Executive Summary
In today's digest — filed during the AATS Annual Meeting in Toronto — a compelling new analysis finds that surgical aortic valve replacement delivers significantly better 3- and 5-year survival than TAVR in dialysis-dependent patients, despite higher early complication rates. A multicenter Chinese trial reports encouraging 1-year results for a novel transapical TAVR system designed specifically for aortic regurgitation — a frontier where both ACC/AHA and ESC guidelines currently offer only limited transcatheter recommendations. And a meta-analysis challenges current guideline requirements for on-site cardiac surgery backup during TAVI, finding no safety difference in centers without it. Meanwhile, Edwards Lifesciences names a new CFO amid insider selling activity, and structural heart stocks broadly decline on a risk-off day.
For the clinical audience: this is a day to pay attention to patient selection nuance. The dialysis-TAVR study underscores a theme we see again and again — transcatheter approaches that look favorable at 30 days can reverse at longer follow-up in high-comorbidity populations. The Ken-Valve AR data from China is intriguing but carries all the usual caveats: single-arm design, transapical access (a route largely abandoned in the West for aortic stenosis), 1-year follow-up, and a device not available outside China. We also flag several important clinical trial updates, including a new head-to-head tricuspid valve replacement pivotal trial (TRICURE) and the Medtronic Intrepid TMVR study continuing enrollment. With AATS presentations ongoing, expect late-breaking data to reshape some of these conversations by week's end.
Today's Key Findings
[NOTABLE] SAVR beats TAVR for long-term survival in dialysis patients — A propensity-matched study of 448 patients from the TriNetX Research Network found that while TAVR had lower 30-day MACCE (HR 1.96 favoring TAVR), SAVR demonstrated significantly better survival at 3 years (HR 0.70, 95% CI 0.52–0.95) and 5 years (HR 0.71, 95% CI 0.54–0.94). This adds to the growing body of evidence that short-term procedural advantages of TAVR do not always translate to durable benefit — particularly in patients with heavy comorbidity burdens. Dialysis patients were underrepresented in the landmark low-risk TAVR trials, and these findings reinforce that the SAVR vs. TAVR calculus must be individualized. Under both ACC/AHA and ESC guidelines, Heart Team deliberation is essential for these complex patients, and this study suggests the pendulum may tip toward surgery when life expectancy permits. Read the study →
TAVI without on-site surgery backup appears safe in meta-analysis — A systematic review of 8 observational studies (22,203 patients) found no significant difference in in-hospital mortality (RR 1.1, p=0.8), 30-day mortality (RR 1.2, p=0.72), or stroke (RR 1.1, p=0.8) between centers with and without on-site cardiac surgery. Emergent conversion to surgery was 0%. This directly challenges current guideline recommendations (both ACC/AHA and ESC) mandating on-site surgical backup. However, editorial caution is warranted: all included studies were observational, and center selection effects are likely — programs operating without surgery backup may be cherry-picking lower-risk patients and simpler anatomies. The 0% emergency surgery rate is notable but reflects modern TAVR realities; it does not eliminate the value of surgical backup for rare catastrophic complications. Read the meta-analysis →
Novel TAVR for aortic regurgitation shows promise at 1 year — A multicenter prospective trial of the Ken-Valve (Jenscare Biotechnology) in 142 high-risk patients with pure AR or mixed AR/AS across 15 Chinese hospitals reported 97.2% technical success, 2.1% 30-day mortality, and 5.6% 1-year all-cause mortality. New permanent pacemaker rate was 14.1%. The ESC 2025 guidelines rate TAVI for AR as Class IIb for inoperable patients; the ACC/AHA 2020 guidelines do not address it. While these results are encouraging for an underserved population, the transapical approach limits generalizability, and the single-arm design without a surgical comparator means we cannot draw efficacy conclusions. Read the study →
Aortic Valve (TAVR/TAVI)
HALP Score Predicts Long-Term Mortality After TAVI
A single-center retrospective study of 785 TAVI patients found that the preprocedural hemoglobin-albumin-lymphocyte-platelet (HALP) score independently predicted long-term mortality (HR 0.94, 95% CI 0.91–0.98, p=0.002), with a cut-off of 36.82 discriminating survival over a median 21.8-month follow-up. Chronic kidney disease and paradoxical low-flow low-gradient AS were also independent predictors. The 8% overall mortality rate is consistent with real-world TAVI registries. While the HALP score elegantly integrates frailty, nutrition, and inflammation into a single metric, its prognostic increment over established scores (STS-PROM, EuroSCORE II) needs head-to-head comparison. Notably, the ESC 2025 guidelines emphasize frailty assessment beyond traditional risk scores — tools like HALP may eventually fill this gap. Limitations: single-center, retrospective, no external validation. Read the study →
Multi-Chamber Strain Imaging Before TAVR
A retrospective analysis of 234 TAVR patients using comprehensive strain echocardiography found that multi-chamber impairment (MCI, ≥2 chambers affected) was present in 29% of patients, with left atrial dysfunction the most common isolated abnormality (88% of single-chamber cases). Three-chamber impairment carried a striking mortality risk (HR 6.84, 95% CI 1.77–26.4, p=0.005) at 12 months. However, a modified staging system incorporating strain did not significantly improve predictive accuracy over existing models — a humbling finding for strain enthusiasts. Post-TAVR improvement was modest and predominantly in LV global longitudinal strain (+1.8%). This reinforces the concept that AS-related cardiac damage extends well beyond the left ventricle, but practical clinical application of multi-chamber strain remains unclear. Read the study →
Regional TAVI Access Disparities in Spain
An analysis of the Spanish National Registry (2016–2023) documented significant interregional variability in TAVI rates (0.63 to 2.28 per 10,000 inhabitants). A survey of 123 centers identified rigid patient stratification (25.6%), insufficient early detection (17.8%), and resource limitations (13.3%) as primary barriers. This mirrors access equity concerns worldwide and takes on added significance as both guidelines expand TAVI indications — if the funnel is wider but access remains unequal, guideline changes could paradoxically widen disparities. Read the study →
Clinical Clustering of TAVI Patients
A study using two-step cluster analysis to profile TAVI patients and their outcomes was published in REC Interventional Cardiology. No abstract was available at press time, but the multivariate approach to patient phenotyping aligns with the broader push toward precision medicine in structural heart disease. Read the study →
ECPR and Emergent Valve-in-Valve TAVI for Cardiac Arrest
A remarkable case report describes a 63-year-old man with severe aortic regurgitation who suffered in-hospital cardiac arrest with 50 minutes of low-flow time, was placed on ECPR, and underwent emergent valve-in-valve TAVI — recovering to CPC 2 at discharge. While a single case, this challenges the dogma that severe AR is an absolute contraindication to VA-ECMO and illustrates the expanding boundaries of percutaneous rescue therapy. Read the report →
Mitral Valve (MitraClip, PASCAL, TMVR)
Transcatheter Mitral Valve Replacement: State of the Field Review
A timely review in Herz surveys the current landscape of dedicated transcatheter mitral valve replacement (TMVR) devices, noting that despite numerous devices in development, only three have achieved CE marking or FDA approval. The authors highlight that while TEER (MitraClip, PASCAL) dominates the transcatheter mitral space, certain anatomies — including non-rheumatic mitral stenosis, severe MAC, and complex MR not amenable to edge-to-edge repair — require replacement rather than repair. The ESC 2025 guidelines acknowledge TMVR for degenerative MS with MAC as Class IIb at experienced centers. This remains a high-risk frontier where patient selection is paramount. Read the review →
Sequential Valve-in-Valve TAVR After Valve-in-Valve TMVR
A case report in JACC: Case Reports describes an 84-year-old with concurrent mitral and aortic bioprosthetic valve failure who underwent sequential ViV-TMVR followed by ViV-TAVR. The key takeaway: when both valves need intervention, performing aortic ViV first is preferable to avoid interaction with the mitral prosthesis. When sequencing forces mitral-first, narrow LVOT and prosthesis proximity can be overcome with careful CT planning. This is the lifetime management challenge the ESC 2025 guidelines emphasize — every index procedure must consider future reintervention feasibility. Read the case →
Surgical vs. Transcatheter Comparisons
[NOTABLE] The standout finding today is the dialysis-dependent patient study showing SAVR's long-term survival advantage over TAVR despite higher early MACCE. This pattern — transcatheter procedures winning the sprint but losing the marathon — is one of the most important recurring themes in structural heart disease. It directly maps onto the age-threshold debate: the ESC 2025 guidelines set the SAVR-preferred cutoff at age <70, while ACC/AHA uses <65, precisely because younger patients have more years over which durable surgical outcomes can compound their advantage. For dialysis patients specifically, expected survival is shortened but not negligible, and the SAVR benefit appeared within 1–3 years — suggesting the mechanism may not be purely durability-related but could involve hemodynamic performance, paravalvular leak rates, or patient-prosthesis mismatch. These nuances need dedicated investigation. Read the study →
Separately, Cardiovascular Business published a feature highlighting how cardiologists and cardiac surgeons navigate the TAVR vs. SAVR decision — emphasizing Heart Team deliberation and individualized care. This is a welcome counterpoint to the "TAVR for everyone" narrative that sometimes dominates lay coverage. Read the feature →
Device & Technology
Ken-Valve for Aortic Regurgitation (Jenscare Biotechnology)
The multicenter Chinese trial of this self-expandable transapical valve for pure AR and mixed AR/AS (n=142) reported solid 1-year outcomes. The 14.1% pacemaker rate is consistent with self-expandable valve platforms. The 97.2% technical success and favorable hemodynamics (mean gradient 9.4 mmHg, EOA 1.9 cm²) are encouraging. However, the transapical approach — which has largely fallen out of favor for TAVR in aortic stenosis due to outcomes data showing inferiority to transfemoral access — limits the competitive positioning of this device. Multiple companies (including JenaValve/J Valve Technology) are developing transfemoral solutions for AR. Watch this space carefully as TAVR for AR is a rapidly evolving Class IIb indication. Read the study →
Hydra THV Spanish Registry Launching
A new prospective registry for the Hydra THV transcatheter aortic valve has been posted to ClinicalTrials.gov, with planned enrollment of 100 patients in Spain. Details on the valve design and differentiating features were not provided, but this adds to the growing roster of next-generation THV platforms seeking clinical data in the European market. View trial →
AI and 3D Imaging for Valve Labs
Cardiovascular Business reports on how artificial intelligence is transforming 3D cardiac imaging laboratories, with implications for preprocedural planning in structural heart interventions. The piece also flags a catheter recall over safety concerns and previews new approaches to predicting TAVR outcomes. Read the coverage →
Industry & Market
Edwards Lifesciences Appoints New CFO
Edwards Lifesciences has named Doretta (Theodora) Mistras as Chief Financial Officer, a significant leadership change at the company that dominates the TAVR market with its SAPIEN platform and is expanding aggressively into tricuspid (EVOQUE, PASCAL) and mitral (SAPIEN M3) territories. The appointment comes during a period of strategic transition for Edwards — the company spun off its Critical Care division and is increasingly positioning itself as a pure-play structural heart company. Mistras' priorities will likely include navigating reimbursement landscapes as TAVI indications expand, managing R&D investment across three valve positions, and communicating the growth story to investors who are watching TAVI market maturation closely. Read the announcement →
Edwards Insider Selling Activity
Multiple Form 4 filings were disclosed today for Edwards Lifesciences, including a sale by Daniel Lippis. While insider transactions are routine and can reflect personal financial planning rather than bearish sentiment, the pattern of sales during AATS week — when structural heart news flow is at its peak — will be watched by market participants. Details →
Note: The Tavia Acquisition Corp ($TAVI) position reduction by Wolverine Asset Management is unrelated to transcatheter valve therapy — TAVI is a special purpose acquisition company that shares its ticker symbol coincidentally with the transcatheter aortic valve implantation acronym.
Financial Analysis
It was a uniformly red day for structural heart equities, with all major players declining amid broader market softness. The most striking story remains Boston Scientific's dramatic 6-month slide — down 43.5% from its highs — which far exceeds sector peers and suggests company-specific headwinds beyond macroeconomic sentiment. Abbott's nearly 30% 6-month decline similarly reflects pressures that extend beyond its structural heart portfolio (likely tariff and trade concerns affecting its diversified medtech business), but the magnitude raises questions about valuation support for the TEER franchise (MitraClip, TriClip).
Edwards Lifesciences is the relative outperformer, essentially flat over 6 months (+0.57%) with modest daily weakness (-0.50%). The CFO transition and insider selling are noise at this point — the more important signal is whether AATS presentations this week validate Edwards' pipeline investments in EVOQUE (tricuspid replacement), PASCAL (TR and MR TEER), and SAPIEN M3 (TMVR). Edwards' forward P/E of 24.65 versus its trailing P/E of 44.82 implies analysts expect substantial earnings growth, likely predicated on international TAVI expansion and new valve indications.
Medtronic's 12.3% 6-month decline brings it to the bottom of its 52-week range ($77.39), which is notable ahead of its June 3 earnings report. The Evolut Low Risk long-term follow-up data (trial still active per today's update) and the Intrepid TMVR system enrollment progress will be key catalysts. Anteris Technologies stands out as the sole gainer today (+5.5%) and over 6 months (+32.2%), suggesting small-cap structural heart innovation continues to attract speculative capital — though its pre-revenue status and negative forward P/E remind investors this is a high-risk story.
Valve Industry Stocks
Edwards Lifesciences (EW)
- Close: $82.91 | Daily Change: -$0.42 (-0.50%)
- 6-Month Performance: +0.57% | 52-Week Range: $72.30 – $87.89
- Market Cap: $47.8B | P/E (trailing): 44.82 | P/E (forward): 24.65 | Beta: 0.87
- Analyst Consensus: Buy | Target: $97.15 (range $84–$110, 27 analysts) — 17% upside
- Next Earnings: July 23, 2026 | EPS est: $0.74 | Rev est: $1.70B
- Commentary: New CFO appointment (Doretta Mistras) and multiple insider Form 4 filings dominate today's news flow. Stock trading mid-range and essentially flat over 6 months. Watch for AATS-related pipeline updates on EVOQUE and PASCAL to serve as catalysts. Analyst consensus reflects confidence in the structural heart pure-play strategy.
Medtronic (MDT)
- Close: $77.79 | Daily Change: -$0.51 (-0.65%)
- 6-Month Performance: -12.28% | 52-Week Range: $77.39 – $106.33
- Market Cap: $99.9B | P/E (trailing): 21.73 | P/E (forward): 12.84 | Beta: 0.63
- Analyst Consensus: Buy | Target: $108.00 (range $90–$121, 25 analysts) — 39% upside
- Next Earnings: June 3, 2026 | EPS est: $1.55 | Rev est: $9.62B
- Commentary: Trading at 52-week lows with significant analyst-implied upside. The Evolut platform and Intrepid TMVR system are key structural heart assets. Today's trial update shows the Medtronic TAVR Low Risk Bicuspid Study (n=150) remains active — important for expanding Evolut into BAV patients, where both guidelines currently rate TAVI as Class IIb. Earnings in 4 weeks will be a pivotal moment.
Abbott (ABT)
- Close: $87.17 | Daily Change: -$0.37 (-0.42%)
- 6-Month Performance: -29.44% | 52-Week Range: $86.16 – $139.06
- Market Cap: $151.8B | P/E (trailing): 24.42 | P/E (forward): 14.38 | Beta: 0.65
- Analyst Consensus: Buy | Target: $118.64 (range $92–$143, 25 analysts) — 36% upside
- Next Earnings: July 16, 2026 | EPS est: $1.28 | Rev est: $12.53B
- Commentary: Steep 6-month decline likely reflects broad medtech and tariff concerns more than structural heart-specific headwinds. Abbott's structural heart portfolio (MitraClip/TriClip for TEER) remains the market leader in edge-to-edge repair. The TRILUMINATE Pivotal trial (active, not recruiting) and REPAIR-MR (active, not recruiting) are critical assets. The new MitraClip G5 registry (n=1,000) launching from Cologne underscores continued investment in next-generation clip technology.
Boston Scientific (BSX)
- Close: $55.98 | Daily Change: -$0.87 (-1.53%)
- 6-Month Performance: -43.48% | 52-Week Range: $55.88 – $109.50
- Market Cap: $83.2B | P/E (trailing): 23.42 | P/E (forward): 14.87 | Beta: 0.62
- Analyst Consensus: Strong Buy | Target: $85.19 (range $60–$110, 32 analysts) — 52% upside
- Next Earnings: July 29, 2026 | EPS est: $0.83 | Rev est: $5.40B
- Commentary: The worst performer in the sector, now trading near its 52-week low. Despite "strong buy" consensus and enormous implied upside, the stock continues to sell off. In structural heart, the ACURATE neo2 TAVR IDE trial (n=1,948) remains a key asset — if it delivers, it could give BSX a meaningful share of the TAVR market dominated by Edwards and Medtronic. The CLASP II TR trial for PASCAL in tricuspid disease continues recruiting. But until the stock finds a floor, sentiment remains fragile.
Anteris Technologies (AVR.AX)
- Close: A$8.79 | Daily Change: +A$0.46 (+5.52%)
- 6-Month Performance: +32.18% | 52-Week Range: A$4.68 – A$9.79
- Market Cap: A$0.9B | P/E (forward): -4.03 | Beta: 0.59
- Analyst Target: A$13.00 (1 analyst)
- Commentary: The sole green name today and the standout performer over 6 months. Anteris' DurAVR single-piece 3D-printed TAVR valve — designed to mimic native valve hemodynamics — has its EU Early Feasibility Study (n=40) in active, not-recruiting status per today's update. Pre-revenue, high-risk, but the market is pricing in the potential for a differentiated next-generation valve platform. Thin analyst coverage (1 analyst) means price discovery remains volatile.
Private Companies of Note: JenaValve Technology (transfemoral TAVR for AR, J-Valve pivotal trial recruiting), J Valve Technology, and Meril Life Sciences remain privately held with no public stock data.
Sector Outlook: The broad weakness across structural heart equities appears more macro-driven than fundamental, with all four major companies maintaining "buy" or better consensus ratings despite significant drawdowns. The AATS meeting this week could serve as a catalyst — particularly late-breaking trial results or pivotal data readouts. The gap between analyst targets and current prices is widest for Boston Scientific (52% upside implied) and narrowest for Edwards (17%), suggesting the market sees Edwards as the safest harbor but BSX as the potential turnaround story. Investors should watch Medtronic's June 3 earnings carefully as the first major structural heart earnings report of the summer cycle.
Clinical Trial Updates
Aortic Valve
- [LANDMARK] Evolut Low Risk — Long-Term Follow-Up (NCT02701283)
- Status: Active, not recruiting | Enrollment: 2,223 | Sponsor: Medtronic
- Last Updated: March 19, 2026
- The pivotal trial that established Evolut noninferiority to SAVR in low-risk patients. Long-term follow-up data beyond 5 years are critical for informing the SAVR vs. TAVI debate in younger patients. The ESC 2025 guidelines cited this trial in setting the ≥70 age threshold for TAVI preference.
- Medtronic TAVR Low Risk Bicuspid Study (NCT03635424)
- Status: Active, not recruiting | Enrollment: 150 | Sponsor: Medtronic
- Last Updated: May 5, 2026
- Critical for expanding TAVR into bicuspid aortic valve disease, which both guidelines currently rate as Class IIb for transcatheter therapy. BAV patients were excluded from major RCTs.
- ACURATE IDE (Boston Scientific) (NCT03735667)
- Status: Active, not recruiting | Enrollment: 1,948 | Sponsor: Boston Scientific
- Last Updated: May 4, 2026
- Compares ACURATE neo2 against both Medtronic CoreValve and Edwards SAPIEN 3 — a three-way comparison that could reshape the competitive landscape if BSX demonstrates noninferiority or superiority.
- J-Valve Transfemoral Pivotal Study (NCT06455787)
- Status: Recruiting | Enrollment: 194 | Sponsor: JC Medical / Edwards Lifesciences affiliate
- Last Updated: May 4, 2026
- A transfemoral TAVR system with particular relevance for aortic regurgitation — one of the few transfemoral options in active pivotal evaluation for pure AR.
- DurAVR EU-EFS (Anteris Technologies) (NCT06510855)
- Status: Active, not recruiting | Enrollment: 40 | Sponsor: Anteris Technologies
- Last Updated: May 4, 2026
- Early feasibility study for the novel single-piece 3D-printed DurAVR valve, designed to replicate native valve hemodynamics.
- Hydra THV Spanish Registry (NCT07566624)
- Status: Not yet recruiting | Enrollment: 100 | Sponsor: Fundación EPIC
- Last Updated: May 5, 2026
- Prospective registry for the Hydra THV system in Spain. Limited details available.
- Impact of TAVI on Gut Microbiota (NCT07565077)
- Status: Active, not recruiting | Enrollment: 40 | Sponsor: Insel Gruppe AG / University Hospital Bern
- Last Updated: May 4, 2026
- Exploratory study examining gut microbiome changes after TAVR — a novel angle reflecting growing interest in the gut-heart axis.
- Dexmedetomidine Sedation for TAVI (NCT07532733)
- Status: Recruiting | Enrollment: 80 | Sponsor: Erasme University Hospital
- Last Updated: April 30, 2026
- Compares dexmedetomidine vs. propofol/remifentanil sedation for TAVI procedures.
- Sedation Regimens and Quality of Recovery After TAVR (NCT07556523)
- Status: Recruiting | Phase: Phase 4 | Enrollment: 126 | Sponsor: David Lyubashevsky
- Last Updated: April 29, 2026
- Three-arm comparison of propofol, dexmedetomidine, and midazolam for TAVR sedation.
- NHLBI-Emory Advanced Cardiac CT Reconstruction (NCT05372627)
- Status: Not yet recruiting | Enrollment: 1,000 | Sponsor: NHLBI
- Last Updated: May 5, 2026
- Advanced CT reconstruction technology with applications for pre-TAVR planning and valve assessment.
Mitral Repair (TEER)
- [LANDMARK] REPAIR-MR — MitraClip vs. Surgery for Primary MR (NCT04198870)
- Status: Active, not recruiting | Enrollment: 500 | Sponsor: Abbott
- Last Updated: November 12, 2025
- This pivotal head-to-head trial of TEER vs. surgical repair for primary MR is one of the most anticipated studies in the field. Results will directly inform whether TEER can challenge surgical repair's dominance in primary MR — currently both guidelines strongly favor surgery when repair is feasible.
- [LANDMARK] PRIMATY — MitraClip vs. Surgery for Secondary MR (NCT05051033)
- Status: Recruiting | Enrollment: 450 | Sponsor: Annetine Gelijns (NHLBI)
- Last Updated: March 3, 2026
- Compares surgical repair vs. transcatheter edge-to-edge repair for secondary MR. Critical for defining the optimal approach in patients who fall between COAPT-eligible TEER and surgical candidates.
- [LANDMARK] COAPT — Long-Term Follow-Up (NCT03706833)
- Status: Active, not recruiting | Enrollment: 1,247 | Sponsor: Edwards Lifesciences
- Last Updated: April 9, 2026
- Extended follow-up of the landmark trial that established TEER benefit in ventricular secondary MR. The ESC 2025 guidelines upgraded TEER for SMR to Class I based in part on COAPT 5-year data.
- MitraClip G5 Registry (Cologne) (NCT07543874)
- Status: Not yet recruiting | Enrollment: 1,000 | Sponsor: University Hospital of Cologne
- Last Updated: May 1, 2026
- Large real-world registry for the next-generation MitraClip G5 system.
- WATCH-TMVR (Watchman + MitraClip) (NCT04494347)
- Status: Completed | Enrollment: 25 | Sponsor: Mayo Clinic
- Last Updated: May 1, 2026
- Small study of combined LAAO and TEER — relevant to the ESC 2025 recommendation for combined MV surgery + AF ablation + LAAO for atrial secondary MR.
Mitral Replacement (TMVR)
- Medtronic Intrepid TMVR System (NCT03242642)
- Status: Recruiting | Enrollment: 1,056 | Sponsor: Medtronic
- Last Updated: May 5, 2026
- The largest active TMVR trial, evaluating the Intrepid system for severe symptomatic MR. Continued enrollment progress is a positive signal for this challenging device category.
Tricuspid Repair (TEER)
- [LANDMARK] TRILUMINATE Pivotal — TriClip for TR (NCT03904147)
- Status: Active, not recruiting | Enrollment: 572 | Sponsor: Abbott
- Last Updated: December 19, 2024
- The pivotal trial that drove the ESC 2025 Class IIa recommendation for transcatheter TR treatment. The ACC/AHA 2020 guidelines did not address transcatheter TR therapy — the next US guideline update will need to incorporate these data.
- [LANDMARK] CLASP II TR — PASCAL for TR (NCT04097145)
- Status: Recruiting | Enrollment: 870 | Sponsor: Edwards Lifesciences
- Last Updated: April 6, 2026
- Edwards' pivotal trial for PASCAL in tricuspid TEER, competing directly with Abbott's TriClip. Continued enrollment at 870 patients makes this one of the largest TR intervention trials.
Tricuspid Replacement (TTVR)
- [LANDMARK] TRISCEND II — Evoque TTVR (NCT04482062)
- Status: Active, not recruiting | Enrollment: 864 | Sponsor: Edwards Lifesciences
- Last Updated: February 27, 2026
- The landmark TTVR trial that demonstrated superiority for symptoms/QoL over medical therapy, now contributing to the ESC 2025 Class IIa recommendation. Higher bleeding and pacemaker rates remain concerns — real-world TVT registry data showed lower complication rates (pacemaker 15.9% vs. higher in trial), providing some reassurance.
- TRICURE US IDE Pivotal Study (NCT07528326)
- Status: Not yet recruiting | Enrollment: 831 | Sponsor: TRiCares
- Last Updated: May 5, 2026
- [NOTABLE — NEW TRIAL] A large pivotal study comparing the TRiCares Topaz TTVR system against the Edwards EVOQUE TTVR system — the first head-to-head TTVR comparison trial of this scale. With 831 planned patients, this represents a significant commitment and signals the maturation of the TTVR market. The inclusion of EVOQUE as the active comparator rather than medical therapy alone represents an evolution in trial design for tricuspid interventions.
Diagnostic/Other
- VoqX Computerized Stethoscope Study (NCT04960280)
- Status: Completed | Enrollment: 400 | Sponsor: Mayo Clinic
- Last Updated: May 5, 2026
- Digital auscultation technology for heart disease diagnosis — relevant to upstream detection of valvular disease.
Social & Conference Highlights
AATS Annual Meeting — Day 3 (May 5, 2026, Toronto): The surgical community's premier meeting continues with scientific sessions spanning aortic, mitral, and tricuspid valve surgery. Today's published literature reflects the meeting's themes — the dialysis-SAVR study reinforces the surgical community's message that TAVR advantages are not universal, while the TAVI-without-surgery-backup meta-analysis pushes back on traditional surgical gatekeeping. Expect late-breaking presentations through Wednesday to generate the week's biggest headlines. We'll be watching for simultaneous publications in NEJM, JACC, and JTCVS — these embargo lifts often coincide with Tuesday and Wednesday AATS sessions.
Cardiovascular Business coverage of AATS continues to highlight the nuanced TAVR vs. SAVR decision-making process, with both cardiologists and surgeons emphasizing individualized care over blanket treatment algorithms — a message consistent with both ACC/AHA and ESC guideline frameworks.
Looking ahead: With the AATS meeting running through Thursday, the next 48 hours should bring late-breaking clinical trial data and potentially practice-changing simultaneous publications. The new TRICURE head-to-head TTVR pivotal trial signals an inflection point for the tricuspid replacement field — we're moving from "does it work?" to "which one works better?" And Medtronic's June 3 earnings loom as the next major financial catalyst for the sector. Stay tuned.
— E. Nolan Beckett | The Valve Wire