 The topic of this presentation is on complications from closure devices. Current FDA approved closure devices for five to seven French sheaths include variety of devices that are listed here. There are unique characteristics for each of the devices as mentioned here. ProStar XL is one of the oldest devices that has been used since 1994. It has a braided suture and it's a 10 French device. ProGlide is a newer version of a closure device which is suture mediated similar to ProStar. The only difference is it has a mono filament suture rather than braided suture and both of them are from Abbott vascular. Another Abbott vascular device is Star-Close SE that uses nightingale clip and this device is not as frequently used as ProStar. Cordyce and Cardinal Health have several devices. ExoSeal Minx Grip and the newest comer is Minx Control. This device uses Extravascular PGA plug and Extravascular PGA PG sealant. Another one is by Cardiva Medical that started with Boomerang and then Catalyst 1, 2, and 3 and the latest one is Vascade. It uses Kaolin and Chitocin and Protamine in earlier generation devices and more recently it uses Collagen for controlling the bleeding. Fish by Morris Innovative devices rarely used. It uses SIS arterial plug and finally Turumo has several devices. Angioseal VIP and more recently Angioseal Evolution that uses Collagen plug and bioabsorable anchor. Now a variety of vascular closure devices have been tried and they all have their idiosyncrasies and complexities and complications related to the use of those devices. As far as vascular closure devices are concerned and incidence of complications the most common one is bleeding that is seen in roughly about 70% of patients that are referred to surgery. Infection is the second most common type of complication that is roughly occurring in about 39% of cases and finally ischemia occurs in about 28% of cases of patients that are referred to surgery. Pseudoaneurism is present in about 20% of patients that are referred for surgery. Manual compression also has obviously complications related to this particular technique and the most common complication is occurrence of pseudoaneurism that occurs in about 71% of cases that are referred to surgery. Hemorrhage is the second most common one and occurs in about 32% of patients and finally AV fistula in about 15% of patients. When we look at the meta-analysis and studies in more than 10,000 of patients related to incidence of complications with the use of vascular closure devices versus manual compression we can see that the incidence of vascular complications with vascular closure devices occurs somewhere between 1.1% to 2.5%. What we can see is that in most of the studies when compared to vascular closure devices and manual compression the risk of complication is somewhat higher with vascular closure devices than with manual compression. So vascular closure devices in general do not decrease the incidence of vascular complications they only save time as far as length of being bedridden after the procedure. Here is one of the studies so-called respect perspective randomized clinical trial that compared manual compression to a variety of devices including angiocele, perclose, proglide, starclose, minx, exocele and what we can see here is that one of the lowest incidence of vascular complications as far as major complications are concerned occurs with manual compression. All the other ones have a significantly higher incidence of vascular complications than manual compression except for exocele and vascate. We can see that certain devices have low incidence of minor vascular complications and certain ones such as exocele has a significantly higher incidence of vascular complications which are qualified as minor which probably relates in most of the occasion to bleeding and occurrence of hematoma. One of the most important factors as far as complications are concerned related to the use of vascular closure devices is operator experience. As we can see here there is a significant learning curve for most of the vascular closure devices and really the incidence of vascular complications drops significantly after the operator gains experience in over 250 to 350 cases and after that we achieve a certain plateau and significantly lower incidence of vascular complications than in the first 25 or 75 or 100 cases. Variety of vascular complications can occur with the use of vascular closure devices and here is one of the examples in the relatively young individual that had a procedure done. This was a diagnostic procedure with the use of collagen-based closure device. We can see thrombosis occlusion of the left iliac artery. In this particular patient intervention was performed with thrombolysis and mechanical thrombectomy to re-establish the flow to the left lower extremity. Another relatively common complication particularly for those that are not using vascular ultrasound to gain access at the common femoral artery is the stick that is too high and bleeding in the retroperineum as shown here. So retroperineal bleeding can carry significant consequences and it should be avoided by all means because this is probably one of the most traumatic and serious complication that can occur due to suboptimal imaging and suboptimal access when using vascular closure devices. Now what about large bore vascular closure devices which are devices for accesses larger than 10 French and all the way up to 25 French. In the United States at the present time we have three devices that are approved for clinical use. The oldest one is ProStar XL. It's a 10 French braided suture medium vascular closure device that has been approved in the European Union for large bore femoral artery closure all the way up to 24 French but not in the United States. This device has a prolonged learning curve, has over 30 steps to be able to deploy the device safely and for that particular reason is not very extensively used. Another device is ProGlide which is a six French suture mediated monofilament vascular closure device that is approved in the United States for large bore closure all the way from 12 French to 21 French OD. This device is very commonly used for diagnostic and also interventional procedures. It has a significantly shorter learning curve than ProStar and therefore it offers to the operators great results with a relatively short experience and short learning curve. One of the disadvantages of this device is that frequently it will require the use of two devices for large bore access and occasionally if you have a failure of hemostasis three devices might be used for large bore access such as 21 French or all the way to 24 French which is not uncommon for T-VAR procedures and also for TAVR procedures. More recently we have a Manta device that has been approved for clinical use for large bore access and there are two devices 14 French device and 18 French device. Those devices are approved in United States and also abroad in European Union for large bore access repair all the way to 25 French OD. This device has a shorter learning curve and what is also very important this device can be used after the intervention so it means at the end of the procedure which is advantageous in certain scenarios such as emergency cases, ruptured abdominal and ruptured thoracic aortic aneurysms. What is very important is that such immediate closure devices such as ProGlide and ProStar can be only used in a pre-closed fashion it means at the end of the procedure we cannot use those devices they have to be used at the beginning of the procedure with which adds extra time. Manta on the other hand has advantages because it can be used at the end of the procedure and it saves time. Some of the complications related to large bore closure devices are for instance ProStar has complexities as we have mentioned as far as deployment is concerned but also it cannot be used in certain scenarios or has a significantly higher incidence of complications when we deal with calcifications, excessive fibrosis or scarring, post-surgery or the use of previous closure devices and also lack of operator experience or inexperience with this particular device. Very rarely we can encounter faulty device but that probably is very rare. As far as per-close ProGlide is concerned this device is commonly used and the advantages are that it can be used over the wire and in case if we have a failure of closure another device can be used to prevent complications such as shown here with hematoma, bleeding, retroperitone, hematoma and so on. Occasionally if this device is not properly used or if we have significantly diseased arteries with atheroma we can encounter dissection as it is shown in the lower picture on the right hand side and then this particular complication can lead to thrombosis embolization and occlusion of the access site artery. Here is another example of a patient that had the procedure done via left femoral approach for TAVR with large bore sheath all the way up to 24 french sheath. We can see before TAVR the access site was accessed with the micro puncture needle. We can see the artery was normal in size without any evidence of significant obstruction and at the end of the procedure after deployment of a collagen-based large bore closure device we can see occlusion of the access site and thrombosis at the access site. So one has to take images from the contralateral approach or use the ultrasound to make sure that the access site is patent after the use of collagen-based large bore closure devices to prevent serious complications like it occurred in this particular patient that needed an intervention to resolve this problem. So in comparison between Manta and other closure devices primarily Sucha media closure devices and surgery here we have this bar graph related to major complications and minor complications and in a table above we can see the results from the european c mark trial with the use of Manta device we can see also the results from the us id pivotal trial with Manta and also european union post market registry with the use of Manta device. What is very important is that obviously in clinical trial we expect better results than in a registry because in registry there is less rigorous analysis and limitations as far as inclusion and exclusion criteria are concerned. We can see that the vark2 major vascular complications occurred in those three studies somewhere in the range between 1.9 to 4.2 percent and as far as minor vascular complications are concerned they occurred from zero to 2.7 percent. Now in the bar graphs if we compare the results from the Manta clinical trials and registries we can see the incidence of major and minor vascular complications are significantly lower than with pro star proglide and also with the surgical access and repair and also as far as composite information is concerned for major and minor vascular complications. So obviously the newer generation devices are addressing this problem in a positive way as far as avoiding major and minor vascular complications are concerned. So why do large bore access site complications persist? There are numerous factors that play a significant role in this particular problem and complication. Some of them are as listed here patient related, vessel diameter matters, the smaller the vessel, the larger the incidence of complications particularly when you have severe vessel calcifications and stenosis and also tortuosity. Multiple procedures also play a significant role as far as complications are concerned because there is more manipulation in the device and the chances that the device might not perform well. Patients with morbid obesity have significantly higher incidence of complications and not all devices are designed to work perfectly in morbidly obese patients. Gender also plays a role not necessarily for any other reason than that females in general have smaller axis vessels and when using large sheets trauma can occur at the axis site and also females that develop vascular disease have in general more extensive disease and more atherosclerotic disease of not only axis vessels but also of the iliac arteries and the aorta as well. Vessel tortuosity plays a significant role and certain devices should not be used with extremely tortuous axis site vessels. Presence of peripheral arterial disease of the lower extremities plays also significant role as well emergency cases that are required to be done on emergency basis and there might not be adequate time to appropriately evaluate the axis site such as the use of CT and ultrasound to achieve proper access. There are also numerous physician related complications that occur and probably the most important one is experience whether with a suture media closure device or with collagen-based closure device that is currently or that are currently available. Presence of a multi-specialty team is also very important which means that a surgical backup is of great benefit and presence of a surgeon during procedure particularly when using large bore sheets is of importance to prevent or efficiently address and resolve the problem. The use of ultrasound to gain access is extremely important particularly for the use of large bore sheets in being able to assess the axis site and decide whether proper access has been obtained. Also aggressive manipulation of devices and sheets during the procedure can add to complexity and complications related to the procedure. Inaccurate measurements or lack of measurements such as CT imaging or ultrasound imaging that is not done or is not properly done can be a problem. Prolong procedures also add to complications particularly related to thrombosis and ischemia of the lower extremities and then finally complications can occur due to different use of devices. For instance EVAR, T-VAR and TAVR procedures require the use of large bore devices and not all devices are created equal and some of them might perform better in one scenario and might not perform better in another scenario. So the interventionist has to become familiar with each device that he or she might be using and to determine the idiosyncrasies advantages and disadvantages of each device in each particular scenario. Now some of the procedures have devices that are sheath based and those might be beneficial as far as avoiding complications because there is less manipulation rather than using a device percutaneously and then placing the sheath after that that can potentially traumatize the axis site. Delivery profile matters to a significant degree and that has been clearly documented in literature and clinical trials. The larger the profile the higher the incidence of complications and finally the use of closure device and familiarity with closure device plays a significant role. So in conclusions proper patient selection and adequate imaging are essential to avoid major axis site complications. This is particularly true when using large bore axis site devices. One should gain experience with axis site closure devices to be able to use them judiciously. When having difficulty in advancing large profile sheets or devices through iliac artery one should anticipate possible complications such as spasm, rupture, laceration, or evulsion and then complications related to such as retroperneal bleed and severe hypotension. To avoid those type of problems and to be able to address them in a judicious and exponential way one should make sure to maintain wire access until hemostasis is achieved. The contralateral femoral artery axis is also very important to prevent or stop retroperneal bleeding by inflating a compliant balloon in abdominal aorta or ipsilateral iliac artery. We should also make sure that we are able to identify the site and type of bleeding and on the basis of this information we'll be able to decide what is the most appropriate procedure to resolve any particular problem. This is particularly true in scenarios of severe iliac artery damage such as dissection, laceration, or evulsion to decide whether the intramational procedure is beneficial or possible or maybe is surgical acts as the only reasonable way to address and resolve this problem. One should also have appropriate size endographed available and this is particularly true for problems related to retroperneal bleeding and trauma to the iliac vessel and that should be available to the operator on a routine basis without any significant delay. Also whenever using large bore devices such as for EVAR, TEVAR, and TAVR, blood transfusion should be available and should be administered in a very expeditious way without major delay when hypotension occurs. And finally surgical and anesthesia services should be available whenever using large bore devices, large bore closure devices, and when encountering complications related to the use of large bore closure. Thank you very much for your attention.