- Great, thank you very much. Thanks to Dr. Veith for inviting me to speak. Thank you Dr. Weinberg for that wonderful introduction. I'm Eric Secemsky from Boston Beth Israel. I have no relevant disclosures. In a brief, this is a very important take home for how much we're spending on our PAD patients.
This is a new study looked at all pairs, private, Medicare, and Medicaid pairs, and we're looking at annual total and inpatient expenditures for their healthcare. As you can see here, there is an extremely disproportionate amount of money that we're spending
on PAD patients compared to those who do not have PAD. I'll summarize it as we spend more than twice on annual care for our PAD patients, and a large bird of that is inpatient care. This is data from the Reach Registry, which means it's been around for awhile.
The most important group here are the ones I'm going to mark, the ones in maroon. Those ones in maroon are the patients who we know have been touched by us in the hospital. They've had an intervention of some sort, a stent or a graft,
and these are the patients that keep coming back. So you don't really need a lot of patients in your clinic if you have patients like these, because you're going to have them in your lab every six months and these are the ones that are really contributing to our healthcare burden and costs.
So where is the biggest chunk of that care being spent? Surprisingly, a lot of it is on readmissions. Over the last couple of years we've spent a lot of focus on readmission care for a lot of non-surgical procedures like heart failure and pneumonia. But we haven't talked too much about those
that undergo procedural care. If you look at patients who come into a hospital, an inpatient hospital, for a peripheral vascular revascularization, 17.6. So one in six are readmitted within 30 days. One in six patients are going to be back to your hospital
in 30 days and admitted for some complication or cause. You can slice and dice this number. Endo only, a hybrid procedure, surgery, critical ischemia, plus or minus 5% across all of them. But that rate still is incredibly high. Why do we care about this?
Well, first off, one in five patients, when they're readmitted are undergoing another procedure, whether that's another stent, whether that's a graft, whether that's an amputation. One in five makes it back to either the procedure room or the OR.
One in 20 die. One in 20 patients who undergo revascularization procedure die within 30 days when they're rehospitalized. That's an incredibly high number. And again, back to money. $11,000 is spent per rehospitalization.
If you weight that nationally, that's $400 million it costs that we're spending on readmissions for patients. So this is an incredibly palpable and prevalent problem. It deserves a lot of attention. Why are patients being readmitted? I tell people one in five of your patients
is going to be readmitted. Why? Well, it's not me. It's something about them. That's what I always hear. So this is the top causes.
Procedural complications, sepsis, diabetes, gangrene, congestive heart failure, peripheral atherosclerosis. What's the most common cause? By far and away procedural complications. 28% for all comers, surgical or endo,
being revascularized in a hospital are readmitted from a procedural complication. You could break it down. Endo, it's smaller. Obviously, 16%. Surgery, it's greater.
It's 40%. But still, procedural complications, which in theory should be avoidable, are driving these readmissions. Next question people say is, well yeah, that's fine for the country,
but it's not our institution that has that number. Right, someone else. There's obviously a dispersion in risk, and our case mix is higher. But we do a better job taking care of our patients. So how do we treat that question.
Well, we risk-standardize all our patients. We take every institution in the country, we level the playing field, we risk-standardize and recompare the rates between institutions. We say if there's a big dispersion in risk,
if there's a lot of outliers, then maybe there's some healthcare quality that's contributing to why they're being readmitted. But if they're pretty similar, then really, this is a patient and procedure issue. It's not a healthcare quality issue.
This is what that distribution looks like. Again, these are risk-standardized readmission rates on the X-axis and we're looking at the range. We want to see how wide that range is. How many outliers are there? You can see the range is pretty tight.
Between 25th and 75th percentile there's only about a 2% difference in the risk of readmission after standardizing for case mix. So what that tells us is this is really not a healthcare quality issue, like pneumonia and heart failure.
This is more of patient population issue. We really need to focus on how to take these high risk patients and keep them out of the hospital. So what can we do? These are just some take homes. A lot of these are what we've incorporated from
the heart failure data in terms of reducing readmissions. The most important thing is identifying those high-risk patients before they leave the hospital. We know these people. Diabetics, the renal disease. The critical ischemia patients obviously
are incredibly important. We need to target those for our interventions. We need close post-discharge follow-up. But everybody knows this. We also need greater use transitional care. Greater than 50% of people
are discharged home without resources. Lastly, we really need a multi-disciplinary approach to how we take care of our peripheral care disease patients. I'm out of time, but thank you very much for listening.
- Good morning, thank you very much to Dr. Veith and Professor Veith and the organizers. So this is real holography. It's not augmented reality. It's not getting you separated from the environment that you're in. This is actually taking the 3D out of the screen
so the beating heart can be held in the palm of your hand without you having to wear any goggles or anything else and this is live imaging. It can be done intra-procedure. This is the Holoscope-i and the other one is the Holoscope-x
where in fact you can take that actually 3D hologram that you have and you can implant it in the patient and if you co-register it correctly then you can actually do the intervention in the patient
make a needle tract to the holographic needle and I'm going to limit this to just now what we're actually doing at the moment and not necessarily what the future can be. This is ultimate 3D visualization, true volumes floating in the air.
This is a CT scan. So it started working, So we get rid of the auto-segmented and you can just interact. It's floating 45 centimeters away from you and you can just hold the patient's anatomy here and you can slice into the anatomy.
This is for instance a real CT of an aorta with the aortic valve which they wanted to analyze for a core valve procedure. This is done by Phelps. If you take the information
and they've looked at the final element analysis and interaction between the stem and the tissue. So here you can make measurements in real time. So if you did the 3D rotation and geography and you had the aorta and you wanted to put in a stent graft EVAR TVAR, and you would see,
and you could put in a typical tuber that you would do, and you could see how it, and this is a dynamic hologram, so you can see how it would open up, you can mark where your fenestration's chimney is and all that type of stuff would be. And you can move it around, and you have
a complete intuitive understanding of a, can we go to the next slide please, I can't, it seems to be clicking, thank you. So how do we do all this? Well, to create a hologram, what you need to do is just conceptualize it as printing in light.
Like if you had plastic and you took the XYZ data and you just put it into a 3D printer, and it would print it for you in light, then you'd go, Okay, so I understand, if it was printed for you in plastic then you'd understand. But imagine it's printing in light.
So we have every single piece of light focused, each photon is focused so that you can see it with a naked eye, in a particular place, but the difference is that it's totally sterile, you don't have to take off your gloves, you don't have to use a mouse,
you can interact with it directly. And all the XYZ data is 100% in place, so we've just seen a beautiful demonstration of augmented reality, and in augmented reality, you have to wear something, it isolates you from the environment that you're in, and it's based on
stereoscopy, and stereoscopy is how you see 3D movies, and how you see augmented reality, is by taking two images and fusing them in one focal plane. But you can't touch that image, because if you look at me now, you can see me very well, but if you hold your finger up 45 centimeters
and you focus on your finger, I become blurred. And so, you can only focus in one plane, you can't touch that image, because that image is distant from you, and it's a fused image, so you have the focus plane and you have the convergence plane, and this is an illusion
of 3D, and it's very entertaining, and it can be very useful in medical imaging, but in intra-operative procedures it has to be 100% accurate. So you saw a very beautiful example in the previous talk of augmented reality, where you have gesturing, where you can actually gesture with the image,
you can make it bigger, you can make it smaller. But what RealView does by creating real holography, which is all the XYZ data, is having it in the palm of your hand, with having above 20 focal planes, here, very very close to your eye, and that in another way, of having all those focal planes not only actually lets you
do the procedure but prevents nausea and having a feeling of discomfort because the image is actually there as of having the illusion of the images there. So just to go back, all RealView imaging is doing, is it's not changing your 3D RA cone, BMCT, MRI,
we can do all those XYZ datas and we can use them and we can present them, all we're doing, so you use your acquisition, we're just taking that, and we're breaking open the 3D displays and seeing all that 3D data limited in the 2D screen, let's set it free and have it floating in the air.
So we have the holoscope-i for structural cardiology and electrophysiology, and obviously the holoscope-x, which makes the patient x-rayed, completely visible. So its an over the head, this is now, obviously, free-standing when somebody buys us like Phillips or Siemens, it will be integrated into your lab,
come down from the ceiling, it's an independent system, and you just have a visor that you look through, which just goes up and down whenever you want to use it. You can interact with it the same as you do with your iPhone you can visualize, you can rotate, you can mark, you can slice, you can measure, as I showed you
some examples of it, and you can do this by voice as well, you just talk to it, you say slice and you slice it with your hand, it recognizes everybody's hand, there's no delay for whatever you're imaging. So structural cardiac procedures, this is what
a mitral valve will look like, floating in the air in front of you, you can see the anterior leaflet, the posterior leaflet. And once the catheter is inside and you're guiding the catheter inside the procedure, you can turn on your doppler, you'll be able to see that the catheter
movements, so for someone doing a mitral clip, or whatever, this would be very very useful. This is an electrophysiological procedure, and you can see how the catheter moves, when the catheter will move, and obviously, as my previous speaker was saying, you are appreciating 3D in a 2D screen,
so it's very difficult to appreciate, you'll have to take my word for it. But I think you can see dynamic colography at this quality, that you can interact with, that is something that is very special, we've presented at a number of conferences,
including at Veith, and we've already done a first in man, and the most exciting thing for now, is just this week, the first machine was installed at Toronto general, at the Peter Munk Cardiac Center, and they've done their first case, and so now we are launching and clinical trials in 2018, and hopefully,
I'll have something which is more vascular relevant, at the next time, Veith 2019, thank you very much.
- It's my pleasure on behalf of the Sentury Trial investigators to present the two year data on the BTG Novate Sentry filter. These are my disclosures. Well, as we have heard this afternoon, it's no surprise to anyone the topic of IVC filter placement is controversial.
We know that IVC filters can protect patients by preventing PE. We also know that retrievable filters that are not retrieved have been reported to have, be associated with some complications. And we talked about FDA advisory,
obviously that has resulted somewhat in a decrease in filter use in this country. Obviously complication rates we've also heard about increase with implant time and include tilting, migration, fracture, perforation and embolization. And retrieval success reduces with implant time.
What's not controversial, and we have heard also about this, is the frequency of PE in this country and the expense associated with it. Obviously, survival benefits have been shown in appropriate populations, that are selected based on known indications. And existing retrieval technology, unfortunately,
as we've heard from Dr. Askandari, has not met the needs of patients when up to 40 to 50 percent are not coming back for retrieval. That was sort of the impetus behind the design of the Sentry Bioconvertible IVC Filter, which is designed to protect patients at transient risk
from PE and reduce complications of existing technologies. It employs a stable frame with filter arms held together by a bioabsorbable filament and designed to provide PE protection during a transient risk period, reduce IVC filter complications, including tilting, migration, fracture, perforation and embolization.
And this just shows an example in vitro and with a CT scan of the filter in the so-called filtering configuration. The filter then automatically bioconverts after the PE risk period is past. That's guaranteed to be in the
filtering position for at least 60 days. It bioconverts by hydrolysis of the bioabsorbable element, which allows the filter arms to retract to the IVC wall, leaving a patent lumen and reducing the risk for IVC occlusion or thrombosis later on, and obviously, the cost of IFC filter retrieval.
Here you can see filters that are in the bioconverted configuration. This just shows the deployment. It's a simple pin and pull seven French delivery system. These stable arms allow this to be placed almost always without any tilting
and is quite easy and accurate to deploy. This is in an ovine modeled pre-clinical study shows in a bioconverted configuration all of the filter elements become endothelialized and in this angioscopic view, really can't even see any of the filter elements.
This is again sort of predicated on something that I believe we're not all that familiar with and that's when the timing of PE occurs. And you can see here, from the trauma literature, orthopedic literature, other literature, on 500,000 patients and in these groups you can see
that over 90 percent of PEs take place in less than 10 days after an initial event and 99 percent of PEs within 20 days. That led the FDA to write a position decision analysis paper, which recommend filter retrieval between
29 and 54 days after implantation. So, on s, 23 sites, 63 operators. You can see this was a relatively imaging-intense protocol with 24 month CT Venogram and CT Venograms also at one month and six months.
Long term follow up, 94 percent of the eligible subjects were imaged at 24 months. You can see that 67.5 percent of the subjects had current PE and/or DVT at the time of enrollment, and 100 percent had contraindication to anticoagulation for some or all of the protection period.
In terms of the composite primary endpoint, there was a high degree of technical success, 100 percent of the patients received the device. 100 percent freedom from new symptomatic PE to 60 days. Two patients had symptomatic caval thrombosis at 8
by angiojet, one by EKOS. And there was no tilting, migration, embolization, fracture or perforation. At 12 months there were no new symptomatic PEs and there were no device related complications out to 12 months.
And at 24 months, two new symptomatic PEs, days 581 and 632,in patients with fully bioconverted filters. There were no device related out to 24 months. Both of these were adjudicated by a clinical events committee as not being device related.
And again, you can see that the bioconversion rate of 96.5 percent compares favorably to published retrieval rates, and we've talked about that. So, in conclusion, the primary endpoint at six months was met with clinical success of 97.4 percent. No new symptomatic PEs at 12 months.
2.4 new symptomatic PEs at 24 months, but no tilting, migration, perforation, fracture or embolization. And the 96.5 percent bioconversion rate compares favorably to published retrieval rates. Thanks very much.
- Thank you chairman, ladies and gentlemen. I have no conflict of interest for this talk. So, basically for vTOS we have the well known treatment options. Either the conservative approach with DOAC or anticoagulation for three months or longer supported by elastic stockings.
And alternatively there's the invasive approach with catheter thrombolysis and decompression surgery and as we've just heard in the talk but Ben Jackson, also in surgeons preference, additional PTA and continuation or not of anticoagulation.
And basically the chosen therapy is very much based on the specific specialist where the patient is referred to. Both treatment approaches have their specific complications. Rethrombosis pulmonary embolism,
but especially the post-thrombotic syndrome which is reported in conservative treatment in 26 up to 66%, but also in the invasive treatment approach up to 25%. And of course there are already well known complications related to surgery.
The problem is, with the current evidence, that it's only small retrospective studies. There is no comparative studies and especially no randomized trials. So basically there's a lack of high quality evidence leading to varying guideline recommendations.
And I'm not going through them in detail 'cause it's a rather busy slide. But if you take a quick look then you can see some disparencies between the different guidelines and at some aspects there is no recommendation at all,
or the guidelines refer to selected patients, but they define how they should be selected. So again, the current evidence is insufficient to determine the most clinically and cost effective treatment approach, and we believe that a randomized trial is warranted.
And this is the UTOPIA trial. And I'm going to take you a bit through the design. So the research question underline this trial is, does surgical treatment, consisting of catheter directed thrombolysis and first rib section, significantly reduce post-thrombotic syndrome
occurrence, as compared to conservative therapy with DOAC anticoagulation, in adults with primary upper extremity deep vein thrombosis? The design is multicenter randomized and the population is all adults with first case of primary Upper Extremity
Deep Venous Thrombosis. And our primary outcome is occurrence of post-thrombotic syndrome, and this the find according the modified Villalta score. And there are several secondary outcomes, which of course we will take into account,
such as procedural complications, but also quality of life. This is the trial design. Inclusion informed consent and randomization are performed at first presentation either with the emergency department or outpatient clinic.
When we look at patients 18 years or older and the symptoms should be there for less than 14 days. Exclusion criteria are relevant when there's a secondary upper extremity deep vein thrombosis or any contra-indication for DOACs or catheter directed thrombolysis.
We do perform imaging at baseline with a CT venography. We require this to compare baseline characteristics of both groups to mainly determine what the underlying cause of the thrombosis being either vTOS or idiopathic.
And then a patient follows the course of the trial either the invasive treatment with decompression surgery and thrombolysis and whether or not PTA is required or not, or conservative treatment and we have to prefer DOAC Rivaroxaban or apixaban to be used.
Further down the patient is checked for one month and the Villalta score is adapted for use in the upper extremity and we also apply quality of life scores and scores for cost effectiveness analysis. And this is the complete flowchart of the whole trial.
Again, very busy slide, but just to show you that the patient is followed up at several time points, one, three, six, and 12 months and the 12 months control is actually the endpoint of the trial
And then again, a control CT venography is performed. Sample size and power calculation. We believe that there's an effect size of 20% reduction in post-thrombotic syndrome in favor of the invasive treatment and there's a two-side p-value of 0.05
and at 80% power, we consider that there will be some loss to follow up, and therefore we need just over 150 patients to perform this trial. So, in short, this slide more or less summarize it. It shows the several treatment options
that are available for these patients with Upper Extremity Venous Thrombosis. And in the trial we want to see, make this comparison to see if anticoagulation alone is as best as invasive therapy. I thank for your attention.
- Dear Chairman, Ladies and Gentlemen, Thank you Doctor Veith. It's a privilege to be here. So, the story is going to be about Negative Pressure Wound Non-Excisional Treatment from Prosthetic Graft Infection, and to show you that the good results are durable. Nothing to disclose.
Case demonstration: sixty-two year old male with fem-fem crossover PTFE bypass graft, Key infection in the right groin. What we did: open the groin to make the debridement and we see the silergy treat, because the graft is infected with the microbiology specimen
and when identified, the Enterococcus faecalis, Staphylococcus epidermidis. We assess the anastomosis in the graft was good so we decided to put foam, black foam for irrigation, for local installation of antiseptics. This our intention-to treat protocol
at the University hospital, Zurich. Multi-staged Negative Pressure for the Wound Therapy, that's meets vascular graft infection, when we open the wound and we assess the graft, and the vessel anastomosis, if they are at risk or not. If they are not at risk, then we preserve the graft.
If they are at risk and the parts there at risk, we remove these parts and make a local reconstruction. And this is known as Szilagyi and Samson classification, are mainly validated from the peripheral surgery. And it is implemented in 2016 guidelines of American Heart Association.
But what about intracavitary abdominal and thoracic infection? Then other case, sixty-one year old male with intracavitary abdominal infection after EVAR, as you can see, the enhancement behind the aortic wall. What we are doing in that situation,
We're going directly to the procedure that's just making some punctures, CT guided. When we get the specimen microbiological, then start with treatment according to the microbiology findings, and then we downgrade the infection.
You can see the more air in the aneurism, but less infection periaortic, then we schedule the procedure, opening the aneurysm sac, making the complete removal of the thrombus, removing of the infected part of the aneurysm, as Doctor Maelyna said, we try to preserve the graft.
That exactly what we are doing with the white foam and then putting the black foam making the Biofilm breakdown with local installation of antiseptics. In some of these cases we hope it is going to work, and, as you see, after one month
we did not have a good response. The tissue was uneager, so we decided to make the removal of the graft, but, of course, after downgrading of this infection. So, we looked at our data, because from 2012 all the patients with
Prostetic Graft infection we include in the prospective observational cohort, known VASGRA, when we are working into disciplinary with infectious disease specialist, microbiologists, radiologist and surgical pathologist. The study included two group of patients,
One, retrospective, 93 patient from 1999 to 2012, when we started the VASGRA study. And 88 patient from April 2012 to Seventeen within this register. Definitions. Baseline, end of the surgical treatment and outcome end,
the end of microbiological therapy. In total, 181 patient extracavitary, 35, most of them in the groin. Intracavitary abdominal, 102. Intracavitary thoracic, 44. If we are looking in these two groups,
straight with Negative Pressure Wound Therapy and, no, without Negative Pressure Wound Therapy, there is no difference between the groups in the male gender, obesity, comorbidity index, use of endovascular graft in the type Samson classification,
according to classification. The only difference was the ratio of hospitalization. And the most important slide, when we show that we have the trend to faster cure with vascular graft infection in patients with Negative Pressure Wound Therapy
If we want to see exactly in the data we make uni variant, multi variant analysis, as in the initial was the intracavitary abdominal. Initial baseline. We compared all these to these data. Intracavitary abdominal with no Pressure Wound Therapy
and total graft excision. And what we found, that Endovascular indexoperation is not in favor for faster time of cure, but extracavitary Negative Pressure Wound Therapy shows excellent results in sense of preserving and not treating the graft infection.
Having these results faster to cure, we looked for the all cause mortality and the vascular graft infection mortality up to two years, and we did not have found any difference. What is the strength of this study, in total we have two years follow of 87 patients.
So, to conclude, dear Chairman, Ladies and Gentlemen, Explant after downgrading giving better results. Instillation for biofilm breakdown, low mortality, good quality of life and, of course, Endovascular vascular graft infection lower time to heal. Thank you very much for your attention.
- [Evan] So today I'm going to talk about Episode Based C because a hemodialysis access measure is currently under development as we speak. This is not technically a disclosure but I do represent the SVS and serve as a co-chair for the Peripheral Vascular Disease Management Clinical subcommittee for Acumen, who's
consultants to CMS, and that will become clear in a minute. In the past, all of us had our cost accountability through the Value-based Modifiers in the old system, but going forward with MACRA, physicians have to choose to participate in an Alternative Payment Model or in a Merit-based Incentive Payment System.
Now in Alternative Payment Models, this is where, as a physician or a group, you share the risk for the possibility of higher gains, and this is exemplified by such things as Accountable Care Organizations, it requires a rather hefty investment of resources, time in order to do this, so most of us will wind up in the MIPS, the Merit-based Incentive
Payment System, and if you do wind up there, your cost accountability is going to be a composite score in these four areas: Quality, Resource Use, which is cost and that's what we're talkin actice Improvement, and Advancing Care.
So by way of background, CMS contracted with Acumen to develop episode-based cost measures. They established Clinical Disease Management Subcommittees, who received input from a Technical Expert Panel, Person-Family committee, which is patients and their families, as well as public commentary with
the goal of selecting one to two episode groups. The measures were developed in waves, which correspond to a given year, and these measures should be high impact. In other words, they should encompass a large number of Medicare beneficiaries, a large number of providers, and have a significant cost impact.
Measures are then eligible for the MIPS cost performance category in the Quality Payment Program, and the Peripheral Vascular Disease group was tasked with choosing between Limb ischemia, Aneurysms, Carotids, Filters, and Hemodialysis Access. In the first wave, which occurred in 2017, you can see there
were seven Disease Management Subcommittees. The Vascular subcommittee chose to focus on Critical Limb Ischemia, the committee had 22 members representing 19 specialty areas, and for this year, the second wave in 2018, Hemodialysis Access Creation was chosen as the measure. So what's an episode group? An episode group is
defined by an acute inpatient condition, like an MI, a chronic condition like COPD, or a procedure, Hemodialysis Access Creation. Cost Measures are Medicare payments during this entire episode and informs clinicians of the cost they're responsible for and allows for
comparison between physicians. It's calculated using Medicare claims data only, so there's no additional reporting burden. These are the basic steps in Cost Measure Development. There are some others, but we'll go through them one by one. The first is to define the episode group,
and for surgical procedures it's more or less straightforward, because you wind up with the CPT codes for the procedures that are encompassed, and you can see these are the CPT codes here that were chosen for this measure. Next, because episodes include more than just the day of
surgery, you have to establish pre- and post-trigger episode windows. These are look back and look forward periods for which related services are included. The Hemodialysis Measure actually has some variability here in that the pre-trigger window can extend as far back as
three days for things like basic labs, all the way back to 60 days for things like a cardiac echo, and the post-trigger window can go forward one day for something like anemia, but up to 180 days for a re-do procedure. Then, because these groups or the procedures tend to be somewhat heterogeneous, you have to define subgroups.
In other words, make the groups more homogeneous while maintaining enough episodes to make the measures meaningful, and in this case we have two basic subgroups: fistulas and grafts. Then you go ahead and define exclusions. So HeRO grafts really can't be compared to either these two
basic groups, so they're excluded, although any excluded procedure is eligible for use in future waves. The next steps include attributing episodes to given clinicians, so the responsibilities assigned based on either Tax Identification Number of groups or ind
e episode are assigned, these are the costs included within the episode and these are based on the role of the attributed clinician, and then risk adjusted for factors that are outside the clinician's control, such as the patient's medical status. This is kind of a schematic of the Hemodialysis episode.
Here in the big, blue triangle this is the trigger service, so is either the creation of a graft or a fistula (HeROs are lated to this can then either be assigned to the episode or not assigned to the episode, and all services that are assigned can either
be attributed to the clinician performing the procedure, or to other clinicians. For example, a balloon maturation or a de-clot done by another physician is attributed as part of the cost to the service, but not the attributed clinician. Services that are not assigned to an episode are generally
only attributable to other clinicians and providers, and the pre-trigger window as we mentioned three to 60 days, post-trigger one to 180 days. Then a score is reported, and in general before the measures go live, there's a field testing period, and this is a sample field test, it's actually
for Hip Arthroplasty, and what you see here is a couple of things: first of all, this particular group has 161 episodes, usually the minimum is somewhere between ten and 30 episodes that are required. The Risk Adjusted Expected National costs here are estimated, about $19,000, and then the actual costs for this
group were estimated here, and you see this group had a cost of $21,000, so their relative performance is 12% more expensive than the national average. There are other details in these reports that get dri n see they
break out your costs by different aspects of care. Then the next thing is what's the timeline of all of this? Here in the orange brackets you see this is the MIPS, these are the four elements for which your composite score is based, and again we're talking about cost here. So in 2019, for providers participating in the MIPS,
you are eligible either for a four percent bonus, or a four percent penalty based on this performance score. And as you march this out to 2022, that increases to plus or minus nine percent. And the APMs you see here are in a separate category. In summary, these measures are part of the MIPS cost
performance category, they are based only on claims data, the Peripheral Vascular Disease Management subcommittee was charged with measure development, the Wave One measure for chronic Critical Limb Ischemia has been proposed for use in the Quality Payment Program in 2019. Ultimately, all these measures are to align
with quality measures, but of course this depends upon either the presence or development of quality measures that are meaningful and can correlate with some of these specific episodes. I can tell you the measure development is tedious, it's complex, you go very deep in the weeds,
and a big point for CMS and for those developing has been to avoid creating unwanted incentives which result in unintended consequences, and if you'd like more information, these articles in the JVS "Under the Macroscope" can give you more detail into this and other programs. Thank you.
- Thank you very much for the very kind invitation, and I promise I'll do my best to stick to time. The answer is probably to this audience I don't really need to say very much about the ATTRACT trial, but I think it is quite important to note that the ATTRACT trials have now been out for some time, and it is constantly being
talked about in its various dimensions. So I'm going to just spend a few seconds really talking about the ATTRACT trial. A large number of patients screened. One in 41 patients were actually recruited into it and it was a trial that ran for a long time.
Wasn't really with respect to the primary endpoint any particularly good evidence, but for those people who had moderate or severe post-thrombotic syndrome, it probably was of benefit. And if you looked at the Villalta score
and the VCSS scores there was some evidence to support it. So overall, probably some positive take-home messages, but not as affirmative as people would have thought. Now the reason that I've dwelled a little bit on that is that actually, what do we mean when we talk about the post-thrombotic syndrome?
Because I would say in the upper limb, because I have never personally seen an ulcer in the upper limb. Has anybody seen an ulcer in the upper limb due to venous disease? No.
So in a way we are talking about a slightly different entity. We are talking about a limb that has undoubtedly much more finer movements. And there was depression by some people with the results of the ATTRACT trial.
But when you look at the five year results from the CaVenT trial, there was some evidence to suggest that actually, as you get further out, there may be some benefit. If you look at this summation analysis, and I completely accept this is related to the leg,
again, there may be some benefit from the CDT. Now, this is a case of mine. Now I wonder if any of you can tell me how many stages may have been involved from going from the right, to having a ballonplasty in the vein. Pick a number, anywhere between five and ten.
The answer is you have numerous checks of the thrombolysis, you may have a venoplasty, you might have a first rib excision. You may then have occlusion and then realize this before you go on and do the first rib. So all I'm suggesting to you that this is not
a cheap treatment to offer patients treatment to the upper limb. Then we looked forward to some help from the guidelines. Well we look at the American guidelines and give or take, I think the answer is we probably shouldn't be doing it and that we should be only offering anticoagulation.
So do the Brits help? Well actually if you look at the Brits, it sort of says well, you can think a bit about doing decompression, but really if I was standing up in a court of law, I really wouldn't want much support from this guideline
that I had done the right thing. And then the International Society of Thrombolysis and Hemostasis really says well, you can do a little bit of this that thoracic outlet syndrome may be a risk factor. But give or take, surgeries still are a little bit dubious.
So, really there's one good review out there, and this is the review of Vasquez that basically looked at 146 articles, and they found some data on just under 1300 patients. And they postulated and chose some evidence to suggest that there was some evidence
that first rib excision and thrombolysis reduce PTS, and that anticoagulation alone was not enough for the majority of the patients. Very difficult to work out how you selected which patients you should or should not intervene on. Now, I'm sure everybody is rather sick and tired
of me talking about money, and I accept it doesn't really apply here. But money is actually quite important. Five interventions to prevent something that may not happen and at worst may be just a few collateral veins across the chest.
So ladies and gentlemen, I would want you to think very hard, is it actually cost-effective to be offering all patients presenting with an early auxiliary vein thrombosis thrombolysis, and then subsequently first rib excision? These are some of the truths, I think the answer is
it does seem to work. You do need to recognize and make the diagnosis. Usually delayed thrombolysis doesn't work, but there are lots of questions that are unanswered. And how would you defend what you have done in a court of law?
Somebody has a stroke, you then do the first rib, they get a large hemothorax, and they then die because there had been too much TPA on board. Yes, give it some thought. So ladies and gentlemen, I'm afraid I haven't actually answered the question,
but I think you need to give it careful consideration, what are the indications and merits? Thank you very much.
- I'd like to share with you our experience using tools to improve outcomes. These are my disclosures. So first of all we need to define the anatomy well using CTA and MRA and with using multiple reformats and 3D reconstructions. So then we can use 3D fusion with a DSA or with a flouro
or in this case as I showed in my presentation before you can use a DSA fused with a CT phase, they were required before. And also you can use the Integrated Registration like this, when you can use very helpful for the RF wire
because you can see where the RF wire starts and the snare ends. We can also use this for the arterial system. I can see a high grade stenosis in the Common iliac and you can use the 3D to define for your 3D roadmapping you can use on the table,
or you can use two methods to define the artery. Usually you can use the yellow outline to define the anatomy or the green to define the center. And then it's a simple case, 50 minutes, 50 minutes of ccs of contrast,
very simple, straightforward. Another everybody knows about the you know we can use a small amount of contrast to define the whole anatomy of one leg. However one thing that is relatively new is to use a 3D
in order to map, to show you the way out so you can do in this case here multiple segmental synosis, the drug-eluting-balloon angioplasty using the 3D roadmap as a reference. Also about this case using radial fre--
radial access to peripheral. Using a fusion of image you can see the outline of the artery. You can see where the high grade stenosis is with a minimum amount of contrast. You only use contrast when you are about
to do your angiogram or your angioplasty and after. And that but all everything else you use only the guide wires and cathers are advanced only used in image guidance without any contrast at all. We also been doing as I showed before the simultaneous injection.
So here I have two catheters, one coming from above, one coming from below to define this intravenous occlusion. Very helpful during through the and after the 3D it can be helpful. Like in this case when you can see this orange line is where
the RF wire is going to be advanced. As you can see the breathing, during the breathing cycle the pleura is on the way of the RF wire track. Pretty dangerous stuff. So this case what we did we asked the anesthesiologist
to have the patient in respiratory breath holding inspiration. We're able to hyperextend the lungs, cross with the RF wire without any complication. So very useful. And also you can use this outline yellow lines here
to define anatomy can help you to define where you need to put the stents. Make sure you're covering everything and having better outcomes at the end of the case without overexposure of radiation. And also at the end you can use the same volt of metric
reconstruction to check where you are, to placement of the stent and if you'd covered all the lesion that you had. The Cone beam CT can be used for also for the 3D model fusion. As you can see that you can use in it with fluoro as I
mentioned before you can do the three views in order to make sure that the vessels are aligned. And those are they follow when you rotate the table. And then you can have a pretty good outcome at the end of the day at of the case. In that case that potentially could be very catastrophic
close to the Supra aortic vessels. What about this case of a very dramatic, symptomatic varicose veins. We didn't know and didn't even know where to start in this case. We're trying to find our way through here trying to
understand what we needed to do. I thought we need to recanalize this with this. Did a 3D recan-- a spin and we saw ours totally off. This is the RFY totally interior and the snare as a target was posterior in the ASGUS.
Totally different, different plans. Eventually we found where we needed to be. We fused with the CAT scan, CT phase before, found the right spot and then were able to use
Integrated registration for the careful recanalization above the strip-- interiorly from the Supraaortic vessels. As you can see that's the beginning, that's the end. And also these was important to show us where we working.
We working a very small space between the sternal and the Supraaortic vessels using the RF wire. And this the only technology would allowed us to do this type of thing. Basically we created a percutaneous in the vascular stent bypass graft.
You can you see you use a curved RF wire to be able to go back to the snare. And that once we snare out is just conventional angioplasty recanalized with covered stents and pretty good outcome. On a year and a half follow-up remarkable improvement in this patient's symptoms.
Another patient with a large graft in the large swelling thigh, maybe graft on the right thigh with associated occlusion of the iliac veins and inclusion of the IVC and occlusion of the filter. So we did here is that we fused the maps of the arterial
phase and the venous phase and then we reconstruct in a 3D model. And doing that we're able to really understand the beginning of the problem and the end of the problem above the filter and the correlation with the arteries. So as you can see,
the these was very tortuous segments. We need to cross with the RF wire close to the iliac veins and then to the External iliac artery close to the Common iliac artery. But eventually we were able to help find a track. Very successfully,
very safe and then it's just convention technique. We reconstructed with covered stents. This is predisposed, pretty good outcome. As you can see this is the CT before, that's the CT after the swelling's totally gone
and the stents are widely open. So in conclusion these techniques can help a reduction of radiation exposure, volume of contrast media, lower complication, lower procedure time.
In other words can offer higher value in patient care. Thank you.
- Thank you very much, so my disclosures, I'm one of the co-PIs for national registry for ANARI. And clearly venous clot is different, requires different solutions for the arterial system. So this is a device that was built ground up to work in the venous system. And here's a case presentation of a 53 year old male,
with a history of spondylolisthesis had a lumbar inner body fusion, he had an anterior approach and corpectomy with application of an inner body cage. And you can see these devices here. And notably he had application of local bone graft and bone powder
and this is part of what happened to this patient. About seven days later he came in with significant left leg swelling and venous duplex showed clot right here, and this extended all the way down to the tibial vessels. And if you look at the CT
you can see extravasation of that bone powder and material obstructing the left iliac vein. And had severe leg swelling so the orthopedic people didn't want us to use TPA in this patient so we considered a mechanical solution. And so at this day and age I think goals of intervention
should be to maximize clot removal of course and minimize bleeding risk and reduce the treatment or infusion time and go to single session therapy whenever possible. Our ICUs are full all the time and so putting a lytic patient in there
reduces our ability to get other patients in. (mouse clicks So this is the ClotTriever thrombectomy device. It has a sheath that is a 13 French sheath and they're developing a 16 French, that opens up with a funnel
after it's inserted into the poplitiel. So the funnel is in the lower femoral vein and this helps funnel clot in when it's pulled down. The catheter has this coring element that abuts the vein wall and carves the thrombus off in a collecting bag
that extends up above to allow the thrombus to go into the bag as you pull it down. So you access the popliteal vein, cross the thrombosed segments with standard techniques and you need to then put an exchange length wire up into the SVC
or even out into the subclavian vein for stability. And then the catheter's inserted above the clot and is gradually pulled down, sort of milking that stuff off of the wall and into the bag that is then taken down to the funnel and out of the leg.
So this is the patient we had, we had thrombus in the femoral and up into the IVC. Extensive, you can see the hardware here. And it was very obstructed right at that segment where it was, had the bone material pushing on the vein it was quite difficult to get through there
but finally we did and we ballooned that to open a channel up large enough to accommodate ClotTriever catheter. We then did multiple passes and we extracted a large amount of thrombus. Some looking like typically acute stuff
and then some more dense material that may have been a few days worth of build up on the wall there. We then stinted with an 18 by 90 across the obstructed segment and this was our completion run.
It's not perfect but it looks like a pretty good channel going through. This is the hardware not obstruction at that level. Hospital course, the patient had significant improvement in their swelling by post-op day one. Was discharged on compression and anti-coagulation.
He returned about two months ago for his three month follow-up and really had very minimal symptoms in the left leg. Venous duplex showed that the left common femoral was partially compressible but did have phasic flow and the stent appeared to be open through it's course.
So of course this is an anecdote, this is early in the experience with this catheter. There have been numerous improvements made to ease the use of it and do it in fewer steps. And so we're starting a ClotTriever outcomes registry
to enroll up to 500 patients to begin to define outcomes with this device. It does offer the promise of single session therapy without lytic administration and we'll see how it performs and which patients it works best in through the registry.
Thank you very much.
- So I'm just going to talk a little bit about what's new in our practice with regard to first rib resection. In particular, we've instituted the use of a 30 degree laparoscopic camera at times to better visualize the structures. I will give you a little bit of a update
about our results and then I'll address very briefly some controversies. Dr. Gelbart and Chan from Hong Kong and UCLA have proposed and popularized the use of a 30 degree laparoscopic camera for a better visualization of the structures
and I'll show you some of those pictures. From 2007 on, we've done 125 of these procedures. We always do venography first including intervascular intervention to open up the vein, and then a transaxillary first rib resection, and only do post-operative venography if the vein reclots.
So this is a 19 year old woman who's case I'm going to use to illustrate our approach. She developed acute onset left arm swelling, duplex and venogram demonstrated a collusion of the subclavian axillary veins. Percutaneous mechanical thrombectomy
and then balloon angioplasty were performed with persistent narrowing at the thoracic outlet. So a day later, she was taken to the operating room, a small incision made in the axilla, we air interiorly to avoid injury to the long thoracic nerve.
As soon as you dissect down to the chest wall, you can identify and protect the vein very easily. I start with electrocautery on the peripheral margin of the rib, and use that to start both digital and Matson elevator dissection of the periosteum pleura
off the first rib, and then get around the anterior scalene muscle under direct visualization with a right angle and you can see that the vein and the artery are identified and easily protected. Here's the 30 degree laparoscopic image
of getting around the anterior scalene muscle and performing the electrocautery and you can see the pulsatile vein up here anterior and superficial to the anterior scalene muscle. Here is a right angle around the first rib to make sure there are no structures
including the pleura still attached to it. I always divide, or try to divide, the posterior aspect of the rib first because I feel like then I can manipulate the ribs superiorly and inferiorly, and get the rib shears more anterior for the anterior cut
because that's most important for decompressing the vein. Again, here's the 30 degree laparoscopic view of the rib shears performing first the posterior cut, there and then the anterior cut here. The portion of rib is removed, and you can see both the artery and the vein
are identified and you can confirm that their decompressed. We insufflate with water or saline, and then perform valsalva to make sure that they're hasn't been any pneumothorax, and then after putting a drain in,
I actually also turn the patient supine before extirpating them to make sure that there isn't a pneumothorax on chest x-ray. You can see the Jackson-Pratt drain in the left axilla. One month later, duplex shows a patent vein. So we've had pretty good success with this approach.
23 patients have requires post operative reintervention, but no operative venous reconstruction or bypass has been performed, and 123 out of 125 axillosubclavian veins have been patent by duplex at last follow-up. A brief comment on controversies,
first of all, the surgical approach we continue to believe that a transaxillary approach is cosmetically preferable and just as effective as a paraclavicular or anterior approach, and we have started being more cautious
about postoperative anticoagulation. So we've had three patients in that series that had to go back to the operating room for washout of hematoma, one patient who actually needed a VATS to treat a hemathorax,
and so in recent times we've been more cautious. In fact 39 patients have been discharged only with oral antiplatelet therapy without any plan for definitive therapeutic anticoagulation and those patients have all done very well. Obviously that's contraindicated in some cases
of a preoperative PE, or hematology insistence, or documented hypercoagulability and we've also kind of included that, the incidence of postop thrombosis of the vein requiring reintervention, but a lot of patients we think can be discharged
on just antiplatelets. So again, our approach to this is a transaxillary first rib resection after a venogram and a vascular intervention. We think this cosmetically advantageous. Surgical venous reconstruction has not been required
in any case, and we've incorporated the use of a 30 degree laparoscopic camera for better intraoperative visualization, thanks.
- Great, thank-you very much, a pleasure to be here. My disclosures. So, we've talked a little bit about obviously percutaneous and thrombectomy techniques. Obviously we have catheter-directed thrombolysis with TPA, but what happens when we can't use TPA
mechanical techniques? We've discussed several of them already in this session, I'm going to try to kind of bring them together and note the differences and how they evolved. And really look at fragmentation, rheolytic therapy, vacuum assisted devices, and vacuum and suction devices.
So when do we need these? Patients that can't tolerate thrombolysis, can't get TPA, that have a high risk of TPA, or maybe there is a situation we need a rapid response. We're trying to create flow and establish flow as much as possible and a lot of times we use this
in combination therapy if we've already hurt. What's the ideal device? I think there are multiple different characteristic's that could define the ideal device. Obviously we want it simple to use, We want it to be reproducible,
we want it to remove a lot of thrombus, but minimize blood loss and trauma to the vessels and to the blood cell. These are just some of them. There's a lot of mechanical thrombectomy devices right now on the market continuing to grow,
both in the arterial and venous system so I think this is going to be an evolution. We started really using mechanical fragmentation with a pig tail and spinning a pig tail. We used that. A lot of times the patient with severe massive pulmonary embolism.
These we're really small antidotes, small case reports. Will Kuo, looked at these in the 2009 and basically saw over all clinical success, about 86% using these mechanical devices. Then we had some that were even more automated.
All these did was break up the clot. So you have the Trerotola Device , Cleaner Device, really almost in the dialysis space. Rheolytic Throbectomy, we've already heard about. Some of how it works and the advantages. Really I think this is the first time we've saw
a system which would try to aspirate and remove some of that thrombus as it got broken up. The PEARL registry really showed for the first time, maybe we can get this done within 24 hours, can we get this done in one session? Unfortunately in this registry only about three or
four percent of patients actually had just rheolytic therapy alone without any TPA. We've discussed a little bit about the use of Ango and this type of device in terms of bradyarrhythmia's and that may be a limitation. But I think we can still use it particularly
outside of the chest. So What about suction devices? You can have a catheter, I think a catheter suction device is very limited. We use that in the arterial tree when there is a small thrombus, a small embolus, I think
we're very limited, not only in the amount of thrombus we can remove but the amount of suction we can apply. Other types like almost mechanical, very simple to use systems is the aspire device. Well you can basically create and suction a
limited area and then help you aspirate the thrombus. And then to the other extreme. We're going to hear my next speaker talk about Angiovac, again a different system, a different system requires a patient on bypass large 26 french devices.
Where we can actually go in and deal with a large amount of thrombus, like this patient had a thrombus cave on both iliac veins. And to be able to basically come with this vacuum aspiration system over wires and kind of pulling them out and you get these little canisters,
seeing what you've actually removed. Very gratifying. But takes a lot of work to get it going. We've heard a little bit about vacuum assisted with the Indigo system. With a system of creating a constant continuous vacuum.
We now have eight french catheters with incredible aspiration volume, almost 20cc's, I'm sorry you can get up to 140cc's of thrombus in a minute can be aspirated quickly. Here is a patient, 80 years old, colorectal CA. You can see the thrombus in the right leg.
There was actually a mass invading this vein. That is where we wanted to use thrombolysis, really went a head and you can see the amount of thrombus. Cleared this out with some passage. You can see this here, the separator. You started seeing thrombus especially when
its acute it kind of looks like this. It's kind of gelatinous, things that we've already seen, and then went ahead and placed a stent, dilated that stent. Had to clean up some more with the device
on top of the stent, but with a good result without needing any TPA. Other types of extraction devices we've seen the Inari device, again this is like a stent Triever device, a nitinol ring we can use this in the pulmonary arteries.
And we've already seen previous and talked about the ClotTriever device Again remove that thrombus, put it into a bag and remove it. So again, capture and removal of thrombus. And this is a solution without the need of TPA. New kid in the block the JETi device
Again very similar to aspiration Indego device, but at the same time it has a jet to macerate the clot and kind of break up the clot a little to smaller areas so we can able to thromb and take more out. I think really here what I've seen and Dr. Razavi
showed me this case. Being able to treat a patient quickly, treat that patient very quickly you can see the amount of thrombus being able to, within about an hour and 15 minutes, get all that thrombus, then create patency in that vein and he showed
some early initial good data. Over the last year we did have a paper that was presented here and published this year in the Journal of Vascular Surgery, venous and lymphatic disorders and again pulled multiple patient's, again showing that
it affective and safe. We still need better data. We need to figure out which patients are best treated with which devices and which again will be affective. Thank-you very much.
- [Speaker] Thank you. My disclosures. So upper extremity dvt occurs in 4-10% of all causes of venous thrombosis. And while a minority, dvt in the upper extremity can often be caused by thoracic outlet syndrome, effort thrombosis, occasionally
idiopathic venous thrombosis. The majority is more likely related to central venous catheters, pacemakers, cancer, etc. This is some of the presentation of someone with Paget Schroeder or venous thoracic outlet syndrome, we're all well aware of this.
Some features of this can be sudden onset of pain, discoloration and some of this subcutaneous collateral veins that we note. Initial treatment of this is traditionally with venous thrombolysis. Although the results are good, this thrombolysis can
be associated with bleeding complications, potential for renal insufficiency, prolonged dwell times, and increased cost. I think it's important that this is not just a talk about a technique but a technique in the context of an operation this is soon to come.
Whether you choose to take out the rib at the same setting or you choose to delay the operation by a week or two, by and large the complications associated with that venous thrombolysis are going to come back and haunt you in the next operations. I think that's the context of this talk.
One of the risks I just mentioned about some of these techniques is, that's sort of curious to me, is the acute kidney injury after AngioJet venous thrombolysis. You see here, this paper, of a hundred patients, 50 AngioJet, 50 catheter directed thrombolysis, shows a statistical significantly
increased risk of acute kidney failure in the AngioJet group. Eight fold odds ratio. The Indigo system enables operators to remove the thrombus in a single setting, while potentially reducing or eliminating the need for thrombolysis.
This has already been discussed by some of the prior speakers, you see the different iterations first introduced in 2014. The CAT8 is the largest device and you can see some of the features of this proprietary technology with the separator and the directional sheaths that
allow us to aspirate nicely. This continuous suction you see here, can be very nicely controlled with an on-off switch that minimizes blood loss. It's single operator design, very easy to set up, hands free aspiration, a very simple set up.
You also heard just recently about the volume that can be aspirated in 20 seconds you see, especially with the larger profile devices, quite impressive amount of thrombus can be removed. Again, with the careful control for blood loss. The directionality of the sheath is also important,
and you can see some of the different directionality sheaths. Here's a couple case examples of a Paget-Schroder patient comes in with an acute sudden onset of arm pain and swelling discoloration, and you can see the penumbra device being used to clean out that vein.
This is another example, a 25-year old male with acute right arm swelling, sort of a body lifter type, and you can see here, this is the separator that's being moved forward and backwards, in and out to help break out the thrombus. This is the CAT8 device.
The pre-intervention picture seen here, we're crossing the lesion with a wire and and you can see the post-intervention on the right. You, of course, have the venous compression from the first rib, thoracic outlet, but the vein is widely open and now we can go ahead and see
the specimen that's retrieved as you've seen other videos in the prior presentations. This, of course, is what we're left with at the time of surgery. I only bring this up to remind us that there is a second stage to this treatment,
which is the rib resection. A combined experience that I just want to put together, very small numbers of course but, 16 patients with thoracic outlet who presented and were treated with the Penumbra system. You can see here, some of the demographic data.
I'll just point out the symptoms, of course, pain, swelling in these patients, imaging mostly venous duplex, occasionally CT or MR venogram. They all of course get venography at the time of procedure. The extent of the thrombus in all of them was complete occlusion and you can see some
of the extent in the subclavian axillary veins. Site of access can be the brachial or the basilic vein. The operative details as well, shown here, and I'll just point out the estimated blood loss, it can be very reasonable, especially with some experience you can sort of control that
on-off valve and minimize blood loss with this technique. Adjunctive therapies are shown here and of course, maybe because we're a little bit stuck on our ways, we did have a fair number of adjunctive lytic therapy. There were only three patients who had overnight lysis. A lot of venoplasty done at the time of the procedure.
All veins remained patent until the day of the rib resection but I will point out that one of these patients did develop a significant complication with hemothorax. This is one of those patients who had overnight lysis. And I point that out to stress that perhaps
this is what we're trying to move away from. So, in conclusion, mechanicothrombectomy using Indigo device shows promising initial results. Minimal blood loss, one complication of the hemothroax with the overnight lytics. No renal insufficiency or distal embolization.
The practice pattern, I think, need to adjust away from routing lytics to additionally minimize complications prior to surgery. Thank you.
- You already heard about different devices which can finish the treatment of acute DVT in the lab and I would like to add one of the devices which is quite widespread in Europe. And share the first study on this device. This is called the Aspirex device. So what is the objective?
Post traumatic syndrome after proximal DVT, I think that's clear. 25% of the patient are at risk for developing post traumatic syndrome. I think that is clear and some of these patient even expect severe post traumatic syndrome.
We already saw this ATTRACT trial outcome and we learned that especially patient with Iliofemoral DVT might benefit from treatment, invasive treatment of Iliofemoral DVT but of course, we need to know that is catheter-directed thrombolysis causes issues
and therefore our way should be to go away from thrombolytic therapy to a pure mechanical thrombectomy approach. This is a typical case example of a patient, 20 year old female patient who came to the emergency room with that leg on the left side in the morning,
back pain in the evening and this is clear that it is a descending Iliofemoral DVT in that patient caused by May-Thurner syndrome. So, with modern devices like this Aspirex, mechanical thrombectomy device, the 10 French device is able to aspirate up to 130 millimeter,
ml per minute of clots. You see that this can be effectively treated and then stinted within the May-Thurner syndrome within one session approach. So, but, what is clear of course that we need to get data
for these modern Mechanical Thrombectomy devices and therefore, we conducted clinical follow-up study to evaluate safety and efficiency of that Aspirex Mechanical Thrombectomy device. This device is based on the Archimedic principle which you can see here it comes with six up
to 10 French systems and with that you are able, as I already showed to sac 130ml of thrombus per minute. So these are the study details I want to show you. We treated 50 psychs, 56 patients with acute, subacute and acute on chronic which means up to 3 months of symptoms patients with Iliofermal DVT.
We performed IVIS on all these patients. We found May-Thurner syndrome in at least half of these patients as a reason for the Iliofermal DVT. You see the patient demographics. Some of the patients had even malignancy condition. A lot of patients were on oral contraceptives.
Here are the clinical symptoms within our cohort. Most of the patients came with swelling and rest pain. The rVCSS at the beginning was 4.5 within this cohort. Most of the traumatic lesions were on the left side involving even the profunda and the common femoral vein in this cohort.
You see here the excess which we used for treating these Iliofermal DVT, we used in the main part of the cohort, the left popliteal vein access or left femoral vein access. 84% were treated with 10 French system, the Aspirex device. As I mentioned we used IVIS
to analyze underlying pathologies. We found in most of the patients underlying pathologies and this explains why we implanted stents in 100% of the patients. You see the treatment duration which was in mean 94 minutes within this treatment cohort.
These are the patency analysis within one year. You see patency at 12 months, 87% percent in these patients, which we could follow up after 12 months. Here you see the Post-thrombotic syndrome analysis after 12 months so only low PTS
and some kind of moderate PTS were seen in these patients. There were no severe Post-thrombotic syndrome. Most of the patients just had a little bit of swelling after that procedure. Of course, it's important to mention safety and those end points.
There were just some small punctures associated, site being complicationS. Of course re-hospitalization is a severe adverse event which you can see here. But there were of course no bleeding events in this cohort. And to follow up
on this much more multicentric perspective trial, we just started a multicenter trial on this and we'll follow up patients up to five years within this just initiated multicenter registry. And I think we can show some preliminary data next year. Thank you very much.
- So I'd like to thank Dr. Ascher, Dr. Sidawy, Dr. Veith, and the organizers for allowing us to present some data. We have no disclosures. The cephalic arch is defined as two centimeters from the confluence of the cephalic vein to either the auxiliary/subclavian vein. Stenosis in this area occurs about 39%
in brachiocephalic fistulas and about 2% in radiocephalic fistulas. Several pre-existing diseases can lead to the stenosis. High flows have been documented to lead to the stenosis. Acute angles. And also there is a valve within the area.
They're generally short, focal in nature, and they're associated with a high rate of thrombosis after intervention. They have been associated with turbulent flow. Associated with pre-existing thickening.
If you do anatomic analysis, about 20% of all the cephalic veins will have that. This tight anatomical angle linked to the muscle that surrounds it associated with this one particular peculiar valve, about three millimeters from the confluence.
And it's interesting, it's common in non-diabetics. Predictors if you are looking for it, other than ultrasound which may not find it, is calcium-phosphate product, platelet count that's high, and access flow.
If one looks at interventions that have commonly been reported, one will find that both angioplasty and stenting of this area has a relatively low primary patency with no really discrimination between using just the balloon or stent.
The cumulative patency is higher, but really again, deployment of an angioplasty balloon or deployment of a stent makes really no significant difference. This has been associated with residual stenosis
greater than 30% as one reason it fails, and also the presence of diabetes. And so there is this sort of conundrum where it's present in more non-diabetics, but yet diabetics have more of a problem. This has led to people looking to other alternatives,
including stent grafts. And in this particular paper, they did not look at primary stent grafting for a cephalic arch stenosis, but mainly treating the recurrent stenosis. And you can see clearly that the top line in the graph,
the stent graft has a superior outcome. And this is from their paper, showing as all good paper figures should show, a perfect outcome for the intervention. Another paper looked at a randomized trial in this area and also found that stent grafts,
at least in the short period of time, just given the numbers at risk in this study, which was out after months, also had a significant change in the patency. And in their own words, they changed their practice and now stent graft
rather than use either angioplasty or bare-metal stents. I will tell you that cutting balloons have been used. And I will tell you that drug-eluting balloons have been used. The data is too small and inconclusive to make a difference. We chose a different view.
We asked a simple question. Whether or not these stenoses could be best treated with angioplasty, bare-metal stenting, or two other adjuncts that are certainly related, which is either a transposition or a bypass.
And what we found is that the surgical results definitely give greater long-term patency and greater functional results. And you can see that whether you choose either a transposition or a bypass, you will get superior primary results.
And you will also get superior secondary results. And this is gladly also associated with less recurrent interventions in the ongoing period. So in conclusion, cephalic arch remains a significant cause of brachiocephalic AV malfunction.
Angioplasty, across the literature, has poor outcomes. Stent grafting offers the best outcomes rather than bare-metal stenting. We have insufficient data with other modalities, drug-eluting stents, drug-eluting balloons,
cutting balloons. In the correct patient, surgical options will offer superior long-term results and functional results. And thus, in the good, well-selected patient, surgical interventions should be considered
earlier in this treatment rather than moving ahead with angioplasty stent and then stent graft. Thank you so much.
- Thanks Bill and I thank Dr. Veith and the organizers of the session for the invitation to speak on histology of in-stent stenosis. These are my disclosures. Question, why bother with biopsy? It's kind of a hassle. What I want to do is present at first
before I show some of our classification of this in data, is start with this case where the biopsy becomes relevant in managing the patient. This is a 41 year old woman who was referred to us after symptom recurrence two months following left iliac vein stenting for post-thrombotic syndrome.
We performed a venogram and you can see this overlapping nitinol stents extending from the..., close to the Iliocaval Confluence down into Common Femoral and perhaps Deep Femoral vein. You can see on the venogram, that it is large displacement of the contrast column
from the edge of the stent on both sides. So we would call this sort of diffuse severe in-stent stenosis. We biopsy this material, you can see it's quite cellular. And in the classification, Doctor Gordon, our pathologist, applies to all these.
Consisted of fresh thrombus, about 15% of the sample, organizing thrombus about zero percent, old thrombus, which is basically a cellular fibrin, zero percent and diffuse intimal thickening - 85%. And you can see there is some evidence of a vascularisation here, as well as some hemosiderin deposit,
which, sort of, implies a red blood cell thrombus, histology or ancestry of this tissue. So, because the biopsy was grossly and histolo..., primarily grossly, we didn't have the histology to time, we judged that thrombolysis had little to offer this patient The stents were angioplastied
and re-lined with Wallstents this time. So, this is the AP view, showing two layers of stents. You can see the original nitinol stent on the outside, and a Wallstent extending from here. Followed venogram, venogram at the end of the procedure, shows that this displacement, and this is the maximal
amount we could inflate the Wallstent, following placement through this in-stent stenosis. And this is, you know, would be nice to have a biological or drug solution for this kind of in-stent stenosis. We brought her back about four months later, usually I bring them back at six months,
but because of the in-stent stenosis and suspecting something going on, we brought her back four months later, and here you can see that the gap between the nitinol stent and the outside the wall stent here. Now, in the contrast column, you can see that again, the contrast column is displaced
from the edge of the Wallstent, so we have recurrent in-stent stenosis here. The gross appearance of this clot was red, red-black, which suggests recent thrombus despite anticoagulation and the platelet. And, sure enough, the biopsy of fresh thrombus was 20%,
organizing thrombus-75%. Again, the old thrombus, zero percent, and, this time, diffuse intimal thickening of five percent. This closeup of some of that showing the cells, sort of invading this thrombus and starting organization. So, medical compliance and outflow in this patient into IVC
seemed acceptable, so we proceeded to doing ascending venogram to see what the outflow is like and to see, if she was an atomic candidate for recanalization. You can see these post-thrombotic changes in the popliteal vein, occlusion of the femoral vein.
You can see great stuffiness approaching these overlapping stents, but then you can see that the superficial system has been sequestered from the deep system, and now the superficial system is draining across midline. So, we planned to bring her back for recanalization.
So biopsy one with diffuse intimal thickening was used to forego thrombolysis and proceed with PTA and lining. Biopsy two was used to justify the ascending venogram. We find biopsy as a useful tool, making practical decisions. And Doctor Gordon at our place has been classifying these
biopsies in therms of: Fresh Thrombus, Organizing Thrombus, Old Thrombus and Diffuse Intimal thickening. These are panels on the side showing the samples of each of these classifications and timelines. Here is a timeline of ...
Organizing Thrombus here. To see it's pretty uniform series of followup period For Diffuse Intimal thickening, beginning shortly after the procedure, You won't see very much at all, increases with time. So, Fresh Thrombus appears to be
most prevalent in early days. Organizing Thrombus can be seen at early time points sample, as well as throughout the in-stent stenosis. Old Thrombus, which is a sort of a mystery to me why one pathway would be Old Thrombus and the other Diffuse Intimal thickening.
We have to work that out, I hope. Calcification is generally a very late feature in this process. Thank you very much.
- Thank you very much both. It was a great pleasure to see you. I continue to be grateful for the guidance you have given me over the years. Thank you to the organizers for advising me to speak. These are my disclosures. So really there are two questions posed by this topic.
One is, is the patent popliteal vein necessary? I would assume from this is it necessary for patency and symptom relief to be achieved in treating patients with both acute DVT and potentially chronic. And has the evolution formic mechanical therapy
led to over stenting. Which means we have to ask the question what is an appropriate rate for stenting. I am not sure we know the answer to that. So being able to answer over stenting requires us to know how many patients
actually need the stent in the first place in acute DVT treatments. The problem is essentially this. Is that when we form lithic therapies and this is a classic case of treatment formed with formic and mechanical device
but without a follow up using lithic in the patient for whom lithic was not feasible. You end up opening up a vessel but you can see from the image on the left hand side that there is a degree still of luminol contrast deficit suggesting some cult left behind
in the external iliac vein. Well there is obviously a May-Thurner legion at the top. The question of over stenting is one of do we just stent the May-Thruner and extend it down into the external iliac vein to trap that thrombus
or would a period of time of lithic have resulted in this clot resolving and not needed a stent at the end of it. To get to the question of how many people should be stented. The only way we can really do this
is try and exstipulate from the literature to some extent. This is the short and long term outcome from the Kevin study. Where there is ultrasound follow up of patients underwent standard treatment only.
And a additional group in the patients had catheter-directed thrombolysis. We can see there that the patients did six months in catheter-directed thrombolysis group is around 60%. And the patency seen with the non treated group
is around 40%. If we kind of use these numbers as a guide we probably expect therefore that the stent rate would be somewhere between 40 and 60 percent. To account for treating the outflow structure that presumably patients see at six months.
But this is clearly not a very rebost method of being absolutely clear on who needs stents. Additional method is we don't really have and answer for who should be stented at the end of a procedure. So if you look at the massive variability
in the other studies. We see that attract stent rate is approximately 28% for the study. Which is obviously a operative discretion and has been criticized for that reason. But there is no comment on the Popliteal vein
or Popliteal vein patency. Cavent did an stent rate of 15% again with no real comment on whether the Popliteal vein was open and it wasn't a prerequisite for treatment in the study. This contrast with the Ansberg Aspirex Registry.
Which is a registry of a purely mechanical device to aspirex clot and the stent rate is 100%. Baekgaard Copenhagen used a catered-directed thrombolysis with a mandated open popliteal vein for purpose to be in the study. He has a stent rate of 60%.
My own personal experience of 160 odd patients is that were stenting around 80% of patients with outflow legion at the end of treatment. And were not really bothered by whether the popliteal vein is clear or not. But that doesn't necessarily answer the question
whether it makes a difference in the long run. So its very difficult even looking at the data we have because there is no standard definition of what a outflow stenosis is. There is no objective measure for an outflow stenosis. So stenting becomes and operative discretion decision.
But you would have to say that if your taking purely mechanical devices and the stent rates are going up to 100% that the inclination would be that there is potential for formic mechanical therapy to lead to overstenting and increase use
for stents for sure. In our experience then we had 81 patients who had CDT alone verse 70 patients who had AngioJet Thrombectomy. The basic characteristics of the group are pretty much identical.
With similar ages and no difference between whether the thrombus with left side or right side of body or so on. And these are the patency curves for the different groups with equivalent primary, primary assisted and secondary patency over two yeas.
We had no difference in stent rates with the median stenting of 80% in both groups with two stents used in average for each of those patients. However in our practice AngioJet is rarely used alone. So we had 70 patients for whom AngioJet was used. 24 of those where AngioJet was used up front
as the first line of treatment followed by some CDT. We have tended find that if we wanted full clock clearance. We have always had omit to some extent. And single stage therapy is quite difficult to achieve unless you spent a lot of time in it.
Patency in the popliteal vein is clearly affected by some extent. These are our follow up results if we don't have a patent popliteal vein at the end. It does drop off in stent patency. So the conclusions then I think.
Is that patent popliteal vein is necessary for long term results. But you can still treat patients that have acute popliteal vein for larsons that is not a contraindication. Pure mechanical therapies may well lead to higher stent rate.
But is this a bad thing or a good thing? We don't really know this at this stage as to what the long term outcomes will be. Thank you very much.
- Thank you very much. It's an hono ou to the committee for the invitation. So, I'll be discussing activity recommendations for our patients after cervical artery dissection. I have no relevant disclosures.
And extracranial cervical artery dissection is an imaging diagnosis as we know with a variety of presentations. You can see on the far left the intimal flap and double lumen in the left vertebral artery
on both coronal and axial imaging, a pseudoaneurysm of the internal carotid artery, aneurysmal degeneration in an older dissection, and an area of long, smooth narrowing followed by normal artery, and finally a flame-tipped occlusion.
Now, this affects our younger patients with really opposity of atherosclerotic risk factors. So, cervical artery dissection accounts for up to 25% of stroke in patients under the age of 45. And, other than hypertension, it's not associated with any cardiovascular risk factors.
There is a male predominance, although women with dissections seem to present about five years younger. And there is an indication that there may be a systemic ateriopathy contributing to this in our patients, and I'll show you some brief data regarding that.
So, in studies that have looked at vessel redundancy, including loops, coils, and in the video image, an S curve on carotid duplex. Patients with cervical artery dissection have a much higher proportion of these findings, up to three to four times more than
age and sex matched controls. They also have findings on histology of the temporal artery when biopsied. So one study did this and these patients had abnormal capillary formation as well as extravasation of blood cells between the median adventitia
of the superficial temporal artery. And there is an association with FMD and a shared genetic polymorphism indicating that there may be shared pathophysiology for these conditions. But in addition, a lot of patients report minor trauma around the time or event of cervical artery dissection.
So this data from CADISP, and up to 40% of cases had minor trauma related to their dissection, including chiropractic neck manipulation, extreme head movements, or stretching, weight lifting, and sports-related injuries. Thankfully, the majority of patients do very well after
they have a dissection event, but a big area of concern for the patient and their provider is their risk for recurrence. That's highest around the original event, about 2% within the first month, and thereafter, it's stable at 1% per year,
although recurrent pain can linger for many years. So what can we tell our patients in terms of reducing their risk for a recurrent event? Well, most of the methods are around reducing any sort of impulse, stress, or pressure on the arteries, both intrinsically and extrinsically,
including blood pressure control. I advise my patients to avoid heavy lifting, and by that I mean more than 30 pounds, and intense valsalva or isometric exercise. So shown here is a photo of the original World's Strongest Man lifting four
adult-sized males in addition to weights, but there's been studies in the physiology literature with healthy, younger males in their 20s, and they're asked to do a double-leg press, or even arm-curls, and with this exercise and repetitions, they can get mean systolic pressures,
or mean pressures up into the 300s, as well as heart rate into the 170s. I also tell my patients to avoid any chiropractic neck manipulation or deep tissue massage of the neck, as well as high G-force activities like a roller coaster.
There are some case reports of cervical artery dissection related to this. And then finally, what can they do about cardio? A lot of these patients are very anxious, they're concerned about re-incorporating exercise after they've been through something like this,
so I try to give them some kind of guidelines and parameters that they can follow when they re institute exercise, not unlike cardiac rehabilitation. So initially, I tell them "You can do light walking, but if you don't feel well,
or something's hurting, neck pain, headache, don't push it." Thereafter, they can intensify to a heart rate maximum of 70-75% of their maximum predicted heart rate, and that's somewhere between months zero and three, and then afterwards when they're feeling near normal,
I give them an absolute limit of 90% of their maximum predicted heart rate. And I advise all of my patients to avoid extreme exercise like Orange Theory, maybe even extreme cycling classes, marathons, et cetera. Thank you.
- Thank you, Dr. Ouriel, Dr. Lurie. Ladies and gentlemen. Brian, that was a very fair overview of the ATTRACT trial as it was published in the New England Journal, so thank you. And these are my disclosures. So Dr. DeRubertis did a very nice review of this paper
that was published in the New England Journal December 7th of last year. He went over very nicely that it was NIH sponsored, phase III, randomized, controlled, multicenter, 692 patients randomized, anticoagulation alone versus anticoagulation plus catheter-based techniques.
Now one thing I want to call your attention to is the fact that patients with deep venous thrombosis, acute deep venous thrombosis, who were eligible for randomization, were stratified before they were randomized into two different groups, iliofemoral DVT or fem-pop DVT.
So in my opinion, these are not subgroups because the randomization of one group had no effect on the randomization of another, so I would argue that these are independent groups. That makes a big difference when you do statistical analyses.
The other important issue that I want to point out is that the outcomes were pre-determined to what we were going to analyze. We had to choose one as a primary endpoint and the others as secondary, but these were pre-determined end points that were up for analysis, not post hoc analyses.
And post-thrombotic syndrome was determined at the time, 12 years ago when we wrote the protocol, to be the primary end point. I would submit that we would not choose that as a primary end point if we wrote the protocol today. Moderate to severe post-thrombotic syndrome
certainly would be more appropriate. Leg pain, swelling, health-related quality of life, certainly important. This is the outcome, and unfortunately, it did not reach significance. There was no difference between the two groups
and there was an increased risk of bleeding, but this is the outcome that drove opinion about ATTRACT, but we don't really do catheter-directed thrombolysis for fem-pop DVT. Therefore, the results of the iliofemoral patients will be the most meaningful and that paper was written
and that paper has been accepted by circulation. It should be out shortly, but there were 391 iliofemoral DVT patients and the primary outcome was no different than the primary outcome in the overall trial. But are they?
If we had chosen the Venous Clinical Severity Score in place of the Villalta score for analysis of that primary end point, it would've been a positive study. So if we chose a different tool to analyze, our primary end point would've been positive for the iliofemoral DVT patients.
If we look at moderate to severe post-thrombotic syndrome, a significant difference. Control patients had a 56% increased risk of moderate to severe PTS versus the control patients. If we look at severe post-thrombotic syndrome, control patients had a 72% increased risk
of severe PTS versus control. If we look at the overall severity of the Villalta score in PTS, we can see that there is a significant difference favoring percutaneous catheter-directed thrombolysis. When we look at pain, the patient's pain was significantly reduced in the PCDT patients compared to control.
We look at edema, significant reduction in edema at day 10 and day 30 in patients who received catheter-directed thrombolysis compared to control. Disease-specific quality of life significantly favored patients who had PCDT compared to control. So we look at moderate to severe, severe, pain,
quality of life. There was a price to pay. Major bleeding was increased, but the P-value was no different. I will not argue that patients are not at increased risk. They are at increased risk for bleeding,
but this is an historically low bleeding rate for catheter-directed thrombolysis and there were no intracranial bleeds. No difference in recurrent deep venous thrombosis. No difference in mortality at 24 months between the two groups.
So in conclusion, the primary end point, reduction of any PTS defined by a Villalta score of 5 or more, no difference, but an item that has not reached the level of discussion that we will need to consider is that 14% of our patients had a normal Villalta score coming into the study.
It's impossible to improve upon that, but there is a significant reduction in any PTS if you use the Venous Clinical Severity Score, reduction of moderate and severe post-thrombotic syndrome, reduction of pain and swelling, and improved disease-specific quality of life compared to controls.
And I think these are the meaningful end points that patients appreciate and these are the points of discussion that will be covered in the article in circulation that will be published very soon. Thank you for your attention.
- Good morning. Thank you for the opportunity to speak. So thirty day mortality following unselected non-cardiac surgery in patients 45 years and older has been reported to be as high as 1.9%. And in such patients we know that postoperative troponin elevation has
a very strong correlation with 30-day mortality. Considering that there are millions of major surgical procedures performed, it's clear that this equates to a significant health problem. And therefore, the accurate identification of patients at risk of complications
and morbidity offers many advantages. First, both the patient and the physician can perform an appropriate risk-benefit analysis based on the expected surgical benefit in relation to surgical risk. And surgery can then be declined,
deferred, or modified to maximize the patient's benefit. Secondly, pre-operative identification of high-risk patients allows physicians to direct their efforts towards those who might really benefit from additional interventions. And finally, postoperative management,
monitoring and potential therapies can be individualized according to predicted risk. So there's a lot of data on this and I'll try to go through the data on predictive biomarkers in different groups of vascular surgery patients. This study published in the "American Heart Journal"
in 2018 measured troponin levels in a prospective blinded fashion in 1000 patients undergoing non-cardiac surgery. Major cardiac complications occurred overall in 11% but in 24% of the patients who were having vascular surgery procedures.
You can see here that among vascular surgery patients there was a really high prevalence of elevated troponin levels preoperatively. And again, if you look here at the morbidity in vascular surgery patients 24% had major cardiac complications,
the majority of these were myocardial infarctions. Among patients undergoing vascular surgery, preoperative troponin elevation was an independent predictor of cardiac complications with an odds ratio of 1.5, and there was an increased accuracy of this parameter
in vascular surgery as opposed to non-vascular surgery patients. So what about patients undergoing open vascular surgery procedures? This is a prospective study of 455 patients and elevated preoperative troponin level
and a perioperative increase were both independently associated with MACE. You can see here these patients were undergoing a variety of open procedures including aortic, carotid, and peripheral arterial. And you can see here that in any way you look at this,
both the preoperative troponin, the postoperative troponin, the absolute change, and the relative change were all highly associated with MACE. You could add the troponin levels to the RCRI a clinical risk stratification tool and know that this increased the accuracy.
And this is additionally shown here in these receiver operator curves. So this study concluded that a combination of the RCRI with troponin levels can improve the predictive accuracy and therefore allow for better patient management.
This doesn't just happen in open-vascular surgery patients. This is a study that studied troponin levels in acute limb ischaemia patients undergoing endovascular therapy. 254 patients all treated with endovascular intervention
with a 3.9% mortality and a 5.1% amputation rate. Patients who died or required amputation more frequently presented with elevated troponin levels. And the relationship between troponin and worse in-hospital outcome remains significant even when controlling for other factors.
In-hospital death or amputation again and amputation free survival were highly correlated with preoperative troponin levels. You can see here 16.9% in patients with elevated troponins versus 6% in others. And the cardiac troponin level
had a high hazard ratio for predicting worse in-hospital outcomes. This is a study of troponins just in CLI patients with a similar design the measurement of troponin on admission again was a significant independent predictor
of survival with a hazard ratio of 4.2. You can see here that the majority of deaths that did occur were in fact cardiac, and troponin levels correlated highly with both cardiac specific and all-cause mortality. The value of the troponin test was maintained
even when controlling for other risk factors. And these authors felt that the realistic awareness of likely long term prognosis of vascular surgery patients is invaluable when planning suitability for either surgical or endovascular intervention.
And finally, we even have data on the value of preoperative troponin in patients undergoing major amputation. This was a study in which 10 of 44 patients had a non-fatal MI or died from a cardiac cause following amputation.
A rise in the preoperative troponin level was associated with a very poor outcome and was the only significant predictor of postoperative cardiac events. As you can see in this slide. This clearly may be a "Pandora's box".
We really don't know who should have preoperative troponins. What is the cost effectiveness in screening everybody? And in patients with elevated troponin levels, what exactly do we do? Do we cancel surgery, defer it, or change our plan?
However, certainly as vascular surgeons with our high-risk patient population we believe in risk stratification tools. And the RCRI is routinely used as a clinical risk stratification tool. Adding preoperative troponin levels to the RCRI
clearly increases its accuracy in the prediction of patients who will have perioperative cardiac morbidity or mortality. And you can see here that the preoperative troponin level had one of the highest independent hazard ratios at 5.4. Thank you very much for your attention.
- First of all I'd like to thank the organizers for inviting me to give this presentation. These are my disclosures. I'm going to divide this presentation into three main parts. I will initially make the case that at the present time we are providing relatively poor value in ESRD and Vascular Access Care.
I'll then submit to you that one way to address this issue is through Patient Centered Device Innovation and then I'll tell you a little bit about some regulatory initiatives in this area. If you define value as being outcomes over cost
then I would argue that in vascular access we actually provide very poor value in that we have pretty bad outcomes and in order to achieve these bad outcomes we actually spend a huge amount of money at about 1.5 billion dollars per year and these is no talk at all
in the construct before you about quality of life. How can we break this cycle of a lack of innovation resulting in poor quality and outcomes and a high cost burden? I would submit to you that one way that we may be able to break the cycle
is through patient centered innovations. Patient centered innovation, whether it's discovery or process of care innovation, is basically innovation that targets the issues that are important to patients, not necessarily the issues that are important to physicians,
or payors, or regulators, or to industry. The reason that this is important is that the things that are relevant and critical to patients are often very different from the things that are important to the other stakeholder groups that I mention. If you look at hemodialysis for example
the things that are important to a patient on hemodialysis are ability to travel, and dialysis free time, and not feeling washed out post dialysis. On the other hand, if you're an nephrologist as I am, the things that are important to me are survival, and hospitalization, and being a nephrologist
I completely obsess about blood pressure which is really not something that patients are that worried or bother about. The next question is, of course, how do we develop therapies that address the issues that are important to patients? I got this slide from Frank Hurst at the FDA.
It basically makes the point that we need to have patient input at every point in the product development process, from initial ideation, to clinical trial design, to patient preferences, to patient centered outcomes. The FDA actually has a number of programs
in this area, one example is their Patient Focused Drug Development Initiative which allows the FDA to speak with patients and patient groups in different therapeutic areas. Closer to home, the Medical Device Innovation Consortium is extremely interested in Patient Preferences
and in a Risk-Benefit analysis. Within the kidney health initiative, which is a public-private partnership between the American Society of Nephrology and the FDA, we are also very interested in patient preferences for renal devices, and the background for this is
that an individual patient's tolerance for risk actually varies tremendously. Patients on home hemodialysis, for example, may be happy to sacrifice some degree of safety with regard to, say, vascular access, in order for an improved
or a more independent quality of life. But if you're a regulator there needs to be a way that you can get insight in to how patients perceive the risk/benefit ratio so that it can be incorporated into the regulatory pathway, and at least at the present time
the tools for this do not exist. The Kidney Health Initiative hosted an extremely successful patient preference workshop in the Baltimore area a couple of years ago. We asked three main questions: how can patients assist in the development
of a new medical device? How can they ensure the success of future clinical trials? And how can they help with the decision to make a new device available? The proceedings of this workshop have been published, and I'm really not going to go into details there.
I'm going to share with you a video that was made to try and attract patients to this webinar, and I think it really epitomizes the importance of patient centered innovation. - Hello, I'm CeCe, a fellow kidney disease patient. For 33 years I've done dialysis, both hemo and PD.
I had a transplant for 10 years and as you can imagine too many pills, shots, and accesses to mention. As kidney patients you and I both know that a few things in life are not optional. Strength, courage,
persistence, and determination. No matter what life throws at us, we try to stay balanced, maintain our routine, and remain positive. But let's face it, we are often in a holding pattern. Kidney disease treatments have not
changed much over the years. The options for patients like us have largely remained the same for many years. You want to help change that? We need you. Each day we're asked to share our lives with our treatment. But now, let's share our voice, ideas, opinions.
From patients like us, they matter. Key people are realizing our voices matter too. Here's what I found out. The Food and Drug Administration, often known as the FDA, is looking for patients living with kidney disease like you and me, to provide input
on how potential treatments of the future could look. Picture a big table. Around it are dialysis caregivers, researchers, doctors, nurses, and companies providing new products and treatments. They want us and our families to sit beside them
and have a seat at this table. We'll work together to bring potential new treatment options, safe and effective ones, and ones that patients like you and me want and need. Imagine the future of your treatment. What does it look like?
How does it improve your day-to-day life? This future doesn't have to remain just a dream. Join me and other patients to contribute our thoughts and make our ideas a possible reality. - The driving force and also the voice behind that video was the lady on the right, Celeste Lee.
She was a dialysis patient for over 30 years, she was a member of the KHI board of directors, and Celeste died a year and a half ago, she basically withdrew from dialysis because of bone disease from the 30 years of dialysis. I really think that her death
should be a charge for all of us really to try and develop therapies that target the things that are important to patients. Thank you very much for your attention.
- Good morning. I'd like to thank Dr. Veith and Symposium for my opportunity to speak. I have no disclosures. So the in Endovascular Surgery, there is decrease open surgical bypass. But, bypass is still required for many patients with PAD.
Autologous vein is preferred for increase patency lower infection rate. And, Traditional Open Vein Harvest does require lengthy incisions. In 1996 cardiac surgery reported Endoscopic Vein Harvest. So the early prospective randomized trial
in the cardiac literature, did report wound complications from Open Vein Harvest to be as high as 19-20%, and decreased down to 4% with Endoscopic Vein Harvest. Lopes et al, initially, reported increase risk of 12-18 month graft failure and increased three year mortality.
But, there were many small studies that show no effect on patency and decreased wound complications. So, in 2005, Endoscopic Vein Harvest was recommended as standard of care in cardiac surgical patients. So what about our field? The advantages of Open Vein Harvest,
we all know how to do it. There's no learning curve. It's performed under direct visualization. Side branches are ligated with suture and divided sharply. Long term patency of the bypass is established. Disadvantages of the Open Vein Harvest,
large wound or many skip wounds has an increased morbidity. PAD patients have an increased risk for wound complications compared to the cardiac patients as high as 22-44%. The poor healing can be due to ischemia, diabetes, renal failure, and other comorbid conditions.
These can include hematoma, dehiscense, infection, and increased length of stay. So the advantages of Endoscopic Vein Harvest, is that there's no long incisions, they can be performed via one or two small incisions. Limiting the size of an incision
decreases wound complications. It's the standard of care in cardiac surgery, and there's an overall lower morbidity. The disadvantages of is that there's a learning curve. Electro-cautery is used to divide the branches, you need longer vein compared to cardiac surgery.
There's concern about inferior primary patency, and there are variable wound complications reported. So recent PAD data, there, in 2014, a review of the Society of Vascular Surgery registry, of 5000 patients, showed that continuous Open Vein Harvest
was performed 49% of the time and a Endo Vein Harvest about 13% of the time. The primary patency was 70%, for Continuous versus just under 59% for Endoscopic, and that was significant. Endoscopic Vein Harvest was found to be an independent risk factor for a lower one year
primary patency, in the study. And, the length of stay due to wounds was not significantly different. So, systematic review of Endoscopic Vein Harvest data in the lower extremity bypass from '96 to 2013 did show that this technique may reduce
primary patency with no change in wound complications. Reasons for decreased primary patency, inexperienced operator, increased electrocautery injury to the vein. Increase in vein manipulation, you can't do the no touch technique,
like you could do with an Open Harvest. You need a longer conduit. So, I do believe there's a roll for this, in the vascular surgeon's armamentarium. I would recommend, how I use it in my practices is, I'm fairly inexperienced with Endoscopic Vein Harvest,
so I do work with the cardiac PA's. With increased percutaneous procedures, my practice has seen decreased Saphenous Vein Bypasses, so, I've less volume to master the technique. If the PA is not available, or the conduit is small, I recommend an Open Vein Harvest.
The PA can decrease the labor required during these cases. So, it's sometimes nice to have help with these long cases. Close surveillance follow up with Non-Invasive Arterial Imaging is mandatory every three months for the first year at least. Thank you.
- Good morning. It's a pleasure to be here today. I'd really like to thank Dr. Veith, once again, for this opportunity. It's always an honor to be here. I have no disclosures. Heel ulceration is certainly challenging,
particularly when the patients have peripheral vascular disease. These patients suffer from significant morbidity and mortality and its real economic burden to society. The peripheral vascular disease patients
have fivefold and increased risk of ulceration, and diabetics in particular have neuropathy and microvascular disease, which sets them up as well for failure. There are many difficulties, particularly poor patient compliance
with offloading, malnutrition, and limitations of the bony coverage of that location. Here you can see the heel anatomy. The heel, in and of itself, while standing or with ambulation,
has tightly packed adipose compartments that provide shock absorption during gait initiation. There is some limitation to the blood supply since the lateral aspect of the heel is supplied by the perforating branches
of the peroneal artery, and the heel pad is supplied by the posterior tibial artery branches. The heel is intolerant of ischemia, particularly posteriorly. They lack subcutaneous tissue.
It's an end-arterial plexus, and they succumb to pressure, friction, and shear forces. Dorsal aspect of the posterior heel, you can see here, lacks abundant fat compartments. It's poorly vascularized,
and the skin is tightly bound to underlying deep fascia. When we see these patients, we need to asses whether or not the depth extends to bone. Doing the probe to bone test
using X-ray, CT, or MRI can be very helpful. If we see an abcess, it needs to be drained. Debride necrotic tissue. Use of broad spectrum antibiotics until you have an appropriate culture
and can narrow the spectrum is the way to go. Assess the degree of vascular disease with noninvasive testing, and once you know that you need to intervene, you can move forward with angiography. Revascularization is really operator dependent.
You can choose an endovascular or open route. The bottom line is the goal is inline flow to the foot. We prefer direct revascularization to the respective angiosome if possible, rather than indirect. Calcanectomy can be utilized,
and you can actually go by angiosome boundaries to determine your incisions. The surgical incision can include excision of the ulcer, a posterior or posteromedial approach, a hockey stick, or even a plantar based incision. This is an example of a posterior heel ulcer
that I recently managed with ulcer excision, flap development, partial calcanectomy, and use of bi-layered wound matrix, as well as wound VAC. After three weeks, then this patient underwent skin grafting,
and is in the route to heal. The challenge also is offloading these patients, whether you use a total contact cast or a knee roller or some other modality, even a wheelchair. A lot of times it's hard to get them to be compliant.
Optimizing nutrition is also critical, and use of adjunctive hyperbaric oxygen therapy has been shown to be effective in some cases. Bone and tendon coverage can be performed with bi-layered wound matrix. Use of other skin grafting,
bi-layered living cell therapy, or other adjuncts such as allograft amniotic membrane have been utilized and are very effective. There's some other modalities listed here that I won't go into. This is a case of an 81 year old
with osteomyelitis, peripheral vascular disease, and diabetes mellitus. You can see that the patient has multi-level occlusive disease, and the patient's toe brachial index is less than .1. Fortunately, I was able to revascularize this patient,
although an indirect revascularization route. His TBI improved to .61. He underwent a partial calcanectomy, application of a wound VAC. We applied bi-layer wound matrix, and then he had a skin graft,
and even when part of the skin graft sloughed, he underwent bi-layer living cell therapy, which helped heal this wound. He did very well. This is a 69 year old with renal failure, high risk patient, diabetes, neuropathy,
peripheral vascular disease. He was optimized medically, yet still failed to heal. He then underwent revascularization. It got infected. He required operative treatment,
partial calcanectomy, and partial closure. Over a number of months, he did finally heal. Resection of the Achilles tendon had also been required. Here you can see he's healed finally. Overall, function and mobility can be maintained,
and these patients can ambulate without much difficulty. In conclusion, managing this, ischemic ulcers are challenging. I've mentioned that there's marginal blood supply, difficulties with offloading, malnutrition, neuropathy, and arterial insufficiency.
I would advocate that partial or total calcanectomy is an option, with or without Achilles tendon resection, in the presence of osteomyelitis, and one needs to consider revascularization early on and consider a distal target, preferentially in the angiosome distribution
of the posterior tibial or peroneal vessels. Healing and walking can be maintained with resection of the Achilles tendon and partial resection of the os calcis. Thank you so much. (audience applauding)
- I want to thank the organizers for putting together such an excellent symposium. This is quite unique in our field. So the number of dialysis patients in the US is on the order of 700 thousand as of 2015, which is the last USRDS that's available. The reality is that adrenal disease is increasing worldwide
and the need for access is increasing. Of course fistula first is an important portion of what we do for these patients. But the reality is 80 to 90% of these patients end up starting with a tunneled dialysis catheter. While placement of a tunneled dialysis catheter
is considered fairly routine, it's also clearly associated with a small chance of mechanical complications on the order of 1% at least with bleeding or hema pneumothorax. And when we've looked through the literature, we can notice that these issues
that have been looked at have been, the literature is somewhat old. It seemed to be at variance of what our clinical practice was. So we decided, let's go look back at our data. Inpatients who underwent placement
of a tunneled dialysis catheter between 1998 and 2017 reviewed all their catheters. These are all inpatients. We have a 2,220 Tesio catheter places, in 1,400 different patients. 93% of them placed on the right side
and all the catheters were placed with ultrasound guidance for the puncture. Now the puncture in general was performed with an 18 gauge needle. However, if we notice that the vein was somewhat collapsing with respiratory variation,
then we would use a routinely use a micropuncture set. All of the patients after the procedures had chest x-ray performed at the end of the procedure. Just to document that everything was okay. The patients had the classic risk factors that you'd expect. They're old, diabetes, hypertension,
coronary artery disease, et cetera. In this consecutive series, we had no case of post operative hemo or pneumothorax. We had two cut downs, however, for arterial bleeding from branches of the external carotid artery that we couldn't see very well,
and when we took out the dilator, patient started to bleed. We had three patients in the series that had to have a subsequent revision of the catheter due to mal positioning of the catheter. We suggest that using modern day techniques
with ultrasound guidance that you can minimize your incidents of mechanical complications for tunnel dialysis catheter placement. We also suggest that other centers need to confirm this data using ultrasound guidance as a routine portion of the cannulation
of the internal jugular veins. The KDOQI guidelines actually do suggest the routine use of duplex ultrasonography for placement of tunnel dialysis catheters, but this really hasn't been incorporated in much of the literature outside of KDOQI.
We would suggest that it may actually be something that may be worth putting into the surgical critical care literature also. Now having said that, not everything was all roses. We did have some cases where things didn't go
so straight forward. We want to drill down a little bit into this also. We had 35 patients when we put, after we cannulated the vein, we can see that it was patent. If it wasn't we'd go to the other side
or do something else. But in 35%, 35 patients, we can put the needle into the vein and get good flashback but the wire won't go down into the central circulation.
Those patients, we would routinely do a venogram, we would try to cross the lesion if we saw a lesion. If it was a chronically occluded vein, and we weren't able to cross it, we would just go to another site. Those venograms, however, gave us some information.
On occasion, the vein which is torturous for some reason or another, we did a venogram, it was torturous. We rolled across the vein and completed the procedure. In six of the patients, the veins were chronically occluded
and we had to go someplace else. In 20 patients, however, they had prior cannulation in the central vein at some time, remote. There was a severe stenosis of the intrathoracic veins. In 19 of those cases, we were able to cross the lesion in the central veins.
Do a balloon angioplasty with an 8 millimeter balloon and then place the catheter. One additional case, however, do the balloon angioplasty but we were still not able to place the catheter and we had to go to another site.
Seven of these lesions underwent balloon angioplasty of the innominate vein. 11 of them were in the proximal internal jugular vein, and two of them were in the superior vena cava. We had no subsequent severe swelling of the neck, arm, or face,
despite having a stenotic vein that we just put a catheter into, and no subsequent DVT on duplexes that were obtained after these procedures. Based on these data, we suggest that venous balloon angioplasty can be used in these patients
to maintain the site of an access, even with the stenotic vein that if your wire doesn't go down on the first pass, don't abandon the vein, shoot a little dye, see what the problem is,
and you may be able to use that vein still and maintain the other arm for AV access or fistular graft or whatever they need. Based upon these data, we feel that using ultrasound guidance should be a routine portion of these procedures,
and venoplasty should be performed when the wire is not passing for a central vein problem. Thank you.
- So my charge is to talk about using band for steal. I have no relevant disclosures. We're all familiar with steal. The upper extremity particularly is able to accommodate for the short circuit that a access is with up to a 20 fold increase in flow. The problem is that the distal bed
is not necessarily as able to accommodate for that and that's where steal comes in. 10 to 20% of patients have some degree of steal if you ask them carefully. About 4% have it bad enough to require an intervention. Dialysis associated steal syndrome
is more prevalent in diabetics, connective tissue disease patients, patients with PVD, small vessels particularly, and females seem to be predisposed to this. The distal brachial artery as the inflow source seems to be the highest risk location. You see steal more commonly early with graft placement
and later with fistulas, and finally if you get it on one side you're very likely to get it on the other side. The symptoms that we are looking for are coldness, numbness, pain, at the hand, the digital level particularly, weakness in hand claudication, digital ulceration, and then finally gangrene in advanced cases.
So when you have this kind of a picture it's not too subtle. You know what's going on. However, it is difficult sometimes to differentiate steal from neuropathy and there is some interaction between the two.
We look for a relationship to blood pressure. If people get symptomatic when their blood pressure's low or when they're on the access circuit, that is more with steal. If it's following a dermatomal pattern that may be a median neuropathy
which we find to be pretty common in these patients. Diagnostic tests, digital pressures and pulse volume recordings are probably the best we have to assess this. Unfortunately the digital pressures are not, they're very sensitive but not very specific. There are a lot of patients with low digital pressures
that have no symptoms, and we think that a pressure less than 60 is probably consistent, or a digital brachial index of somewhere between .45 and .6. But again, specificity is poor. We think the digital pulse volume recordings is probably the most useful.
As you can see in this patient there's quite a difference in digital waveforms from one side to the other, and more importantly we like to see augmentation of that waveform with fistula compression not only diagnostically but also that is predictive of the benefit you'll get with treatment.
So what are our treatment options? Well, we have ligation. We have banding. We have the distal revascularization interval ligation, or DRIL, procedure. We have RUDI, revision using distal inflow,
and we have proximalization of arterial inflow as the approaches that have been used. Ligation is a, basically it restores baseline anatomy. It's a very simple procedure, but of course it abandons the access and many of these patients don't have a lot of good alternatives.
So it's not a great choice, but sometimes a necessary choice. This picture shows banding as we perform it, usually narrowing the anastomosis near the artery. It restricts flow so you preserve the fistula but with lower flows.
It's also simple and not very morbid to do. It's got a less predictable effect. This is a dynamic process, and so knowing exactly how tightly to band this and whether that's going to be enough is not always clear. This is not a good choice for low flow fistula,
'cause again, you are restricting flow. For the same reason, it's probably not a great choice for prosthetic fistulas which require more flow. So, the DRIL procedure most people are familiar with. It involves a proximalization of your inflow to five to 10 centimeters above the fistula
and then ligation of the artery just below and this has grown in popularity certainly over the last 10 or 15 years as the go to procedure. Because there is no flow restriction with this you don't sacrifice patency of the access for it. It does add additional distal flow to the extremity.
It's definitely a more morbid procedure. It involves generally harvesting the saphenous vein from patients that may not be the best risk surgical patients, but again, it's a good choice for low flow fistula. RUDI, revision using distal inflow, is basically
a flow restrictive procedure just like banding. You're simply, it's a little bit more complicated 'cause you're usually doing a vein graft from the radial artery to the fistula. But it's less complicated than DRIL. Similar limitations to banding.
Very limited clinical data. There's really just a few series of fewer than a dozen patients each to go by. Finally, a proximalization of arterial inflow, in this case rather than ligating the brachial artery you're ligating the fistula and going to a more proximal
vessel that often will accommodate higher flow. In our hands, we were often talking about going to the infraclavicular axillary artery. So, it's definitely more morbid than a banding would be. This is a better choice though for prosthetic grafts that, where you want to preserve flow.
Again, data on this is very limited as well. The (mumbles) a couple years ago they asked the audience what they like and clearly DRIL has become the most popular choice at 60%, but about 20% of people were still going to banding, and so my charge was to say when is banding
the right way to go. Again, it's effect is less predictable than DRIL. You definitely are going to slow the flows down, but remember with DRIL you are making the limb dependent on the patency of that graft which is always something of concern in somebody
who you have caused an ischemic hand in the first place, and again, the morbidity with the DRIL certainly more so than with the band. We looked at our results a few years back and we identified 31 patients who had steal. Most of these, they all had a physiologic test
confirming the diagnosis. All had some degree of pain or numbness. Only three of these patients had gangrene or ulcers. So, a relatively small cohort of limb, of advanced steal. Most of our patients were autogenous access,
so ciminos and brachycephalic fistula, but there was a little bit of everything mixed in there. The mean age was 66. 80% were diabetic. Patients had their access in for about four and a half months on average at the time of treatment,
although about almost 40% were treated within three weeks of access placement. This is how we do the banding. We basically expose the arterial anastomosis and apply wet clips trying to get a diameter that is less than the brachial artery.
It's got to be smaller than the brachial artery to do anything, and we monitor either pulse volume recordings of the digits or doppler flow at the palm or arch and basically apply these clips along the length and restricting more and more until we get
a satisfactory signal or waveform. Once we've accomplished that, we then are satisfied with the degree of narrowing, we then put some mattress sutures in because these clips will fall off, and fix it in place.
And basically this is the result you get. You go from a fistula that has no flow restriction to one that has restriction as seen there. What were our results? Well, at follow up that was about almost 16 months we found 29 of the 31 patients had improvement,
immediate improvement. The two failures, one was ligated about 12 days later and another one underwent a DRIL a few months later. We had four occlusions in these patients over one to 18 months. Two of these were salvaged with other procedures.
We only had two late recurrences of steal in these patients and one of these was, recurred when he was sent to a radiologist and underwent a balloon angioplasty of the banding. And we had no other morbidity. So this is really a very simple procedure.
So, this is how it compares with DRIL. Most of the pooled data shows that DRIL is effective in 90 plus percent of the patients. Patency also in the 80 to 90% range. The DRIL is better for late, or more often used in late patients,
and banding used more in earlier patients. There's a bigger blood pressure change with DRIL than with banding. So you definitely get more bang for the buck with that. Just quickly going through the literature again. Ellen Dillava's group has published on this.
DRIL definitely is more accepted. These patients have very high mortality. At two years 50% are going to be dead. So you have to keep in mind that when you're deciding what to do. So, I choose banding when there's no gangrene,
when there's moderate not severe pain, and in patients with high morbidity. As promised here's an algorithm that's a little complicated looking, but that's what we go by. Again, thanks very much.
- So this was born out of the idea that there were some patients who come to us with a positive physical exam or problems on dialysis, bleeding after dialysis, high pressures, low flows, that still have normal fistulograms. And as our nephrology colleagues teach us, each time you give a patient some contrast,
you lose some renal function that they maintain, even those patients who are on dialysis have some renal function. And constantly giving them contrasts is generally not a good thing. So we all know that intimal hyperplasia
is the Achilles Heel of dialysis access. We try to do surveillance. Debbie talked about the one minute check and how effective dialysis is. Has good sensitivity on good specificity, but poor sensitivity in determining
dialysis access problems. There are other measured parameters that we can use which have good specificity and a little better sensitivity. But what about ultrasound? What about using ultrasound as a surveillance tool and how do you use it?
Well the DOQI guidelines, the first ones, not the ones that are coming out, I guess, talked about different ways to assess dialysis access. And one of the ways, obviously, was using duplex ultrasound. Access flows that are less than 600
or if they're high flows with greater than 20% decrease, those are things that should stimulate a further look for clinical stenosis. Even the IACAVAL recommendations do, indeed, talk about volume flow and looking at volume flow. So is it volume flow?
Or is it velocity that we want to look at? And in our hands, it's been a very, very challenging subject and those of you who are involved with Vasculef probably have the same thing. Medicare has determined that dialysis shouldn't, dialysis access should not be surveilled with ultrasound.
It's not medically necessary unless you have a specific reason for looking at the dialysis access, you can't simply surveil as much as you do a bypass graft despite the work that's been done with bypass graft showing how intervening on a failing graft
is better than a failed graft. There was a good meta-analysis done a few years ago looking at all these different studies that have come out, looking at velocity versus volume. And in that study, their conclusion, unfortunately, is that it's really difficult to tell you
what you should use as volume versus velocity. The problem with it is this. And it becomes, and I'll show you towards the end, is a simple math problem that calculating volume flows is simply a product of area and velocity. In terms of area, you have to measure the luminal diameter,
and then you take the luminal diameter, and you calculate the area. Well area, we all remember, is pi r squared. So you now divide the diameter in half and then you square it. So I don't know about you,
but whenever I measure something on the ultrasound machine, you know, I could be off by half a millimeter, or even a millimeter. Well when you're talking about a four, five millimeter vessel, that's 10, 20% difference.
Now you square that and you've got a big difference. So it's important to use the longitudinal view when you're measuring diameter. Always measure it if you can. It peaks distally, and obviously try to measure it in an non-aneurysmal area.
Well, you know, I'm sure your patients are the same as mine. This is what some of our patients look like. Not many, but this is kind of an exaggerated point to make the point. There's tortuosity, there's aneurysms,
and the vein diameter varies along the length of the access that presents challenges. Well what about velocity? Well, I think most of us realize that a velocity between 100 to 300 is probably normal. A velocity that's over 500, in this case is about 600,
is probably abnormal, and probably represents a stenosis, right? Well, wait a minute, not necessarily. You have to look at the fluid dynamic model of this, and look at what we're actually looking at. This flow is very different.
This is not like any, not like a bypass graft. You've got flow taking a 180 degree turn at the anastomosis. Isn't that going to give you increased turbulence? Isn't that going to change your velocity? Some of the flow dynamic principles that are important
to understand when looking at this is that the difference between plug and laminar flow. Plug flow is where every bit is moving at the same velocity, the same point from top to bottom. But we know that's not true. We know that within vessels, for the most part,
we have laminar flow. So flow along the walls tends to be a little bit less than flow in the middle. That presents a problem for us. And then when you get into the aneurysmal section, and you've got turbulent flow,
then all bets are off there. So it's important, when you take your sample volume, you take it across the whole vessel. And then you get into something called the Time-Averaged mean velocity which is a term that's used in the ultrasound literature.
But it basically talks about making sure that your sample volume is as wide as it can be. You have to make sure that your angle is as normal in 60 degrees because once you get above 60 degrees, you start to throw it off.
So again, you've now got angulation of the anastomosis and then the compliance of a vein and a graft differs from the artery. So we use the two, we multiply it, and we come up with the volume flow. Well, people have said you should use a straight segment
of the graft to measure that. Five centimeters away from the anastomosis, or any major branches. Some people have actually suggested just using a brachial artery to assess that. Well the problems in dialysis access
is there are branches and bifurcations, pseudoaneurysms, occlusions, et cetera. I don't know about you, but if I have a AV graft, I can measure the volume flow at different points in the graft to get different numbers. How is that possible?
Absolutely not possible. You've got a tube with no branches that should be the same at the beginning and the end of the graft. But again, it becomes a simple math problem. The area that you're calculating is half the diameter squared.
So there's definitely measurement area with the electronic calipers. The velocity, you've got sampling error, you've got the anatomy, which distorts velocity, and then you've got the angle with which it is taken. So when you start multiplying all this,
you've got a big reason for variations in flow. We looked at 82 patients in our study. We double blinded it. We used a fistulagram as the gold standard. The duplex flow was calculated at three different spots. Duplex velocity at five different spots.
And then the diameters and aneurysmal areas were noted. This is the data. And basically, what it showed, was something totally non-significant. We really couldn't say anything about it. It was a trend toward lower flows,
how the gradients (mumbles) anastomosis, but nothing we could say. So as you all know, you can't really prove the null hypothesis. I'm not here to tell you to use one or use the other, I don't think that volume flow is something that
we can use as a predictor of success or failure, really. So in conclusion, what we found, is that Debbie Brow is right. Clinical examinations probably still the best technique. Look for abnormalities on dialysis. What's the use of duplex ultrasound in dialysis or patients?
And I think we're going to hear that in the next speaker. But probably good for vein mapping. Definitely good for vein mapping, arterial inflow, and maybe predicting maturation. Thank you very much.
- I want to thank Dr. Veith for the invitation to present this. There are no disclosures. So looking at cost effectiveness, especially the comparison of two interventions based on cost and the health gains, which is usually reported
through disability adjusted life years or even qualities. It's not to be really confused with cost benefit analysis where both paramaters are used, looked at based on cost. However, this does have different implications from different stakeholders.
And we look, at this point, between the medical center or the medical institution and as well as the payers. Most medical centers tend to look at how much this is costing them
and what is being reimbursed. What's the subsequent care interventions and are there any additional payments for some of these new, novel technologies. What does the payers really want to know, what are they getting for the money,
their expenditures and from here, we'll be looking mainly at Medicare. So, background, we've all seen this, but basically, you know, balloon angioplasty and stents have been out for a while and the outcomes aren't bad but they're not great.
They do have continued high reintervention rates and patency problems. Therefore, drug technology has sort of emerged as a possible alternative with better patency rates. And when we look at this, just some, some backgrounds, when you look at any sort of angioplasty,
from the physician's side, we bill under a certain CPT code and it falls under a family of codes for reimbursement in the medical center called an APC. Within those, you can further break it down to the cost of the product.
In this situation, total products cost around 1400 dollars and the balloons are estimated to be 406 dollars in cost. However, in drug-coated balloons, there was an additional payment, which average, because they're such more expensive devices than the allotments and this had an additional payment.
However, this expired in January of this year. When you look at Medicare reimbursement guidelines, you'll see that on an outpatient hospital setting, there's a reimbursement for the medical center as well as for the physican which is, oops sorry, down eight percent from last year.
And they also publish a geometric mean cost, which is quite higher than we expected. And then the office based practice is also the reimbursement pattern and this is slated to go down also by a few percentage points.
When you look at, I'm sorry, when you look at stents, however, it's a different family of CPT codes and APC family also. Here you'll see the supply cost is much higher in the, I'm sorry, the stent in this category is actually 3600 dollars.
The average cost for drug-eluting stents, around 1500 dollars and the only pass through that existed was on the inpatient side of it. Again, looking at Medicare guidelines, the reimbursement will be going down 8 percent
for the outpatient setting and the geometric mean cost is 11,700. So, what we want to look at really is what is the financial impact looking at primary patency, target lesion revascularization based on meta analysis. And the reinterventions are where the real cost
is going to come into effect. We also want to look at, when it doesn't work and we do bailout stenting, what is the cost going to happen there, which is not often looked at in most of these studies. So looking at a hypothetical situation,
you've got 100 patients, any office based practice, the payee will pay about 5145. There's a pass through payment which averages 1700 dollars per stent. Now, if you look at bailout stenting, 18.5 percent at one year,
this is the additional cost that would be associated with that from a payer standpoint. Targeted risk for revascularization was 12 percent of additional costs. So the total one year cost, we estimated, was almost a million dollars
and the cost per primary patency limb at one year was 13 four. In a similar fashion, for drug-eluting stents, you'll see that there's no pass through payment, but although there is a much higher payer expenditure. The reintervention rate was about 8.4 percent
at one year for the additional cost. And you'll see here, at the one year mark, the cost per patent limb is about 12,600 dollars. So how 'about the medical center, looking at Medicare claims data, you'll see the average cost for them is 745,000,
the medical center. Additional costs listed at another 1500. Bailout renting, as previously, with relate to a total cost at one year of 1.2 million or at 16,900 dollars per limb. Looking at the drug-eluting stents,
we didn't add any additional costs because the drug-eluting stents are cheaper than the current system that is in there but the reinterventions still exist for a cost per patent limb at one year of 14 six. So in essence, a few other studies have looked
at some model, both a European model and in the U.S. where the number of reinterventions at two to five years will actually offset the additional cost of drug-eluting stents and make it a financially advantageous process.
And in conclusion, drug-eluting stents do have a better primary patency and a decreased TLR than drug-coated balloons or even other, but they are more expensive than conventional treatment such as balloon angioplasty and bare-metal stents.
There is a decreased reintervention rate and the bailout stenting, which is not normally accounted for in a financial standpoint does have a dramatic impact and the loss of the pass through makes me make some of the drug-coated balloons
a little more prohibitive in process. Thank you.
- Thank you Mr. Chairman, good morning ladies and gentlemen. So that was a great setting of the stage for understanding that we need to prevent reinterventions of course. So we looked at the data from the DREAM trial. We're all aware that we can try
to predict secondary interventions using preoperative CT parameters of EVAR patients. This is from the EVAR one trial, from Thomas Wyss. We can look at the aortic neck, greater angulation and more calcification.
And the common iliac artery, thrombus or tortuosity, are all features that are associated with the likelihood of reinterventions. We also know that we can use postoperative CT scans to predict reinterventions. But, as a matter of fact, of course,
secondary sac growth is a reason for reintervention, so that is really too late to predict it. There are a lot of reinterventions. This is from our long term analysis from DREAM, and as you can see the freedom, survival freedom of reinterventions in the endovascular repair group
is around 62% at 12 years. So one in three patients do get confronted with some sort of reintervention. Now what can be predicted? We thought that the proximal neck reinterventions would possibly be predicted
by type 1a Endoleaks and migration and iliac thrombosis by configurational changes, stenosis and kinks. So the hypothesis was: The increase of the neck diameter predicts proximal type 1 Endoleak and migration, not farfetched.
And aneurysm shrinkage maybe predicts iliac limb occlusion. Now in the DREAM trial, we had a pretty solid follow-up and all patients had CT scans for the first 24 months, so the idea was really to use
those case record forms to try to predict the longer term reinterventions after four, five, six years. These are all the measurements that we had. For this little study, and it is preliminary analysis now,
but I will be presenting the maximal neck diameter at the proximal anastomosis. The aneurysm diameter, the sac diameter, and the length of the remaining sac after EVAR. Baseline characteristics. And these are the re-interventions.
For any indications, we had 143 secondary interventions. 99 of those were following EVAR in 54 patients. By further breaking it down, we found 18 reinterventions for proximal neck complications, and 19 reinterventions
for thrombo-occlusive limb complications. So those are the complications we are trying to predict. So when you put everything in a graph, like the graphs from the EVAR 1 trial, you get these curves,
and this is the neck diameter in patients without neck reintervention, zero, one month, six months, 12, 18, and 24 months. There's a general increase of the diameter that we know.
But notice it, there are a lot of patients that have an increase here, and never had any reintervention. We had a couple of reinterventions in the long run, and all of these spaces seem to be staying relatively stable,
so that's not helping much. This is the same information for the aortic length reinterventions. So statistical analysis of these amounts of data and longitudinal measures is not that easy. So here we are looking at
the neck diameters compared for all patients with 12 month full follow-up, 18 and 24. You see there's really nothing happening. The only thing is that we found the sac diameter after EVAR seems to be decreasing more for patients who have had reinterventions
at their iliac limbs for thrombo-occlusive disease. That is something we recognize from the literature, and especially from these stent grafts in the early 2000s. So conclusion, Mr. Chairman, ladies and gentlemen, CT changes in the first two months after EVAR
predict not a lot. Neck diameter was not predictive for neck-reinterventions. Sac diameter seems to be associated with iliac limb reinterventions, and aneurysm length was not predictive
of iliac limb reinterventions. Thank you very much.
- So Beyond Vascular procedures, I guess we've conquered all the vascular procedures, now we're going to conquer the world, so let me take a little bit of time to say that these are my conflicts, while doing that, I think it's important that we encourage people to access the hybrid rooms,
It's much more important that the tar-verse done in the Hybrid Room, rather than moving on to the CAT labs, so we have some idea basically of what's going on. That certainly compresses the Hybrid Room availability, but you can't argue for more resources
if the Hybrid Room is running half-empty for example, the only way you get it is by opening this up and so things like laser lead extractions or tar-verse are predominantly still done basically in our hybrid rooms, and we try to make access for them. I don't need to go through this,
you've now think that Doctor Shirttail made a convincing argument for 3D imaging and 3D acquisition. I think the fundamental next revolution in surgery, Every subspecialty is the availability of 3D imaging in the operating room.
We have lead the way in that in vascular surgery, but you think how this could revolutionize urology, general surgery, neurosurgery, and so I think it's very important that we battle for imaging control. Don't give your administration the idea that
you're going to settle for a C-arm, that's the beginning of the end if you do that, this okay to augment use C-arms to augment your practice, but if you're a finishing fellow, you make sure you go to a place that's going to give you access to full hybrid room,
otherwise, you are the subservient imagers compared to radiologists and cardiologists. We need that access to this high quality room. And the new buzzword you're going to hear about is Multi Modality Imaging Suites, this combination of imaging suites that are
being put together, top left deserves with MR, we think MR is the cardiovascular imaging modality of the future, there's a whole group at NIH working at MR Guided Interventions which we're interested in, and the bottom right is the CT-scan in a hybrid op
in a hybrid room, this is actually from MD Anderson. And I think this is actually the Trauma Room of the future, makes no sense to me to take a patient from an emergency room to a CT scanner to an and-jure suite to an operator it's the most dangerous thing we do
with a trauma patient and I think this is actually a position statement from the Trauma Society we're involved in, talk about how important it is to co-localize this imaging, and I think the trauma room of the future is going to be an and-jure suite
down with a CT scanner built into it, and you need to be flexible. Now, the Empire Strikes Back in terms of cloud-based fusion in that Siemans actually just released a portable C-arm that does cone-beam CT. C-arm's basically a rapidly improving,
and I think a lot of these things are going to be available to you at reduced cost. So let me move on and basically just show a couple of examples. What you learn are techniques, then what you do is look for applications to apply this, and so we've been doing
translumbar embolization using fusion and imaging guidance, and this is a case of one of my partners, he'd done an ascending repair, and the patient came back three weeks later and said he had sudden-onset chest pain and the CT-scan showed that there was a
sutured line dehiscence which is a little alarming. I tried to embolize that endovascular, could not get to that tiny little orifice, and so we decided to watch it, it got worse, and bigger, over the course of a week, so clearly we had to go ahead and basically and fix this,
and we opted to use this, using a new guidance system and going directly parasternal. You can do fusion of blood vessels or bones, you can do it off anything you can see on flu-roid, here we actually fused off the sternal wires and this allows you to see if there's
respiratory motion, you can measure in the workstation the depth really to the target was almost four and a half centimeters straight back from the second sternal wire and that allowed us really using this image guidance system when you set up what's called the bullseye view,
you look straight down the barrel of a needle, and then the laser turns on and the undersurface of the hybrid room shows you where to stick the needle. This is something that we'd refined from doing localization of lung nodules
and I'll show you that next. And so this is the system using the C-star, we use the breast, and the localization needle, and we can actually basically advance that straight into that cavity, and you can see once you get in it,
we confirmed it by injecting into it, you can see the pseudo-aneurism, you can see the immediate stain of hematoma and then we simply embolize that directly. This is probably safer than going endovascular because that little neck protects about
the embolization from actually taking place, and you can see what the complete snan-ja-gram actually looked like, we had a pig tail in the aura so we could co-linearly check what was going on and we used docto-gramming make sure we don't have embolization.
This patient now basically about three months follow-up and this is a nice way to completely dissolve by avoiding really doing this. Let me give you another example, this actually one came from our transplant surgeon he wanted to put in a vas,
he said this patient is really sick, so well, by definition they're usually pretty sick, they say we need to make a small incision and target this and so what we did was we scanned the vas, that's the hardware device you're looking at here. These have to be
oriented with the inlet nozzle looking directly into the orifice of the mitro wall, and so we scanned the heart with, what you see is what you get with these devices, they're not deformed, we take a cell phone and implant it in your chest,
still going to look like a cell phone. And so what we did, image fusion was then used with two completely different data sets, it mimicking the procedure, and we lined this up basically with a mitro valve, we then used that same imaging guidance system
I was showing you, made a little incision really doing onto the apex of the heart, and to the eur-aph for the return cannula, and this is basically what it looked like, and you can actually check the efficacy of this by scanning the patient post operatively
and see whether or not you executed on this basically the same way, and so this was all basically developed basing off Lung Nodule Localization Techniques with that we've kind of fairly extensively published, use with men can base one of our thoracic surgeons
so I'd encourage you to look at other opportunities by which you can help other specialties, 'cause I think this 3D imaging is going to transform what our capabilities actually are. Thank you very much indeed for your attention.
- Thank you. I have two talks because Dr. Gaverde, I understand, is not well, so we- - [Man] Thank you very much. - We just merged the two talks. All right, it's a little joke. For today's talk we used fusion technology
to merge two talks on fusion technology. Hopefully the rest of the talk will be a little better than that. (laughs) I think we all know from doing endovascular aortic interventions
that you can be fooled by the 2D image and here's a real life view of how that can be an issue. I don't think I need to convince anyone in this room that 3D fusion imaging is essential for complex aortic work. Studies have clearly shown it decreases radiation,
it decreases fluoro time, and decreases contrast use, and I'll just point out that these data are derived from the standard mechanical based systems. And I'll be talking about a cloud-based system that's an alternative that has some advantages. So these traditional mechanical based 3D fusion images,
as I mentioned, do have some limitations. First of all, most of them require manual registration which can be cumbersome and time consuming. Think one big issue is the hardware based tracking system that they use. So they track the table rather than the patient
and certainly, as the table moves, and you move against the table, the patient is going to move relative to the table, and those images become unreliable. And then finally, the holy grail of all 3D fusion imaging is the distortion of pre-operative anatomy
by the wires and hardware that are introduced during the course of your procedure. And one thing I'd like to discuss is the possibility that deep machine learning might lead to a solution to these issues. How does 3D fusion, image-based 3D fusion work?
Well, you start, of course with your pre-operative CT dataset and then you create digitally reconstructed radiographs, which are derived from the pre-op CTA and these are images that resemble the fluoro image. And then tracking is done based on the identification
of two or more vertebral bodies and an automated algorithm matches the most appropriate DRR to the live fluoro image. Sounds like a lot of gobbledygook but let me explain how that works. So here is the AI machine learning,
matching what it recognizes as the vertebral bodies from the pre-operative CT scan to the fluoro image. And again, you get the CT plus the fluoro and then you can see the overlay with the green. And here's another version of that or view of that.
You can see the AI machine learning, identifying the vertebral bodies and then on your right you can see the fusion image. So just, once again, the AI recognizes the bony anatomy and it's going to register the CT with the fluoro image. It tracks the patient, not the table.
And the other thing that's really important is that it recognizes the postural change that the patient undergoes between the posture during the CT scan, versus the posture on the OR table usually, or often, under general anesthesia. And here is an image of the final overlay.
And you can see the visceral and renal arteries with orange circles to identify them. You can remove those, you can remove any of those if you like. This is the workflow. First thing you do is to upload the CT scan to the cloud.
Then, when you're ready to perform the procedure, that is downloaded onto the medical grade PC that's in your OR next to your fluoro screen, and as soon as you just step on the fluoro pedal, the CYDAR overlay appears next to your, or on top of your fluoro image,
next to your regular live fluoro image. And every time you move the table, the computer learning recognizes that the images change, and in a couple of seconds, it replaces with a new overlay based on the obliquity or table position that you have. There are some additional advantages
to cloud-based technology over mechanical technology. First of all, of course, or hardware type technology. Excuse me. You can upgrade it in real time as opposed to needing intermittent hardware upgrades. Works with any fluoro equipment, including a C-arm,
so you don't have to match your 3D imaging to the brand of your fluoro imaging. And there's enhanced accuracy compared to mechanical registration systems as imaging. So what are the clinical applications that this can be utilized for?
Fluoroscopy guided endovascular procedures in the lower thorax, abdomen, and pelvis, so that includes EVAR and FEVAR, mid distal TEVAR. At present, we do need two vertebral bodies and that does limit the use in TEVAR. And then angioplasty stenting and embolization
of common iliac, proximal external and proximal internal iliac artery. Anything where you can acquire a vertebral body image. So here, just a couple of examples of some additional non EVAR/FEVAR/TEVAR applications. This is, these are some cases
of internal iliac embolization, aortoiliac occlusion crossing, standard EVAR, complex EVAR. And I think then, that the final thing that I'd like to talk about is the use with C-arm, which is think is really, extremely important.
Has the potential to make a very big difference. All of us in our larger OR suites, know that we are short on hybrid availability, and yet it's difficult to get our institutions to build us another hybrid room. But if you could use a high quality 3D fusion imaging
with a high quality C-arm, you really expand your endovascular capability within the operating room in a much less expensive way. And then if you look at another set of circumstances where people don't have a hybrid room at all, but do want to be able to offer standard EVAR
to their patients, and perhaps maybe even basic FEVAR, if there is such a thing, and we could use good quality imaging to do that in the absence of an actual hybrid room. That would be extremely valuable to be able to extend good quality care
to patients in under-served areas. So I just was mentioning that we can use this and Tara Mastracci was talking yesterday about how happy she is with her new room where she has the use of CYDAR and an excellent C-arm and she feels that she is able to essentially run two rooms,
two hybrid rooms at once, using the full hybrid room and the C-arm hybrid room. Here's just one case of Dr. Goverde's. A vascular case that he did on a mobile C-arm with aortoiliac occlusive disease and he places kissing stents
using a CYDAR EV and a C-arm. And he used five mils of iodinated contrast. So let's talk about a little bit of data. This is out of Blain Demorell and Tara Mastrachi's group. And this is use of fusion technology in EVAR. And what they found was that the use of fusion imaging
reduced air kerma and DSA runs in standard EVAR. We also looked at our experience recently in EVAR and FEVAR and we compared our results. Pre-availability of image based fusion CT and post image based fusion CT. And just to clarify,
we did have the mechanical product that Phillip's offers, but we abandoned it after using it a half dozen times. So it's really no image fusion versus image fusion to be completely fair. We excluded patients that were urgent/emergent, parallel endographs, and IBEs.
And we looked at radiation exposure, contrast use, fluoro time, and procedure time. The demographics in the two groups were identical. We saw a statistically significant decrease in radiation dose using image based fusion CT. Statistically a significant reduction in fluoro time.
A reduction in contrast volume that looks significant, but was not. I'm guessing because of numbers. And a significantly different reduction in procedure time. So, in conclusion, image based 3D fusion CT decreases radiation exposure, fluoro time,
and procedure time. It does enable 3D overlays in all X-Ray sets, including mobile C-arm, expanding our capabilities for endovascular work. And image based 3D fusion CT has the potential to reduce costs
and improve clinical outcomes. Thank you.
- Have nothing to disclose. This is a question we see everyday, we start off with the toe on the left we hope to end up with this, not this and this. And the question is, can we have some
or do we have something in our toolbox that can tell us this will end up here, not here and not here. So, when you look in the literature and most armor materials of vascular oxygen,
we have physical exam the most basic as the ankle break you index which is historically and currently can be inaccurate based on the calcium changes in the diabetic digital pressures are supposed to be
less affected by the cost of five changes in the diabetic, we also duplex which some people use as well as the velocities or the waveform patterns to help to determine blood flow to the foot contrast based imaging although use essentially on all patients with limb savage
really has not provided accurate measurements of whether or not the patient will heal. Over 20 years ago, there was some data to look at two pressures to determine whether or not you heel the toe or in the foot.
At this point, it was felt to be somewhere in the 50 to 60 millimeters of mercury. You saw patients healed statistically better. However, you still see people heal on this side who are under the 50% 50 millimeters of mercury range.
Perspective data has been seen in the literature. This is a paper that it looked at whether or not monitor healing monitoring amputations would heal the toe pressure, the odds ratio was calculated and as you can see
every millimeter of increase in the toe pressure the risk of monitor for an amputation progressing to hire amputation was decreased, and the toe brachial pressure index was also very important in the term of whether or not the patient would heal. This is a meta analysis of the literature
looking at all the different studies that have been used to determine whether or not two blood pressure and to break your index could show predictive value of healing. Unfortunately,
there are a lot of variations in the way these studies are performed. However, it is felt there are some predictive values. One of the things the reason we looked at our data is some people use Doppler waveform. Some of our colleagues,
instead of looking at the actual pressure reading at the level to toe will look at velocities and waveforms and try to use that as a predictive value. In this particular study,
it has been shown in patients on dialysis, looking at their waveform and without wombs, whether or not they'll go on eventually have a major amputation. And in this setting, it may have some impact
but these are patients with wounds but these are patients that you are following who are on dialysis, and waveforms can predict future amputation. Trans cutaneous oximetry and some institutions are readily available.
however, sorry, however, most institutions that I've worked at it's only available in wound healing center and is not readily available in the vascular lab
although this is based on oxygen tension, the numbers are pretty similar to what we expect to find with healing potential with a digital blood pressures. Our experience we looked at this several years ago we presented a vest and also is published in the annuals of vasculature surgery,
we tried to look at whether or not the velocities within the tibia Walgreens the waveforms within the the tibia Walgreens, and or was there a number that was the best number to predict whether or not the patient would heal.
Similar to what is taught in most educational institutions, around 50 millimeters of mercury was statistically significant and that over 90 or close to 90% of patients healed at that level of perfusion. Unfortunately, under 47,
you still had 70 some percent of the people healed. We looked at this when I was in Tampa and fellowship, we had over 90% predictive value whether or not you could heal in the foot or mid foot based on toe pressures.
However, it really doesn't help us that much because there's still a significant portion of patients who will heal in the 30 to 50 millimeter range. Overall, what does all this mean? I'm unsure.
One of the most difficult things we see with patients that we're going to plan amputation and we can improve the revascularization strategies is in the patient who have two pressures in the zero to 20
since we do not going to heal and proceed with major amputation versus those who are in the 30 to 50 it's essentially a coin toss whether or not they will heal and then over 50 is still not a for sure thing.
Like to thank the opportunity to share information. Thank you.
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