TAVI News Daily — 8 Sep 2026
TAVI News Daily — 8 Sep 2026
What changed this week
- [Other / Clinical] TAVI-PCI (ESC Hot Line ~30 Aug 2026; NEJM simultaneous): N=986, 48 EU centers; TAVI-first vs PCI-first (both within 1–45 days). Primary composite at 1 yr: 22.2% vs 24.2% (risk diff −2.0 pp; 95% CI −7.4 to 3.4; p for noninferiority <0.001). Severe bleeding 6.6% vs 9.7%. Trial used Edwards Sapien platform (per CT.gov design).
Sources: https://www.escardio.org/news/press/press-releases/a-tavi-first-strategy-was-noninferior-to-a-pci-first-strategy-in-patients-with-severe-aortic-stenosis-and-concomitant-coronary-artery-disease/ ; https://solaci.org/en/2026/09/02/esc-2026-tavi-pci-tavi-first-vs-pci-first-in-severe-aortic-stenosis-and-coronary-artery-disease/ ; NEJM DOI 10.1056/nejmoa2606924 ; https://clinicaltrials.gov/study/NCT04310046- [MDT] Optimize PRO post hoc (JACC Intv Aug 2026; SOLACI 7 Sep): Evolut PRO/PRO+, n=603. 1-yr PPI by depth: 2.3% (<1 mm), 9.2% (1–≤3), 15.9% (>3–≤5), 20.3% (>5 mm); p<0.001. No significant rise in migration or death/stroke.
Sources: https://solaci.org/en/2026/09/07/tavi-implantation-depth-optimize-pro/ ; DOI 10.1016/j.jcin.2026.05.007
[Payer] CMS TAVR NCD (CAG-00430R2): Decision Memo still not released (checked 8 Sep). Expected completion 13 Sep 2026.
Source: https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?NCAId=321- Abbott / Edwards / MDT product PR since 7 Sep post: nothing material. Skip re-running Meril AU / SMART / EARLY TAVR / VANTAGE / NAVULTRA from yesterday.
2. Competitor talking points (cath lab)
[Edwards] TAVI-PCI → RCT cover for TAVI-first sequencing (Sapien trial) — expect valve-first talk; platform-specific.
- [MDT] Optimize PRO high implant / lower PPI on Evolut.
- [Edwards] CMS asymptomatic watch — final not out; no coverage claims.
3. Navitor leverage points (on-label only)
[Abbott] Deferred-PCI world makes coronary access after TAVI louder — Navitor framing only with approved claims. (Claims review)
- [Abbott] Navitor IDE 5-yr durability still circulating (high/extreme risk) — match primary before field use.
https://solaci.org/en/2026/03/12/navitor-ide-hemodynamic-outcomes-and-5-year-durability-of-an-intra-annular-self-expanding-transcatheter-aortic-valve/ ; https://doi.org/10.1016/j.shj.2026.100917 (Claims review)- US = high/extreme only. Do not borrow Sapien TAVI-PCI or Evolut SMART numbers for Navitor.
4. Papers / abstracts to read
TAVI-PCI — NEJM DOI 10.1056/nejmoa2606924
- Optimize PRO — JACC Intv DOI 10.1016/j.jcin.2026.05.007
- Navitor IDE 5-yr — Structural Heart / CRT
- CMS final — ~13 Sep
5. Ignore list
Rumor, stock tips, off-label US low-risk claims, PHI, analyst share %, reprinting yesterday’s Meril/CMS “new” bullets, X as primary.
Watch: CMS final ~13 Sep.
