Excellent Hemodynamic Results in Patients Undergoing the Ozaki Procedure for Aortic Valve Reconstruction within the First Year

Objectives: Aortic valve reconstruction (AVR) with autologous pericardium using the Ozaki technique might offer a new treatment modality for aortic valve pathologies. The current study focuses on early hemodynamic at discharge and 6 to 12 months after the Ozaki procedure.

Methods: In 77 patients undergoing AVR between October 2016 and August 2018, early hemodynamic and clinical outcome were analyzed. Mean age was 54.9 ± 16.5 years, 31 patients (31.2%) were female. Aortic stenosis was present in 64 (84.4%) and insufficiency (AI) in 13 (15.6%) patients.

Pericardium was harvested, fixed in glutaraldehyde, and rinsed in saline following the Ozaki procedure. Regardless of a bi- or tricuspid configuration of the native valve, trileaflet AVR was performed in all cases. In 25 patients (32.5%), concomitant cardiac surgical procedures were performed. For hemodynamic evaluation transthoracic echo (TTE) prior to the operation, at discharge and 6 to 12 months after surgery was performed.

Results: Freedom from reoperation at 1.76 years was 97.4%. Two patients (2.6%) presented with moderate to severe AI after the procedure. Both received a prosthetic aortic valve replacement within the same hospital stay. There was no need for permanent pacemaker implantation in any patient.

At discharge TTE peak and mean pressure gradients were 16.9 ± 8.1 and 9.3 ± 4.2 mm Hg, respectively. The mean effective orifice area (EOA) was 2.2 ± 0.7 cm² with a maximum value for EOA of 4.3 cm². Eight patients had an EOA > 3.0 cm² (10.4%). The mean EOA index was 1.1 ± 0.3, with no or only moderate patient-prosthesis mismatch in 92.2%.

At 6 to 12 months aortic gradients had significantly decreased compared with discharge (Δ peak aortic gradient: mean 2.2 ± 6.5 mmHg, p = 0.05; Δ mean aortic gradient: mean 1.6 ± 3.4 mm Hg, p = 0.007). In contrast, the EOA did not change (2.1 ± 0.6 vs. 2.2 ± 0.7 cm²).

Conclusion: AVR following the Ozaki procedure reveals excellent early hemodynamic results in terms of EOA, pressure gradients, and patient-prosthesis mismatch. Compared to the values at discharge, mean pressure gradients further decreased within the first year after the Ozaki procedure.