 It is my special pleasure to be part of Texas Heart Institute Global Cardiovascular Forum celebrating 60 years of excellence at our institution. My name is Vaughan Mukherjee. I'm an interventional cardiologist at Texas Heart Institute at CHI Health Baylor St. Luke's Medical Center in Houston. The topic of my presentation is safety and effectiveness of less invasive TAVR protocol with current generation TAVR devices, single center experience. I have no disclosures related to this presentation. Now the first TAVR was performed two decades ago by Dr. Crebier in Rouen, France in 2002. Modern progress has been made in the last two decades as far as TAVR is concerned. And current generation TAVR devices are associated with higher success rate and fewer complications than early generation devices. TAVR technology continues to drive towards less invasive solutions. I would like to share with you the information from the report from 2020 on the situation and status of TAVR in the United States related to the experience that was collected in SDS registry database. As we can see here on the left hand side, we can see that TAVR is exponentially growing over the last decade or so, and the present time, more than 79,000 procedures are being performed in the United States. On the right hand side, we can see that there is also a rapidly increasing number of sites that are performing TAVR in the United States. Another one we can see that in addition to the rapid growth and expansion of TAVR, as we can see to 72,991 patients in 2019, that we can see that the number of SAVRs or surgical procedures are slowly declining. And this is obviously related to the popularity of TAVR. The important thing is that TAVR mortality is rapidly decreasing as far as 30-day mortality and also one-year mortality as shown here. And currently, the mortality at one-year hospital mortality is close to 1%, and as far as 30-day mortality is 2.3%, which is dramatically lower than in 2012 when it was significantly higher. As far as TAVR mortality is concerned for all patients, high and prohibitive risk patients and intermediate risk patients, as well as low risk patients, we can see progressive decrease in mortality. This is particularly true for, as we can see, low-risk patients where the in-hospital mortality is 0.5% and 30-day mortality is 0.8%, but it's also true for other subgroup of patients as well. As far as median length of stay in the hospital is concerned, we can see that for low-risk patients it's one day, and for intermediate and high-risk patients it's two days, which is again dramatically lower than, let's say, 10 years ago. Now as far as discharge disposition is concerned, we can also see significant changes that have occurred in the last decade where the great majority of patients, more than 90% discharged to home, and significantly smaller number of patients need extended care and rehabilitation or nursing home, as we can see on the bottom image of this slide. The great majority of patients, 96% at the present time, are performed by a formal approach, and this is due to progress as far as technology is concerned and the use of lower profile devices that can accommodate even smaller femoral arteries and more diseased femoral arteries. So what are the opportunities to demonstrate benefits of less invasive tower? Now as far as less invasive tower is concerned, it's also called the least invasive tower or minimalist tower or fast-track tower. I would like to use the term of less invasive tower because as the technology progresses and we gain more expertise in the treatment of this condition, we will see even further progress. Number one, important aspect is to improve patient satisfaction. The second important aspect is to improve efficiency and also to reduce hospital expenditures. And how can we achieve that? We can achieve it by performing tower in the cardiac cath lab, which is less costly than the operating room, by using conscious sedation or MAC, and also percutaneous approach for femoral artery access. It's also important that post-procedural monitoring should be done in less costly environment such as the elementary floor rather than costly ICU or recovery room, and our goal is to reduce the length of stay to 24 hours. Now there is ample evidence in literature that to achieve this goal we should be able to demonstrate with less invasive tower protocol 30-day death and stroke of less than 3% and 30-day readmission to less than 10% and the need for 30-day pacemaker rate also to less than 10% and greater than a mild peri-vavilar leak of less than 4%. Now at our institution we wanted to evaluate our experience with less invasive tower. This study was initiated to evaluate the effectiveness of this approach in patient population that satisfied the accepted sapien XT, sapien III, Everlett-R, and Everlett-Pro tower inclusion and exclusion criteria. Our what we call Texas Heart Institute less invasive tower study is a retrospective and non-randomized single center study that was performed by seven Texas Heart Institute operators that are listed here. All procedures were performed at our cardiac cath labs at our institution. The study period was from November 2015 to December 2021. The less invasive tower protocol was considered as a procedure that was performed with conscious sedation or MAC, local anesthesia and again percutaneous approach and repair using current generation femoral artery closure devices. As we can see here as far as our tower protocol is concerned it's important to take into consideration all the aspects pre-procedure which is screening which we call a plan for success. The patient should be evaluated whether they're suitable for tower, whether it's the satisfied criteria for femoral artery access and closure with current generation closure devices, whether they're suitable and willing to undergo local anesthesia or MAC and conscious sedation. And obviously we wanted to exclude patients with anatomic contraindications and patients that had serious core morbid conditions that would require prolonged hospitalization. During the hospitalization and during the procedure our goal is to minimize complications by performing the procedure in cardiac cath lab to reduce the cost and also to be able to perform transfemoral or TAVR by a percutaneous approach and no folly, no NG tube, no radial line or no central line and no TEE would be performed therefore the procedures were performed by trans-terrastic echo. Post procedure our goal is also to minimize the length of hospital stay, the use of a standard approach as far as medications are concerned with clopidogrel and aspirin transferred to a regular intramational floor rather than ICU or recovery room and encourage the patient for early ambulation and the diet and our goal is always to discharge the patient within 24 hours of the procedure. Here we can see as far as devices were used in this study it was sapien XT, sapien 3 and evolut R and Pro as we can see the great majority of procedures were performed by sapien valves, sapien XT and sapien 3 and roughly 12 to 13 percent were performed by evolut R and evolut Pro. We divided the patients in two groups to evaluate the safety and effectiveness of the less invasive protocol and we can see there were 593 patients included in the percutase approach and general anesthesia and 561 patients in less invasive TABR protocol which used the MAC or carcin sedation as we can see there were no significant differences in those groups because this was propensity matched groups that were included in this study as we can also see a small number of patients 0.3 in the percutase and general anesthesia group and 0.5 percent in less invasive TABR group were valve in valve procedures. Now as far as other patient characteristics are concerned we can see that again there was no difference between two groups as far as gender is concerned or mean age is concerned or STS score is concerned. Other patient characteristics again are listed here for two groups and as we can see there were no significant differences as far as incidence of coronary disease, previous bypass surgery, previous intervention, previous AVR, ejection fraction and many other parameters are concerned. As far as procedural outcomes are concerned between two groups we can see significant differences as far as total procedure time, total room time, need to transfer to the limetry and need to transfer to ICU which was dramatically lower in a group with less invasive TABR protocol. As far as the procedural success is concerned there was no difference between two groups and procedural success was 100 percent. As far as procedural and post-procedural complications are concerned the need for conversion to general anesthesia in less invasive TABR was only 1.2 percent, the hospital mortality was not different, the hospital mortality was significantly lower as we can see for less invasive TABR which was 0 and 10 percent for percutaneous TABR in general anesthesia and as far as other parameters are concerned as far as CVA, vascular complications and the need for a new pacemaker there was no significant difference. Also when we look at post-procedural outcomes as far as the length of a stay it was significantly shorter for less invasive TABR, home post-stop day 1 was again more common in less invasive TABR and there were no other significant differences as far as disposition to home, need for transfer to rehab floor or unit or transfer to a SNF or readmission at 30 days or mortality at 30 days is concerned. Now I wanted to share with you some of the information as far as our results are concerned and compare it with previously published data. One of the most recent studies that looked at the aspect of minimalist TABR or fast drag TABR or less invasive TABR is so called 3M study that included 14 leading institutions in North America, 441 patients were included in this study and this was published by Dr. Wood and associates in Jack cardiovascular intervention in 2019. Now one of their goals was to be able to see how many patients can be discharged 24 hours from the day of the procedure. Now when we look at parameters of importance with our less invasive TABR and 3M we can see there was no significant difference as far as SDS score is concerned, no significant difference in age and no significant difference as far as length of stays concerned. You have to remember that their criteria for a successful study was one day hospital stay. Another patient that had to stay longer were excluded from this study. As far as 30 day mortality is concerned we had slightly lower mortality of 0.9% in our study versus 1.5% in 3M study and as far as 30 day stroke rate is concerned there is no significant difference as far as 30 day readmission again no significant difference and the need for a base maker 30 day again there was no significant difference with slightly higher numbers in our study is concerned. Now there is also a huge STS-TVT registry some of the information I shared with you previously were almost 73,000 patients were included and the data was published in 2020 and we can see as far as all the parameters are concerned that our results fare better related to 30 day mortality and also stroke rate as well as other parameters particularly as far as 30 day need for permanent base maker is concerned. So in conclusion we can say that less invasive TABR can be performed safely and effectively improperly equipped cardiac cath lab using consternation or MAC and local anesthesia and femoral artery percutaneous approach. Uncomplicated patients with aortic stenosis post-TABR remain stable and ICU can be eliminated for most patients post-TABR and there is a low incidence of bleeding events as reported in numerous studies and also low incidence of neurological events and it is safe to monitor patients in a step down unit after TABR. In addition to that overall length of stay can be reduced with this approach and significant cost savings can be anticipated with less invasive TABR. However, this procedure should be only performed by an experienced team and our Texas Heart Institute fast-track study or less invasive study is a retrospective non-randomized single center study that obviously needs to be validated in a larger population of patients in a randomized controlled study. Thank you very much for your attention.