Dr. Galper will be presenting “Mapping Out the Journey to TAVR in a Large Integrated Health System: Rates and Clinical Consequences of Delays in Referral of Severe Symptomatic Aortic Stenosis Patients to the Structural Heart Team Stratified by Gender, Ethnicity and Socioeconomic Status” on Thursday, Oct 26, at 11:09am (Moderated Abstracts Station 2 – Emerging Clinical Science & Research, Hall A, Exhibition Level, Moscone South, Moscone Center)

Why study delays in referral to structural heart teams for TAVR?

We know that the longer a patient waits to get a transcatheter aortic valve replacement (TAVR) or surgical intervention for your aortic valve, the more likely you are to have a worse outcome. Wait times for TAVR have actually been going up over the last few years. There has been some discussion around what the optimal time from the diagnosis to referral might be, with a time from diagnosis of severe aortic stenosis (AS) to treatment of 90 days being proposed as an optimal benchmark. There are over 700 TAVR programs right now in the United States. Yet we are only treating half the population with severe AS. At this point, we know TAVR is an amazing technology. There have been multiple studies in all risk profiles, from high risk to low risk, showing that TAVR is just as good if not better than surgery from both the patient outcomes and costs/resource utilization aspects. But for some reason, TAVR is not being disseminated in the population as widely as it should be, given that we have so many structural heart programs across the country. Why is that? Are there particular populations that are less likely to be referred, for whatever reason? If so, how do we address that? What are the consequences of delay?

The Mid-Atlantic Permanente Medical Group is a large integrated health system, which means we have robust data for over 800,000 patients, from the time they are diagnosed with AS through their entire follow-up period. In TAVR DELAY, we examined our echo database for the last five years, and identified all patients with severe AS and then further identified who was symptomatic and who was not. Data were then stratified by several different variables — clinical variables, gender, minority status, and socioeconomic status — and we examined several questions. First, what are the rates of referral? What are the times to referral? Who are we referring early, and who are we referring late or never? And, importantly, what are the clinical consequences of late referral? As an integrated health system, we view ourselves as being the best of the best in terms of efficiency, quality, and ensuring that patients get the optimal care at the right time in our healthcare system. Therefore, we shouldn't be missing out on treating any AS patients, and if we are, we need to determine why.

We found that 51% of patients with severe AS were referred to the structural heart team. Importantly, we found populations that were not being referred as often or as early, particularly Black patients. Black patients were about 30% less likely to be referred early compared to white patients. Next, we also saw decreased referral rates  for patients of low socioeconomic status. For every $50,000 increase in salary, patients were 20% more likely to be referred early for TAVR. There is clearly some correlation with income and socioeconomic status, and the likelihood of receiving a referral. As a system and health care system in general, we need to build strategies to increase referral rates for minority and disadvantaged populations for TAVR in order to ensure that all patients have equal access to this life-saving procedure.  

Next, we looked at why delays in referral are happening overall. The journey from diagnosis to TAVR requires the involvement of many people, who all have to be aligned. It means the echo has to be done appropriately and the diagnosis needs to have been made appropriately. The patient needs to be referred from a cardiologist to a structural heart team. The structural heart team then has to appropriately refer the patient for TAVR or SAVR. There are many steps along the way. We looked closely at all those steps and found that we were doing a good job of getting the patient from their echo to seeing a general cardiologist. The real bottleneck was going from a general cardiologist to a structural heart team. We looked at patients who had Class 1 indication for AVR, where no one would argue that these patients probably should have a TAVR or surgical AVR, but at the very least, certainly should be referred to a structural heart team. These patients had clear-cut severe AS with symptoms and yet, not all of them were being referred, or they weren't being referred in a timely manner. There were delays. More than two-thirds of the delays were because the general cardiologist didn’t refer, and generally, the lack of a referral was because they didn't think their patient’s symptoms were related to AS or there was some ambiguity in the echo. The echo diagnosis of severe aortic stenosis is not subtle. There are clear criteria. The patient’s aortic valve area is <1, mean gradient >40 or peak velocity >4. These are patients that met all of those criteria on the echo, yet for whatever reason, when whomever was reading the echo composed their summary statement, which is what everyone reads, the language was not clear. It would say: “Possible severe AS,” or “Moderate to severe AS,” or, “May have severe AS.” If I am a primary care doctor or a general cardiologist reading that summary, I might think, What am I supposed to do about that?! It is something we are now working on fixing in our system in terms of standardizing the echo report so that it is consistent, reflects the findings in the valve gradients, and clearly guides the ordering clinician regarding next steps in patient evaluation and clinical care.

The primary reason, though, for delay was that general cardiologists were not consistently referring patients with severe symptomatic AS to the structural heart team because despite symptoms, they did not think their patient's symptoms were related to their AS. This tells me that we need to work with general cardiologists so they understand early referral to the structural heart program is key. There is no benefit to holding onto a patient, perhaps thinking, I’m not sure about their symptoms — maybe they are not severe AS. Of the patients that were delayed, 75% ended up getting a TAVR at some point. Meaning that these patients had the diagnosis, they saw a general cardiologist, they may have been delayed more than six months, but eventually they were referred to a structural heart team, usually within a year or so. It is unlikely these patients are truly asymptomatic. Once the diagnosis was made and the patient thought more about it, and/or the general cardiologist thought more about it, they realized they needed to refer them, but referred them late.

What did you find regarding outcomes of delayed referral?

The last part of our study looked at clinical consequences of referral for 400 patients who underwent TAVR. Among those patients, there was a numerically higher trend toward mortality while waiting for TAVR. We did find a statistically significant increase in presentations for heart failure after TAVR in patients with delayed referral. This is interesting, as we might think, you get a TAVR, you fix the problem, and it doesn't make a difference if you had it three months after diagnosis or a year after diagnosis. But that is not the case. For whatever reason, if a patient had delayed referral, but still went on to have a TAVR, they actually did worse after their TAVR. These patients had about a 75% greater likelihood of presenting with heart failure compared to someone who had an early TAVR. They likely were experiencing more cardiac damage while waiting for TAVR and even though they made it to the TAVR, the cardiac damage they sustained while waiting  wasn’t fully recoverable after the procedure.

Did you see any differences in referrals by gender or age?

Yes. Traditionally, reaching women has been the challenge, but in our group, the more delayed patients were actually men. For older patients, we found patients over 80 were more likely to have delayed referral versus patients in their late 60s or earlier. It may be there was concern about benefit, but we know that TAVR benefits all age groups.

How many patients are referred to a structural heart team but then are turned away because their symptoms are not severe enough for TAVR?

In our study, only 10% of patients referred to the structural heart team did not undergo a procedure. Most of that was because of other comorbidities — for example, cancer was discovered. There were a few patients who  were thought to be severe asymptomatic AS and therefore were not referred for TAVR. For the most part, if a patient is given a referral to the structural heart team, they are usually going to get an intervention and will usually get it in a timely fashion. If that doesn’t happen, it is for a good reason. Bottom line, the bottleneck is the thinking that I’m only going to refer to the structural heart team if I think my patient definitely needs a TAVR. But there is a lot of gray area here. As structural heart cardiologists and surgeons, our job is to sort this out. We are experts in one thing, and that is figuring out if people with severe AS or severe valve disease need interventions. I would encourage every cardiologist to refer to their structural heart team the second severe AS is diagnosed, even if you think they are asymptomatic, because there are things we can do, whether it be an aortic valve calcium score, stress test, further eliciting of symptoms, a cardiac catheterization, to better assess whether a patient would benefit from TAVR, even if they are “asymptomatic”, because they probably aren't actually asymptomatic. Other things may be going on that may not be picked up on, and it is our job to figure it out. There is no reason not to refer to a structural heart team.

What are you hoping people take away from your study?

Much of this messaging is to primary care and general cardiologists, but it is valuable for interventionalists as well. We are all involved in the care of these patients. The three takeaway points would be, one, we need to do a better job with our at-risk population, particularly minority patients and those of lower socioeconomic status — patients that may not have the same resources as other patients. We need to make sure we are reaching them and they, along with their primary care doctors, are aware of symptoms of aortic stenosis, so that when people have symptoms, they get an echo, and if they get an echo, they can advocate for themselves to be seen and to have those symptoms be addressed. We are clearly not meeting their needs.. Number two, I think the structural heart physicians need to do a better job reaching out to our general cardiology colleagues. We need to let them know that we are on the same team, we are all here to figure out what is best for these patients, and we are happy to see your patients who may be asymptomatic. They may not need a TAVR today, but they may need a TAVR in six months. The sooner these patients come to us, the sooner we will be able to figure out the best thing for them. Aortic stenosis is a very insidious diagnosis. Yes, there are some patients that show up with syncope, but that is not the average patient. The average patient may have been gradually slowing down in terms of their functional capacity over months to years. The key is teasing that out. Are there incremental changes in your exercise capacity? Can you no longer go up the same steps you went up three months ago? Or can you no longer walk your dog the way you used to? The changes may not be dramatic. Being more attuned to those changes, especially in patients diagnosed with severe AS, is what I would emphasize to primary care and general cardiologists, and referring sooner than later to a structural heart team, because it not only expedites care, but also will help improve their patient’s long-term outcomes. Lastly, we need to make sure we are consistently reporting aortic stenosis on our echo reports and building echo templates that provide clear direction to referring clinicians on (1) whether the patient has severe aortic stenosis and (2) whether referral to the structural heart team may be indicated.

Any final thoughts?

There is a lot to act on. I discussed earlier in particular working closely with general cardiologists to ensure timely referral to the structural heart team, but patient education is also important. Let’s say a patient receives a diagnosis of severe AS. They say, “I’m fine. Not a big deal.” They may initially downplay their symptoms to the cardiologist. But then they talk to their family, they think more about it, and realize, maybe I am more symptomatic. If we take the time to work with patients and ask them more probing questions, I think we will end up unmasking more symptoms than we realize.

Dr. Galper will be presenting “Mapping Out the Journey to TAVR in a Large Integrated Health System: Rates and Clinical Consequences of Delays in Referral of Severe Symptomatic Aortic Stenosis Patients to the Structural Heart Team Stratified by Gender, Ethnicity and Socioeconomic Status” on Thursday, Oct 26, at 11:09am (Moderated Abstracts Station 2 – Emerging Clinical Science & Research, Hall A, Exhibition Level, Moscone South, Moscone Center)

Keep reading about the latest in TAVR research:

TCT 2023 Newsroom

TVT 2023: The Structural Heart Summit Newsroom