The Ozaki procedure yielded lower peak gradients but more severe aortic regurgitation at 6 years (3.6% vs 1.0%; P=0.006) compared with PERIMOUNT bioprostheses, with similar freedom from rereplacement.
Cohort (n=1,403)
Yes
Aortic valve disease (n=1,403)
Ozaki procedure (aortic valve reconstruction with autologous pericardium) vs Stented bovine pericardial valves (PERIMOUNT)
Severe aortic regurgitation at 6 years, p=0.006
Absolute Event Rate: 3.6% vs 1%
p-value: p=0.006
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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Shinya Unai
Cardiac Surgery
Shigeyuki Ozaki
Toho University
Douglas R. Johnston
Cardiac Surgery
Journal of the American Heart Association
Cleveland Clinic
Cleveland Clinic Lerner College of Medicine
Toho University
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Unai et al. (Wed,) conducted a cohort in Aortic valve disease (n=1,403). Ozaki procedure (aortic valve reconstruction with autologous pericardium) vs. Stented bovine pericardial valves (PERIMOUNT) was evaluated on Severe aortic regurgitation at 6 years (p=0.006). The Ozaki procedure yielded lower peak gradients but more severe aortic regurgitation at 6 years (3.6% vs 1.0%; P=0.006) compared with PERIMOUNT bioprostheses, with similar freedom from rereplacement.
synapsesocial.com/papers/6a1c03cfbc71fb1015a92b6b — DOI: https://doi.org/10.1161/jaha.122.027391