The Valve Wire sealThe Valve Wire
May 27, 2026E. Nolan Beckett, MD · Editor
LIVE · 17:16 ET · MAY 27, 2026
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The Weekly

The Valve Wire Weekly

Week of May 17 – May 23, 2026

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Week in Review

This week's defining story is the collision between capital and evidence in transcatheter aortic valve replacement. Boston Scientific committed $1.5 billion to TAVR start-up MiRus, with an exclusive option to acquire the business outright for an additional $3 billion — the largest structural-heart industry transaction of the quarter and a dramatic re-entry into a market BSX abandoned in 2020 when it discontinued Lotus Edge. The same week, two pieces of evidence arrived that should temper enthusiasm: a Medicare analysis of 324,701 patients documented a more than 10-fold rise in aortic valve reinterventions after TAVI over a decade, and the largest-ever meta-analysis of cerebral embolic protection (11,692 randomized patients) found no stroke benefit from routine use. Surgical perspective got two important data points: an STS database analysis of 18,247 patients quantified the cost of deferring SAVR at the time of CABG (25.9% need aortic intervention by year 8), and a 1,597-patient Chinese series put a number on bailout valve-in-valve TAVR (6.2%, with 3-fold higher 30-day mortality). The week closed with the FDA clearing a next-generation mitral valve, the European debate over routine FFR before TAVI sharpening, and patient advocates pushing CMS to loosen TAVR access restrictions — a move that surgical voices argue could erode the volume-outcome safeguards the field has spent two decades building.

Top Stories This Week

1. Boston Scientific Bets $1.5B (with a $3B Option) on TAVR Start-up MiRus

[NOTABLE] Boston Scientific made a $1.5 billion equity investment in MiRus, a private Atlanta-based TAVR developer with a nickel-free balloon-expandable platform built on a molybdenum-rhenium (MoRe) alloy frame. The deal includes an exclusive option to acquire the business for an additional $3 billion and was paired with a $2 billion accelerated share repurchase — capital allocation that signals significant management conviction even as BSX shares have declined 41% over six months from their 52-week high.

This is BSX's de facto re-entry into TAVR after the 2020 wind-down of Lotus Edge. Strategically, it targets a global TAVR market projected at $7B+ currently dominated by Edwards SAPIEN and Medtronic Evolut. The minority-stake-plus-call-option structure lets BSX manage downside while securing optionality on a third major commercial platform. The competitive implication for Edwards in particular is meaningful: a credible third entrant could pressure pricing and force device innovation — though MiRus must still complete pivotal trials before commercial impact materializes.

Editorial perspective: Industry is voting one direction on TAVR expansion at the exact moment the clinical evidence is whispering "slow down." That contradiction is the week's central narrative.

2. Medicare Analysis: Aortic Valve Reinterventions After TAVI Have Risen >10× in a Decade

[NOTABLE] Alabbadi and colleagues, publishing in the Journal of Thoracic and Cardiovascular Surgery, analyzed Medicare claims for 324,701 TAVI recipients between 2013 and 2022 and identified 2,387 reinterventions — 61.3% TAVI-in-TAVI and 38.7% surgical explants. The raw annual count rose from 49 cases in 2013 to 505 in 2022 (Annual Percent Change 22.1%, p<0.001). After an initial decline from 2013–2019, TAVI-in-TAVI accelerated sharply (APC +35.2% from 2019–2022), while surgical explants have risen steadily since 2017 (APC +18.3%). Thirty-day mortality after reintervention was 8.7% and one-year mortality 18.7%.

This is the first nationally-representative, claims-based quantitative description of the "second valve problem" that surgical critics — Badhwar, Mehaffey, Kaul, Miller, Chikwe — have been warning about for years. The trajectory is steepening, not flattening, and it lands directly on the ongoing debate over lifetime management. Trials currently enrolling younger and lower-risk cohorts (Evolut EXPAND TAVR II, ALLIANCE SAPIEN X4, the 4,000-patient TAVI-vs-SAVR comparison NCT05261204) will face precisely this trajectory in their long-term follow-up windows.

Limitations: Medicare claims data restrict the cohort to patients ≥65, meaning younger patients — where the explant signal is largest in single-center series — are under-represented. Reintervention coding may also undercount procedures performed at hospitals other than the index facility.

3. Cerebral Embolic Protection Meta-Analysis: No Stroke Benefit Across 11,692 Patients

[NOTABLE] Kholeif and colleagues aggregated 8 randomized trials and 11,692 patients comparing cerebral embolic protection (CEP, predominantly Sentinel) versus no CEP during TAVI. The findings are unambiguous:

  • Overall stroke at 2–5 days: RR 0.95 (not significant)
  • Overall stroke at 30 days: RR 0.93 (not significant)
  • Disabling stroke at 2–5 days: RR 0.70 (not significant)
  • Disabling stroke at 30 days: RR 1.18 (not significant)
  • No improvement in bleeding, vascular, or AKI endpoints
  • Trial sequential analysis confirmed conclusiveness — additional trials are statistically unlikely to overturn the null result

PROTECTED TAVR (n=3,000, the prior largest single RCT) was already neutral. This meta-analysis triples the sample size and delivers what is now arguably definitive evidence that routine CEP does not reduce clinically meaningful stroke. Selected high-risk subgroups — porcelain aorta, valve-in-valve, prior stroke — may still warrant CEP, but the data don't support broad use.

Industry implication: Direct headwind for Boston Scientific's Sentinel device. The irony is sharp — BSX bet $1.5B on TAVR expansion the same week one of its own structural-heart adjuncts lost its evidence base. The CAPTURE-2 trial (EmStop vs Sentinel, n=663) continues to enroll despite the signal.

4. STS Database: Moderate AS at Time of CABG — Defer SAVR or Combine?

Yu and colleagues, publishing in The Annals of Thoracic Surgery, analyzed the STS Adult Cardiac Surgery Database from 2011–2022. Among 18,247 patients ≥65 with moderate AS undergoing CABG, 9,325 (51.1%) had concomitant SAVR and 8,922 (48.9%) had isolated CABG. Isolated CABG had lower operative mortality and fewer postoperative complications, and risk-adjusted mid-term all-cause mortality was similar. But at 8 years, the aortic valve intervention rate was 25.9% in the isolated-CABG group versus 2.4% in the CABG+SAVR group. Isolated CABG patients also had higher mid-term heart failure readmissions.

Both ACC/AHA 2020 and ESC 2025 list concomitant SAVR for moderate AS during other cardiac surgery as Class IIa. The availability of TAVR as a "safety net" if AS progresses changes the calculus — but at the cost of a guaranteed second procedure in roughly one in four deferred patients, plus heart-failure morbidity in between.

Context for the next 12 months: The PROGRESS trial — a randomized comparison of early TAVR versus clinical surveillance in moderate AS — is expected to complete enrollment and read out before end of 2026, likely at TCT in late October. This Yu paper is the surgical-perspective companion. Both data sets will define the moderate-AS treatment landscape over the next year.

5. Patient Advocacy Pushes CMS to Loosen TAVR Access — Surgeons Push Back

A patient-advocacy group urged the Trump administration to revise the National Coverage Determination for TAVR, arguing that CMS-required site volumes and dual-operator requirements restrict patient access (Cardiovascular Business). The countervailing perspective — and one that deserves equal volume — is that volume thresholds protect patients in a procedure where complication rates correlate strongly with operator and program experience. The history of structural heart in the US suggests indication creep follows access expansion. Removing volume floors without parallel quality safeguards risks worse outcomes in precisely the patients advocacy groups seek to help.

Aortic Valve (TAVR/TAVI)

Beyond the Medicare reintervention and CEP meta-analysis covered above, the week's TAVI literature was unusually rich.

Bailout valve-in-valve in a high-volume Chinese center. Zhang et al. retrospectively analyzed 1,597 TAVR procedures (48.3% bicuspid) and quantified bailout valve-in-valve TAVR — performed for significant residual AR or valve embolization — at 6.2% (BAV 6.87% vs TAV 5.57%). Predictors were anatomically intuitive: larger annulus perimeter, lower calcification volume, non-repositionable self-expanding valves, residual AR after initial deployment, and the operator learning curve. After inverse probability weighting, bailout ViV carried HR 3.09 for 30-day all-cause mortality (p=0.019) and HR 3.49 for 30-day cardiovascular mortality (p=0.021), though mid-term survival converged. A 6% bailout rate is meaningfully higher than what contemporary low-risk randomized trials report — those trials enrolled almost entirely tricuspid anatomy. Both ACC/AHA and ESC continue to rate TAVR for BAV as Class IIb.

Early rehospitalization carries major mortality signal. Alexiou and colleagues retrospectively analyzed 1,347 consecutive TAVI patients and identified a 9.7% 30-day readmission rate — most commonly from infection (22.9%), heart failure (19.8%), and bradycardia (9.9%). Independent predictors included chronic HF, COPD, contrast volume (per 25 mL), ≥mild paravalvular leak, and discharge conduction abnormalities. After adjustment, 1-year mortality was tripled (HR 3.03). Importantly, early (≤2-day) discharge was not a risk factor — supporting the simplified TAVI movement, though selection bias is unavoidable in retrospective data.

Timing of neurological events matters. In the 10,079-patient TRITAVI registry (Tartaglia et al.), 2.6% experienced post-TAVI neurological events; 35% occurred beyond 30 days, and these later events were associated with markedly worse survival. Fatal stroke accounted for 40% of non-periprocedural events versus only 6% of early events. A reminder that embolic protection has focused almost entirely on the wrong window.

TAVI endocarditis — diabetes as the dominant driver. Jordal et al. (71 cases, 213 controls) found 1.2% per patient-year incidence, with diabetes as the only independent predictor (SHR 2.08). Balloon-expandable valves were over-represented (28% vs 13%, p=0.003) and Enterococcus faecalis dominated (30%). A separate systematic review by Khasnavis et al. describes isolated native valve endocarditis after TAVI — affecting 18.4% of post-TAVI endocarditis cases, often the mitral valve, more common with CoreValve (OR 1.55).

Other practical findings:

  • Koontz et al. (n=180): high-BMI patients receiving small balloon-expandable valves had significantly higher 30-day mean gradients — argues for aggressive annular sizing in obese patients.
  • Biyikli et al. (n=742): the EASIX score (LDH/creatinine/platelets) independently predicts mortality after TAVI (HR 1.21 per unit), with meaningful reclassification beyond age, sex, LVEF, and BNP.
  • Krányák et al. (n=33): half of TAVI patients receiving a pacemaker showed conduction recovery at mean 1.7-year follow-up; wider baseline QRS predicted persistent AV block.
  • Saad et al.: three patients presenting with STEMI 10–50 months post-TAVR with normal pre-TAVR coronaries and abrupt 100% occlusions — hypothesis-generating for delayed embolization mechanisms.
  • Wang et al. (n=467): Taiwan's NHI reimbursement expansion shifted TAVI toward higher-risk patients (STS 5.9→7.2%) with no mortality penalty and reduced HF readmission.
  • Polish ACVI expert consensus on simplified TAVI: operationalizes efficiency within a quality framework.

Mainstream and trade coverage: TCTMD reports new evidence that early hemodynamic valve deterioration after TAVI may evade routine echocardiographic surveillance. MedPage Today covered creeping gradients linked to poor longer-term outcomes. Cardiovascular Business covered new data on how TAVR implant depth impacts clinical outcomes. MedPage Today also covered a women-only TAVR trial reinforcing self-expanding platform advantages in small annular anatomy.

Dueling EHJ editorials debated whether routine FFR-guided revascularization in TAVI candidates is overreach (Aarts/Delewi/Voskuil and Ribichini/Pesarini/Tarantini), with TCTMD framing PCI before TAVI as offering "only modest benefit." Abbott released supportive new data backing its Navitor self-expanding TAVI system.

Mitral Valve (Repair & Replacement)

FDA clears next-generation mitral valve. Per Cardiovascular Business, a next-generation mitral valve received FDA clearance this week — details on indication breadth and labeling will determine adoption. The TMVR space remains characterized by extraordinary anatomic variability between patients and incremental device iteration; few patients have been treated outside trials, and the field has yet to deliver a clear "MitraClip moment" for replacement.

Transseptal TMVR momentum. Three pieces of European registry/case-series data this week — Cardiovascular Business on BATMAN, TCTMD on transseptal BATMAN registry results, and TCTMD on European transseptal TMVR experience — all point to procedural simplification gaining traction. The right comparator question remains unanswered: transseptal TMVR has not been compared head-to-head with TEER for repairable anatomy, nor with surgery for non-repairable disease in younger patients.

Same-day discharge after M-TEER appears safe — but rarely used. Watanabe et al. analyzed 12,048 Medicare M-TEER patients (2016–2021); only 1.1% were discharged same-day, with no significant difference in 30-day mortality or HF readmission versus next-day discharge. Hypothesis-generating, not practice-changing — same-day discharge was almost certainly applied to highly selected patients.

Audiovisual distraction reduces sedation needs. In a single-center RCT of 60 patients (Rawish et al., JACC Advances), video glasses with nature documentaries reduced propofol requirements (4.6 vs 5.9 mg/kg/h, p=0.002) and improved patient-reported anxiety and satisfaction during M-TEER. A small but elegant trial.

SMR TEER narrative review. Torres et al. synthesized COAPT, MITRA-FR, RESHAPE-HF2, and MATTERHORN. No new data, but reinforces the now-conventional disproportionate MR framework. The clinically relevant editorial point: ESC 2025 has elevated TEER for ventricular SMR to Class I, LOE A, while ACC/AHA 2020 holds at Class IIa — a transatlantic divergence likely to persist until the next ACC/AHA update.

Tricuspid Valve (Repair & Replacement)

EuroTR T-TEER + prior cardiac surgery (n=2,929). Grassini and colleagues reported from the EuroTR registry on tricuspid TEER between 2016 and 2024, of whom 27.2% had prior cardiac surgery (PCS). Despite comparable baseline TR severity, PCS patients had significantly worse residual TR ≥3+ at discharge (OR 1.41, p=0.01), higher 2-year all-cause mortality (HR 1.25, p=0.02), and a higher composite of death or HF hospitalization (HR 1.24, p=0.01). Functional improvement (≥1-class NYHA reduction) was preserved (66% PCS vs 60% non-PCS, p=0.15).

Editorial significance: ESC 2025 elevated transcatheter TV treatment to Class IIa largely on TRILUMINATE, Tri.Fr, and TRISCEND II — trials that did not stratify outcomes by surgical history. Redo patients are a substantial proportion of real-world referrals (>1 in 4 in EuroTR), and the data suggest the Class IIa recommendation may overstate benefit in this group.

Case literature continues to teach. Marek-Iannucci et al. describe rapid renal and clinical recovery after EVOQUE TTVR in an 85-year-old with torrential TR — the precise ESC IIa scenario. Nguyen et al. describe a novel complication: platypnea–orthodeoxia from acute right-atrial geometric changes unmasking a PFO, requiring percutaneous closure. Jabri et al. describe staged TEER-then-replacement (ANTARCTIC strategy) in an 85-year-old whose annular size precluded primary TTVR.

These complications must be read alongside STS/ACC TVT Registry data showing 15.9% new pacemaker rates and 3.1% 30-day mortality — outcomes driven by QoL and HF hospitalization endpoints, not mortality. JACC Journals coverage of TTVR continues to emphasize symptom benefit.

The pipeline continues to broaden: P+F's TricValve bicaval system (n=780 pivotal, sponsor P+F Products + Features USA) updated its status this week to NOT_YET_RECRUITING.

Surgical vs. Transcatheter Comparisons

The week's central tension — capital flowing into TAVR expansion (BSX–MiRus) at the moment the durability evidence is catching up (Alabbadi Medicare reintervention) — is a surgical-vs-transcatheter comparison in everything but name. The Yu STS analysis is the surgical perspective companion to the upcoming PROGRESS readout on moderate AS.

The ESC 2025 lowering of the TAVI-preferred age threshold to 70 (versus ACC/AHA 2020's >80) looks increasingly out of step as durability concerns reaccumulate. Multiple ongoing trials will shape the next ACC/AHA update:

  • DEDICATE-DZHK6 long-term follow-up — investigator-initiated TAVI vs SAVR, the data underpinning ESC's age threshold shift
  • Cedars-Sinai TAVR vs SAVR in Severe Bicuspid AS (n=1,200, not yet recruiting) — critically needed RCT for the guideline-deficient BAV population
  • REVALVE (n=550) — Redo-TAVI vs surgical explantation vs conservative management
  • ARTIST (n=1,016, JenaValve) — Trilogy TAVR vs SAVR for aortic regurgitation, the pivotal AR trial
  • NCT05261204 — 4,000-patient TAVI vs SAVR investigator-initiated comparison

The investigator-initiated designs are exactly what the field needs to counterbalance industry-driven evidence generation.

Clinical Trials Update

Aortic Valve

Mitral Repair

Mitral Replacement

Tricuspid Repair

Tricuspid Replacement

Valve Industry Stocks — Weekly Performance

6-Month Valve Industry Stock Performance

The week's standout story is the Boston Scientific–MiRus transaction, which lifted BSX shares roughly 6% on Monday before consolidating. Edwards rallied late in the week (+3.1% Friday) to close near six-month highs as the EVOQUE franchise continues to gain traction and the broader sector caught a bid. Anteris closed at A$12.91, a fresh 52-week high.

Edwards Lifesciences (EW)

EW 6-Month Chart

  • Close: $85.78 | Weekly change: +$3.39 (+4.1%) | 6-month: +1.26%
  • Market cap: $49.4B | P/E (TTM/fwd): 46.4 / 25.5 | Beta: 0.87
  • 52-week range: $72.30 – $87.89 (closed near high)
  • Analyst target: $97.15 (range $84–$110, 27 analysts) | Rec: Buy
  • Next earnings: July 23, 2026 (EPS est $0.74, Rev est $1.70B)
  • Commentary: The most resilient name in the cohort. The MiRus deal is a longer-term competitive overhang for SAPIEN but does not change near-term economics. PASCAL CLASP TR data flow and EVOQUE TTVR commercialization (TVT Registry showed 98.4% implant success, 3.1% 30-day mortality) remain key catalysts. Multiple insider sales (Bobo, Lippis, others) totaling >$1.4M over the week appear to be planned dispositions.

Medtronic (MDT)

MDT 6-Month Chart

  • Close: $78.60 | Weekly change: +$1.73 (+2.2%) | 6-month: -22.65%
  • Market cap: $100.9B | P/E (TTM/fwd): 22.0 / 13.0 | Beta: 0.63
  • 52-week range: $74.40 – $106.33
  • Analyst target: $107.08 (range $84–$121, 26 analysts) | Rec: Buy
  • Next earnings: June 3, 2026 (EPS est $1.56, Rev est $9.61B)
  • Commentary: Trading near 52-week lows. Forward P/E of 13.0 reflects deep pessimism. Earnings in less than two weeks will be a key catalyst — watch for Evolut volumes, Evolut EXPAND TAVR II timing, and Intrepid TMVR enrollment trajectory.

Abbott (ABT)

ABT 6-Month Chart

  • Close: $87.41 | Weekly change: -$0.20 (-0.2%) | 6-month: -30.49%
  • Market cap: $152.3B | P/E (TTM/fwd): 24.5 / 14.4 | Beta: 0.65
  • 52-week range: $81.97 – $139.06
  • Analyst target: $118.64 (range $92–$143, 25 analysts) | Rec: Buy
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