Type B dissection starts pretty much at the left subclavian, aneurysmal. It's extensive dissection that involves the thoracic aorta, abdominal aorta,
basically goes down to the iliac arteries. You can see the celiac, SMA, renals at least partially coming off the true and continues all the way down. It's just an M2S reconstruction. You can see again the extent of this disease and what makes this so difficult in that it extends
from the entire aorta, up proximally and distally. So what we do for this patient, we did a left carotid subclavian bypass, a left external to internal iliac artery bypass. We use a bunch of thoracic stent grafts and extended that distally.
You can see we tapered down more distally. We used an EVAR device to come from below. And then a bunch of parallel grafts to perfuse our renals and SMA. I think a couple take-home messages from this is that clearly you want to preserve the branches
up in the arch. The internal iliac arteries are, I think, very critical for perfusing the spinal cord, especially when you are going to cover this much. And when you are dealing with these dissections, you have to realize that the true lumens
can become quite small and sometimes you have to accommodate for that by using smaller thoracic endografts. So this is just what it looks like in completion. You can see how much metal we have in here. It's a full metal jacket of the aorta, oops.
We, uh, it's not advancing. Oops, is it 'cause I'm pressing in it or? All right, here we go. And then two years post-op, two years post-op, you can see what this looks like. The false lumen is completely thrombosed and excluded.
You can see the parallel grafts are all open. The aneurysm sac is regressing and this patient was successfully treated. So what are some of the tips and tricks of doing these types of procedures. Well we like to come in from the axillary artery.
We don't perform any conduits. We just stick the axillary artery separately in an offset manner and place purse-string sutures. You have to be weary of manipulating around the aortic arch, especially if its a more difficult arch, as well as any thoracic aortic tortuosity.
Cannulating of vessels, SMA is usually pretty easy, as you heard earlier. The renals and celiac can be more difficult, depending upon the angles, how they come off, and the projection. You want to make sure you maintain a stiff wire,
when you do get into these vessels. Using a Coda balloon can be helpful, as sometimes when you're coming from above, the wires and catheters will want to reflux into that infrarenal aorta. And the Coda balloon can help bounce that up.
What we do in situations where the Coda doesn't work is we will come in from below and a place a small balloon in the distal renal artery to pin the catheters, wires and then be able to get the stents in subsequently. In terms of the celiac artery,
if you're going to stent it, you want to make sure, your wire is in the common hepatic artery, so you don't exclude that by accident. I find that it is just simpler to cover, if the collaterals are intact. If there is a patent GDA on CT scan,
we will almost always cover it. You can see here that robust collateral pathway through the GDA. One thing to be aware of is that you are going to, if you're not going to revascularize the celiac artery you may need to embolize it.
If its, if the endograft is not going to oppose the origin of the celiac artery in the aorta because its aneurysmal in that segment. In terms of the snorkel extent, you want to make sure, you get enough distal purchase. This is a patient intra-procedurally.
We didn't get far enough and it pulled out and you can see we're perfusing the sac. It's critical that the snorkel or parallel grafts extend above the most proximal extent of your aortic endograft or going to go down. And so we take a lot of care looking at high resolution
pictures to make sure that our snorkel and parallel grafts are above the aortic endograft. This is just a patient just about a year or two out. You can see that the SMA stent is pulling out into the sac. She developed a endoleak from the SMA,
so we had to come in and re-extend it more distally. Just some other things I mentioned a little earlier, you want to consider true lumen space preserve the internals, and then need to sandwich technique to shorten the parallel grafts. Looking at a little bit of literature,
you can see this is the PERCLES Registry. There is a number of type four thoracos that are performed here with good results. This is a paper looking at parallel grafting and 31 thoracoabdominal repairs. And you can see freedom from endoleaks,
chimney graft patency, as well as survival is excellent. This was one looking purely at thoracoabdominal aneurysm repairs. There are 32 altogether and the success rates and results were good as well. And this was one looking at ruptures,
where they found that there was a mean 20% sac shrinkage rate and all endografts remained patent. So conclusion I think that these are quite difficult to do, but with good techniques, they can be done successfully. Thank you.
- [Martin] Dear chairman, dear ladies and gentlemen, sorry for the long title which was given to me. It was not my idea. It's enough for three presentations, but I will try to answer within the given time. These are my conflict of interests. Traditionally, and there's a lot of literature,
also very recent literature. EVAR treatment has limitations in women because first of all, they are less eligible than men for EVAR trials. For instance in the EVAR One trial it was about nine to 10% even though the incidence of aneurysms is higher.
This is due to some specific anatomical restrictions like small iliacs, kinked iliacs, and special necks. Also they have more complications, axis related complications due to these iliacs are shown an example. So lower profile devices are needed
to go through these iliacs and enable their eligibility for female patients. That might improve outcomes. So this is probably one factor, so that's data here showing that in-hospital deaths after EVAR is
even over time not going down, but actually going up a little bit. It might be due to more broad indications, but this is some matter of concern. There are some low-profile devices available. This device, probably all familiar with this,
is approved in the United States, is a 14-F ultra low-profile, it's called ultra low, so it's actually low-profile, it can be placed percutaneously and has very kink-resistant limbs. It has a very good suprarenal fixation
and is polymer fitting with custom seal of the neck. This device is measuring the neck diameter 30 millimeters below the renals. A new Ovation Alto, which is now under IDIE trial in the United States, has only seven millimeters distance
from the renal arteries. So this is one example of one of our first patients which we did. 64 year old, aneurysm size 55 millimeters, very short neck, tortuous, narrow and calcified iliacs. And can still be done with this device.
And you'll see the one year picture without any endoleak. So after the pivotal trial in the United States there was a European post-market registry with prospective data collection. 501 patients with monitoring, so this is not a prospective randomized trial.
And this did not really have the end-point for a gender-specific error variation. But we still did this evaluation. The first patient was enrolled in May 2011 and follow-up was done annually, it's planned up to five years.
And I'll show you the four-year results today. And gender sub-analysis showed a percentage of 14% females. As you can here see, female patients were a little bit older than men. And men had a higher other classification but you can see his neck diameter
was lower in female patients and minimal iliac diameter especially was a big problem in these patients. So in this registry trial, these patients were all included. Anyway, you can see here the numbers of the 432 men and 69 women.
There's no specific EVAR trial so far designed for women, except the LUCI trial, which is now ongoing, actually finished in the United States. And European registry also ongoing. There was no real difference in the early procedure analysis.
Also you can see here, in four years this is the results. At four years the only difference was limb occlusion was a little bit higher, maybe due to the low diameter. But all the other aspects, I'll show you the graphs in a moment.
Freedom from mortality, all-cause mortality. In endoleak there was no difference. Also no conversion rate differences in freedom from rupture. You see reinterventions, this is also an issue. There were a little bit higher
percentage here, but this was not significant. Only more Type Two endoleaks in women. We don't the exact reason, it must be anatomical specific differences in the patient population. Here you see the freedom from mortality is very recent data extracted in October 24.
Freedom from aneurysm related mortality and all-cause mortality was not a significant difference. Type One endoleak and Type Three endoleak, no difference in occlusion. There was a difference because more female patients had limb occlusions,
which could be of course repaired. Freedom from rupture and freedom from conversion was no statistic difference of within four years. And freedom from aneurysm growth, also a matter of concern, if there is Type Two endoleak or persistent Type Two endoleak, there was no difference.
But 10% of the patients developed this problem. So in conclusion, the message would be women, in the past at least, had limited eligibility for, and worse outcomes after EVAR, not only because of anatomical reasons, but because of the management.
Ovation Prime and Ovation IX and other low-profile grafts, if they are available, expand eligibility. And in our prospective data collection we could demonstrate it's possible, indeed possible to derive similar benefits
using such a graft which is maintained over four years. Thank you very much.
- So, I've been tasked with this question. A quick declaration, one declaration was going to be I was an anesthesiologist, so hopefully you won't be too hard on me. So for anybody who doesn't know where Middlesbrough is, it's halfway up the east coast of the United Kingdom there, I wouldn't recommend it as your top ten places to visit,
but that's where our vascular center is. So I'd like to start off by by describing the concept of why pre-operative fitness is important prior to aneurism surgery. So this is a graph of activity status, or dependency, against time in the perioperative period.
So basically, the higher we are above the line here, the higher our activity levels and independency are. And that's really important, because there's increasing evidence now that preoperative fitness actually predicts outcome with major surgery. This is because of the body's ability
to obviously withstand the physiological storm of the surgical stress response. As you can see, we would all experience a drop in physiological functional status with surgery, but it's the body's ability to recover from that that's critical, and patients who do suffer
from complications have a longer term loss of dependency and also survival, in the later term. So the theory of exercise pre-operatively, or pre-habilitation, as it's gaining some traction in the literature, is that by increasing the body's physiological buffer here,
we've got greater resilience to withstand the surgical stress response, and get a quicker, uncomplicated recovery, or if we have complications, to reduce the impact on the short and longer term on health. So, the evidence. So there are two papers
that I want to draw upon, the literature is pretty sparse in actual surgical invention, but this first paper's by the Chetter and Barakat group from Hull in the UK. Now, they randomized 124 patients to receive either exercise preoperatively or their usual care, and they used a six-week pre-operative intervention
prior to AAA repair three times a week for one hour. Now they used moderate, continuous training, which is working at about 70% of maximal aerobic capacity, and in with that, they did some strength and resistance training. So patient characteristics were similar for both groups,
and in a subset of exercise patients, they looked at fitness changes as a consequent of the exercise program, and they saw a significant improvement. Complications were reduced by about 40% in the exercise group, but there was
no clear mortality benefit, probably cause the study was underpowered, and as you can see, median length of stay was also significantly reduced, and there were no exercise related adverse events. This study is one that's about to come out
in the British Journal of Surgery from our own group next month, and what we did was a feasibility study looking at high intensity interval training, rather than moderate continuous training, to evaluate the safety, another enjoyment benefit
with patients, but also to evaluate the most likely or primary outcome for a subsequent definitive study. So after a decision was made about EVAR or Open Repair, patients were randomized to receive exercise or usual care, and we used a four week pre-surgery high-intensity program
with bouts of rest in between, where patients worked at 80% to 90% of maximal capacity, and it was graded by the Borg scale, which you can see below. So we recruited 53 patients, 74% attendance at more than 75% of the pre-op sessions,
which we were very pleased with, with no SAEs, and enjoyment levels were reported as high. A third of individuals in the exercise group gained a significant improvement, but we didn't see a group benefit, a mean group benefit. There were no 30 day deaths and complications were similar.
And we have also demonstrated some preliminary cost effectiveness and improved health related quality of life at 12 weeks post discharge. So in summary, there's encouraging preliminary evidence that exercise prior to AAA surgery improves fitness, although we're aware that there are non-responders
which is consistent with the other exercise literature, apparently has a low adverse event rate, and there's encouraging signals for a reduction in perioperative complications, and also improvement in health related quality of life down the track, post discharge.
It appears to be cost-effective, the optimal program is probably likely to be multimodal, with strength training, inspiratory muscle training, and also rehabilitation phase. And I'd just like to finish with this great picture that I took my first morning in New York at the hotel here,
when there were about 40 fire trucks on scene, and we were evacuated from the hotel at 7:30. Thank you very much.
- [Instructor] Ladies and gentlemen, this is indeed my title and my disclosures are related to the fact that we live only about 30 kilometers away from Siemens. I would like to state that the Hybrid OR now has become the Standard of Care in EVAR and you can see a number of reasons listed in the the left of the slide.
And the next good thing that happened to us is really the fusion imaging with this potential with using less contrast media, less radiation exposure both for the patient and the operators and also a shorter OR time. If we go to the literature, I am very proud
that one of my students was allowed by (inaudible) to come and visit and manage to do this study and the first paper. Latest finding in this group demonstrated very nicely that with all different EVAR procedures, you could reduce radiation exposure in using Fusion. Now Fusion is a moving target as you can see here.
We moved away from the more complex 3D/3D registration to the 2D/3D registration and you can see from the image that it's virtually an automated process. What I am trying to tell you is that we now just do two single shots in AP and lateral or two oblique views and then fuse it with the pre-operative CT scan.
And that whole process of segmentation, detecting the landmarks and the angles is now a semi automated process as shown here. This is the real live, or real timing and you can see how quickly it goes to segment the aorta and to detect the important target vessels.
If you name them, you can click on them and make sure that your C-arm goes into the correct position for a perpendicular approach. So to show you this, I'm going back one slide. Here is a case 66 year old male with a 61mm juxtarenal or suprarenal aneurysm
with some chromobility, you can see the proximal neck here. Two renal arteries on the right which is a bit cumbersome and open IMA which is again a bit of a downside, and the access reach for us was acceptable. So we decided here in this case to do an embolisation of the IMA lower right renal arterial
which is not the standard of care, we rarely do that in a triple fenestrated graft. These are images showing you the embolisation of the two mentioned arteries. And this is the live scenario where you obviously have to load your CT scan into the single view system.
And as shown before, that goes fairly quickly and then this segmentation can begin as I showed you before. It is the same process and it is real time visualization here so that goes very quickly indeed. And then you can give all the correct or control all the names and then continue.
You have to prepare your patient. We still like to do a cut down, sometimes we do percutaneously but we prefer the cut down in complex cases because we are able to remove the big sheaths and reduce the risk of paraplegia or ischemia of the legs.
If I go out of the video this should move forward. This is the 2D registration where you just simply do a one shot in AP and then in the next image, one shot in a lateral view to fuse this with the pre-op CT scan which is shown here.
You can do a manual correction and fine tuning will be done by the machine automatically. Now this is not perfect, the system is not perfect. Now you can see here very nicely the stiff guide wires and especially the systems will distort the aorta.
So you can do a manual correction and then you have your best possible view in all angulations of your C-arm to open your graft. Then the rest is all a little bit standard technique, and you're just aided by the rings that we'll show you where approximately the ostial of the target vessels are.
So this is the lateralization of the C-arm, which again can be automated. And then catheterization of the SMA, we usually let the catheter drop in and then it usually falls in a stable position. As you can see here, I usually don't push it anymore
but go with wire. But the catheter is soft enough to do this fairly gently. And then the rest is of course standard business. You deploy the graft completely, you remove your sheath, you have complete flow through the body. You will inflate one by one your bridging stent graft,
flare them and then do a control angiogram as you can see in this image. And you can also nicely move the image to have the kidney in the image together with the ostial of the target vessel. And the same of course for the other side,
withdrawing your sheath, deploying the stent. In the interest of time, I continue. This is the SMA that you can then provide with a sheath because we do that at a later stage. We only use two guiding sheaths, so we have an (inaudible) in the SMA, advanced guiding sheath,
the bridged stent graft, withdraw the sheath and then deploy the stent as you can see here. And then the same process again. The flaring and then you can finish your job with a bifurcate and a contralateral limb
and do a controlled angio. Closing the access is usually just by tying the purse string sutures. So we don't use vascular clamps in most of the cases. This doesn't mean that you don't need to keep attention on all the other tips and tricks
to reduce the radiation exposure. Here you see very nicely a beautiful image on the left to the term the position of your bridging stent graft and to deploy inflatable balloon and deploy the bridged stent graft in the correct position. But for example for the flaring, you can go on a much lower
quality and spare a lot of radiation. And even more because you do an angio three four times for each target vessel to confirm the position, sometimes to measure the length and to confirm the correct end result. If you do this with a little fluoroscopy
with a short contrast injection, you can see how much energy and radiation can sparecompared to a low dose DSA. This is a low dose DSA and you get virtually the same image, you can save that sequence and use it again as an overlay if needed afterwards.
So in conclusion, Mr. Chairman, ladies and gentlemen, would be fair to say that in all endovascular procedures, you shouldn't forget that the general ALARA priciples with regards to fusion images or imaging, it should be included in the standard of care. And just to give you a number, the radiation exposure
in this case including the embolisation gave a Dose Area Product of 27 Gy/cm2. This is extremely competitive for such cases. Thank you very much for your attention.
- The only disclosure is the device I'm about to talk to you about this morning, is investigation in the United States. What we can say about Arch Branch Technology is it is not novel or particularly new. Hundreds of these procedures have been performed worldwide, most of the experiences have been dominated by a cook device
and the Terumo-Aortic formerly known as Bolton Medical devices. There is mattering of other experience through Medtronic and Gore devices. As of July of 2018 over 340 device implants have been performed,
and this series has been dominated by the dual branch device but actually three branch constructions have been performed in 25 cases. For the Terumo-Aortic Arch Branch device the experience is slightly less but still significant over 160 device implants have been performed as of November of this year.
A small number of single branch and large majority of 150 cases of the double branch repairs and only two cases of the three branch repairs both of them, I will discuss today and I performed. The Aortic 3-branch Arch Devices is based on the relay MBS platform with two antegrade branches and
a third retrograde branch which is not illustrated here, pointing downwards towards descending thoracic Aorta. The first case is a 59 year old intensivist who presented to me in 2009 with uncomplicated type B aortic dissection. This was being medically managed until 2014 when he sustained a second dissection at this time.
An acute ruptured type A dissection and sustaining emergent repair with an ascending graft. Serial imaging shortly thereafter demonstrated a very rapid growth of the Distal arch to 5.7 cm. This is side by side comparison of the pre type A dissection and the post type A repair dissection.
What you can see is the enlargement of the distal arch and especially the complex septal anatomy that has transformed as initial type B dissection after the type A repair. So, under FDA Compassion Use provision, as well as other other regulatory conditions
that had to be met. A Terumo or formerly Bolton, Aortic 3-branch Arch Branch device was constructed and in December 2014 this was performed. As you can see in this illustration, the two antegrade branches and a third branch
pointing this way for the for the left subclavian artery. And this is the images, the pre-deployment, post-deployment, and the three branches being inserted. At the one month follow up you can see the three arch branches widely patent and complete thrombosis of the
proximal dissection. Approximately a year later he presented with some symptoms of mild claudication and significant left and right arm gradient. What we noted on the CT Angiogram was there was a kink in the participially
supported segment of the mid portion of this 3-branch graft. There was also progressive enlargement of the distal thoracoabdominal segment. Our plan was to perform the, to repair the proximal segment with a custom made cuff as well as repair the thoracoabdominal segment
with this cook CMD thoracoabdominal device. As a 4 year follow up he's working full time. He's arm pressures are symmetric. Serum creatinine is normal. Complete false lumen thrombosis. All arch branches patent.
The second case I'll go over really quickly. 68 year old man, again with acute type A dissection. 6.1 cm aortic arch. Initial plan was a left carotid-subclavian bypass with a TEVAR using a chimney technique. We changed that plan to employ a 3-branch branch repair.
Can you advance this? And you can see this photo. In this particular case because the pre-operative left carotid-subclavian bypass and the extension of the dissection in to the innominate artery we elected to...
utilize the two antegrade branches for the bi-lateral carotid branches and actually utilize the downgoing branch through the- for the right subclavian artery for later access to the thoracoabdominal aorta. On post op day one once again he presented with
an affective co arctation secondary to a kink within the previous surgical graft, sustaining a secondary intervention and a placement of a balloon expandable stent. Current status. On Unfortunately the result is not as fortunate
as the first case. In 15 months he presented with recurrent fevers, multi-focal CVAs from septic emboli. Essentially bacteria endocarditis and he was deemed inoperable and he died. So in conclusion.
Repair of complex arch pathologies is feasible with the 3-branch Relay arch branch device. Experience obviously is very limited. Proper patient selection important. And the third antegrade branch is useful for later thoracoabdominal access.
- [Speaker] I have nothing to disclose. We already have disclosed and published that at one year the outcome following repair of thoracoabdominal aneurysms with the Multilayer Flow Modulator was safe and effective. And at three years we added that it was true when used according to the instructions for use.
This was true also at four years, and the problem today is to us to answer the question, is there a place for the MFM in type B aortic dissection? Out of 3,500 patients treated in more than 110 papers, 9% of which relating to the use of the MFM for aortic dissection.
So let's start with the beginning when we had treated in 2003 patient, 40 years old, male, a Jehovah Witness suffering from type A dissection. And he came back in 2010 with a nine centimeter thoracoabdominal aneurysm that we treated with the MFM.
And this guy refused, of course, any transfusion. And he was taking care full time of his totally disabled son after a car accident. This gentleman was lost to follow up, and we called him back three weeks ago. And he came back with his nine centimeter,
came down to six centimeter aneurysm and he is doing fine. Then we published the first case with Professor Chocron that he operated in type A dissecting repair in 2006. And he presented in 2010 with a six centimeter thoracoabdominal aneurysm evolving.
We treated him with two MFM and, at three and seven years, he was doing fine. He is doing fine because seven years, it's one month ago, CT scan. And what happened is that there was a shrinkage of the false lumen until the the left renal artery
which is retrogradely and non expanding, perfused by the false lumen. And this is stable over a year. Then there was this beautiful case published by Professor Costache from Romania who is going to speak in a few minutes.
28 year old female, aortic replacement, type B dissection, normal prognosis: there is no solution. And, as you see, the false lumen is totally compressing the true lumen. And he said, that was very clever, he said that this general disease of the whole aorta.
So he treated the whole aorta with, at that time we didn't have this available from the beginning, but he could cover even the aortic bifurcation with forceps. And the results was good immediately with the true lumen re-expended,
there is no false lumen. And that was true over time. And what also he demonstrated is the mechanism, why there was no paraplegia with this technique, because the vestigial flowed in the false lumen to keep on feeding the intercostals and lumbar arteries.
And that was true at 11 months. But that was true also at two years. And that remained true at three years and published. Then there was the, also, this 74 year old male that we treated. He had a type B dissection treated with stent-graft
with a type one endo leak five years ago, and that we treated this time per an endo leak with an MFM. This is the procedure. And, you see that at five year of follow up, all the branches are patent and the dissection is stabilized
with a shrinkage and obstruction of the false lumen that is no longer patent. So, as you all know, under the hospices of Professor Sultan, there was this 38 patient global registry, 12 month follow up, technical success 97%.
There was no paraplegia, no stroke, no renal impairment, no visceral insult. And at 12 month, the result was superior to INSTEAD, IRAD, ADSORB study. And this is probably the most important slide of my talk, because when you compare the results
with MFM, stent-graft, and open surgical repair in the literature, the 30 day mortality comes down from 11 to 13 to 2.6% with no paraplegia, no renal failure, no stroke, versus five and 12, 12 and 34, 5.6 and 11% with a positive aortic remodeling occurring over time.
And the decrease in the false lumen volume is three times greater than the increase in the true lumen volume due to radial force immediately and lamination and decompression change of flow secondarily. So, what's in the next step? The next step is to design
an international, multicenter, prospective, non-randomized study. The drug named Dragon. This is a preliminary, these are preliminary results. 22 patients, mean age rather young, 56. The longest follow up is five years.
And the result's that we didn't have any post-operative death in the first 30 days, no dissection related death, no paraplegia, stroke, renal impairment, no loss of branch patency, rupture, and device rupture. With a true lumen expansion and false lumen
at discharge, at one, three, six, and 12 month. With thrombosis of in the false lumen evolving. And, branch patency maintained at 12 month and 40 month and 60 month. So, in conclusion, ladies and gentlemen, the MFM.
I didn't do that, I don't know what happened. Okay, TEVAR induced positive aortic remodeling but still it causes up to 30 day mortality of 40%, paraplegia, renal failure and stroke. And the MFM has been used to treat aortic dissection. It's stabilizes and decreases the false lumen,
increases true lumen-- - [Man] Okay, so-- - [Speaker] The conclusion that we think that MFM has some room. Thank you Robert.
- [Instructor] Thank you very much. So, you saw some of the issues that our, oh, this is the slightest cut, but that's okay. Some of the issues that we've seen with these percutaneous mechanical devices, and, back in the 90's, and perhaps even more than a decade ago, there were a lot of these.
And this space gets hot and cold, and one of the problems is that the level of evidence for doing these is very low, and when it is done, it wasn't done well. And this is a nice registry, a lot of patients enrolled, unfortunately we didn't learn
what we had to learn from these types of registries, because of just the study wasn't done well. So the level of evidence is low, and when we did have them, they didn't really work. And you saw some of the problems, that these devices can cause.
And here's another problem that wasn't discussed. You can see the DVT, iliofemoral DVT in here, and a device is pushed a few times up and down, and sort of aspiration, a Bertoulli, that type of thing. And this looks, oh wow, well this looks good,
maybe the thing is working, except all the clot is up here. So, these devices tend to push the clot around. So the issue is, enter now more recently, these are some of the more recent ones. Note that the AngioVac is not here, I don't consider that a practical thrombectomy device,
and so, it's not here. So, we're going to be talking about JETi. This is a system that is an aspiration system with a jet that comes inside the catheter, therefore the clot is engaged and pulled in and broken down by the jet, therefore there's no hemolysis.
And this demonstrated in this case, which is acute and chronic 17 year old multiple DVTs in the past, the iliofemoral segments are stented, as you can see here, this segment is somewhat fresh clot but these, as you can see, are subacute clot. Look at this, so the system now is designed
for over the wire, but for DVT you can use it without the wire, because it works a lot better. As you can see it can really aspirate the clot, in before your eyes. Now this I have passed the device in here once, and you can see the fresh clot is gone,
we have some residual debris in there, we have not established flow yet, and then I turn the device on... and it pulls the whole thing in, okay? So, very powerful aspiration method. So, and as you can see here, we don't have
a flow establish, outflow established yet. Therefore, when you turn it on, you have a vacuum created right here, and so this tells you how strongly this device can aspirate and work. And this isn't on the table.
After a pass here, two passes here, some residual clot in here, obviously there's residual clot there. So we pass it around these areas once more, and this segment obviously needs to get stented and on the table, re-establish antegrade flow. Since May, we've had 19 patients treated, most of them DVT.
And, based on our assessment, 17 of the 19 patients at a total time of 90 minutes on the table, had better than 90% clot retrieve. We have 30-day patency data on only 16 of those patients, because this is really since this May. And 15 of those were open, one re-thrombosed
and we had to retrieve again. Conclusion, so preliminary experience indicates that this is an effective device. There were no safety issues, we don't see any hemolysis, we don't see any pushing around of the clot, but there is a learning curve to it,
and for best application, thank you.
- [Lu Qingsheng] I have no disclosures. We know for indication of EVAR we need favorable proximal neck anatomy but if it not unfavorable maybe we are some Type 1a endoleak it's a serious complication for EVAR. So for prevent and treat Type 1a endoleak
especial for some juxtarenal aneurysm maybe we use the chimney fenestration branch and some sac bag. Could we find a simple safe cheap and effective method? So we find from open surgery we were introduced this fibrin glue
means its complex of thrombin and fibrinogen, it's used hemostasis in open surgery so we put that into inject that into the sac, we call it fibrin glue sac embolization. I will show you some cases.
For this case is very short neck and not quality of deck and after deploy the stent graft, of course very serious Type 1a endoleak. But fortunately, we put a catheter before we deploy the stent graft so this catheter is into the sac of the aneurysm
then we use up a long controlled blood flow and we inject from the catheter into the sac of the aneurysm and we inject the fibrin glue. And you can find the contrast not moved after we withdraw balloon. Then we do the angiogram.
We find no any endoleak. Another case showed is angulated neck as this patient. Of course after we deployed stent graft have a lot of endoleak. And we do again this technique. And control the balloon, control the blood flow,
then inject the fibrin glue, and we check all that and withdrew the balloon, there are no any movement about the sac. And we do the angiogram and no any endoleak. Till now, we did, we begin this technique 2002, so we follow long time that we can show it's safe.
So till now we treat 156 cases and proximal less then short proximal neck is 75 cases even some of less than 10 millimeters. And angulation more than 60 degree even some cases more than 75 degree.
Most of them more than 98% of patients' endoleak was resolved. And during our follow up, the mean time more than 100 months, only three patients died of aneurysm related sac enlargement.
The mean maxim aneurysm diameter decreased and no recurrent Type 1 endoleak so we have confidence that it's safe and no any sealant-related complication for example renal failure and aplasia other things. So we discuss the mechanism
it's not only embolization for endoleak but also coagulating all sac of aneurysm like this in shows how it worked. And we also measure the pressure in the sac. Intrasac pressure decreased significantly in treated cases. And how about that technique we need occlusion
proximal blood flow and protect branch ateliers and prevent distal embolization. And we also treated into the rupture aneurysm and it can treat any type of endoleak as these cases it's a rupture aneurysm we do the EVAR emergency.
And after we deploy this devices, we find this endoleak. We don't make sure which kind of endoleak but anyway we just do that, control the blood flow use the balloon then inject the fibrin glue in that.
And all the sac of aneurysm. Then we do the angiogram and endoleak disappeared. We'll be treat any type endoleak of the rupture EVAR we prevent rupture post-EVAR and we decreased abdominal compartment syndrome. So the conclusion is
fibrin glue sac embolization is a simple and effective treatment method. And this method could expand the current indication of EVAR. For selective the length maybe can to the 5 millimeters, angle maybe can to the 90 degree,
and for emergency we seen it should be into the older EVARs for rupture aneurysms. Thank you very much.
- [Man] Yeah, thank you Kostas and thank you Professor Feith for the invitation. These are my disclosures. So there's big controversy here is is there a big problem with the Gutter Endoleaks after chimney, and coming back to the Pericles Registry was this
is the largest database we have at the time. We see a rate of eight percent at one endoleak immediately, but we only see 2.9 percent persistent type 1A endoleak after six month. And this is in a pretty large patient group, so I don't think so that we have a big problem,
but as always, if you have a complication for these 2.9 percent of patients, it's 100 percent and you have to deal with it. So here we see a typical Gutter Endoleak in an interesting case, a 87-year-old patient who got a single chimney for the
inferior mesenteric because of a colon resection in the past and we feared for colitis if we over-stent the IMA. And this is a control, and you see if there is not a big runoff vessel involved that these endoleaks disappear over time.
And so if you have an elective case, watchful waiting is a strategy to do because over 60 percent of these endoleaks will resolve. So you have a mandatory treatment indication if the patient has an urgent indication for symptomatic or ruptured AAA
you have to deal with it immediately. As we saw in the sessions before, predictors for persisting endoleaks are high flow lesions, multiple run-off vessels in the aneurysm. More than two chimneys and less than two centimeter neo-landing zone
created by the chimney technique. And what we also saw is if the patient has to take anticoagulation. If you have after three to six month persisting endoleak, you have to treat it, because its type 1A and the patient is not treated right.
So for the setting we put the C-arm from cranially we take an access form the arm. General anesthesia, because the embolization can take some time and, and the copolymer is creating some pain during injection. Don't forget to put your copolymer on
the shaker 30 minutes before you plan to use it. And then you need five to six french 90 centimeter sheath four to five french 100 centimeter j-tape glidecath or headhunter. An 014 wire and a 150 centimeter 014 microcatheter. And what is important is all materials
have to be complimentary in a telescope fashion. That your materials fit into each other. So here you see a case of a 77 year old patient with a persistent endoleak, due to a gutter on the back wall of the aorta. And this is certainly something you have to treat.
So we came from a brachial access here this is a headhunter catheter. you cannulate the gutter once you're in you have to confirm that you are really inside the aneurysm sac and not somewhere else, because this would be hazardous
if you embolize at the target vessel. And then in this case we put some coils to reduce flow in the lesion. You can even see that one of the coils went into one of the lumber arteries, draining the endoleak. And once you have put that cause you pull back
your catheter into the region of the neck and start embolizing with the coploymer. And it is important that you do that slow and that you stop putting the onyx in before you reach the upper rim of prothesis, so you don't have an overflow of the coplymer
and distal embolization that you do not want. once you have achieved this you do aspirate and take back your catheter. So here you see the post, post operative angiogram and you see nicely how the liquid embolization went around that
chimney stent and sealed that. And this is why we prefer liquid embolization, because this you can't achieve that with coiling material. Here you see the post operative control with a completely excluded, we prefer to do
MRA angiogram for the controls, because you don't have the artifacts that you will have if you use a onyx or coils. So let me conclude, go with a brachial access, don't do, harm yourself and do 180 degree turn treating these pathologies come from above.
Choose your materials well. You need an angled catheter to canulate between graft and aortic wall. You, check your catheter position before embolizing. Go slow, and go down with the frame rate to not to harm you and your patient
of the radiation, because if you slowly inject you just need one picture per second. And if its a high flow lesion put some coils so you reduce flow in the lesion and reduce amount of polymer you need. Thank you for your attention.
- [Boonprasit] I'd like to thank Dr. Veith for the preface to be here. It's my disclosure. One of the most challenging issues for AAA patients is severely angled neck, particularly those who are not candidates for open surgery. Let me start with these two cases.
This 71-year-old gentlemen presented with a tenderness on his right side of his aneurysm with this kind of the neck. This 77-year-old gentlemen had a rapidly enlarged, over nine centimeters, AAA with also this kind of the neck. Open surgery should be the first choice
to treat these patients. However, it's not an option because of the significant comorbidities. So what's next? We wait until it's ruptured before do anything, or can endovascular repair
is a safe and effective option for us? There are three questions to answer. Can we successfully deploy the device? Will we provide a good long-term results? What are the limits? Angled neck.
I will come back to answer these three questions later on. We reviewed our experience of treating AAA patients with neck over 60 degrees in these 8 1/2 years period with Endurant stent graft. And there were 154 patients we treated with neck over 60 degrees, with the average neck length
of almost three centimeters. We categorized these patient into five groups according to their neck angle, started from over 60 all the way up to over 120 degrees. You can see here, 3/4 of the patient had neck over 75 degrees.
That's outside of the IFU. But these are all high-risk patient for open surgery. This is the longest follow-up case that we have, up to eight years. You can see, we started with quite a long neck, in this case, four centimeters neck.
And you can see that up to eight years aneurysm, kind of stable, a little bit slightly decreased in size, but not significant. This lady had up to five years good results aneurysm shrunk, no migration, no endoleak. This twisted neck with empty aneurysm, also good results,
no migration, aneurysm shrunk, no endoleak. Altogether, we've got, of these 154 patients, they get 95% technical success. We got eight proximal endoleak. 30-day mortality was 2.6%. Two died from MIs.
One died from stroke, and one from ruptured aneurysm because of this proximal endoleak. Of these eight proximal endoleaks, four sealed, one spontaneously, three with some adjunct procedures, proximal extension cuff, EndoAnchor, or chimney. Three ruptured, though, and one patient
still doesn't want to have any second procedure done. We follow him very closely. When you put these unwanted complications in the chart together with those complications that we were able to fix there. This patient, we see in this proximal endoleak
at one-year followup, actually, we missed that small endoleak here at one month. We treat this patient with EndoAnchor to quite a good success. Our followup average of around two years, surprisingly, we've got only two late proximal endoleaks.
And most of these patients are from neck dilatation, and both had persistent type II endoleak. Only once did migration of seven millimeter occur in this hostile group. And you can see, this device migration case, and even though seven millimeters migrated at three years,
aneurysm shrunk anyhow. This patient had a neck dilatation at five years, causing proximal endoleak. We fixed it with a proximal extension with a chimney up through the right renal artery. Up to eight years now, the patient is doing well.
So we put these two delayed endoleak into the chart. You can see which group we have the problem. So there are some technical difficulties with a tortuous angled anatomy when we put a stent wire. The anatomy will be shortened. Can be a problem.
And we have to make sure that our stent won't occlude the renal arteries. And belly pushing seems to be quite a helpful maneuver to help to remove this delivery system in some cases. Chimney procedure is needed in 6% of the cases. Aortic cuff is needed in 25% of the cases.
So we put together all these adjust procedures needed in the chart. We're a little bit too busy. Let's put it this way. The red bars are unwanted complication, mortality. The yellow bars are the problems that we can fix.
And the blue line is those adjunct procedure, either cuff or chimney. So where is the limit, 75, 90s, 100? So I'm sure that you know that the answer for these three questions would be yes. So back to, finally, back to our case.
The first case, we did a sandwich to the left renal artery for the patient. After four years, aneurysm shrunk, no migration, no endoleak. The second case, only EVAR, no adjunct procedure needed. At one year, aneurysm shrunk, no migration, no endoleak.
So Mr. Chairman, ladies and gentlemen, we believe that endovascular repair can be offered safely for AAA patients with severely angled neck who are not candidates for open repair. We may need longer neck lengths. The procedure can be difficult.
And adjunct procedures may be needed. What is the limit? Well, this is quite a bold statement. We believe that we may be able to push the boundaries a little bit. Thank you very much for your attention.
- Thank you, I have no disclosure for this presentation. Aorotopathy is a different beast as oppose to patients with dissections that we normally see in the elderly population, but we have the same options open surgery, endovascular, and hybrid. If they all meet the indications for surgery so why not open surgery?
We know in high volumes centers the periprocedural mortality acceptable in especially high volume centers. The problem is the experience surgeons are getting less and less as we move into more and more prevalence of endovascular. And this is certainly more acceptable in lower or
moderate high risk patients. So why not be tempted by endovascular in these patients? (to stage hand) Is there a pointer up here? So the problem with aorotopathy is the proximal and distal seal zones and we've already heard some talks today about possible retrograde dissection,
we've also heard about nuendo tear distally and aorotopathy is certainly because of the fragile aorta lend itself to these kinds of problems. But it is tempting because these patients often do very well in the very short term. The other problem with aorotopathy is they often have
dissection with have problems for branch unfenestrated technology and then of course if these dissection septum are near the proximal and distal seal zones, you're going to have a lot of difficulty trying to break that septum with a ballon and possibly causing new
entry tears proximally or distally. Doctor Bavaria and his colleagues from Italy were one of the first ones to do a systematic review and these are not a large number of patients but they combined these articles and they have 54 patients. Again, the very acceptable low operative risk, 1.9%.
But they were one of the first ones to conclude and cation that TEVAR in these patients, especially Marfan's patients in this series carries a substantial risk of early and late complications. They actually cautioned the routine use of endovascular stent grafts.
One of the largest series, again stress, these are not large numbers but one of the largest series was just 16 patients and look at this alarming rate of primary failure. 56% treated successfully, 40% required conversion to open operation and interestingly enough
43% of those patients had mortality. My friend and colleague at the podium, doctor Azizzadeh was given the unbeatable task of arguing for endovascular therapy in Marfan syndrome and the best he can come up with was that midterm follow up demonstrates sizeable numbers of complications but,
he identify area where probably it was acceptable in patients with rupture, reintervention for patch aneurysms and elective interventions in which landing zone was in a synthetic graft. So why not hybrid? Well this seems to be the more acceptable version
of using TEVAR, if you can, in these aorotopathy patients. But this is not a great option because in this particular graft that you see this animation, we're landing in native aortic tissues. So really, what you have to do is you have to combine this and try to figure out a way to create a landing zone,
either proximally or distally and this is a patient and not with Marfan's this time but with Loeys-Dietz, who we had presented recently, previous ascending repair but then presented with horticultural abdominal aneurysm as a result of aneurysm habilitation of a previous dissection and here
you see a large thoracal abdominal aneurysm on the axial and coronal and as many of these patients with aorotopathy express other problems with their multisystem diseases and you can see the patients left lung is definitely not normal there, left lung is replaced with bullae and this is a patient who would not do well
with an open thoracal abdominal repair. So what do you do? You have to create landing zones and in this particular patient, he had a proximal landing zone so we were able to just use a snorkel graft from the mnemonic but distally we had to do biiliac debranching grafts to to all his vistaril arteries
and then land his stent-graft in the created distal zone and as you can see, we had an endoleak approximately and thank goodness that was just from a type II endoleak from the subclavian artery which we were able to take care of with embolization and plugs.
And there is his completion C.T. So not all aorotopathy is the same, this is a patient who presented with a bicuspid aortic valve and a coarctation and I would submit to you, this is not a normal aorta. This is probably a variant of some sort of aorotopathy,
we just don't have a name for it necessarily, and do these patients do well or do worst with endovascular stent-graft, I just don't think we have the data. This particular patient did fine with a thoracic stent-graft but this highlights the importance of following these patients and being honest with the patients family and the
patient that they really do have to concentrate on coming back and having closer follow up in most patients. So in summary, I think endovascular is acceptable in aorotopathy if you're trying to save a life, especially in an acute rupture or in an emergency situation, but I think often we prefer to land these
endovascular stent-graft in synthetic. Thank you very much.
- [Andrew] It was said that, "There is nothing new under the sun, but there is something old we do not know" and I think we can say this about the use of compliant balloons in aortic intervention. Really, since the early days of EVAR, we've been using compliant balloons to mold endografts and prevent or treat endoleaks.
And more recently, we've been using compliant balloons for hemodynamic control during EVAR for ruptured aneurysms and of course, in the last few years, there's been an explosion of interest in compliant balloons to provide hemostasis and a range of other conditions, the so-called REBOA, resuscitative endovascular balloon
occlusion of the aorta, for a whole lot of indications. What's also happened is that these compliant balloons, that were very bulky devices originally, are now much lower in profile, and because of this we can start to think of using these balloons in other indications. Here's a very interesting paper, and you'll see that
Tilo Kolbel was a co-author here, where there was a secular aneurysm of the posterior arch. Obviously, they had problems delivering a stent graft that tended to go into the aneurysm, so they inflated a compliant balloon to deflect the endograft and then treat the aneurysm.
I want to talk about aortic branch artery entry and the use of compliant balloon assistance. We call that a C-BABE technique. Really, we've often had problems with cannulation of aortic branches. We can often get a wire into these branches,
but often trying to deliver catheters, sheaths and stents, et cetera, are problematic because these tend to prolapse. The key components of this C-BABE technique are these compliant balloons. It's also very important to have a long, supportive sheath immediately below or above the balloon,
to prevent this balloon displacement. We can use this technique with the balloon placed either above or below the branch artery we're going to access, and I'm going to show you examples in both cases. So, let's first of all use the C-BABE technique. We will use the occlusion balloon below the branch
that we want to cannulate. And this really clinically is relevant in chimney EVAR and chimney EVAS procedures. So here, for example, this is a 76-year-old male patient with an aneurysm. The renal arteries are offset,
and the lowermost left renal artery also had a stenosis. We planned to form chimney EVAS with Nellix with a stent in the left renal artery. We couldn't even get a stable catheter position from above in this renal artery, so I ended up going from below, passing a guidewire from below and then I tried to
"buddy" wire a wire from above. And this video just shows you just how unstable this situation. I'm sure all of you who have tried to do these kind of procedures run into this problem where you've got a lot of support, but it tends to do that,
and it repeatedly does that. In the end, I ended up having to stent the renal artery from below, and then I used the C-BABE technique with a compliant balloon that's inflated from below, really so that this catheter could not push down quarterly, and could not prolapse and we could perform the procedure.
One of the key things, therefore, you'll see is that the sheath is just below the balloon to prevent it from being displaced. You've got to actually often pull these balloons up quite a lot higher than you think. And it's a dynamic process that you can do.
You can be inflating the balloon more or less as you need to. And you'll see this balloon inflating and you may need to change this, but essentially, it's providing resistance for the catheter that you saw prolapsed before, but essentially you can see it pushing against the balloon
and there's really only one way for that catheter to go. And you can use that balloon during all the stages of the procedure to deliver the covered stent and various steps to facilitate success in that particular procedure. Here's another example where we've used the balloon below the branch.
This was a patient who developed a late type-one A endoleak after an endograft, and we decided to use Nellix to repair this particular problem. And again, we used this C-BABE technique. Here, you can see we're having difficulty delivering the catheter into the right renal artery.
We're keeping that balloon up, and delivering that catheter out through the catheter past it to the ostium. And you can do that in all the steps. For example, here now we needed to deliver a sheath so that we could deliver a covered stent and really, it kept prolapsing until we used a compliant balloon, which we
delivered through, in this case, a tin French sheath from the left side to deliver that sheath and catheter out into the artery. So, and completed that particular procedure. We found that Nellix is, a very nice indication for Nellix is for repairing these
endoleaks from endografts. See the type 1A or type three and you can see we got a good result. So what about using C-BABE really with the balloon above the branch that you're wanting to access. And really, we've already learned this technique during
fenestrated repairs, where for example we can push a catheter around the constrained top cap of a cook graft. And that really is the same thing. It's providing constraint to allow us to deliver balloons and wires. Here's an example of ours where we had
to really get the wire right around the top of the graft in order to deliver this. We can do exactly the same thing with a compliant balloon. And now, these are very low profile. And I want to show you multiple examples in our clinical practice where we've used this technique over and above
the use of cannulating fenestrations in endografts. One is particular is cannulating the contralateral gate of a standard graft. This case was very difficult because one of the limbs of this gore graft was compressed against the aortic wall and we just couldn't get up from below.
And every time we tried to pass the catheter across the bifurcation, it prolapsed up. The patient had had thoracic surgery which meant that we couldn't use an upper loom approach. But what we could do is have a compliant balloon sitting above the aortic bifurcation of the graft
and then we could deliver a wire. This catheter has nowhere to prolapse. It's very stable and we could deliver a wire and snare it, and provide through and through access that we could complete the procedure. So you can see this compliant balloon, now a very low
profile above the branch we want to cannulate, has enabled us to facilitate this procedure. Here's another example of a patient with an unusual secular aneurysm of a pararenal aorta. The patient was in renal failure so we're able to cover the renal arteries, but they had an ECMA stenosis, so we wanted
to put a parallel graft from below to a so-called "snorkel graft" from below to keep the IMA patent. And actually, cannulating the IMA, the steeper IMA was very difficult. But we can use the C-BABE technique. And here you can see that you do need to be able to inflate,
deflate, and be prepared to move this around. The wire just kept on wanting to prolapse, but until we actually got the balloon into an appropriate position, that really helped us follow. So I think you'll see in this movie that I've deflated the balloon, taken it up a little bit higher so really,
the catheter really does push off the balloon and inflate that. And you can vary the amount that you inflate. And then really, there's only one place then that that catheter could go. It had to go and follow into the inferior mesenteric artery.
And then that allowed us to successfully do a parallel graft and complete the procedure. Finally, here's another example where you keep the balloon above the branch you want to cannulate. Here's a patient with a graft limb that's pulled out and a type 1B endoleak.
We wanted to put a limit stent down and we needed to embolize the hypogastric artery in this patient. Pretty tough to do it across the bifurcation or from above but a relatively simple way to do this is to use the C-BABE technique with a parallel compliant graft and then, you can push off that
and get into an iliac or hypogastric artery. And really, it's a very simple procedure. You can keep that balloon up and down all the time through the various stages to deliver that catheter. You can see that we could only get a wire in there, but really using the C-BABE technique,
we can get a catheter to follow. Then you can exchange for a stiff wire and you can advance there. And really, it can't prolapse because it's got nowhere to prolapse against. And we can complete this procedure using that intermittently
at the various stages that we needed to to plug the hypogastric artery and put a stent graft extension and treat the patient. So the use of a compliant balloon to facilitate arterial branch cannulation, the C-BABE technique, has really been facilitated by the fact that these devices are now
low in profile, and really I think it's a process you need to use dynamically. Be prepared to inflate, deflate, reposition to get the job done. But it has multiple new applications and I encourage you to think about using them.
Thanks very much.
- [A. Schmidt, MD] Thank you very much. So back to the peripheral arteries. Actually this is the technique that was first introduced for stentgraph implantations in patients with very small aortic arteries to take a cover stent in to crack the artery to be able to get a stentgraph up. However, we use this now here for our fempop lesions
if we find extreme calcified arteries. I occasionally work as a consultant for Abbott. There are clearly different options to treat severely calcified lesions and fempop lesions like lithioplasty as we have heard, and maybe some alternative other
balloon technologies: cutting, scoring. High-pressure non-compliant balloon is actually, I think something which should always be on the shelf. If you treat severely calcified lesions: atherectomy of course, PQ-bypass or to go around the artery into the vein and from the vein then back into the artery.
So to bypass the calcium, and of course stents. What we have experienced with let's say, standard stents, standard nitinol stents, that they frequently do not really open very nicely in severely calcified lesions. This is here, a study of 118 cases. Where we use stenosis cases up a catheter to go through
difficult lesions and many of them were calcified. You can see here that more than 40 percent of these cases had a residual stenosis over 30 percent after taking a stent in. And those with residual stenosis had poor patency compared to those with no residual stenosis.
I think residual stenosis matters and we should treat our patients we treat for severe calcium in an appropriate way. This is one, another example where a regular Nitinol-Stent was implanted in severe calcium. We can see here how it collapses.
This is one month after the implantation. So, that can actually not work. And, not only this is also difficult to get back through the stents here. We tried from undergrade usually these cases also end up with a second approach.
From retrograde over the high or proximal ante-tibal artery, and you can see it was not so easy to get those two wires into one area which eventually worked. And then we balloon. Of course, our intention was not to implant the Supera stent because we think the Supera stent
is a very good solution for severe calcium due to its high crash-resistance force, but everyone who uses these stents know that this kind of pre-dilatation with a 5mm balloon is clearly not enough. You cannot implant a stent now because
then you cannot pack it in. The stent will eventually elongate, and will not have the crash resistant force you want to see. And the re-stenosis rate, will again be very high. So, if you intend to use Supera stent in these kind of cases, you can.
You have to go further. You have to use shorter balloons, bigger balloons. And you have to see the balloons fully open. And clearly of course this can eventually end in perforation as in this case here at several points. And therefore also for these kind of lesions,
I think its very good to have a covered stent on the shelf. So we implanted here Viabahn, 7/150mm Viabahn and after that then we really cracked the artery here and made space for a Supera stent to furlough. This is a 7/20 high pressure balloon. Because, of course, even if you open the balloon fully
and you do not see any waste in the balloon anymore, the Viabahn does not have the force to resist the recoil forces so therefore you can see here after full opening that Viabahn, it really collapses this Viabahn. Therefore, after that, we usually reline the Supera-stent you can see the result here, with six months outcome.
So this is our crack and pave technique, which we then modified a little bit. In our later cases, another case here, severe claudication, also extremely calcified artery as you can see here. Mid-portion has fade down to the first pulpita segment
and this is the outflow here. This is not puncturing for retrograde approach. This is our technique now to give local anesthesia to these arteries because of course, you balloon these arteries consequently 5, 6, or 7mm balloons that can be extremely painful.
And we found this technique very very helpful. We have taken 9cm long 21 gauge needle, we take 1% lidocaine, and with the penetration of the skin lets say 2-3 times of the whole five you can actually reach long lesions different areas here of different plaque-y, don't have to do it every centimeter but let's say every
2-3 centimeters and we know that it will spread around and also longitudinally. If you do this the patients will be absolutely pain-free with any further dilatation. I can only recommend this technique. It really became our standard
in this kind of calcified lesions. This is a 5mm balloon of course not enough, the wire was not yet through so clearly. Again, this case is very often end up with two excess sides, and our standard excess if the lesion goes too far down into the popliteal segment is that we puncture the proximal
anterior tibial artery you can see here. that calcium here. And in these difficult cases we directly take a full French sheath because we know we also need very strong wires from retrograde not only from antegrade. This is some kind of standard that, of course now from both
sides you are trying to get through, you are trying to see from both positions how close these wires are. Eventually the balloon from one side you can see the balloon from undergrade touches now, the moves the wire here from retrograde so you know that you're in the same area from the wire then you snare the wire.
And then, actually the work begins with pre-dilation. So if you want to take a really severely calcified lesion out, a 5mm in diameter, we at least balloon with at least a 6mm balloon. Seeing a ways is clearly a sign that we are not done, we have to continue.
Maybe with more focal ballooning, shorter balloons, bigger balloons and if we still see a waste, than we know that if we proceed now we, we anticipate now rather we change the procedure from perforating to to anticipating that we perforate and first take a Viabahn. And very often balloons get destroyed and if we
save in this regard some money, we should first take a Viabahn in so from crack and pave we change to pave and crack. And after the Viabahn is in, of course we can proceed with compliant balloon in here, high pressure balloon, 50 atmospheres. Sometimes we oversize a little bit
the balloon a 7mm Viabahn actually I ordered an 8mm balloon, the technician gave me a 9mm balloon. This however, really gave us the opportunity to really open here the artery. I cannot really recommend it, but it's really successful to take an oversize balloon into the Viabahn.
You can see here very tiny bleeding from the Viabahn which seared but again the Viabahn is not fully open. Sorry, that didn't move. So you can see there's still a stenosis. Therefore we also realign this here with the Supera. Now it's very easy to get the Supera here,
a property in this severely calcified area. And this here is the result thereafter with a very good ultral. We have collected some cases to see here over quite a long time period. Nearly 70 persons. So it's not standard technique for every calcified artery,
but really reserved for extreme calcification, long lesions, most were total occlusions. So just to demonstrate that compared to any other procedures which we usually do in femoral popliteal arteries we oversize balloons pretty much, also Viabahns, and Supera stents were here, 6.5- 9mm.
Procecdures success 100%. Technical Success so leaving with residual over 30% was in one case that was let's say, the learning curve shouldn't happen with this technique and the patentcy I think is also quite good here with regard to complexity of the lesions.
So I can summarize that this pave and crack technique appears to be very practical and valuable way to successfully treat extremely calcified lesions. Again, only since we know that we can use this technique, we do not exclude any severe calcification in any
patient for endovascular treatment anymore. Thank you.
- [Ralf] Dissections as we know are much more complex that we originally thought and simply because of multiple reentries and not just reentries. So closing just the proximal entry doesn't do the patient any good and you have to go for closing
as many reentries as possible. We already heard about the physics behind this technique so I don't want to go into this for the sake time. It's all about the Bernoulli Principle and about an increase in fluid
in order to get a decrease in pressure and a decrease in wall tension. And this famous case here done by the late Dr. Diethrich shows in a very excellent way what can be done when treating more complex aneurysms like here in the ascending aorta.
What we do see in all these case is an increase in branch velocity which, of course, when talking about the coronaries or the supra-aortic vessels or the renals is exactly what we want. We already heard about endothelialization in these cases
which stops at the origin of the branches. And we do know from the previous speakers that when you have to do an explantation that there there is endothelialization of these venal stent grafts. Guidelines regarding the treatment of dissection,
and we do have enough guidelines now are available to justify a more aggressive approach when dealing with patients with acute type-B dissections in contrast to more conservative approach. Now what's special about this multilayer stent is that the branches, the intercostal branches
and the lumbar branches remain patent. And this is contrast to other technologies which we have. You have to be careful when covering branches arising from the False Lumen because there can be a significant pressure drop, subsequently causing occlusion of the branches.
Here typical examples of intercostal, intralumbar branches which is exactly what we want in order to prevent paraplegia. Type A dissections are still a contra indication no matter what kind of graft technique you want to use, simply because, here the gold standard still is open surgery
but my gut feeling is that this will change over time. Here a case which was rejected for surgery. Here a retrograde dissection, clamp related, treated with multilayer stents. And as you can see all the coronaries are still open. Here another case, retrograde dissection,
cover stent graft salvaged with metal multilayer stents. Here a case where the multilayer stent was combined with a fenestrated graft. First of all, stenting of the descending thoracic aorta with multilayer stent and subsequently we placed the fenestrated graft
and again, very good outcome. Here a patient coming as usual in the middle of the night, true lumen collapse, acute leg ischemia. And using these kind of stents and the radial force of these stents,
the complete collapse or almost complete collapse of the true lumen could be reversed with good results. Here another case, Type B dissection, 74 year old female patient and we wanted to close the entry with one of the well known stent grafts. Lunderquist wire was placed
and retrograde dissection. No vessels any more visible, so coming from the right arm we stented her and after that she was converted to open surgery and left hospital after a week
without any neurological sequelae. When there are stenosis of the branches, they have to be treated beforehand, before using these stents. As you can see here, stability of these stents in the arch is excellent considering the hostile environment
which encountered here in the arch. Here's some penetrating ulcers for the sake of time, I just want to go to one of the last slides. Again, widely patent intercostal arteries. And as we will publish next year, these are some of the results.
Stable situation or reduction of the volume of these penetrating ulcers. So what do you get with these kind of technique is aortic remodeling, false lumen reduction and dissection, preservation of branches, and the most important part, you avoid paraplegia.
Thank you very much.
- Thank you very much, Frank, for the opportunity to be part of this fantastic panel. So, I'm no more a part of the debate, and I will not show the differences, but if we look on the arch, on the literature addressing the different types of repair, we can see that the result are in the same range, approximately.
And despite the fact that we didn't spoke about this, probably, there is a bias of selection where else the best patient will be addressed by open surgery, patient that fits for branched and FEVAR will be treated by those technology, and the remaining of the patient
is addressed by parallel grafts. There is a second point I would like to address and this is one part of my talk, is that the results for the endovascular options are not good, are not so long described in the literature. There are some papers with longer follow-up,
but in the mean, the follow-ups are rather short. So, let's go to our expanse that is a little bit longer. In the arch, we treated 94 patients. We had a mortality of 14% stroke, or neurological complication 8%, endoleak, primary, 18%, but we addressed 40% of acute patients,
and 50 patient with redo thoracic surgery. So, an example: 75 years old patient, he had complicated type B dissection with malperfusion, did get the TEVAR with a sandwich for the LSA. In the follow-up, he showed an aortic enlargement with the dissection extending proximal to the LSA,
and he had, again, and antegrade perfusion of the sur-lumen. He refused general anesthesia because he had severe delire when he was treated first. So we address this with periaortic grafts. We put one chimney for the brachiocephalic trunk in the aorta, one chimney for
the left carotid artery in the ascending aorta, then we deployed a TAG in the aorta then, to match the diameter of the BCT we extended the first viable, which is 13 mm, and you can see here, the six month follow-up with a nice result. So, if we want to go to long-term results,
we freezed a cohort of patient we treated 2009 to 2014. These are 41 patients with an Euroscore II of 28%, 68 years the mean age, 30 day mortality was 12%, so half of the predicted. You see here 42 months follow-up of this cohort. There is this typical mortality of 10% a year
following the procedure, due to the comorbidity cardiac pulmonary renal functions, freedom of branch occlusion is nice and the branch behaved stable. There have been reintervention during the follow-up, mainly to treat endoleaks, branch issues,
or other problems on this patient, but you see there is a three and a half year follow-up and the rate of reintervention is the same than for other endovascular options. Looking now at the more complex patients, the free vessel in the arch, you see
that the results here are good too, for the parallel grafts. Here down, we see one patient dying, no stroke, no endoleak. If we go to the visceral patient, here the literature review shows a mortality of 4.7%, with an endoleak type 1A of 7% for the parallel grafts. If we do compare now CHIMPS with FEVAR and open repair,
you can see that maybe the difference is more redo, but it's not really much more than for the FEVAR/BEVAR, and here is particularly due to the gutters. We treated here also for the long-term follow-up, we freezed a cohort of patient, 127 patient, 40% symptomatic, 11% ruptured patient.
Hostile chest, 37%, hostile abdomen, 26%. Most of the proximal landing was above the renal artery, mostly chimneys, but also reversed grafts and sandwich. Here a case, patient that was rejected after rupture from two centers to one because he was unfit for surgery, the other because he qualified not for FEVAR/BEVAR.
He had a challenging anatomy with an occluded left renal artery and celiac trunk, a shaggy arch and LSA, so we treated him transfemorally with two parallel grafts and you see the outcome of this patient. So, there are reinterventions. The mortality in this cohort is 2.4%, endoleak is 7%.
Reintervention, chimney-related, mainly gutter endoleaks. These are the curves in the follow-up, and you see that the results are similar than the patient in the arch with a need for reintervention, but that's the same for any kind of endovascular procedure in the arch.
18% at three years of reintervention. This has been for branch thrombosis or endoleak cages. So, in conclusion, the results are good for parallel grafts in the arch and in the visceral types, and selected patient, they need an appropriate anatomy, a life expectancy of two years.
They behave durable up to more than three years mean follow-up, taking into account the number of reintervention. The unsolved issue with the parallel graft is the gutter, so this technique can improve, and you can see here that they may be solution for the future.
This is an anti-gutter design from Endospan that really eliminates any kind of gutter endoleak and wandering, and this will be the patient cohort that we will compare with other repair technique in the future. Thank you very much for your attention.
- Good Morning. Thank you very much Dr. Veith, it is an honor and I'm very happy to share some data for the first time at this most important meeting in vascular medicine. And I do it in - oops, that's the end of my talk, how do I go to the --
- [Technician] Left button, left, left. - Okay. So, what we heard on Tuesday were some opinions, of course opinions are very important in the medical field, we heard some hypothesis.
But what I think is critical for the decision-making physician is always the facts. And I would like to discuss some facts in relation to CGuard and the state of the field of carotid revascularization today. One of the most important facts for me,
is that treating symptomatic patients is nothing to be proud of, this is not a strength, this is the failure of the system. Unfortunately today we do continue to receive patients on optimum medical therapy
in the ongoing studies, including the paradigm study that I will discuss in more detail. So if you want to dismiss large level scale level one evidence, I think what you should be able to provide methodologically is another piece of large level one scale evidence.
The third fact is conventional carotid stents do have a problem, we heard about this from Dr. Amor. This is the problem of carotid excess of minor strokes, say in the CREST study. The fact # 4 is that Endarterectomy excludes the problem of the carotid block from the equation
so carotid stents should also be able to exclude the plaque, and yes there is a way to do it one of the ways to do it is the MicroNet covered embolic prevention stent system. And there is intravascular evidence from imaging we'll hear more about it later
that yes it can do this effectively but, also there is evidence from now more that 3 studies with magnetic resonance imaging that show the the incidence of ipslateral embolization is very low with this system. The quantity of the material is very low
and also the post procedural emoblisuent issue is practically eliminated. And this is some examples of intervascular imaging just note here that one of the differences between different systems is that, MicroNet can adapt to simple prolapse
even if it were to occur, making this plaque prolapse protected. Fact # 6 that I think is also very important is that the CGUARD system allows routine endovascular reconstruction of the carotid bifurcation and here is what I mean
as a routine CEA-like effect of endovascular procedure you can minimize residual stenosis by using larger balloons and larger pressure's than we would've used with conventional carotid stent and of course there is not one patient that this can be systematically achieved with different types of plaques
different types of protection systems and different patient morphologies Fact # 7 is that the level of procedural risk is the critical factor in decision making lets take asymptomatic carotid stenosis How does a thinking physician decide between
pharmacotherapy and intervention versus isolated pharmacotherapy. The critical factor is the risk of procedure. Part of the misunderstandings is the fact that we talk often of different populations This contemporary data the the vascular patients
are different from people that we see in the street Of coarse this is what we would like to have this is what we do not have, but we can apply and have been applying some of the plaque risk criteria Fact # 8 is that with the CGUARD system
you can achieve, systematically complication level of 1%, peri procedurally and in 30 days There is accumulating evidence from more than 10 critical studies. I would like to mention, Paradigm and Paradigm in-stent study because
this what we have been involved in. Our first 100 patient at 0.9% now in nearly 300 patients, the event rate is 1.2% and not only this is peri procedural and that by 30 days this low event rate. But also this is sustained through out
now up to 3 years This is our results at 36 months you can see note here, very normal also in-stent velocities so no signal of in-stent re stenosis, no more healing no more ISR signal. The outcome Difference
between the different stent types it is important to understand this will be driven by including high risk blocks and high risk patients I want to share with you this example you see a thrombus containing
a lesion so this patient is not a patient to be treated with a filter. This is not a patient to be treated with a conventional carotid stent but yes the patient can be treated endovascularly using MicroNet covered embolic prevention stent and this is
the final result. You can see that the thrombus is trapped behind the stent MicroNet and Final Fact there's more than that and this is the data that I am showing you for the first time today, there are unmet needs on other vascular territories
and CGUARD is perfectly fit, to meet some of those need. This is an example of a Thrombus containing a lesion in the iliac. This is the procedural result on your right, six months follow up angiogram. This is a subclavian with a lot of material here
again you can preform full endoovascular reconstruction look at the precession` of the osteo placement This is another iliac artery, you can see again endovascular reconstruction with normal 6 month follow up. This is another nasty iliac, again the result, acute result
and result in six months. This is another type of the problem a young man presented with non st, acute myocardial infarction you can see this VS grapht here has a very large diameter. It's not
fees able to address the native coronary issue here So this patient requires treatment, how to this patient: the reference diameter is 7.5 I treated this patient with overlapping CGUARD's This is the angio at 3 months , and this is the follow up at 6 months again
look at the precision of the osteo placement of the device ,it does behave like a balloon, expandable. Extending that respect, this highly calcific lesion. This is the problem with of new atherosclerosis in-stent re stenosis is wrongly perceived as
the proliferation of atheroscleroses tissue with conventional stents this can be the growth of the atherosclerotic plaque. This is the subclavian, this is an example of the carotid, the precise stent, 10 years down the line, symptomatic lesion here
This is not re stenosis this is in-stent re stenosis treated with CGUARD and I want to show you the final result at 2 years. I want to thank you for your attention. Say that also, there is the issue of aneurism that can be effectively addressed , Thank you
- [Gerry] These are my disclosures. When it comes to ilio-femoral deep vein thrombosis, many of us feel that is the most important area to treat. And some of us feel that the inflow is very important, in which case, you've got to worry about it. But if you feel that the inflow doesn't matter at all, then you can forget about it.
So that's for those of you who aren't from New York, that was my Irish accent on a New York, forget it. This is one of the ways to get into the below-knee veins, posterior tibial venous access. It looks quite easy, it's not quite so easy. Although there's two veins side by side,
you typically only get one chance at one vein because the other one goes into spasm. Pardon me, very sensitive mouse, like myself. You choose your wire of choice. I quite like the ED3 Nitrex. And then confirm that you are inside the veins,
because that happens all of the time to me. Those are funny looking veins because I've managed to puncture the artery. And which brings up one of the pitfalls, try not to puncture the artery. If you do manage to get into the vein,
you then insert a catheter and a catheter-directed thrombolysis after that is fairly standard. There's a few little tips and tricks in terms of stitching it in, using a small sheath is possible.
Heparin through the sheath, and then TPA through the infusion catheter. If you are fortunate enough to have the right length of catheter for the thrombus, then you can leave it at that length. Otherwise, you can pull it back
by 10 or 15 centimeters per day. And it typically takes three days to perform catheter-directed thrombolysis in this region. We always put on compression stockings, which sounds fairly basic, but it's important because it means that things don't get pulled.
And curious house officers and doctors don't have a good look at it and pull the whole thing out. Or the patient, for that matter. That's posterior tibial vein access, fiddley, tricky, easy to get into the artery, spasm is coming. You can do it with pharmaco-mechanical thrombectomy
using a 6 French device. The only one that I'm familiar with would be the AngioJet Solent, and not the newer Zelante. Views of the West of Ireland, not from this morning. Then if you want to switch tracks, how else can you get into the deep veins
of the lower extremities? Well, we're talking about improving the inflow, so we're going to now try and go from above and below. This is a patient with massive deep vein thrombosis. You'll see in just a second now. Thrombus starting here,
occlusive thrombus going to the profunda, occlusive thrombus down into the femoral, duplicated femoral vein, and then, most importantly, it goes into the below-knee popliteal. You might say why does this matter? Why do you care about the popliteal at all?
Well, I'm a bit old-school. I do believe that inflow matters quite a lot. Pardon me. So you can see a thrombus starts just here, a rather unusual place for a thrombus to start. Typically it starts much higher in the common iliac vein.
You can see it goes into the profunda femoris here. That's quite important technically, because the profunda is a very important vein in terms of long-term patency of the segment. And you can also see, lordy me, that it goes into the below-knee here as well.
This is what we call criss-cross. Fairly standard, fairly straight-forward, back of the knees, catheters into the popliteal vein from above and below. It sounds very easy, it's actually surprisingly difficult. The problem is that although you start very far apart, your two needles tend to approach
and you tend to puncture the vein in almost identical position, time and time again. So you have to start what feels like an awfully long way apart, in order to get some clearance between the two catheters. This is what you look like
when you're going to start catheter-directed thrombolysis. And what we're doing now, is we start catheter-directed thrombolysis at the bottom end, while working on the top end. The bottom sheath, rather the sheath facing inferiorly, is 6 French, with an infusion catheter
which is typically 20 centimeters long. And then this is a 10 French sheath going north. And through that you can perform AngioJet or whatever your thrombectomy device de jour is. Now this is an initial venogram of the below-knee veins and you can appreciate that there's very little inline flow
going from south to north. And you're seeing a whole lot of collaterals and very little flow going north at all. Pardon me. AngioJet works well here, although there are a variety of thrombectomy devices.
Then I must say I'm a big believer in aspiration. And you can get quite aggressive with a curved 8 French catheter. It sounds very basic, works very well. It's particularly useful, again, to go back to the profunda femoris inflow,
as well as the internal iliac. So this is what it looks like after aspiration. And you can see a rather unusual stenosis. And then, obviously, you need to go on to treat that. We start with our stent at the top to cover the iliac vein compression point,
and then carry on down here, and add a further stent down at the bottom. The inguinal ligament, I don't think is nearly as important as others feel. I think you you have to stent from flow to flow. And you can see that the final flow we've got here
at the end is quite satisfactory. Now this is when I say at the end, this is the end of the above-knee treatment. 'Cause you still haven't dealt with the below-knee veins. So you get your catheters running overnight, and you've got thrombolysis going north and south.
So this is your sort of set-up, your 10 French sheath going north with a catheter through it. A drain fix is quite useful for those of you who have access to that, to keep the catheter in position. And similarly going south, like this.
And this is what it looks like below beforehand, and this is what it looks like afterwards. You might think well, that doesn't really matter very much, but the popliteal vein will guarantee the success of your treatment. If you do not have a patent popliteal vein, in my view,
your success long-term is going to be much more guarded. And then, this is what it looks like from below, and the next morning. You can also appreciate that there's quite significant inflow now from the profunda. You can see the mixing just there, at the top up here.
So you've now guaranteed an inflow from above and below, but it takes two days, typically, because you've got to work one day on the above-knee segment and the second day on the below-knee segment. So could you move it on a bit?
Again, Galway, but not this morning because it was raining. You can do it as a single session criss-cross, so this is very similar to many of the arterial thrombectomies that you perform. I specialize in big, swollen, purple legs,
save the Speedos, they're not mine. But he's got a very, very swollen right leg. Rather unusual when somebody presents with a right leg tense phlegmasia. It starts to get me wondering, why should he have a right leg phlegmasia?
No specific reason. Left, obviously, would be straightforward. A CTV again, heading south here. Nothing really specific there, but you can appreciate this leg is very tense indeed. And there's thrombus in the femoral,
and most importantly, it goes down below-knee again. So you've got no inflow into your popliteal segment. If that popliteal vein is opened, it's a straightforward one hour, one and a half hour procedure. With a thrombosed popliteal vein, it's more difficult.
So here's the view of the external iliac vein, and here's the longitudinal curl reformat, showing A, a very swollen limb, and B, the length of the thrombus. In this case, again, you'd use the same criss-cross technique.
But this time, we were going to attempt a thrombectomy above and below. And starting off, you put a little catheter in here. Niggle it down as far down as you can, and just flush inject five, 10 milligrams of TPA while you're setting up your thrombectomy device.
That usually takes a few minutes. And in that meantime, you then can get to work. And this is just after five to 10 minutes of tissue plasminogen activator. You opened up some segment here. Then you get to work
with, as it happens in this case, the AngioJet. Not perfect, because our puncture points are very close to each other, but you can appreciate that we do have rapid inline flow. And this is over the course of 45 minutes or so. We're now up to about an hour
with, I think that's a Cook Zilver venous stent going from south to north. And this is his CTV, with a filter in situ. At six months, he has a widely patent vein. And the same on the sagittal reformat. You can appreciate that the stent is widely open.
In summary, there's pros and cons to both. First of all, you have to believe that the popliteal vein matters in terms of inflow. I do, I believe that inflow matters in terms of most vascular procedures. CDT is less labor intensive but costs more,
and there are the risks of thrombolysis. Pharmaco-mechanical thrombectomy is faster, and you can do all of your work in one go. But it certainly takes two hours of your time. Posterior tibial vein is more difficult than it it looks. There's lots of ways to skin this particular cat
and Fabritzio and I wrote a little book last year. If you're interested, you can learn more. Thank you so much.
- Okay, thank you. We know that inflammatory AAA have quite low incidence. The main problem is related to the thickness of the aortic wall and to the retroperitoneal fibrosis that involves the organs that are close to the aorta. Open surgery is quite difficult for these reasons. And these imply a higher mortality rate
that is threefold the one for standard AAA. And the higher morbidity related to the surgical dissection in fibrosis with risk of iatrogenic injury of the involved organs. So that some authors suggest the supraceliac clamping. That of course have some other issues.
A recent paper suggests that a pre-op treatment with a cortical steroid therapy can be useful to reduce inflammatory signs and so minimize the operative risk for these patients. On the other hand, endovascular treatment has been proposed since 1997 with different outcomes.
Certainly mortality rate is lower when compared to open surgery, and even the one year mortality is lower. But we have a problem with periaortic fibrosis that does not decrease as well as with open surgery. And there is some progression, in some cases, with higher nephrosis that leads
to other types of complication. This is not a standard. You see in this paper that there is no problem with periaortic fibrosis after endovascular treatment. But in other papers, the situation is different. There is a worsening fibrosis and even the development
of fibrosis after standard EVAR in patients with no history of inflammatory AAA. And certainly the phenotype eg4 seems to be related to a worse outcome after EVAR. So, based on this situation, what we have done in the last year is to use a systemic steroid protocol
for our patients with inflammatory AAA that is the same that is used for arteritis and retroperitoneal fibrosis. And you see how impressive is the situation in this case. We had only four days of therapy, and we have a decrease in periaortic fibrosis of 28%.
We studied all our patients with PET/CT. We made a comparison with the patient with standard AAA, and we observed an increased level of captation that was really significant. This is our population. All of the patients had immunological screening,
and the evaluation of the inflammatory level. This is the operative situation. All the patients had a good result with no mortality at 30 days. Only one patient died three months later for other reasons. And what we observed is that in almost all cases,
the periaortic fibrosis reduced significantly with the, even with PET/CT. All the patients were asymptomatic. And all the patients with hydronephrosis have a release of the situation. You see that the diameter of the aorta decreased
of 9.76 millimeters, and there was a decrease in periaortic fibrosis of more or less one centimeters. So this is really significant, as you can see. And there was a reduce in the uptake for all the patients but one. We don't know exactly, he had a type two endoleak.
Don't know if this can be a correlation because it's a single patient. And another patient stopped corticosteroid therapy, and so there was a recurrence of this problem. The CRP reduced globally, but of course, it's not specific. So in some patients we had an increase for other reasons.
But our policy now is that we do EVAR, when feasible, associated to steroid therapy. That, in our practice, is effective. We use open surgery in patients unfit for standard EVAR, and probably, even for these patients, steroid therapy can be a choice.
- [Francesco] We know that the pitfalls of balloon angioplasty and mostly of the atherosclerotic disease in BTK is characterized by long and multiple occlusions. The result of POBA depends on the residual dissection, elastic recoil, and residual, of course, narrowing. Let's say 20% of patients leaving the cath lab,
they have still mechanical problem inside. And these problems may lead to vessel re-occlusion in the first month. These type of failure are mainly due to unrecognized or underestimation of residual mechanical defect after angioplasty.
Drug-coated balloon may have an impact on restenosis, reducing late lumen loss, but have no potential to face any residual mechanical defect after angioplasty. This is, everyone knows the IDEAS trial, where you can see the drug-eluting balloon arm, post-procedure, has a residual restenosis,
approximately to 40%. So it's very easy to climb over 50% and get restenosis, despite a lower late luminal loss compared to drug-eluting stent. It's not functioning, the video, again. Okay.
So how can we perform an optimal DCB angioplasty? - [Man] No. It's not good. Are you using it here? Probably just go on. Try it.
- [Francesco] Yeah, okay. Thank you. So in this 79-year-od male, type 2 diabetes, hypertension, coronary artery disease, and Rutherford 5 CLI on the right foot. You can see that there is a blunt ostial occlusion
of the anterior tibial artery. And the reperfusion is at the level of the ankle and the dorsalis pedis, so very complex and tough occlusion for the entrance and for the exit of this occlusion. Our aim is to deliver the drug at the level of the intima media
and to keep the drug for antiproliferative effect, which is an antegrade approach 5 French sheath, an Advantage wire, Terumo 0.014 with a numbered wire balloon. We want to enter in the entrance, the proximal CTO cup with an intraluminal fashion.
We do the navigation of the body of the occlusion by a subintimal approach. And then we try to reentry in the distal segment by intraluminal fashion. We also have a distal retrograde TA puncture in case we fail the antegrade approach.
We'll do a predilatation according to the vessel size by duplex, one to one balloon/vessel ratio. And we will use a drug-coated balloon, same diameter as the largest uncoated balloon that we used. Always high pressure, more than 12 for a long time.
So this is the procedure. We entered in the central luminal in the proximal cup of the artery. Then we knuckle the wire, this Advantage wire. And this wire is, in my opinion, the best wire you can use for a BTK occlusions.
When you decide to go subintimal, you don't need to push with the metal of the wire, but with this wire, you can push with a very distal segment. So the damage that you make is not so big. You are joking with me. And so at the end, we can enter the lumen
by a central luminal approach in the distal segment. Then we deliver the balloon, and we open the vessel. And we achieve, let's say a good result with a dissection inside the vessel. We also can see that at the level of the foot, the perfusion is quite nice,
but we know we don't just angiography, so we check the duplex at the level of the proximal. But we can see that there is a decrease of the velocity from the ostium to the proximal segment. Let's say it's quite significant decreasing. And then the flow stays quite constant
for all the vessel size, except for the distal part, where we reentry, where we can see there is an acceleration of the flow. So this is the distal segment of the artery. You can see it pulsing. And we have a nice lumen we can measure,
the proximal, which is 3.4, and the distal segment, which is 3.2. So we can choose a 3.5 balloon. We take another picture before the balloon, and you can see that there are these two problems. One is at the level of the ostium of the anterior tibial,
and one is at the level of the exit of the subintimal navigation of the CTO. So we do, again, the balloon dilatation with a 3.5. We have a very good lumen up to now and a very good flow to the end of the lesions. Then we can check, and there
is no more acceleration in the proximal and no more acceleration in the distal segment. So we achieved what we call an optimal angioplasty result from the anatomy, so the angiography, and from the functional point of view. We can deliver the drug-eluting balloon.
In this case, there is a twisting of the drug-eluting balloon, so we took another drug-eluting balloon where there was a bubble. But anyway, we deliver it, all drug-eluting balloon, for the entire long, long lesion
of the anterior tibial artery, and the result is quite, let's say, excellent. We have a very good flow to the distal. Maybe it will come, maybe not. And we can check, before one month, the result of the duplex.
And you can see that the, from a monophasic flow, it becomes a biphasic flow from the proximal to the distal segment, because what this appears is the maximal vessel dilatation that the foot had in condition of a good limb ischemia. And the result at six months, in red is the six months,
and yellow is the baseline. As you can see, at six months, the vessel is perfect, and comparing to the baseline procedure. And also, the distribution of the flow at the level of the foot increased a lot at six months compared to the past procedure.
So defining an optimal balloon angioplasty by duplex is one of the most important features that we have nowadays. In this long occlusion of the anterior tibial artery, the immediate result is good, and the flow is excellent. So you can deliver the drug-eluting balloon, and you can see that six months,
there is no late luminal loss. Vessel is patent. In this other case of anterior tibial occlusions, also blunt ostium and very long. We deliver the balloon, the drug-eluting balloon. The angiography is quite nice, no residual stenosis,
but a duplex tell that there is an acceleration of the flow at this level, in the distal segment of the artery, very significant acceleration. So you can follow this acceleration at one month that is getting worse, and also at three months that the vessel is occluded.
So we do another angiography. You see the vessel is completely open, except in the point where we had the acceleration after the procedure. So in conclusion, DCB angioplasty works for BTK as much as you do a proper vessel preparation
and balloon sizing. Optimal PTA result is a must. Duplex ultrasound is a fundamental tool for diagnosis, treatment, and followup in peripheral intervention, particularly in BTK. Duplex can enrich angiography evaluation.
And optimal duplex after DCB seems to predict success on long-term. Due to its safety, can be used for patency surveillance and indication for reintervention, so we should get skilled. Thank you.
- Thank you friends who have invited me again. I have nothing to disclose. And we already have published that as far as the MFM could be assumed safe and effective for thoracoabdominal aneurysm when used according to the instruction for use at one, three, and four years. Now, the question I'm going to treat now,
is there a place for the MFM? Since 2008, there were more than 110 paper published and more than 3500 patient treated. 9 percent of which amongst the total of published papers relating the use of the MFM for aortic dissections. So, we went back to our first patients.
It was a 40 year old male Jehovah Witness that I operated in 2003 of Type A dissection and repair with the MFM in 2010 because he had 11 centimeter false aneurysm. Due to his dissection, this patient was last to follow up because he was taking care full time off of
his severe debilitated son. When we checked him, the aneurysm seven years later shrunk from 11 to 4 centimeters wide. And he's doing perfectly well. Then the first patient we treated seven years ago, same patient with Professor Chocron
Type A dissection dissection repair in 2006. Type B treated with MFM in 2010. We already published that at one year that the patient was doing fine. But now, at three and seven years, the patient was totally cured.
The left renal artery was perfused retrogradely by aspiration. That's a principle that has been described through the left iliac artery. So what's next? Next there was this registry
that has been published and out of 38 patients 12 months follow up, there were no paraplegia, no stroke, no renal impairment, and no visceral insult. And at 12 month the results looked superior
to INSTEAD, IRAD and ABSORB studies. This is the most important slide to us because when you look at the results of this registry, we had 2.6 percent mortality at 30 days versus 11 30 and 30.7 no paraplegia, no renal failure, and no stroke vessel
13 to 12.5. 33 and 34 and 13 and 11.8 percent. With a positive aortic remodeling occurring over time with diminishing the true lumen increasing the true lumen and increasing the false lumen.
And so the next time, the next step, was to design an international, multicenter, prospective, non-randomized study. To treat, to use the MFM, to treat the chronic type B aortic dissection. So out of 22 patients to date,
we had mainly type B and one type A with no dissection, no paraplegia, no stroke, no renal impairment, no loss of branch patency, no rupture, no device failure, with an increase in true lumen and decrease in false lumen that was true at discharge.
That was true at one, three, and six and 12 month. And in regards with the branch occluded from the parts or the branches were maintained patent at 12 and all along those studies. So, of course these results need to be confirmed in a larger series and at longer follow up,
yet the MFM seems to induce positive aortic remodeling, is able to keep all branches patent during follow-up, has been used safely in chronic, acute, and subacute type B and one type A dissection as well. When we think about type B dissection, it is not a benign disease.
It carries at 20 percent when it's complicated mortality by day 2 and 25 percent by day 30. 30 percent of aortic dissection are complicated, with only 50 percent survival in hospital. So, TEVAR induces positive aortic remodeling, but still causes a significant 30 day mortality,
paraplegia event, and renal failure and stroke. And the MFM has stabilized decreased the false lumen and increase the true lumen. Keeps all the branch patent, favorize positive aortic remodeling. So based on these data, ladies and gentleman,
we suggest that the MFM repair should be considered for patients with aortic dissection. Thank you very much.
Disclaimer: Content and materials on Medlantis are provided for educational purposes only, and are intended for use by medical professionals, not to be used self-diagnosis or self-treatment. It is not intended as, nor should it be, a substitute for independent professional medical care. Medical practitioners must make their own independent assessment before suggesting a diagnosis or recommending or instituting a course of treatment. The content and materials on Medlantis should not in any way be seen as a replacement for consultation with colleagues or other sources, or as a substitute for conventional training and study.