Minimising Vascular Access Complications in Transcatheter Aortic Valve Implantation

Dr Daniel Blackman, MBChb MD MRCP;  Dr Douglas Muir, MB, ChB, FRCP

Disclosures

June 15, 2018

Dr Daniel Blackman: Hello, my name is Daniel Blackman. I am an interventional cardiologist working in Leeds in the United Kingdom, and I'm here in Paris with Medscape UK.

I’ve got with me my colleague Dougie Muir who’s an interventional cardiologist in the UK from Middlesbrough. We are going to talk this evening about vascular access and complications in TAVI [transcatheter aortic valve implantation].

We’ve got this session tomorrow [May 25th 2018] with the UK and Sweden [Collaboration of the Swedish Working Group on PCI and Valve Intervention and the British Cardiac Intervention Society] looking at vascular access complications. How do you see that, the importance of vascular access complications in TAVI, in general? Is it still an issue today?

Dr Douglas Muir: Yes, it definitely is an issue. And I think as devices have become more sophisticated, the heart end of the procedure becomes more and more predictable. And for me, and for our team, perhaps the most challenging scenarios we encounter are vascular issues, and therefore we think that careful planning and meticulous technique are really important to try and get the best possible outcomes. And we do know from trials that major vascular complications are up to 8 or 9% in some series.[1,2] So, these are not small issues, and they do have a big impact on morbidity and mortality.

Dr Blackman: Now indeed, I mean that's certainly been our experience as well. That’s by far the most common problem we encounter as we've improved at dealing with other things.

But you mentioned pre-procedural planning. What about technique? I think we’ll probably agree that rigorous technique is vital to minimise complications. What do you do in Middlesbrough? What’ s your preferred technique? I know that you have excellent outcomes in terms of vascular morbidity.

Dr Muir: So our approach is quite detailed. We study the CT scans in enormous detail, especially the region of the femoral puncture sites. We’re looking for calcification, especially on the front wall, which might affect your puncture, and more importantly your closure. We’re looking for side branches, we’re looking for bifurcations that are higher than you would like them to be.

Thereafter, we very strongly favour the ultrasound. With a high-quality ultrasound we think you can manage a puncture very carefully. And we also like micropuncture, because even with meticulous technique, with some unfavourable anatomy, larger patients, it’s quite difficult to get your puncture just perfect.

And the micropuncture technique, I think, adds a lot, because when you put the micropuncture sheath in if it’s not quite right there’s very little cost in terms of bleeding risk by just removing it and redoing the puncture.

Dr Blackman: Yeah that’s an excellent tip. It’s not something we’ve used in Leeds. I am a big fan of ultrasound as well.

We still often use the crossover technique. So we’ll take the pigtail catheter around from the contralateral femoral artery, and that gives us a clear bullseye target. We know we can puncture the middle of the anterior wall, we can see side branches. So I think both those techniques are viable, and sometimes you need them in different patients.

Another thing we favour in Leeds, to minimise and enable us to deal with vascular complications, is a protective wire. So we will routinely after using that cross-over technique put a V-18, which as you know is a stiff 018 wire down and leave that down during the procedure and if we have any bleeding, even just minor bleeding, we can quickly get to it. If we have a major problem like an occlusive dissection or a large rupture, we can, we can stabilise things.

I know that you have a slightly, you also use that technique, but with a slight variation?

Dr Muir: Yeah, our variation is really to use the radial artery as our secondary access. And that does have some challenges. Obviously, it’s further away from the area that you’re going to be working on. So, crossing over from the contralateral femoral artery, you are closer to the field of play, if you like.

And so if you are going to use radial techniques, you need to have modified kits. So we have long guide catheters, we use 4-meter, 018’s guide wires, which is analogous to the wire you mentioned.

But we selectively place a wire so if the puncture has been perfect, and we’re very happy with the procedure, we don’t routinely place a wire before we remove the large sheath. But we always have it available, and we have that as our bail-out strategy. So that we, we think we can rescue nearly all vascular complications from the, from the radial, at least in the first instance, to gain haemostasis.

Dr Blackman: And of course, with that technique you avoid placing 7.0 French or a 6.0 French sheath near the femoral artery. We know from our PCI (percutaneous coronary intervention) experience that that’s enough to be a major cause of morbidity. And it’s often the case, even in TAVI, that you can have complications from the small sheath, not the big sheath.

What about closure? I mean that’s obviously the other key part. What’s your technique for vascular closure? What device do you use? Have you got any specific technique that you use for that?

Dr Muir: So right now we use ProGlides. So we use a parallel technique, which has been just described maybe in the last year, where unlike the usual conventional approach where you have a criss-cross effect, where you deploy two devices at 10 o’clock and 2 o’clock, the parallel is a modification of that, so you place both facing upwards to 12 o’clock but you push one to the lateral side of the arteriotomy, and one medial.

There are no hard data on it, but our feeling is that since we started using it we have maybe less requirement for additional devices at the end for closure.

And maybe one theoretical advantage at least is that the sutures do not interfere with one another. There’s a small chance when you’ve got the crisscross technique pulling one suture can interfere with closure on the second. So that’s what we’ve been using now for about a year or so, to quite good effect we think.

Dr Blackman: Yeah, and we’ve seen that, as you say, a new technique, and it will be interesting to see if we can get some data to compare to see if it does have superior outcomes.

We’ve been using in Leeds the MANTA device, which as you know, is one of these new large vessel closure devices. We’re starting to see some alternatives, such as the PerQseal and the ENSEAL, but the MANTA is the one that’s had the most clinical experience, and certainly been positive for us. It’s essentially a collagen plug analogous to the, to the Angio-Seal, but suitable up to 25 French devices. So that offers greater simplicity I think, and certainly our initial experience and the initial data from the CE mark study[3] are that the outcomes and the complications seem to be improved.

The MANTA device is going to have, it’s been through a US trial, and I think we are going to see the results of that at TVT, so that will be the first sense we’ve got as to whether that might be superior to a suture-based device.

Now we talked mainly about femoral and, you know, I think we’re both doing 90 to 95% femoral, but sometimes you can’t go femoral. What’s your chosen non-femoral access route in your centre?

Dr Muir: Well we’re probably in a period of transition right now between, our previous second choice was direct aortic, which we have a lot experience of. Surgeons are very comfortable with it. It’s very good. But does require some type of sternotomy or chest incision at any rate, which has some implications for some patients, especially if they have lung disease in particular.

So we’re moving towards subclavian when the patients are suitable. There’s no ideal device for this. In our armamentarium, we use S3s or dominant devices, not really designed for that access. Maybe the new iteration, the S3 Ultra might give some advantages in that respect, although that would be off-label currently.

But we’re moving towards subclavian approach, and we’re very intrigued by other countries’ experience of using local anaesthesia for access, and that’s something we’re about to start imminently.

Dr Blackman: OK, so well, local anaesthesia with a surgical approach or a percutaneous approach?

Dr Muir: No, percutaneous with some modification of techniques. So for example, where one safe way of doing this is having a wire rail from the femoral externalised out through the radial, so that you’ve always got a wire in place, in a similar way to you described in your femoral crossovers.

And that has the advantage of if there’s an occlusive or bleeding problem, you can balloon immediately over that rail or in fact deliver a covered stent to close, to close the vessel. And there are some Scandinavian centres, for example, that have used that quite extensively to reportedly very good effect. So we’re quite intrigued by that.

Dr Blackman: Yeah, I think, I mean, I think the data are pretty clear, aren’t they, particularly from the randomised controlled trials, and there was a meta-analysis last year showing that if we do TAVI transfemorally, we can demonstrate a clear mortality benefit against surgery.[4] But once we go into a transthoracic route, either transaortic or transapical, then the mortality is just the same as surgical AVR, we are not really winning anything over surgical AVR. So we need to start moving to these alternative non-transthoracic routes.

We’re big advocates of subclavian, as you know, we’ve been doing that for 10 years in Leeds and we’re also, like you, looking to move from surgical to a percutaneous approach. And of course there are other emerging non-femoral approaches, like transcaval, that also looks a very promising strategy.

Dr Muir: Yeah, so that will be quite interesting because, as you mentioned, the difference between a non-femoral or thoracic access TAVI and conventional surgery seems slight, if there is a difference. And one question would be converting to the slightly scary-sounding transcaval route might be a comparator or not, and I would be quite intrigued to hear of a trial of that kind of access. For example, direct-access aortic versus transcaval.

Dr Blackman: Yeah. Whether we’ll see that trial I’m not sure.

Dr Muir: No.

Dr Blackman: Well, I mean, it’s been a great discussion. I think we’ve hopefully covered a lot of the issues around vascular access in TAVI. We spent time talking about femoral access. I think what we’ve hopefully focused attention on, how critical it is to be rigorous at every stage, pre-procedural planning, looking at the CT, doing it yourself, don’t leave it to the radiologist. Make sure you understand the vascular anatomy fully, and you can plan your strategy, whether it is femoral or non-femoral. A robust technique to access, whether it’s ultrasound-guided, or with a crossover technique, thinking about the use of that protective wire which can bail you out of major complications, either routinely or in select high-risk cases. And thinking about your options for non-femoral access, which still is required maybe in at least 5% to 10% of cases. And trying to look at non-transthoracic techniques that may offer at least comparable outcomes to a transfemoral approach.

So I think with that, I am going to wrap it up. Thanks for joining us for this video interview from Paris, from the EuroPCR conference.

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