OBJECTIVE: Three-dimensional (3D) modelling of aortic leaflets remains difficult due to insufficient resolution of medical imaging. We aimed to model the coaptation and load-bearing surfaces of the aortic leaflets and adapt this workflow to aid in the design of aortic valve neocuspidizations.
METHODS: Geometric morphometrics, using landmarks and semilandmarks, was applied to the geometric determinants of the aortic leaflets from computed tomography, followed by an isogeometric analysis using Non-Uniform Rational Basis Splines (NURBS). Ten aortic valve models were generated, measuring determinants of leaflet geometry defined as 3D NURBS curves, and leaflet coaptation and load-bearing surfaces were defined as 3D NURBS surfaces. Neocuspidizations were obtained by either shifting the upper central coaptation landmark towards the sinotubular junction or using parametric neo-landmarks placed on a centreline drawn between the centroid of the aortic root base and centroid of a circle circumscribing the 3 upper commissural landmarks.
RESULTS: The ratio of the leaflet free margin length to the geometric height was 1.83, whereas the ratio of the commissural coaptation height to the central coaptation height was 1.93. The median coaptation surface was 137 mm2 (IQR 58) and the median load-bearing surface was 203 mm2 (60) per leaflet. Neocuspidization multiplied the central coaptation height by 3.7 and the coaptation surfaces by 1.97 and 1.92 using the native coaptation axis and centroid coaptation axis, respectively.
CONCLUSIONS: Geometric morphometrics reliably defined the coaptation and load-bearing surfaces of aortic leaflets, enabling an experimental 3D design for the in silico neocuspidization of aortic valves.

BACKGROUND: Aortic valve reconstruction using glutaraldehyde-treated autologous pericardium, also called Ozaki procedure, is a surgical procedure for patients with aortic valve disease. Gratifying results have been reported in adult patients, however, limited published data is available in paediatric population. This study looked at clinical characteristics and early outcomes of children who underwent Ozaki procedure at our Institute.
METHODS: This was a retrospective descriptive study conducted on children who underwent aortic valve reconstruction at Jakaya Kikwete Cardiac Institute (JKCI) from January 2019 through December 2022. Medical records of these children were reviewed to extract data on demographics, clinical characteristics, redo surgical interventions and survival.
RESULTS: A total of 10 children underwent Ozaki procedure during the study period. Eight children had severe aortic regurgitation while 2 had severe aortic stenosis preoperatively. All children had either none or trivial aortic regurgitation immediately after surgery. None of them had redone operations throughout the follow-up period. There was no in-hospital mortality, however, one child died one-year after surgery. The mean follow-up period was 1.6 years with the longest follow-up time of 4 years.
CONCLUSIONS: Ozaki procedure showed encouraging early results among children with aortic valve disease who underwent surgical repair by this technique. Future studies with larger sample sizes and longer follow up periods to evaluate long-term results in this population are recommended.

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.

The surgical treatment options for pediatric aortic valve disease are limited and have debatable long-term durability. In the current situation, the Ross procedure is considered in children for aortic valve disease(s). It is a complex surgical procedure with the risk of neo-aortic dilatation, converting a single valve disease into double valve disease, and associated with future re-interventions. Conversely, the Ozaki procedure has shown promising results in adults. Thus, the present study aimed to provide comparative evidence on the effectiveness and safety of the Ozaki versus Ross procedure for pediatric patients by performing a meta-analytic comparison of reporting outcomes. A total of 15 relevant articles were downloaded and among them, seven articles (one prospective study, five retrospective studies, and one case series) were used in the analysis. Primary outcomes such as physiological laminar flow pattern and hemodynamic parameters, and secondary outcomes such as hospital stays, adverse effects, mortality, and numbers of re-intervention(s) were measured in the meta-analysis. There were no significant differences in the age of patients between children who underwent the Ozaki procedure and those who underwent the Ross procedure at the time of surgeries. The Ozaki procedure is a good solution to an aortic problem(s) similar to the Ross procedure. Unlike the Ross procedure, the Ozaki procedure has restored a physiological laminar flow pattern in the short-term follow-up without the bi-valvular disease. Mean hospital stays (p = 0.048), mean follow-up (p = 0.02), adverse effects (p = 0.02), death, and numbers of re-intervention(s) of children who underwent the Ozaki procedure were fewer than those who underwent the Ross procedure. The time required for re-intervention(s) is higher for children who underwent the Ozaki procedure than those who underwent the Ross procedure. None of the procedures, including the Ozaki procedure for aortic valve disease(s), has significant effects on hemodynamic parameters and the frequent death rate of children after surgeries. Based on our analysis, we may suggest the Ozaki procedure for aortic valve disease surgery in children.

Aortic valve neocuspidization, initially described by Ozaki and colleagues, has become an increasingly popular treatment approach for aortic valve disease in both adult and paediatric populations. We report a case of an 18-year-old man with severe aortic regurgitation who underwent the Ozaki procedure using photo-oxidized bovine pericardium. Around 5 weeks after the surgery, he developed early symptomatic valve failure due to multiple leaflet tears requiring urgent reoperation.

UNASSIGNED: In 2014, Ozaki et al. introduced the neo-cuspidation (Ozaki procedure), a new valve from the pericardium, to reduce or even prevent the risk of chronic autoimmune inflammation and subsequent rejection or valve degeneration. Thus, the authors aimed to assess the safety and efficacy of the Ozaki technique in treating aortic valve diseases.
UNASSIGNED: A comprehensive search was performed via PubMed, the Cochrane Library, Scopus, and the Web of Science up to 20 February 2022. Random-effects meta-analysis models were employed to estimate the pooled mean and SD or event to the total of the Ozaki procedure. Relevant records were retrieved and analyzed by OpenMeta analyst software.
UNASSIGNED: A total of 2863 patients from 21 studies were finally included in our analysis. Ac. Ozaki technique showed statistical significance in terms of mean cardiopulmonary bypass time of 148 mins (95% CI 144-152.2, P<0.001), mean aortic cross-clamp time of 112.46 mins (95% CI 105.116, 119.823, P<0.001), reoperation with a low risk of 0.011 (95% CI 0.005, 0.016, P=0.047), conversion to aortic valve replacement with a low risk of 0.004 (95% CI -0.001, 0.008, P=0.392), finally ICU stay (days) and hospital length of stay (days) with a mean of 2.061 days (95% CI 1.535, 2.587, P<0.001) and 8.159 days (95% CI 7.183-9.855, P<0.001), respectively.
UNASSIGNED: The Ozaki procedure provides a safe surgical technique with low mean cardiopulmonary bypass time and aortic cross-clamp time; moreover, a mean of 2-day-postoperative hospital stay was observed with the Ozaki procedure with a low risk of conversion to aortic valve replacement, reoperation, ICU and hospital stay, and death.

Aortic valve (AV) replacement is the gold standard treatment for severe symptomatic AV disease. Recently, AV reconstruction surgery (Ozaki procedure) emerges as a surgical alternative with good results in the medium term.
We retrospectively analyzed 37 patients who underwent AV reconstruction surgery between January 2018 and June 2020 in a national reference center in Lima, Peru. The median age was 62 years, interquartile range (IQR: 42-68). The main indication for surgery was AV stenosis (62.2%), in most cases due to bicuspid valve (19 patients, 51.4%). Twenty-two (59.4%) patients had another pathology with surgical indication associated to AV disease, 8 (21.6%) had dilatation of the ascending aorta with indication for replacement.
One in-hospital death occurred (1/38, 2.7%) due to perioperative myocardial infarction. There was a significant reduction in the medians of the peak (70 mmHg, CI 95% = 50.03-79.86 vs. 14 mmHg, CI 95% = 11.93-17.5, p < 0.0001) and mean (45.5 mmHg CI 95% = 30.6-49.68 vs. 7 mmHg, CI 95% = 5.93-9.6, p < 0.0001) AV gradients when we compared baseline characteristics with first 30-days results. In an average of 19 (± 8.9) months of follow-up, survival, reoperation-free survival for valve dysfunction, and survival free of AV insufficiency ≥ II were 97.3%, 100% and 91.9%, respectively. Significant reduction in the medians of the peak and mean AV gradients was maintained.
AV reconstruction surgery showed optimal results in term of mortality, reoperation-free survival, and hemodynamic characteristics of the neo-AV.
El reemplazo de la válvula aórtica es el tratamiento de elección para la valvulopatía aórtica severa sintomática. Recientemente, la cirugía de reconstrucción valvular aórtica (procedimiento de Ozaki) emerge como una alternativa quirúrgica con buenos resultados a mediano plazo.
Analizamos retrospectivamente 37 pacientes intervenidos de reconstrucción de válvula aórtica entre enero de 2018 y junio de 2020 en un centro de referencia nacional en Lima, Perú. La mediana de edad fue de 62 años (rango intercuartílico: 42-68). La estenosis de la válvula fue la principal indicación de cirugía (62.2%), en la mayoría de los casos por válvula bicúspide (19 pacientes, 51.4%). 22 (59.4%) pacientes presentaban otra patología con indicación de cirugía, 8 (21.6%) presentaban dilatación de la aorta ascendente con indicación de reemplazo.
La mortalidad intrahospitalaria fue de 1/38, 2.7%, por infarto de miocardio perioperatorio. Hubo una reducción significativa en las medianas del gradiente máximo (70 mmHg, IC 95% = 50.03-79.86 vs. 14 mmHg, IC 95% = 11.93-17.5, p < 0.0001) y gradiente medio (45.5 mmHg IC 95% = 30.6-49.68 vs. 7 mmHg, IC 95% = 5.93-9.6, p < 0.0001) de la válvula aórtica cuando comparamos las características basales con los resultados de los primeros 30 días. En una media de 19 (± 8.9) meses de seguimiento la sobrevida fue del 97.3%; la sobrevida libre de reoperación por disfunción valvular, 100% y la sobrevida libre de insuficiencia aórtica ≥ II, 91.9%, respectivamente. Se mantuvo una reducción significativa en las medianas de los gradientes máximo y medio de la válvula aórtica.
La cirugía de reconstrucción de válvula aórtica con pericardio autólogo mostró resultados óptimos en términos de mortalidad, supervivencia libre de reoperación y características hemodinámicas de la neo-válvula.

UNASSIGNED: Bioprosthetic valve deterioration remains a major limitation following aortic valve replacement. Favorable results have been reported with an autologous pericardium aortic valve neocuspidization.
UNASSIGNED: Seventy patients (31 women and 39 men) (mean age, 62 ± 12 years) with aortic stenosis (n = 52 [74%]) or aortic regurgitation (n = 18 [26%]) underwent the aortic valve neocuspidization procedure. Thirty-four patients (49%) had a tricuspid valve, 35 (50%) had a bicuspid valve, and 1 (1%) had a monocuspid valve. European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons scores were, respectively, 2.2% ± 2% and 2.0% ± 1.8%. Four patients (6%) had active endocarditis and 2 (3%) had endocarditis sequelae. One patient (1%) had fibroelastoma. A combined procedure was performed in 33 patients (46%).
UNASSIGNED: The follow-up period was 24 ± 12 months. One patient (1%) died in hospital and 1 patient (1%) underwent conventional valve replacement for significant aortic regurgitation. Postoperative peak and mean pressure gradients were respectively 14 ± 5 and 8 ± 3 mm Hg. Aortic valve area was 2.5 ± 0.6 cm2. During follow-up, no patients died. Reintervention occurred in 2 patients (3%). At last follow-up, peak pressure gradient was 13 ± 7 mm Hg, mean pressure gradient was 7 ± 4 mm Hg, and aortic valve area was 2.3 ± 0.7 cm2. There was 1 recurrence of moderate aortic stenosis (1%). All patients were in New York Heart Association functional class I (90%) or II (10%). Freedom from major valve-related events was 92.1%, (98.5% for death, 95.2% for reintervention, and 95.2% for endocarditis).
UNASSIGNED: In our experience, the midterm outcomes of the aortic valve neocuspidization procedure with autologous glutaraldehyde fixed pericardium were acceptable for survival, operative risk and valve-related complications, for our all-comer patient population with various aortic valve diseases.

A 56-year-old man with a history of left nephrectomy for Wilms\' tumor on chronic hemodialysis underwent aortic valve neocuspidization using autologous pericardium (Ozaki procedure) for aortic stenosis (AS) due to a bicuspid aortic valve 6 years ago. The AS gradually progressed and a decrease in the left ventricular ejection fraction was observed. Because of this, we decided to perform reoperative aortic valve replacement using a mechanical valve. Intraoperative findings showed severe calcification at the site where the autologous pericardium was sutured to the annulus. However, the degeneration of the valve leaflets themselves was mild. While excellent mid-term results have been reported for the Ozaki procedure, the long-term results are still unclear. In this case, the annulus was severely calcified, which reduced the mobility of the leaflet. We report the first case of AS progression requiring reoperation in the long-term period after the Ozaki procedure.

BACKGROUND: The Ozaki procedure is an innovative surgical technique aiming at reconstructing aortic valves with human autologous pericardium. Even if this procedure is widely used, a comprehensive biological characterization of the glutaraldehyde (GA)-fixed pericardial tissue is still missing.
METHODS: Morphological analysis was performed to assess the general organization of pericardium subjected to the Ozaki procedure (post-Ozaki) in comparison to native tissue (pre-Ozaki). The effect of GA treatment on cell viability and nuclear morphology was then investigated in whole biopsies and a cytotoxicity assay was executed to assess the biocompatibility of pericardium. Finally, human umbilical vein endothelial cells were seeded on post-Ozaki samples to evaluate the influence of GA in modulating the endothelialization ability in vitro and the production of pro-inflammatory mediators.
RESULTS: The Ozaki procedure alters the arrangement of collagen and elastic fibers in the extracellular matrix and results in a significant reduction in cell viability compared to native tissue. GA treatment, however, is not cytotoxic to murine fibroblasts as compared to a commercially available bovine pericardium membrane. In addition, in in vitro experiments of endothelial cell adhesion, no difference in the inflammatory mediators with respect to the commercial patch was found.
CONCLUSIONS: The Ozaki procedure, despite alteration of ECM organization and cell devitalization, allows for the establishment of a noncytotoxic environment in which endothelial cell repopulation occurs.