Early Outcomes of Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis With Myval Versus Edwards Sapien 3 Valve: A Systematic Review and Meta-Analysis

Q: What are the key findings of this study?

Myval and Edwards Sapien 3 valves showed no significant difference in 30-day all-cause mortality (RR 1.14), new permanent pacemaker implantation, or major vascular complications in patients with severe aortic stenosis.

Q: What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Severe aortic stenosis (n=1973). Intervention: Myval transcatheter heart valve vs. Edwards Sapien 3 transcatheter heart valve. Primary outcome: All-cause mortality at 30 days (RR 1.14, 95% CI 0.55-2.37, p=0.73).

Q: What does this research mean for the field?

In patients with severe aortic stenosis undergoing TAVI, the Myval and Edwards Sapien 3 valves show no significant differences in 30-day all-cause mortality, permanent pacemaker implantation, or major vascular complications. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Dinkar Bhasin; Tsering Sangdup; Arun Sharma; Prashant Panda; Yash Sharma

doi:10.7759/cureus.96410

November 9, 2025CureusOpen Access

Early Outcomes of Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis With Myval Versus Edwards Sapien 3 Valve: A Systematic Review and Meta-Analysis

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Key result

Myval matches Sapien 3 for 30-day mortality, pacemaker implantation, and major vascular complications in severe AS.

RR 1.14
95% CI 0.55-2.37
P=0.73
n=1,973

Figures

Why the study?

This systematic review and meta-analysis aimed to compare the clinical and hemodynamic outcomes at 30 days after TAVI using the Myval versus the Edwards Sapien 3 valve in patients with severe aortic stenosis.

Does the Myval transcatheter heart valve improve 30-day clinical and hemodynamic outcomes compared to the Edwards Sapien 3 valve in patients with severe aortic stenosis?

Study Design

Type

Meta-Analysis (n=1,973)

Multicenter

Yes

Structured PICO

Does the Myval transcatheter heart valve improve 30-day clinical and hemodynamic outcomes compared to the Edwards Sapien 3 valve in patients with severe aortic stenosis?

P

Population

1,973 patients with severe aortic stenosis undergoing transcatheter aortic valve implantation across 4 studies (2 RCTs, 2 observational) followed for 30 days.

I

Intervention

Myval or Myval Octacor balloon-expandable transcatheter heart valve

C

Comparator

Edwards Sapien 3 or Sapien 3 Ultra balloon-expandable transcatheter heart valve

O

Outcome

All-cause mortality, new permanent pacemaker implantation (PPI), and major vascular complications assessed at 30 dayshard clinical

Main Result

Relative Risk: 1.14 (95% CI 0.55–2.37)

p-value: p=0.73

The Myval transcatheter heart valve demonstrated comparable 30-day clinical outcomes to the Edwards Sapien 3 valve, with better hemodynamic parameters but higher rates of moderate-to-severe aortic regurgitation and new-onset atrial fibrillation.

Limitations

Significant methodological, clinical, and statistical heterogeneity among the included studies
Inclusion of both observational studies and RCTs resulting in methodological heterogeneity
Limited medium and long-term follow-up data
Inclusion of both observational studies and RCTs
Differences in the populations studied (e.g., bicuspid vs tricuspid aortic valves), operator expertise, and the types of valves used
Varying proportion of intermediate sizes used in the Myval group
Risk of bias in included studies (e.g., deviation from intended intervention, selection of reported results)

Implication

Supports comparable 30-day safety for Myval versus Sapien 3; extends meta-analytic evidence for TAVR valve selection.

Abstract

The Edwards Sapien (Edwards Lifesciences, Irvine, CA, USA) transcatheter heart valves (THVs) and the Myval THVs (Meril Life Sciences, Vapi, Gujarat, India) are two balloon-expandable valve systems used for transcatheter aortic valve implantation (TAVI). This systematic review and meta-analysis aimed to compare the clinical and hemodynamic outcomes at 30 days after TAVI using the Myval versus the Edwards Sapien 3 valve in patients with severe aortic stenosis (AS). We conducted a systematic search of PubMed, Embase, Cochrane Library, and clinicaltrials.gov up to June 21, 2025. The inclusion criteria were observational studies or interventional trials comparing Myval or Myval Octacor with Edwards Sapien 3 or Sapien 3 Ultra in patients with severe AS undergoing TAVI. The risk of bias was assessed using the Cochrane Risk of Bias Tool 2 for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale for observational studies. Pooled estimates were derived using a random-effects model. The primary outcomes were all-cause mortality, new permanent pacemaker implantation (PPI), and major vascular complications assessed at 30 days. A predefined subgroup analysis was performed based on the study design. The study protocol was registered on the INPLASY database (INPLASY202560110). Four studies (two retrospective cohort and two RCTs) with 1973 patients (18.6% in observational and 81.4% in RCTs) met the inclusion criteria. Out of the total, 1081 (54.8%) patients received Myval and 892 (45.2%) received Sapien 3 valves. No significant difference was observed in all-cause mortality (risk ratio (RR): 1.14, 95% CI: 0.55-2.37; p = 0.73; I2 = 0), rate of new PPI (RR: 0.92, 95% CI: 0.49-1.74; p = 0.81; I2 = 82%), or major vascular complications (RR: 0.70, 95% CI: 0.19-2.52; p = 0.58; I2 = 33%) at 30 days. The findings were consistent in the subgroup analysis among observational studies and RCTs. Moderate to severe aortic regurgitation (AR) (RR: 2.58, 95% CI: 1.14-5.84; p = 0.02; I² = 0%) and new-onset atrial fibrillation (AF) (RR: 2.0, 95% CI: 1.10-3.63; p = 0.02; I² = 0%) were higher with Myval. Mean gradient was lower (mean difference: -2.85 mmHg, 95% CI: -3.88 to -1.82 mmHg; p < 0.001; I² = 82%) and effective orifice area was larger (mean difference: 0.28 cm2, 95% CI: 0.16-0.40 cm2; p < 0.001; I² = 84%) with Myval. Other secondary outcomes and procedural outcomes were comparable. To conclude, primary outcomes were comparable between the two THVs. The Myval had better hemodynamic parameters at 30 days but a higher rate of moderate to severe AR and new-onset AF. Further studies are needed to assess medium- and long-term outcomes between the two valves.

Discussion

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Cite This Study

Bhasin et al. (2025) conducted a meta-analysis in Severe aortic stenosis (n=1,973). Myval transcatheter heart valve vs. Edwards Sapien 3 transcatheter heart valve was evaluated on All-cause mortality at 30 days (RR 1.14, 95% CI 0.55-2.37, p=0.73). Myval and Edwards Sapien 3 valves showed no significant difference in 30-day all-cause mortality (RR 1.14), new permanent pacemaker implantation, or major vascular complications in patients with severe aortic stenosis.

synapsesocial.com/papers/6a95d95ed6dd5cd218250623 https://doi.org/10.7759/cureus.96410

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Early Outcomes of Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis With Myval Versus Edwards Sapien 3 Valve: A Systematic Review and Meta-Analysis

Figures

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Early Outcomes of Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis With Myval Versus Edwards Sapien 3 Valve: A Systematic Review and Meta-Analysis

Figures

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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