Transcatheter Axial Pump Use in Pediatric Patients on Veno-Arterial Extracorporeal Membrane Oxygenation: An ACTION Collaborative Experience.

We report the largest pediatric multicenter experience with Impella pump use and peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support. Utilizing the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) collaborative database, we conducted a retrospective, multicenter study of all patients with cardiogenic shock requiring VA-ECMO support with subsequent Impella implant between October 2014 and December 2021. The primary outcome was defined as death while on Impella support. Secondary outcomes were recovery, transplantation, and transition to durable ventricular assist device (VAD) at the time of Impella explantation. Adverse events were defined according to the ACTION registry criteria. Twenty subjects were supported with Impella; Impella 2.5 (n = 3), CP (n = 12), 5.0/5.5 (n = 5). The median Interquartile range (IQR) age, weight, and body surface area at implantation were 15.6 years (IQR = 13.9-17.2), 65.7 kg (IQR = 53.1-80.7), and 1.74 m2 (IQR = 1.58-1.98). Primary cardiac diagnoses were dilated cardiomyopathy/myocarditis in nine (45%), congenital heart disease in four (20%), graft failure/rejection in four (20%), and three (15%) others. Most common adverse events included hemolysis (50%) and bleeding (20%). There were two deaths (10%) in the cohort. Nine patients (45%) were explanted for recovery, eight (40%) were transitioned to a durable VAD, and one (5%) underwent heart transplantation. Impella percutaneous pump support should be considered in the older pediatric population supported with peripheral VA-ECMO, as a means of left heart decompression, and a strategy to come off ECMO to achieve endpoints of myocardial recovery, transition to a durable VAD, or transplantation.

The Impact of Bicuspid Aortic Valve Leaflet Fusion Morphology on the Ascending Aorta and on Outcomes of Aortic Valve Replacement.

BACKGROUND: Patients with bicuspid aortic valves (BAVs) tend to develop dilation of the ascending aorta. The aim of this study was to analyze the impact of leaflet fusion pattern on aortic root diameter and outcomes in patients undergoing surgery for BAV vs tricuspid aortic valve (TAV) disease. METHODS: This is a retrospective review of 90 patients with aortic valve disease (mean [SD] age, 51.5 [8.2] years) who underwent aortic valve replacement for BAV (n = 60) and TAV (n = 30). Fusion of right-left (R/L) coronary cusps was identified in 45 patients, whereas the remaining 15 patients had right-noncoronary (R/N) cusp fusion. Aortic diameter was measured at 4 levels, and Z values were computed. RESULTS: There were no significant differences between the BAV and TAV groups for age, weight, aortic insufficiency grade, or size of implanted prostheses. However, a higher preoperative peak gradient at the aortic valve was significantly associated with R/L fusion (P = .02). Preoperative Z values of ascending aorta and sinotubular junction diameter were significantly higher in patients with R/N fusion than with the R/L (P < .001 and P = .04, respectively) and TAV (P < .001 and P < .05, respectively) subgroups. During the follow-up period (mean [SD], 2.7 [1.8] years), 3 patients underwent a redo procedure. At the last follow-up, the sizes of ascending aorta were similar among all 3 patient groups. CONCLUSION: This study suggests that preoperative dilation of the ascending aorta is more common in patients with R/N fusion than in patients with R/L and TAV but is not significantly different between all groups in the early follow-up period. R/L fusion was associated with an increased risk of preoperative presence of aortic stenosis.

Early Outcomes of Patients Undergoing Neoaortic Valve Repair Incorporating Geometric Ring Annuloplasty.

OBJECTIVES: During congenital heart surgery, the pulmonary valve and root may be placed into the systemic position, yielding a "neoaortic" valve. With the stress of systemic pressure, the pulmonary roots can dilate, creating aneurysms and/or neoaortic insufficiency (neoAI). This report analyzes the early outcomes of patients undergoing neoaortic valve repair incorporating geometric ring annuloplasty. METHODS: Twenty-one patients underwent intended repair at six centers and formed the study cohort. Thirteen had previous Ross procedures, five had arterial switch operations, and three Fontan physiology. Average age was 21.7 ± 12.8 years (mean ± SD), 80% were male, and 11 (55%) had symptomatic heart failure. Preoperative neoAI Grade was 3.1 ± 1.1, and annular diameter was 30.7 ± 6.5 mm. RESULTS: Valve repair was accomplished in 20/21, using geometric annuloplasty rings and leaflet plication (n = 13) and/or nodular release (n = 7). Fourteen had neoaortic aneurysm replacement (13 with root remodeling). Two underwent bicuspid valve repair. Six had pulmonary conduit changes, one insertion of an artificial Nodulus Arantius, and one resection of a subaortic membrane. Ring size averaged 21.9 ± 2.3 mm, and aortic clamp time was 171 ± 54 minutes. No operative mortality or major morbidity occurred, and postoperative hospitalization was 4.3 ± 1.4 days. At discharge, neoAI grade was 0.2 ± 0.4 (P < .0001), and valve mean gradient was ≤20 mm Hg. At average 18.0 ± 9.1 months of follow-up, all patients were asymptomatic with stable valve function. CONCLUSIONS: Neoaortic aneurysms and neoAI are occasionally seen late following Ross, arterial switch, or Fontan procedures. Neoaortic valve repair using geometric ring annuloplasty, leaflet reconstruction, and root remodeling provides a patient-specific approach with favorable early outcomes.

Capturing Adult Congenital Heart Disease: Framework for Development of an Adult Congenital Heart Disease Mortality Risk Model.

BACKGROUND: As a formative step toward development of adult congenital heart disease (ACHD) risk-adjusted metrics, we describe The Society of Thoracic Surgeons (STS) ACHD population, procedural frequency, and early mortality. METHODS: Adults (≥18 years) with CHD (2014-2019) were identified in the STS Adult Cardiac Surgery (ASCD) and the Congenital Heart Surgery (CHSD) Databases. After deduplication, variable mapping, data concatenation, and harmonization of preprocedure factors, procedures were grouped, and unadjusted mortality was catalogued for the overall cohort and the cohort excluding patients with an isolated bicuspid aortic valve (BAV). RESULTS: Among 171 186 ACSD and 18 281 CHSD records, 152 731 unique records met inclusion criteria. Twenty-eight congenital diagnoses accounted for 86% of the overall cohort, and prevalence of ACHD increased over the study time frame. ACHD patients underwent operations to treat both acquired and CHD. Most common procedures overall and after excluding isolated BAV were aortic valve replacement (AVR), ascending aortic surgery, and coronary artery bypass grafting (CABG). After excluding isolated BAV, major procedure combinations occurred in 46% (31% had 2 major procedures and 3% had ≥4), and the most prevalent combinations included AVR + CABG (n = 2352), AVR + subaortic stenosis repair (n = 1481), and AVR + ascending aortic surgery (n = 1239). Unadjusted 30-day mortality was procedure dependent, 2.8% overall and 3.6% with isolated BAV excluded. CONCLUSIONS: The ACHD surgical population is heterogenous, and patients undergo surgery for CHD-related and adult/acquired procedure combinations. Early mortality is variable and influenced by surgical complexity. Excluding isolated BAV patients and developing procedure-based ACHD mortality risk models may be ideal but will require empirically derived grouping and collaboration.

Assessment of Current Society of Thoracic Surgeons Data Elements for Adults With Congenital Heart Disease.

BACKGROUND: To identify opportunities for enhanced data collection for adults with congenital heart disease (ACHD), a structured review of existing variables in The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database (CHSD) and the STS Adult Cardiac Surgery Database (ACSD) was conducted. METHODS: A working group was assembled representing multiple STS Workforces and Task Forces. The ACSD was reviewed systematically over eight 90-minute calls. ACSD version 4.20.2 and CHSD version 3.41 were used, and the ACSD was approached in sections. ACSD variables were classified as (1) represented in identical form in the CHSD (no further discussion), (2) represented in similar form in the CHSD (discussed for potential harmonization of definitions), or (3) not represented in the CHSD (discussed for potential inclusion). Variables felt to be relevant to ACHD were noted, and special consideration was given to STS required fields and variables used in existing STS adult risk models. Other factors that were examined were the frequency, use, and capture of existing ACSD variables. RESULTS: Over 22 weeks (8 calls), the existing 1069 variables in version 4.20.2 of the ACSD were discussed. Ultimately, 539 total variables were found to be both (1) relevant to ACHD and (2) not currently collected in the CHSD. These were recommended for inclusion in the next CHSD upgrade for patients aged ≥18 years. CONCLUSIONS: For adult patients having case records entered into the CHSD, the inclusion of a limited set of additional data fields from the ACSD should enhance capture of comorbidities and other clinical data relevant to the ACHD population.

Anomalous Aortic Origin of Right Coronary Artery: Outcomes of Surgical and Nonsurgical Treatment.

BACKGROUND: Anomalous aortic origin of right coronary artery (AAORCA) is a congenital heart lesion that may be associated with coronary ischemia and sudden death; however, the management of these patients remains controversial. The aim of this study was to analyze all patients with AAORCA managed at our center. METHODS: The medical records of patients with an isolated diagnosis of AAOCA were retrospectively reviewed, irrespective of symptoms, from 2007 to 2020. Follow-up was obtained by medical record review. AAORCA was diagnosed by echocardiogram and computed tomographic or magnetic resonance imaging studies in all patients. Treatment was based on anatomic, morphologic, and symptomatic features for patients older than 10 years with AAORCA. RESULTS: The review identified 86 patients with a median age of 16 years; of these, 26 (30%) were managed surgically and 60 (70%) are monitored nonsurgically. Surgical intervention included a "classic" unroofing in 10 (39%), neo-ostial creation in 7 (27%), modified unroofing with neo-ostial creation in 6 (23%), a "classic" unroofing with reimplantation in 2 (7%), and reimplantation only in 1 (4%). Surgical patients were significantly older (P = .01), described more chest pain symptoms (P = .004), had the presence of slitlike ostia (P = .03), and longer length of coronary artery narrowing (P = .0002). At follow-up (median, 3 years; range, 0-13 years), 100% of surgical patients underwent functional testing and had no evidence of ischemia. Postoperative evaluation included one or more of echocardiography, computed tomographic angiogram, magnetic resonance imaging, and exercise stress test. CONCLUSIONS: Our program uses a systematic approach for patients with AAORCA. With this paradigm, outcomes are excellent in the midterm, as validated with anatomic- and function-based testing.

Dilatable Pulmonary Artery Banding Palliation in Congenital Heart Disease.

BACKGROUND: Surgical pulmonary artery banding (PAB) has been limited in practice because of later requirement for surgical removal or adjustment. The aim of this study is to describe our experience creating a dilatable PAB via transcatheter balloon dilation (TCBD) in congenital heart disease (CHD) patients. METHODS: Retrospective chart review of adjustable PAB-outline anatomical variants palliated and patient outcomes. RESULTS: Sixteen patients underwent dilatable PAB-median age 52 days (range 4-215) and weight 3.12 kg (1.65-5.8). Seven (44%) of the patients were premature, 11 (69%) had ventricular septal defect(s) with pulmonary over-circulation, four (25%) atrioventricular septal defects, and four (25%) single ventricle physiology. Subsequent to the index procedure: five patients have undergone intracardiac complete repair, six patients remain well palliated with no additional intervention, and four single ventricles await their next palliation. One patient died from necrotizing enterocolitis (unrelated to PAB) and one patient required a pericardiocentesis postoperatively. Five patients underwent TCBD of the PAB without complication-Two had one TCBD, two had two TCBD, and another had three TCBD. The median change in saturation was 14% (complete range 6-22) and PAB diameter 1.7 mm (complete range 1.1-5.2). Median time from PAB to most recent outpatient follow-up was 868 days (interquartile range 190-1,079). CONCLUSIONS: Our institution has standardized a PAB technique that allows for transcatheter incremental increases in pulmonary blood flow over time. This methodology has proven safe and effective enough to supplant other institutional techniques of limiting pulmonary blood flow in most patients-allowing for interval growth or even serving as the definitive palliation.

Scavenging right atrial Bretschneider histidine-tryptophan-ketoglutarate cardioplegia: Impact on hyponatremia and seizures in pediatric cardiac surgery patients.

OBJECTIVE: Custodiol-HTK cardioplegia (Custodiol-HTK Koheler Chemie, GmbH, Bensheim, Germany) causes fluctuations in serum sodium levels, hyponatremia, and is associated with postoperative seizures. We investigated the influence of scavenging right atrial effluent during delivery on intraoperative serum sodium levels and postoperative seizure incidence in pediatric cardiac surgery patients. METHODS: A total of 204 patients younger than age 18 years undergoing congenital heart surgery between January 2016 and March 2018 were analyzed retrospectively. Serum sodium levels after administration of Custodiol-HTK cardioplegia were compared between the scavenge and nonscavenge groups and then in the propensity score-matched cohort (n = 96). Postoperative seizures were documented clinically and with electroencephalogram findings. Logistic regression models were used to identify the independent predictors of serum sodium level after aortic crossclamp. RESULTS: Of 204 patients, 156 (76.5%) were in the nonscavenge, and 48 (23.5%) in the scavenge groups. A serum sodium level <130 mEq/L after crossclamp and administration of Custodiol-HTK cardioplegia in the nonscavenge group were 70% versus 21% in the scavenge group (odds ratio, 8.8; 95% confidence interval, 4.1-18.3; P < .0001) in the entire cohort, and 77% versus 21% (odds ratio, 12.8; 95% confidence interval, 4.8-33.1; P < .0001) in the propensity score-matched cohort. Of 16 patients experiencing a postoperative seizure, 14 (87.5%) had a sodium level <130 mEq/L and 2 (12.5%) had a sodium level ≥130 mEq/L (odds ratio, 5.1; 95% confidence interval, 1.3-22.8; P = .021) after crossclamp. Postoperative seizures occurred in the nonscavenge group but not the scavenge group in the entire cohort (P = .02) and in the propensity score-matched patients (P = .041). Multivariable analysis of the entire cohort showed that scavenge intervention was an independent factor associated with significantly decreased risk of sodium level <130 mEq/L (odds ratio, 0.17; 95% confidence interval, 0.08-0.36; P = .000). CONCLUSIONS: Right atrial effluent scavenging was protective against fluctuations in serum sodium levels after crossclamp and Custodiol-HTK cardioplegia administration independently in both entire and matched cohort, and was also associated with decreased incidence of postoperative seizures.

Reconstruction of the Neopulmonary Root After Coronary Button Harvest for Arterial Switch Operation Using 2-ply Extracellular Matrix (Tyke): A Post-Implant Histology.

In children with Transposition of the Great Arteries (TGA), the pulmonary artery, and aorta are connected to the heart abnormally resulting in blue blood (deoxygenated) recirculating to the body and red blood (oxygenated) recirculating to the lungs. The arterial switch operation (ASO) is the standard of care for transposition of the great arteries (TGA), and given the low risk of early mortality and satisfactory long-term outcomes, focus is now on managing longer term complications such as neo-aortic root dilatation, and pulmonary artery stenosis. Since May 2016, we have used 2-ply extracellular matrix (ECM; Tyke) for reconstruction of the coronary button defects using a pantaloon patch. We present histology of implanted 2-ply ECM (Tyke) from a patient who went back to surgery for development of subaortic stenosis ~12 months after ASO.

The Destiny of Postoperative Residual Ventricular Septal Defects After Surgical Repair in Infants and Children.

PURPOSE: Residual ventricular septal defects (rVSDs) of small size are commonly seen on transesophageal echocardiography after surgical repair. This study aimed to determine the destiny of rVSD found on intraoperative echocardiogram. METHODS: Patients undergoing surgical repair of VSD as the primary procedure with available intraoperative and discharge echocardiograms between 2007 and 2017 were reviewed. Presence of an rVSD on intraoperative echo triggered review of discharge echo and of subsequent follow-up echocardiograms. RESULTS: One hundred four patients were analyzed. The mean age and weight for the entire cohort were 1.4 ± 2.9 years (median, 5.4 months; range, 29 days to 14 years) and 8.8 ± 9.9 kg (median, 5.1 kg; range, 2.7-58 kg), respectively. Sixty (57%) patients had rVSD at discharge, with mean size of residual VSD of 1.38 ± 0.92 mm (mode, 0.6; median, 2.2 mm; range, 0.5-3.9 mm). The mean follow-up time was 3.7 ± 3.1 years (range, 1 month to 9.3 years). Among those with rVSD at discharge, a residual shunt persisted in 73% at one-month follow-up. On follow-up at three years postdischarge, of the 60 patients with early rVSD, 6 had a persistent rVSD (10%) with a mean diameter of 3.0 ± 0.8 mm (range, 2.4-3.9 mm). CONCLUSIONS: Residual VSD after surgical repair is detected frequently on postoperative echocardiogram. The presence of rVSD was not associated with any preoperative, intraoperative, or postoperative factors. By three years of follow-up, only six patients continued to demonstrate rVSD with a mean diameter of 3 mm, suggesting that defects 3 mm or greater may be less likely to close spontaneously after three years.

Aquapheresis (AQ) in Tandem with Extracorporeal Membrane Oxygenation (ECMO) in Pediatric Patients.

Children with cardiopulmonary failure requiring extracorporeal membrane oxygenation (ECMO) are at risk for fluid overload (FO) despite the normal estimated glomerular filtration rate (eGFR). It has been shown that survival in the intensive care unit (ICU) is inversely proportional to FO. Therefore, fluid removal, or prevention of FO, in these critical cases has the potential to improve survival. Aquapheresis (AQ), a procedure used for fluid removal, with success in patients with heart failure has also been used in children with acute oliguric kidney injury (AKI), to prevent and treat FO. The purpose of this article was to describe the use of Aquadex FlexFlow® for AQ in pediatric patients on ECMO, as a means to provide a simplified and safe form of fluid removal with minimal impact on ECMO therapy. The principal variables collected include patients' demographics, urine output, serum creatinine, withdrawal and infusion pressures, ultrafiltration (UF) rates, and ECMO flow ranges, along with length of stay in pediatric ICU and survival. Patient survival was 100% with preserved eGFR. The ECMO flows were not affected by AQ. Urine output decreased somewhat during therapy, with little AQ machine pressure variations. Range of UF tolerated without hemodynamic abnormalities was 1.24-6.2 mL/kg/h, allowing the patients to maintain their pre-AQ body weight, while receiving intravenous (IV) nutrition and medications. This article describes the use of AQ in tandem with ECMO in a user-friendly and safe way to provide UF in children requiring cardiopulmonary support, with minimal flow and hemodynamic disturbance.

Mitral valve replacement using a handmade construct in an infant.

We recently reported the feasibility of a handmade left atrioventricular valve using decellularized extracellular matrix for 3 months in a failed repair of AV canal defect. We present the use of an extracellular matrix mitral valve for 9 months in an infant with an un-repairable congenitally malformed valve. The valve functioned perfectly without anticoagulation until the patient expired from non-cardiac complications of their fibrillin gene defect. This report adds further experience using valves made from extracellular matrix in the systemic ventricle both in terms of application and in terms of short-term durability of the construct.

Feasibility and early effectiveness of a custom, hand-made systemic atrioventricular valve using porcine extracellular matrix (CorMatrix) in a 4-month-old infant.

A need persists for a prosthetic, systemic atrioventricular valve replacement in the pediatric population that can be customized to a wide range of annular sizes, has a low risk of thrombosis, possesses optimal hemodynamic performance, and has the potential to remodel and grow with the patient. We describe a technique for successful systemic atrioventricular valve replacement in a 4-month-old infant by use of a handmade, bileaflet systemic atrioventricular prosthesis constructed from porcine extracellular matrix.

Right ventricular wall-motion changes after infant open heart surgery--a tissue Doppler study.

BACKGROUND: Right ventricular (RV) dysfunction is a well-recognized complication of cardiopulmonary bypass surgery (CPB) in adults. Infants and neonates may also be at high risk for this due to immature myocardium. Conventional assessment of RV function is just qualitative, but novel tissue Doppler echocardiographic (TDI) markers including peak systolic strain rate (SR) and isovolumic contraction acceleration (IVA) permit noninvasive quantitation of RV function. This study assessed myocardial velocities, IVA and SR in infants and neonates undergoing open heart surgery using TDI to study regional myocardial function perioperatively. METHODS: Transthoracic TDI data were obtained in the OR before and 24 hours post-CPB on 53 consecutive infants (age 0.39 ± 0.23 years). They were followed with TDI through hospital discharge. RESULTS: Mean CPB time was 87 ± 49 min (cross-clamp 52 ± 26 min). Peak systolic (STDI ) and diastolic myocardial velocities (ETDI , ATDI ), IVA, and peak SR were recorded in RV and LV from standard views for offline analysis. Postoperatively, LV systolic function and diastolic longitudinal function were unchanged or improved from baseline. LV radial velocities were increased postoperatively indicating adequate support. In contrast, RV longitudinal systolic and diastolic function was significantly diminished after CPB. RV changes persisted through hospital discharge. CONCLUSIONS: In infants and neonates, perioperative measurements of systolic and diastolic tissue Doppler parameters are feasible and revealed significant RV systolic and diastolic dysfunction post-CPB with preserved LV function. As such, TDI provides a sensitive tool to monitor the infant heart after CPB and may potentially be useful to assess different myocardial protection strategies.

Variation in outcomes for risk-stratified pediatric cardiac surgical operations: an analysis of the STS Congenital Heart Surgery Database.

BACKGROUND: We evaluated outcomes for groups of risk-stratified operations in The Society of Thoracic Surgeons Congenital Heart Surgery Database to provide contemporary benchmarks and examine variation between centers. METHODS: Patients undergoing surgery from 2005 to 2009 were included. Centers with more than 10% missing data were excluded. Discharge mortality and postoperative length of stay (PLOS) among patients discharged alive were calculated for groups of risk-stratified operations using the five Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery Congenital Heart Surgery mortality categories (STAT Mortality Categories). Power for analyzing between-center differences in outcome was determined for each STAT Mortality Category. Variation was evaluated using funnel plots and Bayesian hierarchical modeling. RESULTS: In this analysis of risk-stratified operations, 58,506 index operations at 73 centers were included. Overall discharge mortality (interquartile range among programs with more than 10 cases) was as follows: STAT Category 1=0.55% (0% to 1.0%), STAT Category 2=1.7% (1.0% to 2.2%), STAT Category 3=2.6% (1.1% to 4.4%), STAT Category 4=8.0% (6.3% to 11.1%), and STAT Category 5=18.4% (13.9% to 27.9%). Funnel plots with 95% prediction limits revealed the number of centers characterized as outliers by STAT Mortality Categories was as follows: Category 1=3 (4.1%), Category 2=1 (1.4%), Category 3=7 (9.7%), Category 4=13 (17.8%), and Category 5=13 (18.6%). Between-center variation in PLOS was analyzed for all STAT Categories and was greatest for STAT Category 5 operations. CONCLUSIONS: This analysis documents contemporary benchmarks for risk-stratified pediatric cardiac surgical operations grouped by STAT Mortality Categories and the range of outcomes among centers. Variation was greatest for the more complex operations. These data may aid in the design and planning of quality assessment and quality improvement initiatives.

Variation in outcomes for benchmark operations: an analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

BACKGROUND: We evaluated outcomes for common operations in The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSDB) to provide contemporary benchmarks and examine variation between centers. METHODS: Patients undergoing surgery from 2005 to 2009 were included. Centers with greater than 10% missing data were excluded. Discharge mortality and postoperative length of stay (PLOS) among patients discharged alive were calculated for 8 benchmark operations of varying complexity. Power for analyzing between-center variation in outcome was determined for each operation. Variation was evaluated using funnel plots and Bayesian hierarchical modeling. RESULTS: Eighteen thousand three hundred seventy-five index operations at 74 centers were included in the analysis of 8 benchmark operations. Overall discharge mortality was: ventricular septal defect (VSD) repair = 0.6% (range, 0% to 5.1%), tetralogy of Fallot (TOF) repair = 1.1% (range, 0% to 16.7%), complete atrioventricular canal repair (AVC) = 2.2% (range, 0% to 20%), arterial switch operation (ASO) = 2.9% (range, 0% to 50%), ASO + VSD = 7.0% (range, 0% to 100%), Fontan operation = 1.3% (range, 0% to 9.1%), truncus arteriosus repair = 10.9% (0% to 100%), and Norwood procedure = 19.3% (range, 0% to 100%). Funnel plots revealed that the number of centers characterized as outliers were VSD = 0, TOF = 0, AVC = 1, ASO = 3, ASO + VSD = 1, Fontan operation = 0, truncus arteriosus repair = 4, and Norwood procedure = 11. Power calculations showed that statistically meaningful comparisons of mortality rates between centers could be made only for the Norwood procedure, for which the Bayesian-estimated range (95% probability interval) after risk-adjustment was 7.0% (3.7% to 10.3%) to 41.6% (30.6% to 57.2%). Between-center variation in PLOS was analyzed for all operations and was larger for more complex operations. CONCLUSIONS: This analysis documents contemporary benchmarks for common pediatric cardiac surgical operations and the range of outcomes among centers. Variation was most prominent for the more complex operations. These data may aid in quality assessment and quality improvement initiatives.

Preliminary experience with cardiac reconstruction using decellularized porcine extracellular matrix scaffold: human applications in congenital heart disease.

An ideal material for repair of congenitally malformed hearts would encourage tissue regeneration with growth potential. Decellularized porcine small intestinal submucosa extracellular matrix (SIS-ECM) promotes tissue regeneration in animal models and noncardiac human applications. This retrospective review evaluates SIS-ECM for reconstruction of congenital heart defects. From June 2007 to May 2009, SIS-ECM patches were used in 43 operations on 40 patients aged 2 days to 13 years. In 16 cases, the SIS-ECM was used for pericardial closure. The SIS-ECM was used for cardiac or great vessel repair in 37 cases: atrial septal defect repair in 11, pulmonary arterioplasty in 10, right ventricular outflow tract patch in 6, pulmonary monocusp valve creation in 5, superior vena cava patch in 2 and aortoplasty in 2, valve leaflet augmentation in 2, and repair of unroofed coronary sinus in 1. Follow-up was complete. There were 5 deaths, all unrelated to the SIS-ECM. Mean follow-up was 7.85 months (0.5-24 months). No pericardial effusions or intracardiac or intravascular thromboses occurred related to the SIS-ECM. The patches did not shrink or calcify. Four of 5 monocusp valves were competent and none were stenotic. One patient who underwent tricuspid valve anterior leaflet augmentation with SIS-ECM required tricuspid valve replacement 4 months later for severe regurgitation following a catheter-based procedure. Explanted tissue showed resorption of the SIS-ECM, replacement with organized collagen, and re-endothelialization. Repair of congenital heart defects using SIS-ECM is feasible and safe. In valve reconstruction, this procedure shows potential for replacement by autologous tissue. Longer-term follow-up is required to assess the potential for growth.