Early Post-transcatheter Aortic Valve Implantation (TAVI) Haemodynamics With SAPIEN Balloon-Expandable and Evolut Self-Expanding Valve Platforms: A Retrospective Single-Centre Cohort Study.
4 affiliations
- 1Cardiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, GBR.
- 2Internal Medicine, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, GBR.
- 3Acute Medicine, Russells Hall Hospital, Dudley, GBR.
- 4Internal Medicine, University Hospitals of North Midlands NHS Trust, Stoke-On-Trent, GBR.
Abstract
Introduction Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different frame architectures, leaflet positions and distinct deployment mechanics that may influence prosthetic haemodynamics. We compared early echocardiographic gradients after transcatheter aortic valve implantation (TAVI) between SAPIEN BEV and Evolut SEV platforms in a routine-practice cohort spanning several device generations. Materials and methods We retrospectively analysed 665 TAVI procedures: 250 BEV procedures using SAPIEN 3 variants and 415 SEV procedures using Evolut variants. The primary endpoint was the early post-TAVI echocardiographic mean transvalvular gradient obtained within three months of TAVI. Secondary endpoints were absolute and relative gradient reductions, achievement of a post-TAVI mean gradient <10 mmHg, and a residual mean gradient ≥20 mmHg. Because the continuous variables were skewed, they were compared using two-sided Mann-Whitney U tests. Results were reported as medians with interquartile ranges, with bootstrap 95% confidence intervals (CIs) for differences in medians. Categorical variables were compared using Pearson chi-square tests without continuity correction when expected counts were adequate and Fisher's exact tests when cell counts were small. Paired pre- and post-TAVI measurements were compared using Wilcoxon signed-rank tests. Multivariable ordinary least-squares regression with HC3 heteroscedasticity-robust standard errors was used to adjust the post-TAVI gradient for the baseline gradient and available prespecified covariates. Results Complete pre- and post-TAVI gradients were available for 664 procedures (249 BEV and 415 SEV). The median post-TAVI gradient was 8.4 (5.85-11.63) mmHg with SEV and 10.0 (7.93-13.90) mmHg with BEV (median difference, -1.60 mmHg; bootstrap 95% CI: -2.97 to -1.00; Mann-Whitney U test: p < 0.001). The median absolute gradient reduction was also greater with SEVs (36.0 vs 32.0 mmHg; median difference, 4.0 mmHg; p < 0.001), as was the relative gradient reduction (81.52% vs 76.19%; median difference, 5.33 percentage points; p < 0.001), although SEVs had a higher pre-procedural baseline transvalvular gradient. A post-TAVI mean gradient <10 mmHg was recorded in 61.2% of SEV procedures compared with 43.4% of BEV procedures (risk ratio 1.41; p < 0.001). Residual gradients of ≥20 mmHg were uncommon and did not differ between the two groups (6.0% in SEV procedures vs 5.6% in BEV procedures; p = 0.831). After adjustment, in 575 completed cases, SEV use remained associated with a 1.48 mmHg lower post-TAVI mean gradient (95% CI: -2.42 to -0.55; p = 0.0019). Conclusions In this cohort, Evolut SEV procedures were associated with a modestly lower early post-TAVI mean gradient than SAPIEN BEV procedures. The magnitude of this association, and its interpretation alongside baseline gradient, anatomy, and other device-selection factors, can inform further comparative evaluation. No clinical outcomes or valve-durability measures were assessed.
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BibTeX
@article{masood2026early,
title = {{Early Post-transcatheter Aortic Valve Implantation (TAVI) Haemodynamics With SAPIEN Balloon-Expandable and Evolut Self-Expanding Valve Platforms: A Retrospective Single-Centre Cohort Study.}},
author = {Behzad Masood and Mamoon Ahmed and Syed M Usman and Afzaal Aleem Khan and Saba Ayub},
journal = {Cureus},
year = {2026},
month = sep,
doi = {10.7759/cureus.116667},
url = {https://europepmc.org/article/MED/42910130},
note = {CC BY},
}
RIS
TY - JOUR
TI - Early Post-transcatheter Aortic Valve Implantation (TAVI) Haemodynamics With SAPIEN Balloon-Expandable and Evolut Self-Expanding Valve Platforms: A Retrospective Single-Centre Cohort Study.
AU - Behzad Masood
AU - Mamoon Ahmed
AU - Syed M Usman
AU - Afzaal Aleem Khan
AU - Saba Ayub
PY - 2026
DA - 2026/09/21
JO - Cureus
DO - 10.7759/cureus.116667
UR - https://europepmc.org/article/MED/42910130
AB - Introduction Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different frame architectures, leaflet positions and distinct deployment mechanics that may influence prosthetic haemodynamics. We compared early echocardiographic gradients after transcatheter aortic valve implantation (TAVI) between SAPIEN BEV and Evolut SEV platforms in a routine-practice cohort spanning several device generations. Materials and methods We retrospectively analysed 665 TAVI procedures: 250 BEV procedures using SAPIEN 3 variants and 415 SEV procedures using Evolut variants. The primary endpoint was the early post-TAVI echocardiographic mean transvalvular gradient obtained within three months of TAVI. Secondary endpoints were absolute and relative gradient reductions, achievement of a post-TAVI mean gradient <10 mmHg, and a residual mean gradient ≥20 mmHg. Because the continuous variables were skewed, they were compared using two-sided Mann-Whitney U tests. Results were reported as medians with interquartile ranges, with bootstrap 95% confidence intervals (CIs) for differences in medians. Categorical variables were compared using Pearson chi-square tests without continuity correction when expected counts were adequate and Fisher's exact tests when cell counts were small. Paired pre- and post-TAVI measurements were compared using Wilcoxon signed-rank tests. Multivariable ordinary least-squares regression with HC3 heteroscedasticity-robust standard errors was used to adjust the post-TAVI gradient for the baseline gradient and available prespecified covariates. Results Complete pre- and post-TAVI gradients were available for 664 procedures (249 BEV and 415 SEV). The median post-TAVI gradient was 8.4 (5.85-11.63) mmHg with SEV and 10.0 (7.93-13.90) mmHg with BEV (median difference, -1.60 mmHg; bootstrap 95% CI: -2.97 to -1.00; Mann-Whitney U test: p < 0.001). The median absolute gradient reduction was also greater with SEVs (36.0 vs 32.0 mmHg; median difference, 4.0 mmHg; p < 0.001), as was the relative gradient reduction (81.52% vs 76.19%; median difference, 5.33 percentage points; p < 0.001), although SEVs had a higher pre-procedural baseline transvalvular gradient. A post-TAVI mean gradient <10 mmHg was recorded in 61.2% of SEV procedures compared with 43.4% of BEV procedures (risk ratio 1.41; p < 0.001). Residual gradients of ≥20 mmHg were uncommon and did not differ between the two groups (6.0% in SEV procedures vs 5.6% in BEV procedures; p = 0.831). After adjustment, in 575 completed cases, SEV use remained associated with a 1.48 mmHg lower post-TAVI mean gradient (95% CI: -2.42 to -0.55; p = 0.0019). Conclusions In this cohort, Evolut SEV procedures were associated with a modestly lower early post-TAVI mean gradient than SAPIEN BEV procedures. The magnitude of this association, and its interpretation alongside baseline gradient, anatomy, and other device-selection factors, can inform further comparative evaluation. No clinical outcomes or valve-durability measures were assessed.
SN - 2168-8184
ER -