The Ozaki Procedure: A Standardized Protocol for a Complex Aortic Valve Innovation

The Ozaki procedure — aortic valve neocuspidization using the patient’s own pericardium — has captured cardiac surgeons’ imagination as a biological alternative to traditional aortic valve replacement. Yet it is technically demanding, and reproducibility outside expert centres has been uncertain. This Cleveland Clinic series aimed to test whether a standardized protocol could flatten the learning curve.

From May 2015 to February 2021, 46 patients with a mean age of 51 ± 14 years underwent the Ozaki procedure: 7 with unicuspid (15%), 29 with bicuspid (63%), and 10 with tricuspid (22%) aortic valves; two had endocarditis. Endpoints included operative learning curves, perioperative outcomes, intermediate-term valve hemodynamics, reintervention, mortality, and health-related quality of life measured with the MacNew Heart Disease Health-Related Quality of Life Questionnaire.

Cardiopulmonary bypass and aortic clamp times decreased from 145 to 125 minutes and 120 to 100 minutes respectively over the first 20 cases — a clear learning curve effect. There was no major perioperative morbidity or mortality. At two years, survival was 96%, with stable valve function. The MacNew captured how these favourable clinical outcomes translated into improvements in patients’ daily lives.

By incorporating the MacNew alongside clinical and hemodynamic endpoints, the team ensured their adoption of a complex new procedure was evaluated on the dimensions that matter to patients. The MacNew’s role here illustrates how patient-reported outcomes have become indispensable for the responsible introduction of innovative surgical techniques.

Reference:
Patel, V., Unai, S., Moore, R., Layoun, H., Harb, S., Tong, M. Z. Y., Karamlou, T., Najm, H. K., Svensson, L. G., Rajeswaran, J., Blackstone, E. H., & Pettersson, G. B. (2024). The Ozaki Procedure: Standardized Protocol Adoption of a Complex Innovative Procedure. Structural Heart, 8(1), 100217. https://doi.org/10.1016/j.shj.2023.100217