{"id":15780,"date":"2012-01-31T15:32:11","date_gmt":"2012-01-31T20:32:11","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=expert-is-in&p=15780"},"modified":"2012-01-31T15:32:11","modified_gmt":"2012-01-31T20:32:11","slug":"guiding-tavr-into-clinical-practice","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/01\/31\/guiding-tavr-into-clinical-practice\/","title":{"rendered":"Guiding TAVR into Clinical Practice"},"content":{"rendered":"

The ACC, AATS, SCAI, and STS have issued a critical consensus document<\/a> to\u00a0guide the use of transcatheter aortic valve replacement (TAVR) as it enters clinical practice in the U.S. (see also our CardioExchange news coverage here<\/a>).\u00a0CardioExchange Interventional Cardiology moderators\u00a0Rick Lange<\/a>\u00a0and\u00a0David Hillis<\/a>\u00a0posed the following questions to writing committee member\u00a0Steven R Bailey, the\u00a0Janey Briscoe Distinguished Professor of Medicine and Radiology and Chief of the Division of Cardiology at the\u00a0University of Texas Health Science Center at San Antonio.<\/em><\/p>\n

Rick Lange and David Hillis (RL and DH):\u00a0Consensus guidelines are nothing new. Why are these getting so much publicity?<\/em><\/strong><\/p>\n

Steven Bailey:\u00a0<\/strong>Guidelines now address two levels of clinical practice. The multisociety Clinical Practice Guidelines are based specifically upon peer reviewed studies that provide evidence\u00a0on how to treat specific conditions or how\u00a0to use specific modalities (STEMI, stable angina, echo, etc.). These recommendations\u00a0are often population-based.<\/p>\n

The Appropriate Use Criteria (AUC) are designed to provide assistance not only to specialists but also to the general physician who wants to understand how to use testing and procedures in specific patient scenarios. The AUC\u00a0recommendations fall into three\u00a0categories:\u00a0Appropriate, when we have published information to support\u00a0practice;\u00a0Uncertain,\u00a0when\u00a0the procedure is commonly used in\u00a0clinical practice\u00a0but we do not have clear-cut information\u00a0about its use\u00a0in a specific scenario; and Inappropriate, when published data indicates possible harm. These guidelines serve as guideposts\u00a0in areas that require further investigation.<\/p>\n

The current document is an Expert Consensus statement,\u00a0described by the ACC as follows:<\/p>\n

\n

Expert consensus documents are intended to inform practitioners, payers, and other interested parties of the opinion of the ACCF concerning evolving areas of clinical practice and\/or technologies that are widely available or new to the practice community\u2026These documents are evidence-based whenever possible but tend to be shorter than guidelines, as they are developed around a topic that is more narrowly focused, that is new or emerging, and for which a smaller body of evidence is available.<\/p>\n<\/blockquote>\n

The interest is also driven by external groups (patients, payers, and other agencies) who have interests in how we provide care and what choices can be selected.<\/p>\n

RL and DH:\u00a0Transcatheter aortic valve replacement (TAVR) is heralded as “transformational.” Isn’t this\u00a0a bit over the top?<\/em><\/strong><\/p>\n

<\/em>Bailey:\u00a0<\/strong>TAVR has\u00a0transformed delivery of\u00a0care for patients\u00a0with valvular heart disease in two major ways. First, the proof of efficacy, in high-risk surgical patients as well as in \u00a0patients who are not surgical candidates, sets the stage for evolution of this technology to smaller, more effective devices. This is similar to the evolution\u00a0of surgical valves from the Hufnagel valve to the tissue valves we us today.<\/p>\n

But perhaps the most important “transformation” has been in the development of a multidisciplinary team (cardiology, cardiothoracic surgery, echo, imaging, anesthesia, and geriatrics) to make decisions regarding the best care for individual patients.<\/p>\n

RL and DH:\u00a0Are you concerned that “real world” TAVR results won’t be as good as those reported in the PARTNER studies?<\/em><\/strong><\/p>\n

Bailey:\u00a0<\/strong>We should expect that outcomes in\u00a0“real world” patients may not\u00a0be the same as\u00a0in highly selected patients at the few experienced centers who participated in this pivotal study. The current process of only allowing the procedure at a limited number of centers, with state-of-the-art facilities and\u00a0multidisciplinary teams\u00a0who are actively assisted with patient selection and the initial procedures, will be very important in enabling\u00a0the selection of\u00a0those patients who are most likely to have outcomes similar to those seen in the PARTNER nonsurgical arm.<\/p>\n

RL and DH:\u00a0The data from all TAVR patients are supposed to be entered into a national database. Do you think this will be effective in assuring that TAVR is used appropriately?<\/em><\/strong><\/p>\n

Bailey:\u00a0<\/strong>Follow-up of patients who receive TAVR is critically important to allow centers to compare their results to those seen regionally and nationally. It will not be the sole method for assuring appropriate use, but it is critical to ensuring accountability for outcomes.<\/p>\n

RL and DH:\u00a0The transcatheter valve alone will cost \u2248$30,000. Is TAVR cost effective, especially since it is being used in an elderly population?<\/em><\/strong><\/p>\n

Bailey:\u00a0<\/strong>The current cost analysis by Cohen et al. does suggest that the costs of TAVR, even in this elderly population,\u00a0are consistent with costs that our society accepts for lifesaving and life-prolonging therapy such as dialysis. This becomes an important decision in each individual patient. Experience shows that these costs will likely decrease over time, resulting in a more favorable cost-effectiveness analysis.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

The ACC, AATS, SCAI, and STS have issued a critical consensus document to\u00a0guide the use of transcatheter aortic valve replacement (TAVR) as it enters clinical practice in the U.S. (see also our CardioExchange news coverage here).\u00a0CardioExchange Interventional Cardiology moderators\u00a0Rick Lange\u00a0and\u00a0David Hillis\u00a0posed the following questions to writing committee member\u00a0Steven R Bailey, the\u00a0Janey Briscoe Distinguished Professor of […]<\/p>\n","protected":false},"author":442,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,1,9],"tags":[775,795,424,429,423,770],"class_list":["post-15780","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-general","category-interventional-cardiology","tag-aortic-repair","tag-aortic-valve-repair","tag-aortic-valve-replacement","tag-aortic-valve-stenosis","tag-tavi","tag-tavr"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15780","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/442"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=15780"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15780\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=15780"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=15780"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=15780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}