TAVI NEWS WEEKLY — 12 Oct 2026
1. What changed this week
[Market] EACTS Barcelona 8 Oct / TCTMD 9 Oct: Dutch National Registry transportability analysis of DEDICATE-DZHK6 found trial SAVR patients had higher composite stroke/death vs propensity-matched trial-eligible Dutch SAVR (HR 1.63; 95% CI 1.02–2.26). TAVI vs registry SAVR did not reproduce the trial composite benefit (HR 0.71; 95% CI 0.44–1.14); reweighting cut absolute mortality ARR for TAVI from 3.8% to 2.1%. EACTS 2026 President’s Choice.
Source:
[Payer] CMS CAG-00430R3 (TAVR for aortic regurgitation) 30-day public comment period closed on schedule 10 Oct. ACC/SCAI/STS joint letter (9 Oct) supports Medicare coverage of FDA-approved AR-TAVR under CED with Heart Team evaluation and dual-operator safeguards; AATS (6 Oct) similarly urges CED, in-person surgeon evaluation, and dual-specialty operators. No proposed decision memo posted (due 10 Mar 2027; NCA expected completion 8 Jun 2027).
Source:
https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=324
2. Competitor talking points I will hear in the cath lab
[Market] Surgeons: “DEDICATE SAVR outcomes looked worse than real-world Dutch SAVR; the TAVI composite win may not travel.” Expect Heart Team pushback on low–intermediate AS trial generalizability.
[Other] / [Payer] JenaValve AR path: societies want coverage, but under CED with dual operators — not open AS-style access yet.
3. Navitor leverage points
[Abbott] On-label AS-TAVI only: DEDICATE transportability is about trial-to-registry generalizability, not a Navitor head-to-head. Keep Heart Team / shared-decision framing; do not quote HRs or ARR in customer talk without approved claims review.
[Abbott] AR coverage debate is JenaValve Trilogy territory (FDA-approved for native AR). Do not imply Navitor is on-label for pure AR.
4. Papers / congress abstracts to read
[Market] Veen KM. Transcatheter vs. surgical aortic valve replacement in low- to intermediate-risk patients: do DEDICATE trial outcomes translate to real-world populations? Presented EACTS 2026, 8 Oct, Barcelona. Summary:
[Payer] ACC/SCAI/STS joint comment on CAG-00430R3 (9 Oct) and AATS comment (6 Oct):
5. Ignore list
Local JenaValve first-implant PRs; Edwards SAPIEN M3 hospital “introduces” fluff (mitral; older procedure date); Edwards Miami training PR; recirculated PARTNER 3 7-year health-status paper; stock/analyst chatter; patient-level PHI; off-label AR promotion with AS valves.
Watch unchanged: PROGRESS → TCT LBCT II Mon 2 Nov 2026.
