World’s First TAVR with New Cerebral Embolic Protection Device (CEPD) – First-in-Human Experience
World’s First TAVR with New Cerebral Embolic Protection Device (CEPD) – First-in-Human Experience
Journal: JACC: Case Reports
• Publication Date: June 18, 2025.
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 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.
Early stroke risk (within 30 days) may slightly favor TAVR, as seen in PARTNER 3 and Evolut Low Risk trials.
• However, by 1 year, most large randomized trials show no significant difference in stroke incidence between TAVR and SAVR.
Study Highlights:
1. Device Description:
• EnCompass F2 by EnCompass Technologies (Nevada, USA).
• Cylindrical, self-expanding nitinol frame.
• Electrospun filter (pore size ~30 μm).
• Covers all three major cerebral vessels: brachiocephalic, left common carotid, and left subclavian arteries.
• Deployed via single transfemoral access in under 2 minutes.
2. Background:
• Previous CEPDs (e.g., Sentinel by Boston Scientific) failed to consistently reduce stroke rates in TAVR patients.
• Likely reasons: underpowered trials, variable stroke risk, operator inexperience, or limited device effectiveness.
• Persistent unmet need for a reliable and widely usable CEPD in TAVR procedures.
3. First-in-Human Case Report (Published in JACC: Case Reports):
• Patient: 70-year-old male with severe AS, prior right femoral artery stent, PAD, HTN, HLD, and nonobstructive CAD.
• Procedure: Successful implantation of a 26-mm Sapien 3 valve via left transfemoral access.
• Outcome: No procedural complications; no stroke or other adverse events at 30-day follow-up.
• Demonstrated technical feasibility of CEPD use via single femoral access—especially important for patients with vascular disease.
4. Future Outlook:
• Device not yet FDA-approved.
• Larger clinical trials underway to evaluate safety and efficacy.
DOI: 10.1016/j.jaccas.2025.103768