The Valve Wire sealThe Valve Wire
August 28, 2026E. Nolan Beckett, MD · Editor
LIVE · 07:01 ET · AUG 28, 2026
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The Valve Wire Weekly

Week of August 23 – August 29, 2026

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Week in Review

Durability came back as the week's central question in transcatheter aortic valve replacement, and every major dataset pushed in the same direction. A 7,501-patient international registry pegged bioprosthetic valve failure at 8.3% at 10 years after TAVR, with balloon-expandable valves and smaller sizes as modifiable risk predictors. A Swiss single-center cohort found that 43% of balloon-expandable implants were suboptimally deployed, and that suboptimal deployment quadrupled 5-year valve failure. A 52-study bicuspid meta-analysis confirmed higher paravalvular leak and root injury with TAVR versus surgery. All of it landed in the same seven days that Europe's new ESC 2025 guideline is being implemented, which lowered the age threshold at which TAVR is preferred over surgery to 70 — while the American ACC/AHA 2020 guideline still holds that line at 65. Layer in PASCAL's one-year data legitimizing it as a MitraClip alternative in functional mitral regurgitation, a Mayo Clinic head-to-head on tricuspid repair versus replacement, a federal kickbacks lawsuit against Abbott's MitraClip program surviving dismissal, and an FDA recall of all Impella heart pump controllers after three deaths, and the science and the industry pulled in opposite directions all week.

Top Stories This Week

[NOTABLE] TAVR Bioprosthetic Valve Failure Hits 8.3% at 10 Years — Balloon-Expandable Platforms Named as Modifiable Predictor

An international registry across 13 centers and 7,501 TAVR patients, published in Circulation: Cardiovascular Interventions, tracked bioprosthetic valve failure per VARC-3 criteria over a median 4 years. BVF incidence was 5.1% overall and rose to 8.3% at 10 years. Failure independently predicted all-cause mortality (adjusted HR 1.72), cardiovascular mortality (aHR 3.23), stroke (aHR 2.08), and heart failure hospitalization (aHR 1.43). The predictors of failure were uncomfortable for the field: younger age, smoking, balloon-expandable valves, prosthesis size <26 mm, valve-in-valve procedures, and discharge gradients ≥15 mm Hg.

This is the largest dataset to quantify BVF in the modern TAVR era, and it lands into an ongoing guideline disagreement. ACC/AHA 2020 keeps SAVR-preferred below age 65 partly on durability grounds. ESC 2025 pushed the SAVR-preferred zone up to age 70 and the TAVI-preferred zone down to age 70, citing DEDICATE and longer-term PARTNER 3 and Evolut Low Risk follow-up. Today's 8.3% failure rate at 10 years — with younger age itself an independent predictor of failure — is not a rebuttal of the ESC position, but it puts the age-70 expansion under real empirical scrutiny.

[NOTABLE] 43% of Balloon-Expandable TAVR Implants Suboptimally Deployed at a High-Volume Swiss Center

A single-center Bern cohort of 1,032 patients receiving Sapien S3 or Ultra valves, published in JACC Advances, found that 43% of implants met at least one criterion for suboptimal deployment: noncoaxial (23%), too deep (25%), or underexpanded (5%). Suboptimal implantation was associated with a 30-day modified safety endpoint of 43.3% versus 19.9% and a 5-year stage 2 bioprosthetic valve failure subhazard ratio of 4.40. This is the strongest procedural-quality-to-durability link published to date. It undercuts the assumption that TAVR outcomes are uniform across centers, and it hands both guidelines a defensible reason for caution: if four in ten low-risk implants are suboptimal at a high-volume Swiss center, the case for delaying transcatheter treatment in patients under 70 is stronger, not weaker. Single-center and non-randomized, but the effect size is not subtle.

[NOTABLE] Bicuspid TAVR Meta-Analysis: Higher Paravalvular Leak, Higher Root Injury, No Mortality Advantage Over Surgery

A 52-study systematic review and meta-analysis, published in JACC Advances, quantified the bicuspid TAVR versus tricuspid TAVR comparison and the bicuspid TAVR versus SAVR comparison. Against tricuspid anatomy, bicuspid TAVR carried higher paravalvular leak (RR 1.44, 95% CI 1.18–1.77), aortic root injury (RR 1.83), 30-day stroke (RR 1.27), and 30-day mortality (RR 1.25). One-year mortality was lower with bicuspid TAVR, which the authors attribute to selection. Against SAVR in bicuspid anatomy, TAVR carried 7-fold higher paravalvular leak (RR 7.08) with no early mortality advantage. Both ACC/AHA 2020 and ESC 2025 keep bicuspid TAVR at Class IIb; this meta-analysis gives that IIb designation solid empirical footing and reinforces SAVR as the default for young bicuspid patients — the population Cardiovascular Business framed this week as "surgery bests TAVR in young patients."

[NOTABLE] Abbott MitraClip Kickbacks Case Survives Dismissal as ESC Class I Upgrade Takes Effect

A federal court will allow a whistleblower kickbacks case against Abbott's MitraClip program to proceed, as reported by Courthouse News on August 27. Discovery will scrutinize marketing and physician-relationship practices during exactly the period ESC-driven volume expansion is being implemented. ESC 2025 upgraded transcatheter edge-to-edge repair for ventricular secondary mitral regurgitation to Class I with Level of Evidence A, based on 5-year COAPT follow-up and RESHAPE-HF2. ACC/AHA 2020 still holds it at Class IIa. The clinical tailwind and the legal exposure arrived the same year. Hospital compliance officers and Heart Team leads should audit MitraClip referral pathways now.

PASCAL Delivers One-Year FMR Data Across Atrial and Ventricular Phenotypes

The MiCLASP postmarket cohort of 295 patients, published in Circulation: Cardiovascular Interventions, is the first sizable outcome dataset for PASCAL in functional mitral regurgitation. Procedural success reached 96.2% in atrial FMR and 97.1% in ventricular FMR. MR reduced to ≤1+ at one year in 93.1% and 81.3% respectively. Kaplan-Meier freedom from death or heart failure hospitalization was 79.3% in AFMR versus 70.9% in VFMR (P=0.267). KCCQ improved 18.0 points in AFMR and 11.6 in VFMR. PASCAL now has data that place it squarely in COAPT-eligible territory for ventricular FMR and give operators the first meaningful atrial FMR outcome dataset for the platform. Postmarket, non-randomized, industry-sponsored — but the numbers legitimize PASCAL as a MitraClip alternative in functional MR. A separate Leipzig propensity-matched cohort in JAHA (116 pairs) found MitraClip G4 and PASCAL essentially indistinguishable in FMR on procedural success (98.1% vs 97.3%) and one-year survival (86.7% vs 87.8%). Operators can now select on anatomy and cost, not outcomes.

Aortic Valve (TAVR/TAVI)

The durability triple defined the aortic week. The Circulation: Cardiovascular Interventions BVF registry (7,501 patients, 13 centers, median 4-year follow-up, VARC-3 criteria) placed 10-year BVF at 8.3% with independent associations to mortality, cardiovascular mortality, stroke, and HF hospitalization. The Bern deployment-quality cohort (1,032 patients, single-center) tied suboptimal balloon-expandable implantation to a 4.4-fold rise in 5-year stage 2 BVF. The JACC Advances bicuspid meta-analysis (52 studies) confirmed higher paravalvular leak, root injury, and short-term stroke with TAVR versus tricuspid anatomy, and 7-fold higher PVL versus SAVR in bicuspid disease.

Redo-TAVR was the counterweight. A STS/ACC TVT Registry analysis in JACC: Cardiovascular Interventions of 439 patients receiving Evolut for failed prior TAVR showed 1-year mortality, stroke, and readmission comparable to native TAVR after adjustment (hazard ratios 0.66, 0.95, 0.88; all P>0.12), though mean gradients ran higher (11.3 vs 8.2 mm Hg, P<0.001). This is Medtronic-funded and single-year follow-up. As the accompanying editorial by Chakravarty, Rajkumar, and Makkar put it, "the second valve is only half the story." Surgical explant of a failed transcatheter valve carries 12–17% 30-day mortality in contemporary series, but that denominator is patients selected for explant, not an unselected redo-TAVR-eligible population. The ACOR registry (683 valve-in-valve patients) showed comparable gradients between supra- and intra-annular self-expanding platforms with a non-significant trend toward more MACCE with intra-annular devices.

Post-TAVI medical therapy took a step forward. DapaTAVI's pre-specified LVEF analysis in the European Journal of Heart Failure (39 Spanish centers, N=1,223, pragmatic open-label with blinded endpoint adjudication) confirmed dapagliflozin reduced death or worsening heart failure at one year regardless of baseline LVEF (interaction P=0.41), with event rates of 20.2% in LVEF ≤40% and 17.0% in LVEF >40%. Genitourinary infection was the primary safety trade-off. Neither ACC/AHA 2020 nor ESC 2025 addresses post-TAVI SGLT2 inhibition as guideline-directed therapy. This moves that conversation from hypothesis to near-imperative.

Elsewhere in aortic: JenaValve's Trilogy device produced the first credible multicenter dataset for LVAD-associated pure aortic regurgitation — 30 patients across five centers in Artificial Organs, 93.3% VARC-3 device success, 3.3% 30-day mortality. ESC 2025 rates TAVI for AR at Class IIb for inoperable patients; ACC/AHA 2020 does not formally address it. A TAVR-PRO frailty score (N=204, AUC 0.88) outperformed comorbidity aggregation for predicting poor 6-month functional recovery. A 172-patient Evolut FX commissural alignment technique cut moderate/severe misalignment from 30% to 14% — a low-cost tweak with implications for future valve-in-valve access. A Structural Heart narrative review framed balloon aortic valvuloplasty as an under-formalized bridge strategy in acute valve syndrome. And a JACC Advances analysis of rising middle-aged AS mortality and widening rural disparities reminds us that access, not technology, drives outcomes in that population.

A COMPARE-TAVI 1 correction in The Lancet tightened the reported Sapien 3 vs Myval risk difference (–1.2%, one-sided lower 95% CI –4.7) — a data-integrity nudge, not a signal shift.

Mitral Valve (Repair & Replacement)

PASCAL's MiCLASP one-year data (N=295) is the anchor. Procedural success 96.2% AFMR and 97.1% VFMR. MR ≤1+ at one year in 93.1% and 81.3%. Kaplan-Meier freedom from death or HF hospitalization 79.3% AFMR versus 70.9% VFMR. NYHA I/II reached by 76.5% of AFMR and 64.6% of VFMR patients. The Leipzig propensity-matched G4-versus-PASCAL cohort in JAHA (116 pairs) showed the two devices are functionally identical in FMR on efficacy and safety. The device war is over on efficacy — it's now an anatomy-and-economics call.

The sequencing question in atrial FMR moved. A single-center retrospective analysis in Heart Rhythm of 281 patients with AF and moderate to moderate-severe FMR compared upfront AF ablation (n=152) versus M-TEER-first (n=129). TEER reduced MR severity more effectively, as expected. But ablation-first delivered better symptom stability (69% vs 44%), markedly lower two-year all-cause mortality (3% vs 14%, P=0.002), fewer cardiac hospitalizations, and better LVEF recovery. Retrospective and single-center — but the mortality delta is large enough that the field cannot keep clipping every AF-driven MR without asking about the rhythm first. ESC 2025 formally recognizes atrial secondary MR as a distinct entity and recommends MV surgery plus surgical AF ablation and LAAO at Class IIa for operable patients, with TEER reserved at Class IIb for the inoperable. ACC/AHA 2020 offers no formal atrial SMR pathway.

A 293-patient M-TEER cohort in JAHA found women present older, more symptomatic, and with worse baseline 6-minute walk — but 6-month mortality (17% vs 22%) and HF rehospitalization tracked identically to men. Referral timing, not device response, is the sex-gap driver.

Sitting alongside the clinical story: the Abbott MitraClip kickbacks case surviving dismissal arrives the same week ESC's Class I upgrade is expected to drive volume expansion. On TMVR, HighLife received CE Mark approval for its next-generation Clarity valve within the HighLife TMVR system, adding another dedicated European TMVR device without a corresponding FDA pathway. Capstan Medical's early feasibility TMVR study (NCT06600191) advanced to recruiting.

Surgical repair remains the Class I answer for primary MR under both guidelines, and ESC 2025 upgraded early asymptomatic PMR surgery to Class I when three or more risk factors are present (AF, SPAP >50, LA dilation, ≥moderate TR). Today's transcatheter data does not disturb that hierarchy in primary disease.

Tricuspid Valve (Repair & Replacement)

The Mayo Clinic 100-patient invasive-hemodynamics study in JAHA (50 TEER vs 50 TTVR, single-center, 2017–2024) delivered the sharpest modality-selection signal to date. TEER reduced mean right atrial pressure (16→14 mm Hg) and V wave, with RV enlargement falling from 60% to 40% and RV dysfunction trending down (26%→15%). TTVR eliminated tricuspid regurgitation more completely and delivered higher forward stroke volume, but RV dysfunction actually rose (31%→44%). NYHA improvement and survival tracked similarly. The signal: TEER unloads the right ventricle; TTVR volume-loads it while curing regurgitation. Single-center and non-randomized, but the nuance matters — TR "cure" is not the same as RV benefit, and the Heart Team needs to price that in.

ESC 2025 gave transcatheter tricuspid treatment Class IIa with Level A evidence for high-risk symptomatic severe TR with preserved RV function, based on TRILUMINATE Pivotal, Tri.Fr, and TRISCEND II. ACC/AHA 2020 gives no recommendation because those trials post-dated its writing. The Mayo data support the ESC framing but add a modality-selection nuance the guidelines don't yet capture: borderline RV function may favor TEER over "definitive" replacement.

A TRAVEL study of LuX-Valve across three Chinese centers in Artificial Organs (N=62, mean 46-month follow-up) reported 88.8% mid-term survival with 30-day major adverse event rate of 22.6% (major bleeding 12.9%, surgical re-exploration 11.3%, pacemaker 9.7%). TR reduced to mild or less in 95.2% at one year. LuX-Valve is a transatrial device — this is not a percutaneous transfemoral experience — and the retrospective single-arm design limits inference. Trial pipeline activity was steady: the TRINITY Pivotal Trial of LuX-Valve Plus versus EVOQUE continues recruiting to 680 patients, the TRICAV-I bicaval valve study and Versa first-in-human study both moved to active-not-recruiting status, and the NHLBI/Cook trans-atrial intrapericardial annuloplasty (TRAIPTA) early feasibility study was suspended.

Surgical vs. Transcatheter Comparisons

The week's aortic evidence lines up against the ACC/AHA 2020 caution and complicates the ESC 2025 expansion. ACC/AHA 2020 keeps SAVR preferred below age 65 and shared decision-making from 65 to 80. ESC 2025 pushed SAVR-preferred to below age 70 and TAVI-preferred at age 70 or above in patients with tricuspid anatomy and suitable transfemoral access. The 8.3% 10-year BVF rate, with younger age itself an independent predictor of failure, sharpens the durability argument against reflexive TAVR in patients under 70. The 43% suboptimal deployment rate at a high-volume Swiss center undercuts the assumption of operator uniformity that low-risk expansion depends on. The bicuspid meta-analysis showing 7-fold higher PVL with TAVR versus SAVR in bicuspid disease reinforces both guidelines' Class IIb caution and the surgical default for young bicuspid patients.

Cardiovascular Business ran the week's editorial framing straight: "Surgery bests TAVR in young patients." That framing lines up with the data this week.

In mitral disease, ESC 2025 elevated TEER for ventricular SMR to Class I while ACC/AHA 2020 keeps it at Class IIa — a two-tier disagreement into which PASCAL's MiCLASP data now inserts as competitor validation rather than category expansion. Mitral repair remains preferred over TEER for primary MR under both guidelines. For atrial SMR, ESC 2025's Class IIa recommendation for surgery-plus-ablation-plus-LAAO in operable patients sits above TEER (Class IIb) — the Heart Rhythm ablation-first cohort is consistent with that hierarchy.

Clinical Trials Update

Aortic Valve

Mitral Valve

Tricuspid Valve

Other

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