Report of the Multicenter Aortic Valve Neocuspidization Registry: In-Hospital Outcomes of the First 170 Patients

Objectives: This study aims to analyze the operative and postoperative results, along the hemodynamic performance of surgical aortic valve neocuspidization (AVNeo), the so-called Ozaki procedure, for aortic valve disease. It is the first report from the recently launched Multicenter AVNeo Registry.

Methods: From January 2017 to May 2019, a total of 170 adult patients (50.6% women/mean age: 64.4 ± 9.7 years) received rather isolated (group 1, n = 94) or combined (group 2, n = 76) AVNeofor severe aortic valve stenosis (95.3%), severe aortic regurgitation (1.8%), and/or infective endocarditis (2.9%) at three AVNeo centers. The median aortic annulus diameter was 21 mm (20–22 mm), with a minimum of 16 and a maximum of 28 mm. The median NYHA class was III (II–III). LVEF numbered 58.4% ± 9.4, and EuroSCORE II–2.5% (1.7–5.1%). The endpoints were survival after the operation at 30 days, valve-related adverse events, and the hemodynamic performance of the neovalve.

Results: The overall survival was 97.6% without any significant difference for both groups (96.8 vs. 98.7%, p = 0.4). As much as six patients (5.7% of group 1) received minimally invasive surgery (MIS), upper T-sternotomy in five and upper J-sternotomy in one patient. Either the autologous pericardium (98.2%) or xenogenic patch (1.8%) was used. There were no neovalve reoperations, degeneration, thrombosis, nor endocarditis. The overall stroke rate was 0%. The permanent pacemaker implantation rate was 1.2% (1.3 vs. 1.1%, p = 0.7). Cardiopulmonary bypass (CPB, 103.2 ± 31.5 vs. 123.2 ± 44.3 minutes, p < 0.001) and aortic crossclamp times (ACC, 80.9 ± 17.5 vs. 92.8 ± 26.7 minutes, p = 0.001) were lower in group 1. The median peak and mean pressure gradients were 10 mm Hg (7–13.2 mm Hg), and 5 mm Hg (3–7.8 mm Hg), respectively. The indexed effective orifice area was 1.4 cm²/m² (1.2–1.6 cm²/m²).

Conclusion: In the first report of our registry, AVNeo showed promising results regarding survival, valve-related adverse events, and the hemodynamic performance. CPB and ACC times were acceptable. MIS is also possible for the AVNeo procedure. The follow-up, as well as recruitment of new patients and centers are ongoing. This will be presented in the second registry report.