Biatrial Thrombi on a Gore Septal Occluder Despite Early Epithelialization.

ASD and PFO device-related thrombus is an uncommon phenomenon that can be seen both early- and late-post-closure. Typical risk factors include atrial fibrillation, hypercoagulable diseases/states, and lack of device endothelialization. We present an interesting case of a 15-year-old female who underwent PFO device closure after a renal infarction and was found to have biatrial device thrombus 3-month post-closure. She initially was managed with anticoagulation and antiplatelet therapy with intermittent systemic tPA but subsequently developed a new left atrial thrombus after complete resolution. Her device was surgically removed and found to be fully endothelialized. Her case highlights the lack of current guidelines for ASD/PFO device-related thrombus.

Incidence, Predictors, and Outcomes of Cardiac Perforation During Pediatric Cardiac Catheterization: a Retrospective Observational Study from the Congenital Cardiac Interventional Study Consortium (CCISC).

INTRODUCTION: Cardiac perforation is a rare life-threatening complication of cardiac catheterization. There is very little published literature detailing risk factors for cardiac perforation and outcomes from this complication in children. MATERIALS AND METHODS: This was a retrospective study analyzing the cardiac catheterization case registry of the Congenital Cardiovascular Interventional Study Consortium. Children aged < 18 years were included during the study period of 9 years (January 2009-December 2017). The primary outcome measures were incidence of cardiac perforation, risk factors for and outcomes of patients who experience cardiac perforation during cardiac catheterization. RESULTS: Cardiac perforation occurred in 50 patients from a total of 36,986 (0.14%). Cardiac perforation was more likely to occur in younger, smaller patients undergoing urgent/emergent and interventional procedures (p < 0.01). Cardiac peroration risk was significantly different across diagnostic and procedure categories (p < 0.01). Higher CRISP score (Area Under Curve [AUC] = 0.87), lower age, and procedure category (radiofrequency perforation of pulmonary valve, AUC = 0.84) were independent predictors of cardiac perforation. Cardiac perforation was associated with a significantly higher rate of mortality (14%), further emergency procedure (42%), ECMO (14%), and cardiac arrest (6%), p < 0.01. CONCLUSIONS: Cardiac perforation during cardiac catheterization is a life-threatening complication with a range of associated secondary complications. Higher CRISP score, lower age, and radiofrequency perforation of pulmonary valve are independent predictors.

Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams.

OBJECTIVES: Characterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure. BACKGROUND: The presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature. METHODS: This was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ≥700 g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ≤2 kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6 months' follow-up. RESULTS: The implant success rate was 95.5% (191/200) overall and 99% in patients ≤2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ≤2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ≥700 g. CONCLUSIONS: This study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700 g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.

Validation and refinement of the catheterization RISk score for pediatrics (CRISP score): An analysis from the congenital cardiac interventional study consortium.

OBJECTIVES: To externally validate the CRISP score, and determine if refinements might improve clinical utility. BACKGROUND: The CRISP score estimates risk of serious adverse events (SAEs) for pediatric catheterization. METHODS: Pediatric (age < 18) procedures reported to the Congenital Cardiovascular Interventional Study Consortium registry from 05/08 to 09/17 (n = 29,830, 27 centers) were divided into a development dataset of 14,784 earlier procedures, and a validation dataset of 15,046 more recent procedures. The development dataset was used to refit the original CRISP model, and to develop a revised(r) CRISP score, consisting of entirely pre-procedurally collected data. The validation dataset was then used to compare model fit and risk prediction between CRISP, rCRISP and two existing risk scores using Akaike's (AIC), Schwarz's (BIC) Bayes Information Criteria, -log Likelihood (N2LL), area under the receiver operator curve and chi-square goodness-of-fit statistic (across 5 risk categories). RESULTS: Overall 4.31% of patients experienced at least one SAE with frequency increasing from 1.08% in CRISP category 1 to 27.34% in category 5. Both CRISP and rCRISP (entirely pre-procedural) predicted risk of SAEs well, with observed to predicted ratios ranging from 0.71 to 1.18 across the 5 risk categories. Compared to the original CRISP score, rCRISP demonstrated less optimal model fit (higher AIC, BIC, and N2LL) but similar risk prediction (C-statistic = 0.71 vs. 0.70; chi-squared statistic = 6.77 vs. 6.85). CONCLUSION: The CRISP score accurately predicts procedural risk. With minor modifications, the revised version (rCRISP) performed well with arguably greater clinical utility as an entirely preprocedural risk model.

Modeling Major Adverse Outcomes of Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Catheterization: Observations From the NCDR IMPACT Registry (National Cardiovascular Data Registry Improving Pediatric and Adult Congenital Treatment).

BACKGROUND: Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment). METHODS: Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%. RESULTS: The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95). CONCLUSIONS: The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement.

An unusual case of coronary artery compression that did not preclude successful transcatheter pulmonary valve placement.

During transcatheter pulmonary valve placement, coronary compression observed during simultaneous right ventricular outflow tract angioplasty and coronary angiography typically contraindicates valve implantation. We present a unique patient with tetralogy of Fallot who underwent successful transcatheter Melody valve placement despite coronary compression observed during right ventricular outflow tract balloon angioplasty.

Risk Factors for an Elevated Ventricular End-Diastolic Pressure Prior to the Fontan Operation.

Systemic ventricular end-diastolic pressure (SVEDP) is an important determinant of pulmonary artery pressure in those with a Fontan circulation. Predictors of an elevated SVEDP have been incompletely identified in this population. All who underwent the Fontan operation at our center between 1/2009 and 12/2013 were retrospectively identified. SVEDP at the pre-Fontan catheterization and other patient variables were extracted. We identified 61 patients. Pre-Fontan SVEDP was positively associated with systemic ventricular systolic pressure (ß = 0.4, p = 0.004), aortic systolic pressure (ß = 0.3, p = 0.007), aortic mean pressure (ß = 0.3, p = 0.02), and decreased ventricular systolic function (p = 0.03). Compared to those with pre-Fontan SVEDP ≤ 7 mmHg, patients with SVEDP > 7 mmHg had higher average ventricular systolic pressure (85.0 ± 7.5 vs. 78.7 ± 8.3 mmHg, p = 0.003), higher average descending aorta mean pressure (62.4 ± 4.9 vs. 58.6 ± 8.1 mmHg, p = 0.03), and a higher incidence of decreased ventricular systolic function (36 vs. 15%, p = 0.07). For those with a systemic right ventricle, the SVEDP decreased significantly from the pre-Stage 2 to pre-Fontan measurements (8.7 ± 2.6 vs. 7.3 ± 2.0 mmHg, p = 0.02), but not for those with a systemic left ventricle (7.8 ± 2.0 vs. 7.2 ± 1.8 mmHg, p = 0.3). At pre-Fontan catheterization, decreased ventricular systolic function and markers of systemic afterload were positively associated with the SVEDP. SVEDP decreased significantly after Stage 2 for those with a systemic right ventricle, but not for those with a systemic left ventricle; the systemic right ventricle may be particularly vulnerable to pre-Stage 2 volume loading.

Prediction of adverse events after catheter-based procedures in adolescents and adults with congenital heart disease in the IMPACT registry.

AIMS: We sought to identify factors associated with major adverse events (MAE) after cardiac catheterization in adolescents and adults with congenital heart disease (CHD), and create the first model to individualize risk discussions in this growing population. METHODS AND RESULTS: Improving Pediatric and Adult Congenital Treatment (IMPACT), a National Cardiovascular Data Registry, contains congenital catheterization data from over 87 hospitals in the United States. Demographics, pre-procedure, and procedural variables were collected for patients over age 10. Multivariable logistic regression was used to identify significant predictors of MAE, a composite of death, urgent surgery or procedure due to a catheterization complication, transfusion, embolic stroke, tamponade, extracorporeal membrane oxygenation or ventricular assist device placement, and device embolization, malposition or thrombosis requiring surgical intervention. A risk score was built based on the effect sizes of each predictor and validated in a split sample. A MAE occurred in 686 (2.5%) of the 27 293 index procedures meeting inclusion criteria. The independent multivariate predictors of MAE were older age, pre-procedural anticoagulation use, renal disease, lower haemoglobin, lower oxygen saturation, non-elective procedure, higher index procedure risk and having had no prior cardiac procedures. Being underweight or overweight had borderline significance and was added to the model. The C-statistic for the model was robust at 0.787 in the derivation and 0.773 in the validation cohort. CONCLUSION: The factors predicting adverse events after cardiac catheterization in adolescents and adults with CHD are different than in the general population. Validation of this model in other national or multi-institutional datasets is the next step.

SCAI/CCAS/SPA expert consensus statement for anesthesia and sedation practice: Recommendations for patients undergoing diagnostic and therapeutic procedures in the pediatric and congenital cardiac catheterization laboratory.

Current practice of sedation and anesthesia for patients undergoing pediatric congenital cardiac catheterization laboratory (PCCCL) procedures is known to vary among institutions, a multi-society expert panel with representatives from the Congenital Heart Disease Council of the Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Pediatric Anesthesia (SPA) and the Congenital Cardiac Anesthesia Society (CCAS) was convened to evaluate the types of sedation and personnel necessary for procedures performed in the PCCCL. The goal of this panel was to provide practitioners and institutions performing these procedures with guidance consistent with national standards and to provide clinicians and institutions with consensus-based recommendations and the supporting references to encourage their application in quality improvement programs. Recommendations can neither encompass all clinical circumstances nor replace the judgment of individual clinicians in the management of each patient. The science of medicine is rooted in evidence, and the art of medicine is based on the application of this evidence to the individual patient. This expert consensus statement has adhered to these principles for optimal management of patients requiring sedation and anesthesia. What follows are recommendations for patient monitoring in the PCCCL regardless of whether minimal or no sedation is being used or general anesthesia is being provided by an anesthesiologist. © 2016 Wiley Periodicals Inc.

CRISP: Catheterization RISk score for Pediatrics: A Report from the Congenital Cardiac Interventional Study Consortium (CCISC).

OBJECTIVES: We sought to develop a scoring system that predicts the risk of serious adverse events (SAE's) for individual pediatric patients undergoing cardiac catheterization procedures. BACKGROUND: Systematic assessment of risk of SAE in pediatric catheterization can be challenging in view of a wide variation in procedure and patient complexity as well as rapidly evolving technology. METHODS: A 10 component scoring system was originally developed based on expert consensus and review of the existing literature. Data from an international multi-institutional catheterization registry (CCISC) between 2008 and 2013 were used to validate this scoring system. In addition we used multivariate methods to further refine the original risk score to improve its predictive power of SAE's. RESULTS: Univariate analysis confirmed the strong correlation of each of the 10 components of the original risk score with SAE attributed to a pediatric cardiac catheterization (P < 0.001 for all variables). Multivariate analysis resulted in a modified risk score (CRISP) that corresponds to an increase in value of area under a receiver operating characteristic curve (AUC) from 0.715 to 0.741. CONCLUSION: The CRISP score predicts risk of occurrence of an SAE for individual patients undergoing pediatric cardiac catheterization procedures.

SCAI/CCAS/SPA Expert Consensus Statement for Anesthesia and Sedation Practice: Recommendations for Patients Undergoing Diagnostic and Therapeutic Procedures in the Pediatric and Congenital Cardiac Catheterization Laboratory.

Current practice of sedation and anesthesia for patients undergoing pediatric and congenital cardiac catheterization laboratory (PCCCL) procedures is known to vary among institutions, a multi-society expert panel with representatives from the Congenital Heart Disease Council of the Society for Cardiovascular Angiography and Interventions, the Society for Pediatric Anesthesia and the Congenital Cardiac Anesthesia Society was convened to evaluate the types of sedation and personnel necessary for procedures performed in the PCCCL. The goal of this panel was to provide practitioners and institutions performing these procedures with guidance consistent with national standards and to provide clinicians and institutions with consensus-based recommendations and the supporting references to encourage their application in quality improvement programs. Recommendations can neither encompass all clinical circumstances nor replace the judgment of individual clinicians in the management of each patient. The science of medicine is rooted in evidence, and the art of medicine is based on the application of this evidence to the individual patient. This expert consensus statement has adhered to these principles for optimal management of patients requiring sedation and anesthesia. What follows are recommendations for patient monitoring in the PCCCL regardless of whether minimal or no sedation is being used or general anesthesia is being provided by an anesthesiologist.

Standardizing radiation dose reporting in the pediatric cardiac catheterization laboratory-a multicenter study by the CCISC (Congenital Cardiovascular Interventional Study Consortium).

OBJECTIVES: We examine normalized air Kerma area product (PKA ) by body weight (PKA /BW) as a reference value of radiation dose and benchmark PKA /BW in pediatric laboratories using a multicenter registry database. BACKGROUND: Reduction of radiation dose is an important quality improvement task in pediatric cardiac catheterization laboratories. Physicians need to agree on a standard method of reporting radiation dose that would allow comparisons to be made between operators and institutions. METHODS: This was a multicenter observational study of radiation dose in pediatric laboratories. Patient demographic, procedural and radiation data including fluoroscopic time and PKA (µGy m(2) ) were analyzed. PKA /BW was obtained by indexing PKA to body weight. RESULTS: A total of 8,267 pediatric catheterization procedures (age <18 years) were included from 16 institutions. The procedures consisted of diagnostic (n = 2,827), transplant right ventricular (RV) biopsy (n = 1,172), and interventional catheterizations (n = 4268). PKA correlated with body weight better than with age and best correlated with weight-fluoroscopic time product. PKA /BW showed consistent values across pediatric ages. Interventional catheterizations had the highest PKA /BW (50th, 75th, and 90th percentiles: 72, 151, and 281 µGy m(2) /kg), followed by diagnostic (59, 105, and 175 µGy m(2) /kg) and transplant RV biopsy (27, 79, and 114 µGy m(2) /kg). CONCLUSION: PKA /BW appeared to be the most reliable standard to report radiation dose across all procedure types and patient age. We recommend PKA /BW to be used as the standard unit in documenting radiation usage in pediatric laboratories and can be used to evaluate strategies to lower radiation dosage in pediatric patients undergoing cardiac catheterizations. © 2014 Wiley Periodicals, Inc.

Usefulness of PREDIC3T Case Type Risk Category in the CRISP Registry.

Procedural risk in Congenital Cardiac Catheterization (PREDIC3T) was recently reported as the contemporary procedure-type risk metric by the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. The usefulness of this metric has not been evaluated elsewhere. The CRISP registry of Congenital Cardiovascular Interventional Study Consortium (CCISC) data set was analyzed. The study period was 14 years (2009 to 2022). The primary outcome was significant adverse event (SAE). Cases were assigned to the 6 PREDIC3T risk categories. Univariate and multivariable logistic regression models were used to evaluate the association between PREDIC3T and the primary outcome. The model discriminative performance was evaluated by the c-statistic. In a total of 64,419 enrolled cases, PREDIC3T case types were assigned in 59,822 cases (93%). The frequency for PREDIC3T category was 0 = 7,494 (12.5%), 1 = 16,932 (28.3%), 2 = 17,023 (28.5%), 3 = 9,885 (16.5%), 4 = 4,403 (7.4%), and 5 = 4,085 (6.8%). SAE was observed in 2,474 cases (4.1%). The SAE rates for category were 0 = 1.0%, 1 = 2.3%, 2 = 4.0%, 3 = 6.2%, 4 = 8.2%, and 5 = 9.0%. In a multivariable model, PREDIC3T case type risk category (odds ratios for category: 0 = 0.49, 1 = 1.00, 2 = 1.40, 3 = 2.06, 4 = 2.79, and 5 = 3.15; p <0.001) were significantly associated with SAE (c-statistic of 0.707) after adjusting for age, preprocedural inotropic support and systemic illness, low systemic saturation, high pulmonary vascular resistance, and the use of general anesthesia. The PREDIC3T case type risk category was associated with the risk of SAE in the CRISP registry data set and appeared to be a useful procedural risk classification tool.

Balloon angioplasty and stent implantation performed through systemic-to-pulmonary artery shunts in infants and neonates.

Branch pulmonary artery stenosis (BPAS) in the setting of systemic-pulmonary artery shunts (SPS) may result in significant sequelae. Limited information exists regarding the safety and efficacy of pulmonary artery balloon angioplasty and stent implantation via SPS in neonates and infants. This study aimed to examine the feasibility, safety, and efficacy of balloon angioplasty/stent implantation for BPAS performed via SPS in neonates and infants. A single-center retrospective analysis of all patients weighing 10 kg or less who underwent angioplasty for BPAS via SPS was performed. Systemic oxygen saturations and vessel diameter before, during, and after the procedure were compared. Between July 1996 and February 2008, 15 patients underwent 20 catheterizations for the treatment of 27 BPAS via SPS. The patients had a mean weight of 5.6 kg (range, 2.6-10 kg) and a mean age of 7.6 months (range, 7 days to 33 months). The SPS diameter ranged between 2 and 5 mm (median, 3.5 mm). Angioplasty was performed for all 27 lesions, and an additional stent was placed in 5 of these. The average lesion diameter increased from 2.3 ± 1.5 to 4.7 ± 1.7 mm (p < 0.05), and 25 (93 %) of the 27 lesions met the predetermined criteria for success. Systemic oxygen saturation increased from 73 ± 9.5 % to 82 ± 6.8 % immediately after intervention and was 83 ± 7.9 % at discharge (p < 0.05). There were no instances of shunt thrombosis. Two patients experienced transient hypotension during the procedure. No procedural deaths occurred. The study findings suggest that balloon angioplasty or stent implantation performed via SPS appears to be safe and effective treatment for BPAS in neonates and infants.

Shunt reduction to pulmonary arteriovenous malformations using a modified covered stent.

Pulmonary arteriovenous malformations in patients with congenital heart disease have been associated with interruption of hepatic venous return to the lungs. We report a novel technique to improve systemic saturation using a modified covered stent in a patient with unilateral left pulmonary arteriovenous malformations in the setting of a Fontan circulation.

Combination Chemotherapy in Severe Pulmonary Vein Stenosis-A Case Series.

Pulmonary vein stenosis results from a proliferative process that leads to the progressive obstruction of venous return to the left atrium. It is often resistant to catheterization and surgical based interventions and is frequently fatal when encountered in its severe form. Here, we describe three patients with severe, primary pulmonary vein stenosis that was progressing despite aggressive conventional management strategies. All three patients were initiated on combination chemotherapy with imatinib and sirolimus, drugs which have been previously shown to independently have potential benefit against PVS. Soon after the initiation of these therapies, all three patients experienced a stabilization of their disease process and clinical improvement. All three patients remain alive, with tolerable side effects from the medications. Although early in our experience and with only a small number of patients, combination chemotherapy with imatinib and sirolimus shows promise and merits further investigation as a therapeutic option for this aggressive disease.

In-Silico and In-Vitro Analysis of the Novel Hybrid Comprehensive Stage II Operation for Single Ventricle Circulation.

Single ventricle (SV) anomalies account for one-fourth of all congenital heart disease cases. The existing palliative treatment for this anomaly achieves a survival rate of only 50%. To reduce the trauma associated with surgical management, the hybrid comprehensive stage II (HCSII) operation was designed as an alternative for a select subset of SV patients with the adequate antegrade aortic flow. This study aims to provide better insight into the hemodynamics of HCSII patients utilizing a multiscale Computational Fluid Dynamics (CFD) model and a mock flow loop (MFL). Both 3D-0D loosely coupled CFD and MFL models have been tuned to match baseline hemodynamic parameters obtained from patient-specific catheterization data. The hemodynamic findings from clinical data closely match the in-vitro and in-silico measurements and show a strong correlation (r = 0.9). The geometrical modification applied to the models had little effect on the oxygen delivery. Similarly, the particle residence time study reveals that particles injected in the main pulmonary artery (MPA) have successfully ejected within one cardiac cycle, and no pathological flows were observed.

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams.

OBJECTIVE: This study describes 3-year follow-up of 200 infants weighing ≥ 700 grams who underwent transcatheter patent ductus arteriosus (PDA) closure with the Amplatzer Piccolo™ Occluder. STUDY DESIGN: Between June 2017 and February 2019, 200 children were enrolled in this U.S. study (NCT03055858). PDA closure, survival, and device- or procedure-related events were evaluated. A total of 156 of the available 182 patients (86%) completed the study. RESULTS: The implant success rate was 95.5% (191/200). At 3 years, PDA closure was observed in 100% (33/33) of patients. Survival was >95% with 9 reported deaths. No deaths were adjudicated as device- or procedure-related. Notable events included aortic obstruction (2) requiring stent placement and tricuspid regurgitation (5), for which no interventions were required. CONCLUSIONS: This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years. The Amplatzer Piccolo™ Occluder is a safe and effective therapy for PDA treatment in premature infants. CLINICALTRIALS: gov identifier: NCT0305585.

Randomized trial of cutting balloon compared with high-pressure angioplasty for the treatment of resistant pulmonary artery stenosis.

BACKGROUND: We sought to determine the safety and efficacy of Cutting Balloon therapy (CB) compared with conventional high-pressure balloon therapy (HPB) for the treatment of pulmonary artery stenosis. METHODS AND RESULTS: This prospective, randomized, multicenter, investigational device exemption trial compared CB with HPB. Patient eligibility was determined at the precatheterization assessment; vessel eligibility was determined at catheterization. In all vessels, low-pressure balloon dilation to 8 atm was performed, and if it was not successful, the vessel was randomized to CB or HPB. The primary efficacy outcome was percent change in minimum lumen diameter. A core laboratory performed all vessel measurements and angiographic assessment of vessel damage. The primary safety outcome was any serious adverse event attributable to vessel dilation as assessed by the Data and Safety Monitoring Board. Seventy-three patients from 8 institutions were enrolled between 2004 and 2008. In these patients, 72 vessels responded to low-pressure balloon dilation. Of the 173 vessels that met eligibility criteria, 107 were randomized to CB and 66 to HPB. In randomized vessels, CB therapy was associated with greater percent increase in lumen diameter (85% versus 52%; P=0.004). After crossover was introduced, 26 of 47 vessels treated with HPB underwent CB therapy and experienced an additional 48% increase in lumen diameter; the final diameter after CB was 99% greater than the initial diameter. There were no serious adverse events related to treatment in a study vessel. CONCLUSION: CB therapy for pulmonary artery stenosis not responsive to low-pressure balloon is more effective than HPB therapy and has an equivalent safety profile.

The Fontan operation: the pursuit of associated lesions and cumulative trauma.

Our programmatic approach to the Fontan operation has evolved to include using an extracardiac conduit with aggressive presumptive treatment of associated lesions either in the catheterization laboratory or the operating room. Fenestration is used selectively based on hemodynamics, anatomy, and presence of associated lesions. We reviewed our experience to determine the effectiveness and outcome of this strategy and to assess the cumulative trauma to the patients. The records of 137 consecutive patients who underwent Fontan at Miami Children's Hospital from 1995 to 2008 were reviewed. At mean follow up of 5.76 years, freedom from death or transplantation is 94.2% (129/137). Median age at operation was 4.6 years. Longer length of stay correlated with older operative age (P = 0.0056). Pacemakers were implanted in 11.7% (16/137). Additional (not pre-Glenn or pre-Fontan) interventional catheterizations were performed in 51.8% (71/137). Additional operations were done in 10.2% (14/137). No patient has required replacement or revision of the extracardiac conduit. Our current approach to the Fontan operation provides acceptable midterm results. The pursuit of residual lesions results in a significant number of additional interventional catheterizations and operative procedures but might have an important influence on long-term survival after the Fontan procedure.