{"id":7746,"date":"2025-06-27T17:20:10","date_gmt":"2025-06-27T14:20:10","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=7746"},"modified":"2025-06-27T17:20:10","modified_gmt":"2025-06-27T14:20:10","slug":"worlds-first-tavr-with-new-cerebral-embolic-protection-device-cepd-first-in-human-experience","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/worlds-first-tavr-with-new-cerebral-embolic-protection-device-cepd-first-in-human-experience\/","title":{"rendered":"World\u2019s First TAVR with New Cerebral Embolic Protection Device (CEPD) \u2013 First-in-Human Experience"},"content":{"rendered":"
World\u2019s First TAVR with New Cerebral Embolic Protection Device (CEPD) \u2013 First-in-Human Experience<\/div>\n
Journal: JACC: Case Reports<\/div>\n
\u2022 Publication Date: June 18, 2025.\u00a0<\/span><\/div>\n
<\/div>\n
Clinical Context :<\/div>\n
<\/div>\n
Stroke is a serious but relatively<\/div>\n
infrequent complication following aortic valve replacement. While earlier studies raised concerns about embolic risk with TAVR, recent large trials such as PARTNER 3 have shown that in low-risk patients, TAVR is associated with a lower 30-day stroke rate (~0.6%) compared to SAVR (~2.4%). Most strokes occur within the first 72 hours post-procedure. However, risk varies based on patient comorbidities, anatomical complexity, and operator experience.<\/div>\n
Early stroke risk (within 30 days) may slightly favor TAVR, as seen in PARTNER 3 and Evolut Low Risk trials.<\/div>\n
\u2022 However, by 1 year, most large randomized trials show no significant difference in stroke incidence between TAVR and SAVR.<\/span><\/div>\n
<\/div>\n
Study Highlights:<\/div>\n
1. Device Description:<\/span><\/div>\n
\u2022 EnCompass F2 by EnCompass Technologies (Nevada, USA).<\/span><\/div>\n
\u2022 Cylindrical, self-expanding nitinol frame.<\/span><\/div>\n
\u2022 Electrospun filter (pore size ~30 \u03bcm).<\/span><\/div>\n
\u2022 Covers all three major cerebral vessels: brachiocephalic, left common carotid, and left subclavian arteries.<\/span><\/div>\n
\u2022 Deployed via single transfemoral access in under 2 minutes.<\/span><\/div>\n
2. Background:<\/span><\/div>\n
\u2022 Previous CEPDs (e.g., Sentinel by Boston Scientific) failed to consistently reduce stroke rates in TAVR patients.<\/span><\/div>\n
\u2022 Likely reasons: underpowered trials, variable stroke risk, operator inexperience, or limited device effectiveness.<\/span><\/div>\n
\u2022 Persistent unmet need for a reliable and widely usable CEPD in TAVR procedures.<\/span><\/div>\n
3. First-in-Human Case Report (Published in JACC: Case Reports):<\/span><\/div>\n
\u2022 Patient: 70-year-old male with severe AS, prior right femoral artery stent, PAD, HTN, HLD, and nonobstructive CAD.<\/span><\/div>\n
\u2022 Procedure: Successful implantation of a 26-mm Sapien 3 valve via left transfemoral access.<\/span><\/div>\n
\u2022 Outcome: No procedural complications; no stroke or other adverse events at 30-day follow-up.<\/span><\/div>\n
\u2022 Demonstrated technical feasibility of CEPD use via single femoral access\u2014especially important for patients with vascular disease.<\/span><\/div>\n
4. Future Outlook:<\/span><\/div>\n
\u2022 Device not yet FDA-approved.<\/span><\/div>\n
\u2022 Larger clinical trials underway to evaluate safety and efficacy.<\/span><\/div>\n
<\/div>\n
DOI: 10.1016\/j.jaccas.2025.103768 \u200f<\/div>\n","protected":false},"excerpt":{"rendered":"

World\u2019s First TAVR with New Cerebral Embolic Protection Device (CEPD) \u2013 First-in-Human Experience Journal: JACC: Case Reports \u2022 Publication Date: June 18, 2025.\u00a0 Clinical Context : Stroke is a serious but relatively infrequent complication following aortic valve replacement. While earlier studies raised concerns about embolic risk with TAVR, recent large trials such as PARTNER 3 […]<\/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-7746","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/7746","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=7746"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/7746\/revisions"}],"predecessor-version":[{"id":7750,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/7746\/revisions\/7750"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=7746"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=7746"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=7746"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}