 Welcome to Texas Heart Institute Educational Programs on Innovative Technologies and Techniques. The purpose of these presentations is to inform and educate physicians, allied medical personnel, and the general public on the latest advances in cardiovascular medicine. I'm your host. My name is Vanmer Kreyser. I'm an international cardiologist at Texas Heart Institute at Baylor CHI Medical Center. I'm a clinical professor of medicine at Baylor College of Medicine, an immediate past president of the International Society of Endovascular Specialists. The topic today is large bore vascular access site closure devices 2019 and beyond. What are the benefits and what are the disadvantages? We have to face the reality. Technology continues to drive towards less invasive solutions. Payers and hospitals demand better resource utilization and a way to reduce the cost of EVAR, T-VAR, and TABRA procedures and many other procedures that use large bore closure devices. To achieve this goal, surgical femoral artery access and repair has been, for a great part, replaced by percutaneous femoral artery access and repair, as shown here. Now, as far as percutaneous large bore vessel closure devices are concerned, they have basically evolved to prevent the risk of surgery. One of the earliest large bore vascular closure devices was ProStar XL. It's a 10 French braided, suture mediator vascular closure device. It was approved in the European Union for large bore femoral artery closure all the way up to 24 French, but is not approved for that particular application in the United States. There are several disadvantages of these devices. It has a very prolonged learning curve and for that particular reason it is not extensively used. More recent device that has been approved for clinical applications for large bore closure is ProGlide 6 French, suture mediator monofilament vascular closure device. It is approved in the United States for large bore femoral artery closure all the way from 12 to 21 French OD. It has a significantly shorter learning curve than ProStar. It's commonly used for diagnostic and conventional procedures and is therefore more applicable for a great majority of internationalists for the use of large bore vascular closure. There are a couple of disadvantages related to this particular device. Two devices are frequently required for large bore closure for 22 all the way to 24 access side and not infrequently a third device might be needed for large bore closure. As far as ProGlide is concerned, there was a prospective multi-center randomized trial of percutaneous EVAR versus surgical femoral artery pair so-called PVAR trial. We participated in this trial and as far as technical successes concerned ProGlide technical success was 94% for 21 French OD device. There were several benefits related to the use of ProGlide in this particular trial and several of them are listed here. As far as major ipsilateral access side vascular complications at 30 days we can see that ProGlide had significantly lower incidence of vascular complications than a surgical access and repair. In ProGlide arm there was a 6% incidence of vascular complications at 30 days and in surgical arm there was a 10% incidence of vascular complications at 30 days. There were several other benefits as far as ProGlide used for PVAR in comparison with surgery as listed here. The procedure time for ProGlide was significantly shorter than with surgery and time to endostasis for ipsilateral access was also shorter for ProGlide in comparison with surgery. Another very important clinical trial that evaluated the use of ProGlide for large bore closure was life registry or fast track EVAR trial that used local anesthesia, percutaneous femoral artery repair and next day discharge. In this particular trial 14 French EVAR device was used and as we mentioned previously for the PVAR trial we used the 21 French OD device. The successful Baladwal femoral artery repair in this trial with ProGlide was 97% which was higher than in the PVAR trial where the technical success was only 94%. We can also see that in life registry there was a dramatically lower incidence of major adverse events 0.4% in this particular trial which is the lowest of any trial using EVAR devices that has been published so far. There were numerous other advantages in this life registry such as procedure time was dramatically shorter and also hospital stay was also shorter as well as ICU stay was 0 in this particular trial. So we can see tremendous benefits of percutaneous access and femoral artery repair with the low profile device using ProGlide. This was published as listed here. Now when we compare 30 day post EVAR hospital readmissions in life registry with previously published EVAR studies by Gupta and Chen as we can see here there is a dramatic reduction as far as unplanned 30 day readmissions in a life registry. In life registry it was 1.6% versus in Gupta trial it was 7.9% and in Chen trial it was 8.1%. Also operations needed during readmission were 0 in a life registry versus 28% in a Gupta trial. As far as life registry is concerned therefore the readmission rate is 5 times less than contemporary EVAR reports. We also published the information from the life registry as far as total hospital health care cost is concerned. So in life registry with fast track EVAR using local anesthesia and percutaneous approach and next day discharge we can see that if the patients completed the fast track EVAR we could dramatically reduce the cost which was approximately 4,000 saving per hospital admission per patient. So what are the unmet needs for large ball closure at the present time particularly related to the suture medial closure devices? Well one of them is endovascular emergencies such as ruptured abdominal aortic aneurysm, ruptured thoracic aortic aneurysm, cardiac support that is needing during interventional procedures such as use of intraortic balloon pump, impella, tandem heart and others. What's very important is that the current generation suture medial closure devices can only be used in a pre-closed fashion which adds extra time to the procedure. For this particular reason we have numerous emerging dedicated large bore vascular closure devices. None of them have been other than Manta approved in the United States for clinical use. Manta is the only large bore dedicated vascular closure device that has been approved for clinical use in the United States and there are two devices, 14 French and 18 French and we will mention shortly the details related to the Manta device and Manta trial. This particular device was approved for clinical use in the United States in 2018 and in the EU in 2016. There are other devices that are listed here such as percoseal which has not been approved in the United States for clinical use but has been approved in Europe in 2016. Also, enclosure is another vascular closure device for large bore closure that has been approved in the EU in 2016. There are several devices that are currently ongoing clinical trials in the United States in elsewhere such as cross seal, closer LB and Velox LB devices. Now let's mention a few of them that have been approved in Europe for large bore closure. This device is enclosure by in seal medical from Caesarea, Israel. This device closes exercise from 18 French to 20 French. Successful hemostasis in the clinical trial in Europe was achieved in 83% of patients. The time to hemostasis was short, 1.1 minutes and as I mentioned previously, CE Mark approval was achieved in 2016. One of the disadvantage of this device is that it leaves behind a nitinol frame that stays in the artery while the membrane that's in there and sutures are bioabsorbable over a period of time. Another device that has been approved for use in Europe is a percoseal. This vascular closure device is approved for arteriatomies between 12 to 24 French OD. It's over-device device that has only three steps to deploy this device. It has a synthetic absorbable patch that seals from the inside and it absorbs in roughly 180 days. It is not commercially available yet in the United States. Several trials were carried on in Europe and as we can see, the latest one so-called Frontier IV clinical trial in 75 patients had a technical success of 96%. At follow-up, at one month, there were no major adverse events and minor vascular complications were encountered in six patients. Now, as I mentioned previously, Manta by Essential Medical and more recently by Teleflex has been approved for clinical use in the United States. We can see Manta deployment animation that shows the step of deploying Manta device. It is over-the-wire design device that achieves hemostasis by sandwiching arteriatomy with polylactic co-glycolic acid intra-arterial toggle, an extra vascular bovine collagen plug, and two polyester suture so 316L stainless steel suture lock that maintains firm fixation of those two components. It has two sizes, 14 French Manta that closes the access sites up to 18 French and a larger 18 French Manta that closes access sites all the way up to 25 French. Here is one of the cases that we performed using Manta device. As you see, ultrasound access is preferential or I believe mandatory. We have a marking that tells us exactly where to deploy the device. The device is being deployed as we can see by pulling the lever and then pulling the device back to approximate the toggle close to the arterial wall and then we advance this pusher to advance the collagen and also stainless steel lock to the arteriatomy. As you can see, we have complete hemostasis even in a patient that is fully anti-coagulated. So, as far as Manta-US ID people to trial results are concerned, you can see that the great majority of patients or 84% of patients use the larger or 18 French Manta primarily for TAVR procedures and about 20% of patients had a PIVAR or TIVAR done with this large bore Manta. Time to hemostasis was short, less than one minute in 86% of patients and hemostasis in less than five minutes was achieved in 94% of patients. Technical success was high, 97.7%. And VARC2 major complications occurred in 4.2% of patients while VARC2 minor complications were present in 2.7% of patients in this clinical trial. Now, when we compare the EU clinical trial, US ID clinical trial and the EU post-market registry, we can see that in all three trials meantime to hemostasis was roughly one minute or slightly above that. Technical success was high, in the EU trial was 94% and in US ID trial was slightly higher, 97.7% and VARC2 major vascular complications occurred between 2 to 4% and VARC2 minor complications occurred somewhere around 2 to 2.7% of patients. Now, we have several emerging devices that are currently undergoing clinical trials in the United States and one of them is cross-sealed. It is very similar to a proglide or almost a blend between proglide and pro-star. This particular device uses monofilament suture. It's eight French device and closes exercise from eight French to 22 French. It is used in a pre-closed fashion similarly like pro-star and proglide. Another one is closer LB. This particular device is bioabsorbable. It uses spheres and sutures and closes the exercise from 10 French to 18 French and it is used post-procedure. Another device is Velox LB. It also has a bioabsorbable magnesium alloy. It closes exercise all the way up to 16 French and it can be used post-procedure. So, in summary, as far as percutaneous femoral artery access side and repair is concerned, we can state that this particular approach provides benefits across the whole healthcare delivery system. As far as patient benefits are concerned, this procedure is minimally invasive. We can avoid general anesthesia complications. It offers less blood loss. There are fewer growing complications, causes less pain and offers our patients quicker recovery after the procedure. There are also numerous physicians' benefits. The procedure is quicker. No anesthesia delay. The patient satisfaction is greater and obviously we can improve efficiency in our patient care. There are also numerous hospital benefits. Patient satisfaction is better. There is lower incidence of infection and the need for readmission or prolonged hospitalization. The costs are lower. There is less need for blood transfusion and obviously we can offer improved efficiency of care. This has been all reported in multiple publications. So, in conclusion, proglyte technical success in a PIVAR and LIFE trial was 94 and 97% respectively. There are several post-intervention large bore vascular closure devices that are emerging. There are several benefits of those devices. Manta EU clinical trial technical success was 94% and Manta US pivotal trial technical success was 97.7%. Percusil EU trial technical success was 97% and enclosure EU trial technical success was slightly lower 83%. As I mentioned, there are numerous advantages and one of them would be to save time in emergent cases such as ruptured abdominal aortic aneurysm or ruptured thoracic aortic aneurysm and also for patients that need emergent hemodynamic support. Issues to be addressed. There is no reimbursement for any of the post-intervention large bore vascular closure devices at the present time nor for proglyte or pro-star for large bore closure. So that is something that we will need to work on in the future because the cost of those devices is of great concern to the hospitals and also to the interventionalists. Thank you very much for your attention.