{"id":28615,"date":"2012-05-02T17:13:52","date_gmt":"2012-05-02T21:13:52","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&p=28615"},"modified":"2012-05-02T17:13:52","modified_gmt":"2012-05-02T21:13:52","slug":"httpwww-nejm-orgdoifull10-1056nejmoa1008232","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/05\/02\/httpwww-nejm-orgdoifull10-1056nejmoa1008232\/","title":{"rendered":"Real-World Experience with TAVI: Vive la France!"},"content":{"rendered":"

A study of data from FRANCE 2<\/a>,\u00a0a prospectively maintained, multicenter registry of the French national experience with transcatheter aortic valve implantation (TAVI),\u00a0has now been\u00a0published in the New England Journal of Medicine<\/em>. The registry captured every TAVI performed at all 34 active centers in France and Monaco; it therefore\u00a0reflects \u201creal-life” experience with TAVI <\/em><\/strong>in patients with severe aortic stenosis who were not candidates for surgical aortic valve replacement\u00a0(AVR) because of\u00a0coexisting conditions.<\/p>\n

The procedural success rate was 97% in the 3195 patients enrolled between January 2010 and October 2011, with approximately 2\/3 of patients receiving the Edwards SAPIEN device and 1\/3 receiving the Medtronic CoreValve device.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u00a0\u00a0\u00a0\u00a0\u00a0Outcome<\/p>\n<\/td>\n

\n

Incidence<\/p>\n<\/td>\n<\/tr>\n

1 month <\/strong><\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0\u00a0\u00a0\u00a0 Death<\/td>\n\n

9.7%<\/p>\n<\/td>\n<\/tr>\n

\u00a0\u00a0\u00a0\u00a0 Stroke<\/td>\n\n

3.4%<\/p>\n<\/td>\n<\/tr>\n

\u00a0\u00a0\u00a0\u00a0 Periprosthetic aortic regurgitation<\/td>\n\n

64.5%<\/p>\n<\/td>\n<\/tr>\n

\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
1 year<\/strong><\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0\u00a0\u00a0\u00a0 Death<\/td>\n\n

24.0%<\/p>\n<\/td>\n<\/tr>\n

\u00a0\u00a0\u00a0\u00a0 Stroke<\/td>\n\n

4.1%<\/p>\n<\/td>\n<\/tr>\n

\u00a0\u00a0\u00a0\u00a0 Periprosthetic aortic regurgitation<\/td>\n\n

66.9%<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Survival was significantly influenced by preoperative factors (NYHA class, EuroSCORE) and the presence of periprosthetic regurgitation.<\/p>\n

We find\u00a0two things interesting about this study: the procedure and the process<\/em><\/strong>.<\/p>\n

Regarding the procedur<\/strong>e, it is gratifying that the \u201creal-world experience\u201d parallels the results\u00a0of the randomized PARTNER B\u00a0<\/a>trial.<\/p>\n

Regarding\u00a0the process,<\/strong> more than 50,000 patients have been treated by TAVI worldwide,\u00a0despite the\u00a0publication of only one randomized trial comparing TAVI with medical therapy in patients in whom surgery was contraindicated (PARTNER B, in 2010)\u00a0and only one trial\u00a0comparing TAVI\u00a0with surgical aortic valve replacement <\/a>in high-risk patients (PARTNER A, in 2011).<\/p>\n

Both the Edwards SAPIEN and the Medtronic CoreValve devices gained CE Mark <\/a>(abbreviation of French: Conformit\u00e9 Europ\u00e9enne, <\/em>meaning \u201cEuropean Conformity\u201d) approval for European commercial sales in 2007<\/em><\/strong>, well ahead of the randomized trial results published in 2010. The U.S.\u00a0FDA approved the Edwards SAPIEN device in November 2011,<\/a><\/em><\/strong> after review by the Circulatory Device Panel in July 2011 (and only for patients who cannot undergo surgical AVR, not yet for those considered eligible but at high risk for surgical AVR).\u00a0At this time, the Medtronic CoreValve is not FDA-approved.<\/p>\n

The FDA approval process typically lags behind the European one by years. Do you feel safer\u00a0\u2014 or shortchanged\u00a0\u2014 by our device approval process?<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

A study of data from FRANCE 2,\u00a0a prospectively maintained, multicenter registry of the French national experience with transcatheter aortic valve implantation (TAVI),\u00a0has now been\u00a0published in the New England Journal of Medicine. The registry captured every TAVI performed at all 34 active centers in France and Monaco; it therefore\u00a0reflects \u201creal-life” experience with TAVI in patients with […]<\/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":[794,424,710,196,1248,396,912,423],"class_list":["post-28615","post","type-post","status-publish","format-standard","hentry","category-cardiac-surgery","category-interventional-cardiology","tag-aortic-stenosis","tag-aortic-valve-replacement","tag-corevalve","tag-fda","tag-france-2","tag-partner","tag-sapien","tag-tavi"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28615","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=28615"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28615\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=28615"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=28615"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=28615"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}