 Welcome to Texas Heart Institute Educational Programs on Innovative Technologies and Techniques. The purpose of these presentations is to inform and educate the physicians, allied medical personnel, and the general public on the latest advances in cardiovascular medicine. I'm your host, my name is Von Merkrager. I'm an Interim Cardiologist at Texas Heart Institute and Baylor CHI Medical Center and Clinical Professor of Medicine at Baylor College of Medicine and immediate past president of the International Society of Endovascular Specialists. The topic of this presentation is rational evolution and the results of fast-track endovascular repair of abdominal aortic aneurysm or EVAR and endovascular repair of thoracic aortic aneurysm or TIVAR. The question is, is this approach becoming a new standard of care? Now, as far as disadvantage of surgery or concern for EVAR and TIVAR, the great majority of patients will require the use of general anesthesia, the procedure is time-consuming, it is painful after surgery, and also there is a higher risk of infection. We have to face the reality, technology has significantly changed and continues to drive toward less invasive solutions for TIVAR and EVAR. Lower profile devices are now available and are associated with higher success rate and fewer complications than 20 or 30 years ago. We also have to take into consideration patient satisfaction and what is also very important, payers and hospitals demand better resource utilization and demand to find a way to reduce the cost of the procedure. So, how can we decrease morbidity and mortality and the cost of these procedures? One approach would be fast-track EVAR and TIVAR. Now, what is the feasibility of fast-track EVAR and TIVAR? There are numerous publications that address this particular issue and here are some of them that have been already reported in the literature. Fast-track EVAR is being adopted for elective open-infra-renal abdominal aortic acid repair which offers shorter ICU stay and shorter hospital stay and reduced mortality. There is also information as far as the risk appropriate in hospital mortality is concerned following 132,000 elective EVARs at 100,002 and 7 hospitals is as low as 0.7% which is dramatically lower than in early studies with EVAR and TIVAR. The lateral PVAR and local anesthesia offers 94% treatment success and shorter hospital stay of 1.3 days and 0.6% 30-day mortality as we have published this in a previous study. Also, short stay EVAR offers patients to achieve early discharge in an established protocol that is accepted nowadays in most of the institutions. So, what is the premise of fast-track EVAR and TIVAR? We know that traditional EVAR and TIVAR requires femoral artery exposure and repair surgically. Frequently there is a need for general anesthesia due to discomfort. The patients are routinely admitted to intensive care unit and typically the length of stay is between 2 and 3 days. All of those procedures increase perioperative morbidity and contribute to the overall cost of the procedure. So, what is the premise of fast-track EVAR and TIVAR? Well, the most important thing is that the procedure should be performed via percutaneous access to avoid complications of surgical access and repair. There is no need for general anesthesia. Typically it's done with local anesthesia and concious sedation. There is no need for ICU stay. The patients can be admitted to a regular floor and typically they are discharged the following day after the procedure in order to improve patient outcomes, patient satisfaction, and health care resource utilization. Now, to achieve that goal, percutaneous large-ware closure has evolved to prevent the risk of surgery and one of their earlier devices was Prostar XL which is a 10-french braided, suture-mediated vascular closure device. This device has been extensively studied and published by many investigators in single-center studies and is approved in European Union for large bore femoral artery closure but it's still not approved in the United States for this particular application. What's very important is that one device can be used for access closure all the way to 20 for French. Now, another device that is commercially available and approved for large bore closure is ProGlide which is a 6-french suture-mediated monofilament vascular closure device. Obviously this device is lower in profile. It is very frequently used for diagnostic and interventional procedures and the operators are very familiar with this particular device. This device is approved in the United States for large bore femoral artery closure all the way to 21 French OD diameter devices. We have published our early experience with the use of Prostar for large bore closure with very high success rate and also we have shown the technique and the results of the use of pre-close technique for femoral artery aneurysm repair and also for the endovascular repair of abdominal aneurysm using ProGlide device. Now, to prove the concepts of results of this particular technique so-called percutaneous technique with a pre-close technique using ProGlide we have carried on a multi-center prospective randomized trial of percutaneous EVAR versus surgical femoral artery repair so-called PVAR trial. The technical success using ProGlide for this particular use was 94%. When we look at the results of this particular trial looking at major ipsilateral access side vascular complications in 30 days we can see that ProGlide offered only 6% complications or vascular complications in comparison with CVAR that had a 10% incidence of vascular complications which was significantly different. In addition to that PVAR with the ProGlide shortens the procedure in comparison with CVAR and time to hemostasis was also significantly shorter with PVAR than with CVAR and this was published on several occasions in different journals and here we can see the results of those publications related to the PVAR trial results. Now, our personal results with fast-track EVAR that started in 1996 and we looked at our results from 1996 to 2015 2,183 EVAR procedures performed during that period of time and PVAR procedures were performed in 2010 patients. As we can see the fast-track from 1997 to 2014 was performed in 78% of patients but more recently since 2000 so it means for the last 19 years 98% of patients underwent PVAR technique and fast-track protocol. As far as technical success is concerned using ProStar device the technical success was achieved in 97% of patients and with ProGlide the technical success rate was 96%. As far as need for blood transfusion it was low 2% of patients required blood transfusion either during or after the procedure and conversion to general anesthesia was very low and occurred in 0.1% of patients. Hospital mortality was low in all comers 0.3% for all patients including patients with serious comorbid conditions and access site infection was very low at 1%. Now as far as the least invasive fast-track EVAR protocol is concerned we carried on this particular study in so-called life registry. Life registry was done using a 14 French ovation StenGraft under fast-track EVAR protocol so this device is significantly lower in profile than any previously used devices in any of the EVAR clinical trials. The protocol required that the percutaneous femoral artery access and repair was performed with two ProGlide devices in so-called pre-closed fashion or at the beginning of the procedure. No general anesthesia was used no ICU admission was required and the patients were discharged the following day and here are the results of life registry fast-track EVAR using local anesthesia percutaneous approach and next day discharged. Successful bilateral PVAR with ProGlide was achieved in 97% of patients which was higher then in the PVAR trial where the technical success using ProGlide was 94% with a larger profile device with a 21 French OD. When we look at the other parameters as far as life registry is concerned we can see the major adverse events occurred in 0.4% of patients which was the lowest of any clinical trial that was carried on with any of the devices that are commercially available at the present time. Also from this trial the procedure time was dramatically shorter than in any published literature using EVAR devices and the hospital stay was the shortest 1.2 days and the ICU stay was none in this particular trial in comparison with the other publications related to EVAR. Also what is very important as far as the patient's outcomes are concerned quality of light improvement was significantly better in patients that had a successful fast-track EVAR is concerned and this was also published in the Journal of Endovascular Therapy in 2017. More recently we published the results of economic benefits of fast-track EVAR and we can see the patients that completed fast-track EVAR had a significantly lower hospital cost and reduction in the cost was roughly $4,000 per patient. When we compare the EVAR hospital readmissions in previously published studies and compare it with the life registry we can see that the need for unplanned 30-day readmission was dramatically lower in life registry it was 1.6% versus 7.9 and 8.1% in previously published studies and also as far as need for operation during the readmission was zero for life registry and it was significantly higher at 28% in previously published studies. So we can say that life readmission rate is 5 times less than contemporary EVAR reports. More recently we have also seen that there is a newer device that can be used for large foreclosure and this particular device is Manta by essential medical and more recently by teleflix. This device has been approved for clinical use for large foreclosure. We can see here Manta deployment animation. This device has over-the-wire design. It achieves hemostasis by sandwiching arteriatomy with polylactic coagulacolic acid intrarterial toggle and extra vascular bovine collagen plug that is sandwiched with two polyester suture and locked in place with stainless steel suture lock. There are two sizes available 14 French Manta that closes the access sites up to 18 French and larger 18 French Manta that closes the access sites all the way up to 25 French. As far as Manta, US ID, Pivotal Trial is concerned we can see here on the left-hand side the technique using ultrasound for gaining access measuring the depth and then advancing Manta device to close the access site post EVAR. So 18 French Manta was used in 84% of patients in this particular trial, which is a large Manta. The great majority or 80% of patients had a Tervor procedure and about 20% of patients had a PIVAR or TIVAR. As we can see, the time to hemostasis was short. It was achieved in less than one minute in 86% of patients and hemostasis was achieved in less than five minutes in 94% of patients. Technical success was 97.7%. The major vascular complications occurred in 4.2% of patients and minor vascular complications occurred in 2.7% of patients. So as far as the fast track EVAR and TIVAR is concerned we can see that this particular technique provides benefits across the whole healthcare delivery spectrum. There are numerous patients' benefits as listed here. It is a minimally invasive procedure. We can avoid general anesthesia complications. There is less blood loss. There are fewer growing complications. The patients experience less pain and the patients are offered quicker recovery time. There are also several physician benefits such as quicker procedure, no need for anesthesia and anesthesia delay. The patient satisfaction is greater and there is better efficiency. There are also numerous hospital benefits. The patient satisfaction is better. There is lower incidence of infection, lower cost of the hospitalization and the procedure. There is less need for blood transfusion and we have improved efficiency of patient care. Thank you very much for your attention.