Early clinical and hemodynamic outcomes of SAVR, Ozaki neocuspidization, and TAVI: A real-world observational study

Aortic stenosis is a common valvular heart disease associated with substantial morbidity and mortality if left untreated. Surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI), and autologous pericardial aortic valve reconstruction (Ozaki procedure) represent alternative interventional strategies, but direct real-world comparisons remain limited. This study evaluated early clinical and 6-month hemodynamic outcomes following these 3 treatment approaches. This retrospective single-center observational study included 153 consecutive patients with severe aortic stenosis treated between December 2020 and March 2022 (SAVR, n = 67; Ozaki, n = 31; TAVI, n = 55). Early mortality was the primary clinical outcome, and 6-month mean transvalvular gradient was the primary echocardiographic outcome. Other clinical and echocardiographic outcomes were considered secondary or exploratory. Multivariable regression, analysis of covariance, and separate pairwise propensity-score matching models were used to account for baseline differences. Propensity scores were estimated using age, sex, EuroSCORE II, chronic kidney disease, and coronary artery disease. TAVI patients were older and had higher operative risk. No statistically significant differences were detected among the groups in early mortality, stroke, or postoperative dialysis. Permanent pacemaker implantation was more frequent after TAVI, while prolonged intensive care unit stay also differed among treatment groups. At 6 months, the Ozaki group showed favorable hemodynamic parameters, including lower mean transvalvular gradients and maximum transvalvular velocity. However, 6-month echocardiographic follow-up was incomplete, and these findings should be considered exploratory given the small Ozaki cohort, baseline differences, and observational study design. SAVR, Ozaki neocuspidization, and TAVI showed distinct early clinical and hemodynamic profiles in this real-world observational cohort. No statistically significant differences were detected in several major early clinical outcomes, although the study was not sufficiently powered to establish equivalent safety or exclude clinically meaningful differences. The favorable short-term hemodynamic findings observed with the Ozaki procedure should be considered hypothesis-generating. Larger prospective studies with longer follow-up are needed to further evaluate comparative clinical outcomes, hemodynamic performance, and durability.