The Valve Wire sealThe Valve Wire
July 15, 2026E. Nolan Beckett, MD · Editor
LIVE · 20:55 ET · JUL 15, 2026
EW · MDT · ABT · BSX ·

Daily Digest

The Valve Wire

Thursday, June 25, 2026

Executive Summary

Seven-year PARTNER 3 durability data published in JAMA Cardiology show TAVR with Sapien 3 and SAVR running neck-and-neck on structural valve deterioration (7.3% vs 7.6%, HR 0.96) and all-cause bioprosthetic valve failure (6.9% vs 7.5%) in low-risk patients — but thrombosis-related valve dysfunction was 5.5-fold higher with TAVR (5.2% vs 0.9%, P<0.001). Five-year EARLY TAVR follow-up continues to favor pre-emptive intervention over surveillance in asymptomatic severe AS, with the death-or-stroke curves separating after year 2 (HR 0.61). Both findings tighten the case for TAVR in low-risk and asymptomatic populations — only to 7 years, and surgical commentators at New York Valves 2026 were explicit that Trifecta and Mitroflow durability failures surfaced after year 8.

  • PARTNER 3 thrombosis-related valve dysfunction was 5.5x higher with TAVR than SAVR at 7 years, mostly subclinical and early, rarely progressing to failure (JAMA Cardiology).
  • EARLY TAVR 5-year landmark analysis shows death-or-stroke benefit emerging after year 2 (HR 0.61, 95% CI 0.40–0.94), driven largely by heart failure hospitalization reduction (TCTMD).
  • Bicuspid AS meta-analysis of 78,677 patients found no mortality difference between TAVR and SAVR but 2.3x higher pacemaker risk and higher long-term stroke with TAVR (Perfusion).
  • Asia-Pacific BASILICA/UNICORN registry reports 85–97% procedural success across 100 patients undergoing leaflet modification, with 3% coronary obstruction in the BASILICA arm (JACC Asia).
  • JTCVS editorial argues right-heart reversibility — not TR grade in isolation — should drive pre-TAVR decision-making, reframing the Carducci data on TR-associated mortality (JTCVS).

What to watch: longer-term PARTNER 3 and Evolut Low Risk follow-up beyond 8 years, where surgical bioprostheses historically began to fail — and whether CMS payment changes flagged by Cardiovascular Business as "sweeping TAVR changes" reshape volume incentives.


Aortic Valve (TAVR/TAVI)

The PARTNER 3 ad hoc analysis in JAMA Cardiology (N=948 implanted, 80% echo follow-up at year 7) found stage 2/3 SVD-related bioprosthetic dysfunction in 7.3% TAVR vs 7.6% SAVR (HR 0.96, P=0.88) and bioprosthetic valve failure in 6.9% vs 7.5%. The thrombosis signal is the part nobody should skim past: thrombosis-related dysfunction was 5.2% with TAVR vs 0.9% with SAVR (HR 5.52, P<0.001), most subclinical, most within 3 years. [NOTABLE] Patrick O'Gara and Suzanne Baron both emphasized at New York Valves 2026 that 7 years is insufficient — Trifecta and Mitroflow surgical valves failed after year 8. The ACC/AHA 2020 framework still recommends SAVR under age 65 on durability grounds (Class I); the ESC 2025 framework, which extended TAVR-preferred to age 70, now has stronger 7-year data backing it but no answer for the 60-year-old facing a 25-year lifetime management problem.

EARLY TAVR at 5 years reinforces early intervention in asymptomatic severe AS (composite endpoint 15.2% vs 24.2%, HR 0.58), aligning with the ESC 2025 Class IIa recommendation for early intervention in asymptomatic patients. The ACC/AHA 2020 guidelines limited early intervention to specific subgroups (very severe AS, elevated BNP, abnormal exercise test); EARLY TAVR's 5-year curve separation argues for broader application, though the trial enrolled a TAVR-treated population and surgical early-intervention data from RECOVERY and AVATAR carry comparable weight in guideline deliberations.

The bicuspid meta-analysis (78,677 patients, 1 RCT + 13 observational studies) confirms TAVR's pacemaker penalty (OR 2.29) and signals higher long-term stroke — predominantly retrospective cohorts vulnerable to selection bias. Both ACC/AHA 2020 and ESC 2025 classify BAV TAVR as Class IIb. These data offer no reason to move that classification.


Mitral Valve (MitraClip, PASCAL, TMVR)

The propensity-matched OCEAN-Mitral/REVEAL-AFMR comparison shows TEER beating medical therapy for atrial functional MR (HR 0.65 for death/HF hospitalization, P=0.044), with benefit concentrated in patients achieving ≤mild residual AFMR. This sits squarely in the ESC 2025 atrial secondary MR category — formally defined for the first time in any guideline — where TEER is currently Class IIb for inoperable patients only. The ACC/AHA 2020 framework does not formally recognize atrial SMR as a distinct entity. Registry comparisons cannot replicate a randomized contrast; a propensity-matched observational dataset argues for an upgrade in signal strength but not in evidence grade. The randomized data needed to close that gap do not yet exist.

A case report of successful surgical bailout for single-leaflet device attachment 8 months post-MitraClip illustrates what surgeons have flagged for years: once fibrous encapsulation sets in at 2–3 months, isolated clip removal becomes technically prohibitive, and en bloc resection with leaflet repair is mandatory. ESC 2025 and ACC/AHA 2020 both rate TEER as Class IIa for high-risk symptomatic primary MR patients with suitable anatomy — the surgical bailout risk embedded in that indication rarely surfaces in the consent discussion.


Tricuspid Valve (TriClip, TTVR)

The JTCVS editorial by Shuhaiber reframes the pre-TAVR tricuspid question: right-heart reversibility — not TR grade — should drive intervention timing. Carducci's data linking moderate-to-severe TR to worse long-term post-TAVR survival is real, but the editorial argues the field has over-indexed on a regurgitation grade that may already reflect irreversible RV remodeling. This matters directly for the ESC 2025 Class IIa indication for transcatheter TV treatment, which excludes patients with severe RV dysfunction or pre-capillary PH — a threshold the JTCVS commentary argues is harder to define in practice than guideline language implies. The ACC/AHA 2020 framework offered no transcatheter TR recommendation; the ESC moved to Class IIa based on TRILUMINATE, Tri.Fr, and TRISCEND II, all of which showed QoL and HF hospitalization benefit without a consistent mortality signal.

A single case report of concurrent mitral TEER plus K-Clip tricuspid annuloplasty illustrates the operational shift toward combined-valve transcatheter approaches. Single cases do not establish a paradigm. ESC 2025 Class I for concomitant TV surgery during left-sided operations remains the evidence-backed standard for patients eligible for surgery.


Surgical vs. Transcatheter Comparisons

The bicuspid AS meta-analysis provides the day's cleanest head-to-head signal: 78,677 patients across 14 studies, no mortality difference between TAVR and SAVR, but TAVR carried 2.3x higher pacemaker risk and higher long-term stroke. Only one RCT is in the pool — the remainder are retrospective cohorts vulnerable to selection bias. Both guidelines remain Class IIb for BAV TAVR, and these data offer no basis for reclassification.

The PARTNER 3 7-year durability parity in tricuspid aortic valves does not extrapolate to bicuspid anatomy, where asymmetric calcification and aortopathy create different mechanical loading on the prosthesis. Surgical commentators at New York Valves were explicit on a second point: the platforms enrolled in PARTNER 3 (2016–2017) are not the platforms being implanted today. Durability conclusions about Sapien 3 cannot be assumed to apply to Sapien 3 Ultra Resilia or contemporary self-expanding valves without prospective data.


Device & Technology

The Asia-Pacific BASILICA/UNICORN registry (100 patients, 7 centers) reports 85.1% procedural success with BASILICA, 96.7% with UNICORN, and 3% coronary obstruction in the BASILICA arm — consistent with North American series. Annual case volumes increased nearly 10-fold during the study window. A first-in-human report of mechanical leaflet modification (ShortCut, Pi-Cardia) in native AS extends an indication previously limited to degenerated bioprostheses — two cases, both successful, no neurologic events, but N=2. The JACC Cardiovascular Interventions Heart Valve Collaboratory redo-TAVR best practices (Parts 1 and 2 covering short-in-short, short-in-tall, tall-in-short, tall-in-tall configurations) formalize the lifetime management planning the ESC 2025 made central to index-procedure decisions. Nominal-volume "double tap" postdilatation for THV mid-stent underexpansion enters JACC Cardiovascular Interventions as a technique paper.


Regulatory & Policy

Cardiovascular Business flagged "sweeping TAVR changes on the way" alongside FDA recall coverage and pushback against AI-powered prior authorization. Specifics remain thin in available reporting. The convergence of expanded asymptomatic indications following EARLY TAVR FDA approval in 2025, volume growth, and payer scrutiny is the dominant policy theme for the back half of 2026.


Industry & Market

Edwards Lifesciences hit a 52-week high at $89.66 on the strength of the PARTNER 3 7-year readout — a direct translation of durability evidence into market response. The Sapien 3 platform's parity with SAVR at 7 years is the company's strongest defense against the durability skepticism that has hung over the low-risk TAVR expansion since PARTNER 3 first published in 2019. Medtronic, Abbott, and Boston Scientific all traded down or flat, reflecting that PARTNER 3 was a Sapien 3-specific trial and Evolut Low Risk 7-year data have not been similarly granular on durability metrics. Anteris (AVR.AX) continues its 6-month run (+89%) on DurAVR clinical progress, though analyst coverage remains thin (one analyst, A$13 target below current A$14.77).


Financial Analysis

The Edwards rally to a 52-week high pairs directly with today's PARTNER 3 7-year publication — the market is paying for durability evidence in real time. The forward P/E of 26.6 reflects sustained low-risk TAVR growth assumptions that the 7-year data now partially underwrite. Boston Scientific's 6-month decline of 53.7% sits in stark contrast and reflects company-specific issues outside the structural heart narrative; the WATCHMAN and electrophysiology franchises have driven the BSX story more than its valve portfolio. Medtronic's 16% 6-month decline coincides with Evolut Low Risk's quieter durability data flow relative to Sapien — the clinical narrative gap is showing up in valuation. Abbott's 27% 6-month decline is broader-portfolio noise rather than a TriClip-specific signal; the device franchise continues to expand following the ESC 2025 Class IIa recommendation for transcatheter TR therapy.


Valve Industry Stocks

6-Month Valve Industry Stock Performance

Edwards Lifesciences (EW)

EW 6-Month Chart
  • Close: $89.66 (+3.12%), new 52-week high; 6-month performance +3.24%
  • Market cap $51.6B; trailing P/E 48.5; forward P/E 26.6; beta 0.87
  • 52-week range: $72.30 – $90.99
  • Analyst target: $96.92 (26 analysts, buy); range $84–$110
  • Next earnings: 2026-07-23 (EPS est $0.74, revenue est $1.70B)
  • Commentary: PARTNER 3 7-year durability data landing today directly underwrites the Sapien 3 platform's low-risk indication. EARLY TAVR 5-year data extends the asymptomatic AS market opportunity. Edwards is the cleanest pure-play beneficiary of today's clinical news.

Medtronic (MDT)

MDT 6-Month Chart
  • Close: $80.13 (-0.62%); 6-month performance -16.3%
  • Market cap $102.6B; trailing P/E 21.5; forward P/E 12.5; beta 0.60
  • 52-week range: $73.31 – $106.33
  • Analyst target: $98.00 (26 analysts, buy); range $78–$121
  • Next earnings: 2026-08-18 (EPS est $1.39, revenue est $9.55B)
  • Commentary: Evolut platform did not receive a comparable durability publication today. The Sapien-specific PARTNER 3 narrative leaves Medtronic's structural heart story without a matching data point in 2026.

Abbott (ABT)

ABT 6-Month Chart
  • Close: $90.49 (-0.04%); 6-month performance -26.7%
  • Market cap $157.6B; trailing P/E 25.4; forward P/E 14.9; beta 0.62
  • 52-week range: $81.97 – $137.54
  • Analyst target: $116.54 (24 analysts, buy); range $92–$135
  • Next earnings: 2026-07-16 (EPS est $1.28, revenue est $12.53B)
  • Commentary: TriClip franchise continues to ride the ESC 2025 Class IIa indication for transcatheter TR therapy. Stock weakness reflects broader portfolio issues outside structural heart.

Boston Scientific (BSX)

BSX 6-Month Chart
  • Close: $44.46 (-2.50%); 6-month performance -53.7%
  • Market cap $66.1B; trailing P/E 18.6; forward P/E 12.0; beta 0.56
  • 52-week range: $44.05 – $109.50
  • Analyst target: $77.04 (28 analysts, buy); range $55–$106
  • Next earnings: 2026-07-29 (EPS est $0.83, revenue est $5.37B)
  • Commentary: ACURATE neo2 SCOPE outcomes and ongoing structural heart pipeline questions overshadowed by company-wide issues. The stock's 54% drawdown is the most extreme in the cohort.

Anteris Technologies (AVR.AX)

AVR.AX 6-Month Chart
  • Close: A$14.77 (-1.53%); 6-month performance +89.4%
  • Market cap A$1.4B; forward P/E negative; beta 0.73
  • 52-week range: A$4.68 – A$15.00
  • Analyst target: A$13.00 (1 analyst); no consensus recommendation
  • Commentary: DurAVR single-piece bioprosthetic THV remains in early clinical development. The 89% 6-month run is sentiment-driven on platform optionality, not durability evidence.

The market reaction to today's PARTNER 3 publication confirms that durability evidence is the single most important valuation lever in structural heart. Edwards captures the upside; competitors without matching long-term randomized data face a credibility gap until their own platforms deliver comparable readouts. The ESC 2025 guideline shift toward TAVR at age 70 expanded the addressable market across all platforms — but the market will continue to pay a premium for the platform with the data.


Clinical Trial Updates

Mitral Repair

  • NCT05051033 — PRIMARY [LANDMARK]: Percutaneous or Surgical Repair in Mitral Prolapse and Regurgitation for ≥60 year-olds. Status: Active, not recruiting. Enrollment: 450. Sponsor: Annetine Gelijns. Significance: This is the head-to-head RCT the field needs — TEER vs surgical repair in primary MR patients over 60, the exact demographic where the ACC/AHA 2020 (TEER Class IIa) and ESC 2025 frameworks diverge most. PRIMARY readout will define whether TEER deserves an upgrade in primary MR or remains subordinate to surgical repair.
  • NCT07301151 — PASCAL Feasibility Study: Status: Recruiting. Enrollment: 120. Sponsor: University of Minnesota. Phase: NA.

Social & Conference Highlights

New York Valves 2026 dominated structural heart discussion today. Patrick O'Gara (Brigham and Women's) and Suzanne Baron (Mass General) provided the most editorially significant commentary — both flagged that 7-year durability data, while reassuring, cannot answer the lifetime management question for patients with 14–16 year life expectancy. Bernard Prendergast (Cleveland Clinic London) framed EARLY TAVR as having "galvanized the entire valve community." David Cohen joined TCTMD's monthly cardiology podcast to discuss 10-year TAVI data and the FLOW subanalysis.


The next 12 months will determine whether PARTNER 3 and Evolut Low Risk durability holds beyond year 8 — the window where historical surgical bioprostheses began to fail. If it holds, the ESC 2025 age threshold of 70 for TAVR becomes the floor, not the ceiling. If it doesn't, the entire low-risk indication expansion will require a guideline correction.