The Valve Wire sealThe Valve Wire
September 25, 2026E. Nolan Beckett, MD · Editor
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The Weekly

The Valve Wire Weekly

Week of September 20 – September 26, 2026

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Week in Review

The low-risk TAVR narrative met its first serious real-world stress test this week. A Dutch registry transportability analysis of the DEDICATE trial, published Tuesday in JTCVS, found that TAVR's mortality advantage over surgery shrank by roughly 40% when the trial was reweighted against real-world Dutch practice — and, more uncomfortably, the trial's surgical arm underperformed community surgical practice on stroke by a factor of three. That single finding complicates the case the ESC 2025 guidelines built when they lowered the TAVI-preferred age threshold to 70. It arrived in the same seven days that CMS widened Medicare coverage for Edwards' TAVR platform, Edwards booked a $39 million securities class-action settlement, and JACC: Advances documented that Medicare M-TEER volumes have grown 84% while surgical mitral repair fell 29% over four years. The commercial story and the clinical story are asking the same question from opposite ends. For patients, the practical read is that the field is moving fast — perhaps faster than the durability data supports — and shared decision-making with a Heart Team matters more than which door you walk through first.

Top Stories This Week

DEDICATE Doesn't Travel: Trial's TAVR Advantage Shrinks 40% in Dutch Registry [NOTABLE]

Investigators reweighted the DEDICATE trial (n=1,211) against 3,389 SAVR-eligible patients from the Netherlands Heart Registration. TAVR's absolute 1-year mortality benefit shrank from 3.7% in-trial to 2.2% in the transported population (p=0.04). More striking: propensity-matched SAVR patients from the registry had significantly fewer strokes (HR 0.34, p=0.01) and lower composite mortality/stroke (HR 0.46, p=0.02) than SAVR patients enrolled in the trial. The trial's SAVR arm underperformed contemporary community surgical practice — the exact scenario that Chikwe, Badhwar, and Miller have warned about for years.

DEDICATE was one of the pillars the ESC 2025 guidelines leaned on to lower the TAVI-preferred age threshold to 70. If trial SAVR arms systematically underperform real-world surgery, the RCT-derived non-inferiority and superiority claims — including the recent meta-analysis showing 20% mortality reduction with TAVR in low-risk patients at 5 years — need reinterpretation. ACC/AHA 2020's more conservative age-65 SAVR-preferred floor looks better defended today than it did last Friday. Published in The Journal of Thoracic and Cardiovascular Surgery, September 22.

Commercial-Era Tricuspid Data: 3,444 Real-World Procedures Validate the ESC's Class IIa Upgrade [NOTABLE]

The first national commercial-era readout of transcatheter tricuspid intervention, published in JACC: Advances September 24, examined 2,143 T-TEER procedures across 180 hospitals and 1,301 TTVR procedures across 113 hospitals performed between October 2024 and December 2025 after FDA approval. In-hospital mortality was 0.5% for T-TEER and 2.0% for TTVR; major bleeding 6.0% and 12.4% respectively; new pacemaker 11.3% after TTVR. TTVR share climbed from 31.9% to 41.6% of all tricuspid interventions in 14 months.

ESC 2025 elevated transcatheter TV treatment to Class IIa (LOE A) based on TRILUMINATE Pivotal, Tri.Fr, and TRISCEND II. ACC/AHA 2020 carries no recommendation. The real-world 2.0% TTVR mortality undercuts historical isolated surgical TV mortality of 8–20% and will pressure the next ACC/AHA update. Caveats: median hospital volume is only 6.4 procedures annually, KCCQ-driven endpoints still lack hard mortality benefit, and replacement is outpacing repair faster than mitral did — a diffusion pattern worth watching.

Medicare Mitral Repair, Reallocated: M-TEER Up 84%, Surgical Repair Down 29%

Between 2017 and 2021, M-TEER volume rose 84.0% (15.0 to 27.6 per 100,000 Medicare beneficiaries) while surgical MV repair fell 28.9% (29.1 to 20.7), for a net 9.5% expansion of the total repair pool. Adjusted mortality fell at every timepoint (30-day aHR 0.93, 95% CI 0.89–0.97; 2-year aHR 0.98, 95% CI 0.97–0.99) despite rising comorbidity. Surgical patients' Elixhauser burden fell 5.1% as high-risk cases migrated to catheter therapy. Published in JACC: Advances, September 24.

ESC 2025 upgraded TEER for ventricular secondary MR to Class I; ACC/AHA 2020 holds at IIa. The volume shift is the guideline recommendation playing out in the market — but a 29% national volume drop over four years puts surgical MV repair expertise at risk of falling below the volume-outcome threshold Chikwe and colleagues have flagged. The ESC upgrade risks becoming a self-fulfilling prophecy if surgical repair capacity erodes below the point where it remains the durable option for primary MR.

CMS Widens TAVR Coverage; Edwards Books $39M Settlement; SAPIEN M3 EFS Completes

Three catalysts stacked for Edwards this week. On Monday, CMS expanded Medicare coverage for Edwards' TAVR platform. On Friday, Edwards booked a $39 million securities class-action settlement (Dec 13 opt-out deadline). The same day, ClinicalTrials.gov marked the SAPIEN M3 EFS (n=72) complete, clearing the runway for pivotal-trial commentary. Q3 earnings land October 29.

Coverage expansion is a straightforward volume tailwind. The settlement is the commercial mirror of this week's clinical question — whether TAVR growth was oversold ahead of the durability data. And SAPIEN M3 puts Edwards' transcatheter mitral replacement chapter on the table just as M-TEER volumes are structurally displacing surgical repair. The commercial and clinical narratives are asking the same question from opposite ends.

The AR Space Finally Gets a Purpose-Built Transcatheter Option

In 25 high-risk patients with symptomatic severe native aortic regurgitation, transfemoral J-Valve implantation succeeded in 92%, with 95.5% achieving none/trace AR at 1 year. All-cause mortality was 8.0%; stroke 4.0%. Published in JSCAI, September 23.

ACC/AHA 2020 does not endorse TAVI for native AR; ESC 2025 gives it Class IIb for inoperable patients with suitable anatomy. Pure AR remains a surgical Class I domain because off-label SAPIEN and Evolut use has produced inconsistent results — the anchoring problem in a non-calcified annulus defeats devices designed for AS. A dedicated device with a clean 1-year AR profile is the first evidence that transfemoral TAVI for AR is a real category, not a rescue. Sample is small; pivotal-trial data is what matters next. Edwards' off-label SAPIEN AR volumes are now competitively exposed, though the AR market remains small relative to AS.

Aortic Valve (TAVR/TAVI)

The DEDICATE transportability analysis is the aortic story of the week and covered above. Two additional signals complete the picture.

Delay beyond six months doubles death or HF hospitalization. A single-center retrospective in Open Heart (n=149, mean age 85.8) found delaying TAVR beyond six months from diagnosis produced 33% death or HF hospitalization at 2 years vs 16% for earlier intervention. Aligned with EARLY TAVR, RECOVERY, and AVATAR — all trials that pushed the ESC 2025 Class IIa recommendation for early intervention in asymptomatic severe AS. ACC/AHA 2020 reserves early intervention for narrower subgroups. Single-center, retrospective, and confounded by competing non-cardiac mortality, but directionally aligned with the guideline trajectory.

Two-era institutional TAVR data. A single-center comparison of 100 consecutive TAVRs from 2012 versus 2024 in Medical Sciences showed 30-day composite death or stroke fell from 10% to 1% (p=0.010); PVL ≥mild fell from 27% to 3% (p<0.001); length of stay from 6 to 1 day. SAVR composite went from 2% to 0% but the surgical cohort became younger (mean age 74 → 64), and isolated first-time SAVR took 18.9 months to accrue vs 5.7 months a decade ago. This is the redistribution the ESC 2025 guideline codified — SAVR increasingly reserved for younger, bicuspid, and complex anatomy patients while TAVR absorbs the older isolated-AS population.

Small annulus is not a TAVR disqualifier — but valve choice matters. A SCOPE I post-hoc in Clinical Research in Cardiology (n=732) found patients with annuli ≤430 mm² had comparable 3-year mortality vs larger annuli. Within the small-annulus subgroup, balloon-expandable valves underperformed self-expanding (RR 0.59, 95% CI 0.41–0.85; p-interaction 0.004) despite comparable mortality. ACC/AHA 2020 lists small annulus among factors favoring SAVR with root enlargement, especially in younger patients — reference-literature data on 50-70 year cohorts show 19-mm biological valves have the worst long-term survival. SCOPE I patients skewed older; do not extrapolate to a 62-year-old with a 400 mm² annulus.

Pre-TAVI PCI meta-analysis. A meta-analysis of 3 RCTs (n=1,132) in Coronary Artery Disease found routine pre-TAVI PCI increased major bleeding by 61% without reducing all-cause mortality or MI vs deferral. Both ACC/AHA 2020 and ESC 2025 list severe CAD requiring CABG as a factor favoring SAVR; for less severe CAD amenable to PCI, this meta-analysis argues for deferral as the default.

TAVR explantation review. A contemporary narrative review in Cardiology in Review reaffirmed that TAVR explant mortality far exceeds native redo-SAVR because endothelialized fibrotic integration of transcatheter stent frames into the aortic root complicates extraction. Registry data put redo-TAVR at 84% of TAVR reinterventions and TAV explant carries 12–17% mortality. Paired with the JACC: Cardiovascular Interventions valve-in-valve nomenclature consensus published Monday, the field is trying to standardize planning for a reintervention problem that SAVR at the index procedure avoids.

Post-TAVR residual MR. An analysis in JACC: Advances found only 52.9% of patients regressed to mild-or-less MR after TAVR; women and low-flow low-gradient AS patients had worse regression, and in the LFLG AS subgroup, residual severe MR drove excess mortality. LFLG AS with concurrent MR may warrant staged transcatheter mitral planning at the index TAVR, not deferred workup.

Mitral Valve (Repair & Replacement)

The Medicare volume story is above. Additional signals this week:

Baseline anemia nearly doubles long-term mortality after M-TEER. A systematic review of 6 observational studies (n=34,812) in Cureus found HR 1.86 (95% CI 1.57–2.22) for long-term mortality and OR 1.42 for in-hospital mortality after M-TEER in anemic patients. All observational, heterogeneous anemia definitions, lower-tier venue. For ventricular SMR, ESC 2025 upgraded TEER to Class I presuming "optimized medical management" — this argues hemoglobin belongs in that optimization, not passively as a comorbidity.

Plasma volume status as a preprocedural risk stratifier. In 311 prospectively enrolled M-TEER patients in Clinical Research in Cardiology, elevated preprocedural estimated plasma volume status independently predicted mortality (HR 2.38). Combined with elevated NT-proBNP, the combination identified a group with 14-fold higher hazard — a cheap risk-stratifier for subclinical congestion.

SGLT2 inhibitors in diabetic M-TEER patients. A TriNetX propensity-matched cohort of 650 diabetic M-TEER patients in the Journal of Cardiovascular Medicine found SGLT2i use associated with 32% lower 1-year mortality and 53% reduction in major adverse kidney events. Retrospective and confounded by prescriber selection, but directionally consistent with broader HF SGLT2i literature.

Cancer patients and M-TEER. A meta-analysis of 8 observational studies (1,522 cancer patients, 4,716 controls) in GeroScience found HR 1.72 (95% CI 1.03–2.90, I²=74.8%) for long-term all-cause mortality despite identical 30-day mortality and procedural success. Matched cohorts blunt the signal — excess mortality is driven by frailty and treatment-related comorbidity, not the clip. High heterogeneity limits causal inference.

SAPIEN M3 EFS completed. NCT03230747 was marked complete on September 25, closing Edwards' early feasibility phase (n=72) and clearing the runway for pivotal-trial design commentary at October 29 earnings.

Persistent MR after TAVR — sex disparity. Reported via Cardiovascular Business and consistent with the JACC: Advances paper above — post-TAVR MR persistence is more common in women, adding sex-specific texture to what "successful TAVR" looks like a year out.

Tricuspid Valve (Repair & Replacement)

The Vizient commercial-era readout is above. That paper is the tricuspid story of the week and probably the most important real-world validation of a transcatheter category since COAPT confirmed TEER for ventricular SMR.

The context: ESC 2025 elevated transcatheter TV treatment to Class IIa (LOE A) based on TRILUMINATE Pivotal, Tri.Fr, and TRISCEND II. ACC/AHA 2020 has no recommendation for transcatheter tricuspid therapy. The 2.0% real-world TTVR mortality undercuts historical isolated surgical TV mortality (8–20% in older cohorts, better with contemporary earlier referral) and will pressure the next ACC/AHA cycle. The three ongoing pivotal trials — Intrepid TTVR (n=1,186, Medtronic), Laplace TTVR EFS (n=65), and VISTA-US VDyne (n=30) — all posted updates this week, reflecting an unusually active competitive landscape.

Also this week: a JSCAI case report describes electrosurgical septal leaflet liberation to enable TTVR after failed postero-septal TEER — a technique that will matter more as TEER failures accumulate.

Surgical vs. Transcatheter Comparisons

The DEDICATE transportability paper is the head-to-head signal of the week and it cuts against the direction the ESC 2025 guidelines took. When DEDICATE's SAVR arm was matched to Dutch registry SAVR patients, registry patients had significantly lower stroke rates (HR 0.34) and lower composite mortality/stroke. Trial SAVR arms that systematically underperform real-world surgery undermine RCT-derived TAVR non-inferiority claims and strengthen the case for maintaining the ACC/AHA 2020 age-65 SAVR-preferred threshold in patients with long life expectancy.

The Medicare mitral data point in the same direction from a different angle: transcatheter therapies are generalizing beyond trial cohorts faster than surgical alternatives are being defended. That vindicates ESC upgrades for MR and TR while simultaneously exposing the durability and volume-attrition risks the ACC/AHA framework was designed to guard against. Chikwe, Badhwar, and Mehaffey have written extensively on volume-outcome relationships in surgical valve care — a 29% national drop in surgical MV repair volume over four years puts those relationships in play.

The pending PRIMATY trial (NCT05051033) — MitraClip vs surgery for primary MR in patients >60, active not recruiting — remains the trial that could settle the primary MR question directly. Timeline pushed further out this week.

Clinical Trials Update

Aortic Valve

  • NCT03230747 — SAPIEN M3 EFS. Status changed to COMPLETED September 25. Enrollment 72. Sponsor: Edwards Lifesciences. Clears runway for pivotal-trial commentary at October 29 earnings.
  • NCT05172960 — ALLIANCE (SAPIEN X4). RECRUITING, updated September 24. Enrollment 1,234. Sponsor: Edwards Lifesciences.
  • NCT06777368 — Redo-TAVR for Transcatheter Aortic Valve Failure. RECRUITING, updated September 24. Enrollment 225. Sponsor: Medtronic. The reintervention pivotal trial the field needs given the lifetime-management concerns raised this week.
  • NCT06049654 — Allegra vs Sapien Valve-in-Valve. RECRUITING, updated September 24. Enrollment 104. Sponsor: Fundación EPIC.
  • NCT02701283 — [LANDMARK] Evolut Low Risk (long-term follow-up). ACTIVE_NOT_RECRUITING. Enrollment 2,223. Sponsor: Medtronic.
  • NCT06596460 — TAVI imaging cohort. RECRUITING, n=40, Barts & The London.
  • NCT07059728 — TAVR-Highflow II. High-flow nasal O2 during TAVR sedation. Not yet recruiting, n=452.

Mitral Valve

  • NCT04198870 — [LANDMARK] REPAIR-MR (MitraClip vs surgery for primary MR). ACTIVE_NOT_RECRUITING. Enrollment 500. Sponsor: Abbott.
  • NCT05051033 — [LANDMARK] PRIMATY (TEER vs surgery for primary MR >60). ACTIVE_NOT_RECRUITING, updated September 10.
  • NCT03706833 — [LANDMARK] COAPT long-term follow-up. ACTIVE_NOT_RECRUITING. Underpins ESC 2025 Class I upgrade for TEER in ventricular SMR.
  • NCT03242642 — [LANDMARK] Intrepid TMVR Pivotal. RECRUITING, updated September 15. Enrollment 1,056. Sponsor: Medtronic.
  • NCT04147884 — Millipede Annuloplasty Feasibility. ACTIVE_NOT_RECRUITING, updated September 24. Sponsor: Boston Scientific.

Tricuspid Valve

  • NCT03904147 — [LANDMARK] TRILUMINATE Pivotal (TriClip for TR). ACTIVE_NOT_RECRUITING. Foundational for ESC 2025 Class IIa.
  • NCT04097145 — [LANDMARK] CLASP II TR (PASCAL for TR). RECRUITING, updated September 14. Enrollment 1,270. Sponsor: Edwards.
  • NCT04482062 — [LANDMARK] TRISCEND II (EVOQUE tricuspid replacement). ACTIVE_NOT_RECRUITING. Sponsor: Edwards.
  • NCT07321899 — Intrepid TTVR Pivotal. RECRUITING, updated September 25. Enrollment 1,186. Sponsor: Medtronic.
  • NCT06183684 — Laplace TTVR EFS. RECRUITING, updated September 25. Enrollment 65.
  • NCT05848284 — VISTA-US (VDyne TTVR). RECRUITING, updated September 21. Enrollment 30.

Structural Heart AI & Screening

  • NCT07843004 — Capitalizing on AI to Capture Undiagnosed SHD. RECRUITING, updated September 25. Enrollment 4,000. Sponsor: Pierre Elias. EHR-alert intervention aligned with the ACCESS-SHD preprint published this week.

Valve Industry Stocks — Weekly Performance

6-Month Valve Industry Stock Performance

Edwards Lifesciences (EW)

EW 6-Month Chart

Closed the week at $86.29, down ~$1.92 (-2.2%) from Monday's $88.21 close. 6-month change +5.10%; 52-week range $72.30–$96.29. Market cap $49.7B; trailing P/E 51.4; forward P/E 25.6; beta 0.85. Analyst consensus BUY, target $100.96 (26 analysts, range $84–$110). Next earnings October 29 (EPS est $0.74, revenue est $1.68B).

Three catalysts this week — CMS coverage expansion, $39M securities class-action settlement, SAPIEN M3 EFS completion — all pointing at the October 29 print. Coverage expansion is a straightforward volume tailwind. The settlement is the commercial mirror of this week's clinical question about whether TAVR growth was oversold ahead of durability data. The J-Valve pure-AR readout puts Edwards' off-label SAPIEN AR volumes at competitive risk, though the AR market is small.

Medtronic (MDT)

MDT 6-Month Chart

Closed the week at $88.64, down ~$3.10 (-3.4%) from Monday's $91.74. 6-month change +3.70%. Market cap $113.4B; forward P/E 13.84; beta 0.57. Analyst target $104.83 (24 analysts, buy). Next earnings November 17 (EPS est $1.33, revenue est $9.48B).

SCOPE I small-annulus signal favoring self-expanding valves is a modest tailwind for Evolut positioning. The Intrepid TTVR pivotal trial update this week reinforces Medtronic's tricuspid pipeline against Edwards' EVOQUE lead.

Abbott (ABT)

ABT 6-Month Chart

Closed the week at $101.29, down ~$1.38 (-1.3%) from Monday's $102.67. 6-month change -1.83%. Market cap $175.3B; forward P/E 16.7; beta 0.59. Analyst target $120.26 (25 analysts, buy). Next earnings October 14 (EPS est $1.42, revenue est $12.99B).

Abbott is the direct beneficiary of the Medicare M-TEER 84% volume expansion documented this week and of the ESC 2025 Class I upgrade for TEER in ventricular SMR. TriClip is the competing narrative against EVOQUE in the emerging TTVR-vs-repair share war. Cancer M-TEER meta-analysis pressures patient selection more than total volume.

Boston Scientific (BSX)

BSX 6-Month Chart

Closed the week at $43.92, up ~$0.89 (+2.1%) from Monday's $43.03. 6-month change -37.41% — the worst performer in the group by a wide margin. Market cap $63.7B; forward P/E 12.86. Analyst target $61.00 (29 analysts, buy, range $44–$94). Next earnings October 28 (EPS est $0.77, revenue est $5.15B).

The 37% six-month drawdown reflects broader concerns not driven by structural heart. Analyst targets imply 39% upside if execution stabilizes. Millipede Annuloplasty Feasibility (NCT04147884) posted a September 24 update — a small structural heart data point in an otherwise EP-dominated story.

Anteris Technologies (AVR.AX)

AVR.AX 6-Month Chart

Closed the week at A$10.69, down A$0.78 (-6.8%) from Monday's A$11.47. 6-month change +32.80%. Market cap ~A$1.0B; single-analyst target A$13.00. DurAVR single-piece bovine pericardial platform remains the differentiated pre-commercial TAVR story.

Private companies in the space with no public data include JenaValve Technology (J-Valve platform — the transfemoral AR device with the 92% implant success and 95.5% freedom from significant AR at 1 year published this week), J Valve Technology, and Meril Life Sciences.

Market outlook: Structural heart names are trading on two clocks — near-term Q3/Q4 earnings and volume guidance, and a longer clock tied to whether ACC/AHA closes the age-threshold gap with ESC 2025 in its next update. Abbott October 14 and Edwards October 29 will set the tone.

Regulatory & Policy

CMS expanded Medicare coverage for Edwards' TAVR platform on Monday — details on scope were thin in initial reporting, but any expansion is directly accretive to procedure volumes at a time when EARLY TAVR is pulling asymptomatic severe AS into the treatment funnel. Reported via OCBJ.

CMS ACCESS update expanded coverage across heart failure technology categories — reported via Cardiovascular Business. The structural heart read-through is direct: broader HF coverage supports the pre-referral population feeding into TEER and TTVR, since patients meeting COAPT criteria typically arrive through HF-clinic pathways.

The EVOLVE Study protocol was published in JSCAI Wednesday, describing a mixed-methods investigation of US heart teams across 8–20 programs to characterize care-delivery variability in aortic stenosis. Designed to inform future ACC/AHA guideline revisions and health policy. The CMS National Coverage Determination for TAVR still requires a two-surgeon/two-cardiologist heart team evaluation — a mandate the EVOLVE investigators may end up challenging or reinforcing.

Weekend News

CMS posted a National Coverage Determination decision memo for TAVR in aortic regurgitation (CAG-00430R3) on Friday, September 26. The decision memo posting comes in the same week as the J-Valve transfemoral EFS publication showing 92% implant success and 95.5% freedom from significant AR at 1 year in high-risk pure AR patients. If Medicare coverage for TAVR in AR moves forward, the addressable market for dedicated AR transcatheter devices expands materially, and off-label SAPIEN/Evolut use for AR gets a clearer regulatory pathway. Available via CMS.

ACC/AHA 2020 does not endorse TAVI for AR; ESC 2025 places it at Class IIb for inoperable patients. A CMS coverage decision would create a US reimbursement pathway ahead of formal guideline endorsement — an unusual sequence.

Week Ahead

  • October 14: Abbott Q3 earnings — MitraClip volume trajectory and TriClip commentary against this week's tricuspid real-world data.
  • October 28: Boston Scientific Q3 earnings — structural heart segmentation detail against 37% six-month drawdown.
  • October 29: Edwards Q3 earnings — the anchor event. TAVR volume growth, EVOQUE ramp, SAPIEN M3 pivotal transition commentary, and any read on how the DEDICATE transportability paper is landing with the Heart Team community.
  • November 17: Medtronic Q3 earnings.
  • TCT 2026: Next major conference inflection for TAVR durability data and transcatheter tricuspid readouts. Watch for DEDICATE two-year data and EARLY TAVR subgroup analyses.
  • December 13: Edwards securities class-action opt-out deadline.
  • CMS NCA CAG-00430R3 for TAVR-in-AR: track final decision timeline.

All Research & Sources This Week

Research Articles