{"id":6735,"date":"2025-05-05T16:08:40","date_gmt":"2025-05-05T13:08:40","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=6735"},"modified":"2025-05-05T16:08:40","modified_gmt":"2025-05-05T13:08:40","slug":"a-victory-for-early-treatment-fda-approves-first-tavr-valves-for-asymptomatic-severe-aortic-stenosis","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/a-victory-for-early-treatment-fda-approves-first-tavr-valves-for-asymptomatic-severe-aortic-stenosis\/","title":{"rendered":"A victory for early treatment: FDA Approves First TAVR Valves for Asymptomatic Severe Aortic Stenosis"},"content":{"rendered":"
A victory for early treatment: FDA Approves First TAVR Valves for Asymptomatic Severe Aortic Stenosis<\/div>\n
Source: Cardiovascular Business<\/div>\n
Author: Michael Walter<\/div>\n
Date: May 1, 2025<\/div>\n
<\/div>\n
Key Points:<\/div>\n
1. Historic FDA Approval:<\/span><\/div>\n
\u2022 The FDA approved the Sapien 3, 3 Ultra, and 3 Ultra Resilia TAVR valves (balloon-expandable) from Edwards Lifesciences for asymptomatic severe aortic stenosis (AS).<\/span><\/div>\n
\u2022 This marks the first-ever approval of TAVR for asymptomatic patients.<\/span><\/div>\n
2. Trial That Led to Approval \u2013 EARLY TAVR:<\/span><\/div>\n
\u2022 Included 901 patients \u226565 years old with asymptomatic severe AS.<\/span><\/div>\n
\u2022 Patients were randomized to TAVR vs. clinical surveillance.<\/span><\/div>\n
\u2022 Primary outcome (mortality, stroke, or unplanned cardiovascular hospitalization):<\/span><\/div>\n
\u2022 26.8% in TAVR group vs. 45.3% in surveillance group.<\/span><\/div>\n
\u2022 Driven mainly by lower hospitalization: 20.9% (TAVR) vs. 41.7% (surveillance).<\/span><\/div>\n
\u2022 TAVR group also had fewer deaths (8.4% vs. 9.2%) and strokes (4.2% vs. 6.7%).<\/span><\/div>\n
3. Patient Quality of Life (KCCQ score):<\/span><\/div>\n
\u2022 At 2 years, 86.8% of TAVR patients had favorable health status vs. 68% in surveillance group.<\/span><\/div>\n
\u2022 Mean KCCQ score at baseline: 92.7, reflecting a symptom-free cohort.<\/span><\/div>\n
4. Delayed Intervention in Watchful Waiting:<\/span><\/div>\n
\u2022 87% of surveillance group eventually underwent TAVR after median follow-up of 3.8 years.<\/span><\/div>\n
5. Expert Reactions:<\/span><\/div>\n
\u2022 Prof. Bernard Prendergast called this a \u201cmajor reset\u201d in how cardiologists approach asymptomatic AS.<\/span><\/div>\n
\u2022 Criticized current guidelines promoting \u201cwatchful waiting\u201d, advocating instead for early diagnosis and intervention.<\/span><\/div>\n
6. Regulatory and Practice Impact:<\/span><\/div>\n
\u2022 Dr. Philippe G\u00e9n\u00e9reux (lead investigator): Urged a change in guidelines to replace \u201cwait for symptoms\u201d with proactive evaluation and intervention.<\/span><\/div>\n
\u2022 Emphasized unpredictable progression from asymptomatic to symptomatic status.<\/span><\/div>\n
7. Implications:<\/span><\/div>\n
\u2022 Early TAVR may soon become standard of care for selected patients with severe asymptomatic AS.<\/span><\/div>\n
\u2022 May reduce mortality, stroke, hospitalization, and preserve long-term quality of life.<\/span><\/div>\n
https:\/\/clinicaltrials.gov\/study\/NCT03042104.<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"

A victory for early treatment: FDA Approves First TAVR Valves for Asymptomatic Severe Aortic Stenosis Source: Cardiovascular Business Author: Michael Walter Date: May 1, 2025 Key Points: 1. Historic FDA Approval: \u2022 The FDA approved the Sapien 3, 3 Ultra, and 3 Ultra Resilia TAVR valves (balloon-expandable) from Edwards Lifesciences for asymptomatic severe aortic stenosis […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6735","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6735","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/comments?post=6735"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6735\/revisions"}],"predecessor-version":[{"id":6736,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6735\/revisions\/6736"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=6735"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=6735"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=6735"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}