OBJECTIVE: Aortic valve neocuspidization (AVNeo) is a relatively recent advancement in surgical AV replacement. Data on its performance beyond the short term are limited. We assessed the mid-term outcomes in patients undergoing AVNeo, focusing on feasibility, perioperative details, and its role in AV pathology treatment.
METHODS: Sixty-five consecutive patients underwent AVNeo between December 2016 and February 2018. Clinical data were prospectively collected and retrospectively analyzed. Tricuspid reconstruction with autologous pericardium was performed in all cases. Echocardiographic follow-up was conducted post-discharge, at 6 and 12 months, and annually thereafter.
RESULTS: The mean age was 62.6 ± 18.7 years. AVNeo was feasible in all cases. Concomitant procedures were performed in 43 (66.2%) patients. Mean bypass and cross-clamp times were 119.2 ± 30.3 and 87.1 ± 22.9 minutes, respectively. Postoperative transvalvular hemodynamics was excellent. There was one (1.5%) in-hospital death. Follow-up (mean 66.72 ± 12.77 months) was complete in 58 patients (89.2%). There were no detected valve-related or thromboembolic events. Transvalvular hemodynamic parameters were stable during the observation period: peak pressure gradient at discharge and follow-up was 15.3 ± 4.6 mmHg and 15.01 ± 6.3 mmHg, respectively (ρ = 0.346).
CONCLUSIONS: AVNeo demonstrated the feasibility and favorable mid-term outcomes. Studies with longer-term observation are warranted to evaluate its durability.

UNASSIGNED: Aortic valve neocuspidization with autologous pericardium is gaining increasing attention as a surgical treatment option for aortic valve disease. However, little is known about midterm durability and valve-related events.
UNASSIGNED: Patients undergoing aortic valve neocuspidization between 2016 and 2021 were included. Transthoracic echocardiography was performed before the operation, at discharge, and annually thereafter. Data were analyzed for incidences of structural valve deterioration, bioprosthetic valve failure, survival, freedom from reoperation, and hemodynamic performance.
UNASSIGNED: A total of 162 patients underwent aortic valve neocuspidization (mean age, 52.6 ± 16.6 years; range, 13-78 years); 114 (70.4%) were male. A total of 132 patients presented with a bicuspid aortic valve (81.5%) and 126 patients presented with aortic valve stenosis (77.8%). Concomitant procedures were performed in 63 patients (38.9%). Mean follow-up was 3.5 ± 1.2 years. At discharge, peak and mean pressure gradients were 15.6 ± 7.2 mm Hg and 8.4 ± 3.7 mm Hg, respectively, with a mean effective orifice area of 2.4 ± 0.8 cm2. After 5 years, peak and mean pressure gradients were 14.5 ± 4.6 mm Hg and 7.5 ± 2.2 mm Hg, respectively, with a mean effective orifice area of 2.3 ± 0.8 cm2. At 5 years, cumulative incidences of moderate and severe structural valve deterioration and bioprosthetic valve failure were 9.82% ± 3.87%, 6.96% ± 3.71%, and 12.1% ± 4.12%, respectively. Survival was 97.3% ± 1.4%, and freedom from reoperation was 91.3% ± 2.4%.
UNASSIGNED: Aortic valve neocuspidization accomplishes low pressure gradients early after initial surgery and during follow-up. Survival in this young patient population is excellent. The main reason for reoperation is endocarditis, and rates for structural valve degeneration are low.

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.

Aortic valve repair has emerged as the treatment of choice for congenital aortic valvular disease, avoiding the need for a reoperation associated with stented prosthesis overgrowth. The introduction of a leaflet implant represents a recent advancement in a field that originated early techniques, such as simple commissurotomies. In our experimental approach, we assessed two established leaflet-sizing techniques by analysing their resultant coaptation areas. Although both techniques produced competent valves, the large coaptation areas differed significantly from the native aortic valve. This observation prompted us to revisit the functional anatomy of the aortic valve, our goal being to refine leaflet design and implantation for enhanced efficacy and longevity in neo-leaflet procedures. We designed a novel aortic valvar neo-leaflet, utilizing porcine pericardium as our primary source material, and we implanted four tri-leaflet valves in four porcine hearts. All tri-leaflet valves were competent and closely resembled the coaptation area of the native aortic valve. This study serves as a pilot for further experimental aortic valve repair surgery using neo-leaflet implants.

Aortic valve disease is often treated with bioprosthetic valves. An alternative treatment is aortic valve neocuspidization which is a relatively new reparative procedure whereby the three aortic cusps are replaced with patient pericardium or bovine tissues. Recent research indicates that aortic blood flow is disturbed, and turbulence effects have yet to be evaluated in either bioprosthetic or aortic valve neocuspidization valve types in patient-specific settings. The aim of this study is to better understand turbulence production in the aorta and evaluate its effects on laminar and turbulent wall shear stress. Four patients with aortic valve disease were treated with either bioprosthetic valves (n=2) or aortic valve neocuspidization valvular repair (n=2). Aortic geometries were segmented from magnetic resonance images (MRI), and 4D flow MRI was used to derive physiological inlet and outlet boundary conditions. Pulsatile large-eddy simulations were performed to capture the full range of laminar, transitional and turbulence characteristics in the aorta. Turbulence was produced in all aortas with highest levels occurring during systolic deceleration. In the ascending aorta, turbulence production is attributed to a combination of valvular skew, valvular eccentricity, and ascending aortic dilation. In the proximal descending thoracic aorta, turbulence production is dependent on the type of arch-descending aorta connection (e.g., a narrowing or sharp bend) which induces flow separation. Laminar and turbulent wall shear stresses are of similar magnitude throughout late systolic deceleration and diastole, although turbulent wall shear stress magnitudes exceed laminar wall shear stresses between 27.3% and 61.1% of the cardiac cycle. This emphasises the significance of including turbulent wall shear stress to improve our comprehension of progressive arterial wall diseases. The findings of this study recommend that aortic valve treatments should prioritise minimising valvular eccentricity and skew in order to mitigate turbulence generation.

BACKGROUND: Trileaflet aortic valve neocuspidization (AVN) using autologous pericardium (Ozaki procedure) is an emerging surgical treatment option for aortic valve diseases. Although excellent results have been reported from Japan, data pertaining to its use in the United States are sparse.
METHODS: All adult patients who underwent AVN (AVN group) or surgical aortic valve replacement (SAVR) with a bioprosthetic valve (SAVR group) between 2015 and 2022 were identified. Propensity score matching was used to adjust the baseline characteristics between the 2 groups.
RESULTS: A total of 101 patients underwent AVN, and 1816 patients underwent SAVR with a bioprosthetic valve. None in the AVN group required conversion to SAVR. Before matching, mean age in the AVN group was 68.5 ± 8.8 years, and 56 patients (55.4%) underwent concomitant procedures. Preoperatively, 3 (3%) had endocarditis. Bicuspid valve was observed in 38 (38.4%). None died at 30 days in the AVN group. The median follow-up duration was 3.2 years. After propensity score matching, the expected survival and freedom from at least moderate aortic regurgitation at 5 years was 91.7% ± 3.1% and 97.6% ± 1.7%, respectively. Propensity score matching yielded 77 patients in each group. The Kaplan-Meier curve demonstrated equivalent survival at 5 years between the 2 groups (P = .95). Additionally, freedom from at least moderate aortic regurgitation was comparable at 5 years (P = .23).
CONCLUSIONS: AVN can be safely performed for a variety of aortic valve diseases, with or without concomitant operations. AVN demonstrated similar midterm outcomes compared with SAVR with a bioprosthetic valve in the United States adult population.

The Ozaki procedure has emerged as a valuable option for treating various aortic valve pathologies. This review article delves into the intricacies of this innovative surgical approach by exploring its adaptation to the complex anatomy and physiology of the aortic root. The diverse etiologies of aortic valve diseases, ranging from congenital anomalies to degenerative changes, make treatment selection a complex challenge. Aortic valve replacement has traditionally been the gold standard, but emerging evidence supports valve repair techniques, emphasizing the importance of preserving native tissue. Nevertheless, issues like lifelong anticoagulation with mechanical valves and patient-prosthetic mismatch remain. The Ozaki procedure offers a compelling alternative by utilizing autologous pericardium or a tissue substitute to construct new aortic valve leaflets. This technique, standardized by Dr. Ozaki in 2007, provides a customizable and adaptable solution. The article highlights the anatomy of the aortic root, emphasizing the critical role of the sinus of Valsalva and interleaflet triangles in maintaining proper valve function. The procedure\'s unique adaptation to aortic root dynamics allows for reduced mechanical stress during systole and diastole, mimicking the natural valve\'s behavior. Furthermore, Ozaki leaflets exhibit promising hemodynamics and reduced risks of complications, such as permanent pacemaker implantation and patient-prosthetic mismatch. The use of autologous pericardium in the Ozaki procedure presents advantages, including enhanced tissue strength, minimal immunogenicity, and reduced risk of immune-mediated calcification. These factors contribute to the longevity and resilience of the reconstructed valve. This comprehensive review aims to shed light on the procedure\'s intricacies, its alignment with aortic root anatomy and physiology, and its potential as a valuable tool in the armamentarium of aortic surgeons.

Background: In this study, we present our early results with the Ozaki procedure in the treatment of congenital aortic valve disease. Methods: Between July 2021 and July 2023, a total of 14 patients (10 males, 4 females; median age: 13.9 years; range, 8.5 to 15 years) who underwent neoaortic valve reconstruction of three leaflets using Ozaki procedure were retrospectively analyzed. Preoperative, postoperative, and follow-up echocardiogram images were evaluated. Results: Preoperative indications were aortic regurgitation (n=3) or combined aortic stenosis and regurgitation (n=11). The median aortic annular diameter was 23 (range, 19.5 to 25) mm on preoperative echocardiography. The median preoperative peak systolic aortic valve gradient for patients with aortic stenosis was 60 (range, 45 to 93) mmHg. The median preoperative aortic valve regurgitation grade was 4 (range, 3 to 4). Autologous pericardium and bovine pericardium were used in 12 and two patients, respectively. There was no conversion to valve replacement, myocardial infarction, or mortality in the early postoperative period. The median follow-up time was 8.5 (range, 6 to 19) months. One patient who performed the Ozaki procedure with bovine pericardium underwent valve replacement eight months later. Conclusion: The Ozaki procedure can be performed safely and effectively in congenital aortic valve stenosis and insufficiency with promising early results.

Aortic valve operations for the sinus of Valsalva aneurysm are challenging. Several techniques are described in the literature for these kinds of pathologies, such as the David procedure, the Yacoub procedure and the Bentall procedure. The Florida sleeve technique was described in the last decade as a valve-sparing technique for a sinus of Valsalva aneurysm. More recently, the J-Mart technique was described: It combines the Florida sleeve technique with aortic valve replacement. Our goal was to describe our new technique, which depends mainly on combining the Florida sleeve technique and the Ozaki procedure in a small group of patients who had aortic valve disease and a sinus of Valsalva aneurysm.

The original Ozaki technique involves sizing and trimming the neovalve cusps during cross-clamp. It leads to prolongation of the ischaemic time, as compared to standard aortic valve replacement. We use preoperative computed tomography scanning of the patient\'s aortic root to develop personalized templates for each leaflet. With this method, autopericardial implants are prepared before the initiation of the bypass. It permits maximally adopting the procedure to the patient\'s individual anatomy and to shorten the cross-clamp time. We present a case of a computed tomography-guided aortic valve neocuspidization and concomitant coronary artery bypass grafting with excellent short-term results. We discuss the feasibility and technical details of the novel technique.