In this video, Sammy Elmariah, MD, chief of Interventional Cardiology at UCSF, discusses the latest advances in treating aortic stenosis (AS). He presents recent research demonstrating that transcatheter aortic valve replacement (TAVR) is a safe, effective, durable therapy with long-term outcomes comparable to surgical AVR (SAVR) and explains why AVR may be indicated for asymptomatic patients with severe AS. He also describes how electronic provider notifications that include clinical guideline recommendations for AS patient management can aid in clinical workflows to further optimize care.
Hi, my name is Sammy Elmeria. I'm the Chief of Interventional cardiology and director of the cardiac catheterization lab at the University of California, San Francisco. It's a pleasure today to speak to you about TAVR and the title of my talk, Beyond TAVR, Shaping the Next Era of Aortic Stenosis Management. So here first I want to begin with an overview of the interventional cardiology program at UCSF. Really exciting that we've built a comprehensive team that can really address the full gamut of interventional and provide the full gamut of interventional therapies spanning interventional adult congenital heart disease. We have heart failure interventions, of course, with MCS with the utilization of novel investigational shunt devices. A tremendous amount of focus on diagnostic coronary work and coronary physiology to exclude and treat microvascular disease. And finally coming to the trans catheter valve therapies, which will be the major focus for today, uh, we really have the ability to treat patients with nearly every valve lesion at this point, which is truly exciting that as a field, we've really gotten to this point. We strive to deliver a multidisciplinary personalized patient-centered heart team approach with the intent not just of getting patients through that initial procedure, but really providing a solution that's going to be durable and a strategy that will hopefully allow us to treat patients throughout their lifespan. Now, TAVR, of course, is what really set off the trans catheter valve space. TAVR has evolved very rapidly across the United States and across the world, uh, with the first TAVR implanted in human in 2002, and of course soon thereafter that we initiated trials within the high. Risk patient population that were too sick to undergo cardiac surgery. That was followed by the first FDA approval in 2011 within the United States for TABR in the extreme risk population. And since then there have been iterative changes that of course today allow us to treat patients of any risk profile with trans catheter aortic valve therapy, assuming it is appropriate based on their age, their longevity, and of course their patient wishes. Two devices primarily widely available across the United States include the Edward Sapiens system as well as the Medtronic Evolut system and recent FDA approval of the Abbott Navator in 2023, which we also have available at UCSF. But we continue to iterate. So over the early part of 2026, we're anticipating a few balloon expandable valves to be investigationally introduced that offer with the with the Siegel valve access as low as 8 French for the delivery system and for the Enteris valve an opportunity to perhaps improve upon the excellent human dynamics that current systems are providing. And I will say this is also in addition to the fact that we expect Tver prostheses very soon to be uh to be available to us for pure aortic insufficiency. Now, in combination with the evolution of the devices, we have also developed a number of technical advances that really allow us to treat patients with highly complex disease, those who have low lying coronaries, who have undergone prior cardiac surgery, of course, a basilica procedure in which we use electrosurgical techniques to lacerate. The indwelling leaflet, whether it be from a bioprosthetic surgical valve that is in close proximity to the coronary ostia, or in a case as I'm showing in the middle of the screen, a native bicuspid valve in which the coronaries were low, the sinuses were shallow, and there was risk of coronary occlusion. And then more recently, the unicorn procedure was introduced, which allows us to use a balloon. To essentially dilate an orifice within the the leaflet of a bioprosthetic valve and then implant the new TR valve within that, within the leaflet itself to truly exclude the left coronary or right. From occlusion of the coronaries. Now, of course, we can present a number of device iterations. We can talk about how good the procedure has gotten, but really what people have been have been focused on is how does TAVR compare to surgery. And this is of course relevant as we start to treat people in the younger age ranges, certainly between 65 and 70. They want to make sure they have a durable outcome that's going to last them for years to come. And we did recently see data from the Partner 3 trial. This is the low-risk randomized trial that compared TAVR to surgical intervention, and I'm showing the event curves on the right-hand side of the screen. And what you can essentially see is the composite of death, stroke, or re-hospitalization was actually lower in TR. And while the curves continue to remain apart, and there's a slight approximation of the curves out to 7 years, again, we're not seeing any signal in regards to hard clinical endpoints that would suggest that TAVR is less effective. And what this continued separation of these curves means over time is that on average patients that underwent TAVR compared to surgery live approximately 134 days longer over the seven year follow-up period that's been presented to date. So again, very encouraging results so far. The other piece that has really, uh, of course, been at the forefront of our minds as we continue to offer Tvern healthier and healthier patients is the valve durability, not just the hard clinical endpoints. Here again, I'm showing results of the seven year analysis from the partner trial. And at 7 years, there is really no difference whatsoever in any of the human dynamic parameters obtained with TAVR or with surgical aortic valve replacement. We see comparable aortic valve areas and also comparable mean gradients out to 7 years. So it's not surprising that with those successes, TAVR has seen a tremendous expansion across the United States. Here I'm showing data from the NCDR TBT registry that captures every TAVR done nationwide. And in 2003, we see that over 100,000 TAVRs were performed in the US. This is an excess of the nearly 60,000 surgical aortic valves that are performed, uh, aortic valve replacements that are performed in the United States. And these high numbers and the proficiency that teams are developing, as well as the technical advances, has resulted in superb outcomes with in-hospital mortality that's expected to be less than 1%. A median length of stay of 1 day, a stroke rate of under 1.5%, conversion to surgery now occurring at rates that are lower than what we see with PCI. Pacemaker rate with aortic, with trans catheter, aortic valve replacement, uh, approximately 7%, and with more recent data suggesting that perhaps we're getting down into the 5 to 6% range. And then finally, with the recent data that I just shared, comparable durability to SAR out at least to 7 years. So now that we're able to offer aortic valve replacement with such superb outcomes, the question that is being asked is whether it makes sense for us to start intervening earlier, perhaps before a patient develops symptoms due to aortic due to severe aortic stenosis. And so 4 clinical trials have been performed that help to address this question. The Avatar and recovery trials are both surgical AVR trials in which patients were randomly assigned to either undergo SAR early or to wait for symptom onset, so a more traditional approach. Evolved AS was a trial conducted in the UK. That actually identified patients with some elements of cardiac injury and randomized them to early AVR either TAVR or SAR, or to ongoing surveillance, and then finally, the early TAVR trial, which is the largest of the four trials with over 900 patients, randomly assigned patients either to undergo transfemoral TAVR or ongoing surveillance. What these trials collectively demonstrated was results that really started to suggest the favorable outcomes associated with intervening on aortic stenosis early. So there is not, uh, to be clear, a survival benefit. With these trials and with early intervention, however, there very clearly is a robust reduction in heart failure hospitalizations. There is a robust reduction in unplanned cardiovascular or heart failure hospitalizations, and very surprising and contrary to what the investigators had initially predicted, there was actually a reduction of stroke risk across these four trials in patients that actually underwent AVR early. So with this data in hand, there are now European guidelines that suggest that we should in fact consider aortic valve replacement for asymptomatic severe aortic stenosis. That is a class 2 indication within the European guidelines, and the US guidelines are currently being edited and hopefully will be published in 2026. So overall, I think what I've shown is that there is tremendous progress within the management of aortic stenosis. SAR and TAVR are now safe and effective life saving therapies with comparable long-term outcomes. Both SAR and TAVR are widely available across the US. There's currently over 1200 SAR sites and over 800 hospitals that do TAVR. Um, and the safety of ABR is truly phenomenal, certainly with TR and also with SAR, to the point that we are now considering, and it seems appropriate to start offering this to asymptomatic patients with severe aortic stenosis. Despite these successes, however, there's still a lot for us to do, and we know that aortic stenosis is a disease that is associated with morbidity and mortality when left untreated. As I've shown you, we have very effective, safe, curative therapies for symptomatic severe aortic stenosis, but despite that, multiple studies, and I'm showing here data from a study that my group published, demonstrates that nearly 50% of patients with symptomatic severe aortic stenosis do not receive that life-saving therapy within 2 years of being diagnosed. So really pretty dismal statistics that unfortunately also disproportionately affect women, the elderly, and a variety of race and racial and ethnic minority groups. So with that data in hand, the American Heart Association launched the Targeted aortic stenosis Initiative. This is a quality improvement initiative that is intended to improve the clinical management of aortic stenosis and to bolster guideline directed care. This is upstream of what other registries have focused on. So we're not focused on TAVR outcomes, we're not focused on SAR outcomes. This is really looking at the period of time from when aortic stenosis is echocardiographically diagnosed, to when they actually undergo therapy. The primary quality metric that's being defined by the American Heart Association and has also been endorsed by the American College of Cardiology is that patients with a Class 1 indication for ABR receive that aortic valve replacement within 90 days of meeting that indication. So if somebody gets an echo that shows severe aortic stenosis. There's a 30 day window of time during which they need a clinical evaluation to see if they have symptoms. They undergo subsequent diagnostic testing to confirm the severity of aortic stenosis. And again, if the patient's confirmed to actually meet indications for AVR, that 90 day window begins, and the AVR needs to be done within that period of time. So it's really paradigm shifting in regards to the approach taken to improve the quality of care for patients. And so looking at the evolving TAVR landscape, the initial intent was to focus on procedural outcomes, to improve surgical outcomes, improve TAVR outcomes, and then now that we have gotten so good with those therapies, it's really more about getting patients through the pipeline and ensuring that patients are being referred appropriately and that they're being treated in a timely fashion. The Target AS initiative has launched a recognition, uh, program, uh, essentially the Target AS honor roll for institutions that are high performing. Very honored that UCSF was amongst these for the inaugural, honor roll, uh, in 2024 and then again in 2025. Um, but now that we have these quality metrics that we need to meet. The question is how in the world are we going to do it? How are we going to continue to improve our ability to get patients to treatment in a timely fashion? And so we set out to actually identify an effective intervention, specifically an electronic notification tool within the randomized detect AS trial. This is a trial that I ran at my prior institution and just reported this year in 2025 in circulation. But ultimately what we did is we took providers for patients that had been found to have aortic stenosis on an echo. We randomized those providers to either receive a notification within their in-basket apex or epic in basket, or by email. And we then would send these customized notifications based on what the echo showed and the type of aortic stenosis that would not only summarize or highlight the detection of aortic stenosis, but also give a summary of the clinical guideline recommendations for the management of that patient. What we find was truly eye-opening, and that first and foremost, usual care was still associated with severe undertreatment of symptomatic severe aortic stenosis. You see here data from the control arm of that randomized clinical trial in which at a year, less than 50% of patients with symptomatic severe aortic stenosis had actually undergone AVR. And less than 30% had received ABR in a timely fashion that is consistent with the AHA target AS initiative. In the patients that were cared for by providers that received the notification, our little passive nudges within their email inbox, we saw that there was an improvement in treatment rates to over 60% and that just under 40% of patients actually did receive intervention within 90 days. So we're moving the needle. We're still not where we want to be. There's a lot more work to be done, but at least this is starting to show benefits in the way that patients are managed. And concurrent with that, we're also seeing trends suggesting that survival is prolonged. And when we look at the average survival of patients cared for by notified providers versus usual care, on average over the short one year period, patients were on average survived an extra 23 days if they were cared for by a notified provider. Now, interestingly, there's an important gender disparity as well. So in usual care, men with symptomatic severe AS are twice as likely to get treated. Than a woman with symptomatic severe aortic stenosis, and you see the, the, those dismal figures here on the, on the curve that I'm showing. What was really encouraging is that with our intervention, with these electronic provider notifications, we were able to eliminate that disparity. And so in our intervention arm, we actually see comparable rates of aortic valve replacement with men and women who are symptomatic from severe aortic stenosis. So to summarize what I've shown, surgical and trans catheter aortic valve replacement are both efficacious. They're safe, they're durable, and they're both widely available. Emerging data are poised to broaden the indications for aortic valve replacement to include treatment of patients with asymptomatic severe aortic stenosis. Despite the tremendous progress that we've made, undertreatment of symptomatic severe aortic stenosis persists, there are disparities in care and also barriers to care that we need to, that we need to overcome, and hopefully digital technologies will help us get over the hump, and as they've shown promise in aiding clinical workflows to further optimize the care of aortic stenosis. And with that, thank you so much for your attention. I do want to leave you with one take-home point. If you have patients with aortic stenosis, any question of severity, any question of whether or not they're symptomatic, please do default to referring these patients, whether it's to us, um, or elsewhere, so that they can receive the care that they need. And please do feel free to reach out. Thank you so much for your attention.
