When the heart pumps blood around the body and the heart squeezes, the blood comes out of the heart, and then the heart relaxes. We don’t want the blood to come back into the heart, so the valve shuts, and the blood then carries down through the rest of the body. That’s a really important valve. It’s the main valve in the heart muscle.
The most common problem with an aortic valve is in elderly patients, where the valve really becomes worn out and becomes calcified and it no longer opens well or closes well. Most commonly, it doesn’t open all the way and it slowly starts to become like a rusty valve. It opens maybe halfway, and the patient may feel a little short of breath, but then over time it opens minimally and it can get very hard for the blood to leave the heart. The heart gets enlarged and the patient feels generally very short of breath. That’s called aortic stenosis.
It starts during your 70s, and 80s. By the time you get to you 80s in this country, almost 10 percent of patients have this problem. So it’s really a prevalent problem. It’s a very common problem.
There are a lot of patients that have trouble, particularly because it’s a disease of elderly patients. We have a lot of patients that show up for the first time when they’re 95. Obviously, that’s going to be a hard thing for a patient to go through. But even for a young patient, it’s no fun to have your chest opened up, and then the heart opened and then a valve sown into it. What a surgeon does is open up the heart, take out the valve, put in a new valve, put about 20 sutures around it to hold it nice and tight and then put everything back together. Obviously, that’s a pretty big procedure, and has a long recovery time.
With TAVR, it’s much simpler. We put the valve in through an artery, in the leg generally. If that leg artery is not big enough, we can find alternative ways to get it in, but usually it’s an artery in the leg. We just pass it up and we implant it, usually either by blowing a balloon up, and attaching the valve to a frame, or by unsheathing a self-expanding frame. The new valve goes right inside the old valve and starts working right away. It pushes the old valve aside and the new valve starts working right away. It’s important to put it in the right place. We’re very careful about that. We have X-rays, and can actually look at their heart through and see that the valve is positioned perfectly and that we have it exactly where we want it.
The patient takes about an hour to get on the table and draped and all set. Once we start, it’s about a 45-minute procedure. There’s no incision, no scalpel used. It’s just a little needle hole in the artery of the leg. So, the recovery is basically zero. The patient stays in the hospital one night. They wake up right away. We don’t even put them fully to sleep. We don’t usually put a breathing tube in. They’re not intubated. They awake pretty much right away, and they have lunch. The next morning they get up and walk around. We look at their heart again with a sonogram, make sure everything is okay, and they’re usually out by noon. We even had one patient go out the same day. The recovery is very minimal, and that’s really the benefit of it.
With traditional open heart surgery, the main problem is the recovery because you have to open the chest and saw through the breast bone. Recovering from that takes a while. You’re usually in the hospital four or five days. When you get home, you’re not driving for weeks. You’re not really going back to work right away. There is a long recovery process.
At the end of the recovery, in a couple of months, patients who have open chest surgery do really well generally. So, it’s just that recovery period that’s so hard. TAVR avoids that, and that’s its big benefit. It’s much less invasive, much less time spent in the hospital, usually one night, with much quicker time for recovery and walking around. Usually, you can walk right away. You can drive the next day. I’ve met patients out to dinner the next night.
A 94-year-old patient of mine got married a couple of months later. So they really resume their life. One of the things that I’ve noticed is the patients feel about 10 years younger on the average. This is transformative to patients’ lives. I would say about 80 percent are so grateful because they can breathe again. They really get their lives back and they’re the way they were 10 years earlier. It doesn’t stop all their medical problems, but it is a big, big event in their life.
Currently, we only have data on a large number of patients out to about five or six years. So, at five or six years, we know it’s doing at least as well as the surgically implanted valve that requires opening the chest. We assume 10 to 15 years later we’ll have to do it again. But the really cool thing is that we can do that same thing again, and put a new valve inside the old valve that we placed. The procedure is exactly the same. In some ways, it’s even easier to put a second valve in. We can really avoid the need for major open heart surgery.
We’re just at 2,000 now. It’s become a very common procedure. We’re doing upwards of 400 a year. It’s really been a big deal for the hospital. We’ve had to change a lot of the way we do things and schedule things because it’s become now one of our most common procedures.
Very few. The valve comes in certain sizes. Very rarely is a patient too big, and needs to go to the big and tall shop for the valve, and they haven’t built that one yet. A more common reason not to get the valve replaced with a TAVR might be that you have something else wrong with your heart, another valve that we can’t help you with using a catheter, and we need to open up your chest for. Or, you have an aneurysm of the aorta, a swelling of the aorta that ought to be replaced at the same time, and that requires still opening the chest. There are some patients we have to turn down, but it’s now becoming increasingly rare.
Pre-existing kidney disease is always a problem for any kind of procedure. We have to use some dye contrast for these procedures, so that is hard on the kidneys. We’ve gotten very good at limiting the amount of dye we use, and we’re actually really specialized at that at Scripps. We could do these procedures with very minimal dye. In fact, we’ve done a few with no dye, which puts very little stress on the kidneys.
Open heart surgery puts more stress on the kidneys. That’s a big thing for the kidneys to go through. TAVR is usually better for a patient with impaired kidneys. Bleeding problems can be a problem for either procedure. Usually, bleeding is worse for an open procedure. Obviously there’s a lot more bleeding involved and need for blood transfusion.
Bleeding can be a problem for the TAVR. It’s something we watch really closely. We make sure that we minimize it as much as possible.
I usually tell patients there is about a 5 percent chance that something will go badly, about a 1 percent chance of death, about a 2 percent chance of a major stroke. That, of course, is what everyone is most concerned about. It’s a really serious thing when it happens. There is about a 3 percent chance of bleeding. All in all, about 5 percent of the patients have complications. It’s not perfect, but 95 percent of the patients do phenomenally well.
Mother Teresa was in Mexico, in Tijuana, at one of her missions, and she developed a pneumonia and had a heart attack and was sent to Scripps. She needed antibiotics and care for her lungs. She also had a heart attack, so she needed an angiogram, and we did that. In an angiogram, we put a catheter into the arteries that feed the heart and look to see if there are any blockages.
Mother Teresa had cholesterol buildup in all three of her vessels. We treated them with what we had then, which was a balloon. We just stretched them. But one of them, her most important artery, did not come out so well with the balloon. Fortunately at the time, we were also investigating the stent, which is now the routine way we treat this. A stent is a little metal scaffold that you can insert. It’s wrapped on a balloon, and then inflated into the area of blockage. You deflate the balloon and remove it. The stent stays put, and holds the artery open.
We did that with Mother Teresa’s artery and stabilized it fine. It really worked beautifully. It was in some ways related to the TAVR in that it was an investigational procedure we were lucky to be doing at the time that Mother Teresa came. We had access to it, so we used it, just like we treat some of our TAVR patients with investigational valves.
She was in the hospital for a month, and it was really wonderful taking care of her. I got to go to Calcutta afterwards, and visited her. She was a really special part of my career, my life, and she did bless the stent. We called it the sacred stent.
I knew she was very special, but what got my attention was when I went out to talk to the sisters. I told them everything went well and that we had a little problem, but we were able to stabilize it with this new investigational stent. They told me that the Pope had my name and was praying for me during the procedure. That really got my attention. She lived another how eight years and was able to continue her humanitarian work.
We’ve done randomized studies, where half the patients get open chest surgery, and half the patients get the TAVR procedure. Those studies have been completed now. The TAVR outdid the open chest procedure hands down. It was less time in the hospital, much quicker recovery, less stroke and better outcomes. We have data out now to three years, and the TAVR is doing better in the low-risk patients than the open procedure. I believe it will be the usual way we treat patients with aortic stenosis in the future.
Down the road, I see a lot of new incredible medical advances. We are all really lucky to be living in this era where there are technological improvements. They are really helping patients, not just with TAVR, but with everything to do with your heart and then some. Certainly with respect to the heart, we’re replacing a lot of the major open chest procedures with procedures we could do through a little catheter in the leg artery or leg vein.
I think the patients are lucky. We’re all lucky because we’ll all be patients. We’re all living longer partly because of this technology. These are tools that will be really helpful to so many patients.