Mid-Term Outcomes of the Ozaki Procedure: A Single-Center Experience.

Abstract

Background: To assess the midterm clinical and echocardiographic outcomes of the Ozaki (aortic valve neocuspidization (AVNeo)) procedure performed at a single center.

Methods: A total of 258 patients who underwent the AVNeo procedure between February 2019 and February 2025 were retrospectively analyzed. Demographic, operative, and echocardiographic data were evaluated. Patients were followed up with clinical examinations and transthoracic echocardiography at discharge, 3 months, 6 months, and annually thereafter.

Results: The mean follow-up duration was 36 ± 17.5 months. The average age was 56.4 ± 15.1 years, and 31.6% were female. The mean peak pressure gradient across the aortic valve was 17.0 (11.8-20.2) mm Hg immediately after surgery, then 14.0 (11.0-19.0) mm Hg at 1 year and 17.0 (12.0-23.0) mm Hg at 3 years. The Friedman analysis demonstrated a statistically significant change in peak pressure gradient over time (χ² = 68.103, P < .001). Preoperatively, ejection fraction was 58.0 (52.0-64.0) %, increasing to 60.0 (56.0-62.0) % at 1 year and 61.0 (59.0-62.0) % at 3 years. Mild aortic regurgitation was seen in 2.7% of patients, and the reoperation rate was 0.38%. There were 3 in-hospital deaths (1.1%). Minimally invasive approaches (5 patients via a right anterior thoracotomy, 7 patients via an upper J sternotomy) were successfully performed in selected patients without needing to convert to full sternotomy.

Conclusion: The AVNeo procedure provides excellent midterm outcomes with low complication and reoperation rates. Its compatibility with minimally invasive approaches and avoidance of anticoagulation make it a promising, durable alternative to conventional aortic valve replacement.