Synopsis
Five leading specialists in interventional radiology and hepatology share their experiences and knowledge on the benefits of early TIPS procedures for patients with portal hypertension. This minimally invasive procedure is used to create a channel within the liver to connect the portal vein to the hepatic vein, reducing portal hypertension.
The discussion focuses on three main topic areas, and you can select a specific section in the transcript or video using the chapter links and time stamps provided.
Transcript
0:47 Matteo Segoni (Cook Medical EMEA Product Manager, Interventional Therapies, Vascular Division):
Hi everyone. Thanks for joining this Cook webcast, titled TIPS Intervention: The earlier the better.
I am Matteo Segoni, and I work as a product manager for Interventional Therapies program in Cook Medical in Europe, Middle East, and Africa region.
I am honored to introduce this webcast where we will discuss about the timing of the intervention with the transjugular portosystemic shunt, its beneficial effects, and real-life applications.
We will have three different sessions focused on different aspects. But let me introduce our team of experts, and we can start.
I can start from our moderators, and we have two moderators. Dr. Patch is a consultant, hepatologist from the Royal Free Hospital of London. Thank you for accepting our invitation.
And then we have Professor van Delden, interventional radiologist, Amsterdam University Medical Center. Thanks for being here, Professor van Delden.
And then we have our three speakers, and I’m honored to introduce Professor Gebauer, director of the interventional radiology department at the Charity Hospital of Berlin.
Welcome, Professor Gebauer.
Doctor Hernández-Gea, hepatologist at the hepatic hemodynamic unit of the Hospital Clinic in Barcelona. Thanks for accepting our invite [Dr Hernández-Gea].
And then Dr. Rampoldi, director of the interventional radiology department at Niguarda hospital in Milan. Thank you for being here, Dr. Rampoldi.
I hand over to our moderators, and we can kick off this webcast. And thanks again to everyone.
2:33 Dr. David Patch
Thanks very much, Mateo.
So as they said, my name is Dave Patch. I’m a hepatologist.
We’ve got three great speakers: two radiologists and a hepatologist. It’s an important subject, this, because it actually has significant service implications and how one sets up a service.
The success of these sort of webinars is very much dependent on audience participation. And as we say in the army, there’s no such thing as a stupid question. So don’t hold back. Please ask your questions in the chat room and we’ll forward those and share them.
And that’s how we learn from these things. So on that note, I’m going to hand over to Professor van Delden.
FIRST PRESENTATION
3:21 Prof. Otto M. van Delden
Thank you very much David, for doing the kickoff. And I’d like to thank Cook for inviting us all to this very exciting topic called TIPS Intervention: the earlier the better.
Well, actually, without further ado, I’d like to introduce the first speaker, is a pleasure for me to introduce Professor Bernhard Gebauer, who is an interventional radiologist from the University of Charité in Berlin, Germany. He’s a well-known interventional radiologist, and if you go to meetings such as CIRSE or other CIRSE-organized meetings regularly, you may have heard him lecture before on a variety of topics, but one of his specialties is portal hypertension and TIPS interventions.
So Bernhard, please lead us through evidence and literature.
4:10 Prof. Bernhard Gebauer
Dear Otto, thank you very much for the introduction, and thank you very much for the invitation.
So, my topic is here to introduce the evidence and current literature.
So, these are my financial disclosures. I promise you nothing of that influenced my talk.
So what are the objectives I would like to cover? First of all, to provide an update of the latest evident– evidence and literature on early adoption of TIPS in case of refractory variceal bleeding and which limitation are there in the studies and what will be necessary to investigate in the future. And to understand pre-TIPS real-life application at the moment.
So, the pre-emptive TIPS, or early TIPS, in acute variceal bleeding, that concept was first mentioned in 2004, and here it was that within 72 hours of, after diagnostic endoscopy in acute variceal bleeding in hemodynamically stable patients. These patients should undergo. The aim is to provide TIPS implantation within this 72 hours.
And what if you attempt an early TIPS in these patients because these patients are in a high risk of recurrent bleeding, and if you tried to implant TIPS under emergency conditions, then it might be very difficult to get a successful TIPS implantation in these patients. That’s the reason why early TIPS should [be] preferred in these patients.
So, the first study investigating that patients with acute variceal bleeding, they had a single session of endoscopy with sclerotherapy that was state-of-the-art by– in these times. These patients undergone invasive measurement of the hepatic venous pressure gradient between the portal– the wedged and free venous pressures, and if it is below 20 mmHg they were considered low risk. Patients with increased pressure gradient [above 20 mmHg] were added to the study. And then there was an randomization in the group without an TIPS implantation and with an TIPS implantation.
And the results were, if you look at the result chart, then failure of treatment, acute bleeding or failure to stop early rebleeds in this paper fall in early TIPS. The early TIPS was the last column here on the right. You see that, I start from the first, that was failure of treatment, it was better than in the patient cohort without an early TIPS.
Acute failure was better. Early rebleed was, of course, better. Even in-patient, in-hospital mortality was better, and [we will] discuss that a little bit later.
A risk where you always discuss if you should implant an TIPS in these patients was the same in both groups.
So, next slide.
So, the critical issues were suboptimal. Or what was discussed in that study was that in sclerotherapy used and not banding therapy, which is a little bit more advanced bleeding controlling in endoscopy, and of course because there the data was rather old, it was only bare metal stents and not stent grafts used.
And other study, they looked at either randomized to either band or a TIPS implantation. And if you then go to the results, you see that even, you know, if you look at freedom from uncontrolled bleeding or rebleeding and survival. Both of them, if you look at freedom from uncontrolled bleeding or rebleeding and survival. Both of it was better with an early TIPS implantation compared to drugs and endoscopic banding ligation therapies.
The high-risk definition that was used in this study was acute variceal bleeding and patients with an Child B or Child C up to 13 points.
There were a lot of other studies looking at this topic with early TIPS in acute variceal bleeding. You see an overview of the studies. If you then analyze the studies, then not all studies could confirm that early TIPS increase survival, as we seen in the last study, but most of them could confirm that.
That what was shown a lot of studies that there are logistic problems to perform TIPS within 24 hours or even 72 hours after a first bleeding.
That’s a topic we don’t– we discover sometimes as well. So, we see a lot of referrals from other clinics, even experienced clinics where a lot of TIPS are placed. But if you’ll see then the time before Christmas or Easter, we get a lot of referrals from these clinics because they have sometimes logistical problems around special holiday seasons.
Some other studies show no survival benefit for patients with Child B cirrhosis. We will discuss that a little bit later, as well, but there is a benefit for Child C cirrhosis.
Studies could show that there is not a difference between viral and alcohol cirrhosis, and there are other risk factors like Child-Pugh above 14 and bilirubin above 4.7 [mg/dL] that are risk factors for reduced survival. So, probably be careful in placing an early TIPS in these patients.
Acute liver failure: Early TIPS significantly increases the survival. An early encephalopathy within one year, early hepatic encephalopathy within one year, in preemptive TIPS is more frequent, but no difference in long-term [hepatic encephalopathy] in these patients.
Another, I think important question, is to discuss in which patients an early TIPS might be a benefit and what are the risks for patients. You always have to balance between hepato encephalopathy of hepatic liver deterioration after TIPS implantation, and there is one index for example that was investigated or published in this year, so-called Freiburg index, where you try to predict the outcome of patients after TIPS implementation. And it’s a very complicated formula (a little bit like the MELD formula you see above the complete formula) but it showed in very large cohort of patients that it could predict the survival after TIPS implantation quite well.
12:55 Prof. Bernhard Gebauer continues
TIPS and survival and the TIPS size. That is a very important question that– to raise. You know that most of the TIPS we implanted in the past had 10 millimeters in diameter, and this study now looked at the survival in patients of 8 millimeter stent graft versus a 10 millimeter stent graft. And it could be shown that patients with a smaller TIPS have a better survival compared to patients with a larger TIPS size.
So, the tendency nowadays goes a little bit more to implant smaller TIPS instead of large diameter stent grafts. And there are, of course, other publications going in the same direction, as I mentioned before. And interestingly enough, it could be shown that patient benefit from a variceal embolization using glue instead of coils.
An interesting topic I’ve seen in Hanover was that they implant TIPS together within a very small diameter stent they placed before that has only 6 millimeter in diameter. It is red here. And this one is bending the TIPS stent graft. And so, it will reduce the flow. That’s a very interesting topic: to reduce the TIPS flow right after implantation.
So, thank you very much for your attention, and probably we could go now into the discussion.
15:03 Prof. Otto M. van Delden
Well, thank you very much, Professor Gebauer, for that was a wonderful talk. We enjoyed that. Very informative. Lots of data and statistics there. I’m sure there’s lots of questions.
I’ll just kick off with the first question, which is a question that comes up on the screen. You talked about TIPS size. You said how we used to put in 8 or 10 millimeter TIPS. Now we’re sort of tending towards using smaller ones. So, at this current moment, what were your first choice? Would you go for the controlled expansion stent and then put in and leave it at 8? Or do you start even smaller?
15:53 Prof. Bernhard Gebauer
No, actually, at the moment, we use the controlled expansion stent graft and only to 8 millimeters, but I’ve had a look at the literature. There is not so much randomized studies comparing these new controlled expansion stent grafts.
16:18 Prof. Otto M. van Delden
The other speakers? Would starting out with 8 millimeters stent and then deciding later where you’re going to go and dilate to 10. Would that be your strategy or what is your strategy?
16:36 Dr. Antonio Rampoldi
My personal strategy is sometimes to start dilating the TIPS just to 6 millimeters, but in case of patient with recurrent ascites and then to expand to 8, if necessary. But in the last years, we start with the dilatation of the TIPS maximum to 6–7 millimeters at the beginning.
17:09 Prof. Otto M. van Delden
Okay.
17:10 Dr. Virginia Hernández-Gea
Yeah, so–
17:10 Prof. Otto M. van Delden
Dr. Hernández-Gea would this be your advice as well?
17:16 Dr. Virginia Hernández-Gea
Yes, I share the same concept, and I would say that we have to reduce the GPP the minimum necessary, so especially the patient, it’s a refractory ascites is one. We know that a small reduction in the gradient are enough to maintain the patient away from the hospital.
Probably in the setting of variceal bleeding, I sometimes dilating with a 6 millimeter balloon is not enough, but I will do always in a stepwise manner, starting from 6, then 8, and if we need a pressure that’s not go down, go for 10.
17:58 Prof. Otto M. van Delden
Okay. So now that we talk about pressures, what gradients do you aim for? What will be an ideal gradient for bleeding patients and ascites patients? [laughter from the group]
18:10 Dr. David Patch
How long have you got? So, the only other thing I’d add is in the Budd-Chiari, I’ll take a stent up to 10. So, I think for the Budd-Chiari patients, I think they need a good flow.
18:28 Dr. Antonio Rampoldi
From our experience, the gradient, above all for patients with refractory ascites, is not important in the end. It’s important only to have flow and to small diameter of TIPS. It’s different, the question when we consider patient with bleeding. In this case, a 12 millimeter of pressure gradient continue to have importance.
19:05 Prof. Otto M. van Delden
Thanks. Uh, David, you had a question on general anesthetic versus sedation?
19:11 Dr. David Patch
Yes, I guess that was a– is a question about people’s practice.
19:19 [multiple people speaking]
19:22 Dr. Antonio Rampoldi
In my hospital, general anesthesia.
19:26 Prof. Otto M. van Delden
Others?
19:27 Dr. Antonio Rampoldi
My first experiencing in the past was sedation, but now, from last years, general anesthesia.
19:37 Prof. Otto M. van Delden
Other speakers?
19:40 Dr. Virginia Hernández-Gea
Okay. So, I think so. We have been most of the– a long time doing this sedation with remifentanil and propofol only, but I think I think that if the patient is a complicated one, it’s a complicated TIPS, you would be– I would prefer to intubate the patient and do it under general anesthesia and now it’s our policy. Like most of the time we do that with, with the patient intubated.
20:13 [multiple people talking]
20:14 Dr. David Patch
I think it improves the success rate.
20:18 Prof. Otto M. van Delden
On a personal note, I’ve been doing TIPS under general anesthesia for a very long time, and I’ve changed to doing deep sedation a few years ago. And I like both. I think for me it doesn’t make a lot of difference, but I think depending on you know what your practice is and how easy it is to get general anesthetic or deep sedation, I think both could be used. I think that’s my experience.
What do people feel about the pressure measurements? One of the arguments that the proponents of deep sedation use is that you cannot get proper gradients because patients who are ventilated, you’ll have– they’ll have abnormal central venous pressure. You know, difficult to get an appropriate gradient measurement for your portal hypertension.
Do you think this is a problem or this is something that we can ignore?
21:11 Dr. Antonio Rampoldi
Could be. But we control, again, the pressure before discharge the patient, in the patient, just in the local anesthesia, we go inside again and we measure the pressure later. The day after or two day after.
21:33 Prof. Otto M. van Delden
Okay. There is a question on–
21:35 Dr. Virginia Hernández-Gea
If I may add something. So, I think that the impact of sedation in the pressure measurement is a fact, and it’s, they really interfere. So, what we do is, in the day of the TIPS placement, we are minimally aggressive as possible. So, we need not dilating as much the stent, and read measure once that the patient is stable without intubation, without vasoactive drugs. And then we measure again the pressure in this hemodynamically stable conditions. And then, in my opinion, this is the day where you have to adjust and if you need to dilate more these TIPS, because this is the pressure that will maintain over the follow up.
22:29 Prof. Otto M. van Delden
Okay, so it’s used in like a second session, when the patient stabilized.
22:33 Dr. Virginia Hernández-Gea
Exactly.
22:35 Prof. Otto M. van Delden
Okay, is it like a couple of days after the initial TIPS procedure?
22:39 Dr. Virginia Hernández-Gea
It can be, you know, if the patient was just intubated and under general anesthesia to do the TIPS, and you can extubate the patient the day after and it’s hemodynamically stable. I would do that in 24 hours. If the patient is still intubated because it has a pneumonia or whatever, I will wait until the patient is totally awake and without any supportive drug treatment. Can be like 3–4 days, but let’s say the first day that the patient is stable.
23:14 Prof. Otto M. van Delden
Any other comments on this? David?
23:19 Dr. David Patch
I have to say we don’t do that. We discharge the patient, you know, if the TIPS for ascites, they’re home the next day. But there are a couple of other questions, actually.
Is there a cut off in Child-Pugh score? We don’t want to select. Can I share that with the panelists? What do you, how would you answer that one? Is there a Child score that you won’t do a TIPS?
23:45 Dr. Virginia Hernández-Gea
Well, I think that we have data coming from France evaluating patients with Child more than 14, meaning 14 or 15. Where if you place a TIPS and then you rapidly go for liver transplant, you can improve survival, and even if they had only a small number of patients, the numbers were pretty good.
So I would say that if you do not have this option, after they have a liver transplant coming right away, I will go for TIPS because it’s for time. Continuity rate is very high, but if you have this option you may go for TIPS, stop the bleeding, and go for liver transplant in 14 and 15 points.
24:34 Dr. David Patch
I’d agree with that. I think there is a selection of those very sick ACLFs [acute chronic liver failure] who TIPS might just control that bleeding, but they need to then be, as you say, going to transplantation. So, actually, that will be the minority.
24:51 Prof. Otto M. van Delden
There is a question on the role of embolization as a add on. On a personal level, I’ve usually thought that lowering the pressure is more important than actually embolizing. But there’s also literature that states that survival goes up when you embolize varices.
How do the faculty feel about this? Doctor Rampoldi and Doctor Hernández? Do you routinely use embolization?
25:18 Dr. Antonio Rampoldi
Yes, we perform embolization in two cases. First case, in case of emergency—when the patient is bleeding, and we perform TIPS for bleeding and there are important varices—we embolize.
In the second case, in case of thrombosis, partial thrombosis of the portal trunk to favor the flow in direction of the liver. In this case we embolize the varices, to maintain the patency of the TIPS.
26:01 Prof. Otto M. van Delden
Do you like to use coils or glue or something else?
26:06 Dr. Antonio Rampoldi
Coils and coils. Coils or sometimes plug.
26:15 Prof. Otto M. van Delden
Dr. Hernández, do you feel the same about the indications?
26:18 Dr. Virginia Hernández-Gea
Not really. I wouldn’t do in a routine basis an embolization. I think that, especially if the bleeding is due to esophageal variceal bleeding, lowering the pressure, most of the time, is enough. It’s true that in cases of gastric varices where, after placing the TIPS then you still see a lot of flow going through big gastric collaterals. And then I would go for embolization.
But not in a routine basis. Just case by case and after placing the TIPS, evaluating how the collaterals, how the TIPS compresses the collaterals.
27:11 Prof. Otto M. van Delden
Thanks.
David, I suppose that we’re going to go for the last question and then proceed to the next speaker.
You agree with that?
27:21 Dr. David Patch
Yes, I think that sounds good.
There’s a question on coagulopathy problems in cirrhotic patients and cut off INRs [international normalized ratios]. I have my own opinion on that, but that’s– my role is as moderator, not panelist, so, I’ll ask the panelists to comment on that.
27:43 Dr. Virginia Hernández-Gea
So, I think that the most important thing is to understand that the variceal bleeding is related to portal hypertension, not to coagulopathy. There is a term that pathologists, we don’t like it that much. So, I would say that it’s not an INR that can be used as a cut off for not performing the procedure and especially when we don’t really know what does it mean in a cirrhotic patient, but probably the baseline, they have altered INR. So, I think it’s not– we shouldn’t be stick to a cut off.
28:31 Dr. David Patch
Virginia. Virginia, could I ask, do you even give any products?
28:37 Dr. Virginia Hernández-Gea
No, no. Rarely, we rarely correct either INR or platelets. We go– I mean, if you do that in a center of expertise and you do that puncture with ultrasound guidance, I think we cannot recommend a cut off for transfusion or to correct the INR, and this is what the most recent guidelines are showing. We have a very new guideline coming, endorsed by EASL [European Association for the Study of the Liver], saying that there is no cut off that we should use for invasive procedures.
29:28 Prof. Otto M. van Delden
Thanks. I know it’s time. But one last question, because it just came in, I thought it was a good question. “For practical purposes, what do we like to use? Do we use a Child-Pugh score or the MELD score or to select patient for preemptive tips? Or do we use both?”
29:45 Dr. Virginia Hernández-Gea [multiple speakers talking]
We’ll address that in my– I will address that issue in the following talk. [laughter]
29:50 Prof. Otto M. van Delden [multiple speakers talking]
Excellent, okay, let’s abridge to the next talk then. Okay, we’ll discuss that later.
David, do you want to announce next speaker?
SECOND PRESENTATION
29:57 Dr. David Patch
Yes, please. So, that’s a good introduction for me to have the pleasure to invite Virginia Hernández-Gea. Many of you are probably aware. Actually, she is one of the real driving force support portal hypertension not just in Barcelona, not just in Spain, and actually not just in Europe now, but she extending beyond there.
So, her energy and output is phenomenal, and I actually find it quite embarrassing, because I’m always late with my work and she’s always bang on time. So, it’s an absolute delight to invite her to speak.
So, Virginia, please, over to you.
30:36 Dr. Virginia Hernández-Gea
Thank you very much for the nice presentation, and thanks for the invitation.
It’s a pleasure to be here with you, even if I’m an hepatologist, and this is a more radiological field.
So, I first want to give you a few words of what’s the role of TIPS in patients with variceal bleeding. So, I want to remember that there is no indication for TIPS as a primary prophylaxis treatment. And then we have in the patient with acute variceal bleeding, we have two different scenarios.
One is the scenario where we really want to stop the bleeding, and this is when we do the TIPS with this, this is a rescue TIPS, but when we stabilize the patient and we want to prevent failure of the bleeding because we know that these patients are high-risk patient, then is when we call that TIPS pre-emptive TIPS. And of course, if we have a patient like bleeding and bleeding and coming once and again with several bleeding episodes and we want to stop that, this is also a rescue TIPS that we can plan and putting in a non-emergent scenario.
So, this is usually the case when we are placing a salvage or a rescue TIPS. This is the kind of patients that we have intubated with a lot of drug support and sometimes with a Sengstaken-Blakemore balloon.
So, this is a place that that we put in a patient with a massive or uncontrolled bleeding or a patient [who] experienced failure, and most of the time we place the TIPS after a bridge therapy, either balloon tamponade or esophageal stent. So, this is a very critical scenario where the mortality is very high.
Can we really select a futility? We spoke before about futility, and we have this recent paper coming from France and Spain saying that in the setting of rescue TIPS, those patients with high lactate levels equal or more than 12 or a MELD score equal or more than 30, the mortality here is very, very high and we should consider them futile and probably we should concentrate in the other group of patients because, here, no matter what we do, mortality is pretty high.
This is different than the pre-emptive or early patient scenario where we have the patient, we do everything. We have to do general management, we do hemostatic treatment with endoscopy. We place bands, we start with vasoactive drugs, we control the bleeding.
But we know that 20% of these patients, they will experience failure to control bleeding or early re-bleeding, and they may end up needing a rescue TIPS.
So, can we do something to identify this population with high risk of bad outcome to do something else and prevent the re-bleeding or the failure? And this is the concept of the pre-emptive TIPS.
So, these TIPS are TIPS that we will place in a high-risk patient, but after stabilizing the patient, after the treatment with vasoactive drugs and EBL and before the failure arise. And it has been called, even if I like better the word “pre-emptive,” it has been called “early” because we have to place the TIPS as early as possible. And this is important because if we look at the data coming from now, this landmark study from the ’80s, we see that the re-bleeding and the mortality really concentrates in the first three days, especially in the 24–48 hours.
So, if we place a TIPS with the aim of preventing the re-bleeding, preventing failure, and increasing mortality, we have to put that as soon as possible because we will prevent more cases if we do that as soon as possible. [EDITORIAL NOTE: “increasing” in the preceding sentence was misspoken. The speaker meant to say “decreasing.”]
And the same thing happened in the most recent studies, and this is the individual meta-analysis that we have published recently in Gastroenterology, where we could also see that the mortality and also the re-bleeding occurs at the beginning in the first days.
35:30 Dr. Virginia Hernández-Gea continues
How do we select patients even if there are different factors that can help us to identify patients with high risk? The only two scores that can help us in guiding treatment are the HVPG more than 20 or clinical criteria. That’s the combination of the Child-Pugh classification and active bleeding at the initial endoscopy, and in my opinion, those are the criteria we should follow to identify patients at risk and place pre-emptive TIPS because those are the ones that we can refer in the literature.
We have different studies now, randomized clinical trials and observational studies. And the first one there is from Monescillo is the only one using hemodynamic criteria. All the other papers use a clinical criteria, and I think this is the most easy way to identify patients as high risk, and everyone can do that in our hospitals. So I could go for a clinical criteria better, and we know that the high-risk population concentrates in those patients with Child-Pugh less than 14 points or B plus active bleeding at the endoscopy because we have data from the Chinese trials showing that the Child B without active bleeding, they do not really benefit.
But all the patients, the C and the B patients, do they benefit the same way? And we have in this recent meta-analysis evaluating most of the trials available so far in the setting of pre-emptive TIPS.
So when that the impact that we have in mortality occurs in the two groups of patients in Child C less than 14 and in Child B with active bleeding at endoscopy.
However, if you look at the Kaplan Meier curves you could see as in Child B, the curves are not as widely separated as the Child C.
And we were very curious to know what is going on in the Child B population because we have been wondering in the last years, whether these patients, they really benefit or not, for TIPS placement. And as you can see here, we could detect that those patients, a Child B more than 7 points, are the patients who really have the benefit in survival. So, now we should stratify patients and go for Child B more than 7 points with active bleeding to place the TIPS.
38:25 Dr. Virginia Hernández-Gea continues
Another important point is where should we place the TIPS, and then I like this American study evaluating more than 5,000 patients, where you can see how the mortality is correlated with a number of TIPS that you place at your institution and how hospitals placing more than 20 TIPS per year, they have lower mortality. So, in my opinion, I think that they have to be performed in centers of expertise.
And if you, in your centers, you are not placing a lot of TIPS and only like placing two or three TIPS, it is probably the best thing for the patient is to refer the patient to a center of expertise.
39:15 Dr. Virginia Hernández-Gea continues
And I want to end up by giving a few technical consideration, because if we want to be successful with the TIPS we have and most of the time, our patients are also candidates for liver transplant, we should not jeopardize the liver transplant procedure. So, it’s important to place the covered stent in the right position, and in the right position means that the covered part must begin at the entrance of the portal vein and having the 2 cm uncovered, there, after the entrance in the liver to allow perfusion of the intrahepatic portal branches and then the covered part has to cover the confluence between the hepatic vein and the inferior vena cava. Because if we are not doing so, this is the most frequent place of dysfunction.
We have been speaking a lot about pressure measurement before, and here it is, a graphical way of showing you how a sedation can impact in your measurement. And as you can see in the first graph, it’s sometimes very difficult to end up with a value of pressure when you have a big oxidations in the patient intubated and you cannot really rely on this measurement. And this is why having a measurement before discharging the patient, once that the patient is not under general anesthesia and intubation, it’s way more accurate. And if we do that in a more in a stable hemodynamic conditions, we know that PPG less than 12 is able to predict outcome during follow up and in the patient and this should be our target.
Following up the patient: it’s really important and to get the success that we really want. So, we have to monitor the patient closely after placing the TIPS, and what we do in Barcelona is that we place the TIPS, we adjust the measurement, and then one month later, when the patient is hemodynamically stable and at home, we do an hemodynamic relation together with an ultrasound to have basal levels of the flow in the portal vein and inside the TIPS. And we will consider this as a basal measurement, and every six months we will do an ultrasound to see if we have same values that in baseline, and if we see that the velocity in the portal vein is below 28 if it’s a fugal flow or below 39 if it’s petal, then this can be considered as a sign of dysfunction and then we will do hemodynamic relation to make sure that everything is okay for the TIPS, and if not, we can adjust or dilate or re-stent or whatever the TIPS needs.
And that’s everything. I will be happy to take more questions. And thank you for your attention. And also I would like to thank my group in Barcelona, because placing a TIPS will be a multi-disciplinary procedure.
Thank you.
42:01 Dr. David Patch
Right, Virginia, I’m going to ask you some questions for my input.
Do you think that the data is now definitive, or you think that after the Scottish study that actually there is still need for further trials with bigger numbers?
43:19 Dr. Virginia Hernández-Gea
I think that we have a lot of evidence showing an increase in survival, and we have data coming from the East and data coming from West, a big number of patients now analyze in the individual meta-Analysis. And I think it should be enough to recommend a pre-emptive TIPS in this clinical scenario. I know during the Scottish trial they couldn’t see benefits in survival, but I think that there are also a few methodological drawbacks in this study. Especially that they did randomization not immediately. And if I show you in the graphs coming from the study from Smith and Graham, this is critical and probably you are like missing patients. If you do randomization within the 24 hours and a couple of things more in this copy trial, that may explain why they do not see a benefit in survival. But I think that not, we do a lot of things in medicine without the evidence that we have for the pre-emptive TIPS. And I think that the data like very, very strong and I think we should really recommend and we should convince mainly the pathologists, because sometimes I’ll meet pathologists who are not referring the patient to the interventional cardiologist. Probably because it’s always complicated, or sometimes complicated, to convince the other is that this is an emerging procedure that can—that should—go with the same, how do you say, the same importance that other vascular procedures.
45:20 Dr. David Patch
Just, I was going to ask you question, is the accessibility, and this is really for the whole panel, accessibility of TIPS at the weekend? So, for all three of you, are you able to provide a genuine 24/7 service?
45:40 Dr. Antonio Rampoldi
We are on call, as the international ideologist for 24 hours a day and the entire year.
Also, because Niguarda is a trauma center, so, we have to treat the patient with trauma and also we are able to perform TIPS every time.
46:05 Prof. Otto M. van Delden
Do all interventional radiologists in your group, do they all perform TIPS?
46:12 Dr. Antonio Rampoldi
We are six. Also the younger, the new entry, are able to perform sometimes with the presence of me or another older people who is more experienced. But the great part, quite the entire 100% of my team is able to perform TIPS.
The problem is the second operator for guide that during the night and during the weekend. Sometimes we have the help of the radiologist to do echo guide.
47:13 Prof. Otto M. van Delden
Yes, I was going to say we have the same. We like to have one operator on the head end and one doing ultrasound. And if you do a case on the weekend, you end up just phoning around trying to find someone who’s going to do the other part, because of one on call.
But I suppose you have the same problems in Milan.
How is that in Spain? Do you have? I mean, Barcelona is a big city. But it’s also a big country. I suppose not all rural hospitals do this. So, you get a lot of referrals from outside I suppose?
47:50 Dr. Virginia Hernández-Gea
Yeah. So, it’s the case, and I think that only big hospitals, they do have interventional radiologists on call over the weekend. So, and for the others it’s referral. So, in my institution it’s even more complicated because we are a pathologist performing the TIPS and we, usually, we are not on call over the weekend for TIPS placement at most of the time. It’s like, well, they call you on the phone and then you arrange everything to come to the hospital and to do that, and we try to cover weekends and vacations to be able to coordinate everything just in case we have a patient or the referral. But it’s true that we need like more policies to really organize that in the territory, and then we have to learn from the cardiologists and the neurologist that they really do that and they really have the circuit to do the procedures.
48:53 Prof. Bernhard Gebauer
So, in Berlin we have a 24-hour service of course, and on the weekends as well. We place a lot of TIPS, as I said, even on holidays or so where other clinics probably have problems to have a 24-hour service. And as you said before, on rural areas or in areas where you know the population is lower, of course, it’s like in the other countries, so the experience not so broad. But in the Charité we can offer it 24, on seven days a week, and we always have a senior interventional radiologist who has more than 20 TIPS procedures successfully placed, and we have a junior interventional radiologist and that one is usually assisting during the echo.
49:49 Prof. Otto M. van Delden
Okay. Thanks.
Yeah, I don’t know about the UK situation. At least the Netherlands, we are tiny country, so we only have seven centers that actually do TIPS, but we are such a small country that you’re never more than one hour away from a TIPS center wherever you are. So that’s the luck we have, I know from my contacts in the UK that it’s also difficult to get quick access to TIPS in some areas.
Is that correct?
50:31 Dr. David Patch
I think it is, yes. I think there is a variation in practice depending on your locality to a hospital, so there’ll be some hospitals which will deliver a 5/7 TIPS service or a 3/7 TIPS service, and a lot of the hospitals which will deliver 24/7 TIPS service. And these are quite important aspects in terms of delivery of care, etc.
One of the questions has been about sarcopenia and its impact on TIPS. I think my own personal practice is sometimes it’s almost an indication for TIPS when patients are very sarcopenic with ascites and they can actually have quite good outcomes longer term. But, again, for the panelists, and particularly Virginia, I think we would agree it’s a risk factor for a poorer outcome, isn’t it?
51:17 Dr. Virginia Hernández-Gea
Yeah. And I think we have more and more data showing this, and probably interventions to try and correct that before placing the TIPS is the future. Of course, when you have an emergency TIPS in a bleeding patients, you do not have time to prepare the patient for the TIPS. Now, but in those patients with refractory ascites, probably like interventions aim to improve the nutritional status and the sarcopenia, could be the future of TIPS, also improving the outcome and rates of encephalopathy and so on. So, it’s a very important point.
51:58 Dr. David Patch [multiple speakers talking at first]
I think it’s actually quite interesting, because I think–
Sorry. Go on, but I just comment on the TIPS for ascites, TIPS for ascites, you see, a lot of the time they’re sarcopenic because of the ascites. And so actually attempts to get to improve their sarcopenia are actually just delaying things, when actually you need a TIPS in order for them to eat and then exercise and build up their muscle. And the trouble is, you’re then dealing with the fact that you haven’t got muscle, and you’ve got more risk of encephalopathy. It’s a really complex problem, isn’t it?
52:32 Dr. Virginia Hernández-Gea
Yeah. And I think that especially for ascites, we should think about TIPS, once that the patient got the first paracentesis, right? And we should start like anticipating, and if once that the ascites this is a refractory ascites, we shouldn’t end at like one year. Say once the patient has three total volume paracentesis, this is the right time to go for TIPS and to start considering and start thinking.
Because if we wait too much, yes, of course, the patient’s going to be sarcopenic and bad nutritional status and, and you don’t want to be at that clinical scenario, yes.
53:18 Dr. David Patch
100% agree in the way it’s like early TIPS for bleeding. You know the definitions of diuretic ascites actually almost predefined a fairly sarcopenic patient, doesn’t it? So, we actually need to be thinking about early TIPS for ascites as well as bleeding. I think you’re absolutely right in that respect.
53:35 Dr. Virginia Hernández-Gea
Exactly.
53:37 Dr. David Patch
Some, someone’s just asking is TIPS a good option in patients with antiphospholipid syndrome. And the only thing I would say is, yes, but don’t give them a NOAC [new oral anticoagulants]. That patient is going to have to be on warfarin. So NOAC that would be contraindicated in that patient.
53:57 Dr. Virginia Hernández-Gea
Yes. So, I think, yes, it is a good treatment for, for Budd-Chiari, especially for Budd-Chiari. If you cannot manage that with anticoagulation. But before going for TIPS, make sure that you spoke with your hematologist. If the patient has a myeloproliferative disorder, is well treated, is very good anticoagulated, and then once you are placing the TIPS, they have, like really high thrombotic risk. So once that you place the stent, you should start with heparin right away, during the procedure just to prevent thrombosis of the stent. So those are like really critical points in these patients.
54:38 Prof. Otto M. van Delden
Can I ask you? I know we only have a couple of minutes left before the last speaker, but can I just, you touched upon the topic of duplex ultrasound follow up. Again, here I’m a moderator, so I’m not going to express my opinion. I’m just going to say the data that we’ve found in our own center, we’ve looked at 100 or so patients in retrospect and looked at the outcomes of the follow-up duplex ultrasound. What we found, particularly in ascites patients is that the yield isn’t very high, meaning that, you know, the patient has TIPS dysfunction, they present with re-accumulation of ascites or a edema thing. So, and you’ll probably find these before they occlude. So, do you think in ascites population you could just do away with these duplex ultrasounds and just follow them as the yield of ultrasound is so low? I wouldn’t– it could be different for the bleeding population because you don’t want a patient to present with a re-bleed, but in terms of ascites patients. What are your feelings on this?
55:41 Dr. Virginia Hernández-Gea
Yeah. So, I really think that there are like two different patients, and when you place a TIPS in a patient with refractory ascites, what I’m always telling the physician in charge and also the patient is that it will take a few months to control the, the ascites, right?
Because it’s not like the bleeding the effect is not right away after TIPS placement, so they require a very close follow up. And even during the first months we will schedule a visit like at 15 days after TIPS and then one month after, to adjust the diuretics and adjust everything, because they still have these ascites and you need these clinical close follow up. It’s not only about the pressure or not only about the ultrasound flow velocity.
So, yes, I agree that it’s important to follow them up and be adjusting the diuretics not to be the dehydrated, but also start like reducing the diuretics they were taking before. And in this case, this is most important than the velocity ultrasound.
57:00 Prof. Otto M. van Delden
Yeah. I was going to add a remark. We wanted to do away with all these ultrasounds, but as David pointed out already, is one of his, his messages is that we’re going to see these patients anyhow, because they’re all going to be in an HCC ultrasound screening program. And so, we end up seeing them anyway. So, it doesn’t make much difference whether you add on or leave out the duplex part of the ultrasound because you’re going to see them anyway in outpatient clinic.
David, do you think should we proceed to the next speaker?
57:30 Dr. David Patch
Yep, good idea.
THIRD PRESENTATION
57:31 Prof. Otto M. van Delden
Okay. So the next speaker is Doctor Rampoldi, well-known, expert IR in the topic of portal hypertension from Milan, Italy. And he’s going to talk about implementation, facility protocols, and IR success requirements.
57:54 Dr. Antonio Rampoldi
Good afternoon to everybody. Thank you very much for the kind invitation. My topic is about how you can do the earlier, the better TIPS intervention. But my first question is “When?”
The earlier, the better, for acute variceal bleeding, recurrent ascites, acute Budd-Chiari syndrome, and also acute portal vein thrombosis.
We have already heard about the efficacy of early TIPS in a subgroup of a patient with bleeding Child C, Child B with the difference we had already heard. And the literature indicates us also that ascites controlled by TIPS is more successful in case of patient with low frequency of paracentesis. And this one, this TIPS is also associated with improved survival.
But also in the Budd-Chiari syndrome—‚in symptomatic acute Budd-Chiari syndrome—TIPS reduce the requirement for liver transplantation.
Last, but not least, above all, in this period, when we have observed a lot of cases of portal vein thrombosis related with the COVID virus and unfortunately with few but severe complication of the vaccine. TIPS is very important in the treatment of acute portal vein thrombosis.
But what we need to have a good results? We need for sure, a dedicated team, and the team is done by interventional radiologist, minimum two. Anesthesiologist. We have involved in the intervention the hepatologist, nurses, and the radiographers.
But what we need? The team must perform some things in correct way. For example, the team must create the TIPS with just one puncture with echo guide to avoid the complications.
Must calibrate in good way the intrahepatic shunt, when needed, because the team must know that would overload on the right part of the heart at the time of a TIPS could be dangerous.
And also the importance, we have already discussed about this, the importance sometimes of embolization of gastric varices.
And also the difficulties, in case of the Budd-Chiari syndrome, because the starting point is sometimes the wall of the vena cava without stump of suprahepatic vein.
Again: skills to recanalize a complete portal vein thrombosis. And again, last but not least,, the skill to recanalize the portal trunk, sometimes through splenic access.
1:02:18 Dr. Antonio Rampoldi continues
What about quality assessment?
A center which performs TIPS must, in my opinion, perform a minimum of 40 TIPS a year. It must have a high percentage of technical success. Echo guide is mandatory. And the involvement of the hepatologist inside the TIPS team, it’s for me absolutely necessary to obtain the best clinical success that would choose the current calibration of a TIPS to avoid hepatic and cardiac failure.
How is our organization in Niguarda?
The team is done by an hepatologist, and interventional radiologist does the periodical internal meeting with gastroenterologist and surgeon. And there is an involvement of a general practitioner and the hepatologist and gastroenterologist of the hospital of the region to share clinical data and new guidelines. We utilize a sort of network hub and spoke, where the hepatologist is the reference clinician, and we add the interventional radiologists, validate the feasibility of treatment after imaging visualization.
My final key point. What we need to do to increase the number of TIPS placed earlier?
We need culture because we have to know the current indication of TIPS. We need skill. We need the organization, and we need the centralization.
Thank you for your attention.
1:04:44 Prof. Otto M. van Delden
Thank you very much, Doctor Rampoldi. It was a very interesting talk. Thank you very much.
Lot of questions that come to mind. The first that I see on the screen is anti-coagulation after TIPS.
Could you? If yes, which drug and how long? I suppose it’s a question to all speakers.
1:05:07 Dr. Antonio Rampoldi
Depends on the indication. As Dr. Hernández told before, in case Budd-Chiari, it’s important to do anti-coagulation, for sure. In case of bleeding, in case of ascites after procedure, normally we don’t do anti-coagulation. In case of the portal thrombosis, we open up the TIPS, and then we perform thrombolysis, echo guided, low dose of RTPA.
And anti-coagulation, 15,000 unit of heparin each 24 hours to avoid the peri-catheter thrombosis.
1:06:09 Prof. Otto M. van Delden
Okay. Thanks. Now that you’re talking about thrombolysis, do you only use thrombolysis for portal vein thrombosis, or do you use thrombectomy or thrombo-suction or something to get out clot before you start lysing? Or do you usually just put in the catheter and start lysing?
1:06:31 Dr. Antonio Rampoldi
Well, actually, we use thrombolysis with echo assisted, because maximum, we inject the 20 milligram of RTPA, and the risk of bleeding is really very low.
1:06:51 Dr. David Patch
My experience of the AZ vaccine due thrombosis patients, was that actually their platelet counts were sort of five or six. So, thrombolysis initially and particularly if they also had intracranial sinus thrombosis. They’re quite a difficult group of patients and initially we couldn’t use TPA until their platelet counts were higher. So, we were using a lot of mechanical thrombolysis. So Angio Jet, we were using balloons. We were using pigtail catheters, etc., etc., etc. We were just using anything that we had in the cupboard for some of these patients. They’re not straightforward.
The other thing with the TIPS for portal vein thrombosis I’ve found is that if you’ve got a short segment of portal vein thrombosis, these are quite easy. But when they’re acute and they’ve blocked off not just the main trunk, but all the way down there, SMV and IMV. SMV is the most important vessel, but you need to get flow distal, sorry, proximal in the SMV, and that can be really hard. So, we’ll use systemic TPA, fountain catheters with TPA, again Angio Jet, etc. I think there’s no clear one device which works best in my experience.
1:08:21 Dr. Antonio Rampoldi
We have had two cases of total thrombosis of splenic vein, mesenteric vein, and portal vein. Not related to vaccine, but one related to virus, to COVID, and the second one was not clear the origin of the thrombosis. We open up the TIPS just 6, 7 millimeters, and then we place two catheters, one inside the mesenteric vein and the second one in the splenic vein, and for delivery RTPA with echo guide, with echoes, and we obtain in both cases a total reperfusion of this splanchnic venous system.
1:09:23 Prof. Otto M. van Delden
Okay. Thanks. Yeah, I was going to ask the last one on the on the clipboard is “Do you routinely use antibiotic prophylaxis?” Question to all.
1:09:43 Prof. Bernhard Gebauer
So, we don’t use antibiotic prophylaxis during TIPS procedures.
1:09:47 Prof. Otto M. van Delden
OK, you don’t?
1:09:52 Dr. Virginia Hernández-Gea
We always use. We always use antibiotic prophylaxis for a TIPS placement.
1:10:01 Dr. Antonio Rampoldi
We use one shot prophylaxis. We use. We normally use.
1:10:08 Prof. Otto M. van Delden
Okay, so there is some practice variation there. I suppose many of the bleeding patients will already be on, on antibiotics.
There’s a question here. “What are the main obstacles to = overcome before actually implementing early TIPS implementations?” So, what are the drawbacks or problems that we have to face and overcome in practice?
1:10:39 Dr. Antonio Rampoldi
You need to defuse the culture, first of all, in your hospital, and also after outside around your hospital. Is the only way to share your result. And to try to do meetings with colleagues with pathologists, enterologists, general practitioners to share this type of activity.
1:11:16 Dr. Virginia Hernández-Gea
Yeah, I think that the most important thing is probably to convince a hepatologists still, because when you see in the surveys and in the observational studies, we have detected that only 10% of the patients, candidates for early TIPS, they really get the TIPS. And probably it’s because– and the reason, when you ask the people when you ask a hepatologist, “Why are you not placing the TIPS?” They always tell you, “Well, you know, it’s difficult in my hospital. I do not have the service or the radiologists. They won’t do that in 24 or in 72 hours.” So, I think that the most important thing is to convince that it’s a real indication, that it’s something that really improves survival in this population. And no matter if you cannot put that in your center, you still have to indicate the procedure and try to transfer the patient to another hospital, and as you said it, it happens in the Netherlands or in the north countries. It’s the same everywhere, and probably you are one hour driving distance away from a center placing TIPS. So, I think we should work more on training people and showing them that the data that we have where the benefit in survival is very clear if you select very well the patients.
1:12:52 Prof. Otto M. van Delden
A further question– [multiple people talking]
1:12:55 Prof. Bernhard Gebauer
Actually, my– [multiple people talking]
1:12:56 Prof. Otto M. van Delden
Yup, Bernhard.
1:12:59 Prof. Bernhard Gebauer
Sorry, a little delay from my microphone. I totally agree. My personal experience is that sometimes, even if we, or especially if we get referrals from other countries, it takes a little too long until we get the patients.
As Virginia said, it’s probably only one hour driving away. But you have to transport the critically ill patient and that sometimes takes hours and then first he goes to hepatology department. They make a second opinion and then a second check up of the patient, probably. And sometimes they try again to do in a central clinic to do sclerotherapy or a band ligation, and then they call the radiologist for placing a TIPS. And these procedures take quite long. And as we know from stroke therapy, you have to improve or you have to speed things up to give patients a quicker response for interventional treatment.
1:14:03 Dr. David Patch
There’s a, sorry, I’m going to interrupt. There’s a very good question from Erwin here, which is, “What’s the principal cardiological contraindications to TIPS placements?” And, actually, this is something I’m beginning to get a bit more concerned about nowadays, particularly with the sort of NASH [nonalcoholic steatohepatitis] patients with their ascites.
Can I ask the panelists? And I think, Virginia, your opinion here is important. What what’s your feeling?
1:14:31 Dr. Virginia Hernández-Gea
Well, I think that the absolute contraindication is when you have patient with portopulmonary hypertension or with a cardiac decompensation and the patient is symptomatic and, is well, it’s so clear.
Things are not so clear when the patients, when they do not have manifestation, and sometimes we have patients with cirrhotic myocardiopathy that it’s not symptomatic, and then you don’t really know. What I would recommend it’s like in the same procedure you can do, right catheterization, and you can get, at least you can get the pressures, how pressure in the pulmonary artery is and cardiac output to detect any abnormality. Of course, if you can have an echo, it could be also—an echocardiography—it could also help to detect these problems. And with the present data that we have from France, patients with aortic stenosis, we should not place TIPS in those patients. And probably having the BNP [natriuretic peptide tests] or the full BNP may help us to really identify patients at risk of developing cardiac failure during the follow up.
So we should take a moment and evaluate the patient. And trying to really stratify risk, yes, it’s an important thing.
1:16:12 Dr. David Patch
So, one of the questions for the guests is, “Do you perform echocardiography routinely before TIPS?” And I know UK guidelines are that we shouldn’t perform routinely in an elective case, but we do perform a BNP, a natriuretic peptide, and use that as a gatekeeper for echocardiography. I think this is right and kind of makes sense and feels okay for me. The problem for me is actually in the acute bleeders, where they’ve had a lot of fluid resuscitation, and under those circumstances hemodynamics are quite different from their stable states, so these patients may be well filled, sometimes overfilled, and fairly hyperdynamic, etc., etc., and making those assumptions on those patients is quite hard, I think.
1:17:04 Dr. Virginia Hernández-Gea
Yes, yes, it’s a difficult decision that you have to take. This is why, like doing a right catheterization can help you in this setting, and we shouldn’t forget that if we make a mistake and we place a TIPS in our patient that develops refractory complication over follow up, we can always close or recalibrate these TIPS, and this is also something that we usually do not speak about.
But it’s true that if someone is bleeding, you have to stop the bleeding and do whatever you have available to keep the patient alive. And then including follow up, he has problems with cardiac function, we can always think on recalibrating or even closing, closing the TIPS.
1:17:57 Dr. David Patch
So, my experience of closing patients who’ve had cardiac, dysfunctional, cardiac decompensation and you close them, you reduce them and even consider closing them. Some of them seem to have just been pushed over that Starling curve, and actually pulling them back is hard, so, it’s often a lot of work for these patients. It’s not a good outcome, is it?
1:181:18 Dr. Virginia Hernández-Gea
No, no. And definitely we need more studies and better markers to really identifying in this population, with unstable hemodynamic condition likely to be, to stratify the patient, yes, totally agree.
1:18:42 Prof. Otto M. van Delden
We have about one or two more minutes, I suppose. David, do you want to wrap up?
1:18:54 Dr. David Patch
I was just going to ask one question before we do that. What do you think would be like, the next thing is going to alter our TIPS practice going forward? You know, I was thinking about virtual wedge pressures with MRI. Virginia, you’ve hinted at sort of much earlier TIPS in the patients with ascites, which sounds very sensible and logical to me, but for the panelists, what do you think will be the big, big changes for you?
1:19:27 Prof. Bernhard Gebauer
Okay. I personally think that if you are able to integrate the CT data we already have into the into the angiography machine to have an idea where the liver is and where the portal vein is to make the puncture much more easy. I think that would be a big benefit and a big way forward in safe TIPS procedures. And also what, you know, our American colleagues use a lot, they use the ICE on echo that is in the vena cava to see the portal vein. I’ve seen a very good images from that technique, especially if you look at the very obese American patients they usually treat.
1:20:09 Dr. David Patch
I think, on that note of increasing obesity around the world, now is a good time to stop because I have to say, doing TIPS on some of these patients with really fatty liver and you can hardly see the portal vein. It’s just a heart sink for me sometimes, and I’m sure you’ve also experienced that same.
I’m going to wrap up now, if that’s alright, I think.
Thank you to the panelists. Thank you for your contributions and your insightful comments. It’s been really good and if I may, I’ll just hand over to Matteo to bring the proceedings to a close.
1:21:51 Matteo Segoni
Yeah. Thank everyone. I think that this has been a really nice and amazing session. We learned a lot and I want to thank you, then, all our moderators, our speakers, and plus, especially, all the attendees, that’s been your time, you would spend your time for this session, for submitting your question. I hope that most of the questions that you submit have been addressed, and so I hope that this session has been valuable for you.
I thank you again everyone, and I wish you a nice rest of the day.