Seth Bilazarian, MD


September 26, 2014

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Seth Bilazarian, MD: Hi. Seth Bilazarian, for on Medscape. I'm here at Transcatheter Cardiovascular Therapeutics (TCT) 2014 in Washington, DC, and I've been really affected by the PARTNER five-year outcomes data.[1] For some time, I've been thinking about doing a blog called, "TAVR or DNR." I often see patients being managed by other physicians in our community who aren't referred for even consideration of transcatheter aortic valve replacement (TAVR)—patients who are octogenarians or nonagenarians with severe aortic stenosis, but the patient's internist and cardiologist haven't felt it appropriate or reasonable to send them for a TAVR consultation. These patients then end up having an ST-segment elevation myocardial infarction (STEMI), or they're in the hospital with congestive heart failure and acute pulmonary edema or worse. One patient I saw recently had STEMI with cardiogenic shock. We're asked to perform percutaneous coronary intervention or support in these patients in the setting of a severe aortic stenosis that might have been better managed electively, or they could have at least had a conversation about TAVR.

The PARTNER five-year data hopefully will extend from a procedural evaluation (which much of the PARTNER trial was) to a diffusion into the community. That's what the purpose of this blog is. I'm hoping that more of my community-based colleagues and internal medicine and cardiology colleagues will feel somewhat compelled to make the case to patients and their families that they should at least hear about the benefits and risks of TAVR when they have severe aortic stenosis that's symptomatic.

I think many people know about the PARTNER trial; the five-year data have been presented here at TCT and have been well summarized on this website. I was a physician who referred patients to the PARTNER trial, but I'm not a PARTNER investigator; I'm not a TAVR operator. I'm a clinical interventional cardiologist who refers a significant number of patients for TAVR. I guess the take-home message for this blog in my mind is to look at these data and then decide whether it's appropriate—to use the colloquialism—to "sit" on the patient and wait when they have severe aortic stenosis. We all have the challenge of deciding, if the patient is really symptomatic—are we allowing them to tell us that they're just getting older and they're slowing down and having difficulty climbing stairs, or are we doing a good job assessing those patients for their symptomatic status and making a decision about whether they should have TAVR?

PARTNER Trial: Last of Its Kind

The PARTNER trial was very representative of what we deal with. It's the last trial we'll see of TAVR vs no therapy. Those trials can never be done again, so this is why these data, I think, are so valuable. Patients were 83 years old with an average Society of Thoracic Surgeons (STS) risk score of around 11 or 12, about 40% of them had chronic obstructive pulmonary disease (COPD), and 20%-25% had oxygen-dependent COPD. These are patients who by any evaluation would be considered very high risk. They were considered inoperable by a surgeon; that's why they entered the trial.

But the most important take-home part of this is that 50% of the patients who didn't get TAVR were dead at the end of one year vs 31% of the patients who underwent TAVR. Going out to five years, 94% of the patients who didn't get TAVR were dead at five years, as were 72% of the patients who got TAVR, so this is an older patient population. It's said that patients in their 80s have about an 8% annual mortality, and these patients have about a 10% annual mortality with TAVR. So we know that this is near the end of their lives, but we need to make a decision about how to best manage them at the end of their lives to have a good quality of life.

TAVR Extends Life by a Median 15 Months

For me, the most impactful data that were presented—and it's very simple to tell patients—were that the median survival in this patient set is 11 months if they don't undergo TAVR vs 30 months if they do, so that's about a year and a half more median survival with TAVR.

My policy has been to take an almost stern stand and ask the patient to come in with their family, often their children. I bring multiple family members into my office, and I have a conversation. I say you have to understand that we are now in a situation where your life expectancy is very limited. Sometimes physicians say, "You're going to either die with this problem or because of this problem." I say, "That's not the case. You are going to die because of this problem, because of your severe situation now, and your quality of life in the next several months is likely to be very poor as we go ahead with repeated hospitalizations and worsening congestive heart failure symptoms. I implore you to at least be evaluated for TAVR at a really good center." That's the message that I strongly advocate. All I'm asking them to do is go and sit with a qualified team, a heart team, to have a conversation about this, about how best to go forward on this.

I have had really good success with that, and some patients go and meet with the heart valve team, and the heart valve team decides that the patient is too frail and shouldn't proceed, or the family decides with the patient that they don't want to proceed. I think this is a much better approach. It's not really patient-centered care to decide that they're too old or they're too infirm, that they shouldn't proceed.

Another piece of data that is very compelling is that when you look at all-cause mortality stratified by the STS score, patients with the highest STS score seem to do as well as the patients with intermediate STS scores. That was a remarkable finding—you would think that those patients who we would consider to be at extreme risk for surgery would also be at extreme risk for TAVR, but that does not seem to be the case in this PARTNER dataset.

Refer to Experienced Centers That Keep You Posted

Look for a qualified TAVR program in your area. I'm fortunate to be in an area with several really good TAVR programs. Look for a program that provides all of those things you want when you advocate for your patient—not only excellent procedural benefits but also excellent nursing care and excellent follow-up. I would also urge you to think seriously about a program that works collaboratively with community-based physicians. In our area, some programs do a better job than others at discussing preprocedural concerns with me and communicating with me after the procedure for follow-up care. These patients are frail, and we really need excellent collaboration between TAVR centers and community practicing physicians.

Until next time, I'm calling you out, community physicians in internal medicine and cardiology, to seriously consider referring patients for evaluation for TAVR. Push patients to get a consultation. You're not asking them to take on the procedure, just to get an understanding of what's best for them and to make the best decision for their quality of life and longevity. Until next time, I'm Seth Bilazarian, on on Medscape. Thanks.


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