Daily Digest

The Valve Wire

Monday, May 4, 2026

Executive Summary

Edwards Lifesciences dominates today's headlines with 10-year pivotal data from the COMMENCE trial demonstrating long-term durability of its RESILIA tissue technology for surgical heart valves — a critically important dataset as the field debates whether bioprosthetic valves can last long enough to justify their use in younger patients. A JAHA meta-analysis comparing valve-in-valve transcatheter mitral valve replacement (ViV-TMVR) to redo surgical MVR finds a sobering crossover: early mortality favors the transcatheter approach, but after six months, redo surgery pulls ahead — reinforcing that less invasive doesn't always mean better long-term. Meanwhile, a JACC: Asia registry analysis of ViV-TAVR for small surgical bioprostheses reveals that patient-prosthesis mismatch remains a vexing problem with real prognostic consequences. And as the AATS Annual Meeting convenes, new data on the Ross procedure versus TAVR and SAVR in younger adults from the Annals of Thoracic Surgery enters the conversation about optimal valve strategy in patients with decades of life ahead.

For clinicians tracking this week's AATS meeting agenda, the convergence of durability data, reintervention challenges, and age-threshold debates couldn't be more timely. The Edwards RESILIA 10-year results provide ammunition for bioprosthetic advocates, but they also underscore why lifetime management planning — a major emphasis of the 2025 ESC/EACTS guidelines — must begin at the index procedure. From the Netherlands Heart Registration comes real-world evidence on how prior cardiac surgery shapes the TAVR-versus-SAVR decision in patients under 75, while emerging AI tools for predicting paravalvular leak in bicuspid valve TAVI remind us that this anatomically challenging subset remains poorly served by current transcatheter platforms. Let's unpack it all.

Today's Key Findings

[NOTABLE] Edwards RESILIA Tissue: 10-Year COMMENCE Trial Data Released. Edwards Lifesciences announced pivotal 10-year results from the COMMENCE aortic trial, reinforcing durability claims for its RESILIA anti-calcification tissue technology. This is the longest prospective follow-up for this tissue platform, and multiple analyst firms (TipRanks, GuruFocus, MassDevice) have highlighted the data as supporting Edwards' elevated 2026 outlook. The timing — coinciding with the AATS Annual Meeting — is strategic. Editorial note: While 10-year surgical bioprosthetic durability data is encouraging, it must be interpreted alongside the reality that structural valve deterioration (SVD) curves typically steepen beyond decade one. The 2025 ESC/EACTS guidelines explicitly note that lifetime management planning should account for durability beyond available follow-up. We await the full dataset to assess SVD definitions used, patient age distribution, and whether these results apply to the younger patients increasingly receiving bioprosthetic valves. (Business Wire)

[NOTABLE] ViV-TMVR vs. Redo Surgical MVR: Early Gains Erode After 6 Months. A meta-analysis in the Journal of the American Heart Association (13 studies, 15,941 patients) found that valve-in-valve TMVR had lower in-hospital mortality (RR 0.72), stroke, bleeding, AKI, and pacemaker rates compared to redo surgical MVR. However, landmark analysis revealed a mortality crossover: ViV-TMVR was superior in the first 6 months (HR 0.69) but inferior thereafter (HR 1.47). Five-year overall survival did not differ. This is a textbook case of why short-term procedural safety cannot be conflated with long-term efficacy — a caution that applies broadly across structural heart interventions. (Sá et al., JAHA)

[NOTABLE] ViV-TAVR and the Small Bioprosthesis Problem. From the OCEAN-TAVI registry in JACC: Asia, an analysis of 367 ViV-TAVR patients showed that small surgical bioprostheses (true internal diameter ≤20 mm) were associated with a 3.5-fold higher risk of cardiovascular death or HF hospitalization at 3 years (HR 3.48), driven by severe patient-prosthesis mismatch (PPM) in 21.3% of cases. When small valves were combined with severe PPM, the hazard ratio reached 6.65. This directly supports the 2025 ESC emphasis on planning for future valve-in-valve feasibility at the index procedure — and raises hard questions about implanting small surgical bioprostheses when a future ViV may be the exit strategy. (Kamioka et al., JACC Asia)

Ross vs. TAVR vs. SAVR in Younger Adults. An Annals of Thoracic Surgery analysis compares outcomes after Ross procedure, TAVR, and SAVR in younger adults — a critical population where both ACC/AHA and ESC guidelines favor surgical approaches but where optimal surgical strategy (mechanical, bioprosthetic, or Ross) remains debated. The full abstract is not yet available, but this contribution from Alabbadi and Egorova arrives at the ideal moment as AATS attendees weigh long-term data across all three strategies. Both guidelines recommend SAVR for patients under 65 (ACC/AHA) or 70 (ESC), but neither prescribes the Ross procedure specifically — despite growing enthusiasm from select centers. (Alabbadi & Egorova, Ann Thorac Surg)

BAV Bridge to TAVR BAV: Temporizing BAV as Bridge to Elective TAVR Appears Viable. Using the US Medicare database (n=227,145 TAVR; n=16,643 BAV), Jagadeesan, Mehaffey and colleagues found that urgent BAV followed by elective outpatient TAVR was associated with lower index mortality (OR 0.61), stroke (OR 0.55), and longitudinal mortality (HR 0.67) compared to urgent inpatient TAVR. Urgent BAV-to-urgent TAVR fared worse. This supports a staged strategy for decompensated severe AS — stabilize first, then optimize. Notably, co-author Mehaffey has been a thoughtful voice on appropriate TAVR expansion. (Jagadeesan et al., Am J Cardiol)

Aortic Valve (TAVR/TAVI)

SAVR vs. TAVR in Dialysis Patients

A new JTCVS analysis by Tahhan and colleagues compares morbidity and mortality outcomes of isolated SAVR versus TAVR in dialysis-dependent patients over 5 years. This is a population with notoriously poor outcomes regardless of intervention approach, and one where both guidelines leave considerable room for Heart Team discretion. Dialysis patients were underrepresented in the pivotal low-risk TAVR trials, making real-world comparisons essential. Full results will be important to contextualize; historically, TAVR's procedural advantages may be offset by accelerated bioprosthetic valve calcification in the dialysis milieu. (Tahhan et al., JTCVS)

TAVR and Prior Cardiac Surgery: Netherlands Heart Registration

A Dutch nationwide analysis of 1,284 patients aged 50–75 with prior cardiac surgery found roughly equal utilization of TAVR (54%) and SAVR (46%), but with dramatically different outcomes: 5-year survival was 56% for TAVR versus 83% for SAVR (p<0.001). Before interpreting this as a SAVR advantage, note the significant selection bias: TAVR patients were older (71 vs. 67), had higher EuroSCORE II (5.7 vs. 4.4), and were more likely to have prior CABG. LVEF ≤30%, poor mobility, and obesity/cachexia predicted TAVR selection — classic confounders. Pure native AR and bioprosthesis failure predicted SAVR selection. The key determinants of mortality (severe LV dysfunction, chronic lung disease) were more impactful for SAVR, suggesting appropriate risk-based channeling. (van Niekerk et al., J Cardiothorac Surg)

Porcelain Aorta: Not the TAVR Risk Multiplier You'd Expect

A single-center analysis of 2,037 TAVR patients (40 with porcelain aorta) found that after IPTW adjustment, porcelain aorta was not associated with increased mortality, stroke, or renal failure — though it did predict longer hospital and ICU stays. While porcelain aorta is a Class I indication favoring TAVR over SAVR in both guidelines (since aortic cross-clamping is contraindicated), this study suggests it doesn't add incremental procedural risk to TAVR itself. Caveat: only 40 PA patients, limiting power. (Tagliafierro et al., Medicina)

AI Predicts Paravalvular Leak in Bicuspid TAVI

A deep learning model integrating 3D CT imaging with clinical variables achieved AUC 0.822 for predicting residual ≥moderate paravalvular leak (PVL) after TAVI in 402 BAV patients with self-expanding valves — substantially outperforming conventional models (AUC 0.694). PVL occurred in 9%, associated with larger aortic roots and heavier calcification. Both guidelines rate BAV-TAVI as Class IIb, and PVL has been a persistent challenge in this anatomy. While promising, sensitivity was only 43%, and this is a single-center, internally validated model. External validation is essential. (Yao et al., Biomedicines)

CALLY Index for Post-TAVI Risk Stratification

The CRP-albumin-lymphocyte (CALLY) index was independently associated with all-cause mortality after TAVI (HR 3.80 for low CALLY) in a 303-patient, single-center retrospective study. AUC was modest at 0.698. This adds to the growing body of evidence that inflammatory and nutritional biomarkers may complement traditional surgical risk scores, but the single-center design and moderate discrimination limit immediate clinical applicability. (Güner et al., Medicina)

CTCA as Gatekeeper for Invasive Coronary Angiography Before TAVI

A comprehensive review argues that CT coronary angiography (already performed for TAVI planning) can safely replace invasive coronary angiography in a substantial proportion of patients, citing 90-97% sensitivity and 94-99% negative predictive value for excluding significant proximal CAD. This is bolstered by ACTIVATION and NOTION-3, which showed questionable benefit of routine pre-emptive revascularization in stable TAVI candidates. The authors propose a practical CT-first algorithm. (Apostolos et al., Medicina)

Additional Aortic Valve Studies

New-onset LBBB after TAVI review: LBBB remains the most common TAVI complication. This updated review covers incidence, mechanisms, and management with newer-generation devices. (Mayol et al., J Clin Med)
LBBAP vs. deep septal pacing post-TAVR: In 82 patients requiring permanent pacemakers after TAVR, left bundle branch area pacing provided superior symptom relief (NYHA improvement: 54% vs. 28%, p=0.043) versus deep septal pacing, despite similar hard endpoints. Confirmed LBB capture was key. (Qu et al., J Cardiovasc Electrophysiol)
Frontal QRS-T angle predicts conduction disturbances: Post-procedural ΔQRS-T angle ≥46.5° was associated with electrical disturbances after self-expandable TAVI (87% specificity, 46% sensitivity). Single-center, n=135. (Alıç et al., J Electrocardiol)
14F vs. 18F plug-based vascular closure devices: No significant difference in VARC-3 vascular complications in a propensity-matched comparison (n=170). Reassuring for either device size, though a prospective trial is warranted. (Lerchner et al., J Clin Med)
ACEi/ARB before AVR: In 198 patients, preoperative ACEi/ARB use trended toward lower 1-year mortality (7% vs. 19%), but significance was lost after multivariable adjustment (p=0.075). Hypothesis-generating only; confirms ACEi/ARBs are not harmful pre-AVR. (Abid et al., J Clin Med)
Anesthesia type and TAVI outcomes: Local anesthesia showed apparent early survival advantages over general anesthesia in 401 patients, but IPTW-weighted analysis eliminated the difference — suggesting confounding by indication rather than a causal anesthesia effect. (Kiris et al., Life)
Anti-thrombotic therapy after structural heart interventions: A comprehensive state-of-the-art review covering antithrombotic management across TAVR, mitral, tricuspid, and closure devices. Useful reference for balancing thrombotic and bleeding risks. (Tartaglia et al., J Clin Med)

Mitral Valve (MitraClip, PASCAL, TMVR)

EROA/LVEDV Ratio Predicts MitraClip Outcomes in Secondary MR

A multicenter retrospective study of 221 MitraClip patients found that a lower preprocedural EROA/LVEDV ratio — indicating disproportionately mild MR relative to LV dilation — was significantly associated with symptom worsening at 1 year (OR 0.95, p<0.01), with moderate predictive value (AUC 0.74). This directly supports the COAPT "proportionate MR" concept and reinforces why the ESC upgraded TEER for ventricular SMR to Class I with specific patient selection criteria. The MITRA-FR population, which had more LV dilation relative to MR severity, showed no TEER benefit — and this study essentially provides an echocardiographic tool to identify those MITRA-FR-like patients less likely to benefit. Limitation: retrospective, moderate sample, and 39% event rate suggests a relatively sick cohort. (Varughese et al., Medicina)

ViV-TMVR vs. Redo Surgical MVR: The Durability Crossover

As noted in Key Findings, this JAHA meta-analysis (13 studies, 15,941 patients) provides the clearest evidence yet that ViV-TMVR's procedural safety advantage reverses after 6 months. The mortality crossover (HR 0.69 early, HR 1.47 late) suggests that patient-prosthesis mismatch, limited hemodynamic performance of transcatheter valves inside degenerated surgical valves, and potentially accelerated deterioration may compromise long-term survival. This has direct implications for how we counsel patients about reintervention strategies and underscores the 2025 ESC emphasis on planning for future valve-in-valve feasibility at the index SAVR. (Sá et al., JAHA)

MitraNav: Robotic System for Transcatheter Mitral Valve Replacement

A biomedical engineering publication introduces MitraNav, described as the first robotic system designed for dock-based TMVR. Using a two-stage control strategy with cross-attention-fused deep learning, the system achieved tip positioning errors under 2.5 mm — within acceptable range for catheter-based interventions. While this is far from clinical application, it signals the convergence of robotics and transcatheter mitral replacement, which remains technically the most challenging frontier in structural heart. (Wang et al., Ann Biomed Eng)

Tricuspid Valve (TriClip, TTVR)

CAPTURE Pilot: Who Needs More Than T-TEER?

The CAPTURE pilot study (NCT06838611) screened 147 patients referred for transcatheter TR treatment and found that only 52% were eligible for T-TEER, with 23% identified as potential candidates for alternative strategies (orthotopic or heterotopic valve implantation). Those needing alternatives had more advanced disease: 77% had torrential TR, 44% had ascites, and laboratory markers suggested hepatic dysfunction and elevated bleeding risk. Procedural success among treated T-TEER patients was 77.5% — lower than the 87% reported in TRILUMINATE's pivotal cohort. This real-world snapshot highlights two realities: (1) T-TEER eligibility is far from universal, creating a substantial unmet need for transcatheter TV replacement; and (2) patients who fail or are ineligible for T-TEER represent a sicker, higher-risk cohort where any intervention carries substantial risk. The 2025 ESC rates transcatheter TV treatment as Class IIa but emphasizes excluding severe RV dysfunction — exactly the population that appears overrepresented in the "alternative strategy" group. (Rdzanek et al., Life)

Pulse Contour Monitoring During T-TEER

An exploratory pilot study of 12 patients showed that pulse contour analysis detected a 30% increase in cardiac output and 0.68 L/min/m² rise in cardiac index within 4 hours of T-TEER, along with reduced right atrial v-wave amplitude. While the sample is tiny, this suggests real-time hemodynamic monitoring could provide intraprocedural feedback on procedural success — potentially complementing echocardiographic guidance. (Uhle et al., J Cardiothorac Vasc Anesth)

Surgical vs. Transcatheter Comparisons

The ViV-TMVR mortality crossover (detailed above) is today's most important surgical-transcatheter comparison: early transcatheter advantage, late surgical advantage. This pattern echoes concerns raised in TAVR durability debates and reinforces a core editorial principle of The Valve Wire — procedural safety and long-term efficacy are different endpoints that serve different patients differently.

SAVR vs. TAVR in dialysis: The new JTCVS study examines 5-year outcomes in this high-risk population. Dialysis patients represent perhaps the strongest case for individualized Heart Team decisions, as both approaches carry substantial risk and neither has strong RCT representation. (Tahhan et al., JTCVS)

Ross vs. TAVR vs. SAVR in young adults: The Annals publication arrives during AATS week, when the surgical community is most receptive to data supporting the Ross procedure as a durable alternative for young patients in whom both guidelines recommend surgery over TAVR. (Alabbadi & Egorova, Ann Thorac Surg)

Netherlands Heart Registration: Five-year survival of 56% (TAVR) vs. 83% (SAVR) in patients under 75 with prior cardiac surgery, but confounded by dramatically different risk profiles. A reminder that registry comparisons in non-randomized populations must be interpreted with extreme caution — exactly the kind of data that can be misused to argue for or against either approach. (van Niekerk et al., J Cardiothorac Surg)

Device & Technology

Edwards RESILIA Tissue — 10-Year COMMENCE Data: The headline device story of the day. Edwards is positioning RESILIA as the tissue platform that could extend bioprosthetic durability sufficiently to justify use in younger patients and improve ViV-TAVR planning. If SVD rates at 10 years are genuinely lower than historical bovine pericardial tissue, this has implications for the mechanical-vs-bioprosthetic decision in patients aged 50–70. Recall that a recent European Heart Journal study found mechanical valves had better long-term survival in the 50–70 age group. RESILIA's value proposition is that it could narrow that gap. We'll analyze the full dataset when published. (Business Wire)

Hydra THV System Expands Registry Footprint: Sahajanand Medical Technologies (Meril Life Sciences subsidiary) continues enrolling across Italy (500 patients), Copenhagen (50 patients), and the UK (250 patients) for its Hydra transcatheter aortic valve. This Indian-origin device represents growing competition in the THV space from non-traditional manufacturers — important for global access and pricing dynamics.

Industry & Market

TAVI Global Expansion: Two news items highlight the continuing spread of TAVI into emerging markets. Libya announced the second phase of its TAVI localization project for 2026 (Libya Herald), while Hyderabad reported a sharp rise in TAVR volumes as minimally invasive valve care expands in India (BW Healthcare). Both underscore the growing global addressable market, though access equity and appropriate patient selection in resource-limited settings remain pressing concerns.

TAVR Case Report — Aortic Regurgitation in Takayasu Arteritis: A Cureus case report describes TAVR for severe AR in a young adult with Takayasu arteritis — an off-label application. The 2025 ESC rates TAVI for AR as Class IIb for inoperable patients; the ACC/AHA 2020 guidelines do not address it. Case reports like this push boundaries but should not be confused with evidence for routine use. (Cureus)

Financial Analysis

The structural heart device sector enters AATS week in a bifurcated state. Edwards Lifesciences stands out as the steadiest performer, buoyed by strong Q1 results and the strategically timed release of 10-year RESILIA durability data. Analyst consensus maintains a Buy rating with a $97 target — roughly 16% upside — and the COMMENCE data provides a narrative catalyst heading into the July earnings cycle. Edwards' forward P/E of ~25x reflects premium positioning but also high expectations for TAVR volume growth and surgical bioprosthetic tissue adoption.

The broader medtech selloff has been particularly brutal for Boston Scientific (-43% over 6 months) and Abbott (-27%), both of which have been caught in the crossfire of macro headwinds, tariff fears, and sector rotation. Abbott's TriClip and MitraClip franchises represent major structural heart growth vectors, but the stock is trading near its 52-week low of $89.14. Medtronic has also declined ~10% over 6 months and reports next on June 3, where its Evolut TAVR platform and Intrepid TMVR pipeline will be focal points.

Kornitzer Capital Management reduced its Edwards stake (per MarketBeat), which may reflect routine portfolio rebalancing rather than a fundamental view change, given the broad Buy consensus across 27 analysts. On the small-cap/development stage front, Anteris Technologies (+17% over 6 months) continues to attract speculative interest in its DurAVR single-piece tissue valve, though with no revenue and a market cap under $1B, this remains a high-risk proposition.

The key financial question for the sector: Can structural heart procedure volumes grow fast enough to offset pricing pressure and macro headwinds? The Edwards RESILIA data supports the thesis that tissue innovation can drive both surgical and transcatheter revenue, while the global TAVR expansion stories from India and Libya point to untapped volume. But the severe multiple compression at BSX and ABT suggests the market wants to see execution, not just data.

Valve Industry Stocks

6-Month Valve Industry Stock Performance

Edwards Lifesciences (EW)

Close: $83.98 | Daily Change: +$0.48 (+0.57%)
6-Month Performance: +1.10% ($83.07 → $83.98)
Market Cap: $48.4B | P/E (trailing): 45.39 | P/E (forward): 24.97 | Beta: 0.87
52-Week Range: $72.30 – $87.89
Analyst Consensus: Buy | Target: $97.15 (range $84–$110, 27 analysts) — 16% upside
Next Earnings: July 23, 2026 | EPS est: $0.74 | Rev est: $1.70B
Commentary: The dominant story is the 10-year COMMENCE/RESILIA data release, reinforcing Edwards' tissue technology moat. Q1 results were strong, and TipRanks notes an unchanged $97 price target with elevated 2026 outlook. The stock has been relatively range-bound for 6 months (+1.1%), reflecting a market that has already priced in near-term fundamentals and is waiting for the next catalyst — which could be either AATS presentations or the July earnings beat/miss.

Medtronic (MDT)

Close: $80.00 | Daily Change: -$0.97 (-1.20%)
6-Month Performance: -9.93% ($88.82 → $80.00)
Market Cap: $102.7B | P/E (trailing): 22.35 | P/E (forward): 13.20 | Beta: 0.63
52-Week Range: $78.91 – $106.33
Analyst Consensus: Buy | Target: $108.00 (range $90–$121, 25 analysts) — 35% upside
Next Earnings: June 3, 2026 | EPS est: $1.55 | Rev est: $9.62B
Commentary: Trading near its 52-week low with the widest upside-to-target gap in the group (35%). The Evolut FX platform is in a head-to-head trial versus SAPIEN 3 Ultra RESILIA (NCT06470022, enrolling 1,346 patients), and the Intrepid TMVR program continues recruiting. June 3 earnings will be a critical inflection point. The Evolut Low Risk long-term follow-up trial (NCT02701283) remains active and could provide pivotal durability data.

Abbott (ABT)

Close: $89.46 | Daily Change: -$1.33 (-1.46%)
6-Month Performance: -26.94% ($122.45 → $89.46)
Market Cap: $155.8B | P/E (trailing): 25.06 | P/E (forward): 14.75 | Beta: 0.65
52-Week Range: $89.14 – $139.06
Analyst Consensus: Buy | Target: $118.64 (range $92–$143, 25 analysts) — 33% upside
Next Earnings: July 16, 2026 | EPS est: $1.28 | Rev est: $12.53B
Commentary: The steepest decline among the majors, closing just $0.32 above its 52-week low. Abbott's structural heart portfolio (MitraClip, TriClip) is arguably the broadest in the industry, but the stock has been hammered by broader portfolio concerns. The TRILUMINATE pivotal trial (NCT03904147) remains active but not recruiting, and COAPT long-term follow-up (NCT03706833) continues. Today's EROA/LVEDV ratio study validates MitraClip's patient selection paradigm. The CAPTURE pilot data suggesting ~23% of TR patients need alternatives to T-TEER underscores Abbott's addressable market constraints in tricuspid.

Boston Scientific (BSX)

Close: $56.50 | Daily Change: -$1.11 (-1.93%)
6-Month Performance: -42.69% ($98.59 → $56.50)
Market Cap: $84.0B | P/E (trailing): 23.64 | P/E (forward): 15.01 | Beta: 0.62
52-Week Range: $56.05 – $109.50
Analyst Consensus: Strong Buy | Target: $85.19 (range $60–$110, 32 analysts) — 51% upside
Next Earnings: July 22, 2026 | EPS est: $0.83 | Rev est: $5.40B
Commentary: The most battered stock in the structural heart universe, down 43% in 6 months despite a Strong Buy consensus and the widest upside gap (51%). BSX's PASCAL TEER system competes with Abbott's MitraClip/TriClip, and CLASP II TR (NCT04097145) is actively recruiting for the tricuspid indication. The Millipede transcatheter annuloplasty program (NCT04147884) is active but not recruiting, with only 4 patients enrolled — reflecting the challenges of novel mitral device development. The Watchman LAAO franchise and EP portfolio are larger revenue drivers, making BSX's structural heart exposure a smaller proportion of the story, but the extreme valuation compression may create opportunity if macro conditions stabilize.

Anteris Technologies (AVR.AX)

Close: A$8.35 | Daily Change: +A$0.20 (+2.45%)
6-Month Performance: +17.44% (A$7.11 → A$8.35)
Market Cap: A$0.8B | P/E (forward): -3.83 (pre-revenue) | Beta: 0.59
52-Week Range: A$4.68 – A$9.79
Analyst Target: A$13.00 (1 analyst)
Commentary: The best 6-month performer in the group (+17%), though from a very low base. Anteris' DurAVR single-piece 3D-printed tissue valve and ADAPT anti-calcification technology represent a potential paradigm shift, but the company remains pre-revenue with limited clinical data. Speculative interest only; no near-term earnings catalyst.

Private companies of note: JenaValve Technology (TAVR for aortic regurgitation), J Valve Technology (AR-focused THV), and Meril Life Sciences (Myval THV, Hydra THV) are all private and not publicly traded. Meril's Hydra THV registries (Italy, Denmark, UK) continue enrolling, expanding the competitive landscape for next-generation transcatheter aortic valves.

Market Outlook: The structural heart sector is experiencing a paradox: clinical data and procedure volumes continue their upward trajectory, but stock performance for three of the four major public players has been sharply negative. Edwards' relative stability (+1%) versus the severe declines at BSX (-43%), ABT (-27%), and MDT (-10%) suggests the market is rewarding pure-play structural heart focus over diversified medtech exposure. With three earnings reports in late July and Medtronic on June 3, the next 8 weeks will be decisive. The Edwards RESILIA durability data, AATS meeting readouts, and any signals on the ACC/AHA guideline update timeline could all serve as catalysts.

Clinical Trial Updates

Aortic Valve Trials

[LANDMARK] Evolut Low Risk Long-Term Follow-Up (NCT02701283) — Medtronic's pivotal low-risk TAVR trial with 2,223 patients. Status: Active, not recruiting. Long-term durability data from this trial will be critical for the next ACC/AHA guideline update and for validating the ESC's decision to lower the TAVI-preferred age threshold to 70. Last updated March 2026.
Evolut FX vs. SAPIEN 3 Ultra RESILIA Head-to-Head (NCT06470022) — Randomized comparison of the two dominant THV platforms. Enrolling 1,346 patients. Status: Recruiting. This investigator-initiated trial (Terkelsen, Denmark) could provide the first randomized data directly comparing current-generation self-expanding vs. balloon-expandable valves.
Dexmedetomidine Sedation for TAVI (NCT07532733) — Erasme University Hospital. Enrolling 80 patients to compare dexmedetomidine vs. propofol/remifentanil sedation. Status: Recruiting.
TAVR Sedation Quality of Recovery (NCT07556523) — Phase 4, comparing propofol vs. dexmedetomidine vs. midazolam. Enrolling 126 patients. Status: Recruiting.
Hydra THV Registry — Italy (NCT05956652) — 500 patients. Status: Recruiting.
Hydra THV — Copenhagen (NCT06342635) — 50 patients. Status: Recruiting.
Hydra THV Registry — UK (NCT06507579) — 250 patients. Status: Recruiting.
NHLBI-Emory Advanced Cardiac CT Reconstruction (NCT05372627) — 1,000 patients, NHLBI-sponsored. Status: Not yet recruiting. Focused on advanced CT reconstruction techniques relevant to TAVR planning.

Mitral Repair Trials

[LANDMARK] REPAIR-MR — MitraClip vs. Surgery for Primary MR (NCT04198870) — Abbott-sponsored, 500 patients. Status: Active, not recruiting. This is the pivotal trial that could reshape primary MR management. Both guidelines currently rate TEER as Class IIa for high-risk primary MR; a positive result here could change that. Last updated November 2025.
[LANDMARK] PRIMATY — MitraClip vs. Medical Therapy for Secondary MR (NCT05051033) — NHLBI-funded, 450 patients comparing surgical MV repair vs. TEER. Status: Recruiting. Critical for validating TEER in secondary MR beyond COAPT-like patients. Last updated March 2026.
[LANDMARK] COAPT Long-Term Follow-Up (NCT03706833) — Edwards PASCAL and Abbott MitraClip. 1,247 patients. Status: Active, not recruiting. Extended follow-up of the landmark COAPT trial. The ESC upgraded TEER for ventricular SMR to Class I based on 5-year COAPT data. Last updated April 2026.
MitraClip G5 Registry (NCT07543874) — University Hospital of Cologne. 1,000 patients for next-generation MitraClip. Status: Not yet recruiting. Updated May 1, 2026.
Millipede Transcatheter Annuloplasty Ring (NCT04147884) — Boston Scientific. Only 4 patients enrolled. Status: Active, not recruiting. This minimal enrollment reflects the challenges of novel transcatheter mitral annuloplasty approaches.
WATCH-TMVR (Watchman + MitraClip) (NCT04494347) — Mayo Clinic, 25 patients combining LAAO with TEER. Status: Completed. Relevant to the 2025 ESC's new atrial SMR pathway, which recommends MV surgery + AF ablation + LAAO.

Mitral Replacement Trials

[LANDMARK] Intrepid TMVR Pivotal (NCT03242642) — Medtronic, 1,056 patients. Status: Recruiting. The furthest-advanced TMVR pivotal trial. Today's MitraNav robotic TMVR paper underscores the technical complexity these devices face. Last updated March 2026.

Tricuspid Repair Trials

[LANDMARK] TRILUMINATE Pivotal — TriClip for TR (NCT03904147) — Abbott, 572 patients. Status: Active, not recruiting. The trial that drove the 2025 ESC Class IIa recommendation for transcatheter TR treatment. Today's CAPTURE pilot data showing only 52% T-TEER eligibility provides important real-world context. Last updated December 2024.
[LANDMARK] CLASP II TR — PASCAL for TR (NCT04097145) — Edwards, 870 patients. Status: Recruiting. Head-to-head vs. optimal medical therapy for tricuspid TEER. Last updated April 2026.

Tricuspid Replacement Trials

[LANDMARK] TRISCEND II — Evoque Tricuspid Replacement (NCT04482062) — Edwards, 864 patients. Status: Active, not recruiting. The pivotal TV replacement trial. CAPTURE pilot data suggests ~23% of TR patients may need replacement rather than repair, underscoring the importance of this trial. Last updated February 2026.

Social & Conference Highlights

AATS Annual Meeting (May 3–7, 2026) is underway. The timing of today's publications is no coincidence: Edwards' RESILIA 10-year data drop, the Annals of Thoracic Surgery piece on Ross vs. TAVR vs. SAVR in younger adults, and the JTCVS SAVR-vs-TAVR dialysis analysis all align with the meeting's surgical audience. Watch for late-breaking clinical trial presentations, simultaneous publications, and updated long-term follow-up from ongoing pivotal trials throughout the week. The Valve Wire will be covering all major readouts.

Key sessions to watch: Any presentations addressing TAVR durability beyond 5 years, the role of the Ross procedure in young adults, concomitant procedures during cardiac surgery (AF ablation, tricuspid repair), and lifetime valve management strategies. The tension between surgical and transcatheter approaches is the defining theme of this meeting — and of this era in structural heart disease.

That's today's Valve Wire. The RESILIA 10-year data and the ViV-TMVR mortality crossover tell the same story from different angles: durability is the currency that matters most in structural heart, and we still don't have enough of it for the patients who need it most — the young. More from AATS tomorrow.

— E. Nolan Beckett

← May 1, 2026