Key result
Aortic valve neocuspidization lowers median aortic gradient by ~41 mmHg at 6 months.
Why the study?
Aortic valve neocuspidization using autologous pericardium is a reconstructive option for aortic valve disease, and this study evaluated the early hemodynamic and clinical outcomes of the Ozaki procedure for severe aortic stenosis.
Does aortic valve neocuspidization using autologous pericardium (Ozaki procedure) improve 6-month hemodynamic performance and provide acceptable 1-year clinical outcomes in patients with severe aortic stenosis?
Cohort (n=31)
No
Does aortic valve neocuspidization using autologous pericardium (Ozaki procedure) improve 6-month hemodynamic performance and provide acceptable 1-year clinical outcomes in patients with severe aortic stenosis?
Aortic valve neocuspidization (Ozaki procedure) for severe aortic stenosis achieved substantial reductions in transvalvular gradients and favorable valve competence at 6 months with 93.5% 1-year survival, though a fatal infective endocarditis event highlights the need for ongoing surveillance.
Early hemodynamic gains with aortic valve neocuspidization in severe aortic stenosis remain hypothesis-generating; larger prospective trials are needed to define durability and safety.
Objective: Aortic valve neocuspidization using autologous pericardium is a reconstructive option for aortic valve disease. We evaluated the early hemodynamic and clinical outcomes of the Ozaki procedure in a single-center cohort. Methods: This retrospective study included 31 consecutive patients with severe aortic stenosis who underwent aortic valve neocuspidization between January 2023 and June 2025. Pre-operative and 6-month echocardiographic findings were compared in 30 patients with paired data. Clinical outcomes were assessed through at least 12 months of follow-up among surviving patients. Results: Median age was 65.0 years, and seven patients (22.6%) underwent a concomitant cardiac procedure. The median mean transvalvular gradient decreased from 50.5 mmHg preoperatively to 9.0 mmHg at 6 months (p<0.001). The maximum gradient decreased from 83.0 to 18.0 mmHg, and peak aortic jet velocity decreased from 4.60 to 1.85 m/s (both p<0.001). At 6 months, aortic regurgitation was absent in 16 patients (53.3%), mild in 12 (40.0%), and moderate in two (6.7%); none had severe regurgitation. One patient (3.2%) died during the index hospitalization. Another developed infective endocarditis with acute severe aortic regurgitation at 9 months and subsequently died. Overall 1-year survival was 93.5%. Conclusion: Aortic valve neocuspidization was associated with low transvalvular gradients and generally favorable valve competence at 6 months. The fatal endocarditis event underscores the need for continued surveillance. Larger studies with longer follow-up are needed to assess durability.
No takes yet. Share an insight, caveat, or question.
Özçelik et al. (2026) conducted a cohort in Severe aortic stenosis (n=31). Aortic valve neocuspidization (Ozaki procedure) using 0.6% glutaraldehyde-treated autologous pericardium vs. Preoperative baseline (paired within-patient comparison, n=30) was evaluated on Mean transvalvular gradient at 6 months (as part of 6-month hemodynamic performance) (Median change -40.5 mmHg, p=<0.001). Aortic valve neocuspidization reduced median mean transvalvular gradient from 50.5 to 9.0 mmHg at 6 months (p<0.001) with 93.5% 1-year survival in patients with severe aortic stenosis.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: