Welcome to Lesson 1 of ACC's Transcatheter Valve Certification Overview course. This learning activity was developed by myself. I am Liza St. Clair and I will also be narrating this presentation. The purpose of this lesson is to provide a basic understanding of the current obstacles that many structural heart programs are enduring to establish and maintain their transcatheter valve programs. Our objective for this module is to define the current heart valve disease population and their current challenges. First, let's review the prevalence of valvular heart disease. More than 5 million Americans are diagnosed each year with valvular heart disease. About 1.5 million suffer from aortic stenosis, with a third of those actually suffering from severe aortic stenosis and showing symptoms. An estimated 4 million people also suffer from mitral valve insufficiency, with an annual incidence of 250,000 suffering from mitral regurgitation. As shown here and published by the Centers for Disease Control and Prevention, the percentages of death due to valvular heart disease are mostly due to disease with the aortic valve or aortic stenosis. Next comes mitral valve disease, which comes at 15%. So we know that many are in fact diagnosed with heart disease at 5 million, but in actuality it is staggering to look at how many patients are undiagnosed and may benefit from proper care or intervention, which is partly stemmed from inequities within the health care systems and access to care. Without an aortic valve replacement, those with severe aortic stenosis will have a 25% mortality rate in one year. And as many as 50% of patients with severe aortic stenosis will not survive more than an average of 2 years after the onset of symptoms. And as shown in this graph, there is between a 60-70% mortality rate at 5 years. And as shown in this illustration, there is a 57% mortality rate at 1 year for those suffering with severe mitral regurgitation. So facing such a high probability of mortality, there had to be a way to address the need for those needing a valve repair or replacement for this population. Many of those diagnosed with valvular heart disease are exhibiting symptoms late in the stage of this disease, are of older age, and have significant risk factors that would prohibit them from undergoing a regular open heart valve surgical intervention. Already released in the European market, the FDA approved the first transcatheter aortic valve replacement device in the United States in the fall of 2011. This was essentially a large stent-like device with a bioprosthetic valve in the middle. The first FDA approved device was the Edward Sapien TAVR valve and was indicated for inoperable patients. Within a short 5 year time frame, the company has made enhancements such as adding skirts to minimize paravalvular leaks to the product and is now on their third generation of this device. They now offer Edward Sapien III, XT, and Ultra. In addition, Medtronic Corevalve's family of devices has also been FDA approved and is comprised of the Medtronic Corevalve system, which was the first device to be approved for valve-in-valve. The second generation device was Medtronic Corevalve's Evolute-R system. This allowed the operator to recapture and reposition the valve device if necessary. The third generation device is Medtronic Corevalve Evolute-Pro system. This actually provides an external tissue wrap that again minimizes paravalvular leaks. And the latest product that they offer is the Evolute-Pro Plus, which provides a smaller profile catheter for delivery and implantation. As the devices became more sophisticated, the FDA's indication for use also became more laxed. So, the devices that were once deemed to be only appropriate for inoperable, high-risk patients is now available to low-risk patients. And more options were provided on access site to implant the device and move beyond the standard femoral approach. And almost one year later, after the first TAVR device was introduced, in October of 2013, Abbott received FDA approval for their MitraClip transcatheter device to repair the mitral valve. With this rapidly growing market, there are many transcatheter valve devices that are awaiting FDA approval. Therefore, we anticipate that the structural heart programs of today must be nimble and prepared to accept and provide these new technologies as they are released into the market. Six months after the first TAVR device was released, in May of 2012, the Centers for Medicare and Medicaid provided a long-anticipated national coverage decision memorandum. It stipulated certain requirements needed to be met in order to receive reimbursement for TAVR procedure. CMS provided the basis for how TAVR programs would be established and maintained. Certain criteria needed to be met. And the CMS NCD for TAVR was last updated in 2019. It stipulated that not just the suitability of TAVR needed to be evaluated, but also the appropriateness for surgical aortic valve replacement, TAVR, medical, or palliative therapy must also be considered for treatment of valve disease. They also adjusted staffing levels and hospital volume requirements, and also required hospitals to track the incidence of complications that were related to dysrhythmias and needing a new permanent pacemaker. It also stipulated that sites that do provide the TAVR procedure need to continue participation in a national registry. CMS also released a national coverage decision memorandum for the transcatheter mitral valve repair procedures in 2014, and was recently updated early this year in 2021. The memorandum re-termed transcatheter mitral valve repair to mitral valve transcatheter edge-to-edge repair to better reflect the technology of the MitraClip device. It also expanded the use of this device for both degenerative and functional mitral regurgitation. It also stipulated that the mitral valve heart team must be expanded and include an interventional echocardiographer, which could be a cardiologist or anesthesiologist, and a heart failure cardiologist must be available for functional MR and evaluate the patient. It also stipulated that those that provide this procedure must continue to participate in a national registry. And until recently, there were questions on the timing of a surgical or transcatheter intervention. And in 2020, the ACC and AHA updated the valvular heart disease guidelines to provide additional guidance on this. The guidelines are provided within the references of the essential components within the online tool. In this specific example and diagram, you can see for aortic stenosis when a surgical or transcatheter AVR would be appropriate. And most importantly, the new guidelines establish a class one recommendation for a shared decision making process when determining the patient's course of treatment. The guidelines also provided recommendations for patients to undergo mitral valve surgery or a mitral valve tear procedure for degenerative mitral regurgitation or primary mitral regurgitation. And lastly, the guidelines also provided guidance on when to consider mitral surgery for those patients suffering from functional mitral regurgitation or secondary mitral regurgitation. Transcatheter AVR outcomes are very favorable and cannot be ignored. They are comparable to surgical AVR outcomes. As previously noted, all cause mortality was close to 25% at one year for those suffering with severe aortic stenosis. Now with an intervention, the mortality in any major complication is down to 10%. The same can also be said for the mitral valve tear procedure, where one year mortality was predicted at 57% is now down to 25.8%. And due to the success of these transcatheter devices, hospitals are now racing to establish their structural heart programs. But remember, we are only at the beginning of this long marathon. We have tapped into valuable knowledge and are learning to apply these new concepts into other areas. So we need to remember it's a marathon and not a sprint. This concludes lesson 104. Thank you for your participation.

structural heart programs

transcatheter valve programs

valvular heart disease

transcatheter valve replacement devices

favorable outcomes

TAVR

transcatheter mitral valve repair

CMS guidelines

ACC's Transcatheter Valve Certification Overview

obstacles faced by structural heart programs

transcatheter valve interventions

evolution of transcatheter valve devices