A New Valve with No Open-Heart -- In-Depth Doctors Interview

Can anyone interested in having the procedure be involved in the trial?

Dr. Lasala: We were screening one or two patients a day for this potential procedure, but everybody needs to recognize is it not an FDA approved item yet. The trial is for the purposes of FDA approval. It is a randomized trial, which means that half the people will get the valve; the other half will get some other conventional therapy. Sometimes that is surgery, or in cases where theyíre not surgical candidates, they will end up getting just medical therapy alone. Unfortunately, that group is considered to have about 30 percent mortality in the first year and they are very, very sick people. They have been turned by two surgeons; they have been really ruled out for any type of surgery. This is not a disease that lends itself well to medical therapy because it has a relentless progressive decline.

And is that the problem with the valve itself?

Dr. Lasala: Yes, the valve itself. Once it becomes fixed and immobile, you canít use any sort of medicine to help it open better or get the heart to beat better. Basically, there is a log jam upstream and not enough blood can get through to meet the bodyís demands.

[B]How common is the problem with the valve in the aorta?[/B]

Dr. Lasala: Well, the valve is related to age and as our populations get older there is going to be a higher prevalence of this. It's been estimated that one out of every seven people in the future will have a significant valve problem.

And that requires a replacement. Is there anything you can do besides that?

Dr. Lasala: Thatís the only thing thatís going to really help. You can go on some water pills for a while to get rid of some of the swelling, but eventually the valve becomes so fixed that nothing will ever really improve the blood flow to the rest of the body.

Until this new procedure, was open heart surgery the only thing you could do to remove that valve?

Dr. Lasala: Correct. Itís a well traveled surgical operation to open up the chest, get to the valve, size it and take it out, put a new or prosthetic valve in and that relieves most of the obstruction. Now, those valves work for a long period of time and you can get 15 to 20 years or more out of the surgically implanted valve. The problem is that this particular problem -- aortic stenosis, the narrowing of this valve -- frequently occurs in elderly populations, people in their late 70s, 80s, even into their 90s. And their age alone will give you a very, very high operative mortality. It might be 10 to 15 percent just to have their heart exposed and take the old valve out.

Do patients who are too weak to have open heart surgery respond better to this new procedure?

Dr. Lasala: We think that as many as a third of patients out there who have a critical aortic stenosis -- life threatening narrowing of this valve -- are either not good surgical candidates or completely eliminated from any having surgery because its frightfully high. These are the ones that are best approached by using this nonsurgical method.

How much of a difference is there in recovery time for the non-surgical method versus the surgical method?

Dr. Lasala: In terms of recovery, these people are awake several hours after we finish. Currently, we do use general anesthesia, but in the future there wonít have to be any general anesthesia. They may be awake right on the table when they have their valve replaced. That has already been attempted and shown to be feasible, but from the standpoint of what weíre currently doing, they will be up several hours later and theyíll feel a little groggy from the anesthesia. Most of them will get up and walk that evening and they can be potentially discharged within a day or two. Just a matter of getting their wind back since most of them have been decompensated for a long period of time. They need to get some of their strength back first, but they feel the effects right away.

Would you say so far, the results of the study are better than you expected?

Dr. Lasala: I think the results as far as Iíve seen have been spectacular. Admittedly, we are choosing very specific patients, ones in which we do not anticipate much in the way of complications from our procedure. The procedure is done using a very large tube to go up the legs to deliver the valve to the heart itself. That tube can cause trauma -- some damage to the leg -- so we have to choose those people very carefully. But in those appropriate patients, we are seeing a very low complication rate -- much lower than what would be seen in surgery and such a short recovery time that they donít have an opportunity to develop a lot of the postoperative complications that one might see.

How does the procedure work?

Dr. Lasala: First of all, we want to put the patient to sleep, but in the future that may not be necessary. We are also going to put a tube down the throat called a transesophageal echo, so it's like a regular echo, taking ultrasound pictures of the heart, but from inside, and this gives us a good visualization. The next thing weíre going to do is come up from the leg by using a small puncture, the same way that one would have a stent placed, if you were going to have a heart operation or something like that. Weíre doing the same thing in delivering this valve. The big difference, of course, is the size of the tube is going to be two and a half to three times larger than the size of the tube that you would normally have a stent placed in the arteries around the heart. Now, once thatís in place, we have to travel all the way up to the heart, go across the valve with a wire, use a balloon to open up the valve initially, try to get that valve as large as possible and then weíll come back with this system that is mounted on a balloon of its own, position it across the valve, take a lot of pictures with the echo under X-ray and then blow the balloon up. The balloon will have its own version of a stent on it. That stent will push the previous valve to the side and inside the stent will be the patientís new valve made out of the tissue around the heart of a cow, called a pericardium. So this is what we call a bovine pericardial valve. Immediately after that is deployed, it goes right into operation, so the patient doesnít lose more than a few seconds where there is no blood flow and it begins to work immediately.

How do you get the new valve to stay where it's supposed to?

Dr. Lasala: The stent, which is really just a metal scaffolding, expands and maintains its rigid force so it pushes the old valve to the side and in doing so kind of locks itself in place. It's sort of like pushing yourself against the wall and fixing yourself in space; if you're strong enough, you can force yourself to say suspended and this one will suspend itself right where the old valve was.

How does the valve itself stay inside the stent?

Dr. Lasala: It's tied with sutures inside the stent and is pretty firm; it's amazing. You can really pull hard on this. If you had a heart from an autopsy and implant a valve, you can actually suspend it in air by a string and it doesnít move at all. It's fairly rigid and sturdy and we anticipate that it will last the life of the patient.

So far you said youíve only performed this on older patients?

Dr. Lasala: Most of them have been over the age of 70 and even over the age of 90. Again, the limiting features are the leg vessels and if they're large enough to allow these large tubes to go up. Keep in mind that this is a first generation device.

Would you prefer to use this type of method over an open heart type of method?

Dr. Lasala: Iím a little biased because this is what I do; Iím an interventional cardiologist who tries to do things to repair the heart without doing surgery. So my biased aside, I believe for older populations, particularly where the risks are much higher with surgery, that this is a very, very good alternative technique. Now, weíll have to make it a lot better than its current form to recommend it for young people, in which you would expect it to last 20 to 30 years or more. Weíll have to see what the data shows before we can get to that point.

What else needs to be done to get this on the market?

Dr. Lasala: As far as getting it into the marketplace, we have to have a successful outcome in this trial. We have to show that in people who have been totally turned down for surgery, then we can probably cut their mortality in half in the first year. I mean that is the goal and the endpoint of this particular part of the study. On the other side, part two of the study, we have to show that in people who could still be operated on albeit at a much higher mortality, that we can do at least as good a surgery. So we have two end points; one is to show that the valve is better than just sitting and watching whatís going to happen and have the disease take its inevitable path in people that are completely inoperable and the second is to show in people who have high operative mortalities that this is just as good as surgery.

How long does the procedure take?

Dr. Lasala: Well, the length of the procedure is somewhat variable because everybodyís anatomy is different, but from start to finish, we can be finished in about 60 to 90 minutes.

And thatís a shorter time being under anesthesia than a full-blown heart surgery?

Dr. Lasala: Yeah, overall it's going to be at least half the length of what a general surgery would be with all the cutting and sewing up at the end.

What do you think is the biggest advantage?

Dr. Lasala: The biggest advantage is we are not exposing people to the risks of an open heart surgery and since that is very traumatic to many of these older patients, as well as the long recovery periods where there are things like infections and heart rhythm problems and bleeding complications that can take place, a lot of those things can be circumvented by using this particular method.

How excited are you about the progress of this new procedure?

Dr. Lasala: Iíve been doing this job for over 20 years -- since I was a fellow -- and it has been a very rapidly moving field; probably one of the fastest moving in all of medicine and weíve seen a number of incredible improvements come along down the pike and watched our patients benefit by these things. Iíll have to say that this ranks right up there as perhaps number one or number two -- maybe itís a tie. As to what the potential benefit is, we can provide for our patient population thatís not currently being served, particularly one that is so critically ill. The true reward at the end is to see somebody whoís been virtually bed bound, canít move without being really short of breath, to suddenly be up tending their garden, going out to the mailbox to pick up the mail and going shopping again; activities that they thought were long over for them. Once you see that restored, itís a very heartwarming experience.

So this is really a huge breakthrough?

Dr. Lasala: I believe it is, and you know, usually we make incremental breakthroughs here and there, small advancements but I believe that this is a monumental breakthrough.