Glutaraldehyde-treated Autologous Pericardium Research Articles

Precise reconstruction of the aortic valve using glutaraldehyde-treated autologous pericardium in new formula: a case report

BackgroundThe current study presents a novel and precise surgical technique for complete reconstruction of the aortic valve using glutaraldehyde-treated autologous pericardium in a patient with aortic valve disease and endocarditis. The technique aims to provide a more effective and reproducible method for aortic valve repair, with the goal of improving outcomes and quality of life for patients with aortic valve disease.Case presentationA 35-year-old Iranian male with aortic valve disease and endocarditis underwent aortic valve reconstruction surgery. Preoperative echocardiography showed a degenerative aortic valve with severe regurgitation, reduced left ventricular ejection fraction, and specific aortic root dimensions. The surgical technique involved precise measurements and calculations to design the size and shape of the new aortic valve cusps using autologous pericardium, with the goal of optimizing coaptation and function. The surgeon calculated the intercommissural distance based on the aortic annulus diameter to determine cusp size and shape. He tailored the pericardial cusps to have a height equal to 80% of the coaptation margin length. Detailed suturing techniques were used to ensure proper alignment and coaptation of the new cusps. Intraoperative evaluation of the valve function using suction and transesophageal echocardiography showed good coaptation and minimal residual regurgitation. At the 3-year follow-up, the patient had a well-functioning aortic valve with only trivial leak and was in satisfactory clinical condition.ConclusionsGlutaraldehyde-treated autologous pericardium is a validated leaflet alternative, and the causes of its failure are late annular dilatation and other technique breakdowns. Current evidence reveals that aortic valve reconstruction with glutaraldehyde-treated autologous pericardium is associated with many advantages with the potential to improve patient outcomes and quality of life. Further clinical studies are warranted to evaluate the long-term durability and efficacy of this approach.

Long-term Outcomes of Surgical Correction of Ischemic Mitral Regurgitation

Objective: To evaluate long-term outcomes of mitral valve annuloplasty using an autologous pericardial strip (“soft support ring” type) and a rigid support ring in combination with coronary artery bypass graft (CABG) in patients with ischemic mitral regurgitation.Materials and methods: We carried out retrospective and prospective analyses of the treatment outcomes in 90 patients with coronary heart disease (CHD) and ischemic mitral regurgitation. Ischemic mitral regurgitation (grade 2 or above) was an inclusion criterion for patients with CHD. Exclusion criteria were as follows: nonischemic mitral regurgitation, acute myocardial infarction, progressive angina pectoris, and repeated heart interventions. The patients were divided into 2 groups. Patients from group 1 underwent CABG with mitral regurgitation correction using a strip of glutaraldehyde-treated autologous pericardium (“soft support ring” type) according to our own method, whereas patients from group 2 underwent CABG with mitral regurgitation correction using a rigid support ring. The analysis revealed that the groups were comparable in all the studied parameters.Results: There was no statistically significant difference in the number of postoperative complications and hospital mortality between the groups. According to the analyzed data obtained at the time of discharge, all the patients had grade 0-1 mitral regurgitation, which shows a complete restoration of the mitral valve function after annuloplasty. In addition, there was a statistically significant decrease in the end-diastolic volume and an increase in ejection fraction, which is a sign of reverse left ventricular (LV) remodeling. The mean follow-up was 44±7.4 months. No deaths were reported during the follow-up. The results of the examination in the long-term period did not reveal negative dynamics in most patients compared with the findings in the early postoperative period. The LV size also did not change significantly, and the ejection fraction demonstrated an upward trend. One patient in each group had a recurrence of grade 3 mitral regurgitation.Conclusions: The immediate outcomes showed no recurrence of mitral regurgitation, a low number of intraoperative and postoperative complications, and pronounced reverse LV remodeling. We observed stable results in the long-term follow-up: only one patient in each group had a recurrence of mitral regurgitation. Reverse LV remodeling persisted throughout the follow-up. There were no significant differences between the groups in any parameter, which indicates that the developed annuloplasty method is not inferior to the traditional technique with a rigid support ring.

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

BackgroundAortic 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.MethodsThis 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.ResultsA 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.ConclusionOzaki 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.

Single center two years' experience of Ozaki procedure: Early follow-up.

The Ozaki Procedure is an innovative surgical technique aiming of aortic valve neocuspidization using glutaraldehyde-treated autologous pericardium was first developed by Ozaki et al in 2007. With this newly developed technique, valve replacement was achieved without using prosthetic material due to both aortic stenosis and aortic insufficiency. Between December 2020 and December 2022, a total of 59 patients were operated on with the Ozaki Procedure due to aortic valve pathologies in our center. We evaluated the pre- and postoperative as well as the first-month data of a total of 44 patients with isolated the Ozaki Procedure and compared their echocardiographic changes. Patients with isolated aortic valve pathology were included in the study. Fifteen patients who underwent simultaneous coronary artery bypass surgery and Ozaki Procedure were excluded from the analysis. In the first month after the operation, n:2 (%4.5) patients died. When the preoperative and postoperative 1st month echocardiographic data of the remaining patients were compared, it was found that the decrease in mean gradient, max gradient and peak velocity values in the aortic valve was statistically significant. This is due to the fact that reaching neo-valves has very similar hemodynamics to the native aortic valve. Aortic valve neocuspidization by Ozaki Procedure may be a viable alternative to both surgical aortic valve replacement (AVR) and transcatheter aortic valve implantation. Its popularity and application is increasing all over the world. Short and mid-term results are available in the literature. The short and mid-term results are good, and the long-term results are hopeful.

Use of glutaraldehyde-treated autologous pericardial patch in complete atrioventricular septal defect repair.

Synthetic patch materials, such as polytetrafluoroethylene and knitted polyester, are commonly used for the repair of complete atrioventricular septal defects using the double-patch technique. In our study, we investigated the impact of glutaraldehyde-treated autologous pericardial patch on postoperative atrioventricular valve function. In this retrospective study, patients who underwent repair of complete atrioventricular septal defects using the double-patch technique between January 1, 2018, and May 15, 2023, at our pediatric cardiac center were included in the study. Patients were divided into two groups based on the type of patch used for the repair of the ventricular component of the atrioventricular septal defect: autologous pericardial patch (group 1) and polytetrafluoroethylene patch (group 2). Postoperative data of the patients were retrospectively analyzed. Thirty-four patients (57.6%) were female, and 25 (42.4%) were male, with a median age of 7 (5-18) months. The median body weight at the time of surgery was 5.5 (4.1-10) kilograms. Down syndrome was present in 45 (76.3%) patients. The autologous pericardium was used for ventricular septal defect closure in 44 (74.6%) patients (Group 1), while polytetrafluoroethylene was used in 15 (25.4%) patients (Group 2). Permanent cardiac pacemaker placement was required in 4 (6.8%) patients due to postoperative atrioventricular block. Hospital mortality was 11.9% (n=7). Among these cases, 4 (6.8%) patients died from low cardiac output syndrome, and 3 (5.1%) patients died from sepsis. Postoperative echocardiographic evaluation revealed insignificant residual ventricular septal defects in 17 (28.8%) patients. No significant differences were observed between the groups in terms of mortality and postoperative atrioventricular valve insufficiency. The median follow-up duration for discharged patients was 5 months (7 days to 3.9 years). Throughout the follow-up period, there were no reoperations due to valve insufficiency or left ventricular outflow tract obstruction. Glutaraldehyde-treated autologous pericardium is a safe material that can be confidently used for the repair of the ventricular component of complete atrioventricular septal defects. This patch material does not adversely affect atrioventricular valve function and allows for the successful closure of ventricular septal defects.

Bicuspidization using autologous pericardium for neonatal quadricuspid truncal valve

BackgroundNeonatal truncal valve plasty remains a significant challenge. Several surgical techniques have been reported, but there is no standard procedure. We herein report a novel operative technique for the quadricuspid truncal valve with axisymmetric morphology.Case presentationA 17-day-old neonate with severe truncal valve insufficiency developed persistent congestive heart failure and underwent urgent truncal valve plasty. The truncal valve was quadricuspid with four equal sinuses, and all four cusps were hypoplastic, resulting in a complete lack of coaptation. We performed bicuspidization valvuloplasty with leaflet reconstruction using autologous pericardium for this valve. The patient had an uneventful recovery and was free from recurrent truncal valve insufficiency for 10 months.ConclusionsBicuspidization with leaflet reconstruction is a suitable surgical option for overcoming neonatal truncal valve insufficiency in cases with quadricuspid truncal valves with axisymmetric morphologies. Although the durability of a bicuspid neo-leaflet using glutaraldehyde-treated autologous pericardium is unknown, this technique is expected to postpone subsequent truncal valve replacement in such neonates.

Ozaki procedure

Background and aim Mechanical heart valves require lifelong anticoagulation and therefore predispose to hemorrhagic events. Ozaki developed their aortic valve (AV) reconstruction technique at Toho University Ohashi Medical Center, where they standardized the use of glutaraldehyde-treated autologous pericardium to perform a trileaflet aortic valve. Therefore, it achieves maximum effective orifice area (EOA) and low transvalvular gradients. The current study aimed to assess the short-term Ozaki procedure in our center. Patients and methods A total of 86 patients were enrolled in the current study; group A included 43 patients who had undergone AVR using a biological aortic valve prosthesis, and group B included 43 patients who had undergone aortic valve replacement (AVR) using the Ozaki procedure. Results Both groups had comparable findings either at baseline, perioperative data, or during the follow-up. During follow-up either in the 3rd or 6th month both groups had insignificant differences. Renal dysfunction was reported in five (11.6%) patients of the biological valve group and two patients of the Ozaki group. Endocarditis was developed in only two patients with biological valves. Mild aortic regurgitation was noticed in one patient in the 3rd month and two patients in the 6th month in the case of the Ozaki procedure, while only one patient in the biological valve group developed mild AR in the 6th month of follow-up. Nearly all patients had improved NYHA classes in both groups. No patient in the Ozaki group was converted to AVR. Conclusion We have described our initial experience with the Ozaki procedure in adults. The current study reported promising results for the Ozaki procedure. Yet, multiple future studies in multiple centers are warranted to draw a firm conclusion and support our findings.

Partial Tracheal Defects Closure using Glutaraldehyde-Treated Autologous Pericardium.

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. 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. 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. 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.

Understanding aortic valve repair through Ozaki procedure: A review of literature evidence.

Aortic valve neocuspidization (AV Neo) using glutaraldehyde-treated autologous pericardium was first reported by Ozaki et al. in 2007. This technique has become an alternative to tissue and mechanical valve in selected patients as long-term anticoagulation is not required and shows promising midterm results and durability. A comprehensive search was performed on the major database using the search terms "Ozaki technique" AND "Aortic Valve Neocuspidization" AND "AV Neocuspidization" AND "Autologous pericardium" AND "glutaraldehyde-treated autologous pericardium."Articles up to August 1st, 2021 were included in this study. A total of nine studies with a total of 1342 patients were included. The mean age was 67.36 and 54.23% were male. 66.32% and 23.92% of patients had aortic stenosis and aortic regurgitation, respectively. 66% of patients had a native tricuspid aortic valve (AV) and 31.37% ofpatients' native AV was bicuspid. Three studies reported their experience performing AV Neo via ministernotomy. AV Neo can be a suitable alternative to surgical AV replacement in selected patients. The short- and midterm outcomes are comparable without the need for long-term oral anticoagulation. Long-term follow-up data are required for this novel approach to be widely adopted.

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

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). 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. A comprehensive literature search was performed using multiple electronic databases including PubMed, Ovid, Embase, and Scopus to collate the relevant research evidence. 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. 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 with glutaraldehyde-treated autologous pericardium to avoid the prosthesis-patient mismatch of a severely obese 57-year-old patient—a case report

Video 1 Aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium in a severely obese non-elderly patient: a way to avoid the prosthesis-patient mismatch.

A single-centre, retrospective study of mid-term outcomes of aortic arch repair using a standardized resection and patch augmentation technique.

OBJECTIVESThe aim of this study was to evaluate the mid-term outcomes after the repair of aortic arch using a standard patch augmentation technique.METHODSThe study included all patients who underwent repair of a hypoplastic/interrupted aortic arch (IAA) in a single institute from June 2012 to December 2019 by a standardized patch augmentation (irrespective of concomitant intra-cardiac lesions). End points evaluated were reintervention for arch obstruction and persistent/new-onset hypertension.RESULTSThe study included 149 patients [hypoplastic aortic arch, n = 92 (62%), IAA, n = 9 (6%), Norwood procedure, n = 48 (32%)]. The patch material used for augmentation of the aortic arch included pulmonary homograft (n = 120, 81%), homograft pericardium (n = 18, 12%), CardioCel® (n = 9, 6%) and glutaraldehyde-treated autologous pericardium (n = 2, 1%). The median age and weight at surgery were 7 days [interquartile range (IQR) 5–17 days] and 3.5 kg (IQR 3–3.9 kg), respectively. The median follow-up was 3.27 years (IQR 1.28, 5.08), range (0.02, 8.76). Freedom from reintervention at 1, 3 and 5 years was 95% [95% confidence interval (CI) = 89%, 98%], 93% (95% CI = 86%, 96%) and 93% (95% CI = 86%, 96%) respectively. One patient (0.6%) had persistent hypertension 8 years after correction for interrupted arch with truncus arteriosus.CONCLUSIONSRepair of hypoplastic/IAA by transection and excision of all ductal tissue and standardized patch augmentation provide good mid-term durability. The freedom from reintervention at 5 years is >90%. The incidence of persistent systemic hypertension following arch reconstruction is low. The technique is reproducible and applicable irrespective of underlying arch anatomy.

Reconstruction in left main coronary artery atresia with bypass graft obstruction.

Paediatric coronary artery bypass surgery with internal thoracic artery grafting is the optimal choice for left main coronary artery atresia; we report successful reconstruction in a patient with bypass graft obstruction. The pulmonary trunk was transected to expose the left main coronary stem, which was opened beyond the obstruction and the incision extended through the left main coronary artery to the circumflex bifurcation and left anterior descending artery. A funnel-shaped coronary ostium was created with a glutaraldehyde-treated autologous pericardium onlay patch. Surgical reconstruction is a good alternative for left main coronary artery atresia with graft obstruction and preserves the remaining internal thoracic artery for future use.

Corrigendum to: 1292 Aortic Valve Neocuspidization Using Glutaraldehyde-Treated Autologous Pericardium: A Literature Review.

Corrigendum to: 1292 Aortic Valve Neocuspidization Using Glutaraldehyde-Treated Autologous Pericardium: A Literature Review.

Aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium in a severely obese non-elderly patient: a way to avoid the prosthesis-patient mismatch.

Aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium in a severely obese non-elderly patient: a way to avoid the prosthesis-patient mismatch.

1292 Aortic Valve Neocuspidization Using Glutaraldehyde-Treated Autologous Pericardium: A Literature Review

Abstract Background Aortic Valve Neocuspidization using glutaraldehyde-treated autologous pericardium was first performed by Ozaki et al. in 2007. This technique has become an alternative to tissue and mechanical valve as long-term anticoagulation is not required and shows promising midterm results and durability. Method A comprehensive search was performed on the major database using search terms “Ozaki technique” AND “Aortic Valve Neocuspidization” AND “AV Neocuspidization” AND “Autologous pericardium” AND “glutaraldehyde-treated autologous pericardium”. Articles up to 1st of August 2020 were included in this study. Results A total of 9 studies with a total of 1342 patients were included. The mean age was 67.36 and 54.23% were male. 66.32% and 23.92% of patients had aortic stenosis and aortic regurgitation, respectively. 66% of patients had a native tricuspid aortic valve and 31.37 % patients’ native aortic valve was bicuspid. Three studies reported their experience performing Aortic Valve Neocuspidization via mini sternotomy. Conclusions Aortic Valve Neocuspidization is an alternative to biological and mechanical prostheses for surgical aortic valve replacement. The short and mid-term outcome are comparable without the need for long term oral anticoagulation. Long term follow-up data is required for this novel approach to be widely adopted.

Single leaflet reconstruction in paediatric aortic regurgitation using the Ozaki procedure

Aortic valve repair in children is still a challenge. The aim of this study was to analyse the surgical results of children with aortic regurgitation who underwent single leaflet reconstruction using the Ozaki procedure in our medical centre. A retrospective study was conducted of nine children with aortic regurgitation who received single leaflet reconstruction from May 2017 to September 2019. Paired t-tests and Wilcoxon signed rank tests were used to compare the data at different time points. The median surgical age was 4.7 (3.5, 6.4) years. Eight patients were pre-operatively diagnosed with severe aortic regurgitation, while one had moderate regurgitation. The left ventricles were significantly enlarged, with an average z-score of 3.8. Single leaflet reconstruction was carried out using glutaraldehyde-treated autologous pericardium under the standard Ozaki procedure. The median follow-up was 22 (14, 33) months. There was no post-operative death or re-intervention. One patient had moderate or more aortic regurgitation during the follow-up. The average degree of aortic regurgitation was mild, and the average z-score of the left ventricle decreased to -0.2 in the last follow-up. Single leaflet reconstruction using the Ozaki procedure was an effective surgical method for treating children with aortic regurgitation in our centre with satisfactory short-term results.

Three\u2010month outcomes of aortic valve reconstruction using collagenous membranes (biosheets) produced by in\u2010body tissue architecture in a goat model: a preliminary study

BackgroundAutologous pericardium is widely used as a plastic material in intracardiac structures, in the pulmonary artery, and in aortic valve leaflets. For aortic valve reconstruction (AVRec) using the Ozaki procedure, it has produced excellent clinical results over a 10-year period. In-body tissue architecture (iBTA), which is based on the phenomenon of tissue encapsulation of foreign materials, can be used to prepare autologous prosthetic tissues. In this preliminary study, we examined whether biosheets can be used as valve leaflet material for glutaraldehyde-free AVRec by subchronic implantation experiments in goats and evaluated its performance compared with glutaraldehyde-treated autologous pericardium for AVRec.MethodsBiosheets were prepared by embedding molds for two months into the dorsal subcutaneous spaces of goats. Autogenic biosheets (n = 4) cut into the shape of the valve were then implanted to the aortic valve annulus of four goats for three months without glutaraldehyde treatment. Autologous pericardium (n = 4) was used in four goats as a control. Valve function was observed using echocardiography.ResultsAll goats survived the three-month study period. With biosheets, the leaflet surfaces were very smooth and, on histology, partially covered with a thin neointima (including endothelial cells). Biosheets were more thoroughly assimilated into the aortic root compared with autologous pericardium.ConclusionsFor the first time, biosheets were used for large animal AVRec. Biosheets could function as leaflets in the aortic position and may have the ability to assimilate into native valves.

Aortic valve neocuspidization with in-body tissue-engineered autologous membranes: preliminary results in a long-term goat model

Aortic valve neocuspidization has shown satisfactory clinical outcomes; however, autologous pericardium durability is a concern for young patients. This study applied an autologous collagenous membrane (Biosheet®), produced by in-body tissue architecture, to aortic valve neocuspidization and investigated its long-term outcome in a goat model. Moulds were embedded subcutaneously in 6 goats. After 2 months, Biosheets formed in the moulds. We performed aortic valve neocuspidization using a portion of the sheets with a thickness of 0.20-0.35 mm, measured by optical coherence tomography. Animals were subjected to echocardiography and histological evaluation at 6 months (n = 3) and 12 months (n = 3). As a control, the glutaraldehyde-treated autologous pericardium was used in 4 goats that were similarly evaluated at 12 months. All animals survived the scheduled period. At 6 months, Biosheets maintained valve function and showed a regeneration response: fusion to the annulus, cell infiltration to the leaflets and appearance of elastic fibres at the ventricular side. After 12 months, the regenerative structure had changed little without regression, and there was negligible calcification in the 1/9 leaflets. However, all cases had one leaflet tear, resulting in moderate-to-severe aortic regurgitation. In the pericardium group, three-fourths of the animals experienced moderate-to-severe aortic regurgitation with a high rate of calcification (9/12 leaflets). Biosheets may have regeneration potential and anti-calcification properties in contrast to autologous pericardium. However, in order to obtain reliable outcome, further improvements are required to strictly control and optimize its thickness, density and homogeneity.

Outcomes of pulmonary valve leaflet augmentation for transannular repair of tetralogy of Fallot

ObjectiveTo evaluate the midterm results of pulmonary valve leaflet augmentation in transannular repair of tetralogy of Fallot (TOF). MethodsFrom 2007 to 2019, 131 patients underwent a transannular repair with pulmonary leaflet augmentation for TOF (n = 120) and double outlet right ventricle with pulmonary stenosis (n = 11). Patch material was expanded polytetrafluoroethylene (n = 76), glutaraldehyde-treated autologous pericardium (n = 47) and bovine pericardium (n = 8). ResultsMedian age at repair was 8.9 months (interquartile range, 5.4-14.8). There was no operative mortality. Median follow-up was 6.25 years (interquartile range, 2.77-7.75). Freedom from severe pulmonary regurgitation (PR) was 85% (95% confidence interval [CI], 77%-90%) and 76% (95% CI, 66%-83%) at 1 and 5 years, respectively. Freedom from moderate or greater PR was 69% (95% CI, 60%-76%) and 30% (95% CI, 21%-39%) at 5 and 10 years, respectively. Three patients required pulmonary valve replacement for PR. Nine patients required pulmonary balloon valvuloplasty. Freedom from intervention for pulmonary valve stenosis was 98% (95% CI, 93%-99%) and 94% (95% CI, 87%-97%) at 1 and 5 years, respectively. One patient with severe PR had an indexed right ventricular volume >160 mL/m2. Use of expanded polytetrafluoroethylene resulted in a greater freedom from moderate or greater PR (log-rank test P < .001; Cox regression hazard ratio, 0.40; 95% CI, 0.25-0.63; P < .001). ConclusionsAt midterm follow-up of transannular repair with pulmonary valve leaflet augmentation, severe PR occurs in less than 50% of patients. The expanded polytetrafluoroethylene patch performs better than pericardium.