A personalized aortic valve replacement using computed tomography-guided aortic valve neocuspidization. Analysis of mid-term results compared to standard Ozaki technique

Background The original Ozaki technique involves sizing the neovalve cusps during cross-clamp. It leads to prolonging the ischemic time compared to standard surgical AVR. Measurements taken on the collapsed Aortic Root (AR) may also be inaccurate. We use preoperative Computed Tomography (CT) to perform more accurate sizing in physiological conditions and shorten the ischemic time. This study analyzes the results of the CT-guided Aortic Valve Neocuspidization (AVNeo) compared with the Ozaki technique. Methods The validity of the concept was evaluated ex vivo. Experimental valves underwent geometric, CT, and hydrodynamic controls. In the clinical phase of the study, we prospectively analyzed patients who received CT-guided AVNeo (N ​= ​7, Group 1). The control group enrolled patients who were operated on after the standard AVNeo technique (N ​= ​15, Group 2). Results In Group 1, Aortic Cross-Clamp (70.3 ​± ​17.0 vs. 91 ​± ​21.3 ​min, ρ ​= ​0.026) and Bypass times (92.9 ​± ​21.0 vs. 123 ​± ​24.8 ​min, ρ ​= ​0.011) were significantly shorter. At discharge, the peak (11.7 ​± ​2.75 vs. 15.4 ​± ​4.66 ​mm Hg, ρ ​= ​0.032) and mean Aortic Valve (AV) gradient (6.29 ​± ​1.25 vs. 7.87 ​± ​2.33 ​mm Hg, ρ ​= ​0.052) were lower in Group 1. Only one patient in Group 2 had Aortic Insufficiency (AI) greater than mild. The mean follow-up was 49.6 ​± ​6.9 months in both groups. There were no late deaths or any valve-related events detected in any patient. EchoCG revealed that peak (10.0 ​± ​2.65 vs. 12.6 ​± ​4.05 ​mm Hg, ρ ​= ​0.090) and mean AV gradient (5.14 ​± ​1.35 vs. 6.73 ​± ​2.25 ​mm Hg, ρ ​= ​0.054) also were lower in Group 1. AI indexes were stable in both Groups. Conclusions CT-guided AVNeo is an example of personalized medicine in the surgical treatment of heart valve pathology. It allows the development of a biological AV that adapts to the patient's anatomy, shortens ischemic time, and results in better hemodynamics.A more significant number of clinical observations and longer follow-up are warranted to prove the viability of the concept.