 Welcome to Texas Heart Institute Educational Programs on Innovative Technologies and Techniques. I'm a Zvonimer Crazier. I'm an international cardiologist at Texas Heart Institute and Baylor CHI Medical Center. The topic of today's presentation is the update on TAVR versus SAVR. TAVR is maturing 18-year-old technology. The first in-man TAVR procedure was performed by Alain Cribier with Cribier-Edwards valve in 1 France in 2002. This procedure was done by a transeptal-integrate approach and published in circulation. Now, what progress has been made for patients undergoing TAVR in the last 18 years? Currently, in the United States, we have three TAVR systems available for clinical use. Edward Sapien original valve was Sapien followed by Sapien XT and the latest generation is Sapien III. Metronic also had several progress made as far as design is concerned. The first one was core valve followed by the evolut R and the last one was evolut Pro valve. Boston's scientific valve was just approved this year for clinical use and the name of their valve is Lotus. As far as the evolution of TAVR is concerned, at the beginning only the patients with prohibitive surgical risk were including in a trial, that was so-called partner trial. Of course, the endpoint at that point of time was mortality and comparison was between endovascular treatment with TAVR versus medical treatment for patients with prohibitive surgical risk. This was later followed by high surgical risk patients and again we looked at the mortality as endpoint. Following this, we analyzed the group of patients that were at intermediate surgical risk and again we looked at mortality and also stroke. More recently, low surgical risk patients were included in the trials and we looked at mortality, stroke and CV hospitalizations post procedure. So what are the future trials that might be considered as far as TAVR is concerned? It's probably going to be asymptomatic patients with severe aortic stenosis and the endpoint of this particular variation is still not clearly known. Now what have we seen over the last 18 years as far as morbidity is concerned post TAVR? If we look at all cause mortality at 30 days from partner one and partner two trial, we can see that the incidence with a variety of valves and particularly when we look at the newer generation of valve has decreased tremendously from 6.3 at the beginning to 1.1 in one of the latest clinical trials. When we look at all strokes at 30 days in comparison with earlier trials to the latest trials we can see that the number of strokes has decreased dramatically and currently at the present time we can see the disabling stroke is occurring in somewhere between 1 to 0.8% while at the beginning it was 7.3%. So obviously the technology is improving and our techniques are improving and our skill and patient inclusion in those trials is also playing a significant role in reduction of those morbidities and mortalities as well. One of the concerning factors as far as TAVR is concerned particularly in comparison with SAVR is the incidence of perivabular leak. And here we can see when we look at partner one trial and partner two trial and then the latest information with sapien three valve we can see that the incidence of moderate to severe perivabular leak has decreased tremendously from in the range of 24% to 2.5% at the present time. There is no doubt as I mentioned previously that expertise learning curve plays a significant role in the outcomes and decrease in mortality and morbidity after TAVR. And here we can see that the incidence of a major vascular complication was above 15% in the earlier clinical trials and at the present time it's in the range of 1%. So obviously this has to do not only with experience but also with the profile of the devices that are decreasing significantly for the last several years. Let's look at TAVR versus SAVR for intermediate risk patients which is relatively recent trial and if we look at the so-called SIR TAVR trial that includes intermediate risk patients with evalute valves we can see as far as 30 days safety and procedural related complications are concerned that there is no significant difference between all cause mortality or even disabling stroke between TAVR versus SAVR and that is also true for major bleeding as we can see but we can see that surgical patients had a higher need for blood transfusion than TAVR patients and also higher incidence of acute renal injury. However the vascular complications were higher for TAVR patients than for surgical patients. The other parameters were not significantly different other than the need for a permanent pacemaker that was significantly higher for TAVR patients than for SAVR patients. However the incidence of post-procedural atrial fibrillation was significantly higher for SAVR patients than TAVR patients. When we look at this particular study as far as clinical outcomes are concerned at 12 months and 24 months we can see that TAVR is a durable procedure and there were no dramatic differences as far as all cause mortality is concerned, incidence of stroke is concerned and disabling stroke or TIA or myocardial infarction or a need for re-intervention or need for re-hospitalization between two groups of patients. Another important factor is look at the hemodynamics and we see here very interesting information that SAVR patients with evolut valves had a higher aortic valve area and lower gradients than surgically placed valves. Not only immediately a discharge but also at six months, at one year and also at two years. What about aortic regurgitation after TAVR is concerned in comparison with SAVR? Well aortic regurgitation always has been Achilles heel of TAVR in comparison with surgical procedure is concerned but what we can see is that even though the incidence of mild or trivial aortic regurgitation is higher after TAVR we can see that as far as severe aortic regurgitation is concerned or peri valve leak is concerned it's not dramatically different and therefore I think that the newer generation valves offer significant benefits in comparison with the previous generation valves and are slowly approaching the outcomes as far as this particular parameter is concerned to a surgical valve replacement. Let's look at the latest data related to the low risk TAVR trials with both balloon expandable and self-expandable valve. Those two manuscripts were simultaneously published in New England Journal of Medicine and we can see as far as sapien tree trial with balloon expandable valve is concerned the number of patients with a little bit smaller 950 were included there was no significant difference in age between two trials and STS score was similar between two trials and there was no difference as far as comorbid factors are concerned. So if we look at the evolut low risk trial results at outcomes are concerned at 30 days comparing TAVR to SAVR we can see that all cause mortality after TAVR was the lowest ever 0.5% and it was 1.3% after TAVR disabling stroke was also lower after TAVR than after SAVR as we can see here as well as life-threatening or disabling bleeding which was very interesting here this is totally new as far as incidence of bleeding is concerned particularly related to vascular access complications also the kidney injury was slightly lower after TAVR than SAVR and we can see low incidence of vascular complications that were not significantly different between two groups again as previously shown the incidence of atrial fibrillation after TAVR is dramatically lower than after SAVR however permanent pacemaker implantation was significantly higher after TAVR occurring in 17.4% of cases versus 6.1% after SAVR the all cause mortality and disabling stroke was not significantly different at long term intermediate term of follow-up and aortic valve reintervention was equal between two groups further data as far as evolut R is concerned in comparison with SAVR we can see that as we mentioned with the previous study the gradients are lower after TAVR than SAVR and we can see that the valve area is larger after TAVR versus SAVR also improvement of newer heart classification is similar between two groups as far as patients quality of life assessment as well is concerned what about sapien 3 low risk trial well we can see one interesting parameter that was not available in the evolut trial that conscious sedation in sapien 3 low risk trial was used in 65% of patients which is very high and this is a new trend as far as TAVR is concerned procedure time was dramatically shorter after TAVR in comparison with SAVR there was no different length of stay in ICU but there was a shorter length of stay in the hospital for TAVR patients comparison with SAVR and what was also very interesting that 96% of patients after TAVR would discharge home to self care versus 73% of patients that had a surgical repair which is statistically significant also as far as concomitant procedures are concerned they were less common after TAVR than after surgery as far as in hospital mortality is concerned it was lower after TAVR which is the first time reported significant difference in this type of subset and population of patients also as far as bleeding major bleeding is concerned was lower after TAVR the vascular complications were low after TAVR 2.3 and 1.5 after surgery the new need for pacemaker was 6.5% versus 4% after SAVR and the new left bundle branch block was higher after TAVR in comparison with SAVR as far as reintervention is concerned it was zero for both subgroups and as far as asymptomatic valve thrombosis is concerned it was occurring in 0.3% of patients after TAVR versus zero after SAVR indicating that this is an issue of low importance at the present time at short term of follow up in this subset of patients additional information from this trial nuanced atrial fibrillation at 30 days was dramatically lower after TAVR again confirming the information also from a low risk evolut trial the length of hospital stay was also significantly shorter after TAVR as well as all cause of death stroke and re-hospitalization at one year again shorter after TAVR and quality of life was better in this particular study after TAVR death of all stroke at 30 days was again lower after TAVR and all stroke at 30 days again lower after TAVR so when we look at the primary endpoints in this particular study with sapien 3 valve we can see that there is a statistically significant difference and trend for most of the studied parameters favoring TAVR in comparison with SAVR patients in this particular study what about perivalular regurgitation in this particular study we can see that no perivalular leak was higher at 30 days post SAVR then post TAVR but at one year follow up we can see that a very small number of patients in sapien group had mild endo-leak and very few had moderate endo-leak of course the numbers were in favor of surgical population of patients as far as no endo-leak or mild endo-leak is concerned one of the things that is of importance is to know when we look at multi-center studies and meta-analysis of all the clinical trials that have been carried on as far as randomized clinical trials are concerned to look at the risks and benefits of TAVR versus SAVR we can see one of the publications that included a large number of patients and they looked at all the parameters of importance and here we can see in the top panel in hospital or 30-day mortality we can see that it is slightly favoring TAVR in comparison with SAVR in hospital or 30-day stroke and or TIA again it was slightly in favor of TAVR versus SAVR is concerned when we look at long-term outcomes in this meta-analysis on a three-year mortality again it was slightly in several studies in favor of TAVR versus SAVR and we look at one to three-year stroke and or TIA it was equivalent between TAVR and SAVR for most of the study parameters when we look at the need for a pacemaker implantation or ICD placement again there was favoring SAVR rather than TAVR and that has been shown in several more recent randomized trials when we also look at more than moderate aortic regurgitation is concerned it favors SAVR for most of the studies that were analyzed when we look at the cost of hospitalization and additional expenses needed as far as reinterventions are concerned comparison of TAVR and SAVR is shown here in this particular publication from a partner, a trial we can see that there is no statistically significant difference as far as costs are concerned at 12 months of follow-up comparing transfer more TAVR versus surgical aortic valve replacement so what is happening at the present time in comparison with the early beginning of TAVR is concerned we can see that as far as TAVR is concerned it is on a very rapid rise basically for almost all patients or all subgroups as far as patients younger than 74 patients older than 74 patients with low severity and also patients with high severity as far as risk of surgery is concerned so obviously TAVR is here to stay and is showing very promising results I would like to share with you just briefly the information from the fast-track protocol or the least invasive TAVR is concerned and how this is impacting the outcomes of TAVR on our patients of course the most important thing is pre-procedural information and screening of patients to make sure that there are candidates for this particular approach during the procedure we should minimize complications and do the procedures that are the least invasive which includes local anesthesia, conscious sedation, percutaneous approach, trans-terrathic echo rather than trans-vigil echo is concerned in post procedure the patients admitted to a regular floor obviously on telemetry they receive dual antiplatelet therapy until different modality of treatment is necessary no ICU stay is necessary and the next day discharge I would like to share with you some of our information that we gathered recently and we compared our personal experiences with fast-track TAVR with a recently published 3M trial that included 14 centers in North America using so-called least invasive or fast-track protocol as we can see in our population of patients the patients were slightly sicker and STS score was higher they were a little bit younger than in a 3M study conscious sedation in our patients were used in 100% of patients versus 98.3 in a 3M study conversion to general anesthesia in our population patients was 1.3 versus 1.5% in 3M study median length of stay in our study was 1.3 versus 1 in 3M next day discharge in our population was achieved in 67% of patients versus 80 in 3M discharge within 48 hours was achieved in our population of patients in 84% of patients major vascular complications were not significant difference different between two trials and the host mortality was zero in our population of patients versus 1.5 in 3M trials and 30 day mortality was 0.8% in our institution versus 1.5 in 3M study and 30 day stroke was 0.8% in our population versus 1.5 in 3M study and 30 day readmission rate was 8.6% in our study versus 9.2 in 3M which is not statistically significant and discharge to self care at home was achieved in 97% of our patients and 30 day need for a new pacemaker occurred in 7.5% of patients in our study versus 5.7% of patients in 3M study so comparison of two studies showed very similar results as far as outcomes are concerned with evidence of some minor improvement in certain parameters as far as our patient population and outcomes are concerned when we compare this with the other studies that have been published from a partner tree trial low risk patients evolut low risk patients and partner 2A trial we can see that our results show very satisfactory results with evidence of better outcomes I believe on the basis of the use of almost exclusively concentration percutaneous approach and discharge within 24 to maximum 48 hours after procedure so where do we stand as far as SAVR 2020 is concerned we can say that SAVR has been the standard of care with proven safety and durability for most patients of course younger patients that do not have a contraindication to the use of anticoagulants are still recommended to undergo surgical repair with mechanical aortic valves and that's on the basis of durability of those type of valves are concerned however TAVR has been truly transformative and is now preferred approach for patients with prohibitive and high risk surgical risk this has been clearly shown in previous randomized clinical trials TAVR is now also an alternative to SAVR for patients at an intermediate and low risk surgical risk patients which has been clearly shown in recently published and carried on clinical trials the incidence of all complications mortality and morbidity is concerned is rapidly declining with TAVR with the implementation of newer technologies and techniques the threshold for TAVR is declining in clinical trials, in registries and also in clinical practice however multi-disciplinary team is essential for good outcomes thank you very much for your attention