{"id":29567,"date":"2019-03-17T13:05:56","date_gmt":"2019-03-17T18:05:56","guid":{"rendered":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/?p=29567"},"modified":"2019-08-21T18:05:59","modified_gmt":"2019-08-21T23:05:59","slug":"low-risk-tavr-clinical-trial-results","status":"publish","type":"post","link":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2019\/03\/17\/low-risk-tavr-clinical-trial-results\/","title":{"rendered":"Low-Risk TAVR Clinical Trial Results Released"},"content":{"rendered":"<p>Finally!\u00a0 We have results for one of the most talked about heart valve clinical trials at HeartValveSurgery.com!<\/p>\n<p>On Friday, at the <a href=\"https:\/\/www.acc.org\">American College of Cardiology (ACC)<\/a> conference in New Orleans, the results for the low-risk, transcatheter aortic valve replacement (TAVR) were released.<\/p>\n<p>As for the results&#8230; Drum roll please&#8230;<\/p>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-29569\" src=\"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/..\/Images\/low-risk-tavr-clinical-trial.jpg\" alt=\"\" width=\"600\" height=\"314\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><!--more--><\/p>\n<p>The results of this clinical trial, known as the PARTNER 3 research study, were quickly applauded, cheered and celebrated!<\/p>\n<p>In fact, words like &#8220;game changer&#8221; have been used to describe the success of the clinical trial which investigated the use of the SAPIEN 3 device, a non-invasive treatment of aortic stenosis, in low-risk patients.\u00a0 <a href=\"https:\/\/www.heart-valve-surgery.com\/aortic-stenosis-valve-heart-narrowing.php\">Aortic stenosis<\/a> is an often mis-diagnosed and under-treated form of heart disease that can be fatal.<\/p>\n<p>&nbsp;<\/p>\n<h2>Data Compares Low-Risk TAVR to Surgical Aortic Valve Replacement<\/h2>\n<p>Similar to other clinical trials, the PARTNER 3 research study evaluated the outcomes of the current standard of care &#8211; surgical aortic valve replacement (SAVR) &#8211; to TAVR.\u00a0 As you may know, TAVR is a percutaneous and minimally-invasive method for replacing a stenotic aortic valve (i) without an incision the patient&#8217;s chest or ribs and (ii) without the use of the heart-lung machine.\u00a0 You can learn more about TAVR <a href=\"https:\/\/www.heart-valve-surgery.com\/tavr-procedure.php\/\">here<\/a>.<\/p>\n<p>Although TAVR was previously approved by the Food &amp; Drug Administration (FDA) in the United States for inoperable, high-risk and intermediate risk patients, the use of TAVR for low-risk patients was the sole focus of the PARTNER 3 study sponsored by Edwards Lifesciences.<\/p>\n<p>When comparing TAVR to SAVR in this low risk trial, here select data that Dr. Marty Leon and <a href=\"https:\/\/www.heart-valve-surgery.com\/surgeons\/dr-Michael-Mack-Plano-Texas.php\">Dr. Michael Mack<\/a>, the national principal investigators of PARTNER 3, revealed at the ACC for the 1,000 patient study:<\/p>\n<ul>\n<li>All cause death was 1% for TAVR and 2.5% for SAVR<\/li>\n<li>Stroke was 1.2% for TAVR and 3.1% for SAVR<\/li>\n<li>Re-hospitalizations were 7.3% TAVR and 11% for SAVR<\/li>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/atrial-fibrillation\/\">Atrial fibrillation<\/a> incidence was 5% for TAVR and 39.5% for SAVR<\/li>\n<\/ul>\n<p>At the same time&#8230;\u00a0 There was similar data to the previous TAVR clinical trials in which SAVR outperformed TAVR specific to select complications including:<\/p>\n<ul>\n<li>Vascular complications was 1.5% for SAVR and 2.2% for TAVR<\/li>\n<li>Permanent pacemaker implants was 4.1% for SAVR and 6.6% for TAVR<\/li>\n<li>Paravalvular leak was 0% for SAVR and 0.8% for TAVR<\/li>\n<li>Coronary artery obstruction was 0.2% for SAVR and 0.7% for TAVR<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2>Will TAVR Get FDA Approval for Low-Risk Patients?<\/h2>\n<p>Given the impressive results and data for the PARTNER 3 study, I&#8217;m guessing you might be wondering, &#8220;Will the FDA approve TAVR for low-risk patients?&#8221;<\/p>\n<p>Reflecting on that question, there are two important and integrated considerations.\u00a0 First, the data for PARTNER 3 is limited to a single year of patient outcomes and research.\u00a0 Second, the results do not address the potential long-term durability of the SAPIEN 3 aortic valve in low-risk patients.<\/p>\n<p>That said&#8230; The flood gates supporting FDA-approval of TAVR in low-risk patients have sprung wide open&#8230;<\/p>\n<ul>\n<li>According to a\u00a0<a href=\"https:\/\/www.nytimes.com\/2019\/03\/16\/health\/aortic-valve-replacement-heart.html?action=click&amp;module=Well&amp;pgtype=Homepage&amp;section=Health\">New York Times report<\/a>, &#8220;The Food and Drug Administration is expected to approve the procedure for lower-risk patients. As many as 20,000 patients a year would be eligible for TAVR, in addition to the nearly 60,000 intermediate- and high-risk patients who get the operation now.&#8221;<\/li>\n<li>Dr. Howard Herrman, a cardiologist at the University of Pennsylvania&#8217;s Heart &amp; Vascular Center stated, &#8220;[This] trial will result in approval of TAVR for low-risk patients.&#8221;<\/li>\n<li>Dr. Mack stated, &#8220;This is a clear win for TAVR.&#8221;<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2>Congratulations to the Research Teams &amp; Edwards Lifesciences!<\/h2>\n<p>On behalf of the patient community at HeartValveSurgery.com, I need to extend an extraordinary and mighty &#8220;THANK YOU&#8221; to the 50+ research teams who participated in the PARTNER 3 low-risk TAVR research study.\u00a0 \u00a0Without your curiosity, without your patient support, without your patient care, and without your willingness to try something new, I would not be able to write the encouraging words above.\u00a0 Your dedication to this trial was amazing.<\/p>\n<p>To the Edwards Lifesciences team that sponsored this massive clinical trial,\u00a0 I can not thank you enough for developing the SAPIEN 3 and all of its previous, evolutionary iterations.\u00a0 Your research, your development, your investment, your patient-centric approach, and your innovative spirit continues to transform valvular science, next-generation therapies and, most importantly, the lives of patients, their family members and friends.<\/p>\n<p>Great job to everybody who participated on this Low-Risk TAVR Clinical Trial!<\/p>\n<p>Keep learning about TAVR and aortic stenosis:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/fda-approval-low-risk-tavr.php\">Low-Risk TAVR Gets Approved by FDA<\/a><\/li>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/tavr-procedure.php\/\">Discover the TAVR Educational Platform<\/a><\/li>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2019\/03\/04\/aortic-stenosis-mortality-incidence\/\">The &#8220;Aortic Stenosis Danger Zone&#8221; is Here<\/a><\/li>\n<li><a href=\"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2018\/08\/21\/tavr-bicsupid-aortic-james-wudell-dr\/\">Is TAVR Used for Bicuspid Aortic Valves?<\/a><\/li>\n<\/ul>\n<p>Keep on tickin!<br \/>\nAdam<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":29570,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[28],"tags":[],"class_list":["post-29567","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-aortic-valve-replacement"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts\/29567","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/comments?post=29567"}],"version-history":[{"count":0,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/posts\/29567\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/media\/29570"}],"wp:attachment":[{"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/media?parent=29567"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/categories?post=29567"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/wp-json\/wp\/v2\/tags?post=29567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}