Abstract：
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.
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.
摘要：
背景：原始的Ozaki技术涉及在交叉夹钳期间调整新瓣尖的大小。与标准手术AVR相比，它导致缺血时间延长。对塌陷的主动脉根(AR)进行的测量也可能是不准确的。我们使用术前计算机断层扫描（CT）在生理条件下进行更准确的大小确定并缩短缺血时间。这项研究分析了与Ozaki技术相比，CT引导的主动脉瓣新缓冲术（AVNeo）的结果。
方法：离体评估该概念的有效性。实验瓣膜经历了几何形状，CT,和水动力控制。在研究的临床阶段，我们前瞻性分析了接受CT引导AVNeo的患者(N=7，第1组)。对照组纳入标准AVNeo技术后手术的患者(N=15，第2组)。
结果：在第1组中，主动脉交叉钳（70.3±17.0vs.91±21.3分钟，ρ=0.026）和旁路次数（92.9±21.0与123±24.8分钟，ρ=0.011)明显更短。出院时,峰值(11.7±2.75vs.15.4±4.66mmHg，ρ=0.032）和平均主动脉瓣（AV）梯度（6.29±1.25vs.7.87±2.33mmHg，ρ=0.052)在第1组中较低。第2组中只有一名患者的主动脉瓣不足（AI）大于轻度。两组平均随访时间为49.6±6.9个月。在任何患者中均未发现晚期死亡或任何瓣膜相关事件。EchoCG显示峰值（10.0±2.65与12.6±4.05mmHg，ρ=0.090）和平均AV梯度（5.14±1.35与6.73±2.25mmHg，ρ=0.054)在第1组中也较低。两组的AI指数均稳定。
结论：CT引导的AVNeo是心脏瓣膜病理外科治疗中个性化医学的一个例子。它允许生物AV的发展，适应病人的解剖结构，缩短缺血时间，并导致更好的血液动力学。有必要进行更多的临床观察和更长的随访以证明该概念的可行性。
方法：离体评估该概念的有效性。实验瓣膜经历了几何形状，CT,和水动力控制。在研究的临床阶段，我们前瞻性分析了接受CT引导AVNeo的患者(N=7，第1组)。对照组纳入标准AVNeo技术后手术的患者(N=15，第2组)。
结果：在第1组中，主动脉交叉钳（70.3±17.0vs.91±21.3分钟，ρ=0.026）和旁路次数（92.9±21.0与123±24.8分钟，ρ=0.011)明显更短。出院时,峰值(11.7±2.75vs.15.4±4.66mmHg，ρ=0.032）和平均主动脉瓣（AV）梯度（6.29±1.25vs.7.87±2.33mmHg，ρ=0.052)在第1组中较低。第2组中只有一名患者的主动脉瓣不足（AI）大于轻度。两组平均随访时间为49.6±6.9个月。在任何患者中均未发现晚期死亡或任何瓣膜相关事件。EchoCG显示峰值（10.0±2.65与12.6±4.05mmHg，ρ=0.090）和平均AV梯度（5.14±1.35与6.73±2.25mmHg，ρ=0.054)在第1组中也较低。两组的AI指数均稳定。
结论：CT引导的AVNeo是心脏瓣膜病理外科治疗中个性化医学的一个例子。它允许生物AV的发展，适应病人的解剖结构，缩短缺血时间，并导致更好的血液动力学。有必要进行更多的临床观察和更长的随访以证明该概念的可行性。
