Intrapulmonary administration of recombinant activated factor VII in pediatric, adolescent, and young adult oncology and hematopoietic cell transplant patients with pulmonary hemorrhage.

Introduction: Diffuse alveolar hemorrhage (DAH) is a devastating disease process with 50-100% mortality in oncology and hematopoietic cell transplant (HCT) recipients. High concentrations of tissue factors have been demonstrated in the alveolar wall in acute respiratory distress syndrome and DAH, along with elevated levels of tissue factor pathway inhibitors. Activated recombinant factor VII (rFVIIa) activates the tissue factor pathway, successfully overcoming the tissue factor pathway inhibitor (TFPI) inhibition of activation of Factor X. Intrapulmonary administration (IP) of rFVIIa in DAH is described in small case series with successful hemostasis and minimal complications. Methods: We completed a single center retrospective descriptive study of treatment with rFVIIa and outcomes in pediatric oncology and HCT patients with pulmonary hemorrhage at a quaternary hematology/oncology hospital between 2011 and 2019. We aimed to assess the safety and survival of patients with pulmonary hemorrhage who received of IP rFVIIa. Results: We identified 31 patients with pulmonary hemorrhage requiring ICU care. Thirteen patients received intrapulmonary rFVIIa, while eighteen patients did not. Overall, 13 of 31 patients (41.9%) survived ICU discharge. ICU survival (n=6) amongst those in the IP rFVIIa group was 46.2% compared to 38.9% (n=7) in those who did not receive IP therapy (p=0.69). Hospital survival was 46.2% in the IP group and 27.8% in the non-IP group (p=0.45). There were no adverse events noted from use of IP FVIIa. Conclusions: Intrapulmonary rFVIIa can be safely administered in pediatric oncology patients with pulmonary hemorrhage and should be considered a viable treatment option for these patients.

Optimizing haematopoietic stem and progenitor cell apheresis collection from plerixafor-mobilized patients with sickle cell disease.

We adjusted haematopoietic stem and progenitor cell (HSPC) apheresis collection from patients with sickle cell disease (SCD) by targeting deep buffy coat collection using medium or low collection preference (CP), and by increasing anticoagulant-citrate-dextrose-solution A dosage. In 43 HSPC collections from plerixafor-mobilized adult patients with SCD, we increased the collection efficiency to 35.79% using medium CP and 82.23% using low CP. Deep buffy coat collection increased red blood cell contamination of the HSPC product, the product haematocrit was 4.7% with medium CP and 6.4% with low CP. These adjustments were well-tolerated and allowed efficient HSPC collection from SCD patients.

Impact of Regional Cerebral Perfusion on Outcomes Among Neonates Undergoing Norwood Operation.

OBJECTIVES: To evaluate the impact of regional cerebral perfusion (RCP) during heart operation on outcomes in neonates undergoing Norwood operation. METHODS: We performed a retrospective cohort study using data from the Single Ventricle Reconstruction trial data set. The adjusted effect of RCP use on each outcome was studied using a penalized logistic regression model with bootstrap validation. RESULTS: Of 549 patients included in the study, 252 patients (45.9%) received RCP during their heart operation. In univariate comparisons, the majority of the baseline characteristics and preoperative risk factors were similar in the RCP and No RCP group. The total cardiopulmonary bypass (CPB) time and the total cross-clamp (CC) time were longer in the RCP group (RCP vs No RCP, median CPB time: 161 minutes vs 109 minutes; median CC time: 63 minutes vs 43 minutes). In adjusted models, the use of RCP was not associated with decreased mortality and/or need for heart transplant at hospital discharge (odds ratio [OR]: 0.73; 95% confidence interval [CI]: 0.43-1.25) or prolonged mechanical ventilation (OR: 1.20, 95% CI: 0.62-2.28) or prolonged hospital length of stay (OR: 1.30, 95% CI: 0.73-2.30). We demonstrated that use of RCP was associated with longer CPB times, increased use of ultrafiltration, and higher probability of open chest after Norwood operation. CONCLUSIONS: This study did not demonstrate any impact of RCP on in-hospital mortality and/or heart transplantation, prolonged mechanical ventilation, and prolonged hospital length of stay among neonates undergoing Norwood operation.

Creation of an empiric tool to predict ECMO deployment in pediatric respiratory or cardiac failure.

PURPOSE: To create a real-time prediction tool to predict probability of ECMO deployment in children with cardiac or pulmonary failure. MATERIALS AND METHODS: Patients ≤18 years old admitted to an ICU that participated in the Virtual Pediatric Systems database (2009-2015) were included. Logistic regression models using adaptive lasso methodology were used to identify independent factors associated with ECMO use. RESULTS: A total of 538,202 ICU patients from 140 ICUs qualified for inclusion. ECMO was deployed in 3484 patients (0.6%) with a mortality of 1450 patients (41.6%). The factors associated with increased probability of ECMO use included: younger age, pulmonary hypertension, congenital heart disease, high-complexity cardiac surgery, cardiomyopathy, acute lung injury, shock, renal failure, cardiac arrest, use of nitric oxide, use of either conventional mechanical ventilation or high frequency oscillatory ventilation, and higher annual ECMO center volume. The area under the receiver operating curve for this model was 0.90 (95% CI: 0.85-0.93). This tool can be accessed at https://soipredictiontool.shinyapps.io/ECMORisk/. CONCLUSIONS: Here, we present a tool to predict ECMO deployment among critically ill children; this tool will help create real-time risk stratification among critically ill children, and it will help with benchmarking, family counseling, and research.

Incidence of Immediate Extubation After Pediatric Cardiac Surgery and Predictors for Reintubation.

OBJECTIVES: The objectives were to assess the incidence of immediate tracheal extubation in the operating room after pediatric cardiac surgery and to investigate predictors for subsequent reintubation. METHODS: This is a single institutional retrospective study including all patients who had a cardiac operation with cardiopulmonary bypass from 2011 to 2016. Patients who required preoperative ventilator support, postoperative open chest, or mechanical support were excluded. Predictors for reintubation after immediate extubation were analyzed only for patients with stage II palliation for single ventricle physiology. RESULTS: Nine hundred nine qualifying operations were identified. Immediate extubation was performed in 590 (64.9%) operations. A multivariable logistic regression model showed that the identities of anesthesiologist ( P = .0003), year of the operation performed ( P < .001), cardiopulmonary bypass time ( P < .001), and type of operations ( P < .001) were significantly associated with immediate extubation. Reintubation was significantly less frequent in patients with immediate extubation compared to those without (6.1% vs 15.0%; P < .001). A subgroup analysis for stage II palliation showed that reintubation after immediate extubation was significant for younger age (0.42 vs 0.54 years, P = .044), lower Po2/Fio2 and Po2 at the last blood gas analysis (66 vs 98 mm Hg, P = .032 and 39 vs 47 mm Hg, P = .008), and higher inotropic score (2 vs 0, P = .034). A multivariable logistic regression model showed that only inotropic score was significantly associated with reintubation ( P = .018). CONCLUSIONS: Immediate extubation in the operating room after pediatric cardiac surgery can be performed in most patients. Inotropic score is a predictor for reintubation in stage II palliation.

Reclassifying by highest complexity operation rather than first operation influences mortality after pediatric heart surgery.

OBJECTIVE: To evaluate the effect on mortality of reclassifying patients undergoing pediatric heart reoperations of varying complexity by operation of highest complexity instead of by first operation. METHODS: Data from the Virtual Pediatric Systems Database on children aged < 18 years who underwent heart surgery (with or without cardiopulmonary bypass) were included (2009-2015). Only patients who underwent reoperations during the same hospitalization were included. Patients were classified based on the first cardiovascular operation (the index operation), and on the complexity of the operation (the operation with the highest Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery [STAT] mortality category of each hospital admission) performed. RESULTS: Of 51,047 patients (73 centers), 22,393 met inclusion criteria. Using index operation as the classifying operation, the number of patients classified in the STAT 1 category increased by approximately 2.5 times compared with the highest-complexity operation (index, 7,077 and highest complexity, 2,654). In contrast, when the highest-complexity classification was used, we noted an increase in the number of patients in other STAT categories. We also noted higher mortality in all STAT categories when patients were classified by index operation instead of by highest complexity (index vs highest STAT category 1, 0.6% vs 0.2%; category 2, 2.4% vs 0.8%; category 3, 3.1% vs 2.1%; category 4, 5.8% vs 5.6%; and category 5, 16.7% vs 16.5%). CONCLUSIONS: This study demonstrates differences in the reported number of patients and reported mortality in each STAT category among children undergoing various heart reoperations during the same hospitalization by classifying patients based on index operation compared with the operation of highest complexity.

Short-Axis Diastolic Ventricular Area Ratio as a New Index in Screening Patients with Repaired Tetralogy of Fallot.

Right ventricular (RV) end-diastolic volume measured by cardiovascular magnetic resonance imaging (CMR) is a criterion for pulmonary valve replacement in patients with tetralogy of Fallot (TOF). We sought to determine if the ratio of echocardiographic, short-axis RV-to-left ventricular (LV) end-diastolic areas (EDA) could be used to predict RV volume on CMR. We retrospectively reviewed the echocardiograms of all patients with repaired TOF who underwent CMR at our institution from 2011 to 2015 and also had an echocardiogram within 6 months of the CMR. The short-axis RV and LV EDAs were measured and the ratio of the two was calculated. Results were compared with CMR RV end-diastolic volume index (RVEDVi) and RV:LV end-diastolic volume ratio. The sensitivity and specificity values predicting RV volumes > 150 ml/m2 were calculated. Fifty-eight studies met inclusion criteria. There were 47 studies with RVEDVi < 150 ml/m2 and 11 with RVEDVi > 150 ml/m2. RV:LV EDA and CMR RV:LV end-diastolic volume ratio correlated strongly (r = 0.76, p < 0.0001). An RV:LV EDA ≥ 1.57 had a 90% sensitivity to predict RVEDVi > 150 ml/m2 (area under the curve = 0.74, 95% CI 1.5-27.9; p = 0.012). An RV:LV EDA ≥ 1.88 had an 81% specificity to detect RV volume index > 150 ml/m2. Short-axis RV:LV EDA correlates well with an increased RVEDVi as measured by CMR. This new and simple measure can be used to predict optimal timing for CMR in anticipation of pulmonary valve replacement in repaired TOF.

An Empirically Derived Pediatric Cardiac Inotrope Score Associated With Pediatric Heart Surgery.

We aimed to empirically derive an inotrope score to predict real-time outcomes using the doses of inotropes after pediatric cardiac surgery. The outcomes evaluated included in-hospital mortality, prolonged hospital length of stay, and composite poor outcome (mortality or prolonged hospital length of stay). The study population included patients <18 years of age undergoing heart operations (with or without cardiopulmonary bypass) of varying complexity. To create this novel pediatric cardiac inotrope score (PCIS), we collected the data on the highest doses of 4 commonly used inotropes (epinephrine, norepinephrine, dopamine, and milrinone) in the first 24 hours after heart operation. We employed a hierarchical framework by representing discrete probability models with continuous latent variables that depended on the dosage of drugs for a particular patient. We used Bayesian conditional probit regression to model the effects of the inotropes on the mean of the latent variables. We then used Markov chain Monte Carlo simulations for simulating posterior samples to create a score function for each of the study outcomes. The training dataset utilized 1030 patients to make the scientific model. An online calculator for the tool can be accessed at https://soipredictiontool.shinyapps.io/InotropeScoreApp. The newly proposed empiric PCIS demonstrated a high degree of discrimination for predicting study outcomes in children undergoing heart operations. The newly proposed empiric PCIS provides a novel measure to predict real-time outcomes using the doses of inotropes among children undergoing heart operations of varying complexity.

Is Magnet® recognition associated with improved outcomes among critically ill children treated at freestanding children's hospitals?

PURPOSE: With increasing emphasis on high-quality care, we designed this study to evaluate the relationship between Magnet® recognition and patient outcomes in pediatric critical care. MATERIALS AND METHODS: Post hoc analysis of data from an existing administrative national database. We used inverse probability of treatment weighting and multivariate models to compare outcomes between two study groups after adjusting for confounding variables. RESULTS: A total of 823,634 pediatric patients from 41 centers were included. Of these, 454,616 patients (55.2%) were treated in 23 Magnet hospitals. The majority of baseline characteristics did not vary significantly among the two study groups. In adjusted models, there was no difference in mortality between the two groups (Magnet vs. non-Magnet; odds ratio: 0.92, 95% confidence interval: 0.77-1.11). When stratified by various subgroups, such as cardiac, non-cardiac, ECMO, cardiac arrest, respiratory failure, use of nitric oxide, genetic abnormality etc., Magnet status of the hospital did not confer a survival advantage. In a sensitivity analysis on patients from crossover hospitals only, attainment of magnet status was associated with increased hospital charges. CONCLUSIONS: This large observational study calls into question the utility of the Magnet Recognition Program among children with critical illness, at least among the freestanding children's hospitals.

Development and Validation of an Empiric Tool to Predict Favorable Neurologic Outcomes Among PICU Patients.

OBJECTIVES: To create a novel tool to predict favorable neurologic outcomes during ICU stay among children with critical illness. DESIGN: Logistic regression models using adaptive lasso methodology were used to identify independent factors associated with favorable neurologic outcomes. A mixed effects logistic regression model was used to create the final prediction model including all predictors selected from the lasso model. Model validation was performed using a 10-fold internal cross-validation approach. SETTING: Virtual Pediatric Systems (VPS, LLC, Los Angeles, CA) database. PATIENTS: Patients less than 18 years old admitted to one of the participating ICUs in the Virtual Pediatric Systems database were included (2009-2015). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 160,570 patients from 90 hospitals qualified for inclusion. Of these, 1,675 patients (1.04%) were associated with a decline in Pediatric Cerebral Performance Category scale by at least 2 between ICU admission and ICU discharge (unfavorable neurologic outcome). The independent factors associated with unfavorable neurologic outcome included higher weight at ICU admission, higher Pediatric Index of Morality-2 score at ICU admission, cardiac arrest, stroke, seizures, head/nonhead trauma, use of conventional mechanical ventilation and high-frequency oscillatory ventilation, prolonged hospital length of ICU stay, and prolonged use of mechanical ventilation. The presence of chromosomal anomaly, cardiac surgery, and utilization of nitric oxide were associated with favorable neurologic outcome. The final online prediction tool can be accessed at https://soipredictiontool.shinyapps.io/GNOScore/. Our model predicted 139,688 patients with favorable neurologic outcomes in an internal validation sample when the observed number of patients with favorable neurologic outcomes was among 139,591 patients. The area under the receiver operating curve for the validation model was 0.90. CONCLUSIONS: This proposed prediction tool encompasses 20 risk factors into one probability to predict favorable neurologic outcome during ICU stay among children with critical illness. Future studies should seek external validation and improved discrimination of this prediction tool.

Congenital Heart Surgery on In-Hospital Mortality in Trisomy 13 and 18.

BACKGROUND AND OBJECTIVES: Congenital heart disease (CHD) is common in trisomy 13 (T13) and trisomy 18 (T18), but surgical repair has not been offered in most centers. Data on outcomes of congenital heart surgery (CHS) for T13 and T18 are lacking. We sought to determine the impact of CHS on in-hospital mortality in T13 and T18. METHODS: Data from the 2004 to 2015 Pediatric Health Information System database were used to identify inpatients with T13 or T18 and CHD. Data were restricted to newborns with T13 or T18 admitted at ≤14 days of age. Hospital readmissions were examined to analyze longer-term in-hospital mortality. In-hospital mortality and length of stay were compared between infants with and without CHD and with and without CHS. RESULTS: The study cohort included 1020 infants with T18 and 648 infants with T13. CHD was present in 91% of infants with T18 and 86% of infants with T13. CHS was performed in 7% of each group. In-hospital mortality was decreased in those who underwent CHS (64% lower in T18 [P <.001]; 45% lower in T13 [P = .003]) and remained decreased throughout the 24 months of follow-up. In-hospital mortality was decreased in infants with higher weight, female sex, and older age at admission. CONCLUSIONS: CHS is associated with decreased in-hospital mortality in T18 and T13. These results suggest CHS may be beneficial in select cases.

A prognostic tool to predict outcomes in children undergoing the Norwood operation.

OBJECTIVES: To create and validate a prediction model to assess outcomes associated with the Norwood operation. METHODS: The public-use dataset from a multicenter, prospective, randomized single-ventricle reconstruction trial was used to create this novel prediction tool. A Bayesian lasso logistic regression model was used for variable selection. We used a hierarchical framework by representing discrete probability models with continuous latent variables that depended on the risk factors for a particular patient. Bayesian conditional probit regression and Markov chain Monte Carlo simulations were then used to estimate the effects of the predictors on the means of these latent variables to create a score function for each of the study outcomes. We also devised a method to calculate the risk of outcomes associated with the Norwood operation before the actual heart operation. The 2 study outcomes evaluated were in-hospital mortality and composite poor outcome. RESULTS: The training dataset used 520 patients to generate the prediction model. The model included patient demographics, baseline characteristics, cardiac diagnosis, operation details, site volume, and surgeon experience. An online calculator for the tool can be accessed at https://soipredictiontool.shinyapps.io/NorwoodScoreApp/. Model validation was performed on 520 observations using an internal 10-fold cross-validation approach. The prediction model had an area under the curve of 0.77 for mortality and 0.72 for composite poor outcome on the validation dataset. CONCLUSIONS: Our new prognostic tool is a promising first step in creating real-time risk stratification in children undergoing a Norwood operation; this tool will be beneficial for the purposes of benchmarking, family counseling, and research.

Experience Using Kaolin-Impregnated Sponge to Minimize Perioperative Bleeding in Norwood Operation.

PURPOSE: A kaolin-impregnated hemostatic sponge (QuikClot) is reported to reduce intraoperative blood loss in trauma and noncardiac surgery. The purpose of this study was to assess if this sponge was effective for hemostasis during Norwood operation. DESCRIPTION: We conducted a retrospective review of patients undergoing Norwood operation in infancy between 2011 and 2016 at our institution. EVALUATION: Of 31 identified Norwood operations, a kaolin-impregnated sponge was used intraoperatively in 15 (48%) patients. The preoperative profiles and cardiopulmonary bypass status were similar between the operations with or without kaolin-impregnated sponge. The comparison on each operative outcome between operations with or without kaolin-impregnated sponge showed that the intraoperative platelets, cryoprecipitate, and factor VII dosage were significantly less in the operations with kaolin-impregnated sponge (55 mL, 10 mL, 0 µg/kg vs 72 mL, 15 mL, 45 µg/kg; P = .03, .021, .019), as well as the incidence of perioperative bleeding complications (second cardiopulmonary bypass for hemostasis or postoperative mediastinal exploration, 0% vs 31%, P = .043). A logistic regression model showed that the nonuse of kaolin-impregnated sponge and longer aortic cross clamp time were associated with perioperative bleeding complication in univariable model ( P = .02 and .005). CONCLUSIONS: Use of kaolin-impregnated hemostatic sponge was associated with reduced blood product use and perioperative bleeding complications in Norwood operation at a single institution.

A ferromagnetic surgical system reduces phrenic nerve injury in redo congenital cardiac surgery.

A ferromagnetic surgical system (FMwand®) is a new type of dissection device expected to reduce the risk of adjacent tissue damage. We reviewed 426 congenital cardiac operations with cardiopulmonary bypass through redo sternotomy to assess if this device prevented phrenic nerve injury. The ferromagnetic surgical system was used in 203 operations (47.7%) with regular electrocautery and scissors. The preoperative and operative details were similar between the operations with or without the ferromagnetic surgical system. The incidence of phrenic nerve injury was significantly lower with the ferromagnetic surgical system (0% vs 2.7%, P = 0.031). A logistic regression model showed that the use of the ferromagnetic surgical system was significantly associated with reduced odds of phrenic nerve injury (P < 0.001).

Characterizing cardiac arrest in children undergoing cardiac surgery: A single-center study.

OBJECTIVES: To characterize cardiac arrest in children undergoing cardiac surgery using single-center data from the Society of Thoracic Surgeons and Pediatric Advanced Life Support Utstein-Style Guidelines. METHODS: Patients aged 18 years or less having a cardiac arrest for 1 minute or more during the same hospital stay as heart operation qualified for inclusion (2002-2014). Patients having a cardiac arrest both before or after heart operation were included. Heart operations were classified on the basis of the first cardiovascular operation of each hospital admission (the index operation). The primary outcome was survival to hospital discharge. RESULTS: A total of 3437 children undergoing at least 1 heart operation were included. Overall rate of cardiac arrest among these patients was 4.5% (n = 154) with survival to hospital discharge of 84 patients (66.6%). Presurgery cardiac arrest was noted among 28 patients, with survival of 21 patients (75%). Among the 126 patients with postsurgery cardiac arrest, survival was noted among 84 patients (66.6%). Regardless of surgical case complexity, the median days between heart operation and cardiac arrest, duration of cardiac arrest, and survival after cardiac arrest were similar. The independent risk factors associated with improved chances of survival included shorter duration of cardiac arrest (odds ratio, 1.12; 95% confidence interval, 1.05-1.20; P = .01) and use of defibrillator (odds ratio, 4.51; 95% confidence interval, 1.08-18.87; P = .03). CONCLUSIONS: This single-center study demonstrates that characterizing cardiac arrest in children undergoing cardiac surgery using definitions from 2 societies helps to increase data granularity and understand the relationship between cardiac arrest and heart operation in a better way.

Single center experience of aortic bypass graft for aortic arch obstruction in children.

The purpose of this study is to access the outcomes of aortic bypass graft placement in children. This is a retrospective review of all children having aortic bypass graft placement for aortic arch obstruction for the first time between 1982 and 2013 at a single institution. The actuarial survival and the freedom from aortic arch reoperation were calculated and compared between the groups. Seventy consecutive children underwent aortic bypass graft placements. The median age and body weight at the operation were 14 days and 3.6 kg. There were 7 early deaths, 6 late deaths, and 7 heart transplants during the median follow-up of 10.8 years (0.0-31.5 years). The actuarial transplant free survival was 64.7 % at 20 years and the freedom from aortic arch reoperation was 50.5 % at 10 years. Between the children younger than 1 year old and older than 1 year old, there were significant differences in actuarial transplant free survival (56.4 vs. 100 % at 15 years, p = 0.0042) and in the freedom from aortic arch reoperation (18.7 vs. 100 % at 10 years, p < 0.001). The children who received aortic bypass graft larger than 16 mm in size had no aortic arch reoperation at 15 years. The aortic bypass graft placement for aortic arch obstruction can be done with low mortality and morbidity for children who can receive bypass graft larger than 16 mm in size. However, it should be avoided for the neonates and infants except selected situations.

Risk factors for mechanical ventilation and reintubation after pediatric heart surgery.

OBJECTIVE: To determine the prevalence of and risk factors associated with the need for mechanical ventilation in children following cardiac surgery and the need for subsequent reintubation after the initial extubation attempt. METHODS: Patients younger than 18 years who underwent cardiac operations for congenital heart disease at one of the participating pediatric intensive care units (ICUs) in the Virtual PICU Systems (VPS), LLC, database were included (2009-2014). Multivariable logistic regression models were fitted to identify factors likely associated with mechanical ventilation and reintubation. RESULTS: A total of 27,398 patients from 62 centers were included. Of these, 6810 patients (25%) were extubated in the operating room (OR), whereas 20,588 patients (75%) arrived intubated in the ICU. Of the patients who were extubated in the OR, 395 patients (6%) required reintubation. In contrast, 2054 patients (10%) required reintubation among the patients arriving intubated postoperatively in the ICU. In adjusted models, patient characteristics, patients undergoing high-complexity operations, and patients undergoing operations in lower-volume centers were associated with higher likelihood for the need for postoperative mechanical ventilation and need for reintubation. Furthermore, the prevalence of mechanical ventilation and reintubation was lower among the centers with a dedicated cardiac ICU in propensity-matched analysis among centers with and without a dedicated cardiac ICU. CONCLUSIONS: This multicenter study suggests that proportion of patients extubated in the OR after heart operation is low. These data further suggest that extubation in the OR can be done successfully with a low complication rate.

The Midterm Outcomes of Bioprosthetic Pulmonary Valve Replacement in Children.

The purpose of this study was to assess the outcomes of bioprosthetic pulmonary valve replacement (PVR) in children. This is a retrospective review of all bioprosthetic PVR in children (≤ 20-year old) between 1992 and 2013 at a single institution. Most outcomes studied included pulmonary valve reintervention and bioprosthetic valve function. A total of 136 bioprosthetic PVRs were identified for 123 patients. The median age and body weight at the time of operation were 13.2 years and 48.4 kg. There were 1 early death and 3 late deaths during the median follow-up of 7.2 years (0-22.0 years). The actuarial transplant-free survival was 97.6% at 10 years. There were 43 bioprosthesis reinterventions with 29 reoperations and 14 catheter-based interventions. The freedom from bioprosthesis reintervention was 89.6% and 55.0% at 5 and 10 years, respectively. Echocardiographic bioprosthesis dysfunction (≥ moderate bioprosthesis insufficiency, ≥ 50 mmHg peak gradient through bioprosthesis, or bioprosthesis endocarditis with vegetation) was found in 57 bioprostheses. The freedom from bioprosthesis dysfunction was 74.0% and 32.8% at 5 and 10 years, respectively. Results from the Cox proportional hazards models showed that age had significant association with freedom from bioprosthesis reintervention and freedom from bioprosthesis dysfunction (P < 0.001 and P = 0.03), whereas bioprosthesis type had nonsignificant association with freedom from bioprosthesis dysfunction (P = 0.068). Bioprosthetic PVR in children had excellent early outcomes but rapidly deteriorating midterm outcomes. Careful and close follow-up are necessary for children with bioprosthesis in the pulmonary position.

Valved Polytetrafluoroethylene Conduits for Right Ventricular Outflow Tract Reconstruction.

BACKGROUND: The purposes of this study were to review our early outcomes using valved expanded polytetrafluoroethylene (ePTFE) conduits, with or without bulging sinus structure, for right ventricular outflow tract reconstruction and to examine the mechanical properties of the ePTFE material after bulging sinuses were created. METHODS: A retrospective review was performed of all patients who received the valved ePTFE conduit between 2008 and 2014 at a single institution. The surface morphologies and the mechanical strengths of the ePTFE conduit with bulging sinuses examined by scanning electron microscopy and unidirectional pull test were compared with those of the original ePTFE material. RESULTS: There were 120 operations with the valved ePTFE conduit (60 with bulging sinuses). The patients median age and weight were 6.9 years and 23.7 kg. The conduits were a median size of 22 mm. At 5 years, freedom from conduit reoperation was 92.7% (95% confidence interval, 82.7% to 97.0%), and freedom from severe conduit insufficiency or more than a 50 mm Hg gradient was 74.8% (95% confidence interval, 60.8% to 84.4%). No significant differences in the surface morphologies were observed by the scanning electron microscopy or in the maximum tolerated loads obtained by the pull test between the original ePTFE material and the ePTFE with bulging sinuses (121 and 122 N in longitudinal direction and 115 and 121 N in circumferential direction; p = 0.88 and p = 0.68). CONCLUSIONS: The valved ePTFE conduits demonstrated excellent early clinical outcomes. The mechanical property examinations showed no obvious difference after bulging sinuses were created on the ePTFE material.

Outcome of right ventricle to pulmonary artery conduit for biventricular repair.

BACKGROUND: The objective of this study was to assess the outcomes of the right ventricle to pulmonary artery conduit for biventricular repair. METHODS: This is a retrospective review of all right ventricle to pulmonary artery conduit operations for biventricular repair of congenital heart disease between 1982 and 2013 at a single institution. Results were compared among the conduit size and materials. RESULTS: A total of 476 physiologic right ventricle to pulmonary artery conduit operations were identified, with 195 pulmonary homografts, 105 handmade valved expanded polytetrafluoroethylene conduits, 103 Medtronic Hancock (Minneapolis, MN) bioprosthetic valved conduits, 38 non-valved expanded polytetrafluoroethylene tubes, and 35 others. The actuarial survival was 92.4% and the freedom from conduit reoperation was 33.0% at 20 years. The freedom from conduit reoperation was significantly different among conduit materials (76.8%, 92.1%, 81.9%, 80.6%, and 63.8% for pulmonary homograft, valved expanded polytetrafluoroethylene conduit, Hancock conduit, non-valved expanded polytetrafluoroethylene tube, and others at 5 years, p = 0.0001). The Cox proportional hazards model showed that age (p < 0.001 and p = 0.04), preoperative diagnosis (p < 0.001 and p < 0.001), conduit size (p < 0.001 and p < 0.001), and conduit material (the valved expanded polytetrafluoroethylene conduit versus combined other materials; p = 0.01 and p = 0.02, respectively) were significant factors for the freedom from conduit reoperation both when treating conduit size as a categoric predictor and as a quantitative predictor. CONCLUSIONS: The handmade valved expanded polytetrafluoroethylene conduit showed excellent early outcome as a right ventricle to pulmonary artery conduit for biventricular repair. A longer follow-up and a randomized study will be necessary to explore the advantages of the valved expanded polytetrafluoroethylene conduit.