Great. Thank you so much, David. That's a wonderful talk and overview, and I think, you know, David really highlights important areas in the future for indications for this procedure, some of which are still quite controversial at this point. So Dr. Kavinsky next will be speaking to us on the physician and institutional recommendations for the procedure. Please go ahead, Clifford. Thank you, Jackie. I'll try and be brief. I hope everyone hears me okay and everyone sees my slides. You know, the process, the regulatory process leading to approval of percutaneous devices for left atrial appendage occlusion is a long one, spanning 18 to 20 years and finally leading to approval on March 13, 2015. And the various stakeholder societies who were involved, mainly SCAI and HRS and ACC, realized immediately that the importance of establishing some kind of criteria for the performance of this procedure. And it planned in advance to have a series of several documents over time to guide the dissemination of this procedure to a broader population of patients. It was felt that the societies were responsible to ensure the safe and effective use of this. And as I said, it was a decision of the stakeholder societies to form a coalition to address left atrial appendage closure. And this began with the first publication in 2015. Again, multisocietal, addressing the critical issues surrounding left atrial appendage occlusion. To address the important questions that needed to be answered in subsequent documents. For example, what should be the equipment of performing centers, physician training, the importance of patient follow up, institutional reporting, the need for registry, and to address patient selection in terms of those patients not included in the randomized clinical trials. And then that was followed the following year by the again multisocietal recommendation summarizing operator and institutional requirements for left atrial appendage occlusion. And the questions addressed in this document, namely focused on, began to laser in on who should be performing this procedure in terms of the cognitive and technical skill sets. What should be the training and experience physicians performing this procedure. What should be the institutional resources to support this procedure, and then the importance of reporting outcomes in a registry format and quality metrics. So those that was the purpose of this document, and the cognitive skill sets are summarized here and I'm not going to go through them in any great detail except people need to understand the diagnosis and management of atrial fibrillation, specifically the oral anticoagulants, and the anti arrhythmic agents and understanding the leading issues surrounding oral anticoagulants. They needed to understand the indications risks and benefits of the various procedures used to address the left atrial appendage, and to understand the anatomy. Again, the issues of proper patient selection has been particularly important for this procedure. The technical skill sets included a knowledge and appropriate experience with transeptal puncture techniques through an intact septum. This is obviously essential to the safe and effective performance of this procedure manipulation of sheath and catheters within the left atrium. To build upon this, it was felt that performing physicians should have a background in both transeptal puncture and manipulating devices and catheters in the left atrium and there are a whole series of procedures which we feel we felt gave you requisite experience to move on to left atrial appendage closure. And then the technical skill sets we felt people had to know, be knowledgeable about the interpretation forms of imaging, which are essential for this procedure. The indications and contraindications, a mastery of recognition of procedure related complications in their treatment and management of vascular access and of course once again transeptal puncture. The document also addressed training, which could be accomplished through any number of mechanisms including fellowship or industry sponsored training, viewing live cases, having proctors, any number of ways in which you can get proper training for a potential implanter. So this led up to this final table which focused on the procedural and institutional requirements for this procedure, and I'm not going to go through every line but I'm going to focus on certain key aspects. For a proceduralist implanter, it was felt that they should have a 15 lifetime structural left-sided catheter ablation procedures of at least 25 should be involved transeptal puncture through an intact sectum. This said, you should have understanding of stroke and the bleeding risk and atrial fibrillation and the appropriate treatment strategies. Be able to recognize and treat complications. Have adequate training on the devices to be used, understand the anatomy, and over two years on an ongoing basis individual should perform 25 procedures involving transeptal puncture, 12 of which should be left atrial appendage occlusion, and the process for identifying any additional training that should be focused on as well. The institution should have adequate experience in structural procedures. There should be adequate support in terms of transesophageal echocardiography, anesthesiology, as well as a multidisciplinary team and a cardiovascular surgical support. And then data collection and quality focus on registry reporting and quality metrics. So this is where the field stands and this is what led up to the current document which we're discussing tonight. And if we look further into the future, I believe that there will be a guideline document coming in the next couple of years.

left atrial appendage occlusion procedures

regulatory process

recommendations

percutaneous devices

stakeholder societies