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We developed a handmade expanded polytetrafluoroethylene (ePTFE) pulmonary valvular conduit (PVC) with bulging sinuses and a fan-shaped ePTFE valve for right ventricular outflow tract (RVOT) reconstruction. We aimed to investigate the results of this device in this multicenter study. From 2001 to 2020, 1776 patients underwent RVOT reconstruction using ePTFE PVCs at 65 institutions in Japan. The median age and body weight were 4.1 years (range, 3 days to 67.1 years) and 13.3 (range, 1.8-91.3) kg, respectively. The median PVC size was 18 (range, 8-24) mm. The median Z-value of the ePTFE PVC was 1.1 (range, -3.8 to 5.0). The ePTFE PVC conditions were investigated by cardiac echocardiography and catheterization. The median follow-up period was 3.3 years (range, 0 day to 16.2 years). There were only 9 cases (0.5%) with PVC-related unknown deaths. Reintervention was performed in 283 patients (15.9%), and 190 patients (10.7%) required explantation. Freedom from reintervention and explantation at 5/10 years were 86.7/61.5% and 93.0/69.1%, respectively. At the latest echocardiography, PVC regurgitation grade was better than mild in 88.4% patients. The average peak RVOT gradient was 15.7 ± 15.9 mm Hg at the latest cardiac catheterization. ePTFE PVC infection was detected in only 8 patients (0.5%). Relative stenosis due to somatic growth was the most common cause of PVC explantation. The performance of ePTFE in terms of durability, valvular performance, and the resistance against infection is considerable and may replace conventional prosthetic materials. Further improvement of the ePTFE membrane is essential to prevent valvular dysfunction. [ABSTRACT FROM AUTHOR]

Objectives: We report the first use of a biorestorative valved conduit (Xeltis pulmonary valve–XPV) in children. Based on early follow-up data the valve design was modified; we report on the comparative performance of the two designs at 12 months post-implantation.Methods: Twelve children (six male) median age 5 (2 to 12) years and weight 17 (10 to 43) kg, had implantation of the first XPV valve design (XPV-1, group 1; 16 mm (n = 5), and 18 mm (n = 7). All had had previous surgery. Based on XPV performance at 12 months, the leaflet design was modified and an additional six children (five male) with complex malformations, median age 5 (3 to 9) years, and weight 21 (14 to 29) kg underwent implantation of the new XPV (XPV-2, group 2; 18 mm in all). For both subgroups, the 12 month clinical and echocardiographic outcomes were compared.Results: All patients in both groups have completed 12 months of follow-up. All are in NYHA functional class I. Seventeen of the 18 conduits have shown no evidence of progressive stenosis, dilation or aneurysm formation. Residual gradients of >40 mm Hg were observed in three patients in group 1 due to kinking of the conduit (n = 1), and peripheral stenosis of the branch pulmonary arteries (n = 2). In group 2, one patient developed rapidly progressive stenosis of the proximal conduit anastomosis, requiring conduit replacement. Five patients in group 1 developed severe pulmonary valve regurgitation (PI) due to prolapse of valve leaflet. In contrast, only one patient in group 2 developed more than mild PI at 12 months, which was not related to leaflet prolapse.Conclusions: The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being free of reintervention at 1 year. Early onset PI seen in the XPV-1 version seems to have been corrected in the XPV-2, which has led to the approval of an FDA clinical trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708.

Objective: Valved conduits play a pivotal role in the right ventricular outflow tract (RVOT) reconstruction in patients with congenital heart disease (CHD), and valved homografts have become the most commonly used conduits in pediatric cardiac surgery. This study aimed to assess the midterm performance of aortic and pulmonary homografts used in pulmonary position in patients with CHD. Methods: Ninety-eight patients underwent surgical RVOT reconstruction with a homograft from January 2012 to December 2017. We collected all patient details from the institute patient record system. Echocardiographic data were obtained from the records. Postoperative data included survival and follow-up echocardiography. The primary endpoints of the study were homograft failure, homograft dysfunction, and freedom from re-intervention. Results: We observed allograft failure in two patients (2%), one each due to pseudo-aneurysm formation and infective endocarditis. There were 8 early deaths (8/98, 8.2%) and 9 late deaths (9/98, 9.2%). The mean survival time was 6.1 years, and the postoperative survival rate at 1 and 5 years was 89.73% and 82.65%, respectively. Homograft regurgitation and homograft dysfunction were higher in the pulmonary homograft group. However, the re-intervention rates were more in the aortic homograft (24.24%) group due to the higher incidence of calcification associated with them. Conclusion: Homografts used for RVOT reconstruction provide excellent intermediate-term outcomes, irrespective of the type of homograft used. Pulmonary homografts are more durable than aortic homografts and provide satisfactory results even in infants. [ABSTRACT FROM AUTHOR]

Objective: The Ross procedure is an established option for aortic valve disease in children. Due to limited availability of pulmonary homograft, we devised a novel technique for right ventricular outflow tract (RVOT) reconstruction by preparing indigenous Dacron valved conduit. Methods: Forty consecutive cases of modified Ross procedure done at our center (2013–2018) were analyzed. Thirty-seven patients (95%) were followed up with median duration of 2.5 (0.08–5.5) years. Median age was 12 (5–39) years. Nineteen (47.5%) patients had rheumatic aortic valve disease, while 19 (47.5%) had congenital aortic valve disease. Aortic root replacement with pulmonary autograft was performed in all patients. Dacron conduit for RVOT reconstruction was used with on table sewn bileaflet valve using Dacron patch (n = 22), expanded polytetrafluoroethylene (ePTFE) membrane (n = 10), bioprosthetic valve (n = 4), and pericardium (n = 4). Additional surgical procedures included mitral valve repair (n = 10), septal myectomy (n = 2), ascending aorta replacement (n = 1), ruptured sinus of valsalva (RSOV) repair (n = 1), and ventricular septal defect (VSD) closure (n = 1). Results: There was one in-hospital mortality while one late death occurred at 3.5 years postoperatively. The neo-aortic valve regurgitation on echocardiographic evaluation at last follow-up was trivial (n = 28), mild (n = 7), and moderate (n = 2). Mild RVOT obstruction was present in 8 patients while 18 patients had mild pulmonary regurgitation. No patient required reintervention during follow-up. Conclusion: Our early results of modified Ross procedure are encouraging, however, long-term follow-up is required. [ABSTRACT FROM AUTHOR]

Abstract Objectives Bioprosthetic pulmonary valve conduits have been reported with an increased risk of endocarditis. Thrombus formation is considered as source of these serious and life-threatening infections. We reviewed a series of explanted valved pulmonary conduits for histological evidence for thrombus formation. Materials and methods Explanted bioprosthetic pulmonary valves were fixed in formalin and embedded in paraffin or in methylmethacrylate. Standard staining as well as immunohistochemical staining techniques were applied. Native pulmonary valves of German domestic pigs served as controls. Results 47 valved pulmonary conduits (Hancock n = 23, Homograft n = 7, Contegra n = 7, Melody n = 7, other n = 3) were analyzed histologically. Average time of implantation had been 63 months (6 to 342 months). Indications for explantation included significant obstruction (n = 45), regurgitation (n = 7), and/or endocarditis (n = 6). In 44/47 (93%) specimen, we found accumulation of thrombotic material at the basis of the semilunar valve sinus to a variable degree. 11 patients had been treated with antiplatelet agents, 2 had received anticoagulants at the time of explantation. There was no suspicion of thrombus formation clinically or echocardiographically prior to explantation in any of the patients. Control porcine pulmonary valves (n = 5) did not show any evidence of accumulation of thrombotic material. Conclusions In a large series of explanted valved pulmonary conduits, formation of subclinical, mostly non-infectious thrombotic material was an almost ubiquitous finding. We speculate that high incidence of endocarditis in bioprosthetic valves may in part be explained by thrombus apposition at the basis of conduit valve sinus. Highlights • Histology reveals subclinical thrombus formation in bioprosthetic valves. • Incidence of subclinical thrombus formation in bioprosthetic pulmonary valves is high. • Aspirin does prevent formation of fibrin condensations at bioprosthetic valves. [ABSTRACT FROM AUTHOR]

Background and objective Complex congenital heart diseases (CHDs), such as the tetralogy of Fallot (TOF), often warrant reconstruction and augmentation of the right ventricular outflow tract (RVOT). This procedure requires the use of both synthetic and natural materials. However, finding the ideal material for tissue implants can be challenging. Biological materials often face issues such as tissue degeneration, calcium deposition, antigenicity, rejection, shrinkage, and fibrosis. These issues can lead to complications such as stenosis and insufficiency, potentially requiring early reoperations. In light of this, this study aimed to investigate the effectiveness of the Invengenx® bovine patch for RVOT reconstruction and augmentation. Methods This was a retrospective observational study conducted among eight children who underwent TOF correction cardiac surgery. Their demographic and clinical characteristics, intraoperative findings, and postoperative follow-up results at six months were collected from the hospital patient database. Results There were no deaths or complications in this study. We observed a significant reduction in the gradient across the pulmonary valve and the outflow tract at six months post-procedure. The analysis demonstrated that the Invengenx® bovine patch was successful and did not lead to any complications. Conclusions This study demonstrates the safety and efficacy of this engineered bovine pericardial patch (Invengenx®) as a cardiovascular substitute for surgical repair of both simple and more complex congenital cardiac defects., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Bhende et al.)

Reconstruction of RVOT in patients with a congenital heart defect in various age groups still remains a controversial issue in valve disease surgery. Early identification of RVOT dysfunction, proper timing, and choosing an appropriate method of reconstruction all have an essential effect on postoperative outcomes and long-term survival of the valve replacement used. There are a number of options for RVOT reconstruction. The use of each prosthesis is associated with the development of various complications. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Allograft conduits are used for reconstruction of the right ventricular outflow tract in congenital heart malformations (biventricular repair) and autograft procedures. A retrospective evaluation of allograft reconstruction of the right-ventricular-outflow-tract reconstruction was conducted and a cross-sectional quality of life study was performed. Methods: Between August 1986 and March 2009, 509 allografts (435 pulmonary and 74 aortic) were implanted in 463 pediatric and adult patients (308 right-sided congenital heart malformations and 155 autograft procedures). Perioperative and follow-up data were collected and analyzed. Kaplan–Meier analyses were done for survival, valve-related re-operation, and valve-related events. Cox regression analysis was used for evaluation of potential risk factors. In addition, the Short Form-36 was presented to patients to assess the perceived quality of life. The results of the Short Form-36 were compared to age-adjusted Dutch population norms. Results: The mean age at allograft implantation was 19 years (1 week–66 years). Mean follow-up was 9 years (2 days–22 years). Forty-eight patients died during follow-up. Patient survival was 93% at 10 years and 88% at 15 years. A total of 63 re-operations were required for allograft dysfunction in 58 patients. Freedom from valve-related re-operation was 89% at 10 years and 81% at 15 years. Freedom from valve-related events was 86% at 10 years and 74% at 15 years. Younger patient age (p =0.007) and the use of an aortic allograft (p <0.001) were identified as independent risk factors for allograft re-operation. Patients between 14 and 40 years scored significantly lower on ‘physical functioning’ and ‘general health’ subscales than the general Dutch population, but scored better on the subscales ‘emotional role functioning’ and ‘bodily pain’. Except for the subscale ‘general health’, on which patients within our study population scored lower, patients between 41 and 60 years had comparable average scores as the general Dutch population. The older patient group (61 years or older) had a better average score on the subscale ‘bodily pain’ and similar scores on other subscales with respect to the general Dutch population. Conclusions: Right-ventricular-outflow-tract reconstruction with an allograft conduit can be performed with good patient survival, acceptable long-term allograft durability, and good perceived quality of life. [Copyright &y& Elsevier]

Objective Our institution uses a valved polytetrafluoroethylene conduit as an alternative to homografts. The objective of this study was to investigate the performance of bicuspid valved polytetrafluoroethylene conduits used for right ventricular outflow tract reconstruction in children aged less than 2 years and to evaluate risk factors for earlier conduit explant. Methods We performed an Institutional Review Board–approved retrospective chart review of all patients aged less than 2 years who underwent surgical right ventricular outflow tract reconstruction with a bicuspid valved polytetrafluoroethylene conduit or homograft conduit from July 2004 to December 2014. The end points of the study were defined as conduit explant, conduit explant or reintervention, conduit stenosis, and conduit insufficiency. Results Fifty-four patients underwent 65 right ventricular outflow tract reconstructions with a bicuspid valved polytetrafluoroethylene conduit (n = 39) or a homograft conduit (n = 26, 23 pulmonary, 3 aortic). The majority of diagnoses were truncus arteriosus (n = 28) and tetralogy of Fallot with pulmonary atresia (n = 19). Median age of patients at surgery was 134 (8-323) days and 128 (7-384) days in the PTFE and homograft groups, respectively. There was no difference in demographic data between the 2 groups. Time-to-event analysis demonstrated no difference in time to explant ( P = .474) or time to explant or reintervention ( P = .206) between the 2 conduit types. Younger age at surgery was the only independent risk factor for conduit explant (subdistribution hazard ratio 1.104 per 30 days younger, P < .001). There was no significant influence of conduit type on the development of moderate conduit stenosis ( P = .931) or severe conduit insufficiency ( P = .880). Larger conduit z score was protective for the development of moderate conduit stenosis (subdistribution hazard ratio, 0.46; P = .001). Conclusions Bicuspid valved polytetrafluoroethylene conduits are a satisfactory choice for right ventricular outflow tract reconstruction in patients aged less than 2 years. Their availability, low cost, and lack of potential sensitization make them an appealing alternative to homograft conduits. [ABSTRACT FROM AUTHOR]