{"id":29926,"date":"2012-06-26T11:05:58","date_gmt":"2012-06-26T15:05:58","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&p=29926"},"modified":"2012-06-26T11:05:58","modified_gmt":"2012-06-26T15:05:58","slug":"unlikely-partners-support-tavr","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/06\/26\/unlikely-partners-support-tavr\/","title":{"rendered":"Unlikely PARTNERs Support TAVR"},"content":{"rendered":"

I had the privilege of serving on both Circulatory Device Advisory Panels that recommended FDA approval of the Sapien Transcatheter Heart Valve (Edwards LifeSciences) in patients with severe, symptomatic, aortic stenosis \u2014\u00a0in June 2011<\/a> for those who are inoperable and in June 2012 <\/a>for those at high risk for complications of surgical aortic valve replacement (AVR) \u2014\u00a0on the basis of the PARTNER B<\/a> and PARTNER A<\/a> trials, respectively.<\/p>\n

Here\u2019s an insider\u2019s perspective on the process:<\/em><\/strong><\/p>\n

1) The collaborative support for TAVR by cardiac surgeons and interventional cardiologists is unprecedented.\u00a0I never imagined I\u2019d see the president of the Society of Thoracic Surgery (STS) championing a percutaneous cardiac procedure . . .\u00a0<\/em><\/strong>much less\u00a0doing so twice.<\/p>\n

2) Sponsor collaboration with the FDA, the Center for Medicare Services (CMS), STS, and the American College of Cardiology (ACC) resulted in a groundbreaking collaborative national registry for TAVR. This sets the standard for future post-marketing studies . . . <\/em><\/strong>a long overdue development.<\/p>\n

3) Edwards LifeSciences demonstrated a disciplined commercial rollout of this technology in the United States, a sincere commitment to training, and ongoing tracking of procedure success. Hats off to Edwards. Take a bow.<\/em><\/strong><\/p>\n

Any concerns\u00a0about TAVR?\u00a0 Naturally!<\/em><\/strong><\/p>\n

1) Patient\u00a0sex <\/em><\/strong>may influence effectiveness. \u00a0A post hoc analysis of PARTNER\u00a0A<\/a> data showed noninferiority of TAVR\u00a0to surgical AVR in\u00a0women but not in men (in fact, treatment effects were in the opposite direction for men and women).<\/p>\n

2) Strokes<\/em><\/strong> are more common with TAVR than with surgical AVR (at\u00a01 year, 5.5% vs. 2.9%) and more common with the transapical then with the transfemoral approach (at\u00a01 year, 9.6% vs .4.6%). Interestingly, the stroke rate in the Continued Access Protocol (nonrandomized) cohort appears to have decreased (at\u00a01 year, 3.7%). Studies are needed to determine the role of procedural technique, patient selection, antithrombotic agents or other factors that may be responsible for this difference.<\/p>\n

3) Approximately 15% of TAVR-treated patients develop moderate or severe paravalvular aortic regurgitation, <\/em><\/strong>which is associated with increased mortality.<\/strong><\/em><\/p>\n

4) Valve<\/em><\/strong> durability<\/em><\/strong> is unknown.\u00a0It just hasn\u2019t been around long enough.<\/p>\n

The FDA and sponsor agree that post-approval studies are essential. In addition to extending follow-up for the patients enrolled in the PARTNER trial, a prospective registry of\u00a0consecutively enrolled patients undergoing TAVR is needed.<\/p>\n

Based on what we know,\u00a0would you generally prefer\u00a0TAVR\u00a0over surgical AVR in patients considered to be high-risk (surgical mortality ><\/span>15%)?<\/em><\/strong><\/p>\n

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

The FDA approval of TAVR and the design of postmarketing surveillance involved a remarkable degree of collaboration and cooperation among the stakeholders. What to do while we wait for data to accumulate?<\/p>\n","protected":false},"author":214,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,9],"tags":[424,222,396,770,1051],"class_list":["post-29926","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-interventional-cardiology","tag-aortic-valve-replacement","tag-fda-approvals","tag-partner","tag-tavr","tag-valve-surgery"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29926","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\/214"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=29926"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29926\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=29926"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=29926"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=29926"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}