SAVR, Ozaki neocuspidization, and TAVI showed distinct early clinical and hemodynamic profiles in this real-world observational cohort, with no statistically significant differences detected in several major early clinical outcomes, while the Ozaki procedure showed favorable short-term hemodynamic findings that should be considered hypothesis-generating.
Key Findings
Results
No statistically significant differences were detected among SAVR, Ozaki, and TAVI groups in early mortality.
153 consecutive patients with severe aortic stenosis were treated between December 2020 and March 2022
The study was noted to be 'not sufficiently powered to establish equivalent safety or exclude clinically meaningful differences'
Multivariable regression and propensity-score matching were used to account for baseline differences
Results
No statistically significant differences were detected among the three groups in stroke or postoperative dialysis rates.
Stroke and postoperative dialysis were considered secondary or exploratory outcomes
These findings were assessed across all three treatment groups: SAVR, Ozaki, and TAVI
Propensity scores were estimated using age, sex, EuroSCORE II, chronic kidney disease, and coronary artery disease
The observational design and baseline differences limit the interpretation of these comparisons
Results
Permanent pacemaker implantation was more frequent after TAVI compared to the other treatment groups.
Permanent pacemaker implantation was identified as differing among treatment groups
This finding is consistent with known procedural characteristics of transcatheter valve implantation
TAVI patients were older and had higher operative risk at baseline
Separate pairwise propensity-score matching models were used to account for baseline differences between groups
Results
Prolonged intensive care unit stay differed among the three treatment groups.
ICU stay duration was identified as a secondary or exploratory outcome that differed among SAVR, Ozaki, and TAVI groups
The specific direction and magnitude of differences are not detailed in the abstract
Baseline differences between groups, including age and operative risk, may have influenced ICU stay outcomes
Analysis of covariance was among the statistical methods used to account for baseline differences
Results
The Ozaki group showed favorable hemodynamic parameters at 6 months, including lower mean transvalvular gradients and maximum transvalvular velocity.
6-month mean transvalvular gradient was the primary echocardiographic outcome
The Ozaki group demonstrated lower mean transvalvular gradients and maximum transvalvular velocity compared to the other groups at 6 months
6-month echocardiographic follow-up was incomplete, limiting the reliability of these findings
The authors state these findings 'should be considered exploratory given the small Ozaki cohort, baseline differences, and observational study design'
The Ozaki cohort had only 31 patients
Methods
TAVI patients were older and had higher operative risk compared to SAVR and Ozaki patients at baseline.
Baseline differences were present across the three treatment groups
TAVI patients had higher EuroSCORE II scores, indicating greater operative risk
Propensity score estimation included age, sex, EuroSCORE II, chronic kidney disease, and coronary artery disease to adjust for these differences
This retrospective single-center study enrolled consecutive patients treated between December 2020 and March 2022
What This Means
This research studied three different treatments for severe aortic stenosis — a condition where the heart's main outflow valve becomes narrowed and stiff — by comparing outcomes in 153 patients treated at a single hospital over about 15 months. The three approaches were traditional open-heart surgery to replace the valve (SAVR), a newer surgical technique where the patient's own tissue is used to reconstruct the valve leaflets (the Ozaki procedure), and a minimally invasive catheter-based method that threads a new valve through a blood vessel without open-heart surgery (TAVI). The study found no statistically significant differences between the groups in early death, stroke, or need for emergency dialysis. However, patients who received TAVI more often needed a permanent pacemaker afterward, and the length of time patients spent in intensive care varied across the three groups.
At six months after treatment, patients who had the Ozaki procedure appeared to have better valve function, with lower pressure gradients across the valve — a sign that blood is flowing more easily through the heart. However, the authors caution strongly that this finding should be treated as preliminary and hypothesis-generating rather than definitive, because the Ozaki group was small (only 31 patients), follow-up data were incomplete, and the patients in each group were not identical at the start of the study — for example, TAVI patients tended to be older and sicker.
This research suggests that all three approaches can be used to treat severe aortic stenosis with broadly similar early safety profiles in real-world practice, though each has distinct characteristics. The promising short-term valve function results seen with the Ozaki procedure are intriguing but need confirmation in larger, longer studies before firm conclusions can be drawn. The authors emphasize that this study was not large enough to definitively prove the treatments are equally safe or to rule out meaningful differences between them.
Özçelik S, Eren S, Özdemir K, Peynirci F, Özden Y, Şensöz Y, et al.. (2026). Early clinical and hemodynamic outcomes of SAVR, Ozaki neocuspidization, and TAVI: A real-world observational study.. Medicine. https://doi.org/10.1097/MD.0000000000050738