Key result
Bioprosthetic SAVR sustains favorable hemodynamics at 5 years with a mean gradient of ~12 mmHg.
Why the study?
An early overview of midterm safety, hemodynamic performance, and valve durability was needed for patients undergoing SAVR with a novel bioprosthetic valve in a real-world setting.
Cohort (n=556)
Open-label
Yes
Surgical aortic valve replacement with a novel bioprosthetic valve demonstrated stable hemodynamic performance and preserved effective orifice areas at 5 years in a real-world cohort.
Answers are grounded in this paper and cite their sources.
Supports bioprosthetic SAVR durability at 5 years; leaves open need for longer-term randomized confirmation.
All articles of this category (opens in new window) Background: An early overview of midterm safety, hemodynamic performance, and valve durability is provided for patients undergoing surgical aortic valve replacement (SAVR) with a novel bioprosthetic valve in the real-world IMPACT cohort of patients. Methods: IMPACT is a prospective, open-label, multicenter, international study that enrolled consecutive patients undergoing SAVR with a bioprosthetic valve between December 2019 and June 2021 at 21 sites. Here we report preliminary 5-year outcomes for the total cohort, focusing on clinical outcomes as well as haemodynamic performance. This analysis represents an early look at closing-phase data ahead of final study completion in 2026. Results: A total of 556 patients were enrolled with a mean age of 63.4 ± 8.5 years, EuroSCORE II of 2.2 ± 2.5% and STS score of 1.7 ± 2.2%; 29.0% were female. Five-year event rates for all-cause mortality, cardiovascular mortality, stroke, reintervention, and haemodynamic valve deterioration were reported. Left ventricular mass index decreased postdischarge and remained low through 5 years (128.5 at baseline, 107.1 at 1 year, and 105.2 g/m 2 at 5 years). Haemodynamic performance likewise improved early and sustained levels until 5 years: mean aortic valve gradient was 42.7 at baseline, decreasing to 11.3 mmHg at 1 year and 11.9 at 5 years, while baseline indexed effective orifice area increased from 0.5 at baseline to 0.9 and 0.8 cm2 at 1 and 5 years, respectively. Preliminary findings indicate stable haemodynamic performance, with preserved gradients and effective orifice areas at 5 years. Conclusion: Bioprosthetic surgical aortic valve replacement showed sustained haemodynamic performance and good overall outcomes at 5 years in a real-world population. Final results, including complete follow-up, will be reported after study close-out. Publication History Article published online: 17 February 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
No takes yet. Share an insight, caveat, or question.
Bakhtiary et al. (2026) conducted a cohort in Aortic valve disease requiring surgical aortic valve replacement (n=556). Bioprosthetic surgical aortic valve replacement was evaluated on Mean aortic valve gradient at 5 years. Bioprosthetic surgical aortic valve replacement demonstrated sustained haemodynamic performance at 5 years, maintaining a mean aortic valve gradient of 11.9 mmHg and an effective orifice area of 0.8 cm2.
Synapse has enriched 10 related papers. Consider them for comparative context: