Chapters
Chronic Low Back Pain |PRP, Gelstix |56| Female
Chronic Low Back Pain |PRP, Gelstix |56| Female
2015discGRIBOIherniatedLindare Medical
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Algorithms For Managing Steal Syndrome: When Is Banding Appropriate
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Episode Based Payment Models For Dialysis Access Creation
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Non-Fasting Lipid Profiles Are A Simplification With No Negative Consequences For Diagnosis, Risk Evaluation And Treatment
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Minimizing Risks From Long-Term Central Venous Catheter Use In Dialysis Patients
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Update On The everlinQ Percutaneous Fistula Device
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2018 Update On KDOQI Guidelines For Dialysis Access
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Results Of Phase 3 Trials Of Vonapanitase In Vascular Access
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Long-Term Results Of AV Fistulas And Grafts
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Educating Your Patients To Advocate For Themselves In The Dialysis Clinic
Educating Your Patients To Advocate For Themselves In The Dialysis Clinic
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When To Refer Patients For Hemodialysis Access And Who Should Monitor The Maturation Process
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Developing Efficient And Effective Regulatory Pathways For Patient Centered Device Innovation
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Pump Speed, Needle Size, And Fistula Flow: Means To What End
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Current Management Of Bleeding Hemodialysis Fistulas: Can The Fistula Be Salvaged
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International Differences In The Location And Use Of AV Access Created For Hemodialysis: Results Of The DOPPS
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Transcript

iii to me iii point eight post six weeks there is 1.5 26 months

0.5 and you'll see here the disc and the iii into the disc I don't see it here because it's somewhere, sorry I have to go back sorry this also room bottom, no not on show previous okay here we go back back back yeah that's a hydrogel/g here.

Have to look closer because I don't see it from the distance here and here. Okay, that's the hydrogel/g and the disc here and here. You can see it actually. The here, it even dislocated a little bit, and here.

That's why you should not put it in your herniated disc. If there's, that's contrary indication,

- 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.

- [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, I have no conflict of interest. Although less represented in studies, it has been clearly shown that women are less likely to benefit and more likely to suffer carotid procedural stroke or death compared to men. So let's look at procedural benefit for women in particular first, carotid endarterectomy first.

The only women with carotid stenosis who have been shown to receive a statistically significant overall benefit from carotid endarterectomy have been symptomatic women with 70 to 99% NASCET stenosis without near occlusion who had carotid endarterectomy performed within two

to three weeks of their last cerebral event. They also had to satisfy all the trial inclusion and exclusion criteria. So, symptomatic women in the randomized trials did not receive a benefit from endarterectomy compared to medical treatment on its own

if they had 70 to 99% NASCET stenosis, and endarterectomy was performed more than two to three weeks from the last cerebral event. Or if they had 50 to 69% NASCET stenosis no matter the timing of the endarterectomy. Now, symptomatic men in the

randomized trials had more benefit. Symptomatic men with 70 to 99% NASCET stenosis actually had an overall statistically significant benefit from endarterectomy up to at least three months after their last cerebral event. And I haven't seen it published exactly

when that benefit period finished. Also, men with 50 to 69% NASCET stenosis had overall benefit from endarterectomy, but only if the surgery was performed within two to three weeks of their last cerebral ischemic event. With respect to asymptomatic women,

there's been no clear benefit from endarterectomy in randomized trials. So they did not benefit in ACAS, and the closest to benefit ACST were aged less than 75 years of age. But this was only borderline statistically significant. Asymptomatic men also had more benefit in the randomized

trials of endarterectomy versus medical treatment. So, overall, they had a benefit if they had at least 60% NASCET stenosis, and they were aged less than 75 to 80. What about transfemoral, transaortic stenting? Women and men have not been shown to benefit from stenting

compared to medical intervention alone or endarterectomy. Now, I've head some rumors that women in ACT-1 trial had less harm from stenting compared to endarterectomy. But I haven't seen that result published yet. And when it is published they need to include the peri-procedural risk of stroke and death.

Of course, women and men are much less likely to benefit from any carotid procedure now due to advances in medical intervention. What about procedural harm, endarterectomy? Well, in the randomized trials of endarterectomy versus medical treatment and other studies women

are more likely to have peri-operative stroke and death compared to men. That's seen in randomized trials, but also in non-randomized trials. What about trans-femoral/aortic stenting? Randomized trials and other studies

have been underpowered to compare outcomes with stenting in symptomatic women versus men, but across both sexes stenting has significantly more harm associated with it. In a meta-analysis of randomized trials symptomatic women had one and a half times more peri-procedural stroke

and death with stenting compared to endarterectomy. Again, for asymptomatic patients the trials have been underpowered, but a trend to more harm with stenting. And, also, seen in CREST with combined symptomatic and asymptomatic women.

As Cosmas mentioned, more harm with stenting. TCAR, doesn't look like we're planning to do adequate comparisons with current medical treatment, so no current indication. In summary, overall, the only women shown to benefit from endarterectomy were symptomatic

with 70 to 99% stenosis with endarterectomy within two to three weeks of the last event. Overall, all women are more likely to be harmed by endarterectomy compared to men, and to be harmed by stenting compared to endarterectomy. Everyone is less likely to benefit

from these procedures now. So given all this information, why are we doing so many procedures in women? Thank you.

- Thank you very much. So, this audience certainly knows that the higher the triglyceride, the greater the cardiovascular morbidity mortality, similarly if you have a low HDL that same relation holds, and certainly for the non-HDL-C or LDL-C calculated the higher the worse outcome and there's

multiple drugs related to this. Similarly with stroke, triglyceride the same relationship. Ischemic stroke increased with low HDL and again LDL-C correlates. So the historical precedent has been that you should get a fasting lipid level

when you first encounter the patient, but to make this simple that's really probably not true. So there's various things that are measured and that are calculated, but LDL is generally calculated, HDL is measured and then the triglycerides are calculated as remnant cholesterol.

So if you compare just the measured LDL compared to calculated LDL in a non-fasting state, it's a little bit of a wider linear relationship here as compared with the fasting, it's a little bit tighter. But when you look at this in more depth, and this reference here really nicely puts it all together

but the total cholesterol really doesn't vary if you've fasted one hour or 16 hours, similarly between men and women. The only thing that varies a little bit is triglycerides and we'll go on to that in just a little bit of depth.

But again that's variable, triglycerides go up if you eat really not much difference with the other lipid levels. And if you look just in terms of triglycerides, they overlap between non-fasting and fasting, really at almost all levels

so there's not really discrepancy. Similarly with LDL, same amount of overlap here whether or not you have diabetes it doesn't seem to make a difference. So for lipid panels, profile testing, in most patients you can get a non-fasting

initial lipid profile in any patient for cardiovascular risk assessment, I'd say that's where it's most commonly done in most of our practices. Similarly with acute coronary syndrome, if preferred by the patients et cetera.

But really it's where the non-fasting triglycerides are highly elevated that you want to get a fasting lipid panel. So what causes secondary hyperlipidemia related particularly to hypertriglyceridemia? Certainly certain diet factors, certain drugs,

cyclosporins for example, biliary obstruction and hypothyroidism. And so, one algorithm is that in terms of screening with non-fasting, and if it's less than 200 you're good to go, you really don't need to do anything further,

and if it's greater than 200 then probably a fasting lipid profile, lipoprotein panel is indicated. So reasons that non-fasting lipid measurement is fine most of the time is that again most trials have used non-fasting levels for determination of effectiveness of various medications.

This Friedewald formula actually uses total cholesterol, HDL, and triglycerides to calculate LDL-C, and LDL really is not directly measured, it's not standardized by the CDC such as these other cholesterol moieties are. And again most CV risk factor calculators don't use LDL-C.

So again, non-fasting is acceptable for the initial risk estimation in untreated and primary prevention screening. For patients with genetic hyperlipidemia probably fasting is required. Diagnosis of metabolic syndrome, non-fasting is fine.

And again some other more highly specialized scenarios you may want a fasting profile. Thank you.

- Thank you. Here are my disclosures. Our preferred method for zone one TAVR has evolved to a carotid/carotid transposition and left subclavian retro-sandwich. The technique begins with a low transverse collar incision. The incision is deepened through the platysma

and subplatysmal flaps are then elevated. The dissection is continued along the anterior border of the sternocleidomastoid entering the carotid sheath anteromedial to the jugular vein. The common carotid artery is exposed

and controlled with a vessel loop. (mumbling) The exposure's repeated for the left common carotid artery and extended as far proximal to the omohyoid muscle as possible. A retropharyngeal plane is created using blunt dissection

along the anterior border of the cervical vertebra. A tunneling clamp is then utilized to preserve the plane with umbilical tape. Additional vessel loops are placed in the distal and mid right common carotid artery and the patient is systemically anticoagulated.

The proximal and distal vessel loops are tightened and a transverse arteriotomy is created between the middle and distal vessel loops. A flexible shunt is inserted and initially secured with the proximal and middle vessel loops. (whistling)

It is then advanced beyond the proximal vessel loop and secured into that position. The left common carotid artery is then clamped proximally and distally, suture ligated, clipped and then transected. (mumbling)

The proximal end is then brought through the retropharyngeal tunnel. - [Surgeon] It's found to have (mumbles). - An end-to-side carotid anastomosis is then created between the proximal and middle vessel loops. If preferred the right carotid arteriotomy

can be made ovoid with scissors or a punch to provide a better shape match with the recipient vessel. The complete anastomosis is back-bled and carefully flushed out the distal right carotid arteriotomy.

Flow is then restored to the left carotid artery, I mean to the right carotid artery or to the left carotid artery by tightening the middle vessel loop and loosening the proximal vessel loop. The shunt can then be removed

and the right common carotid artery safely clamped distal to the transposition. The distal arteriotomy is then closed in standard fashion and flow is restored to the right common carotid artery. This technique avoids a prosthetic graft

and the retropharyngeal space while maintaining flow in at least one carotid system at all times. Once, and here's a view of the vessels, once hemostasis is assured the platysma is reapproximated with a running suture followed by a subcuticular stitch

for an excellent cosmetic result. Our preferred method for left subclavian preservation is the retro-sandwich technique which involves deploying an initial endograft just distal to the left subclavian followed by both proximal aortic extension

and a left subclavian covered stent in parallel fashion. We prefer this configuration because it provides a second source of cerebral blood flow independent of the innominate artery

and maintains ready access to the renovisceral vessels if further aortic intervention is required in the future. Thank you.

- So first of all I want to tell everybody that you're going to have a hard time finding these tools that I'm going to show you. So before I start the talk I want to tell you how you can find these. Everybody's got phones out there that you can Google on. If you would Google "One minute access check"

it will take you to the website that is the ESRDNCC.org site, and that's where you can find the tools. The other place that these are all located is on the VASA website. If you go to the VASA website, which is

the Vascular Access Society of the Americas, which is VASAMD.org, and you go under "Vascular Access Team", all of these tools are linked. The tools that we're going to talk about were put together by the FistulaFirst and I was on the work group that created these tools,

and they're going to solve the problems that you just heard the rest of the group talk about. It talks about how to collaborate the care, how to assess the maturing and the healing access, and to level the playing field so we're all doing it the same way.

And that's basically what these tools were developed for. That's my conflict of interest. So the patient video that just showed you, the patient said patient education. This is a free, your tax-dollar money paid for this booklet. You can print these for free,

there's no copyright issues on it. This is a patient access planning booklet that explains to the patient all of their choices for renal replacement therapy, what is an access, and what's going to happen to them when they get this access.

This is a fantastic booklet and it also serves as the patient's care plan if you fill this out and use it. It can go between the dialysis facility, the surgeon, and the interventionalist. And I'm sorry it doesn't project well,

but this is just a snippet from the booklet that shows you, for the surgeons in the audience, what's going to happen at your office when the patient comes in. And it gives questions that the patient and the family should ask.

So as surgeons, if you look at this booklet, you use it with your team at your office, you'll be able to be prepared for patients coming in and you can use this tool. This is what I consider the plain ice in the sandbox tool.

This tool was created to define all of the various roles of the dialysis access care team, because we all do different parts of the process, but if we don't work together, it doesn't work. So this booklet explains what everybody's roles are, and again this is a great tool.

If you've got a nephrology practice that you're not happy with how things are coming to you with referrals, or you've an interventionalist that you're having issues with, sit down, have a team meeting, bring all the players together

and use this book to guide it. It really tells you what to do and how to do it. And this is an example of what's going to happen with the care team coming together how you go through the access planning, okay? And this is just some information of what

the surgical appointment should get. When you get the patients to show up and they come to you with no information, you don't really know much about the patient, this booklet helps to prepare the dialysis facilities so they know what to send

and they understand those records should come to you. Now, the main part of these booklets of what we're talking about today is this whole issue of what Ted's slide was about who should assess the access for maturing. Well, this answers that question.

There is a basic tool that will give you a weekly assessment of whether or not that graft or fistula is ready to go. And basically this is the care planning part of it where we make that access plan, we then find the best place to get the access,

we choose, we get the patient to the surgeon so you can place the access, patient goes for the surgery. Then we wait for it to mature, heal, we use the access, we then have to get the catheter out, and then we

have to take care of the lifeline for the rest of the patient's time on dialysis or their transition between different modalities. So, how do we do that? The tools are based, this weekly assessment tools are based on the classic one minute check.

This is actually from Dr. Bether's physical exam that's been taught to nephrologist and dialysis staff for many years. It's a simple look, listen, and feel. There's also an advanced test for the care side. This is for the patient,

and this is for the clinician side. It's the look listen and feel with the arm elevation test, and the augmentation test is also added on at the expert level. Again, all these tools are on the website for you to use. Please use them.

Once you understand the one-minute check, this is then the graft healing slides, and again it's a weekly assessment, and we called it graft healing because grafts don't mature, we just are waiting for the surgery line to heal so that

we can go ahead and cannulate it. If it's an early cannulation graft, this would be adopted for those early cannulation grafts, this is for standard graft material. So we go into week two, this tells the patient, the staff, the nephrologist, everybody on the team

what should we be looking for and what should be happening with that access and when it should be ready to cannulate. By week four, if it's not ready to cannulate, this triggers notifying the surgeon, re-engaging with the team, and figuring out

what's going on with the patient's access, okay? We cannot just let these patients sit there with accesses that are not being used for weeks and weeks and weeks. We have to have a plan. And this is what the tool does. The fistula maturation tool is the same thing.

Again it's weekly assessments, there's week one and two, week three, by week four we're looking for actual signs of change with the fistula. If it's not, we would start to already think of a plan of does this need some assisted maturation.

Week five, we're looking to see is it ready to cannulate. By week seven through ten, it certainly should be ready to go and we should be dealing with catheter freedom. There's also a catheter version, because patients with catheters still need to have their catheters

well maintained so they don't get infection. There's a patient version and a staff version. And again it's the same look listen and feel. We obviously don't listen to a catheter like we do a graft or fistula, but we listen to the patient to make sure they're not having symptoms

of infection or problems with the catheter. And we have to do that because we're all part of this interdisciplinary team. I'm a dialysis nurse, so I'm part of the dialysis team, but we have an interdisciplinary team in the dialysis unit, we have to work with the surgeons,

the interventionalists, whether you're an IN or an IR, we have to work with the patients, we have to bring the family in, it's all about this process of care, and hopefully you'll look at these tools and maybe these tools will help you

with your process of care. Thank you.

- Thanks very much Ken, Thanks for the in shape comment. I'm not sure that necessarily true. These are my disclosures. I think it's critical to understand that Atherosclerosis is not just the deposition of cholesterol, but it's really inflammatory cells acting

upon that environment where the cholesterol has been deposited. That ultimately leads to the inflammatory process that osis, plaque rupture, and complications related to it.

If we look specifically at our best marker of inflammation that we have, hsCRP. It's elevated with hypertension, type two diabetes, independently of LDL C.

Statins we know can lower this CRP sum, which lowers cardiovascular risks, and it does it independently of LDL C reduction. And that was shown in the Cantos trial. Cholesterol and inflammation thus equals cardiovascular disease.

And methods to reduce inflammation include: smoking cessation, regular exercise, weight loss, and actually getting adequate sleep. But the final thing, and probably in my view one of the more important things, is the diet that we take in.

You've heard recommendations through the Mediterranean, vegetarian, and low carbohydrates diet. You haven't heard recommendations to the adopt the southern diets, which is the only diet that has been proven

to increase the risk of hypertension and Atherosclerosis. And my move to South Carolina, has prompted a look at diet overall. What are anti-inflammatory diets? They're basically diets that increase the color of the foods that you eat.

Increased fruits and vegetables, minimizing trans and saturated fats, and limiting refined of processes c which are probably more important in developing inflammation than any other part of our diet.

It increases whole grains and lean protein sources. Avoiding refine sugars and spices that are anti-inflammatory can be helpful as well. Eliminating soda and all beverages that are sweetened, are particularly important. And again here you can see here that olive oil

essentially is the only oil that is actually beneficial in an anti-inflammatory diet. What to avoid: fried foods- no matter what they are fried in. Vegetable oils increase inflammation.

Anything that's a substitute for butter or milk products are problematic. And processed carbohydrates, again, are problematic along with processed meats. The benefits of an anti-inflammatory diet have been shown in a number of conditions

including cardiovascular disease. And each one of these inflammatory conditions has at least two studies that show benefits of reducing inflammatories in the diet. The association between diet and arterial stiffness and precursor turatorial disease

has been shown in this study, where these authors took almost 500 individuals, recorded their food and tonometry to assess arterial elasticity. In each situation where you increase carbohydrates versus fats or proteins,

you increase aortic pulse pressure and mean arterial pressure. And when you remove carbohydrates and replaced with protein, you reduced aortic and mean pressures. Clearly and diet affects what's happening in the arteries. This is another look at the dietary inflammatory index,

which is new categorization of diets to access their degree of inflammation. And in this study, which really looked at six different bio markers of inflammatory process in the blood stream. The authors assessed a relationship

of dietary and inflammatory index to hsCRP, and showed that if you reduce the inflammatory index, you can reduce the hsCRP. This says elevated dietary and inflammatory index cause the authors looked at index as a method to reduce overall inflammation.

But it reduces hsCRP and reduces colon risk cancer in the populations that they've studied. And in this look at metabolically obese people, whether they were metabolically unhealthy or healthy, the authors looked at over 300 individuals and recorded and their diet.

And notice that a worse inflammatory diet was associated with an increase risk for metabolic unhealthiness, And increased the risk of all these other things which elevate inflammatory markers

in the blood stream as well. In summary then, vascular disease is an inflammatory process as is obesity. And vascular specialists need to include diet recommendations into the things we use routinely

to modify lifestyles and reduce Atherosclerotic risk for our patients. Thank you.

- Thank you very much, I appreciate the invitation to this great meeting. So I'm going to talk a little more broadly about beta blockade, then Dr. Mollis, and let's review again some of the randomized control trial data. So, just like the first slide with prior speaker, this really kind of turned me on to beta blockade.

It did show a benefit to Atenolol over placebo, fairly far out with regards to when its effect really was manifest, but it started to change practice, and then really, the decrease one trial was a game changer based on, it was high risk vascular surgical patients all had a positive stress test, moderate dose of Bisoprolol,

and they found a significant reduction in death and MI out to 30 days, but as many of you are aware, many of these are discredited. They didn't really look back at decrease one to see if that was fraudulent of fictitious, but many of their further trials have since been discredited.

So then, the POISE Trial came, and again, this was previously mentioned, and it does include vascular, non-vascular patients, but 8300 patients, Troprolol, pretty high dose right around the time of surgery versus placebo, and you can see that the non-fatal MI was significantly reduced, as well as a composite endpoint,

but stroke and bradycardia were significantly increased, and in fact, if you look at this out to one year, you can see that it was a 16% increase in all cause mortality, no difference in CV mortality, and then again, non-CV mortality was increased 22% and caused 54 excess deaths

compared to placebo, so that's real. Put it another way, 1,000 patients treated with a beta blocker would benefit from reducing 12 MIs and six revascularization, but increase harm significantly with 13 deaths and six strokes. Some of these trials, again, were otherwise mentioned,

and this is in vascular surgical patients, howbeit, not just AAA patients, but about 50 in each group, relatively small, and with 30 day assessment, it again was 50 to 100 milligrams Metoprolol the day before or on the day of surgery, mortality was not significantly different at the time of their discharge.

Another, slightly larger trial in patients with diabetes and beta blockade, 100 milligrams of Metoprolol, at least two hours prior to the OR, and they did two tests dosing to make sure the patients tolerated this out to day eight, and then they did a control for those who had bradycardia

or hypotension weren't included, so about 460 patients in this trial, and again, early 30 day outcome, not significantly different, and out to 700 days, again, the composite of death and cardiovascular morbidities. Last trial in terms of this review, same dosing regimine, basically, with Metoprolol here, about 250 patients

in each group, and again, no significant difference at six months, but significantly increased intraoperative hypotension requiring treatment in intraoperative bradycardia. So, putting these together with meta-analyses, looking at the effect of beta blockade

and perioperative death, actually a significant increase based on this meta-analysis, and particularly more striking was the 73% increase in overall nonfatal strokes with beta blockade. Again, the thing it did reduce was nonfatal MIs out to 30 days, even if you did

discount the decreased trials. A database review was presented by Dr. Mallis, and this was a VA cohort study, slightly different one, 37,000 patients in the VA system propensity matched and had received beta blockade within one day of surgery and thereafter, and I'm pointing out that

the vascular surgical patients, whether they were low risk or high risk, all achieved no benefit from this. So again, it may be just as much an issue of two large a dose as too short of time for it to, the medication to be administered,

and if you don't totally disbelieve the decrease one trial, they found that when the heart rate was titrated less than 65 compared to over 65, the benefit was really striking there. So, what do the guidelines say about this? Well, the AHA and 2014 perioperative beta blockade

started with one day or less before non-cardiac surgery prevents non-fatal MI, but increases the risk of stroke, death, hypotension, and bradycardia. So, what do I recommend? Well, I think that you need to keep your patients on beta blockers, if they're on them for

any indication already, such as heart failure. If they're at high risk for perioperative MI, such as those with positive stress tests that aren't a candidate for revascularization, start low dose Metoprolol, and/or Atenolol, and at least 15 to 30 days in advance,

try to titrate that heart rate, avoid the dose on the morning of surgery, and really do need a randomized control trial of titrated low dose beta blockade in high risk patients, thank you.

- I'd like to thank Dr. Veith and the organizers for the invitation. I'm a speaker for Gore medical, and I receive grant support and speaking fees from Acelity. I'd also like to thank my former partners at UPMC for their help with this study.

So are catheters really that bad? Of course we all know the answer's yes. The risk of bacteremia is 10-fold higher than with an AV fistula, and approximately 5 1/2 septic episodes per 1,000 catheter days are seen

in dialysis patients. This is not only a costly but can be a deadly problem. This is a shot of a 23 year old patient of mine who had been maintained on catheters for a long while,

and I was treating for SBC syndrome. So why can't we place fistulas earlier and avoid catheters altogether? 80% of patients start dialysis with a catheter. This is a multifactorial problem including late referrals to nephrology,

a difficulty of nephrologist to find available surgeons. Perhaps percutaneous fistula creation which is on the cutting edge of dialysis technology might help with this problem. But right now nationwide there's a backlog

of dialysis patients needing surgeons. Compounding this problem is that many patients don't have coverage for surgery until three months of dialysis care. And the proportion of patients getting dialysis fistulas pre-dialysis may be declining

according to a recent Canadian survey. In this survey they found that even in patients who had fistulas created, 11% of those fistulas weren't usable at the time of dialysis initiation. And in patients who had had

two or more surgeries, 35% of those fistulas were not able to be used. AV grafts are associated with a faster catheter removal, but more interventions over the first year of placement than AV fistulas.

TDC removal is faster with AV grafts, but it still takes longer than we all expect. We think an AV fistula should be ready to use at six weeks when indeed the median time to use is closer to 18 weeks. AV grafts we think are ready to use at two weeks,

when the median is actually closer to 9 weeks and this data is also from UPMC. Our aim in this recent study was to compare the real world performance of standard AV grafts and immediate use AV grafts in a dialysis population looking at catheter time.

Taking results from Duke and UPMC combined, we made three groups of patients: the standard AV graft patients, immediate use AV graft patients in a conventional configuration, and immediate use grafts combined

with a HeRO catheter. The demographics across these groups were similar with the exception of HeRo patients having more central venous occlusions, and immediate use AV grafts having a lower percentage of prevalent TDCs.

This was due to a small number of patients getting immediate use AV grafts on initiation of dialysis in place of a catheter. When we looked at complications across these groups, we found that there was no significant difference

in perioperative deaths, steal or AV graft infection. However we found that AV grafts were able to be used in the immediate access group significantly more often than in the standard group.

We found no results, no significant differences in our patency results either primary or secondary between the groups. However, immediate use AV grafts matured at a significantly faster rate, they had significantly fewer catheter days,

and most importantly had fewer catheter-related complications and fewer reinterventions for prolonged patency. We also looked at other authors who had studied this problem, and found that the majority

of immediate use grafts are able to be used within 24 to 72 hours. Other facilities to or other measures to facilitate early catheter removal are to have an organized approach to dialysis access.

In my office we have a schedule and we stick to it. We schedule all appointments at the patient's original visit, and I found that this is especially important for two-stage basilic vein transpositions.

Where we schedule their pre-op, their first and second surgery, all of their post-op visits and even their catheter removal visit at the initial time. Of course these can change,

but it gives us a structure to work in. We get patients back early to clinic sort of like Dr. Shenoy was just talking about. We see patients at four weeks with a fistula, and at two weeks with a graft. And if the access is not usable at that time,

we go immediately to fistulagram. We make an appointment to return to the clinic one month after we clear fistulas for use, with the plan to remove the catheter in clinic. If the catheter is not ready to come out for any reason,

then we troubleshoot the problem to make sure we stay on track. Our goal is to get those catheters out. So in conclusion, reducing catheter days can be accomplished through several means.

I believe we can do better through early fistula placement, and insurance that the fistula is ready to use at the time that the patient is ready to start dialysis. I think we can benefit our patients by

having more practitioners place fistulas. We should consider the judicious use of immediate access grafts, and perhaps use immediate access rather than standard grafts whenever possible. And we should have protocols to facilitate

early follow-up and troubleshooting of accesses as well as being proactive in catheter removal. Thank you.

- I'd like to thank Larry and John for the opportunity to speak today. This really is kind of an exciting time in Vascular Access 'cause you know this whole session's devoted to all the new tools and technologies, and they're really a lot of different options

that are available to us now to create functioning fistulas in patients. Those are my disclosures. I just want to mention one thing, when I was asked to give this talk, the name of the device was the Everlink device then,

and that was first developed by TBA Medical at Austin, Texas. Eventually the company was bought by Bard, and then Beckett Dickinson bought Bard, and then they changed the name of the device to the WaveLinq device,

just so that we're all on the same page here. The basic gyst of this system basically it's a two-catheter system, it involves punctures in the brachial artery and brachial vein above the elbow over wires, the catheters are then aligned

in the ulnar artery and ulnar vein. The venous catheter has an RF electrode on it, the arterial component has a ceramic foot plate, and there's rare earth magnets in the catheters that help them align in the artery and vein. They'll coapt, you deploy the foot plate,

and then you fire the RF energy from the RF generator, and the RF energy then creates a four millimeter hole between the artery and vein. This is just what it looks like under fluoroscopy, this is the arterial catheter going in here's the footplate here

this is the venous catheter then being directed and you can see the magnets on these they look like Lincoln Logs they'll kind of line up. You rotate the catheters 'til the foot plate aligns, you do some flyovers with the II make sure everything's lined up,

and then you create the fistula with the RF energy. Then this is just what Fistulagram looks like once the fistula's created. At the completion of that, for this device we then place coils, occluding coils, in the deep vein which was just beyond the sheath

where we accessed the brachial vein. And by putting those plugs in there, coils in there, It helps to direct the flow up to through the superficial veins which we cannulated for dialysis, and much like the other device

that Dr. Malia was talking before, this creates essentially a split vein fistula, it's going to mature both the cephalic and basilic if those veins are available through that from the perforator coming on out. This is just what it looks like you know,

this was in some early studies in the animal model, you can see that it creates exactly a four millimeter hole between the artery and vein. Eventually this will re-endothelialize they had endothelialization at 30 days. So really the nice thing about it is

it standardizes the size of the arteriotomy because it makes exactly a four millimeter fistula. Now, as I mention this is created at the level of the ulnar artery and ulnar vein, so the requirements basically to do this you need a adequate size obviously ulnar artery and vein,

but the big component is to have that adequate perforator vein that's going to help feed the superficial veins to mature that fistula. And then it's just creating a side to side fistula between the ulnar artery and vein.

This is just a composite of all the data that's been collected on the device so far so this is what the global registry looks like. The FLEX study was kind of the first studies in man. The NEAT trial was run in the Canada and the UK, that was one of the earlier trials.

Then there's a post-market registry, uh, in Europe that's being run now. The EASE trial is the trial with the Four French device and I'll share a little bit about that at one of the slides at the end. But basically pull all the data from this

there's almost 157 patients that they collected data on. And, you can see that with this the primary patency, or the primary patency's on at 75 percent, and the accumulative patency's almost 80 percent, and then the number of fistulas that were cannulated at six months successfully with two needles was 75 percent.

If you look at some of the interventions that've had to be done it really seems to be a lower number of interventions that have to be done to get a mature functioning fistula, uh, using this device. I just want to point out a couple things on this slide,

there was never any requirement for angioplasty at the uh, the ulnar artery the ulnar vein anastomosis, and there was, you know, with these embolizations that were performed, 12 of these were performed on patients prior to incorporating that into the procedure itself,

so right now in the IFU it says that the deep veins should be coiled to help direct that flow up into the superficial veins. Now as, uh, was alluded to earlier with the Ellipsys device this kind of falls somewhere between, uh, the radiocephalic fistula and a brachiocephalic fistula,

and again comparing these two devices basically you're creating, this is the Ellipsys device is radial-radial, and this device is really ulnar-ulnar, but again you're creating that split-flow fistula it's going to allow flow both up

into the basilic and cephalic veins. So, where can this be used? It can be used for primary access creation so that's the first option to provide a patient with a functioning fistula. It can be a secondary option to radiocephalic fistula,

or those that have failed the radiocephalic fistula, and it also is an alternative to surgery so there are patients that may not want to have open surgery to have a fistula created, and this obviously provides an option for those patients. In the UK now they're using it to condition veins,

so they'll create the fistula hoping to condition the cephalic and basilic veins to allow them to become usable for dialysis, and they're also using it in patients that have no superficial veins actually using it to mature the brachial vein

or the deeper veins, uh, and then superficializing the brachial vein to create a native fistula for patients who don't have adequate superficial veins. Now I mentioned the Four French device and what the Four French device allows is basically access

from a lot of different points. So now because it's a smaller device, we can place it, if the vein and artery are large enough, it can be placed at the wrists, so radial-radial fistula, so you come in from the wrist, put both catheters up, create the fistula at the radial-radial,

you can do it from the ulnar-ulnar, so it's just two catheters up from the wrist. And these cases are nice, the other option is you can come arterial from the wrist and you can come from the vein at the top, match up the catheters in a parallel

and create that fistula at the ulnar-ulnar level. And the nice thing about this is it really makes managing the puncture very easy you just put a TR band on 'em, and then you're good to go. So it really kind of opens up a lot of different options for creating fistulas.

So in summary this device seems to create a functional fistula without the need for open surgery. It has very good primary and cumulative patencies and seems to take fewer interventions to maintain and mature the functioning fistula, and this may add another tool that we have to create

functioning fistulas in patients who are on dialysis. So thank you very much.

- I will be talking about new KDOQI guidelines. I know many of you have heard about KDOQI guidelines being revised for the past maybe over a year or maybe two. Yes, it is being done, and it is going slow only because it's being done in a very different way. It's more than an update.

It's going to be more of an overhaul for the entire KDOQI guidelines. We in KDOQI have looked at access as a solitary problem like we talked about grafts, catheters, fistulas for access, but actually it sort of turns out

that access is part of a bigger problem. Fits into a big ESKD lifeline of a patient. Instated distal patients come in many varieties. It can affect any age, and they have a lot of other problems so once you have chronic renal failure, renal replacement mortality fits in

only when it becomes Stage IV or Stage V. And renal replacement mortality is not just access, it is PD access, it's hemo access, it is transplant. So these things, we need to see how they fit in in a given person. So the new KDOQI guidelines concentrates more

on individualizing care. For example, here the young Darien was an 11 year old with a prune belly syndrome. Now he has failed PD. Then there's another person here who is Lydia who is about 36 or 40 year old lady

with a insulin dependent diabetes. Already has bad vascular pedicle. Lost both legs. Needs access. Now both these patient though they need access, it's not the same.

It's different. For example, if you think of Darien, he was in PD but he has failed PD. We would love to get him transplanted. Unfortunately he's got terrible social situation so we can't get him transplanted.

So he needs hemo. Now if he needs hemo, we need to find an access that lasts for a long time because he's got many years ahead of him. On the other hand we have Lydia, who has got significant vascular disease.

With her obesity and existing infectious status, probably PD won't be a good option for her. So she needs hemo, and she's obviously not a transplant candidate. So how are we going to plan for hemo? So these are things which we are to more concentrate

and individualize when we look at patients, and the new guidelines concentrate more on these sort of aspects. Doing right access for right patient, right time, and for right reasons. And we go about planning this keeping the patient first

then a life plan ESKD lifeline for the patient, and what access we are looking at, and what are the needs of the patient? Now this is also different because it has been done more scientifically. We actually have a evidence review team.

We just poured over pretty much 1500 individual articles. Recent articles. And we have looked through about 4000 abstracts and other articles. And this data is correlated through a workgroup. There a lot of new chapters.

Chapter specific surgery like peri-operative, intra-operative, post-operative, cat issues, managing complication issues. And we started off with the coming up with the Scope of Work. The evidence review team took the Scope of Work

and tried to get all the articles and sift through the articles and came up and rated the evidence using a certain rating system which is very scientific. The workgroup then kind of evaluated the whole system, and then came up with what is clinically relevant.

It's one thing for statisticians to say how strong evidence this is, but it's another thing how it is looked upon by the clinicians. So then we kind of put this into a document. Document went through internal and external review process.

This is the process we have tried to do it. Dr. Lok has been the Chair of the group. Myself and Dr. Yevzlin are the Vice-Chairs. We have incredible workgroup which has done most of the work. And here are the workgroup members.

We comprised of nephrologist, transplant surgeons, vascular surgeons, Allied Health personnel, pediatric nephrologist so it's a multi interventional radiologist and interventional nephrologist. This is a multi disciplinary group which has gone through this process.

Timothy Wilt from Minnesota was the head of the Evidence Review Team, who has worked on the evidence building. And now for the editorial sections we have Dr. Huber, Lee, and Dr. Lok taking care of it. So where are we today?

We have pretty much gone through the first part of it. We are at the place where we are ready for the Internal Review and External Review. So many of you probably will get a chance to look through it when it comes for the External Review and would love

to have your comments on this document. Essentially, we are looking at access in the context of end stage renal disease, and that is new. And obviously we have gone through and done a very scientific review, a very scientific methodology to try

to evaluate the evidence and try to come up with guidelines. Thank you.

- [C. Keith] Thank you Larry and John. I appreciate the invitation. I do have disclosure that I have consulted for Proteon Therapeutics. Also, some of the data I'm going to talk about today is unpublished and supplied by Proteon. So, Vonapanitase is a recombinant human elastase

and it cleaves elastin peptide bonds. Surgically, this can be applied to the outside of a recently created fistula and it's left on for 10 minutes. It's only active at the site of application, if it gets in the blood, it's deactivated.

Biologically, Vonapanitase may stimulate outward vascular remodeling and also inhibit intimal hyperplasia. I'm going to update you now on the Vonapanitase Fistula Trial Program. These trials have all been multicenter, randomized, double blinded, placebo controlled studies

and each includes a follow up registry. Three of these trials are already in print and one is in press. The phase two trial of which I was an investigator showed a dose dependent improvement in maturation of dialysis access fistulas at the wrist.

And thus, it moved to phase three trials. I'm an investigator in both of those and these are going to be the focus of my comments today. The patency-3 trial is fully completed. The patency-1 trial is fully completed and in press. And the patency-2 is fully enrolled.

Patency-1 enrolled about 300 patients undergoing a radiocephalic fistula and it was randomized two to one vonapanitase to placebo. Follow up was one year. The primary endpoint was primary patency and the secondary endpoint was secondary patency.

Other important endpoints were examined and also, statistically, they looked at these other endpoints beyond just the single primary patency. The primary patency was not statistically different in the trial, though there was a substantial trend. Here you see a p of 0.25 for the difference

between the vonapanitase and the placebo treated patients. However, there was a statistically significant 34% reduction in the risk of secondary patency loss and those receiving the treatment drug and this was statistically significant. It even became more statistically significant

when we discarded those that had early failure of the fistula, certainly showing a biological effect probably of this compound. And then, finally another point that we're very interested in would be actual use of the fistula for hemodialysis

and it was almost a 50% increase in use of the fistula for hemodialysis in those receiving the drug versus those getting placebo. The safety profile looked quite good for this compound and there were basically similar rates between the placebo and vonapanitase for stenosis,

thrombosis, nerve issues and post procedural pain. The patency-2 trial is almost identical but it actually began enrolling during the patency-1 trial and the analysis plan allowed for a sample size adjustment based on results of the patency-1 trial. So in negotiating with the FDA,

they agreed to the validity of reordering the endpoints to create new primary and secondary endpoints or co primary endpoints. And so, for the patency-2 trial, secondary patency and use for hemodialysis were made co primary endpoints. Also, the sample size was increased

to 600 patients to ensure adequate power. Here you're going to see some of the baseline characteristics of these patients that were enrolled in the patency-2 trial. It's a typical age and typical North American body mass index and most of the patients were male in a three to one ratio to females.

There's a nice mix of ethnicities and race. Many of the patients had been former smokers and most had diabetes and hypertension and hyperlipidemia. About half the patients were on hemodialysis at the time of randomization. And interestingly, when you look at

the anesthetic approaches, about half the cases were done under local and the others were done under nerve block or general anesthetic. The actual expose vein length was about three centimeters in this patient cohort. The vein diameters were a little over three millimeters

and the artery diameters a little under three millimeters. Most of the surgeons tended to make an arteriotomy that was about eight millimeters long. The patency-1 results have been accepted or in press in the journal of vascular surgery. The patency-1 registry data with a total of three years

of follow up will be available towards the end of this year. Patency-2 enrollment is completed, that was completed this past March and the top line data will be available in March of 2019. If the data supports these statistical significance on the co primary endpoints in this patency-2 trial,

Proteon intends to file for US approval in 2019 and EU approval shortly thereafter and they're actually planning clinical trials in Europe currently. So in summary, vonapanitase data to date in radiocephalic fistula's, certainly I think,

shows evidence of the biologic signal which I think is quite impressive in view of all the events that go into fistula maturation. The secondary analysis suggests positive impact on things that we find clinically meaningful. That is use for hemodialysis,

unassisted use for hemodialysis and secondary patency. The patency-2 trial data, the big 600 patient cohort will be available in about four months and vonapanitase certainly stands as a potentially novel adjunct to enhance AV fistula use for hemodialysis. Thank you.

- (Speaker) Thank you very much So we're going to try to tackle all of these issues. I do have some disclosures. The indigo system that we're going to talk about does have FDA approval in the vascular system. It is contraindicated for neurovascular and coronary use although there are specific catheters made by this company

for use in those areas, so we're going to talk about the use strictly in the periphery. So we know that Acute Limb Ischemia requires revascularization and we use this Power Aspiration system, we call it XTRACT, using the Indigo system for a number of different therapeutic options.

The device we're talking about, these are reinforced catheters so there's no collapsing of the tip during aspiration. They're atraumatic, this technology was developed and really pirated in some way from stroke work, where we were putting these catheters in the

middle cerebral artery, so these catheters track, it's exceptionally rare to see any vessel damage. We have not dissected any vessels in over 120 cases. The catheters are hooked up to direct tubing to a small handheld pump,

which is easy to use, which sucks, an essentially true vacuum, so that you get maximal aspiration. And, they come in different sizes: 3, 5, 6, and 8 French and you can see there's a large increase in aspiration power as we go up

in size. So this would be a typical case where we have an SFA occlusion, in the distal SFA. There's also a TP trunk occlusion. There's an anterior tib. which is a stump distally. And we don't see any real flow below the TP trunk.

Here we can take a CAT6, we place it in the clot. It's very simple to use. The learning curve here is extremely low. You turn the vacuum on, you just be patient and wait. You don't run this through the clot, and if you suck this way and be patient,

embolization is extremely rare, and I'll show you some of that data. We clean that up as I showed you, then we advance down into this tibioperoneal trunk, and after two or three minutes of aspiration with some gentle catheter moving,

we're able to clear up the TP trunk, we can come back and balloon the underlying lesions and leave this patient who had no runoff, essentially with two vessel runoff. In Press right now, we're actually online, published, and in print, are the results of the PRISM trial,

which is using this system as a retrospective registry, and this is used in 79 patients after failed thrombolysis, as a primary device for acute limb ischemia, for distal emboli caused by other interventional procedures such as angioplasty stem placement.

We looked at patients who had little flow or no flow, TIMI 0-1, and basically we evaluated the flow before. We use this system after we use the system and after any other adjunctive intervention. And along the bottom you can see that we restored flow,

excellent flow, TIMI 2 or 3 flow, and 87% percent of the patients, after the final intervention, so treating the underlying lesion, 96% of patients had essentially normal flow. So, 87% as I say success

just with the device alone, and then using adjunct devices. There were no serious adverse events. The complications from this include vasospasm. We did not have any vessel dissections, or vascular injuries, and

no serious event directly related to the catheter. So where do we use this? Well, we can use this as I mentioned for acute limb ischemia. We can use it as a primary therapy for embolic occlusions. We can use it after iatrogenic emboli.

We use it after incomplete thrombolysis when there's residual clot, so we don't have to lyse someone up further. We can save lysis time and money overnight. And we've expanded our uses out of the arterial and now we're looking at venous, pulmonary, mesenteric,

and dialysis applications. We just published our results in the pulmonary circulation from the single center. There's a retrospective study that's been completed, and now a prospective study which we're just beginning right now.

We actually have our first sites up and ready. We've had experience with DVT, and we're also using this in the mesenteric and portal circulation. A quick image of a before and after on a pulmonary embolism. There's an extensive mass of patient who came in with profound hypotension,

post-using the XTRACT system. So the benefits, simple and easy to use, highly trackable. Limitations, blood loss if you don't know how to use this right. You just can't run this vacuum in flowing blood. Once you learn that and control the switch

blood loss can be minimized. As I mentioned, the learning curve is small. A few tips, not to use the separator much in the arterial system. Just be patient with your suction. Be careful damaging the tip when you introduce it

through the sheath, there's an introducer. In conclusion, we think this is an effective method to primarily treat arterial occlusions, venous pulmonary occlusions, and more data will be coming to you on the venous and pulmonary sides but I think in the arterial side,

we actually have several publications out, demonstrating safety and ethicacy. Thank you.

- Thank you Dr. Asher. What an honor it is to be up here with Dr. Veith and Dr. Asher towards the end. You guys are leading by example being at the end of the meetings. So, thank you for allowing me to be up and talking about something

that not a lot of vascular surgeons have experience with, including me. I have no disclosures. On your left, I have listed some of the types of diseases that we most commonly see in the vertebral artery, and there are quite a lot.

And on the right, the standard types of treatment that we pursue in vascular surgery or as a vascular specialist. And often, in the vertebral artery, if we are going to pursue treatment, it's the endovascular route.

But I'll talk a little bit about open surgery. The clinical presentation is often vague. And the things I wanted to point out here in this long list are things like alternating paresthesias, dysphagia, or perioral numbness may be something in the history to look for

that you may not be thinking about when you're thinking about vertebral basilar disease. The anatomy looks straightforward in this picture, with the four segments, as you can see. It gets a little more complicated with just the arterial system,

but then when you start looking at all these structures, that you have to get out of of the way to get to the vertebral artery, it actually can be a difficult operation, particularly even in the V1 segment. The V1 typically is atherosclerotic disease.

V2 is often compression, via osteophyte or musculo-tendon structures. And V3 and V4, at the top, are typically from a dissection injury from sort of stretch or trauma injury. The pathophysiology isn't that well understood.

You have varying anatomy. It's very difficult to access this artery. Symptoms can be difficult to read, and treatment outcomes are not as reliable. But I'm going to take you through a very quick path through history here in the description

of the V1 segment exposure by Dr. Rentschler from 1958. And I love these pictures. Here is a transverse incision over the sternocleidomastoid, just above the clavicular head on the right side. And once you get the sternoclavicular head divided, you can see the longus colli muscle there.

Anteromedial is the carotid. Of course, you surround that with a Penrose drain. And then once you do that, you can separate your longus colli, and deep to that, the vertebral artery just easily slips right up, so you can do your transposition.

It's not quite that easy. I've done one of these operations, and it was difficult finding t e. And, again, here is on the opposite side, you can see the transposition in this cartoon.

Dr. Berguer is the world's expert, and a lot of this open surgical work comes out of the University of Michigan. Here is a study looking at 369 consecutive extracranial vertebral artery reconstructions. You can see the demographics of clinical presentation.

And note that about 34% of patients are presenting with hemispheric symptoms, with 60% in the vertebral basilar distribution. 300 of these reconstructions were for atherosclerosis. And the outcomes were pretty good. Before 1991, there wasn't really a protocol in place

in assessing and doing these procedures. And you can see the stroke and death rates of 4.1 and 3.2% respectively. And then the outcomes after 1991 are considerably better with a five year patency rate of 80%. So, in summary, vertebral artery disease is,

I think if you review this, is somewhat under diagnosed. Revascularization is a viable option. Most often, it's endovascular. But if you have endo-hostility, then an open, particularly for the V1 segment, may be a better option.

And this requires people with good operative experience. Thank you very much.

- Ladies and gentlemen, I thank Frank Veith and the organizing committee for the invitation. I have no disclosures for this presentation. Dialysis is the life line of patients with end-stage renal failure. Hemodialysis can be done by constructing an A-V fistula, utilizing a graft or through a central venous catheter.

Controversy as to the location of A-V fistula, size of adequate vein and priority of A-V fistula versus A-V graft exists among different societies. Our aims were to present our single center experience with A-V fistulas and grafts. Compare their patency rates,

compare different surgical sites, and come up with preferences to allow better and longer utilization. We collected all patients who underwent A-V fistula or A-V graft between the years 2008 through 2014. We included all patients who had preoperative

duplex scanning or those deemed to have good vessels on clinical examination. Arteries larger than two point five millimeter and veins larger than three millimeter were considered fit. Dialysis was performed three times per week. Follow up included check for a thrill,

distal pulse in the arter non-increased venous pressure or visible effective dialysis and no prolonged bleeding. Any change of one of the above would led to obtaining

fistulogram resulting in either endovascular or open repair of the fistula. We started with 503 patients, 32 of which were excluded due to primary failure within 24 hours. We considered this, of course, the surgeon's blame. So we left with 471 patients with a mean age of 58 years,

51 were older than 60, there was a male predominance of 63%, and over half were diabetics. The type of fistula was 41% brachio-cephalic fistula, 30% radio-cephalic fistula, 16% A-V Graft, and 13% brachio-basilic fistula.

Overall, we had 84% fistulas and 16% grafts. The time to first dialysis and maturation of fistula was approximately six weeks. First use of grafts was after two weeks. 11 patients with A-V fistula needed early intervention prior to or after the first dialysis session.

In sharp contrast, none of the A-V grafts needed early intervention. 68 patients were operated for their first ever fistula without duplex scanning due to clinically good vessels. Their patency was comparable to those who underwent a preoperative scanning.

Looking at complications, A-V grafts needed more reintervention than fistulas. All of them were late. Infection was more prominent in the graft group and pseudoaneurysms were more prominent in the A-V fistula group, some of them occluded

or invaded the skin and resulted in bleeding. Here's a central vein occlusion and you can see this lady is after a brachio-basilic A-V shunt. You can see the swollen arm, the collaterals. Here are multiple venous aneurysms. Here's an ulcer.

When we looked at primary patency of A-V fistulas versus graft, A-V fistulas fared better than grafts for as long as five years. When you looked at 50% patency in grafts, it was approximately 18 months, in Fistula, 13. Here's an assisted primary patency by endovascular technique

and when we looked at the secondary patency for the first 24, two years, months, there was no difference between A-V fistulas and A-V grafts, but there's a large difference afterwards. Comparing radio-cephalic fistula to brachio-cephalic fistula there was really no big difference in maturation.

The time was approximately six weeks. As for primary patency there is a trend towards better patency with brachio-cephalic fistula after six months, one year, and two years, but it didn't reach statistical significance. For patients with diabetes,

differences were statistically significant. Brachio-cephalic fistula showed a trend toward shorter maturation time, needed less reintervention, and had a longer patency rate. In conclusions then, ladies and gentlemen, A-V fistula require a longer maturation time

and have higher pseudoaneurysm formation rate, but better patency rates compared to A-V grafts. A-V grafts have a faster maturation time, but more late interventions are required and infection is more common. Finally, diabetic patients have a better result

with proximal A-V fistulas. Thank you for the opportunity to present our data.

- This is what we're going to talk about today. It's a vascular approach to hypertension and AV fistula. This implant was first designed in the early 2000s and directed, actually, at COPD, but then redirected to hypertension. Disclosures. Hypertension, as we age, is largely a result

of the loss of compliance in our arteries. Approximately 85% of uncontrolled hypertension patients are those over 50 with predominantly mechanical hypertension. This is the implant and the procedure. It's simply an AV fistula created

in the external iliac artery with an endovascular procedure done under local. Takes about an hour to do, and it creates a very precise AV fistula that doesn't grow over time, about four millimeters, mediated by the implant.

This is a just sort of appetizer before we get into the data. This is a patient done recently and presented in June of 2018. Patient in Toulouse, France. The difference from renal denervation, of course,

is that it get an immediate effect on the table, a very large drop in blood pressure. And you can see ambulatory blood pressure is roughly 30 points lower systolic, 20 diastolic. And as we'll see that's backed up by long-term data. This is the main body of data that's been generated

to date, a randomized trial in Europe, has six and 12 month data now, and we'll review that. So the Prospective Trial, 83 patients, 44 treatment, 39 control. All of these patients had to be on maximal medical therapy. And the exclusion criteria

were generally cardiovascular morbidities. You can see the groups are very similar. And actually, these results are for the prior renal denervation group. So of note, patients who have had prior renal denervation also respond to this therapy quite well.

Here you can see a very significant drop in both office and ambulatory blood pressure at six months. Here's the broader study. Both six and 12 month data with the right panel being a consistent cohort, just the patients that were not lost to followup.

But you see very consistent results. Again, significant drops, 26 points and 20 points for systolic and diastolic respectively. And if we look at 24-hour ambulatory blood pressure changes at six and 12 months, not quite as much, but still very significant, 13 drop

in both systolic and diastolic. There was a crossover group after six months. Those randomized to no therapy can be crossed over to the therapy, and we see that those respond as well, much smaller group. The primary complication in this procedure

is not congestive heart failure or anything like that, it's iliac vein stenosis. We see this with our other work in arteriovenous fistulas for dialysis. As we know, stent therapy for iliac vein stenosis is very successful in non-thrombotic patients,

and so all of these patients were treated with an iliac vein stent and all resolved without incident or recurrence. Some of these patients in the European study were done from the left and it's always done from the right to avoid the May-Thurner physiology.

Two patients didn't respond. And now the therapy is going into a much larger trial, a 500-patient randomized trial. This is an adaptive study, double blind, sham-controlled, and of course multicenter. These patients have to have, as a primary endpoint,

of 24-hour ambulatory blood pressure and then secondary endpoint of office blood pressure. The inclusion criteria are very rigorous. These patients have to be on maximal drug therapy. They have to be on that same drug therapy and have the same blood pressures on multiple checks

over a three-month period before they're randomized and stay on that same drug therapy, if possible, for six months after randomization. The exclusions are similar to the European study. So in summary we look at this technique of using an AV fistula to reduce blood pressure.

With denervation we don't have a procedural endpoint on the table. Often it's a smaller and less consistent blood pressure effect. What we don't talk about is the fact that autonomic nerves do regenerate,

it's dependent on renal artery anatomy, and there's some risk of renal artery injury, albeit small. But with an AV fistula there's a very immediate and significant effect. It's scalable and reversible with covered stent. It's independent of the renal artery anatomy,

and it's effective in patients with prior renal denervation and durable. Thank you very much.

- Alright, well thank you, everybody, for having me. Thanks, Larry for inviting me to give this talk. My only disclosure is that I am the vice president of operations for (clears throat), excuse me, Azura Vascular Care and we operate 65 office based laboratories and ambulatory surgery centers. So, the undertaking to go ahead

and become a ambulatory surgery center is massive and requires a tremendous amount of pre-planning. You have to have a very sound financial model, you have to have a stable physician pool, you have to have a good patient referral base. And without lining up all those elements first,

you are sort of dead in the water. So the first thing to understand is that a physician's office and an ambulatory surgery center are separate and distinct entities. Today if you have a physician's office through an extension of your practice

you can then set up an Angio Suite, you can then perform procedures on the patients as needed. But once you're an ambulatory surgery center, you no longer have sort of the office space part. So you can't do ultrasounds, well you can do them, you just can't bill for them, right.

And so you can't concurrently run a physician's office practice out of the ambulatory surgery center, it's actually not permitted in the Medicare conditions for coverage. So that changes things for sure.

And then so if you're really based out of a physician's office and you have your Endo Suite there, you sort of have to have two offices moving forward. Anyway, you must comply with Conditions for Coverage. The ASC is now subject to State, CMS, and Accrediting bodies and they can show up at any time.

It's a major difference in the way you practice. If it's your doctor's office right now, you know, maybe there's a inspection once a year for a radiation certificate or something like that, but there's really not a whole lot of oversight. ASCs have very strict physical plant guidelines.

There are enhanced staffing requirements, circulating nurses, facility administrators, directors of nursing, all of these extra things that add a very significant amount of cost. You also have to have governance, right. So there's a governing body, a Medical Executive Committees

and requirements, right. Now they're not difficult but there's all this extra documentation that has to go along with it which is just time consuming, burdensome, task oriented. There's disclosures of ownership.

There's a quality improvement program which you have to show that you're doing and documented, and the accrediting bodies, if you don't have it right, they could cite you and it's really a lot of extra work. You need transfer agreements and patient satisfaction surveys,

all these kinds of things. Alright, other ASC fact, okay. In a typical two room facility, you can get away with essentially 35 hundred square feet versus five thousand square feet in an ASC. You would instead of typically having six employees,

you need nine employees, adding all this extra expense. The expertise of the staff is very different, alright. You actually need facility administrators, not just, you can't just pluck a nurse out of their daytime job of seeing patients on the floor and say, okay, now you're facility administrator.

They have to understand regulations, they have to understand the Medicare Conditions for Coverage, et cetera. They have also very extended timeline, which I'll show you on another slide, but the regulatory requirements from life safety,

fire safety, staffing requirements, state licensure, Medicare Deem status, accreditation, all of these things factor into the overall cost to set up an OBL, depending on how you do it, is probably about 1.5 million dollars, versus an ASC at 3.5 million dollars.

So the 800 pound gorilla in states in New York, and about 25 or 30 other states is the process of getting a certificate of need. So if you're in a certificate of need state, it's a whole thing, right. So first you have to get the CON.

The CON then allows you to get state licensure. The state licensure then allows you to apply for Medicare Deem status to an accrediting body. Once you have your Deem status, then you can submit for your PTAN, your physician transaction number, so that you can actually bill Medicare for facility fees,

and then and only then can you then initiate the entire process of getting your private payor contracts. So, all that being said, your application for a CON could be outright rejected. You could be blocked by local hospitals. You could be blocked by local politics.

There's a tremendous amount of issues. Now the one thing that's interesting, if you're in a state that doesn't have a Certificate of Need process, then one of the things that's interesting is they sort of, you sort of get tied up in the local fire marshal, the Department of Health

and this very disjointed Department of Health survey. The Certificate of Need at least, at the very least, allows you to kind of cruise through the process, so that you can, at least you understand your pathway. In states that don't even have a CON process, it can be very disjointed.

Now if you're thinking about building a new facility, well, that's about two to two and a half million dollars. If you're thinking of retrofitting, I'd go by the rule of 200 thousand. So if you need a semi-restricted corridor, and you have to move walls,

that'll cost you about 200 thousand. If you, you're going to need 20 air exchanges per hour in your procedure room, that's a hard requirement. You have to be, you have to get stuff that certifies that you are achieving that, right. That new HVAC system will cost you 200 thousand dollars.

You need three electrical panels. One to power the HVAC, one to power the electrical outlets and one to power the overhead lighting. I mean, the requirements are very, very different. Then, maybe now you're going to need a generator. Well, am I in a building where you're going to

put the generator on the roof, then the fire marshal tells me I can't store the gasoline on the roof, it has to be on the ground, and then you wind up in this big back and forth fight as to where you can put your generator.

Just for time's sake, this is a basic floor plan with semi-restricted corridors, eight foot wide hallways, enough seating for 30 people. The staffing requirements change significantly, in terms of you need a facility administrator, somebody who really knows it.

Now god forbid the facility administrator's on vacation when the state shows up or when an accrediting body shows up so you better have your DON, your director of nursing, all tuned up so that she knows how to answer the questions and knows where all of your paperwork are because otherwise you could be cited

and you could be sunk and it's very burdensome. But the difference in staff costs for typical two room facility is probably about 300 thousand dollars cumulatively. For your hours of operation, right, so now you have a business that's operating as an OBL,

now you want to convert it to an ASC, well that's great. But now you don't have your private payor contract, so what are you going to do? You going to start rejecting patients? So, no, you're not going to do that. So either you're going to lose money on those patients

or you're going to wind up having to form this hybrid operation where you flip back and forth, one day to the next day, et cetera. And the problem with doing that is each one requires its own tax ID number, its own NPI, its own billing codes. And then the staff has to be trained

that they're dedicated to one versus the other. This is your timeline to show you how everything lines up, in terms of your construction, then getting your state licensure, then getting your Medicare accreditation, and then only after you get your Medicare accreditation,

can you then submit for your PTAN, which then takes 90 days. And then only after you get your PTAN, can you being your private payor contracting. So, in conclusion, it requires more time, more staff, more oversight and regulation. The complex hours of operation ought

to maintain your existing patient base. You need a payor contracting strategy. It's probably an additional two million dollars to build out an ASC, including the working capital requirement. So for the solo practitioners that were out there thinking about it,

unless there's a very compelling financial reason to convert, it's probably best to stay an OBL at this time. Thank you.

- Hello, thank you again for the invitation. I have the disclosure here is kind of funny because I'm going to talk about CLaCS but I don't profit on that. Those are the most frustrating result on sclerotherapy and obviously death. These are very frustrating result. Sorry.

And this is not like funny but it's unfortunately the worst part is that all those cases are not published and that's less change from frustrating to devastating, the death cases. Let's talk about the less common, sorry,

the most common problems, skin ulcer. Like skin ulcer. Skin ulcer may be also terrible. Those are slides from my father's collection from the 60s probably. And I suggest you to read this paper.

It took me 20 years to get published with the help of Ted King of this hypothesis from the 70s and he studied on rabbit ears and I cannot have time to explain all that but he simulated the skin ulcer and showed that the causes the reflux to the arterial venous system

and how to avoid it, CLaCS is a great solution and by using the extra 75% due to its high viscosity, you avoid 100% of reflux to the arterial system. Matting is another problem.

Those are theories of my father as well. He said divided in two types of angiogenic where you inject on the telangiectasia and you destroy veins that you wanted to close or you didn't want to touch. And then you have reflux a new reflux and

a lot of telangiectasia. There would be occlusive, where you destroy too much, you destroy the drainage of those telangiectasias. And then how to avoid? Is to be less aggressive or to be more focal. That means treat only the feeder vein

and the telangiectasia and avoid injecting a lot of volume and because those sclerotic agents will reach another vein that you don't want to touch. Pigmentation is another problem. And to control pigmentation of course

you have to have less thrombus and once again ClaCS would be very nice idea because the transdermal lazer causes vein wall edema and contraction and then you inject the Dextrose 75%. And then you have less internal diameter

in the vein, that means you have less outflow, the Dextrose will stay there it's a synergy, and you have less clot, less pigmentation. Also Dextrose is a medium power sclerosing agent that doesn't cause too much pigmentation as the other agents.

Well once again my father, and my father is at the hospital right now, and he probably will not survive, but here is a tribute for him. And he developed this surgical treatment of the telangiectasia by removing

the feeder veins. And, sorry. Here a study with phlebography showing a double perforant insufficient vein, and these telangiectasia wouldn't respond. And that's a complex telangiectasia, not a simple telangiectasia.

Like here another example, the phlebectomy showing the result of the treatment of telangiectasia. Well, diagnosis is very important if you are a skipper of a boat, if you have a special device to diagnose you certainly will have a better result.

And here are very tricky, looks simple to treat but as you compress you see there is a reflux, and this reflux is going have five feeder veins and one is going to the reflux in saphenous vein and patient the patient is CEAP1. Well, I also.

Sorry. Next slide. If you are a painter and you want to paint this wall, it's not easy you need to find a feeder vein and that's why I've developed this classification where you have three, two questions

and you look for varicosities and telangiectasias and here you have, lets go fast, the ultrasound showing reflux and the augmented reality showing if there is feeder vein or not. And here a good example of a patient that was,

the examination would lead to a CEAP 1, but as we exam, we noticed that she's score nine, where she had a long reflux asymptomatic that was treated with endovenous lazer phlebectomy and CLaCS, and that's how we got the result. Then treatment failure is also can be avoided

by a good classification and then CLaCS. If you want to learn more about that, we have a congress, it's going to be the ninth in IMAP in Saul Paulo next year, and I kindly invite you to participate. Thank you.

- Thank you, Larry and Tony, for the invitation. Larry told me I should be provocative so here we go. (chuckles) Those are my disclosures, mostly in the aortic space, although I was a PI for the Humanity Phase II trial. So this is a quote that interventional nephrologists in Arizona told me one day when we were trying

to have a educational, meaningful discussion, so we provide care that is better, faster, and cheaper than what you can provide in the hospital. And we'll address this a little later. What's the roles of the access surgeon, when it comes to advocating or educating

your dialysis patients? Well, when you google advocating for anything, you're going to find mostly political references. And I think there are a number of excellent patient related groups to advocate for policies and principles. But as the surgeon, I think we have

a couple of important roles. One, we need to create the most durable, successful access possible, and as Ted just said, that needs to be individualized for the patient. We need to try and protect and maintain the access and we also have a role in protecting the patient.

We can't underestimate or underemphasize the importance of vessel mapping, both arterial and venous. We frequently get patients referred who have already had their mapping somewhere else but as the surgeon is going to be doing the procedure, we tend to repeat that in the office,

so that we can see it ourselves, because mapping can be variable, can depend on environmental conditions, how cold the patient's room is, their hydration status, so we really try and nail that down. And frequently we find a high bifurcation

of the brachial artery, that's not noted on other mapping. And, again, I think to emphasize what Ted just said, we really need to champion communication between the patient, the nephrologist, and the surgeon, just because you don't receive communication, doesn't mean you can't be the person who provokes

and stimulates communication back to the nephrologist to try and really develop a clear plan. The timing of the hemodialysis is imperative and I think we should consider early cannulation grafts in appropriate patients. What about protecting and maintaining the access,

well these slides were provided to me by Dori Schatell, who's given this talk, you need to arm your patients with information to advocate for themselves and that's really, kind of the theme of what I want to talk about later. Give them pictures of their access,

write them very clear postop instructions, teach patients about cannulation patterns, teach them how to use topical anesthetics for cannulation. Make sure they know what to do in the case of an infiltration or prolonged bleeding, or loss of the thrill.

Make sure they have your contact information, and encourage patients to learn how to self-cannulate. What about protecting the patient? Well, I think it's our, it's the team's obligation but seems to fall on us a lot to educate the patient and their family about their right to choose.

Educate the patient and their family about available providers and facilities in their area. And educate the patient and their family about what services are available at different facilities, and nephrologists , radiologists, surgeons and anesthesiologists.

- Okay, I went to my nephrologist. He told me I needed to get this fistula put in, and then I was directed to the access center, because the way he said it, that's where I had to go to get it done, after I'd already talked to another doctor about doing it,

I was told I had to go to the access center. Okay-- - Oop, let's see. - Um, what she didn't say is that, she didn't like the center in the first place, because originally the doctor that saw her there for the fistula, didn't give us any help.

So he said, I can't do it for you, I don't know what's going to happen, and every time we would ask him, well, is there any solution for her to get a fistula, he wouldn't answer our question and he's like, well, I can't, I can't help you, I'm not going to take it.

So, when they told her told to go to that center, she had told him, can I go somewhere else, somewhere where they're a little bit more professional? And they said, no, you have to go there, they're the specialists. - So, going back to the original comment.

We provide care that is better, faster, and cheaper than what you can provide in the hospital. Well, when you're talking about better, that's really measured only by safety and durability of the interventions, not opinions. And faster, unfortunately, in our area,

some of our access centers are closed on Wednesdays, some of them are closed on Fridays and the weekend. And it's interesting, we often, the surgeons in town often get pummeled on Friday because the access center is closed. And I can tell you that my weekend on call,

I spent about half my day Saturday doing access interventions. And cheaper, cheaper's really only a function of how payers have decided to reimburse. You pay the same amount for staff, electricity, and supplies, whether you're at a hospital,

a surgery center, or an OBL. Unfortunately, some access centers frequently choose therapies that are less effective but cheaper to protect their margins. And perfect examples of these are stent grafts, and drug-coated balloons.

I think hemodialysis patients really want care that is safe, effective and durable. And really, where that's going to be best achieved will depend on what's available in a particular community or region. And most importantly, and I think,

as Ted highlighted, they're really the commitment to providing excellence in access care. And I'll finish with one more little vignette from one of my patients, and these patients, actually this was unsolicited, they just happened to be going off in the office one day

and I had gotten this assignment, I said, you mind if I video this and use it in my presentation? - Basically, in my opinion, what it is, it needs to be patient education. The ones that do talk to me, 'cause I do take control

of my treatments completely. That's why my fistula's in such good shape, 'cause I'll only run 16 gauge needles, which slows down my treatment, which keeps my heart in better shape. That's why I'm still up, walking, doing what I do.

- Thank you very much.

- Thank you, Larry, thank you, Tony. Nice to be known as a fixture. I have no relevant disclosures, except that I have a trophy. And that's important, but also that Prabir Roy-Chaudhury, who's in this picture, was the genesis of some of the thoughts that I'm going to deliver here about predicting renal failure,

so I do want to credit him with bringing that to the vascular access space. You know, following on Soren's talk about access guidelines, we're dealing with pretty old guidelines, but if you look at the 2006 version, you know, just the height--

The things that a surgeon might read in his office. CKD four, patients there, you want a timely referral, you want them evaluated for placement of permanent access. The term "if necessary" is included in those guidelines, that's sometimes forgotten about.

And, of course, veins should be protected. We already heard a little bit about that, and so out our hospital, with our new dialysis patients, we usually try to butcher both antecubital veins at the same time. And then, before we send them to surgery

after they've been vein-marked, we use that vein to put in their preoperative IV, so that's our vascular access management program at Christiana Care. - [Male Speaker] That's why we mark it for you, Teddy. (laughing)

- So, you know, the other guideline is patients should have a functional permanent access at the initiation of dialysis therapy, and that means we need a crystal ball. How do we know this? A fistula should be placed at least six months

before anticipated start of dialysis, or a graft three to six weeks. Anybody who tells you they actually know that is lying, you can't tell, there's no validated means of predicting this. You hear clinical judgment, you can look at

all sorts of things. You cannot really make that projection. Now there is one interesting study by Tangri, and this is what Premier brought to our attention last year at CIDA, where this Canadian researcher and his team developed a model for predicting

progression of chronic kidney disease, not specifically for access purposes, but for others. They looked at a large number of patients in Canada, followed them through chronic kidney disease to ESRD, and they came up with a model. If you look at a simple model that uses age, sex,

estimated GFR from MDRD equation and albuminuria to predict when that patient might develop end stage renal disease, and there's now nice calculators. This is a wonderful thing, I keep it on my phone, this Qx Calculate, I would recommend you do the same,

and you can put those answers to the questions, in this app, and it'll give you the answer you're looking for. So for instance, here's a case, a 75-year-old woman, CKD stage four, her creatinine's 2.7, not very impressive,

eGFR's 18. Her urine protein is 1200 milligrams per gram, that's important, this is kind of one of the major variables that impacts on this. So she's referred appropriately at that stage to a surgeon for arteriovenous access,

and he finds that she really has no veins that he feels are suitable for a fistula, so an appropriate referral was made. Now at that time, if you'd put her into this equation with those variables, 1200, female, 75-year-old, 18 GFR, at two years, her risk of ESRD is about 30%,

and at five years about 66%, 67%. So, you know, how do you use those numbers in deciding if she needs an access? Well, you might say... A rational person might say perhaps that patient should get a fistula,

or at least be put in line for it. Well, this well-intentioned surgeon providing customer service put in a graft, which then ended up with some steal requiring a DRIL, which then still had steal, required banding, and then a few months, a year later

was thrombosed and abandoned because she didn't need it. And I saw her for the first time in October 2018, at which time her creatinine is up to 3.6, her eGFR's down to 12, her protein is a little higher, 2600, so now she has a two-year risk of 62%, and a five-year risk of 95%,

considerably more than when this ill-advised craft was created. So what do you do with this patient now? I don't have the answer to that, but you can use this information at least to help flavor your thought process,

and what if you could bend the curve? What if you treated this patient appropriately with ACE inhibitors and other methods to get the protein down? Well, you can almost half her two-year risk of renal failure with medical management.

So these considerations I think are important to the team, surgeon, nurses, nephrologists, etc., who are planning that vascular access with the patient. When to do and what to do. And then, you know, it's kind of old-fashioned to look at the trajectory.

We used to look at one over creatinine, we can look at eGFR now, and she's on a trajectory that looks suspicious for progression, so you can factor that into your thought process as well. And then I think this is the other very important concept, I think I've spoken about this here before,

is that there's no absolute need for dialysis unless you do bilateral nephrectomies. Patients can be managed medically for quite a while, and the manifestations of uremia dealt with quite safely and effectively, and you can see that over the years, the number of patients

in this top brown pattern that have been started on dialysis with a GFR of greater than 15 has fallen, or at least, stopped rising because we've recognized that there's no advantage, and there may be disadvantages to starting patients too early.

So if your nephrologist is telling I've got to start this patient now because he or she needs dialysis, unless they had bilateral nephrectomies that may or may not be true. Another case,

64-year-old male, CKD stage four, creatinine about four, eGFR 15, 800 milligrams of proteinuria, referred to a vascular access surgeon for AV access. Interesting note, previous central lines, or AICD, healthy guy otherwise.

So in April 2017 he had a left wrist fistula done, I think that was a very appropriate referral and a very appropriate operation by this surgeon. At that time his two-year risk was 49, 50%, his five-year risk 88%. It's a pretty good idea, I think, to get a wrist fistula

in that patient. Once again, this is not validated for that purpose. I can't point you to a study that says by using this you can make well-informed predictions about when to do vascular access, but I do think it helps to flavor the judgment on this.

Also, I saw him for the first time last month, and his left arm is like this. Amazing, that has never had a catheter or anything, so I did his central venogram, and this is his anatomy. I could find absolutely no evidence of a connection between the left subclavian and the superior vena cava,

I couldn't cross it. Incidentally, this was done with less than 20 CCs of dye of trying to open this occlusion or find a way through, which was unsuccessful. You can see all the edema in his arm. So what do you do with this guy now?

Well, up, go back. Here's his trajectory of CKD four from the time his fistula is done to the time I'm seeing him now, he's been pretty flat. And his proteinuria's actually dropped

with medical management. He's only got 103 milligrams per gram of proteinuria now, and his two-year risk is now 23%, his five-year risk is 56%, so I said back to the surgeon we ligate this damn thing, because we can't really do much to fix it,

and we're going to wait and see when it's closer to time to needing dialysis. I'm not going to subject this guy to a right-arm fistula with that trajectory of renal disease over the past two years. So combining that trajectory with these predictive numbers,

and improved medical care for proteinuria I think is a good strategy. So what do you do, you're weighing factors for timing too early, you've got a burden of fistula failure, interventions you need to use to maintain costs, morbidity, complications,

steal, neuropathy that you could avoid versus too late and disadvantages of initiating hemodialysis without a permanent access. And lastly, I'm going to just finish with some blasphemy. I think the risk of starting dialysis with a catheter is vastly overstated.

If you look at old data and patient selection issues, and catheter maintenance issues, I think... It's not such an unreasonable thing to start a patient with a catheter. We do it all the time and they usually live.

And even CMS gives us a 90-day grace period on our QIP penalties, so... If you establish a surgeon and access plan, I think you're good to go. So who monitors access maturation? I don't know, somebody who knows what they're doing.

If you look at all the people involved, I know some of these individuals who are absolute crackerjack experts, and some are clueless. It has nothing to do with their age, their gender, their training, their field. It's just a matter of whether they understand

what makes a good fistula. You don't have to be a genius, you just can't be clueless. This is not a mature usable fistula, I know that when I see it. Thank you.

- Thank you and maybe we trying to get rid of women's, I don't know, we'll see. Thank you Dr. Veith. No relevant disclosures to this talk. But we know statin is very beneficial in carotid endarterectomy. Several published data already,

one of them is threefold reduction in the risk of stroke and fivefold reduction in the risk of death done by Dr. Perler over 1,500 patients. Another study by Kennedy, showing 75% reduction in the risk of stroke as well and this is one larger cohort, about 3,300 patients.

So what about carotid stenting? If you look at the data, there's not a lot of data out there so we did a lot of work looking at medication in general in carotid stenting. For instance, we know that dual antiplatelet therapy is very beneficial.

We don't have one, we actually have two randomized trials comparing clopidogrel or ticlopidine with asprin versus Heparin and asprin. Both studies showed significant reduction in the risk of neurological event. In the first study, reduction from 25% to 0%.

In the second one, from 16% to 2%. So beta-blockers, not a lot of people believe this data but this is very powerful study, a large cohort of patients that received beta-blockers. There was a 65% reduction in the risk of stroke and death in carotid artery stentings

and mainly in the group who developed hypertension after the procedure. So how about statin? Statin and carotid artery stenting, if you look in the literature, very poor data. This is one of the largest studies out there,

it has about a thousand patients, a little over a thousand patients, about 40% of them are on statin and in this particular study there was 70% reduction in the risk of stroke and death if you're on a statin versus not.

And that persisted at long term followup. So if you're on statin at five years, your risk of mortality overall was reduced by 50% and your risk of stroke also was reduced by about 60%. We went out to see what happened in real world data so we used the Premier dataset

to represent 20% of all discharges in the United States. And it has more than 700 hospitals. So we have from 2009 to 2015, 17,800 carotid stent, making this the largest retrospective study done to date. 70% of these patients were on statin and as you can expect they're slightly older, more male,

more history of hypertension, diabetes and prior stroke, prior MI and coronary artery disease, there was significantly more CHF, COPD. Bottom line, they were a lot more sicker and that's why they were on statins. But the group that did not receive statin,

were more likely to receive an urgent or emergent carotid artery stenting. Surprising was that actually the risk of stroke and MI was larger in the group who are on statin but the death was half. So that making a case for a rescue phenomenon

and as you can see here, chances of dying, if you're on statin and develop major stroke or MI after carotid stenting was reduced from 26% to 11%. When we did the adjusted analysis, the difference in stroke went away but the difference in MI persisted.

So if you're on statin, twice as much MI. Obviously, this is why you're on statin in the first place because you have a lot of coronary artery disease so it is not surprising why there is more MI. But again, the risk of death was reduced by more than 60% and the risk of death following a major stroke

or major MI was reduced by 63%. Limitation, of course, is a retrospective analysis. We only looking at post-operative outcomes, we don't know really the exact, we do but we didn't analyze the dosage and the type of statin, that's another study.

But this study is published recently in the Journal of Vascular Surgery. And in conclusion, 64% reduction in odd of death, 18% reduction in odd of stroke and death if you're in statin verus not and undergo a carotid artery stenting.

And most interesting finding, 63% reduction in failure to rescue. And I urge you to have all your patients on statin, if you're performing carotid artery stenting based on this and other data but we need further study to look at the dose effect

and the type of statin that need to be used. Thank you so much.

- Thank you. Disclosure related to this talk. So the evidence on beta blocker use has been very controversial, and with the first randomized trial being discredited, this is one of the earliest trial that showed, actually, a benefit,

and this one was not discredited, and showed significant reduction in mortality in patient undergoing non-cardiovascular surgery, and this was persistent up to one and two years. This particular study that was published in Lancet

shows just the opposite, with larger number of patient to post trial, showing no benefit of beta blockers. In these two next slides I'm going to show you both of them were randomized trials, comparing metoprolol to a, basically a sham,

or placebo, and showed in vascular patient, no benefit. However, the problem with both of these randomized trial that they included apple and oranges in vascular surgery, so they included aneurism and peripheral vascular disease, axbifem, and even amputation. Very different procedures.

Despite this controversial evidence, both the European Society of Cardiology and American Heart Surgery revised their guideline and recommended to continue use of chronic beta blockers, but not to initiate beta blocker before surgery. And the problem that I have with a lot of this data is

that they did not really look at the specific type of beta blocker, the route of administration or dose, and also what I've showed you, the inclusion of apple and oranges, or even in the first 2 large randomized trial, not just vascular patient, they included colorectal patient,

plastic surgery and orthopedic. So what I wanted to do is to look at real world data and we used the Premier Health Data with a cut from the data from 2009 to 2015. And we included non-rupture aneurysms

in looking at all adverse events and mortality. And we did the usual statistical analysis. But you can see here, we had 6,500 patients, 1,000 of them were not on beta blocker, and the remainder receive a different kind of beta blockers. In table one, you see that the group that receive

beta blocker as expected were a little bit sicker, with the more urgent, non-rupture presentation, more statin use, and they had more coronary artery disease, as well as kidney disease. And the conclusion with the results was

that there was a lot more complication, actually, in the beta blocker user, but the mortality was significantly less, about 4 versus 8%, and there was significant rescue phenomenon, i.e., people who develop major adverse event,

but they survived the adverse event, was a lot higher in a group that received a beta blockers. And some of the predictor of mortality, the usual suspect being older, have more significant coronary artery disease, and other cardiovascular morbidity,

as well the urgency of the presentation, but the interesting thing that I'm showing you here, that when we tried to see if the coronary artery disease has an effect, and there was clearly an effect modification. Meaning, if you have coronary artery disease,

the benefit was a lot higher, as you can see, 80% reduction in mortality, versus 60%. And then when we further stratified this, having or not having adverse event, we saw the same thing in the group that have adverse event. The more benefit in coronary artery disease patient,

but the interesting finding, if you did not have coronary artery disease, and did not develop a complication, there is really no benefit for beta blocker. That is the only group that did not benefit. But the group that had no adverse event and

coronary artery disease, had the most benefit, 93% reduction in mortality. Another unique finding that I don't think any other the study looked at, we looked at different kind of beta blockers, and we found that if you give IV beta blockers,

you actually have higher mortality if you don't have beta blocker at all. And we found that metoprolol is the most beneficial, comparing to other kind. Another thing that we did, we showed that there is a dose response.

So if you go from no dose to intermediate, to low dose to intermediate, you see the mortality dramatically dropping, specifically from 5 to 2% within the dose, so the dose has an effect, and if you go supertherapeutic dose,

you actually have no benefit. Limitation, of course, the usual retrospective study. And the conclusion is that in hospital mortality was reduced by 55%, there was failure to rescue, with 60% lower in the group that received beta blockers. There was a dose response,

and metoprolol is the most beneficial. And based on that, I think recommendations should be revised, specifically for triple A. Thank you.

- [SPEAKER] I have a disclosure, this talk is about a cannulation simulator that I've been working on for about 3 years. It's finally come to the point where we have established a company that, to further develop it and TMC is the initials of my son, whose a lawyer. I told him if you set up this company for free,

I will put your name on as the, the company. I also want to acknowledge Debbie and Janet for this. You know, as a surgeon it would be full hearty for me to sit down and invent a simulator. You need users of the device for all the in-put, so I kept going back to them, going back to the

dialysis nurses in my community, to get their input and so this is what we've come up with. I really don't need to talk about the importance or the consequences of mystics and there's a lot of literature

on that area, but what is interesting is for a surgeon to go into the nursing literature and learn about the psychological impact on patient's from mystics but also the psychological impact on the nurses and the techs. It is, it is really

it is devastating to the nurses and there are nurses that over time become less confident of their cannulation skills. There's this notion of perpetual novice, there's a lot of discussion about the culture in dialysis units that I was unfamiliar with as a surgeon and all

of these papers talk about the need for on-going education and practice. Their cannulation camps, these are expensive and they provide very little training, the simulators are un-realistic, they have high-maintenance, they don't really provide a thrill or a pulse and so most of

these nurses actually can't practice on patients. So, before we started developing this, we had a hypothesis that the perpetual novice is unable to visualize the fistula based on palpation alone and that is the fundamental problem. They have to be able to see a fistula

like this to reliably cannulate a fistula. So we went to Debbie, we went to Janet and asked, OK what is the characteristics of the ideal cannulation simulator? Would need teach the 4 core cannulation steps, we need to be affordable, low-maintenance, preferably fluid-less,

as the nurses it would be able to test those folks that are just beginning cannulation as well as more advanced nurses. It would have an alarm to prevent back-wall sticks, it would train nurses in the identification of a stenosis within in fistula. It would create a

realistic thrill and there would be no based on our initial hypothesis, this was ours. We did not want to provide any visual clues as to the location of the fistula or the depth. It would require only palpation to stick it. And this is what we came up with,

there's no up, there's no down, there's no In this, under our simulator, there are a number of fistula elements and we can turn on these individually and they are tasked to identify the fistula elements that is actually live. The skin on top of the fistulas

is silicon, it's resistant to stick, it's hard to see this cannulation needle punctures, however if those needle punctures, when they develop you can lift tops, spin it and those punctures are no longer correlated to the location of the fistulas underneath.

This is the control panel. You can control the level of the thrill, you can have different levels of the skin to make it more challenging to stick these. The wings of this needle

has been removed but the cannulator uses a standard dialysis needle for the device. When you hit the fistula it creates a light which simulates the return of blood.

So in looking at what we were able to capture all of these elements of the ideal simulator, it's affordable, it's a plug-in play where if an element breaks you can, it's modular, you can disconnect it and plug-in another one. No fluids,

it has just like the old operation games, you touch the back-wall, it alarms. We have one element that's not meant to be stuck but it creates a pulse on one side, a weak thrill on the other side to train that stenosis. We have curved fistulas.

The thrill is quite simple, we generate the thrill through the use of a cellphone motors that create the vibration. Those can be bought for less than $1 on Amazon and it provides no visual clues to the location. We've completed the development of the

device that now needs manufacture specifications, we have a manufacture initial testing has been completed by a large dialysis company and we're working through our first purchase order. We are developing a prototype that's much cheaper, must simpler sleeve that will go over a

patient's arm that overlies their existing fistula and they can self-train on cannulation and I'm working with a Ph.D. who started this project, he's applied complex sensors to the cannulation device that you saw earlier and he's received a K-1 award to study the

mechanics of cannulation and Prabir Roy-Chaudhury is his mentor for that project. Thank you.

- Thank you Dr Veith, and thank you for inviting me, once again, to this excellent meeting. So, I'll talk about the differences in randomized clinical trials and registry results for stenting, and how they are important. Now as you probably all know, in July 2010

a landmark randomized controlled trial CREST reported that among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, MI, or death did not differ significantly

in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. Based largely on these CREST results, the American Stroke Association, a Division of American Heart Association, five months later published their guidelines

where stenting was indicated as an alternative to CEA for symptomatic patients. We did not agree with this recommendation, and Dr Veith kindly invited the SVS representatives, Dr Riles and Dr Moore, and together we published this commentary

saying that it's easy for the term "alternative" to be misinterpreted as "equivalent", which is clearly not true. Following this, we looked at stroke and death rates following carotid artery stenting and carotid endarterectomy

in real life dataset registries, to see if the results from registries actually agree with CREST, and this is a graph that shows the stroke and death rates in asymptoma

the blue dots are for endarterectomy, the red dots are for stenting. There's a line across the 3%, which is the recommended thresholds in asymptomatic patients, as you will see,

there is only one registry for CA above the 3%, whereas there are several stenting registries above the 3%. The size of the dots represents the size of the registries. This registry included more than 1.5 million patients, so these were real strokes, and real deaths. For symptomatic patients the situation was even worse.

Again, you see the blue dots are the endarterectomy and the red dots are the stenting ones, and the 6% is the recommended threshold, by the American Heart Association. You will see that many CAS registries had higher than 6% stroke and death rates.

So, why is this difference and why is it important? First of all, there was a difference in experience and expertise between CAS practitioners participating in randomized controlled trials, and in real life. There were several CAS practitioners

which were performing less than 10 CAS procedures a year. So that was one of the reasons for the results. Also, registries don't have any inclusion/exclusion criteria, there is no cherry-picking, and they include all-comers, so they report results as they occur.

In fact, the Society for Vascular Surgery guidelines show clearly which patients are preferred for stenting instead of CEA, and these include those with tracheal stoma, those with scarred necks, with fibrotic necks, or those after external beam radiotherapy.

Carotid endarterectomy is preferable to CAS for patients older than 70 years, or symptomatic patients, and for females. And in fact, the CREST subgroup analysis showed exactly that. This is the first subgroup analysis

for bisymptomatic status, and you can see here that the perpirocedural stroke and death rates were almost double for stenting compared with endarterectomy. And here's the second subgroup analysis by gender,

which showed that men had similar outcomes whether undergoing stenting or endarterectomy, but women, they had more than 2.5-fold higher stroke and death rates, and this is very significant differences. That's the third subgroup analysis, by age,

which showed that actually the age of 70 years was the time when the outcomes of the stenting were similar with endarterectomy, after that, stenting was considerably worse. By this I would like to thank you all for your attention.

- I'll address a recipe for functional and financial success with smoking cessation for our tobacco addicted patients. We're all very acutely aware of the financial, physical and psychological devastation of tobacco. For our vascular patients it's the most important modifiable risk factor.

Most vascular patients have a high level of initial smoking, it's characterized by failed efforts, and there really are very rare evidence-based cessation programs in place. This was confirmed recently by a publication, American Heart or the PORTRAIT Trial.

I said to myself, "well if I wanted to do counseling "I should have been a psychologist "but I want to be a surgeon, I like to operate." And operating vascular surgery we do, at the middle point of my career

it felt like a revolving door. The right carotid, the left carotid, the left fem-pop, the right fem-pop. And a little more senior in my career as I started the restenosis I felt like I was doomed to the myth of Sisyphus where I just

have to keep pushing that rock up to the top of the hill, only to have it roll down again. I submit to you that if all we do is operate for our patients, our field will be disrupted the same way our cardiac surgical colleagues

have been disrupted. A few years ago, Medicare and many private insurances assigned a payment to smoking cessation counseling, that a ICD10 diagnosis needs to be linked to a tobacco disorder, like vascular disease. Their time based codes for intermed and extensive--

the 99406 is 3-10 minutes, the 99407 is greater than 10 minutes. Now, if you link that to Medicare dollars, it's pretty meager, at $38 per RVU, that's $9 and $19 at additional, respectively. Say your hospital employ at $50 an RVU,

that ups a bit to $12 and $25, respectively. And that's how before you read the Medicare guidelines they say that you have to document that a patient is mentally competent, it needs to be done by a physician or Advanced Care Provider.

You get two attempts per year, four sessions per attempt, or eight sessions per year. About this point I felt like I was reading out of this book instead of the Medicare guidelines. But there is a recipe, and I think it's an important recipe. What we do is put take-away literature

printed ahead of time, in all the patients' rooms, including our online resources, we have the prescriptions and pads pre-printed, and then we have the templates of electronic documentation so we're able to claim the payment for the work that we do do.

We point out to our patients the benefit of smoking cessation, we rely heavily on the CDC website for resources, and the pharmacotherapy really boils down to three:

you need to be careful that you don't double up on your patients who are smoking. Zyban is mor it's basically an extended-release antidepressant and it works on the craving related chemicals in the brain.

It reduces withdrawal symptoms and cravings. You need to start it a couple weeks in advance. You have to be careful with drinkers or cirrhotics, people who have seizures or prior head injuries, and anyone with a psychiatric history. Chantix is the most successful,

it interferes with the nicotine receptors, it lessens the pleasure, and reduces withdrawal symptoms. You also need to start this in advance of cessation efforts. It has GI, headache, sleep disorders, seizures, mood changes, and it got a black-box warning for

suicidal ideations and suicide. Now, at the Harvard School of Business, professor Christensen pointed out that if all we do is operate, we'll be at risk to be disrupted, and he's done business analysis, so he's successful and he's got collabs, such as

Borders, Detroit Auto, stock brokers, and travel agents, and I submit vascular surgeries on that list. He points out that high achievers are the most vulnerable that's because all we do is focus on the highest ROI, that would be that all we do is operate. So how can we avoid being devoured by the next disruptor,

whether it's a cardiologist, new technology, or an overbearing hospital administrator? And he describes this as he evaluates healthcare by saying "What we need to do is focus on the job to be done." We need to say "What does a patient need from us?", not frame them with our attributes.

So we should say they hire us to fix their broken blood vessels, and we should do this whether it's a scalpel, prolene, a stent, a statin, or Chantix. I have (mumbles), but I submit that if we answer what the patient needs, and not what we do for them

that will leave us in a position of leadership where we can make important contributions for our patients.

- 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.

- 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.

- Thank you. No relevant disclosures to this presentation. The means to the end is removing Uremic toxins. That's what we want to do. That's what this is all about. We don't really know all the Uremic toxins and how they inter-relate, but there are a bunch

of compounds that have been identified. Urea obviously being one of them, although not necessarily being a particularly toxic compound. It's a small molecular weight marker of Uremia, which is convenient to use

if not clinically meaningful. We've developed, or Frank Gotch and Sargent developed this dimensionless concept of the Kt/V, an index of the body volume water space, which has been cleared fully of Urea and this index has been the standard for comparing dosing of dialysis for about 30 years now.

Since the National Cooperative Dialysis Study in the 80's. And the most recent iteration of this study has been the HEMO study in 2002, I believe this was published. Where they compared a high dose of Kt/V of 1.71 versus standard dose Kt/V of 1.3 and looked at patient outcomes and they were

concluding that the higher dose of dialysis wasn't beneficial. But this 1.3 was certainly better than we were seeing in the old days of 0.9 out of the NKDS studies, so 1.3 or that range has been accepted as the target dose

for dialysis and KDOQI guidelines now suggest that we strive to achieve a single pool Kt/V of 1.4, so we have a little cushion with a minimum delivery of 1.2, and that has been adopted now by CMS and the payers.

That's in our conditions for coverage that we achieve or we strive for a Kt/V 1.2 and now we have this quality incentive program, which might relate a little bit to the question earlier about saving access as we get penalized or incentivized

for doing certain things, and right in our penalty methodology in the top categories Kt/V, if we don't hit that target we get dinged up to 2% of the total payment for dialysis on that.

So it's something that's being identified, monitored, and if you like ... Not negatively incentivized. It's not a reward. It's a penalty for failing to achieve. And also you can go to dialysiscompare.gov now.

You login your unit. Here's my little unit in Hockessin. We got four stars. A nearby unit got three stars. They're really just as good as us, but somebody thinks those stars mean something,

and one of the components in those stars is hitting your Kt/V target, so if I want to get stars and not be seen as a poor performing unit, I need to hit these performance parameters, so that's why the Kt/V is the holy grail for Nephrologist. We need to get that number.

It's a very simple concept. Mathematically, you've got two items in the numerator and one in the denominator, and you want to maximize that parameter. Number one we can dispense with the volume of distribution

of Urea is pretty much determined by the patient. It's total body of water times the fraction. It varies a lot depending on the age, weight, gender, obesity, etc. You can put it in the calculator and same qx metal to deliver that number for you.

But we can't really change that, unless somebody has an amputation, or a large amount of weight loss or gain, then it changes. Time we have complete control over. We can dialyze theoretically as long as we want and in the U.S. we sort of like

to believe four hours has been adopted as a standard. There are some recommendations that wouldn't do that. Patient acceptance of that is variable. I can sit in front of a patient and tell them they need four and half hours, and they may look at me askance,

because they know they don't want it, and if you look at dialysis times in different countries, you can see certain countries like Germany, typically dialyzes closer to three hours. Typical dialysis time in the United States is more like... Did I say three hours?

I meant five hours. And typical dialysis time in the United States is about three and a half hours. There are also resource limitations and cost involved in that. So the third variable is the one we have

the most control over, which is the clearance of Urea. And that's depending on the dialyze of the blood, in the blood, out. the dialyze of that... capacity of that filter to remove the solute of interest, Urea in this case in a dialysate flow,

and there are specs for each kidney. Here is a Optiflux F160 at a blood flow of 300 and a dialysate flow of 500. It predicts we should get a Urea clearance of 271 mL per minute, or conversely a larger kidney, an F180 had a blood flow of 500, a dialysate flow of 800.

We should get a Urea clearance of 412. Obviously, none of these are perfect clearances. The maximum theoretical clearance would be that of the blood speed, but it's impossible to clear it 100% of the blood. So when your asked as a surgeon or a provincialist

to make a functional access what your Nephrologist is really asking for in a customer service world is give me a fistula that flows 150% higher. 150% of my intended pump speed and we're good to go. Need a little cushion on that as well.

And here's how it translates into action. Here's an example on a calculator. Here's a patient, who's a 70 kilogram female, dialysis time three and a half hours, 210 minutes. Her Kt/V calculates at 1.77. All good.

Same parameters three and a half hours, 120 kilogram, 40 year old male. His Kt/V is 0.96, clearly below the target. You're not going to get that guy's clearance with those parameters. If you goose him up to 500 mL per minute

on a minute on a bigger kidney and you achieve a clearance of 410, then the same male with the same treatment parameters will get 1.45, so you've met their target. If you want to do better than targets just put him on four hours and you only get 1.66,

so these are very easily definable, measurable, predictable quantities that you can achieve. And then you've got limiting factors. What is the pump speed? Well, hemolysis through needles is really an overstated concern.

This arterial negative pressure alarm won't let you go below 250 on this machine and if-- 300 is it Debbie? 250, 300 and at that point it will cut off, so you won't be able to drive the negative pressure that high,

and so you've got parameters for each needle, which are fairly fixed, a little latitude in it, but with 17-gauge needle you can go up to 300 and so on. With a 14-gauge needle you can go up to 500 or more, and it's a pretty si le higher flow.

And here's a case where you've got a 2 millimeter radial artery, a small fistula. The access flow measures at 450. You can dialyze at a blood speed of 300 with a 17-gauge needle and you're good to go. Where as you got a huge brachial artery here.

This access flow is greater than 2000. You can run the blood speed at whatever you want. And you can use a needle size of 14-gauge. You can put whatever needle size you want in this fistula. So the point is that one size doesn't fit all. Dialysis dose, and dialysis needles,

and dialysis fistulas need to be scaled to the size of the patient. You got a neonate. You got Shaquille O'Neal. Somewhere in between is our patient. Thank you.

- We are talking about the current management of bleeding hemodialysis fistulas. I have no relevant disclosures. And as we can see there with bleeding fistulas, they can occur, you can imagine that the patient is getting access three times a week so ulcerations can't develop

and if they are not checked, the scab falls out and you get subsequent bleeding that can be fatal and lead to some significant morbidity. So fatal vascular access hemorrhage. What are the causes? So number one is thinking about

the excessive anticoagulation during dialysis, specifically Heparin during the dialysis circuit as well as with cumin and Xarelto. Intentional patient manipulati we always think of that when they move,

the needles can come out and then you get subsequent bleeding. But more specifically for us, we look at more the compromising integrity of the vascular access. Looking at stenosis, thrombosis, ulceration and infection. Ellingson and others in 2012 looked at the experience

in the US specifically in Maryland. Between the years of 2000/2006, they had a total of sixteen hundred roughly dialysis death, due to fatal vascular access hemorrhage, which only accounted for about .4% of all HD or hemodialysis death but the majority did come

from AV grafts less so from central venous catheters. But interestingly that around 78% really had this hemorrhage at home so it wasn't really done or they had experienced this at the dialysis centers. At the New Zealand experience and Australia, they had over a 14 year period which

they reviewed their fatal vascular access hemorrhage and what was interesting to see that around four weeks there was an inciting infection preceding the actual event. That was more than half the patients there. There was some other patients who had decoags and revisional surgery prior to the inciting event.

So can the access be salvaged. Well, the first thing obviously is direct pressure. Try to avoid tourniquet specifically for the patients at home. If they are in the emergency department, there is obviously something that can be done.

Just to decrease the morbidity that might be associated with potential limb loss. Suture repairs is kind of the main stay when you have a patient in the emergency department. And then depending on that, you decide to go to the operating room.

Perera and others 2013 and this is an emergency department review and emergency medicine, they use cyanoacrylate to control the bleeding for very small ulcerations. They had around 10 patients and they said that they had pretty good results.

But they did not look at the long term patency of these fistulas or recurrence. An interesting way to kind of manage an ulcerated bleeding fistula is the Limberg skin flap by Pirozzi and others in 2013 where they used an adjacent skin flap, a rhomboid skin flap

and they would get that approximal distal vascular control, rotate the flap over the ulcerated lesion after excising and repairing the venotomy and doing the closure. This was limited to only ulcerations that were less than 20mm.

When you look at the results, they have around 25 AV fistulas, around 15 AV grafts. The majority of the patients were treated with percutaneous angioplasty at least within a week of surgery. Within a month, their primary patency was running 96% for those fistulas and around 80% for AV grafts.

If you look at the six months patency, 76% were still opened and the fistula group and around 40% in the AV grafts. But interesting, you would think that rotating an adjacent skin flap may lead to necrosis but they had very little necrosis

of those flaps. Inui and others at the UC San Diego looked at their experience at dialysis access hemorrhage, they had a total 26 patients, interesting the majority of those patients were AV grafts patients that had either bovine graft

or PTFE and then aneurysmal fistulas being the rest. 18 were actually seen in the ED with active bleeding and were suture control. A minor amount of patients that did require tourniquet for a shock. This is kind of the algorithm when they look at

how they approach it, you know, obviously secure your proximal di they would do a Duplex ultrasound in the OR to assess hat type of procedure

they were going to do. You know, there were inciting events were always infection so they were very concerned by that. And they would obviously excise out the skin lesion and if they needed interposition graft replacement they would use a Rifampin soak PTFE

as well as Acuseal for immediate cannulation. Irrigation of the infected site were also done and using an impregnated antibiotic Vitagel was also done for the PTFE grafts. They were really successful in salvaging these fistulas and grafts at 85% success rate with 19 interposition

a patency was around 14 months for these patients. At UCS, my kind of approach to dealing with these ulcerated fistulas. Specifically if they bleed is to use

the bovine carotid artery graft. There's a paper that'll be coming out next month in JVS, but we looked at just in general our experience with aneurysmal and primary fistula creation with an AV with the carotid graft and we tried to approach these with early access so imagine with

a bleeding patient, you try to avoid using catheter if possible and placing the Artegraft gives us an opportunity to do that and with our data, there was no significant difference in the patency between early access and the standardized view of ten days on the Artegraft.

Prevention of the Fatal Vascular Access Hemorrhages. Important physical exam on a routine basis by the dialysis centers is imperative. If there is any scabbing or frank infection they should notify the surgeon immediately. Button Hole technique should be abandoned

even though it might be easier for the patient and decreased pain, it does increase infection because of that tract The rope ladder technique is more preferred way to avoid this. In the KDOQI guidelines of how else can we prevent this,

well, we know that aneurysmal fistulas can ulcerate so we look for any skin that might be compromised, we look for any risk of rupture of these aneurysms which rarely occur but it still needs to taken care of. Pseudoaneurysms we look at the diameter if it's twice the area of the graft.

If there is any difficulty in achieving hemostasis and then any obviously spontaneous bleeding from the sites. And the endovascular approach would be to put a stent graft across the pseudoaneurysms. Shah and others in 2012 had 100% immediate technical success They were able to have immediate access to the fistula

but they did have around 18.5% failure rate due to infection and thrombosis. So in conclusion, bleeding to hemodialysis access is rarely fatal but there are various ways to salvage this and we tried to keep the access viable for these patients.

Prevention is vital and educating our patients and dialysis centers is key. Thank you.

- Thank you to the host for inviting me to speak again this year. I don't have any disclosures other than the fact that I'm a co-author on the paper that's being presented, but got no reimbursement for that. So I flew in from Chicago on Thursday

during your first snow, for those of you who live in New York, and this was the afternoon I'd made it unscathed on my flight, everything subsequent to that from Chicago got canceled, and I got here

and it was a lot like a Chicago winter. Lots of snow, women wearing impractical shoes, but there were two things that were missing: snow plows and salt. Where's your salt game? I mean I don't understand New York,

there was nothing. So I claim that Chicago has a better snow clearing game than New York does, - [Man] And weathermen. - And weathermen, that's right.

Okay. I'm in charge with giving you some information about a publication that we did this year on the DOPPS. And for those of you who are unfamiliar with the DOPPS, just a quick background.

The DOPPS Outcomes Practical Patterns Study started in 1996, and it's resulted in a series of prospective studies from more than 20 countries around the world. It includes a cohort of Hemodialysis, CKD, and PD patients,

which now totals 70,000 patients. And its principal goal was to identify modifiable clinical practices to improve patient outcomes. And just to give you an idea of which countries are represented,

those in the blue, each wave of the DOPPS has incorporated a broader span of countries, and the most recent wave included China and many countries in the Middle East. So it's quite representative of what's going on around the world.

So we elected to look at issues related to AV fistula location and use, and compare those to countries in Japan, Europe, and New Zealand, and looked at a prospective study that spanned between 2009 and 2015.

It involved over 4,000 fistulas, about 1,000 grafts. And in order to get some trend analysis, we used DOPPS data that was collected between 1996 and 2015. And we looked at three specific outcomes:

AV fistula location, time to first use, and continued use. Some key findings here are that, for any of you who've traveled to Japan and spent time with dialysis patients, it's impressive.

This dark color represents lower arm fistulas and this lighter color represents upper arm, and you can see here that over time, as the DOPPS gone successively from the 1990s through 2015, Japan has maintained principal use

of lower-arm fistulas. When we go to Europe, what you can see is that there's been a slight decline in lower-arm fistulas from about 77% of those in the cohorts down to about 66%.

But when we get over to the U.S., we find that interestingly, there's been an inversion. Where previously, there had been lower-arm fistulas, in the 1990s, this is now switched to upper-arm fistulas,

despite the fact that the U.S. has the lowest mean age of those people that are undergoing dialysis. And interestingly, among those patients that we consider to have the lowest risk for fistula maturation failure,

namely young men, less than 50% of U.S. males less than 50 years of age, had fistulas located in the lower arm in our most recent DOPPS cohort compared to 73% in Europe and 98% in Japan. And the implications of this are two-fold.

Principally exhausting AV access sites and then complications that can be related to upper arm high-flow access. So just quickly, I want to touch on successful use, which differs internationally.

You can see here that for those patients that had continuous use for more than 30 days, Japan had 87% of its cohort who maintained this, while the United States, 64% of its cohort did. And these numbers are similar to USRDS reporting.

Japan's AV fistula use was more successful, or, I'm sorry, the AV fistula use was more successful in the upper arm versus the lower-arm fistulas in the U.S. and in Europe, but not in Japan. It didn't seem to matter

whether it was upper or lower arm, they still seemed to work equally well. Interestingly too, time differs in terms of cannulation. The mean days to AV fistula cannulation in Japan were only 10 days,

compared to nearly three months for the United States. And when they looked at median days to graft cannulation, similar pattern existed, Japan had six days to cannulation

whereas the U.S. had 30 days. So what are some possible differences for these? There're many. But Fistula First is obviously the big, the big one that comes to mind because its implementation mirrors

the timing and the trend, the shift in upper-arm fistulas in the U.S. There's also a known high AV fistula maturation rate in the United States, which may discourage surgeons

from placing lower-arm fistulas initially. There are a limited number, in my view, of experienced and skilled surgeons that have a broad fistula repertoire in the lower arm, lack of widespread pre-operative ultrasound

vessel mapping, and lack of attention to vessel preservation. So what are some possible reasons for greater time to use in the U.S.? I think that it's largely superficialization procedures that are needed

because of body habitus. There's some hesitancy around cannulation segments, maybe being limited or deep. Nephrologists really don't know how to examine and access,

and I'm one of, I'm a Nephrologist, I can say that. And then lack of cannulation expertise in a dialysis unit. So how does Japan do it? Despite an older mean age for dialysis,

there's a much lower median blood flow for dialysis. They use a 200 pump speed, whereas we use 400 to 500 millimeters per minute pump speed. And this largely achieved because they, many times, have a smaller body weight,

but they also accommodate longer treatment times and smaller gauge needles. And they limit their surgeons to those that really have experience. So for visual learners out there, this is the summary of what I've said.

The percent of fistulas in the lower arm in Japan is 95%, U.S. is 32%. The number of days to a successful fistula cannulation is significantly longer in the U.S. And some takeaways are three, then I'm done.

Patients don't necessarily require high-flow fistulas, just a modified dialysis prescription, and this can come about through an expansion of home and nocturnal dialysis.

Improvements are needed for surgical expertise and training. And, in fact, the Endo AV fistula, which you'll be hearing about later today, may, in fact, increase fistula usability and reduce time to cannulation

in certain patient populations. And because I'm the President of ASDIN, I invite all of you to come to our February meeting, escape the cold, it's in Atlanta this year. Thank you for your attention.

Disclaimer: Content and materials on Medlantis are provided for educational purposes only, and are intended for use by medical professionals, not to be used self-diagnosis or self-treatment. It is not intended as, nor should it be, a substitute for independent professional medical care. Medical practitioners must make their own independent assessment before suggesting a diagnosis or recommending or instituting a course of treatment. The content and materials on Medlantis should not in any way be seen as a replacement for consultation with colleagues or other sources, or as a substitute for conventional training and study.

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