Chapters
More Effective Techniques Of Thrombolysis With Microbubbles And Ultrasound: Feasibility, Safety And Effectiveness In A Clinical Study (The MUST Trial)
More Effective Techniques Of Thrombolysis With Microbubbles And Ultrasound: Feasibility, Safety And Effectiveness In A Clinical Study (The MUST Trial)
acuteadversealteplaseangiographyarterialboluscontrastduplexendothelialfeasibilityhypersensitivityinfarctionintensityischaemiaischemiclimbmechanicalmicrobubblesmilligrammyocardialnanoparticlesnativeoccludedpatientsperipheralprostheticrevascularizationrutherfordsafetyTherapeutic / DiagnosticthrombolysisthrombolyticthrombolyticsthrombosedthrombustreatedtrialultrasoundurokinaseVeithvenous
Advantages And Limitations Of The Various Pharmaco-Mechanical Thrombectomy Devices: When And Why Is Each Device The Best One To Use
Advantages And Limitations Of The Various Pharmaco-Mechanical Thrombectomy Devices: When And Why Is Each Device The Best One To Use
AngioVac (AngioDynamics) / AngioJet (Boston Scientific) - Thrombectomy System / Jeti (Walk Vascular) - Thrombectomy System / ClotTriever (Inari Medical) - Thrombectomy SystemaspirationAspiration SystembloodcatheterCDTclotcoresdevicedevicesdisruptiondistalendovascularextractionnitinolpedalPenumbraPenumbra’s Indigophysicalportionpulmonaryremovalrenalstiffersuctiontherapeutic
Improved Endovascular Mechanical Vacuum Assisted Indigo Clot Extraction System From Penumbra: When Is It The Treatment Of Choice For Arterial Thrombo-Embolectomy: From The PRISM Trial
Improved Endovascular Mechanical Vacuum Assisted Indigo Clot Extraction System From Penumbra: When Is It The Treatment Of Choice For Arterial Thrombo-Embolectomy: From The PRISM Trial
adverseafibangioplastyarrhythmiasarterialaspiratedaspirationAspiration SystematrialAtrial Fibrillation; Peripheral Arterial OcclusionbrachialcathetercatheterscentimeterclotdevicesdistallyembolicembolusfibrillationinterventionlesionmechanicalocclusivepatencypatientsPenumbraPenumbra’s IndigorestorationrevascularizationrunoffscleroticstentsuctiontechniquetherapeuticThrombectomy - Penumbra CAT 8 XTRACTthrombolyticstibialtimitreatmentunderlying
Vacuum Assisted Thrombectomy With The Penumbra Indigo System For Visceral And Lower Limb Artery Occlusions
Vacuum Assisted Thrombectomy With The Penumbra Indigo System For Visceral And Lower Limb Artery Occlusions
Aorto-Renal BypassAspiration SystemGore Viabahn VBX (Gore Medical)PenumbraPenumbra’s Indigotherapeutic
Vacuum Assisted Catheter Based Thrombo-Embolectomy For Acute Limb Ischemia (ALI): How Does It Work And Results: From The INDIAN Registry
Vacuum Assisted Catheter Based Thrombo-Embolectomy For Acute Limb Ischemia (ALI): How Does It Work And Results: From The INDIAN Registry
ACE64 (Penumbra) - Reperfusion CatheteracutearcharteryaspirationAspiration SystematraumaticballooncabgcathetercenterschallengingchronicclotdedicateddevicedistalembolectomyemboliendograftendovascularengageevarfogartyFogarty EmbolectomyhemolysishybridhyperplasiaincompletelimblysismaneuverpatencyPenumbraPenumbra’s IndigoperipheralplantarpoplitealpreliminaryprospectiveproximalremovereperfusionresultstentsystemtherapeuticthrombustibialtimiVeithvessel
New Techniques In Endovascular Aspiration Thrombectomy: The World Has Changed For Treatment And Rescue Clot Extraction With Penumbra Indigo Suction Devices In Various Vascular Beds
New Techniques In Endovascular Aspiration Thrombectomy: The World Has Changed For Treatment And Rescue Clot Extraction With Penumbra Indigo Suction Devices In Various Vascular Beds
Acute Bowel IschemiaAspiration SystemAspiration ThrombectomyOscor Directional Sheath (Oscor) / AngioJet (Boston Scientific) - Thrombectomy SystemPenumbraPenumbra’s IndigoTherapeutic / Diagnostic
Tips And Tricks For Thrombo-Embolectomy For Clot Removal From All Arteries Using The Indigo System: How To Measure Success
Tips And Tricks For Thrombo-Embolectomy For Clot Removal From All Arteries Using The Indigo System: How To Measure Success
Aspiration SystemAspiration ThrombectomyCovered stentInjured infa-renal aorta with embolegenic thrombusPenumbraPenumbra’s Indigotherapeutic
Simplifying Treatment Of ALI With The Use Of The Indigo Thrombectomy System: When Is Open Surgery Required
Simplifying Treatment Of ALI With The Use Of The Indigo Thrombectomy System: When Is Open Surgery Required
acuteadjunctiveadvanceafibALIangiographyangioplastyarcharterialAspiration SystemballooningcalibercathetercatheterschronicclotcutaneousembolectomyemboliembolicfavorablefogartyiliacipsilateralischemialevellyticsOpen SurgeryPenumbraPenumbra’s IndigopercutaneousperinealpoplitealremoveremovedrunoffsheathstenosissubacutesystemtechniquetherapeuticthrombectomyThrombectomy - XTRACT Techniquethrombithrombustibialtpa
Panel Discussion (Session 62) 2018
Panel Discussion (Session 62) 2018
Aspiration SystemPenumbraPenumbra’s Indigotherapeutic
Transcript

- So thank you ladies and gentleman, thank you Doctor Veith for inviting me again this year. These are my disclosures. So more effective thrombolysis by microbubbles and ultrasound has been proven actually effective in earlier studies, treating a myocardial infarction or acute ischemic stroke.

But what are these microbubbles? These are 1 to 10 micrometers, gas-filled bubbles with a lipid shell. It oscillate when subjected to low intensity ultrasound, and can cavitate when subjected to high intensity ultrasound. Initially they were designed for diagnostic use

as intravascular contrast enhancers. However, they have many advantages, non-specifical mechanical effects, to induce thrombus breakdown due to mechanical force of microbubbles if they are subjected to ultrasound. So we conducted the first human trial

in peripheral arterial diseases in Microbubbles and UltraSound-accelerated Thrombolysis, the MUST study for peripheral arterial occlusions. Which is a single phase two trial for actually safety and feasibility study. The MUST-TRIAl consist out of 20 patients

for safety and feasibility, which in 10 patients will be treated with Urokinase, and 10 with Alteplase. And then added, for the first hour, microbubbles and we evaluated the VAS pain scores, duplex echography for circulation or revascularization, microcirculation and daily angiography as usual.

Included were men and women 18 to 85 years. A maximum of two weeks of symptoms of lower limb ischaemia due to thrombosed or occluded lower limb peripheral native arteries or venous or prosthetic bypass grafts. And Rutherford class 1 or 2A. They have to understand the nature of the procedure

and written informed consent. And excluded were all known factors that exclude standard thrombolysis therapy, hypersensitivity to contrast enhanced agents, a recent acute coronary syndrome. Endpoints, again, it's a safety

and then a technical feasibility trial. Also we looked at the organisation, and the treatment duration for technical, angiographic, and clinical success. We looked at the severe adverse event and mortality rates, VAS-pain scores and microcirculation.

If the patients came in, we inform them about the MUST trail, we performed an ECG analysis and informed consent. They fill out some questionnaires and when they come in to the angio-room, we started a thrombolysis with a catheter, the Mc Nemara.

And the first group, the Urokinase 10 patients, we treated with 500 units of bolus and then continued with a 50,000 units of Urokinase per hour. The Alteplase group had started with a 5 milligram bolus and then they continued with 1 milligram per hour

for the first 24 hours. And then, the ultrasound room, they got a bubble infusion for the first hour of treatment. Then we would continue with thrombolysis on a surgical ward, every sixth hour we'd look at if there was revascularization at the duplex ultrasound.

And if signs of revascularization are observed on the duplex ultrasound or on the next day, we routinely perform the angiography. Then we could cessate the thrombolytic therapy, and if necessary, acute or elective additional intervention to correct underlying lesions,

or to establish patencies. We check the wound and then we follow-up these patients every six weeks, three months, 6 months, and one year after thrombolytic therapy. So these are the patient characteristics, mostly of these were male, 70 years,

and five of them were native bypass, and five were a bypass occlusion, venous or prosthetic. And two of them had multiple occlusions, whether Rutherford class 1 or 2A. And these were the first 10 patients that were treated with Urokinase and I will present here

the results of these 10 patients first. So, very important, there were no deaths, no severe adverse events, and it was technical feasible. The flow at the duplex examination was there after 24 hours, but most of our patients actually had it already after 6 hours.

The amputation rate, right now, is zero. And also no bypasses were now needed. So we will continue this MUST trial right now and January we probably will have the inclusion of the group with the Alteplase, which I'll present next year.

And we think that microbubbles with Urokinase is a safe combination right now. We will further include the groups of adults placed and further optimalisation of the microbubbles technique with nanobubbles. Had a talk about that yesterday, so you can look it up.

And nanobubbles are nanoparticles of 5 to 500 nanometers, which are very small, they do not penetrate the endothelial barrier of the doubt and it damage. And it can carry the thrombolytics actually to the side the aorta catheter need it. You can also make the magnetic paste,

which means you can paste these patients on the MRI. Then you can have local treatment of thrombolytic therapy. So thank you for your attention.

- I'll start, I have no disclosures. The need for speed. So as we all know catheter thrombolysis is well-studied and allows for a slow melting of an acute clot however new devices offer much faster thrombolysis. Some offer physical removal of the clot,

either by aspiration or extraction or by disruption of the clot or a combinations of the two. The poster child for physical removal is the Penumbra Indigo CAT system which as you know is a reinforced catheter connected to a pump system.

However, as you know it also has poor transition in the wire, you have to advance the catheter straight into the arteries or veins. There is a risk of advancing the clot as you push forward which could potentially worsen distal ischemia/embolization. Also when the device clogs,

you have to remove the entire system, take it out, clean it. Or use a little separator which increases the cost and can be a bit laborious. Continuous removal of a clot while you're doing this also is blood and you can lose up to 160 ml in 20 seconds.

There's no reperfusion system. In corolary, the AngioVac system is a large volume aspiration system. It's protected with the filter veno-veno bypass circuit. Large system put in the vena cava, connected to extra corporeal pump.

And requires two, very large 22 French sheaths to suck the blood in and to give the blood back. It's designed for large vessels but thrombus is extracted depending on how large it is. And it will limit yourself and of course you can't use it in an artery.

Extra corporeal pumps are very expensive and they're not reimbursed in the United States, as they're not really indicated as such. Combination systems. The classic one is Angiojet. As you know, it sprays out high-pressure fluid.

It can be TPA and then has an inward-facing jets which cause the negative pressure Bernoulli effect to suck clot. It removes soft clot through the little side holes. The sprayed volume can potentially damage the vessel and has been shown to be ruptured

so you cannot use it pulmonary vasculature. And I've seen aneurysmal degeneration a few weeks after putting in a cadaveric vein. It also causes hemolysis to the fragmentation. As you all know, it causes hematuria which is considered normal.

However, both myself and Dr. Cashup has shown that it can cause a renal injury. What about pulmonary microembolization? Anybody in this room who's ever used AngioJet, has seen a patient that's suddenly has Dyspnea and every time that happens it causes me chest pain

but it happens and we just say it's okay. Interesting new devices are the Jeti, by Walk Vascular which has a combination approach of the idea of aspiration. At the same time as internal disruption so it's a catheter very similar to the CAT6 from Punumbra but it also has this downward-shooting,

high-pressured jet inside the catheter which acts like a bandsaw to cut through the clot to aid in the aspiration. It attaches to the wall suction or the Punumbra system and it's kind of neat 'cause it has a little pedal and that pedal adjusts the suction

so you can actually use your feet to control it rather than having to have someone to do it on the outside. It seems agile, it looks good. There's no publications out yet. I'm excited to try it out. The ClotTriever is an interesting device it incorporates the distal protection system.

It cores to remove the clot and it has a physical extraction of the majority of the clot. You don't have to use lytics. You essentially put it inside, you pass the clot. Once you pass the clot, you expand a little basket. And the very back part of the basket has a stiffer portion

of nitinol and that stiffer portion of nitinol as you pull it through the clot, cores the clot, wall to wall. It's 13 millimeters in maximum diameter. So it's pretty much an iliac or ephemerol system. As you pull it back,

you get your clot and theoretically it traps pretty much everything you got. Pull it through and out the sheath. And you can clean it and reapply it. The downside is that you always have to put it antegrade.

So you have to go popliteal and you have to get beyond the clot. So sometimes to get it in far enough, the original device was much longer than the current device. You had to stick it in the subclavian

just to get it to deploy to bring it down. However the question is, whether or not you can get subacuter chronic hard clot. This is a case we did last week. You can see, you can get pretty impressive extraction of clot without using thrombolytics.

In summary, be judicious when you're choosing your approach. Consider the potential downsides of your product. There are certain risk benefits associated with each one. Renal dysfunction, contraindication to lysis, sheath size Old school lysis or open thrombectomy may be the better choice

don't always go to a device. New devices are improving old ideas. Endovascular thrombectomies are not like cars. When you're doing an endovascular thrombectomy, you have many devices and yet say, I know this is faster, but maybe I should think about it.

Whereas in cars, speed has no conceivable downside. Thank you very much.

- Thank you very much. So what we're going to talk about today, the PRISM trial, the multi-center trial that looked at the use of the penumbra-indigo system. This is what's new with that, that was actually presented here last year, and has been published,

but we're going to look at a sub-analysis of that data, I do have some disclosures, and we're going to look at the sub-analysis of that data, and what happens to patients who had atrial fib, and had embolic disease treated with this. So, the PRISM trial,

it demonstrated the safety of this extract technique, which is a power aspiration-based treatment using the CAT-6 or the CAT-8 with an aspiration pump that aspirates at near-true vacuum. It was a single-arm study, multi-center and retrospective, the primary end points had to do with immediate patency

after the procedure, and the flow was scored using the TIMI flow system, and also looked at serious adverse events. So if we look at all patients versus the atrial fib patients, we can see that one difference is that there's

a lot more women in the atrial fib patients, whereas in the all-comer patients we had a lot less women, and also a lot less diabetes, so these are patients that primarily had arrhythmias that threw emboli. The vessels treated included all the tibial vessels,

TP trunk, and also in 8% of the patients, the brachial artery. And the devices really include the six and eight french catheters, the eight french catheters come angled, and it was mentioned in a previous talk,

the bigger the catheter, the more power aspiration that you'll see, so you have to modify how you do this, and there is a bit of a learning curve, it's a low learning curve in doing this. What is the XTRACT technique?

Well, the XTRACT technique involves taking the indigo catheter, not turning the suction on, embedding it in to the clot proximally, turning the suction on proximally, allowing it to suck for 60-90 seconds, and then either advancing the catheter in,

or slowly retracting the catheter, and corking the clot. It does not involve using the separator device in the arterial system. So, when this was used as a frontline patient, this was used in 58% of the patients as a frontline treatment,

it was used after thrombolytics, it was also used after other mechanical devices failed, and it was also used after thrombolytics and other mechanical devices failed. Revascularization rates as a frontline treatment, successful TIMI two or three blood flows obtained

in 71% of the patients. Well, why not 100%? Because a number of these patients had underlying stenoses, and lesions that needed to be treated. When a secondary intervention was added, such as an angioplasty or stent placement

of the underlying lesion that caught the embolus, there was 100% revascularization to TIMI two three flow. Serious adverse events were none in the PRISM trial for either the Afib arm or all patients, that were related to the device. There were serious adverse events unrelated to the device.

So a representative case might look something like this, an 86 year-old develops a sudden left foot pain with associated decreased sensation and motor loss on Rutherford 2B, perhaps, no pedal pulses, you can see a non-invasive exam flatline below-knee.

Ankle and digital wave forms on the left side, relatively normal on the right, duplex map shows this relatively focal 10 centimeter clot, here it is, running, here's the pre, as we come down and look at the distal runoff the second embolus distally in the TP trunk.

This is a CAT-6 being placed over a wire, placed in place, being patient, after two passes of aspiration, restoration of flow, and then going down to this tibial lesion that we saw, doing the same thing,

having complete restoration of flow, although the runoff isn't normal, this is after sclerotic disease in an 86 year-old, and not embolic disease, so we're able to get this type of result. And then when the clot is corked,

it can be aspirated out as we see here, and sometimes it's brought out on the end of a catheter if it doesn't make it all the way through to the canister. So, in conclusion, this system, using the XTRACT technique is a safe and effective intervention for treatment of patients

with atrial fibrillation and underlying peripheral arterial occlusive disease. It was used as both a frontline treatment and as a salvage technique when other techniques didn't work completely. In the future, we're looking at more prospective trials,

and newer generations of catheters and pumps will definitely enhance the aspiration potential. Thank you very much.

- Thank you for introduction. Thanks to Frank Veith for the kind invitation to present here our really primarily single-center experience on this new technique. This is my disclosure. So what you really want

in the thromboembolic acute events is a quick flow restoration, avoid lytic therapies, and reduce the risk of bleeding. And this can be achieved by surgery. However, causal directed local thrombolysis

is much less invasive and also give us a panoramic view and topographic view that is very useful in these cases. But it takes time and is statistically implied

and increases risk of bleeding. So theoretically percutaneous thrombectomy can accomplish all these tasks including a shorter hospital stay. So among the percutaneous thrombectomy devices the Indigo System is based on a really simple

aspiration mechanism and it has shown high success in ischemic stroke. This is one of my first cases with the Indigo System using a 5 MAX needle intervention

adapted to this condition. And it's very easy to understand how is fast and effective this approach to treat intraprocedural distal embolization avoiding potential dramatic clinical consequences, especially in cases like this,

the only one foot vessel. This is also confirmed by this technical note published in 2015 from an Italian group. More recently, other papers came up. This, for example, tell us that

there has been 85% below-the-knee primary endpoint achievement and 54% in above-the-knee lesions. The TIMI score after VAT significantly higher for BTK lesions and for ATK lesions

a necessity of a concomitant endovascular therapy. And James Benenati has already told us the results of the PRISM trials. Looking into our case data very quickly and very superficially we can summarize that we had 78% full revascularization.

In 42% of cases, we did not perform any lytic therapy or very short lytic therapy within three hours. And in 36% a long lytic therapy was necessary, however within 24 hours. We had also 22% failure

with three surgery necessary and one amputation. I must say that among this group of patients, twenty patients, there were also patients like this with extended thrombosis from the groin to the ankle

and through an antegrade approach, that I strongly recommend whenever possible, we were able to lower the aspiration of the clots also in the vessel, in the tibial vessels, leaving only this region, thrombosis

needed for additional three hour infusion of TPA achieving at the end a beautiful result and the patient was discharged a day after. However not every case had similar brilliant result. This patient went to surgery and he went eventually to amputation.

Why this? And why VAT perform better in BTK than in ATK? Just hypotheses. For ATK we can have unknown underlying chronic pathology. And the mismatch between the vessel and the catheter can be a problem.

In BTK, the thrombus is usually soft and short because it is an acute iatrogenic event. Most importantly is the thrombotic load. If it is light, no short, no lytic or short lytic therapy is necessary. Say if heavy, a longer lytic therapy and a failure,

regardless of the location of the thrombosis, must be expected. So moving to the other topic, venous occlusive thrombosis. This is a paper from a German group. The most exciting, a high success rate

without any adjunctive therapy and nine vessels half of them prosthetic branch. The only caution is about the excessive blood loss as a main potential complication to be checked during and after the procedure. This is a case at my cath lab.

An acute aortic renal thrombosis after a open repair. We were able to find the proximate thrombosis in this flush occlusion to aspirate close to fix the distal stenosis

and the distal stenosis here and to obtain two-thirds of the kidney parenchyma on both sides. And this is another patient presenting with acute mesenteric ischemia from vein thrombosis.

This device can be used also transsympatically. We were able to aspirate thrombi but after initial improvement, the patient condition worsened overnight. And the CT scan showed us a re-thrombosis of the vein. Probably we need to learn more

in the management of these patients especially under the pharmacology point of view. And this is a rapid overview on our out-of-lower-limb case series. We had good results in reimplanted renal artery, renal artery, and the pulmonary artery as well.

But poor results in brachial artery, fistula, and superior mesenteric vein. So in conclusion, this technology is an option for quick thromboembolic treatment. It's very effective for BTK intraprocedural embolic events.

The main advantage is a speeding up the blood flow and reestablishing without prolonged thrombolysis or reducing the dosage of the thrombolysis. Completely cleaning up extensive thromobosed vessels is impossible without local lytic therapies. This must be said very clearly.

Indigo technology is promising and effective for treatment of acute renovisceral artery occlusion and sub massive pulmonary embolism. Thank you for your attention. I apologize for not being able to stay for the discussion

because I have a flight in a few hours. Thank you very much.

- Jim, thanks so much, and thanks to Doctor Veith for the opportunity to get involved. Here's my disclosure. So, certainly you don't want to be an expert on limb thromboses, however, it happens. And so, when you see these patients, no longer are we looking at fem-fem,

or even lytics, catheter-directed lytics. So how do we get from screen left to screen right in a single session therapy? Well, as we know, when these patients present, there's several different management options. You can do open thrombectomy with or without

a fem-fem, pharmacomechanical thrombectomy. There's catheter delytic and ultrasound accelerated thrombolytics, and then now, today, we have vacuum-assisted thrombectomy, as we've heard throughout this session, or continuous aspiration thrombectomy,

however you want to mention it. Regardless, when you end up with lytics, this is exactly what you're dealin' with. You're playing with fire, and if we do it long enough, you're going to see this complication. So we've really adopted a clot extraction

instead of a clot dissolution policy at our institution. I think Jim just showed you this technique that is afforded to us by the Indigo thrombectomy system, as you can see here in a Vivo model, this catheter actually does work extremely well.

It'll remove this soft thrombus, as you can see here. My first experience with this was actually for an occluded popliteal stent, as you can see here. We had a occlusion of the standard nitinol stent. This aspiration power was incredibly surprising to me. As you can see, it collapsed the standard nitinol stent.

So at that point, several years ago, we realized how good this device was, and how we want to minimize lytics for our folks. So we started in 2014 and recently this year at the Midwest Vascular forum in Saint Louis, we presented our data.

At that time, we had 73 patients over the years with acute limb ischemia. And here you can see the breakdown. For this presentation I'm going to focus on this cohort here, which is seven. But as you can see, like my panelists here,

we use it for occlusions, for not only occlusions but emboli as well, and also we had one case of an upper extremity embolism that we were able to successfully treat with this device. At that time, again, looking at all 73 patients,

you can see here that it's a very efficacious device. There were a couple folks who needed transfusion and perhaps the blood loss was a little higher than 300. However, as you can see here, the folks who had a blood loss, all five had open adjunctive interventions as well, and the ones who needed transfusion

all had catheter directed lytics as adjunctive therapy. As far as our efficacy endpoints, what we looked at was antegrade flow. As you can see here, oftentimes with your vacuum system thrombectomy, you're able to get antegrade flow. However, intermittently there's also other

adjunctive therapies that we had to use frequently as well. Going back to what, you know, my topic for today, how do you go from screen left to screen right, where here you can see one of our patients who came in. We did a retrograde ipsilateral stick,

crossed the lesion with the wire, then we delivered our eight french Indigo catheter and were able to get, in a single session, as you can see here, antegrade flow. So here's another, all this in one single session therapy. Here's another patient of ours.

As you can see to the left, one of our Gore Excluder limbs had occluded, and again, with single session therapy we were able to provide patency to that occluded right limb. Another case here, you can see one of our other Medtronic grafts.

And what you'll see here as you're looking to the right, here we are with our eight french Indigo catheter, is the separator, which is like a pipe cleaner. And we were able to clear out this clot and provide patency to this

all in a single session therapy. And again, here you can see from left to right how we were able to thrombectomize that limb. So over the years, the last three years, we do about 80 to 90 EVARs a year. During that time period, we have seven patients

come in with limb occlusions. And as you can see here, four of them were chronic, three claudicants and one res-pain, and three of them were acute limb Rutherford one, two A or two B. As you can see here, 42% of the time for these

occluded limbs, we were able to do it with no lytics, not even a pulse spray, nothing, not one drop of lytics. As you can see here, some of them we did have to do it in a single session. What we do is use a McNamara catheter.

We would squirt out, you know, anywhere from, as you can see, 14 to 18 milligrams of lytics, go get a cup of coffee, go make rounds, come back 20 minutes later, then utilize your device. And again, you can see, in a single session therapy we were able to afford patency.

And then finally, you can see here the blood loss was minimal. So this is a safe device. So in conclusion, I think that single session therapy is safe. It can facilitate achieving antegrade flow

in the management of stent graft limb occlusions. And single session therapy is the future of not only stent graft limb occlusions but all acute limb ischemia. Thanks so much.

- First of all let me thank Dr. Veith for the kind invitation to be here again and it's my great pleasure to share with you the preliminary result of our Indian registry. So these are my disclosures. So as vascular surgeon we have to admit that the Fogarty embolectomy has many possibility

but also some limitation. You can see here in this short video that we were able to remove thrombus, but thrombus was mixed up with plaque, hyperplasia and the final result was a very poor backflow from this vessel.

So already a couple of years ago we published our experience comparing the Fogarty embolectomy with the hybrid treatment that at that time was Fogarty plus a lot of endovascular rescue maneuver and of course hybrid was better, but we were very surprised by this.

What we found that the introvert in geography after Fogarty we had a number of chronic disease this is normal, but we also found a number of residual thrombus because firmly adherent to the arterial wall or just not appropriately reached by the Fogarty balloon embolectomy.

Even the over the Y Fogarty balloon embolectomy cannot work enough well. And then finally we also had a number of case with the injuries. Probably from inappropriate Fogarty balloon maneuver into the vessels so we had to find something more.

We had to find something less traumatic and so we realized that at the same time our colleagues from stroke unit, the neurologist had already a very nice tool in their hands. It's the Penumbra system which has began the market leader in stroke because it's very atraumatic,

dedicated for intracranial vessel navigation and then has a very high aspiration power system. So a couple of years later the company came on the market with the family dedicated to peripheral artery, the Indigo System from three to eight French catheter

designed for peripheral artery. So really improved trackability and atraumatic tip of this catheter. So how does the system work? You have already seen this video, but anyway you have first to engage the clot then you switch on

the aspiration power and then from proximal to distal you can remove all the thrombus, you can use the separator guide wire that breaks up the clot when ingested into the catheter and so the final result is that the tip of catheter is all we part and that you can remove all the thrombus

in very few minutes. Now I want to show to you my very first case it was four years ago and the system was not yet available and I for prefer I had some conflicting result with the other with competitors. I have incomplete reperfusion or hemolysis.

I have very positive feedback from my colleagues from the stroke unit at my University. I had the possibility to borrow the neuro catheters. So in this very first patients, unfit for lysis with a lot of thrombus, fresh thrombus in a vein popliteal area and the tibial artery I used

neural catheters, separate was very easy even at the beginning of our experience and we were able to engage the clot use the separator and removing in a couple of passage old thrombus even from the very distal localizations. So up to now we have used the Indigo family,

Indigo system in a lot of situation I can go through all this the one, but I want to show you how far we can go and it's a very challenging situation within dialysis dependent patients with the calcify kink and tibial artery and thrombus in the plantar arch

we were able to reach the plantar arch with the CAT 3 device and remove all the thrombus. Since then we have decided to collect data in a prospective national registry, the Indian registry. We want to collect 150 case in this prospective registry. We started last year and we actually included any kind

of acute lower limb ischemia embolism, thrombosis, graft endograft thrombosis, distal emboli and secondary to preceding intervention or even incomplete reperfusion after Fogarty and lysis. We evaluated the vessel patency by TIMI score of course we have now 136 patients enrolled by 17 centers active

and Ethiological hypothesis of the ischemia was in the 3/4 of case thrombotic, so the most challenging case. Acute and chronic ischemia mainly in very popliteal area or even below the knee or below the ankle in arteries. And here are preliminary result available for 120 patients.

After the Indigo use we already have a 90% TIMI two or three flow restoration will raise up to 96% after additional PTA or stent or additional lysis. So in conclusion these are only the preliminary result I hope to share with you our final result next year,

but at that moment we can already say that the Indigo is safe and effective option for acute lower limb ischemia, technical success is high even in small arteries, and up to now adverse event related to the device is very low and bleeding and hemolysis are not reported.

Thank you.

Thank you, Mr Chairman. In order to avoid unnecessary repetition, I'm going to try to move forward with some of my slides. There we go. And, again, in order to avoid that, we're just going to move through the cases. I have some cases that are different

to the ones presented before. It seems that everybody's happy with this technology. This is a CTO recanalization of a patient with subacute total occulsion of the SFA that previously had a stent in place,

in the distal SFA. And here you can see how we are able to reopen the vessel and look at the clot in the entire length at the end of the catheter there. So, this technology really works.

Let me show you now an acute bowel ischemia case. A patient that comes with abdominal pain. A CTA shows that the patient has an occlusion of the proximal SMA. We put a catheter there,

we do a diagnostic angiogram confirming the occlusion, then we cross the lesion and we inject distali showing that the branches are patent. And then we put in place

an oscar directional sheath that will give us great stability to work and through that one we use a Cat Eight, from Penumbra. As you can see here, advancing the catheter in combination with the separator,

and this is the final angiogram showing complete opening of the main SMA and you can see very clearly the elements that were occluding the MSL. We are also using this technology in DVT, acute DVT, with proprietal access

and here you can see the before, and then, sometimes we use it alone, sometimes we use it in combination with angiojet and with the bull spray, followed by this technology for the areas that did not respond.

But this is usually a technology that is helping us to get rid of most of the clot. Like here, you see there is some residual clot. And after Penambra, you can direct the catheter and you can really clean the entire vein. Same here, before and after.

We are also using it for PE. I know that you guys in Miami are doing the same and we are happy with the results. And then, just to finish, I think this is a really nice case that was done by one of our partners in vascular surgery.

A patient with an occluded carotid subclavial bypass. So you see access from the brachial artery on one side. And this person, the person who did this, was smart enough to also came from the groin

and put the filter in the internal carotid artery, just in case. So then he starts to manipulate that occluded subclavial carotid bypass. As you can see here. And at a certain point,

he does a follow-up angiogram showing that the entire carotid, including the internal and external, is totally occluded. So, because he was prepared, he had a filter,

he didn't panic, he went and used the indigo device, and he was able to get all that clot out and re-establish nice anterial flowing in the carotid artery,

completely clean. The carotid subclavial bypass. And he did a final angiogram in AP and lateral view, confirming that there is no distimbolisation at the intercranial level. So, this technology really works.

I think that we all agree. And these are good examples on how we can help patients with that technology. Thank you for your attention.

- Thank you, it's a pleasure to be here. I'll address how the Indigo Thrombectomy technology can expand the reach of what you can do for your patients. It will preserve treatment options, improve patient outcomes, conserve hospital resources,

and perhaps most importantly, improve your day. The old treatment strategy, every time I had someone with acute limb ischemia I felt like I was shopping at this store. When I went to surgery, I wished I could put a drip catheter in, it lasts a little longer,

to mop up some di when I went to the angio suite, I wished I could cut down and remove some more macroscopic debris. I submit that the new Indigo technology

will provide a new strategy for treating acute arterial ischemia. On the same concepts are predicated STEMI, code stroke, Level I trauma alerts, we've instituted acute aorta, and piggybacked on that, an acute arterial ischemia protocol.

So that means when a patient like this presents with acute arterial ischemia, they get an algorithmic, systemic, trained, metered approach. They go past the holding room directly to the endovascular suite,

and all the processes happen in parallel, not in series. The call team is trained and dedicated, and while anesthesia is working up top with labs and lines, we use the duplex ultrasound to pick carefully our access sites. A faster time to reperfusion allows us to

do it and avoid general anesthesia, incision in hostile groins, and the exposure of lytic therapy, resulting in a decreased morbidity and mortality. Being able to treat the full spectrum of the arterial tree allows us to run options.

We preserve options by first mopping up more proximal clot, and then dripping distally when we need to, or, dripping distally to open up distal targets for surgical bypasses. As an example, this was a recent case

on a trauma CT scan, injured inthrelane aorta with emblogenic thrombus confirmed on intravascular ultrasound. We went in with a large bore system, a cath to aspirate the clot, and then used a cover stent to repair the aorta.

We shot an arteriogram the lower extremities, noticed that it embolized distally, and we used a Cat 6 to pluck out this clot and restore flow. Able to work up and down the full arterial tree. A learning curve for me was to understand that debris has to be corked to removal, which means no flow.

And most other worlds in vascular surgery, flow is good. No flow is bad. Also, you have to vacuum the clot out. Which means you have to uncross the lesion, which is counter intuitive for most of the precepts I've learned.

I've learned to use long sheaths to approach the lesion and to use larger catheters to remove more macroscopic debris. I rarely use the separator, I engage it and cork it for 90 seconds. That allows it to get a firm grip and purchase on it.

And I have to remember that no flow is good. This demonstrates how you approach the catheter with a large sheath. Under roadmap guidance you turn the aspiration vacuum on immediately before you cork it to minimize blood loss. And you use it like a vacuum by uncrossing the lesion

and let it slowly engage and aspirate the catheter. Ninety seconds allows it to get a firm grip and purchase so you can extract it without breaking it loose. I rarely use a separator, I use it only for large thrombus burdens, sub-acute clot, adherent debris,

or when the Indigo catheter is clogged. I strip out the catheter with the separator like a pipe cleaner, and then, every once in a while, on a subacute clot, I'll peck and morcellate it with a separator. Typically, in my lab, when I have new technology

I never have the team trained when I have just the right case, so I've learned over time, to train the team first. And with a trained team, they've taught me a lot. I've found with the Indigo catheter it's hard for me to watch the monitor,

work the catheter, handle the on-off switch, and watch the flow in the canister. So, what we do is we have a spotter who's not scrubbed. They taught me to take the on-off switch out, and then mechanically kink the tubing to make and on-off switch.

And they provide me feedback and just say fast, slow, or corked, so I can run the catheter and watch the monitor. I've learned to beware of the Cook Flexor sheaths, because they scuff up the tip. Use a check flow valve that unscrews from the

catheter if possible. I use coaxial catheters whenever possible, and I telescope them. You can telescope large catheters over small catheters. I use large sheaths and catheters whenever possible, using the preclose technique,

and then you can preserve options if you want to press more distally, you can cinch down, remove the large sheath, put in a 4 5 French, and then press ahead. I also, after I use a pulse technique, will occasionally use the Jungle Juice.

The team taught me the Jungle Juice is half strength contrast, some TPA and some nitroglycerine. When I lace the clot with Jungle Juice, I can observe fluoroscopically, the progress I'm making as I'm aspirating the clot. Thank you.

- Thank you for the opportunity to give this presentation. It is the last presentation of the session. So, I hope I'm not regurgitating everything that was said prior to this. As we know, the Indego system. There's my disclosures.

As we know, the Idego system has been available now for many years. Why we use percutaneous embolectomy and how it allows us to remove thrombi and emboli in one setting. Also, to treat the underlying stenosis given

if there is a SFA arterial lesion that requires ballooning, angioplasty or, some other therapy. Additionally, given the fact that it can be used in a single setting, it certainly does have the ability to reduce cost for the hospital system.

Which is obviously of importance these days. Easier access to the below-the-knee vessels. Additionally, reduce the use of lytics which has it's own set of complications. Additionally, if this does fail. We still have the ability to perform

open thrombectomy embolectomy if needed. The Indigo system that's previously been stated, comes in a very number of different catheter sizes. These sizes allow you to treat the entire Arterial tree. From the petiole arch all the way up to the iliac vessels.

My recommendation is to always use the largest catheter possible for that particular vessel. Here's a nice video showing the CAT 3 system, traversing the entire petiole arch with great ease. These catheters are highly designed but they are somewhat fragile.

So, it's important to be careful with the tip. My technique for acute lymphocythemia is very similar to what we've previously heard. Essentially we advance the sheath all the way up to the level of clot. On some occasions, we actually do traverse

the clot given the scenario. We do infuse TPA in a pulse spray manner. Either, with an infusion catheter or with a jet stream catheter depending on the scenario. We advance the largest caliber sheath into the system

or into the clot itself and using an extract technique which has been previously demonstrated. Adjunctive techniques which often utilize include, ballooning angioplasty, Fogartys and potentially even stints. Here's a reiteration of the extract technique

again the catheters advance up to the level of the thrombus itself. The system is engaged for roughly 90 seconds and again the clot is corked until it can be fully removed through the sheath system. This is an example of a very nice piece

of cloth that was removed from the SFA. In a cork technique fashion. So starting from the Iliac system we'll work our way down. Here's a patient with a subacute thrombus, an embalis in the left iliac distribution. We used a ipsilateral retrograde crossing technique

to reestablish flow. The CAT 8 system was then used to engage the thrombus within the iliac artery. It was removed in whole and on completion angiography there was a residual stenosis which, did require stinting.

Here's an example of a cronic or subacute SFA lesion. Again, we advance the catheter up to the level of clot, engaged it and we were able to remove the thrombus in whole through the sheath system. Finally, the next case include a popliteal artery thrombus and a post knee surgery patient.

Again, this is an acute thrombus, which is actually very nice 'cuz it's very soft. We advance to CAT 6 catheter up to the level of the thrombus itself and removed it in whole. Afib Occlusions, obviously these patients are often times quite sick.

Not great candidates to go to the operating room. Percutaneous technique is often very favorable for their overall outcome and here we see popliteal and distal tibial perineal trunk disease and thrombus. We were able to remove this in whole and reestablish three vessel runoff to the patient.

Here's an example of a patient who's post-atherectomy within the SFA with a significant plaque burden. We often see embolic debris of this nature using the CAT 6 system, we were able to remove that thrombus from the tibial-peroneal trunk. So, when is open surgery necessary or the best option?

When the clock burden is extensive, when it's multilevel, when percutaneous techniques are going to be inadequate. Obviously, when there's dense ischemia with motor and neuro muscular compromise. Additionally, a compartment syndrome

would probably not be a great candidate for a percutaneous thrombectomy and additionally when the chronic or the clot appears to be chronic it is less responsive to cutaneous techniques. Thank you.

- I think we have time. If there are any questions, please come up to the microphone and any of the panels have questions for each other. I have a number of questions I could ask but I just see if anyone wants to start out. Claudio?

- I have a question Doctor Mark. He show us very nice utilization of this device for occluded limbs. My question is, do you protect in any way the other side? If not, don't you have, you're not concerned

or you're not afraid of pushing clots from one side to the other one when you're manipulating the device? And the second one, do you do this percutaneously? And if that's the case, do you have any concern about having destabilization?

Because once you start to manipulate the clot that is occupying the entire graft, and there is reestablishment of flow in an antegrade flush, and you may have some of that clot dislodge and embolize distant. - Yeah, as I mentioned,

nobody wants to be the guru of limb occlusions. However, we have seen them and we always go retrograde ipsilateral, not seen emboli once from those seven cases and in fact, the 73 we presented at the midwest there was only two instances of embolization

when we utilized this device. And both times we were able to extract those just by going further down with the cat six and both of them was below the knee popliteal. In particular, the acute ones, it's soft and it's no different than watching it in vivo

or in vitro model, as you know better than I, comes out quite easily. - Let's take our question from the audience. - [Scott] Hi, Scott Tapart from Stuart, Florida. So I'd like to poll the panel there about are you doing every single

acute limb ischemia percutaneously? The pictures are elegant, the techniques are elegant, but the last speaker touched on the profoundly ichemic Rutherford 2B patient, where you're most likely going to have to do a fasciotomy. Are you going to the OR

or are you doing this percutaneously and then watching and waiting and seeing about fasciotomy? Or has this changed your fasciotomy approach? - So since we have a number of people, that's a great question. Why don't we start at the end

and let's just go kind of rapid fire, maybe one or two sentences, how do you choose your patients and what do you do with those 2Bs and we'll try to get through everybody. - Sure, so, to reiterate the last slide of the presentation,

essentially anybody with a significant motor or neutral deficit is somebody I tend to do in an open fashion. And if I'm the least bit concerned about doing a fasciotomy or there's evidence of compartment syndrome I do that patient open.

- We try to start endovascular, and if we can clean and reestablish antegrade flow, that would take care of the problem. And of course, I'm a radiologist, so I always consult with my colleagues in surgery and they decide if a fasciotomy needs to be done or not.

And it's that at the end. - Okay, I have to be honest, we start with the selective indication but now we move maybe to 90% of our patients doing percutaneously. We will adjust patients with probably an embolization,

a huge embolization, into the common femoral artery for open surgery. Of course, in our mind, also in the registry, we have some cases of fasciotomy after percutaneous approach so it's not a limitation. - The advantage of acute arterial protocol,

as they all go to the end of asher suite and they all run along our protocol but you can run the option. You get them to treatment quicker because they don't dilly-dally around in the holding room. But then according to how the patient's doing

you can mop up as much clot as you can with the percutaneous technique and then do the fasciotomy when you're done or press head and drip more if you need to. So I think to have an algorithm where you can treat the full spectrum

is what's best for the patient. - I think it depends on the time as well because I did two weeks ago a patient who needed a fasciotomy directly so I performed that first and then it rules out any traumalitic therapy

or whatever that you want to do. And actually, if I do antivascular techniques I usually give a shot or RTPA or something and then go further with it. But anomerization of this patient's arteries as well so prefer actually if it's really a case

that needs fasciotomy just to perform surgical thrombectomy. - Yeah, percutaneous eight French up and over and almost always, you're going to be done with your thrombectomy within about 30 to 45 minutes. I don't think you're adding that much time

and for us, by the time we get anesthesia in him assuming anesthesia's anesthesia no matter what part of the world you're in, so you can get to the hybrid room quicker and then if it's going to fail then you're going to call in the OR or call an anesthesiologist.

- I wouldn't have much else to add. I do think there is some patient selection, if you have an entire SFA, 30 centimeter clot, that's going to take you hours to do so for these thromboembolic things that are 10 centimeters or shorter

lodged in the popliteal TP trunk, this method works really well. I think for the longer patients, you might think about something else. - But just a comment on the general anesthesia. If a patient is in real or really pain,

he can't lie down for 30 minutes, even. I mean, they are rolling in pain and I would do the fasciotomy first because general anesthesia is needed because there is so much pain or, yes, so yeah.

- So, let me say, does that answer it, Scott? So let's, since we have a number of panelists and we're running out of time, how about if we ask each person going down the room, you heard a whole bunch of different speakers here with a lot of experience

and if you haven't used this, there is a learning curve. The learning curve is pretty shallow. Really, a lot of it has to do with controlling your blood loss. But if we ask each person for just one tip

and we'll see if we can get through everybody. If you telling people who hadn't done a lot of this, one tip or one trick, let's see if we can get seven or eight tips and tricks out. So, I'll go last. Let's start back down at that end

and we'll end up at this end. - Sure. Use the largest catheter that the vessel will comply to. - Amen, brother. - I agree with that.

And the way I do it, in order to avoid too much blood loss, I like to engage with a syringe. So I come with my catheter, I hook a syringe in the bag, 20cc or sometimes even larger, and when I have the fish at the end of my line, then I connect to the pump and I continue.

That way if I'm aspirating, I'm not going to aspirate a large volume so I want to engage the clot. And then I bring the clot out. That's my trick. - Okay.

Very nice comment. Of course, I agree with the previous colleagues but I will say that first the trick is really the largest catheter is better, then my idea that I developed during my learning curve is the use of separate to cut away.

I probably use now in 95% of cases because it just makes everything quicker and faster and better. - I use the perclose device for large-bore catheters often and that allows me to pull the plug out, especially if it's fibrous plugs,

safe from the heart without shearing it off on the end of the catheter. I've got one question for Claudio, on that case of the carotid subclabian with the acute carotid occlusion, do you think the nitroglycerin would have helped?

- For the doctor? - For the surgeon. - Absolutely. - And then, change the diapers. - Well, I would advise if you do a surgical embolectomy do it also on the hybrid room

and try to do it also over the wire. Especially be careful if you do it below the knee. I would suggest do it open below the knee, even. - I would say don't afraid to use an eight French for ALI and that closure devices are your friends here. But you can use an eight all the way down to the pop

and then for us, the tibials, we'll use a six. - Yeah, I would agree with that. So I guess my tip would be, I agree with everything everyone said, although I don't use the separator very often in the arterial side, I do in the veins.

But one tip is, if you're not going to use a separator, if you're going to start without it, let's say you want to give it a try, I don't work through a 2E borst because the angle, the eddy currents that form around that 2E borst

trap clots and you constantly have to clean that 2E out so if you're going to start with a focal embolis in the artery my recommendation is take the 2E off, hook up to the vacuum directly, and you'll get less clot stuck in the 2E. If you want to go to the separator

then you can always add that on at the back end. - So I have a question for Fennel. I used a penumbra like a few weeks ago and it ended up really bad because the surrounding catheter from the penumbra, everything got, you know, clotted

and then I didn't have any outflow did I choose the wrong size or what is it that happened, did you see it ever? - We have not had that problem. We're usually working on heparinized patients and have not seen that happen.

- She was heparinized. No? Okay. - Okay. Any other comments? Otherwise, we'll end one minute early

on a nice, long day.

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