 Welcome to Texas Heart Institute Educational Programs on Technologies and Techniques. I'm Zvonmer Kreyser. I'm an interventional cardiologist at Texas Heart Institute and CHI Health, Baylor St. Luke's Medical Center in Houston. The title of this presentation is STAVER for Bicuspid Aortic Valve. What are the outcomes and what are the unmet needs? I have no conflict of interest pertinent to this presentation. Bicuspid aortic valve disease, pathogenesis, consists of development of valvular sclerosis in bicuspid aortic valve patients that typically begins early in life and progresses more rapidly than in tri-leaflet patients. Bicuspid valve disease can progress to severe aortic stenosis and as little as between 10 to 12 years while patients with tri-leaflet valves have approximately 20 to 30 years to progress to severe aortic stenosis. The eccentric jets that are caused by asymmetric bicuspid aortic valve leaflets lead to increase in wall stress and contribute to a formation of calcifications of the leaflets and also progressive dilatation of the ascending aorta. Now what is the prevalence of this disease? The prevalence of bicuspid aortic valve disease varies significantly according to geography. For instance, in the United States the incidence is somewhere between 1 to 1.6% in published studies while in Europe it is significantly higher and is occurring in up to 6.7% of patients. Now in Asia and particularly from this publication in China the incidence is close to 11%. So what are the unfavorable bicuspid aortic valve features that complicates tarot? One of them is aortic valve annulus that is more elliptical as shown here. Another one is frequent asymmetric calcium location as shown in the second slide. The third one is frequent extensive calcifications extending into the left ventricular outflow tract that can lead to a potential rupture during balloon dilatation of the valve. There is also more frequent association of shorter distance to the annulus from the coronary ostia as shown here and also frequent association of aortic dilatation of various types as well more frequent horizontal aorta as shown in the last slide. Now as far as the classification and morphology is concerned bicuspid aortic valve morphology severs and co-workers describe this clearly and this is the most commonly used classification in patients with a cuspid aortic valve. Severs type 1 occurs in about 7% of patients and it consists of two fully developed cusps without any fusion of raffae. Severs type 1 that is the most common type in their study occurred in 88% of patients and as we can see it consists of one fully developed cusp and two underdeveloped cusp and then raffae that occurs more commonly between the left and right coronary cusp in 71% of patients or between the right coronary cusp and non-coronary cusp that occurs in about 15% of patients and then less commonly between left coronary cusp and non-coronary cusp in 3% of patients. The least common one is the severs type 2 which is actually the most complex type of bicuspid morphology that occurs in about 5% of patients and consists of one fully developed cusp and two underdeveloped cusp and then two either complete or partial raffae. Now more recently there is another novel classification as far as bicuspid aortic valve pathology that was published by Ewan and coworkers in 2020 and as we can see he divided them in three categories that are predictive of mortality and morbidity as far as the classification is concerned. The worst one is one that's shown on the right-hand side in a red color that shows a scenario where you have severe calcification of leaflets and also fusion of the raffae where the mortality at two years of follow-up is somewhere close to 27% in comparison of a significantly lower instance of problems and morbidity and mortality in patients that have minimal calcification and no fusion of raffae that is shown in the dark blue line. More recently the technology has been developed to analyze patients with bicuspid aortic valve anatomy and to design a patient-specific simulation for optimal implantation depth of the prosthesis in an effort to prevent complications such as infolding and aortic regurgitation. So as we can see on the left-hand slide we have a severe calcification of both leaflets and fusion of the raffae that frequently can lead to complications such as significant aortic regurgitation at the end of the procedure. Now in the second slide we can see this valve which is a self-expanding valve is partially deployed and we can see a significant infolding that would lead to aortic insufficiency. On the third slide we can see actually the prosthesis that has been removed where we have significant infolding. And in the last slide we can see a simulation image where we can predict the severity of insufficiency that might occur if appropriate size of the valve and also the depth of deployment is not being used. So what are the outcomes as far as bicospid aortic valve anomaly is concerned? And here we can have a pretty extensive study from the ACC-TVT registry in bicospid aortic stenosis related to mortality and morbidity and incidence of stroke. And we can see here in a huge number of patients 2700 with bicospid and close to 8000 of tricuspid we can see that after using the propensity score matched pairs we can see there was no difference in mortality at 30 days between bicospid and tricuspid pathology and actually there was only a significant difference as far as stroke is concerned between two entities with stroke being higher for patients with bicospid aortic valve which is obviously related to a more complex aortic pathology particularly related to a fusion of the raffae and a more severe calcification of the valve. Now here is another study. It's a meta-analysis of bicospid versus tricuspid valve in a collection of 12 relevant clinical studies and we can see the only difference between two entities is incidence of residual regurgitation at 30 days which is significantly higher in patients with bicospid aortic valve. There was no difference in mortality at 30 days or no difference in mortality at one year and also no difference as far as the need for permanent pacemaker implantation is concerned. Now the CMS analysis in a very large number of patients also revealed from the Prompesti score matching for 3,000 patients that underwent surgical repair in comparison with 1,000 patients that had a bicospid aortic valve and underwent a TABR. And we can see here on the right-hand side that as far as mortality, stroke, and heart failure is concerned after two years of follow-up there was no significant difference between TABR and TABR. So when should we consider surgery for patients with bicospid aortic pathology? The studies have shown that patients that are younger less than 65 years of age should undergo TABR or surgical repair. Also patients that are candidates for mechanical valve would benefit obviously more from surgery and patients that have extensive coronary artery calcifications and disease as well as patients with a significant dilatation of the ascending aorta of more than 4.5 centimeters and patients with multi-valvular disease as well as patients that have unfavorable calcification pattern of the valve that might lead to a higher risk of annular rupture. And also patients that have a risk of residual paravalvular regurgitation. And also patients that have a challenging axis, particularly in patients that have hostile iliofemoral anatomy. So in conclusion, TABR and bicospid aortic stenosis poses significant challenges due to aortic valve disease complexity that I've described and frequent association of orthopathy and dilatation of the ascending aorta. However, the results have improved as far as TABR is concerned in this type of a pathology with current generation devices in term of procedural success and lower incidence of paravalvular leak. The association of orthopathy is, however, less of concern in all the patients at high surgical risk. However, it should be carefully considered in younger patients. The durability and long-term results of TABR in this pathology is yet to be defined because we do not have until now any randomized studies to compare either the combination of problems related to bicospid pathology or comparison between bicospid pathology and tricospid pathology. Thank you for your attention.