Mid-Term Experience With 1,196 Ozaki Procedures

Introduced in 2007, the Ozaki procedure-templated cusp replacement with autologous pericardium-is a new option for treating aortic valve disease. Mid-term outcomes and valve performance have not yet been reported.

This study assesses longitudinal hemodynamics, left ventricular reverse remodeling, reoperation, and survival in the original Ozaki cohort.

1,196 patients underwent Ozaki procedures (60% male, age 11-90 years) at Toho University Ohashi Medical Center from April 2007 to May 2021: 2.4% had infective endocarditis, 27% had bicuspid valves, 54% had aortic stenosis, 24% had aortic regurgitation, 7.3% had mixed lesions, and 46% underwent concomitant procedures. Clinical outcomes, echocardiograms, and follow-up data (50% followed >3.2 years, 10% >9 years) were analyzed using nonlinear mixed-effects regression for valve performance and time-to-event analyses for reoperation and mortality.

Mean cardiopulmonary bypass and aortic clamp times for isolated Ozaki procedures were 151 ± 37 and 105 ± 29 minutes, respectively. Thirty-day mortality was 1.7%, new stroke occurred in 2.6%, new dialysis in 4.0%, and permanent pacemakers were implanted in 1.5%. At 6 months, 5 years, and 10 years, mean aortic valve gradient was 7.4, 8.0, and 8.2 mm Hg, and ≥2+ regurgitation was 0.30%, 2.9%, and 6.6%, respectively. Left ventricular mass index decreased from 141 ± 52 g/m² preoperatively to 90 ± 51 g/m² at 10 years. Survival and freedom from reoperation at 10 years was 78% and 92%, respectively.

The Ozaki procedure creates a good aortic valve with stable low gradients and left ventricular reverse remodeling. A low but increasing rate of regurgitation is observed over time, with low reoperation risk, supporting its continued use.