Outcomes post Ozaki procedure among children with aortic valve disease at Jakaya Kikwete Cardiac Institute, Dar es Salaam, Tanzania: a retrospective descriptive study.

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. CONCLUSION: 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.

Outcomes Following Use of Bovine Pericardium (Xenoprosthetic) Grafts for Reconstruction of Mycotic Aortic Aneurysms and Infected Aortic Grafts: A Systematic Review and Meta-Analysis.

BACKGROUND: Infected aortic grafts and mycotic aneurysms represent one of the most complex challenges faced by vascular surgeons. Treatment has progressed from extra-anatomical bypass to in situ reconstruction. Additionally, bovine pericardium reconstruction (BPR) has increased, due to accessibility and reduced lower limb morbidity. There remains, however, limited evidence for its use. The aim is to pool all known data to understand outcomes following BPR of mycotic aneurysms or infected vascular grafts. METHODS: A systematic review was conducted in November 2021 with subsequent computerized meta-analysis of the pooled results and a final search in March 2022. Three databases, Excerpta Medica dataBASE (EMBASE), Cumulative Index of Nursing and Allied Health Literature (CINAHL), and National Institutes of Health PubMed (PubMed), were searched for the search term "(bovine OR xenoprosthetic) AND (aneurysm)", according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: From 9 studies, there were 133 patients: 67% graft infections and 33% mycotic aneurysms. Fifty-seven percent of reconstructions were in the abdominal aorta and 33% were in the thoracic aorta. One hundred fifty-eight pathogens were identified, including Staphylococcus aureus (23%), Candida albicans (13%), and Escherichia coli (13%). In 12%, no microorganisms were identified. Thirty-day mortality was 19.14% (CI 10.83-28.71), late mortality was 19.08% (confidence interval [CI] 7.76-32.83), and overall mortality was 40.20% (CI 29.82-50.97). One patient died intraoperatively. There were a total of 151 in-hospital complications after 30 days postoperation. Common complications were acute renal failure (17%), pneumonia (14%), delirium (12%), respiratory insufficiency (11%) and renal insufficiency (7%). Lower limb ischemia was low, occurring in 5.66% (CI 0.54-13.82) of patients. Loss of graft patency leading to reintervention occurred in 1.20% (CI 0.00-7.71) of the grafts. Reinfection rate was 0.00% (CI 0.00-1.21). CONCLUSIONS: This meta-analysis highlights low reinfection and high graft patency using BPR with medium-length follow-up; however, there remain limited long-term and comparative data regarding options for aortic reconstruction. As expected in this complex cohort, the complication rate and 30-day mortality remain high.

Predictors of Mid-Term AVNeo Insufficiency.

INTRODUCTION: Aortic stenosis (AS) is the most common valvular heart disease and the most common indication for aortic valve replacement in adults. Aortic valve neocuspidization (AVNeo) with fixed autologous pericardium, also known as the Ozaki procedure, is a possible alternative treatment of AS. Autopericardial valves save the dynamics and physiological anatomy of the aortic root, however, the service life of autopericardial leaflets is limited. There is no data about factors that may influence the development of AVNeo insufficiency. Here, we assessed the effect of autopericardial leaflet symmetry on the development of aortic insufficiency after Ozaki procedure. METHODS: This study included 381 patients with AS who underwent Ozaki procedure. Patients were divided into group 1 (171 patients with symmetric aortic root) and group 2 (210 patients with asymmetric aortic root). RESULTS: The maximum observation period was up to 65 months. Sixteen cases of aortic insufficiency were detected in group 1, and 33 cases were detected in group 2. Based on the results of Cox regression, the predictors of aortic insufficiency in the late postoperative period are age and asymmetry of neocusps. According to results of Kaplan-Meier analysis, insufficiency of AVNeo in the maximum follow-up period after surgical correction of AS for group 1 patients was significantly lower than for group 2 patients (P=0.006). CONCLUSION: Asymmetric neocusps increase the risk of aortic insufficiency in the mid-term period after Ozaki procedure. And the older the patients at the time of surgery, the less likely they develop AVNeo insufficiency.

Safety, Effectiveness, and Hemodynamic Performance of the Bovine Pericardium Organic Valvular Bioprosthesis.

OBJECTIVE: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). METHODS: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. RESULTS: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. CONCLUSION: According to this analysis, BVP meets world standards for safety and clinical efficacy.

Mechanical failure analysis of patch materials used in aortic arch reconstruction: implications for clinical practice.

OBJECTIVES: Thick-patch pulmonary homograft, autologous pericardium and CardioCel Neo are common patch materials for aortic arch reconstruction. Insufficient data exist on sutured patch strength and limits of use. We evaluated failure strength of these materials to develop a failure prediction model for clinical guidance. METHODS: Patch failure strength was evaluated via sutured uniaxial and burst pressure testing. In sutured uniaxial testing, patches were sutured to aortic or Dacron tabs and pulled to failure. In burst pressure testing, patches were sewn into porcine aortas or Dacron grafts and pressurized to failure. Failure membrane tension was calculated. A prediction model of membrane tension versus vessel diameter was generated to guide clinical patch selection. RESULTS: Combining sutured uniaxial and burst pressure test data, pulmonary homograft failure strength {0.61 [interquartile range (IQR): 0.44, 0.78] N/mm, n = 21} was less than half that of autologous pericardium [2.22 (IQR: 1.65, 2.78) N/mm, n = 15] and CardioCel Neo [1.31 (IQR: 1.20, 1.42) N/mm, n = 20]. Pulmonary homograft burst pressure [245 (IQR: 202, 343) mmHg, n = 7] was significantly lower than autologous pericardium [863 (IQR: 802, 919) mmHg, n = 6] and CardioCel Neo [766 (IQR: 721, 833) mmHg, n = 6]. Our model predicts failure limits for each patch material and outlines safety margins for combinations of aortic diameter and pressure. CONCLUSIONS: Sutured failure strength of thick-patch pulmonary homograft was significantly lower than autologous pericardium and CardioCel Neo. Patient selection (predicted postoperative arch diameter and haemodynamics) and blood pressure management must be considered when choosing patch material for arch reconstruction. In older children and adolescents, autologous or bovine pericardium may be more suitable materials for aortic patch augmentation to minimize the risk of postoperative patch failure.

Ozaki Procedure Plus Aortic Annular Enlargement in an Extremely Narrow Aortic Annulus: A Surgical Challenge.

We report a 19-year-old woman with a history of percutaneous aortic valve (AV) balloon valvuloplasty 3 years ago. She was admitted with severe symptomatic AV stenosis with narrow aortic annulus. We decided to perform AV reconstruction with autologous pericardium. However, surgical findings revealed a very narrow AV annulus with a unicuspid valve; therefore, an AV enlargement was added.

A New Technique for De Novo Tricuspid Valve Construction Using Autologous Pericardium.

Treatment of tricuspid valve endocarditis remains an unsolved problem. When the native valve is unsalvageable, implanting a prosthetic valve becomes a problem of its own. This is a case of de novo tricuspid valve construction using autologous pericardium after prosthetic tricuspid valve reinfection.

Outcomes of vein reconstruction using bovine pericardial patch.

BACKGROUND: The bovine pericardium is a good alternative material to the autogenous vein in vascular reconstruction. This study aimed to evaluate the results of angioplasty in venous reconstruction using bovine pericardium and identify the risk factors for significant complications. MATERIAL AND METHODS: A retrospective review was performed of the demographic data, clinical characteristics, and complications of patients who underwent vessel repair using bovine pericardium between February 2012 and December 2020. Univariate analysis was used to compare complication frequencies within several categories. RESULTS: There were 36 cases of patch angioplasty using bovine pericardium. The median age was 65 years; 61% of them were men. Of the 36 venous repairs, 31 (86.1%) were from cancer surgery and five (13.9%) were from iatrogenic injury. Patch shape was used in 27 cases (75.0%), while tube shape was used in nine cases (25.0%). The incidence of occlusion and partial thrombus was five (13.9%) and three (8.3%) cases, respectively. Of the nine tube-shaped angioplasties, four (44.4%) required reoperation due to early thrombosis (three cases) and hematoma (one case). CONCLUSION: The use of a bovine pericardial patch in the reconstruction of a damaged vein from tumor invasion or iatrogenic injury is feasible. However, the complication rate of vessel patency remains substantial, especially in cases of iatrogenic injury or when a tube-shaped form is used for repair.

Pulmonary Valve Reconstruction Using Autologous Pericardium: A Promising Technique to Consider.

Pulmonary valve (PV) surgical treatment is uncommon in adults; however, when it is indicated, replacement with a prosthesis is suggested. Nevertheless, mechanical prostheses have an inherent risk of complications derived from anticoagulation and thrombosis, and biologic prostheses do not have adequate long-term durability. In this context, PV reconstruction surgery emerges as an alternative, avoiding anticoagulation and promising good durability. We present our experience with this procedure in 3 patients with severe PV insufficiency and 1 patient with severe PV stenosis.

Partial Tracheal Defects Closure using Glutaraldehyde-Treated Autologous Pericardium.

BACKGROUND: The usefulness of autologous pericardium treated with glutaraldehyde (GA) for tracheal defect closure is unknown. This study preliminarily evaluated whether a GA-treated autologous pericardial graft can effectively close tracheal defects in a beagle model. METHODS: Defects of 10 mm × 10 mm were created on the trachea of 10 beagles and divided into a GA-treated group (n = 5), with tracheal reconstruction using GA-treated pericardium, and control group (n = 5), using fresh pericardium. Repair sites were evaluated through bronchoscopy and histology. Blood flows on graft were measured using laser Doppler technique on postoperative days (PODs) 0, 4, 7, 14, 28, and 56. Repair sites were histologically evaluated on POD 56. In addition, GA-treated pericardia of three other beagles were histologically evaluated 12 months postoperatively, for long-term follow-up. RESULTS: All animals survived; none developed anastomotic insufficiency. The mean suturing time and frequency of additional suture were significantly shorter and lower in the GA-treated group than in the control group (p = 0.002, 0.004). All animals in the control group exhibited graft contraction, whereas the GA-treated group healed with most graft residual and reepithelialization in the bronchoscopic and histological findings (p = 0.01, 0.004). Further, all long-term GA-treated pericardia of three beagles were confirmed as residual grafts with reepithelialization, without contraction, at 12 months postoperatively. Blood flows on graft using laser Doppler technique in the GA-treated group were detected at POD 14 or thereafter. CONCLUSION: GA-treated pericardium was easier to handle and provided favorable scaffolding, without graft contraction, compared with the nontreated pericardium at short- and long-term follow-up.

"Y" incision and rectangular patch enlargement of aortic annulus and valve reconstruction with autologous pericardium in congenital aortic stenosis.

Surgical aortic valve replacement in children who have undergone prior balloon or surgical valvuloplasty or both is a formidable challenge. The aortic annulus is small, there is no ideal prosthesis and lifelong anticoagulation is highly undesirable. A "Y" incision and rectangular patch enlargement of the aortic annulus introduced by Dr. Bo Yang in 2020 combined with aortic valve reconstruction introduced by Dr. Shigeyuki Ozaki in 2011, is feasible, as described in this case.

[Midterm Outcomes of Pulmonary Valve Leaflet Augmentation using Fresh Autologous Pericardium for Transannular Patch Repair of Tetralogy of Fallot].

BACKGROUND: Although valve sparing (VS) for patients with smaller pulmonary valves has been increasing, transannular patch repair( TAP) accounts for more than half of the total tetralogy of Fallot corrections worldwide. We use fresh autologous pericardial patches to perform a modified TAP procedure with pulmonary valve leaflet augmentation as proposed by Sung et al. We aimed to explore the early and midterm outcomes of this procedure. METHODS: We retrospectively reviewed 37 patients( group TAP:12;group VS:25) who underwent total tetralogy of Fallot corrections from April 2018 to December 2021. RESULTS: No midterm mortality was observed at a median observation period of 20.4 months in both groups. The midterm rates of freedom from moderate or more pulmonary regurgitation( PR) were 64.2 % and 21.4% in group TAP and 100% and 100% in group VS at 1 and 3 years, respectively( p<0.001). The midterm rates of freedom from pulmonary stenosis reintervention were 100% and 100% in group TAP and 96% and 96% in group VS at 1 and 3 years, respectively( p=0.51). CONCLUSIONS: TAP showed acceptable midterm survival and reintervention rate. Longer follow-up is essential considering the significantly higher PR in the postoperative period in group TAP.

Aortic valve neocuspidization using autologous versus bovine pericardium: Ozaki versus Batista.

BACKGROUND: The average living age of the population is constantly increasing and so is the incidence and prevalence of aortic valve disease. Surgical aortic valve replacement (SAVR) is the current gold standard treatment. Nevertheless, the use of prosthetic valves in SAVR is associated with issues that impact patients' quality of life. Aortic valve neocuspidization (AV Neo) offers a means to solve this dilemma by minimizing foreign valve tissue. AV Neo can either be performed using glutaraldehyde-treated autologous pericardium (Ozaki procedure) or bovine pericardium (Batista procedure). AIMS: This commentary aims to discuss the recent study by Chan and colleagues which highlighted the surgical approach, clinical outcomes, and limitations of the Ozaki procedure, and compare this to the Batista procedure. METHODS: A comprehensive literature search was performed using multiple electronic databases including PubMed, Ovid, Embase, and Scopus to collate the relevant research evidence. RESULTS: Although the Ozaki procedure can achieve favorable results whilst mainly avoiding the need for life-long oral anticoagulation with mechanical valves, it still has several limitations that may hinder results. AV Neo using glutaraldehyde-treated bovine pericardium, developed by pioneer cardiac surgeon Dr. Randas J. Vilela Batista, yields superior clinical outcomes to Ozaki's, including excellent survival, lower complications, and minimal need for reoperation as well as shorter operative times. CONCLUSION: AV Neo offers a means to perform SAVR whilst escaping the prosthetic valve issues. However, the Batista procedure has shown beyond doubt that it can be considered the superior approach for AV Neo over the Ozaki procedure.

Aortic valve neocuspidization using autologous pericardium compared to surgical aortic valve replacement.

INTRODUCTION: Aortic valve neocuspidization (AVNeo) for trileaflet aortic valve reconstruction using autologous pericardium (Ozaki procedure) depicts an encouraging new technique for the surgical treatment of aortic valve pathologies. The current study analyzes the early hemodynamic outcome of AVneo compared with surgical aortic valve replacement (SAVR) using the Abbott/St. Jude Trifecta aortic valve biological prostheses. METHODS: All patients who underwent either AVNeo or SAVR between March 2017 and April 2020 were included. Exclusion criteria were emergency cases, endocarditis, redo- or additional root procedures. Main endpoints were differences between the two groups in terms of the effective orifice area (EOA) and the effective orifice area index (EOAI) at discharge. RESULTS: During the study period, 105 AVNeo patients and 458 SAVR patients met the inclusion criteria. EOA was significantly higher in the AVNeo group (2.4 cm2 ± 0.8 vs. 2.1 cm2 /m2 ± 0.6 in the SAVR group, respectively; p < .001). Multiple regression analysis, including AVNeo, annulus size, bicuspid valve, preoperative stenosis, left ventricular ejection fraction (LVEF), and diastolic diameter (LVEDD) found two factors, which favor larger EOA: Annulus size (p < .0001) and AVneo (p = .005). EOAI was significantly higher in the AVNeo group (1.23 ± 0.4 vs. 1.02 cm2 /m2 ± 0.3, respectively; p < .001). Multiple regression analysis for EOAI showed effects for AVneo (p = .005) and bicuspid valve (p = .029). Mean pressure gradients (MPG) were lower in the AVNeo group than in the SAVR group (AVNeo: MPG = 8.0 mmHg ± 3.6 vs. SAVR: MPG = 8.3 mmHg ± 3.6), but this finding did not reach statistical significance (p = .091). CONCLUSIONS: AVNeo shows significantly larger EOA and EOAI compared to SAVR using the Abbott/St. Jude Trifecta aortic valve biological prostheses.

Long-term outcome of extensive mitral valve reconstruction with autologous pericardium and artificial chordae for treatment of destructive active infective endocarditis of the mitral valve.

OBJECTIVE: Mitral valve (MV) repair is a well-accepted surgical approach for infective endocarditis (IE). In our hospital, extensive MV reconstruction with fresh autologous pericardium (AP) and artificial chordae (AC) has been performed for patients with profoundly extensive and destructive IE in which valve reconstruction would be extremely challenging, especially in young patients to avoid mechanical valve replacement. Long-term outcome including the future performance of the newly created leaflet has not been established. METHODS: Five patients (54 (38-60) years of age; 3 men, 2 women) underwent this procedure from January 2011 to April 2022. In all patients, preoperative cardiac function was good (left ventricular ejection fraction, 69 (66-75)). After complete debridement of the infective valve tissue, the MV was reconstructed with large, fresh, trimmed AP and AC. RESULTS: The reconstructed leaflets were anterior in three patients and posterior in four, and AC were placed in four patients. All patients showed an uneventful postoperative course and were discharged to home 36 (28-42) days postoperatively after completion of intravenous antibiotic therapy. Pre-discharge echocardiography revealed no or trivial mitral regurgitation (MR) in all patients. The median follow-up period was 9.6 (6.0-10.4) years, and no patients developed recurrence of the IE. The latest echocardiography in four patients showed trivial/mild MR with good leaflet function. One patient developed recurrence of MR, 5 months postoperatively. CONCLUSIONS: The short- and long-term outcomes of this procedure might be acceptable. This procedure might be considered as an effective and valuable option, especially in young patients.

Pediatric aortic valve neocuspidization.

Treatment of pediatric aortic valve disease is controversial. In this regard, interest is growing in the neocuspidization of the aortic valve according to Ozaki. In this video tutorial, we illustrate briefly the entire reconstruction technique of a neoaortic valve with pretreated autologous pericardium used in our institution in pediatric patients by describing a case of an incompetent native tricuspid aortic valve.

Standardized Aortic Valve Neocuspidization for Treatment of Aortic Valve Diseases.

BACKGROUND: Aortic valve replacement is the traditional surgical treatment for aortic valve diseases, yet standardized aortic valve neocuspidization (AVNeo) is a promising alternative that is gaining popularity. The purpose of this article is to review the available published literature of AVNeo using glutaraldehyde-treated autologous pericardium, also known as the Ozaki procedure, including indications, outcomes, potential benefits, and modes of failure for the reconstructed valve. METHODS: A comprehensive literature search was performed using keywords related to aortic valve repair, AVNeo, or Ozaki procedure. All articles describing performance of AVNeo were reviewed. RESULTS: Reported early mortality after AVNeo varies from 0% to 5.88%. The largest cohort of patients in the literature includes 850 patients with an inhospital mortality rate of 1.88%. Cumulative incidence of aortic valve reoperation was 4.2% in the largest series. Reoperation was uncommon and mainly due to infective endocarditis or degeneration of the reconstructed valve (most commonly due to aortic valve regurgitation, rather than stenosis). CONCLUSIONS: Aortic valve neocuspidization is a versatile and standardized alternative to aortic valve replacement with a biological prosthesis. Early to midterm outcomes from a number of centers are excellent and demonstrate the safety and durability of the procedure. Long-term outcomes and clinical trial data are necessary to determine which patients benefit the most from this procedure.

Long-term performance of untreated fresh autologous pericardium as a valve substitute in pulmonary position.

Background: Pulmonary regurgitation is imminent after transannular patch (TAP). We analyze the long-term performance of untreated autologous pericardium (UAP) as valve substitute at pulmonary position in patients requiring TAP. Material and Methods: This cross-sectional study include patients operated between 2007 and 2012 (n = 92). A sample of 19 patients was selected for this study which had a follow-up of more than 3 years. This includes patients with no TAP (n = 4) and with TAP and valve substitute, a monocusp (n = 11) or a tricuspid valve (n = 4) at neopulmonary annulus. Patients underwent echocardiography for assessment of right ventricle function and 18 fluoro-deoxyglucose PET CT scan for measurements of valve substitute at neopulmonary annulus. The target to blood ratio (TBR) of uptake of glucose by monocusp was measured at the cooptation edge of the neopulmonary valve. Results: The median age of the patients is 14 (9 - 37). RV function is preserved (TAPSE 18.9 (10.6 - 22.8)) at a mean follow-up of 4 years (3-9). The measurements of monocusp shows a shrinkage in height of the cusp by 35.5% (70% - 1.0%) and length by 7% (-44% - +104%). There was less shrinkage observed in patients below 15 years of age. The TBR of monocusp was 0.945 (0.17 - 3.35) with a strong correlation between the TBR values of aortic valve leaflet and monocusp leaflet of same patient. Conclusion: The UAP is functional and successful as a valve substitute at neo pulmonary annulus at long-term follow-up. It has resisted calcification and has shown uptake of glucose in physiological limits.