Key result
Ozaki procedure linked to ~260% higher severe AR at 6 years vs PERIMOUNT despite lower gradients.
Why the study?
The study evaluated the Ozaki procedure regarding its learning curve, hemodynamic performance, and durability compared with a stented bioprosthesis.
Does the Ozaki procedure improve hemodynamics and durability compared to a stented bioprosthesis in patients requiring aortic valve replacement?
Observational (n=1,254)
Yes
Does the Ozaki procedure improve hemodynamics and durability compared to a stented bioprosthesis in patients requiring aortic valve replacement?
Absolute Event Rate: 3.6% vs 1%
p-value: p=0.006
The Ozaki procedure provides superior hemodynamics with lower gradients but carries a higher risk of recurrent aortic regurgitation compared to standard stented bioprostheses, with comparable midterm survival and reoperation rates.
Higher AR risk with Ozaki may warrant closer surveillance; leaves open durability versus stented valves in randomized trials.
Background We assessed the Ozaki procedure, aortic valve reconstruction using autologous pericardium, with respect to its learning curve, hemodynamic performance, and durability compared with a stented bioprosthesis. Methods and Results From January 2007 to January 2016, 776 patients underwent an Ozaki procedure at Toho University Ohashi Medical Center. Learning curves, aortic regurgitation (AR), and peak gradient, assessed by serial echocardiograms, valve rereplacement, and survival were investigated. Valve performance and durability were compared with 627 1:1 propensity‐matched patients receiving stented bovine pericardial valves implanted from 1982 to 2011 at Cleveland Clinic. Learning curves were observed for aortic clamp and cardiopulmonary bypass times, AR prevalence, and early mortality. Decreased aortic clamp time was observed over the first 300 cases. New surgeons performing parts of the procedure after case 400 resulted in a slight increase in aortic clamp and cardiopulmonary bypass times. Among matched patients, the Ozaki cohort had more AR than the PERIMOUNT cohort (severe AR at 1 and 6 years, 0.58% and 3.6% versus 0.45% and 1.0%, respectively; P [trend]=0.006), although with a steep learning curve. Peak gradient showed the opposite trend: 14 and 17 mm Hg for Ozaki and 24 and 28 mm Hg for PERIMOUNT at these times ( P [trend] < 0.001). Freedom from rereplacement was similar ( P =0.491). Survival of the Ozaki cohort was 85% at 6 years. Conclusions Patients undergoing the Ozaki procedure had lower gradients but more recurrent AR than those receiving PERIMOUNT bioprostheses. Although recurrent AR is concerning, results confirm low risk and good midterm performance of the Ozaki procedure, supporting its continued use.
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Unai et al. (2023) conducted an observational in Aortic valve disease (n=1,254). Ozaki procedure vs. PERIMOUNT stented bovine pericardial bioprosthesis was evaluated on Severe aortic regurgitation at 6 years (p=0.006). The Ozaki procedure resulted in lower peak aortic gradients but a higher rate of severe aortic regurgitation at 6 years (3.6% vs 1.0%) compared to the PERIMOUNT bioprosthesis.
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