Utility of perinatal natriuretic peptide for predicting neonatal heart failure.

BACKGROUND: We evaluated the significance of perinatal plasma natriuretic peptide (NP) levels in neonates with congenital heart defects (CHDs) or arrhythmias and determined whether measurement of perinatal plasma NP levels and echocardiographic assessment in utero could predict heart failure after birth. METHODS: The study was conducted between 2012 and 2016 to evaluate the correlation of perinatal atrial NP (ANP) and brain NP (BNP) levels at birth with the modified Ross score after birth and the cardiovascular profile (CVP) score before birth. RESULTS: A total of 122 singletons with CHDs or arrhythmias and 27 controls were analyzed. Neonatal blood sampling was performed at a median of 0.7 h (range, 0.1-1.5) after birth. The neonatal plasma ANP and BNP levels shortly after birth were significantly higher than those in the umbilical artery (UA) plasma. The ANP and BNP levels in UA and neonatal blood were correlated with the modified Ross score. The neonatal plasma ANP and BNP levels and the modified Ross scores were inversely correlated with the CVP score in neonates with CHDs or arrhythmias. The area under the receiver operating characteristic curve of UA ANP levels for predicting neonatal heart failure was highest among those for the CVP score, perinatal plasma ANP and BNP levels, and their combinations. CONCLUSIONS: The plasma ANP and BNP levels increased markedly shortly after birth. Assessment of the UA plasma ANP level at birth and the CVP score in utero may be utilized to predict neonatal heart failure.

Plasma natriuretic peptide levels reflect the status of the heart failure in fetuses with arrhythmia.

OBJECTIVES: To evaluate the significance of natriuretic peptide (NP) levels in fetal arrhythmia. STUDY DESIGN: Cardiovascular profile (CVP) scores and umbilical vein (UV) NP levels at birth were compared by different fetal arrhythmia statuses. RESULTS: Fetal tachyarrhythmia (n = 22), bradyarrhythmia (n = 12), extrasystole (n = 12) and controls (n = 127) were enrolled in this study. Fetal antiarrhythmic therapy was performed in fetuses with tachyarrhythmia (n = 18) and bradyarrhythmia (n = 5). Fetal arrhythmias were divided into three groups: group A (arrhythmia controlled at birth, n = 17), Group B (arrhythmia uncontrolled at birth, n = 9) and Group C (fetal therapy not indicated, n = 20). Group B had significantly lower CVP scores and higher NP levels than the other two groups and controls (p < .01). Groups A and C had significantly lower CVP scores than controls, but NP levels in Groups A and C showed no differences compared with controls. CONCLUSIONS: UV NP concentrations reflect the severity of fetal arrhythmia and responses to fetal therapy.

Prognostic value of von Willebrand factor in adult patients with congenital heart disease.

OBJECTIVES: von Willebrand factor (vWF) has prognostic value in patients with heart failure (HF) and in those with liver disease. Liver congestion, due to right-sided HF (RHF), is one of the major clinical pathophysiologic manifestations in adults with congenital heart disease (ACHD). The present study's purpose was to clarify the prognostic value of plasma levels of vWF antigen (vWF:Ag) in ACHD. METHODS: We measured vWF:Ag (%) in 382 consecutive patients (20 unrepaired cyanotic ACHD, 172 Fontan patients and 190 ACHD after biventricular repair) and compared the results with the clinical profiles and prognosis. RESULTS: The plasma vWF:Ag level was 130±53 (normal range: 55%-190%), and 48 patients (13%) showed high levels of vWF:Ag (≥190%). Older age, Fontan circulation, higher central venous pressure, lower arterial oxygen saturation and lower plasma levels of albumin were independently associated with high log (vWF:Ag) (p<0.05-0.0001). During the follow-up of 2.4±1.4 years, 15 patients died. High log (vWF:Ag) predicted the all-cause mortality (HR 1.63 per 0.1, 95% CI 1.40 to 1.96, p<0.0001). Specifically, patients with high vWF:Ag (≥165%) had a substantially higher risk of all-cause mortality (HR 56.4, 95% CI 11.4 to 1020, p<0.0001), and this prognostic value was independent of plasma levels of brain-type natriuretic peptide. CONCLUSIONS: High vWF:Ag may reflect RHF severity and related liver dysfunction with a strong prognostic value of all-cause mortality in ACHD. Thus, vWF:Ag might be an excellent biomarker for monitoring ACHD with RHF.

Retraction Note to: Primary Draining Vein Stenting for Obstructive Total Anomalous Pulmonary Venous Connection in Neonates with Right Atrial Isomerism and Functional Single Ventricle Improves Outcome.

The authors have retracted this article [1] because, contrary to the statement in the article, this research did not obtain ethics approval from the National Cerebral and Cardiovascular Center Institutional Review Board prior to submission of the manuscript to Pediatric Cardiology. All authors agree to this retraction.

Cardiovascular profile and biophysical profile scores predict short-term prognosis in infants with congenital heart defect.

AIM: To predict the prognosis of infants with congenital heart disease, accurate prenatal diagnosis of structural abnormality and heart failure are both necessary. The aim of this study was to investigate whether cardiovascular profile (CVP) and biophysical profile (BP) scores are useful for predicting prognosis in infants with congenital heart defect (CHD). METHODS: A retrospective review of singletons prenatally diagnosed with CHD at a tertiary pediatric cardiac center between 2011 and 2015 was undertaken. RESULTS: A total of 202 patients with CHD were analyzed. Perinatal and infant deaths occurred in 16 (7.9%) and 10 cases (5.0%), respectively. Infants with the last CVP score ≤ 5 had 18.7-fold higher perinatal mortality than those with a last CVP score > 5 (P < 0.01). Infants with a last BP score ≤ 6 had 18.7-fold higher perinatal mortality than those with a last BP score > 6 (P < 0.01). Infants with a CVP score decrease in utero had 4.5-fold higher infant mortality than those with an increase or no change (P < 0.01). Multivariate analysis showed that single-ventricle physiology, pre-term birth at <37 weeks of gestation, last CVP score ≤ 5, and last BP score ≤ 6 were independent predictors of perinatal mortality. Single-ventricle physiology and a CVP score decrease were independent predictors of infant mortality. CONCLUSION: CVP and BP scores are useful for predicting perinatal prognosis in infants with CHD. A CVP score decrease in utero is associated with infant mortality, suggesting that serial CVP score assessment may be useful for management planning.

Prediction of postnatal arrhythmia in fetuses with cardiac rhabdomyoma.

OBJECTIVES: Fetal cardiac rhabdomyomas are rare but well-known to be associated with arrhythmia or conduction abnormalities. However, since in utero electrophysiological information is quite limited, it remains unclear which type of rhabdomyoma will develop arrhythmia after birth. The aim of this study is to identify factors that predict postnatal arrhythmia requiring therapy in fetuses with cardiac rhabdomyoma. STUDY DESIGN: A retrospective review of infants prenatally diagnosed with cardiac rhabdomyoma was performed at our tertiary pediatric cardiac center between 1990 and 2016. Fetal arrhythmia was diagnosed using fetal echocardiography and magnetocardiography. We compared the characteristics of cases with and without antiarrhythmic therapy after birth. Cases without antiarrhythmic therapy after birth consisted of those who had postnatal arrhythmia but did not require antiarrhythmic therapy and those who had no postnatal arrhythmia. RESULTS: A total of 20 fetuses with cardiac rhabdomyoma were included in this study. Ten cases (50%) were confirmed as having tuberous sclerosis after birth. The mean gestational week at diagnosis and delivery were 32.1 ± 2.7 and 37.6 ± 2.8 weeks, respectively. Mean cardiac tumor size in utero was 21 ± 11 mm (range, 7-54 mm) in diameter. Fetal arrhythmia was found in six cases; three resolved in utero with transplacental antiarrhythmic therapy. Postnatal arrhythmia or conduction abnormalities were found in 12 cases; 7 required antiarrhythmic therapy. Cases with antiarrhythmic therapy after birth had larger cardiac tumor in utero than those without therapy (29.6 ± 12.8 mm versus 16.3 ± 5.8 mm, p < .01). Cardiac tumor size >30 mm in diameter predicted postnatal arrhythmia requiring therapy with sensitivity of 57.1% and specificity of 100%. Location and number of cardiac tumor and presence of arrhythmia or conduction abnormalities in utero were similar between the two groups. CONCLUSIONS: Cardiac rhabdomyomas >30 mm in diameter are associated with postnatal arrhythmia requiring therapy regardless of number and location.

Amniotic Fluid Natriuretic Peptide Levels in Fetuses With Congenital Heart Defects or Arrhythmias.

BACKGROUND: We have previously demonstrated that umbilical cord plasma natriuretic peptide (NP) levels reflect the severity of heart failure (HF) in fetuses with congenital heart defects (CHD). The aim of this study was to evaluate the significance of amniotic fluid (AF) NP levels in the assessment of HF in fetuses with CHD or arrhythmia. Methods and Results: This was a prospective observational study at a tertiary pediatric cardiac center. A total of 95 singletons with CHD or arrhythmia, and 96 controls from 2012 to 2015 were analyzed. AF concentrations of atrial NP (ANP), B-type NP (BNP) and N-terminal pro-B-type NP (NT-proBNP) at birth were compared with ultrasonographic assessment of fetal HF using the cardiovascular profile (CVP) score. Multivariate analysis showed that a CVP score ≤5 and preterm birth are independently associated with high AF NT-proBNP levels. AF NT-proBNP levels of fetuses with CHD or arrhythmia inversely correlated with CVP score (P for trend <0.01). In contrast, AF concentrations of ANP and BNP were extremely low, and it was difficult to assess the degree of fetal HF based on them. CONCLUSIONS: AF NT-proBNP concentrations increase in stepwise fashion with the severity of HF in fetuses with CHD or arrhythmia; it was the optimal NP for assessing the fetal HF.

Primary Draining Vein Stenting for Obstructive Total Anomalous Pulmonary Venous Connection in Neonates with Right Atrial Isomerism and Functional Single Ventricle Improves Outcome.

For neonates with right atrial isomerism (RAI), functional single ventricle (f-SV), and obstructive total anomalous pulmonary venous connection (TAPVC), primary TAPVC repair (TAPVCR) has a poor outcome. At our hospital, the survival rate at 1 year of such neonates undergoing primary TAPVCR between 1999 and 2010 (TAPVCR group) was 30% (3/10). Most deceased cases suffered from capillary leak syndrome and unstable pulmonary resistance after the surgeries. We sought to determine whether less invasive primary draining vein stenting (DVS) improved the outcome of these neonates. We investigated outcomes in consecutive nine such neonates (median gestational age 38 weeks, birth weight 2.8 kg, females 4) who underwent primary DVS with 6-mm-diameter Palmaz® Genesis® stents at our hospital between 2007 and 2017 (DVS group). Eight patients underwent subsequent surgeries to adjust the pulmonary flow after decreased pulmonary resistance. The survival rate at 1 year after the first interventions in the DVS group improved to 77% (7/9), although there was a difference between the interventional eras of the two groups. Of the seven patients who underwent multiple stent redilations with a larger balloon or additional stenting in other sites until the next stage of surgery at a median age of 8 months, four received a bidirectional Glenn (BDG) shunt and TAPVCR and three underwent TAPVCR, with two of those cases reaching BDG. Less invasive primary DVS improved the outcome of neonates with RAI, f-SV, and obstructive TAPVC, with many reaching BDG. Patient selection to advance toward Fontan is thought to further improve the outcome.

Fetal echocardiographic findings in right pulmonary artery to left atrium communication: a case report and review of the literature.

Right pulmonary artery to left atrium communication (RPALA com) is a fatal congenital heart disease with right-to-left shunting. We present a rare case of RPALA com that was prenatally diagnosed and confirmed by autopsy. We focus on some unique echocardiographic findings for prenatal diagnosis of RPALA com by reviewing our case and the literature. Asymmetric cardiomegaly with a pear sign and dilatation of the pulmonary artery might be useful for screening tests. A larger stalk with the pear sign, high-velocity of shunt flow, and absence of a dilated pulmonary vein might support the prenatal diagnosis of RPALA com.

Cardiovascular profile score as a predictor of acute intrapartum non-reassuring fetal status in infants with congenital heart defects.

OBJECTIVES: To investigate the predictive factors of urgent cesarean delivery (CD) due to acute intrapartum non-reassuring fetal status (NRFS) in infants with congenital heart defects (CHDs). STUDY DESIGN: This was a retrospective review of 199 singletons prenatally diagnosed with a CHD and for whom vaginal delivery was attempted in our institution between 2007 and 2014. A cardiovascular profile (CVP) score was used to assess fetal heart failure. RESULTS: The number of urgent CDs due to NRFS was 37 (18.6%). Fetuses with a CVP score ≤7 were significantly more likely to require urgent CD due to NRFS than those with a CVP score ≥8 (p < 0.001). Infants with right heart defects or biventricular cyanotic heart defects had a significantly higher frequency of urgent CD due to NRFS than those with other types of CHD (p = 0.017). Multivariate analysis showed that a CVP score ≤7, a birth weight <2500 g, and primipara status were significant predictors of urgent CD due to NRFS. CONCLUSIONS: Fetal heart failure, low birth weight, and primipara status were revealed to be independent predictors of urgent CD due to acute intrapartum NRFS in CHD infants. The CVP score may be a useful echocardiographic marker in perinatal management planning.

Comorbid Epilepsy and Developmental Disorders in Congenital Long QT Syndrome With Life-Threatening Perinatal Arrhythmias.

OBJECTIVES: Given the association of long QT syndrome (LQTS) and neurological disorders, we speculated that the more severe LQTS phenotype, perinatal LQTS, would exhibit more frequent comorbid neurodevelopmental anomalies than LQTS without perinatal arrhythmias (nonperinatal LQTS). BACKGROUND: Congenital LQTS with life-threatening perinatal arrhythmias (perinatal LQTS) has a poor life prognosis. METHODS: Twenty-one consecutive LQTS patients diagnosed before 1 year of age at our institution and 3 previously reported perinatal LQTS patients with neurological seizures were enrolled. In total, the clinical course was evaluated in 24 patients. RESULTS: Among 21 infantile LQTS patients, 5 of 6 with perinatal LQTS (83%) were diagnosed with epilepsy and 4 (67%) with developmental disorders, but none with nonperinatal LQTS were. The total development quotient by Kinder Infant Development Scale scores was 17 to 72 (median 67) in 5 epileptic perinatal LQTS. In the 8 perinatal LQTS patients with neurological disorders, including 3 previously reported cases, epileptic seizures occurred at 2 days to 2.5 years of age and 5 had developmental disorders. Mutations in these 8 patients were located in the transmembrane loop of KCNH2, and D3/S4-S5 linker, D4/S4, or the D4/S6 segment of SCN5A. CONCLUSIONS: A high comorbidity of neurodevelopmental anomalies was observed in perinatal LQTS. Mutations in patients with neurological comorbidities were in loci linked to LQTS with a severe cardiac phenotype. These observations indicate the possibility that neurological disorders in perinatal LQTS are manifested as neurological phenotypes associated with severe cardiac phenotypes, while we could not completely exclude another possibility that those were caused by a brain perfusion injury.

Fetal critical aortic stenosis with natural improvement of hydrops fetalis due to spontaneous relief of severe restrictive atrial communication.

We describe a rare case of fetal critical aortic stenosis with spontaneous relief of severe restrictive atrial communication, resulting in complete resolution of hydrops fetalis in utero. Fetal ultrasonography showed hydrops fetalis caused by critical aortic stenosis with a severely restrictive foramen ovale and severe mitral regurgitation at 23 weeks of gestation. Hydrops fetalis, however, spontaneously resolved, showing an obvious increase of flow through the foramen ovale and pulmonary vein at 26 weeks of gestation. The neonate required balloon dilation of the aortic valve and balloon atrioseptostomy immediately after birth and also received bilateral pulmonary artery banding and arterial duct stenting 1 week later. The patient was in good condition after conversion to biventricular circulation via Ross procedure at 8 months old. The present case suggests that atrioseptostomy as a fetal intervention may improve outcome in even a hydropic condition.

Cardiovascular modeling of congenital heart disease based on neonatal echocardiographic images.

This paper proposes a 3-D cardiovascular modeling system based on neonatal echocardiographic images. With the system, medical doctors can interactively construct patient-specific cardiovascular models, and share the complex topology and the shape information. For the construction of cardiovascular models with a variety of congenital heart diseases, we propose a set of algorithms and interface that enable editing of the topology and shape of the 3-D models. In order to facilitate interactivity, the centerline and radius of the vessels are used to edit the surface of the heart vessels. This forms a skeleton where the centerlines of blood vessel serve as the nodes and edges, while the radius of the blood vessel is given as an attribute value to each node. Moreover, parent-child relationships are given to each skeleton. They are expressed as the directed acyclic graph, where the skeletons are viewed as graph nodes and the connecting points are graph edges. The cardiovascular models generated from some patient data confirmed that the developed technique is capable of constructing cardiovascular disease models in a tolerable timeframe. It is successful in representing the important structures of the patient-specific heart vessels for better understanding in preoperative planning and electric medical recording of the congenital heart disease.

Clinical characteristics of acute mitral regurgitation due to ruptured chordae tendineae in infancy-experience at a single institution.

In infants, acute mitral regurgitation resulting from ruptured chordae tendineae is very rare, but often fatal. There are a few case reports, but the characteristics and etiology of chordae tendineae rupture have not been elucidated. Our aim was to determine the clinical characteristics of idiopathic acute mitral regurgitation due to chordal rupture in infancy. A retrospective analysis was performed on ten consecutive patients, with a mean onset age of 4.6 ± 1.3 months. Despite nonspecific initial symptoms, all patients developed respiratory distress and four required resuscitation within a few days (mean, 1.8 ± 1.8 days). Chest radiographs showed pulmonary congestion with a normal or mildly increased cardiothoracic ratio in all ten patients. Laboratory data and electrocardiograms showed nonspecific findings. Echocardiography revealed ruptured chordae in all patients; locations were anterior (50%), posterior (20%), and both (30%). Surgical intervention was performed within 24 h of admission in eight patients (mean, 3.6 ± 5.1 h). Pathological findings included inflammatory cells in six specimens and myxomatous degeneration in two. No bacteria were isolated from preoperative blood cultures, pathological tissues, or excised tissue cultures. Autoantibody levels were insignificant. Three preoperatively resuscitated patients developed neurological sequelae and arrhythmias occurred in four after mitral valve replacement. Acute onset and rapid deterioration in patients with ruptured chordae tendineae necessitates early surgical intervention to improve outcomes. Though the etiology remains unknown, onset is in infants approximately 4 months of age, suggesting a definite disease entity.

The clinical course and incidence of supraventricular tachyarrhythmias after extra-cardiac conduit Fontan procedures in relation to an atrial situs.

BACKGROUND: The extra-cardiac conduit Fontan (EC) has a lower incidence of tachyarrhythmias than other types of Fontan. However, some intrinsic arrhythmogenic conditions, such as atrial isomerism, have been associated with a high incidence of arrhythmias. METHODS AND RESULTS: We retrospectively reviewed the clinical course of the supraventricular tachyarrhythmias (SVTs) in 212 patients after an EC, compared the results according to the atrial situs and investigated the substrate of the SVTs. The atrial situs was a solitus or inversus (SS/SI) in 152 patients, right isomerism (RI) in 45 and left isomerism (LI) in 15. Twenty-four SVTs occurred in 22 (11%) patients ≥3 months after the EC. The freedom from SVT after the EC was 95%, 76% and 77% in the SS/SI, RI and LI patients at 5 years, respectively (P<0.0001). Among the 16 SVTs associated with atrial isomerism, 10 were not related to the atrioventricular (AV) node. For the atrial isomerism, the predictors of SVT ≥3 months after the EC were a history of an AV valve repair (risk ratio (RR) 1.9; P=0.02) and complications associated with sinus node dysfunction (RR 1.9; P=0.03). Death related to SVT occurred in 3 patients. CONCLUSIONS: Postoperative SVTs after the EC with an atrial isomerism were not uncommon, mostly did not involve the AV node and possibly were caused by atrial tissue damage. A comprehensive therapeutic strategy should be considered.

Pulmonary valve replacement in adult patients with a severely dilated right ventricle and refractory arrhythmias after repair of tetralogy of fallot.

BACKGROUND: Refractory arrhythmias caused by right ventricular (RV) volume overload resulting from pulmonary regurgitation are the main concern in adult patients after repair of tetralogy of Fallot (TOF). Early pulmonary valve replacement (PVR) may prevent irreversible RV dysfunction and refractory arrhythmias, so the present study evaluated the PVR outcomes in adult patients with a severely dilated RV (d-RV) and refractory arrhythmias after TOF repair. METHODS AND RESULTS: Three TOF patients with a d-RV and tachyarrhythmias underwent PVR between the ages of 28 and 38 years. All had a d-RV (RV end-diastolic volume index (RVEDVI) >200 ml/m(2)) with a polymorphic nonsustained ventricular tachycardia (NSVT). Atrial tachycardia (AT) was identified in 2 patients and they underwent radiofrequency catheter ablation. The arrhythmias in all 3 were refractory to antiarrhythmic drugs. One year after PVR, the RVEDVI, left ventricular ejection fraction, right atrial pressure, cardiac index, cardiothoracic ratio, brain natriuretic peptide levels, and peak VO(2) improved in all, but without normalization. During the 2.6-3.8 year follow-up, all experienced tachyarrhythmias (NSVT or AT), which were controlled with medication. CONCLUSIONS: PVR may be beneficial for refractory arrhythmias, even in TOF patients with a d-RV, but it is difficult to completely normalize the hemodynamics and resolve the arrhythmogenicity.

Efficacy and safety of sotalol for refractory tachyarrhythmias in congenital heart disease.

BACKGROUND: Sotalol is a class III antiarrhythmic agent that is highly effective for tachyarrhythmias in adults, but its efficacy in patients with congenital heart disease (CHD) remains unclear. The purpose of this study was to assess the efficacy and safety of sotalol for refractory tachyarrhythmias in patients with CHD. METHODS AND RESULTS: Forty four-patients with CHD and refractory tachyarrhythmias (age, 23+/-12 years; follow-up period, 13+/-12 months) were administered sotalol orally during the period December 2002 to May 2007, resulting in complete control of tachyarrhythmias in 18 patients (41%), partial control in 15 patients (34%), and no control in 11 patients (25%). Non-pharmacological intervention (eg, surgery, pacemaker implantation, catheter ablation) was performed in 9 patients and resulted in an augmented response to sotalol in 6 patients. Tachyarrhythmia combined with atrial fibrillation was a risk factor for treatment failure with sotalol (odds ratio, 18.3; 95% confidence interval, 1.8-189.6; p=0.0053). CONCLUSION: Sotalol is partially or completely effective for refractory tachyarrhythmias in patients with CHD, and non-pharmacological interventions improve the efficacy of sotalol. This multimodal approach should be considered in patients with refractory tachyarrhythmias and CHD.

Long-term outcome of isolated congenital complete atrioventricular block pacing since neonatal period: experience at a single Japanese institution.

BACKGROUND: Few investigators have examined the outcome of patients with isolated congenital complete atrioventricular block (CCAVB) paced from the neonatal period. The present study follows the clinical course and describes the outcome of patients who have been paced with CCAVB since they were neonates. METHODS AND RESULTS: The medical records of 20 patients with CCAVB paced as neonates between 1981 and 2006 were retrospectively studied and reviewed; 18 were diagnosed in utero and 2 at birth. SS-A antibodies were detected in 9 of 14 (64%) mothers tested. The median age at follow-up was 5.6 years (range, 2 days to 21.9 years). Three (15%) of the early neonates died and 3 (15%) died later: 2 from dilated cardiomyopathy (DCM) and 1 from pneumonia. The total mortality rate was 30%. The cumulative probability of survival at 10 years was 73%. Of the 14 survivors, 4 developed DCM, representing a total morbidity of 30%. The cumulative probability of freedom from DCM at 10 years was 59%. CONCLUSIONS: Patients with CCAVB who undergo pacing as neonates have high mortality and high morbidity because of DCM. Left ventricular pacing or resynchronization can benefit patients who develop DCM and left ventricular epicardial pacing is recommended for neonates with CCAVB.

Balloon angioplasty of postoperative coarctation in the transverse arch in infants: protecting the common carotid artery.

We performed balloon angioplasty in three patients with postoperative coarctation in the transverse arch adjacent to the left common carotid artery. The age at arch reconstruction was 5, 6, and 2 days, while the interval between operation and balloon dilatation was 59 days, 87 days, and 12 months, respectively. Two balloons, one in the stenosis and the other in the left common carotid artery, were introduced over a wire sequentially and inflated simultaneously until the waist of the balloon in the arch disappeared. After balloon dilatation, a significant reduction in the peak-to-peak pressure gradient and an increase in vessel diameters were observed in all patients. Further growth of the transverse arch was documented at follow-up in two patients. No aneurysm has been detected in any patients. We believe that placing a protective balloon in the neck vessel increases safety during balloon dilatation of coarctation in the transverse arch.