 Welcome to Texas Heart Institute Educational Programs on Innovative Technologies and Techniques. My name is von Merkrazier. I'm an Interimational Cardiologist at Texas Heart Institute and Baylor CHI Medical Center. The topic of this presentation is fast track TAVR. As we know TAVR is maturing technology 18 years old. The first procedure was performed with Cribier-Edwards Valve by Alan Cribier in 1 France in 2002. Since then significant progress has been made in this particular procedure. So what is the current status of TAVR? Technology continues to drive towards less invasive solutions and current generation TAVR devices are associated with higher success rate and fewer complications. For example here at our institution the beginning of TAVR as you can see involved a lot of individuals, cardiologists, international cardiologists, cardiovascular surgeon, pump team, anesthesiologist and so on. More recently the procedure has been simplified and it's safer as you can see. Here now we typically have two internationalists, an international cardiologist and a cardiovascular surgeon performing procedures and you can see there are no other individuals being actively involved in the procedure. Another great breakthrough that has happened as far as TAVR is concerned is evolution of TAVR devices and delivery systems. As we can see in 2002 24 French sheaths were used to deliver the device. At the present time since 2013 we typically use a 14 French sheaths for this particular device. And therefore due to decreasing profile of the delivery systems we have seen significant reduction in major vascular complications. As we can see at the beginning the complication rates related to vascular access was 15.5% with large bore sheets that were 22 and 24 French. And more recently now with 14 and 16 French sheets the vascular complications has decreased tremendously down to less than 6%. So what are the future opportunities to demonstrate further benefits of TAVR? One is to make TAVR procedure less invasive. Another one is to improve patient satisfaction and also it's important to reduce the cost of the procedure and improve efficiency. It's important to reduce the cost of the hospitalization and the procedure because cost pressures are growing and the current TAVR devices are very expensive. So the goal would be to perform TAVR in a cardiac cath lab that's less expensive than the operating room under conscious sedation rather than general anesthesia with percutaneous approach rather than femoral artery surgical access and repair and post-procedural monitoring on a step down unit or a telemetry floor rather than in the costly recovery room or ICU and then finally to be able to discharge the patient within 48 hours of the procedure. To achieve this goal we should be able to demonstrate with less invasive TAVR on the basis of the recent clinical trials and the publications that the 30-day mortality and stroke rate should be less than 3%. 30-day readmission should be less than 10% and 30-day pacemaker rate should be less than 10%. And there should be a significant reduction in peri-valvular leak that should be less than 4%. I would like to share with you our personal experience with fast-track TAVR and the title of this presentation is Safety and Effectiveness of Fast-Track Protocol with Current Generation TAVR devices A single center experience, this procedure was performed by myself and Dr. Neil Strickman both of us are interventional cardiologists at Texas Heart Institute and Baylor CHI Medical Center. The methods included in this study evaluation of safety and effectiveness of the minimalist TAVR protocol in patient population that satisfied accepted sapien XT, sapien III and evolut R and evolut PRO TAVR inclusion and exclusion criteria. The THI minimally study is retrospective non-randomized single center study performed by two operators and all the procedures were performed at Texas Heart Institute Baylor College of Medicine CHI Medical Center cardiac cath lab. The study protocol was initiated on November 1, 2015 and was completed on November 1, 2019. The minimalist approach again was considered as procedures that were performed with conscious sedation, local anesthesia and percutaneous access and repair using current generation femoral artery closure devices such as ProStar and Manta. Here is a in more detail THI minimally stable protocol. Screening included planning for success. The patients were evaluated and determined whether they were suitable for TAVR and suitable for pre-close with ProStar or Manta closure devices. They also had to be suitable for local anesthesia and conscious sedation. Of course, they should not have had any anatomic contraindication as far as exercise is concerned or for TAVR procedure itself. There were no comorbidities that would require significantly extended hospitalization. During the procedure to minimize complications, the patients were discharged on the same day of the procedure and the procedure was performed in the cardiac cath lab via a trans-femoral approach with percutaneous access, local anesthesia and conscious sedation. We purposely made an intention to make the procedure less invasive by avoiding placement of a follicator, NG tube or radial line or central venous line and the procedures were performed with trans-terrassic echo rather than trans-surgio echo. Post procedure we had an intention to minimize the length of hospital stay. The patients were treated on a routine basis with clopidogrel load after the procedure. No ICU admission unless there was a complication and early discharge within 24 to 48 hours and diet on the same day of the procedure. Typically, most of the patients had to be discharged the next day through this protocol. So, as far as procedural data is concerned, 371 patients satisfied the minimalist approach protocol. The devices that were used were sapien X3, XT in 12% of patients, sapien 3 valve in 87.3% of patients, core valve evolut R and pro in 12.4% of patients and valve in valve procedures were performed in 5.3% of patients. Further procedural data revealed that the procedural success was 100%. The total procedure time was 100 minutes. 97% of patients were transferred to a regular step down unit or telemetry floor and only 3.2% of patients required transfer or admission to ICU and those were typically patients that required placement of a permanent pacemaker or had some other kind of complications. As far as stabber outcomes are concerned in 371 patients, conversion to general anesthesia was needed in 1.3% of patients which is very low. CVA occurred in 1.6% of patients and complete heart block that required permanent pacemaker implantation was needed in 7.5% of patients. For core valve patients it was higher, it was 17.8% and for sapien XT and sapien 3 it was 6.1% of patients. Vascular complications occurred in 6.1% of patients. There was no hospital mortality. Post-procedural outcomes revealed that median length of stay was 1.4 days. This position home was achieved in 97% of patients and transfer to skilled nursing facility occurred in 2.9% of patients and readmission within 30 days was needed in 8.6% of patients and 30-day mortality was very low 0.8% of patients in all comers. We compared our results with Vancouver multi-disciplinary but minimalist clinical pathway which facilitates safe next-day discharge home at low, medium and high volume transformational transcategorical valve replacement centers, so-called 3M TAVR study which included 13 North American centers and was performed in 411 patients. This particular study was published by Wood and Associates in the Journal of American College of Cardiology, Cardiovascular Intervention in 2019. Their study protocol included evaluation of efficacy, feasibility and safety of the next-day discharge home in patients undergoing balloon-expandable transformational TAVR utilizing the Vancouver 3M clinical pathway. Patients were considered in this study at increased surgical risk and patients had to meet anatomical, functional and periprocedural inclusion and exclusion criteria. Their primary outcomes were all cause mortality or stroke at 30 days and the proportion of patients that were discharged the next day. So here we can see a comparison of the Texas Heart Institute of Minimally Study in 371 patients versus 3M investigators' experience in 411 patients. As far as age is concerned, our patients were slightly younger. There was no significant difference in gender. Our STS score was slightly higher. It means that the slightly sicker patients were included in our study particularly as far as STS score more than 8 is concerned. The mean ejection fraction was not significantly different. Chronic lung disease was slightly more common in Texas Heart Institute of Population of Patients as well as diabetes mellitus and also prior revascularization such as coronary vipersurgery or coronary interventional procedures. There was no significant difference in prior valve procedures and as we can see prior pacemaker implantation was slightly higher in our population of patients. Now as far as the procedure related variables are concerned we can see that 3M investigators had significantly higher numbers of sapien X3 valves implanted. We had significantly higher number of S3 valves implanted. The procedure time was higher in our experience than for 3M investigators. As we can see, no difference in conscious sedation and no significant difference in conversion to general anesthesia and no abortion of the procedure in either study. Next day discharge was higher in 3M investigator population but as we can see discharge home within 48 hours was not significantly different between two studies. As far as primary and secondary variables are concerned we can see that mortality in THI minimally study was 0.8% versus 1.5% in 3M study. The stroke rate was 0.8% in our minimally study versus 1.5% for 3M investigators and vascular complications were 2.6% in the minimally study versus 4.1% for the 3M study. As far as readmission is concerned there was no significantly different numbers and as far as renal functional impairment there was no significant difference and as far as the pacemake amputation and gun there was no significant difference between two studies and the peri-valveal leak was not significantly different between two studies as well as valve related interventions were very low for both studies. So in comparison THI minimally study when we compare it with 3M study and all other previously large volume studies such as German-Gerry study, STS-TVT study, STS-TVT with consciousness study, partner 2A study, sapien 3216 and aqua we can see that our study as far as STS score is concerned has a slightly higher STS score than several other studies. Age was slightly lower than the other studies. Median length of stay was 1.4 days which is significantly lower than most of the other published studies. 30-day mortality was extremely low 0.8% which is lower than in any other published study that are shown here. 30-day stroke rate was 0.8% which again is very low and 30-day readmission was not significantly different between our study and the other published studies as well as a 30-day new permanent pacemaker implantation which was 7.5% in our study and significantly lower than most of the other studies. So in conclusion minimally STS-TVT can be performed safely and effectively in properly equipped cardiac cath lab using MAC, conscious sedation, local anesthesia and femoral artery percutaneous approach. Uncomplicated patients remain stable post-stabber using this particular approach. ICU can be safely eliminated for most of the post-stabber patients because there is low incidence of bleeding events and other complications and there is also low incidence of neurological events with current technologies and technique and experience and it is safe to monitor patients in a step-down unit. In addition overall length of stay can be significantly reduced by using fast-track protocol and there are significant cost savings that can be achieved and anticipated with this particular approach. This procedure and this protocol should only be performed by an experienced TAVR team. Texas Heart Institute minimally study is a retrospective non-randomized single center study that was performed only by two operators and therefore cannot be considered to be safe in some other environment where those criteria are not met. Thank you very much for your attention.