Real-World Comparison of Balloon-Expandable Valves for Transcatheter Aortic Valve Replacement: Data From the Aortic+Mitral TRAansCatheter Valve Registry

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Severe, symptomatic aortic stenosis (n=1903). Intervention: MyVal transcatheter heart valve vs. Edwards Sapien transcatheter heart valve (Sapien 3 / Ultra). Primary outcome: All-cause 2-year mortality (p=0.6).

Q: What does this research mean for the field?

Following transcatheter aortic valve replacement, the MyVal balloon-expandable valve achieves comparable 2-year all-cause mortality to the Sapien platform but results in significantly higher rates of permanent pacemaker implantation and paravalvular leak. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Yeela Talmor‐Barkan; Kush  P. Patel; Marco Barbanti; Sofia Sammartino; Giuliano Costa; Carmelo Grasso; Ole De Backer; Davorka Lulić; Carmen Olmos; Giulia Masiero; Marianna Adamo; Dabit Arzamendi; Mario Garcia Gomez; José Antonio Baz-Alonso; Klemen Steblovnik; Victor Mauri; Matti Adam; Hendrik Wienemann; Manuel Hein; Philipp Ruile; Bing Wei Thaddeus Soh; Luca Branca; Rodrigo Estévez‐Loureiro; Ignacio Jesus Amat-Santos; Darren Mylotte; Matjaž Bunc; Giuseppe Tarantini; Michael  J. Mullen; Luis Nombela-Franco y; Leor Perl; Ran Kornowski; Amos Levi; Guy Witberg

doi:10.1016/j.shj.2026.101104

Figures

Why the study?

Comparative real-world data on newer balloon-expandable valve platforms for TAVR remain limited, necessitating evaluation of clinical, procedural, and hemodynamic outcomes.

Does transcatheter aortic valve replacement with the MyVal platform compared to the Sapien platform improve or affect 2-year survival and procedural safety in patients with severe aortic stenosis?

Key Points

To compare clinical, procedural, and early hemodynamic outcomes following transcatheter aortic valve replacement using Sapien 3/Ultra versus MyVal balloon-expandable valves.
Analyzed 1903 consecutive patients undergoing TAVR with balloon-expandable valves (Sapien, n=1676; MyVal, n=227) from the multicenter international AMTRAC registry.
Generated a 1:3 propensity score-matched cohort of 743 patients (Sapien, n=557; MyVal, n=186) to assess the primary endpoint of 2-year all-cause mortality and secondary in-hospital complications defined by VARC-3 criteria.
In the propensity-matched cohort, 2-year all-cause mortality did not differ significantly between groups (19% Sapien vs. 15% MyVal; p=0.6), and in-hospital mortality was identical across platforms (1.1%).
New permanent pacemaker implantation occurred significantly more often with MyVal than Sapien (26.6% vs. 10.1%; p<0.001), alongside longer hospital stays (5.25 ± 5.62 vs. 3.79 ± 4.63 days; p<0.001).
Predischarge mean transvalvular gradients were comparable (9.84 ± 5.01 mmHg for MyVal vs. 10.45 ± 5.37 mmHg for Sapien; p=0.234), but more-than-mild paravalvular leak was more frequent with MyVal (9.8% vs. 2.1%; p<0.001).

Study Design

Type

Observational (n=1,903)

Multicenter

Yes

Structured PICO

Does transcatheter aortic valve replacement with the MyVal platform compared to the Sapien platform improve or affect 2-year survival and procedural safety in patients with severe aortic stenosis?

P

Population

1,903 older adults (mean age 81) with severe, symptomatic aortic stenosis undergoing transcatheter aortic valve replacement, evaluated in a propensity-matched cohort up to 2 years post-procedure.

E

Exposure

TAVR with the MyVal balloon-expandable valve

C

Comparator

TAVR with the Edwards Sapien 3 or Sapien 3 Ultra balloon-expandable valves

O

Outcome

All-cause 2-year mortalityhard clinical

Main Result

Absolute Event Rate: 15% vs 19%

p-value: p=0.6

Limitations

Observational design with residual confounding from unmeasured variables
Reduction in cohort size following propensity matching may limit statistical power
Lack of centralized core laboratory for adjudicating imaging assessments
Lack of long-term outcomes beyond 2 years to assess valve durability
The newest Sapien Ultra RESILIA valve was not included in the analysis
Uncaptured operator experience and implantation depth factors
Not designed to specifically evaluate the impact of intermediate valve sizing on outcomes
Retrospective observational design with potential residual confounding
Lack of centralized core laboratory adjudication for imaging and echocardiography
Lack of long-term clinical and durability outcomes beyond hospitalization and 2 years
Not specifically designed to evaluate the impact of intermediate sizing
Exclusion of the latest-generation Sapien Ultra RESILIA valve

Implication

While contemporary balloon-expandable valves demonstrate comparable 2-year survival, the MyVal platform is associated with higher rates of permanent pacemaker implantation and moderate-or-greater paravalvular leak compared to the benchmark Sapien platform.

Abstract

Background Comparative real-world data on newer balloon-expandable valve (BEV) platforms remain limited. We sought to compare clinical, procedural, and early hemodynamic outcomes following transcatheter aortic valve replacement (TAVR) using 2 contemporary balloon-expandable valves in a multicenter international registry. Methods Consecutive patients undergoing TAVR with Sapien 3/Ultra and MyVal from the AMTRAC multicenter registry were included. Propensity score matching (PSM) was used to generate a balanced 1:3 cohort. The primary endpoint was 2-year all-cause mortality. Secondary endpoints included in-hospital complications, defined according to Valve Academic Research Consortium–3 criteria. Results A total of 1903 patients undergoing TAVR with BEV were included (Sapien, n=1676; MyVal, n=227). Baseline clinical and echocardiographic characteristics were largely comparable between groups. In the propensity-matched cohort (n = 743), 2-year all-cause mortality did not differ between groups. In-hospital mortality and major procedural complications were similar across platforms. New permanent pacemaker implantation (PPI) occurred more frequently with MyVal compared with Sapien (26.6% vs.10.1%; p < 0.001). Postprocedural mean transvalvular gradients were comparable between valves, but a greater proportion of Sapien recipients had elevated mean gradients (>10mmHg), (44.0% vs.32.3%; p=0.019). Paravalvular leak (PVL) distribution differed, with more-than-mild PVL observed more frequently in the MyVal group (9.8% vs.2.1%; p < 0.001). Conclusions In this analysis, both BEV platforms demonstrated comparable safety, mortality, and overall hemodynamic performance following TAVR. However, MyVal was associated with higher rates of PPI and PVL. These findings highlight important platform-specific differences that may inform valve selection and warrant further long-term evaluation.

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Cite This Study

Talmor‐Barkan et al. (2026) conducted an observational in Severe, symptomatic aortic stenosis (n=1,903). MyVal transcatheter heart valve vs. Edwards Sapien transcatheter heart valve (Sapien 3 / Ultra) was evaluated on All-cause 2-year mortality (p=0.6).

synapsesocial.com/papers/6ad0fc6c3afa093ea9acfe79 https://doi.org/10.1016/j.shj.2026.101104

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Real-World Comparison of Balloon-Expandable Valves for Transcatheter Aortic Valve Replacement: Data From the Aortic+Mitral TRAansCatheter Valve Registry

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Real-World Comparison of Balloon-Expandable Valves for Transcatheter Aortic Valve Replacement: Data From the Aortic+Mitral TRAansCatheter Valve Registry

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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