Transcatheter Aortic Valve Replacement

Open-heart surgery is the gold standard for patients with severe aortic stenosis, but a recently published report in the New England Journal of Medicine confirms what researchers had earlier suspected. A new minimally invasive technique to repair heart valves is saving the lives of patients who are too sick for traditional surgery.

95 year-old Harry Forbes and his wife enjoy taking care of the flowers on the patio outside their Dallas apartment.

Until recently, Harry could barely walk across the room. He suffered from severe aortic stenosis.  Because of his age, doctors say he wasn’t a candidate for open-heart surgery. Now, he can walk half a mile and lift weights.

Forbes took part in a clinical trial using a procedure called “TAVR”, transcatheter aortic valve replacement. During the procedure doctors operate through a small, thin tube, inserted in the patient’s leg. The artificial valve begins working immediately.

Researchers studied the results of 800 heart surgeries nationwide and found after one year, the rate of death was much lower in the TAVR group than the patients who had traditional surgery.

Forbes has no doubt TAVR saved his life. “It is Miraculous.” He told Ivanhoe.

One of the greatest benefits of the procedure is that the recovery time is cut down from several months to a few hours or days.  Dr. Robert Stoler, Co-Director of the Division of Cardiology at Baylor Heart & Vascular Hospital in Dallas has been heavily involved in TAVR. The Baylor Heart & Vascular Hospital is one of 45 national sites taking part in the clinical study.

OPEN HEART SURGERY: Open heart surgery is any surgery involving the opening of the chest in order to replace or repair faulty parts of the heart including valves, muscles and arteries. Open heart surgery is often used as a treatment for coronary heart disease which occurs when the heart’s arteries become clogged. If blood can’t flow properly to the heart, a heart attack could occur.  When open heart surgery has completed, lifestyle changes must be made in order to prevent further blockages from occurring. Doctors recommend eating a healthy diet, keep blood pressure under control and absolutely no smoking. (Source: http://www.healthline.com/health/open-heart-surgery#Overview1)

RISKS: Though results are typically successful and well-received, there are still many risk factors that stem from having open heart surgery. Some minor reported issues have included bleeding, infection, fever and swelling. The more serious risks include damage to vital organs (kidneys, liver and lungs), stroke and death. (Source: http://www.nhlbi.nih.gov/health/health-topics/topics/hs/risks.html)

NEW TECHNOLOGY: A new alternative to open heart surgery can give patients with aortic stenosis life-saving results with a much faster recover time. The transcatheter aortic valve replacement, or TAVR, is a minimally invasive surgery that places a bioprosthetic valve into the heart through a catheter in a small tube inserted into a vein in the patient’s groin or rib area. There is no surgical removal of the hardened valve. Instead, the newly implanted heart valve expands and pushes the old one out of the way, allowing the blood to flow properly to the heart once more. Currently, most patients to receive TAVR have been in their 70s and 80s and had existing medical conditions that made this procedure the safest for them. TAVR procedures have shown a significantly higher rate of survival at one year than surgical aortic-valve replacement.  (Source: http://www.heart.org/HEARTORG/Conditions/More/HeartValveProblemsandDisease/What-is-TAVR_UCM_450827_Article.jsp

http://www.nejm.org/doi/full/10.1056/NEJMoa1400590)

FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:

Paz Mcdonald
Valve Clinic Coordinator
valvecenter@baylorhealth.edu
214.820.3604

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com

Robert Stoler is the Director of the Cardiac Catheterization Lab and the Co-Director of the Division of Cardiology at Baylor Heart & Vascular Hospital in Dallas, Texas.

First of all, what is the procedure and how does it work?  

Dr. Stoler: The general procedure is called TAVAR which stands for transcatheter aortic valve replacement.  The specific valve that we’re talking about today that went into Harry is called a core valve. TAVAR means putting a valve in a patient’s heart that does not involve opening up the chest.  Transcatheter means putting the valve through a catheter which is a small, thin tube which most of the time can get up from a patient’s leg in what’s called the femoral artery. The catheter can go all the way up around the aorta and we can put a valve into the heart that basically pushes the old valve out of the way and the new valve starts working essentially immediately. There are other ways we can get to the heart if the legs are blocked up. Sometimes we can go through the artery in the shoulder which is called the subclavian artery. The surgeon can make a small incision in the chest and we can literally put the catheter directly into the aorta, go down across the valve and open it up. Sometimes we actually go through the tip of the heart, which is called the apex of the heart and put these in trans-apically.  There are a number of different ways to get the valve into the heart, but the common thread in all this is the patient doesn’t have to have their entire chest opened up; he or she doesn’t have to go on the heart and lung machine and this is a much gentler, easier procedure to recover from than a regular open heart operation would be.

It sounds almost miraculous compared to the alternative.  

Dr. Stoler: I find it interesting that one of the surgeons that works with us has been around doing open heart surgery for decades and he considers this one of the two or three biggest advances that he’s seen in his entire time doing open heart surgery. He trained with Denton Cooley in Houston and he’s seen essentially every major advance in open heart surgery and considers this to be one of the most drastic advances he’s seen.  In the clinical trials that have been done so far, putting a valve in a patient that otherwise is too sick to have an open heart surgical valve; for every four patients we treat, we’ll save one.  That’s as huge an impact in medicine as any advance has made in decades.  It’s a bigger advance than cholesterol pills. It’s a bigger advance than angioplasty for heart attacks. It’s a bigger advance than almost everything.  Treat four patients, one will be alive at a year that otherwise would not have been and the benefits continue to stay.   

You’re a cardiologist but you’re not a surgeon, is that correct?

Dr. Stoler: That’s correct.  I’m what you call an interventional cardiologist.  I fix people by putting catheters in the groin and in the wrist, but I do not open patient’s chests like an open heart surgeon would do.

But if a patient needed that, you would be a doctor in the chain of?

Dr. Stoler: Absolutely.  I’m the one who would usually put the catheters in, take a patient’s pictures, determine that he or she needs open heart surgery and often find the surgeon in conjunction with the patient’s general cardiologist that’s appropriate to do the surgery.

So one of the real breakthroughs is that it enables you to treat and save older people who would not be good candidates for the open heart?

Dr. Stoler: Yes, that’s among the best features of starting a program like this.  Many, if not most of the patients that we treat now wouldn’t have another option. They’re patients who if seen by the heart surgeon, the surgeon would often say, “I’m sorry you’re too old, too ill and you have too many other medical problems for me to do open heart surgery on you.” Many of these patients wouldn’t even be referred by their primary care physician.  The primary care physician or sometimes the cardiologist would look at a patient, let’s say a 90-year-old patient, and say, “You’re too old and too ill.  I’m not going to send you to the cardiologist or to the heart surgeon.  There are no options for you.”  But with this, it’s so much easier to recover from that we can put these valves in patients and they get better almost immediately.  In fact, when we talk to a patient after he or she is awoken from anesthesia, often the patients will immediately say, “I can breathe again. I haven’t been able to breathe like this for years.” You hear it patient after patient. It’s incredibly consistent.

And how does that make you feel?

Dr. Stoler: It makes me feel fantastic.  That’s when I see patients in a valve clinic with a couple of heart surgeons and another cardiologist and when we see these patients who have been told previously that no one really has anything to offer for them, we’re able to see them, put a valve in them and they feel so much better. That’s what practicing medicine is all about.  That’s why I do what I do. 

It’s an amazing breakthrough.  To actually go in and replace the valve and before the procedure is over, it’s fixed.    

Dr. Stoler: When I finished my training in Boston 17 years ago, if you’d told me we would have been doing this, I would’ve said you’re crazy. As you watch technology advance over the years, we have been a major site in doing basically every interventional cardiology research study and therapies continue to get smaller.  They continue to be able to be placed using easier and more steerable and more deliverable equipment. That goes for stents which are the little metal scaffolds that fix blockages in arteries.  Now, they’ve moved to valves which are bigger, but are continuing to be able to be placed in smaller catheters and delivered in a way that we can really help patients that otherwise had no option.

You get to know these guys like Harry. He is going to be our principal subject here. He has had an opportunity and he does have an opportunity to continue living.  He wants to live.

Dr. Stoler: We love Harry; our team and as a group.  I first met Harry when his cardiologist walked him into this office, pulled me out of a room, had me meet him, shake his hand and this other cardiologist said, “Bob, you need to put a valve in Harry.” Here stands this handsome white-haired gentleman who’s a little on the older side to having open heart operation, but who’s active, drives, enjoys his life and is profoundly limited by his valve disease.  Within a month or two after that, we had a valve in Harry and Harry sits up and says, “You have to finish up with me quickly because I have to get out of here before rush hour traffic comes.” To watch my old patient and friend jump in the car and drive home is a fantastic feeling, a fantastic breakthrough and he’s productive and happy and he’s living a real life that otherwise without the valve he wouldn’t have the opportunity to do.

What would his prognosis have been without this?  

Dr. Stoler: The likelihood that a patient who has what Harry has will survive to a year is only 50 percent. In Harry’s case, he was admitted to the hospital several times right before we put his valve in because he had continued to decline and worsen.  I believe the likelihood that he’d made it three to six months was minimal at the rate he was declining.

And now?

Dr. Stoler: Now he’s essentially limitless.  He’s going 100 percent full speed ahead doing everything he wants, enjoying his life and breathing well. I think he’s fantastic.

He told us he is going to be 95 years old in November.  When you think about the overall topic and what’s going on here, this seems like a very amazing breakthrough.

Dr. Stoler: This is as big as it gets. This is as big as a breakthrough as we’ve seen since I’ve been practicing cardiology and interventional cardiology. I can’t site you another therapy as we said that saves one out of four patients treated and has such a profound effect on how the patients feel.  Not only do they live longer, but if a patient like Harry comes in and talks to us about getting a procedure and we say “Harry, you’re going to be 95, we can make you live longer.” Harry might say, “Look doc, I’m 95, how much more do you want?” But if we can say to Harry, “You’re going to go from not being able to breathe when you walk 10 feet across the floor to being able to jump in your car, drive where you want, walk wherever you want, do whatever you want, enjoy however much time you have left.” Harry’s going to be pleased. We can put him back on the golf course but cannot make him drive the ball straight or putt any better.

Are there any indicators of the kind of problem that Harry had that people could be aware of?

Dr. Stoler: Sure, the number one thing that makes people present with this aortic stenosis is shortness of breath especially when you do stuff.  If six months or a year ago you walked up the stairs and you felt okay, but now you walk up the stairs and you’re huffing and puffing and out of breath, if any of the regular daily things you do make you short of breath, that’s one manifestation.  Another manifestation is passing out.  If you’re doing something or you’re sitting somewhere and something happens and boom you pass out, that’s not uncommon presentation of aortic stenosis.  Sometimes tightness in the chest or pressure or discomfort or even chest pain is a manifestation of aortic stenosis.  Finally, sometimes swelling in your legs or trouble breathing at night when you lie down can be signs and symptoms of aortic stenosis, but the three main ones that you can remember are chest discomfort, trouble breathing and fainting.  Those are the sort of cardinal symptoms of aortic stenosis.

Does it happen at any particular age.  Could it happen to anybody?

Dr. Stoler: It can, but for the most part, it’s a disease of the elderly. It can start in patients 60 or 70 years of age, but often we’re talking in the late 70s or 80s or 90s.  It’s something that often your primary care doctor can figure out when he or she puts a stethoscope on your chest and hears a heart murmur.  That heart murmur may lead to a test that’s a noninvasive test called an echocardiogram which is an ultrasound of your heart and is very good at determining how narrow and how blocked that aortic valve is. If we find that the aortic valve is blocked on an echocardiogram then it’s good for a patient to see a cardiologist and we can start the thought process and the decision-making process for what we need to do.

So this procedure, this is part of a national study that you’re doing, right?  

Dr. Stoler: There are parts of it that are involved still in a national study, but the valve has also been FDA approved for the patients who cannot have surgery and are at too high risk or who are too ill to have open heart surgery.

What will this mean for the future?  How will this fit in with our desire to live longer? 

Dr. Stoler: Right now, we can say, generally in patients that are not an operative candidate or in patients who by certain risk criteria are a very high risk for open heart surgery, the best treatment for those patients is a transcatheter valve.  That’s going to make them feel better and make them live longer.  However, as we age, we’re looking at lower risk populations to place these valves in.  We’re doing the research to see.  Suppose you’re 70 and not 90.  Does this type of valve do just as well as an open heart surgical valve?  If it does, then it saves that patient the open heart operation.  Now the question involved is we know that open heart surgical valves have been studied for decades and may last 15 years or so, these types of valves have been implanted really even in Europe for about the last eight years. We don’t have that timeframe of follow-up to see if they last as long as the open heart surgical valves.  If it turns out they do last as long, then there is very little downside to placing them because the morbidity associated with the surgery is far less.  On the other hand, if it turns out they only last on average eight or nine years, then maybe the age group that we’re treating with them and the degree of illnesses group that we’re treating with them is goanna be higher.

The artificial valve that you’re placing with the catheter, what is that made of?

Dr. Stoler: It’s what you could loosely refer to as a pig valve.  It is a bioprosthetic valve which means it’s made out of tissue as opposed to metal and it is made out of the lining that surrounds the heart in a pig.  It’s not really the valve that’s taken out of a pig’s heart and put in a human heart.  The pericardium or the sac around the heart from a pig is trimmed in fashion to make three leaflets that open and close and those leaflets are attached to Nitinol cage. Nitinol is self-expanding so when we’re placing the valve in the catheter; it’s placed in an ice bath so it helps to shrink and we can wind it and put it in the little catheter. At body temperature which is much warmer, that catheter is pulled back and the valve opens on its own and embeds or implants itself into the area of the heart where it needs to be with a little steering from us.

That’s pretty cool.

Dr. Stoler: Very cool.

Are they using 3D printers to make these things?  

Dr. Stoler: They are not using 3D printers yet.  I wouldn’t be shocked if at some point there is some algorithm that makes these come out of a 3D printer. I talk to kids that are studying this kind of thing in college and the capability of 3D printers is staggering now, when you look at a device that’s reasonably small, you never know.  

Anything that you could think of that you were thinking you might want to say we didn’t talk about?

Dr. Stoler: I think the one other really interesting and helpful piece of putting in transcatheter based valves is it’s really revolutionized the way we look at valve disease.  We all see patients together in a valve clinic and so it’s a truly thoughtful academic relatively selfless way to decide what’s best for a patient. I’m going to a valve clinic later today with two other heart surgeons and another cardiologist. Patients that are felt to be high risk get referred in, we see them together. We analyze all their data together.  We decide together what the best treatment is for the patient and that’s a much more collaborative way to treat patients that’s 100 percent best for the patient. The byproduct of that is the interest level for the doctors. I learn more about how the open heart surgeons think and work. They learn more about how I think and work and it makes us all smarter; it’s better care for the patient and it’s more interesting for us.  It’s really partly revolutionized the process by which we treat valve disease.

A lot of the general public doesn’t understand that if a guy does open heart surgery that’s generally what he’s going to go to.  You’ve got to back away from these guys, because that’s what they do.

Dr. Stoler: Right. In this, we sit together, look at them, talk and there are a handful of us that go in and talk to the patient at the same time. There may be five or six of us talking to a patient and his or her family at the same time telling them what the thought process was and how we’ve reviewed all the studies and how we’ve come up with what we think is the most thoughtful and the best likely outcome for them. I think that makes a big difference and I think the patients get that.  They understand when you come in as a group, that we’re thinking about them and that’s why we’re all there putting our heads together that day.  That’s what it’s all about.

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.


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