TAVR for pure aortic regurgitation performs well.<\/p>\n
Align-AR Trial Summary \u2013 Key Points(presented as a Kate-breaking study at the American College of Cardiology (ACC) 2025 annual meeting).
\n1. Trial Focus: First 500 patients with pure aortic regurgitation (AR) treated with the JenaValve TAVR system showed highly encouraging results.
\n2. Clinical Challenge: Pure AR lacks calcification, making standard TAVR devices (designed for aortic stenosis) prone to migration or embolization. This late-breaking clinical trial marks a significant step forward for a population long underserved by current transcatheter options. Unlike aortic stenosis, pure AR presents unique challenges due to the absence of valve calcification, making standard TAVR devices more likely to embolize. The JenaValve, was designed specifically for non-calcified anatomy and has received FDA Breakthrough Device designation. The prognosis in patients who have symptomatic aortic regurgitation, especially when they have NYHA Class III or IV heart failure symptoms is pretty dismal. Almost half the patients may be dead at the end of five years. The only approved treatment is surgery, but a lot of patients are not treated because they’re high-risk surgical candidates.
\n3. Device Advantage: The JenaValve uses leaflet-locating clips to anchor the valve without needing calcium, minimizing valve displacement and leakage.
\n4. Clinical Results:
\n\u2022 Zero intraprocedural deaths.
\n\u2022 30-day mortality: 1.6% (vs. 4% expected).
\n\u2022 One-year mortality: 8% (vs. 25% performance goal).
\n\u2022 Stroke rate: 0.8% disabling strokes at 30 days.
\n\u2022 Paravalvular leak: Moderate or greater in only 0.3%.
\n\u2022 Symptom improvement: Over 90% reached NYHA Class I or II by 30 days.
\n\u2022 Sustained valve performance and quality of life up to 2 years.
\n\u2022 Cardiac remodeling: Reduced LV volume and mass.
\n\u2022 KCCQ scores improved by ~20 points at 1 and 2 years.
\n5. Limitation: High new pacemaker implantation rate (23%), especially with larger valves:
\n\u2022 16.8% (23 mm valve) vs. 28.9% (27 mm valve).
\n\u2022 Predictors include baseline heart failure, large annulus, RBBB.
\n6. Regulatory Status:
\n\u2022 FDA premarket approval is underway.
\n\u2022 Supported by 2-year follow-up data on >200 patients.
\n7. Next Step: ARtist Trial \u2013 randomized study comparing TAVR vs. surgery in >1,000 non-high-risk surgical patients, with up to 10 years of follow-up.<\/p>\n","protected":false},"excerpt":{"rendered":"
TAVR for pure aortic regurgitation performs well. Align-AR Trial Summary \u2013 Key Points(presented as a Kate-breaking study at the American College of Cardiology (ACC) 2025 annual meeting). 1. Trial Focus: First 500 patients with pure aortic regurgitation (AR) treated with the JenaValve TAVR system showed highly encouraging results. 2. Clinical Challenge: Pure AR lacks calcification, […]<\/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-6402","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6402","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=6402"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6402\/revisions"}],"predecessor-version":[{"id":6403,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6402\/revisions\/6403"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=6402"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=6402"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=6402"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}