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

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.