Timothy J. Gardner, MD; Franz H. Messerli, MD; Mary Norine Walsh, MD

Disclosures

June 09, 2014

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How Old Is Too Old for TAVR?

Timothy J. Gardner, MD: Hello. I'm Dr. Tim Gardner. I'm reporting here with my colleagues from Washington, DC, at the American College of Cardiology (ACC) Scientific Session 2014. I'm a cardiac surgeon. I'm also Medical Director of the Center for Heart and Vascular Health at Christiana Care Health System in Delaware.

We have some interesting things to talk about today. First, I will ask Minnow to introduce herself.

Mary Norine Walsh, MD: I'm Minnow Walsh, and I am the Medical Director of the Cardiac Transplant and Heart Failure at Saint Vincent Heart Center in Indianapolis.

Dr. Gardner: Franz?

Franz H. Messerli, MD: I'm Franz Messerli. I specialize in hypertension at Saint Luke's and Roosevelt Hospital in New York, and I'm a Professor of Medicine at the Icahn Medical School.

Dr. Gardner: Great. One of the big trials that we talked about was the CoreValve trial[1] -- the transcatheter valve trial. One of the things that occurs to us when we see a trial like this is the interventions that we're now doing in the elderly.

Minnow, tell us, what your perspective is on the CoreValve trial? Are we in the right space, operating on patients? In that trial, the mean age was over 80 years.

Dr. Walsh: I think it's a new option that's available to patients. They were also randomized to surgical aortic valve replacement (SAVR) in this case, and so they were eligible for surgery. I think the more data that we have on TAVR, the question is going to be, how old is too old for this type of intervention? Clearly, it has been successful. I don't know that we know the long-term outcome in our elderly patients.

For example, many of the TAVR patients at our center have heart failure. They continue to have heart failure symptoms. Their quality of life has definitely improved as far as being able to move and do what they want, but we still see them frequently in heart failure clinic. I don't know if we know the answer.

Dr. Gardner: Right. On the other hand, and from the perspective of the cardiac surgeon, we're being referred these patients to consider for surgery. I was referred a patient who was 96, and she was quite functional. You have to ask yourself, "Is that appropriate?" Having the option of a less invasive procedure with the transcatheter valve is a major step forward, but it doesn't relieve us of the obligation to figure out when it is appropriate and when it isn't. What do you think, Franz?

Dr. Messerli: I think it's a philosophical point, but there are 2 main issues in medicine. One is that you want to prolong life, and the other is that you want to improve quality of life. As you just have said, obviously we can improve quality of life. We may not necessarily prolong life, but the few days or weeks or months that they live, they live much better. I think that's a very important role if you can achieve it.

Shared Decision-Making

Dr. Walsh: A really important part of this is the patient's choice. I know you've been talking to patients about surgery your whole career. How we frame the decision is very important.

An actual formal process of shared decision-making with patients is something that we're using more and more in cardiovascular medicine. It's been used in other surgical areas much more than in cardiology until recently, where a patient is getting information in written format or even video format beforehand that not only addresses my choices are, but also what my values are. What do I value? They then approach the choice with the surgeon, the cardiologist, or whoever is offering the procedure.

Dr. Gardner: We don't do enough of that. In fact, I've been confronted with situations where the patient has been referred to me by a cardiologist. We have a discussion, maybe a 15-minute discussion. I talk about the actual surgical technique and so on, and then they say, "Doctor, what do you think?"

Dr. Walsh: Or, "What would you do if it were your family member?"

Dr. Gardner: Yes. I feel uncomfortable with that. Obviously, my own personal bias may come into play.

Dr. Walsh: In my field, our partnership with our surgeons with regard to ventricular assist devices (VADs) is for destination therapy. The age question comes up in this population, too. How old is too old? Certainly, there are risk scores that we can look at and then try to make an informed choice with the patient.

When we offer a surgical therapy vs none, I'm not sure people (no matter how old they are) understand what continuing with medical therapy or successful surgery means for them. Is surgery successful for you if you end up in a nursing home 6 months later? We might not have told you that on the front end for either of these interventions.

Assessing Frailty

Dr. Gardner: We've talked about this new concept of frailty and how to assess that in patients who are candidates for interventions of any kind -- certainly major interventions, such as valve replacement. How do you handle that?

Dr. Walsh: Well, it's been used in the TAVR trial. That hasn't been as yet integrated into the VAD trials, but I think it's important. We do such things as a 6-minute walk test to see how functional patients are. I think a more global frailty risk assessment is really needed, because I think it helps inform the patient's decision. Sometimes, as you said, you are referred a patient. The patient expects the procedure without a thorough understanding of how the procedure might go.

Dr. Gardner: Right.

Dr. Walsh: I think the same is true in the data that came out here with regard to renal denervation for hypertension.[2] Are we going to instrument older people with these techniques?

Dr. Messerli: "Frailty" is the new buzzword. It is exceedingly important. You need to look at this very carefully. Even when you treat patients medically, frailty is an issue. Orthostatic hypotension can lead to a fall with a hip fracture; that's not to be taken lightly. The frailty concept has become a very important one.

Dr. Gardner: We recently had a visitor at our center from Mount Sinai: Diane Meier, who is an expert in palliative care. I really got a new perspective on palliative care. Coming from the surgical world, palliation means you're not going to cure the patient. It's end-stage. It's a different concept, and it really helps us achieve shared decision-making with patients. That's the conversation with elderly patients about end-of-life issues.

Hospice vs Palliative Care

Dr. Walsh: Yes. I think there has been a lot of confusion, especially on the part of physicians, about the difference between hospice care and palliative care, where they ask, "Why would we talk about hospice versus surgery?" Now, in order to be a destination therapy center, you have to offer palliative care consultation in advance of the surgery so that the patient has an individual (such as the one who visited your center) talk through the choices with them. Again, this is a list of the patient's values, what their lifestyle is like, and what they wish for.

Dr. Gardner: Let me ask you about VADs for destination therapy.

Dr. Walsh: What a great name.

Dr. Gardner: Are we getting a little beyond where we should be? I mean, we have the technology (the same thing could happen with the transcatheter valves), but I worry whether we are offering some patients support with a VAD when in fact we should be supporting their end-of-life struggles.

Dr. Walsh: It's an evolving field. There is a multidisciplinary team that helps these patients make a decision. I think we've learned a lot in the past few years, and we will continue to learn.

Most centers that have been working in this field for a while find that their destination VAD volume went up initially and then came down a little bit, because of exactly what you're saying. We all have experience with a patient who was treated too late. Maybe there was a misjudgment, and the patient never left the hospital.

We're refining how we assess these patients. There is the HeartMate II risk assessment score.[3] There is the Lietz-Miller risk stratification system,[4] et cetera, but our surgeons like to say that there's nothing like the eyeball test. We all know what that is.

I also think the VAD centers have the problem that you have, which is that a patient comes expecting a procedure: "I came for this, or I was transferred for this." More commonly, they were transferred from another hospital for this procedure. The family expects it. The patient expects it. I think we're refining our recommendations to patients to include a discussion of how they'll do after the surgery.

Dr. Gardner: I think the oncologists have learned this lesson better than we have as cardiovascular physicians. From their understanding of the disease process, they know when it's better to help a patient deal with end of life rather than continuing to offer treatment options.

Dr. Messerli: Tim, how do you handle a patient who simply doesn't have the intellectual capacity to make a decision like the one you just described?

Dr. Gardner: I think that if they are unable to actively participate in the required postoperative treatment or the therapeutic situation afterward, then they don't qualify. Certainly, that's a big disqualification for VAD therapy. In terms of transcatheter valves, we don't want to be treating patients who are in the early stages of dementia.

Dr. Messerli: It doesn't necessarily have to be dementia. This is decision-making at a highly sophisticated level -- to understand all of the ins and outs and possible complications. It may well be beyond the average patient.

Dr. Walsh: I think that's an important point, because sometimes families drive the decision-making and the patient may not be actually in the same space. We've had some experience eliciting that. It's important to always speak to the patient alone to find out who wants what. There are some 90-year-olds who are going to benefit from transcatheter valves.

Dr. Gardner: There are certainly 90-year-olds who would benefit from a therapy that's going to help them be comfortable for the next 2, 3, or 4 years, because there are plenty of people coming into their 90s who are functional but have calcific aortic stenosis.

No Cure for Aging

Dr. Walsh: I do think that especially for TAVR (less so for the VAD decision), patients think that they are going to have the surgery and everything is going to be better. It doesn't take care of arthritis or other mobility issues. Having heart failure due solely to the aortic stenosis is not that common. Most patients probably have some diastolic dysfunction as well. There is a little bit of an expectation gap that patients and families have.

Dr. Gardner: Absolutely; I agree. The SYMPLICITY HTN-3 trial[2] was big at ACC, with some disappointing results. Do you want to tell us your perspective?

Dr. Messerli: No question that renal denervation needs to be looked at again. We need to reboot and see what the story is.

It's reassuring that in the elderly, resistant hypertension is not very common. These patients who have long-standing hypertension are prone to heart failure. Heart failure is actually a good treatment for hypertension.

Dr. Gardner: I hadn't thought of it that way. Had you?

Dr. Walsh: Not really.

Dr. Gardner: One last thing I thought was quite notable was the cardiac resynchronization therapy (CRT) study,[5] but not necessarily as it applies to the elderly.

Dr. Walsh: I think the decision to do CRT alone without an implantable cardioverter-defibrillator (ICD) does apply to the elderly. It's a therapy that I think will grow even for patients with low ejection fraction heart failure who haven't had cardiac arrest (VT/VF), where we're offering CRT as a therapy to feel better. In those cases, the defibrillator discussion is a little bit different.

Dr. Gardner: It's an issue I hadn't thought of. That's great.

Thank you all very much. Thank you for being with us as we've reflected on what we've seen at the American College of Cardiology 2014. Thank you.

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