The effect of coenzyme Q10 on idiopathic chronic dilated cardiomyopathy in children.

The objective of this study was to assess the effect of coenzyme Q10 (CoQ10) as supplementation to conventional antifailure drugs on quality of life and cardiac function in children with chronic heart failure due to dilated cardiomyopathy (DCM). The study was an open-label prospective study performed in two of the largest pediatric centers in Thailand from August 2000 to June 2003. A total of 15 patients with idiopathic chronic DCM were included, with the median age of 4.4 years (range, 0.6-16.3). Presenting symptoms were congestive heart failure in 12 cases (80%), cardiogenic shock in 2 cases (13.3%), and cardiac arrhythmia in 1 case (6.7%). Sixty-one percent of patients were in the New York Heart Association functional class 2 (NYHA 2), 31% in NYHA 3, and 8% in NYHA 4. Cardiothoracic ratio from chest x-ray, left ventricular ejection fraction, and left ventricular end diastolic dimension in echocardiogram were 0.62 (range, 0.55-0.78), 30% (range, 20-40), and 5.2 cm (range, 3.8-6.5), respectively. CoQ10 was given at a dosage of 3.1 ? 0.6 mg/kg/day for 9 months as a supplementation to a fixed amount of conventional antifailure drugs throughout the study. At follow-up periods of 1, 3, 6, and 9 months, NYHA functional class was significantly improved, as was CT ratio and QRS duration at 3 and 9 months follow-up with CoQ10 when compared to the baseline and post-discontinuation of CoQ10 at 9 months (range, 4.8-10.8). However, when multiple comparisons were taken into consideration, there was no statistical significant improvement. In addition to the conventional antifailure drugs, CoQ10 may improve NYHA class and CT ratio and shorten ventricular depolarization in children with chronic idiopathic DCM.

Cardiac troponin T: a marker in the diagnosis of acute myocarditis in children.

This study was conducted to assess the use of serum cardiac troponin T (cTnT) level as a noninvasive indicator to diagnose acute myocarditis in children. Noninvasive conventional methods often fail to diagnose myocarditis, A median cTnT level of 0.088 ng/ml (0.04-3.11) was reported in pediatric patients with acute myocarditis in our previous study. Hence, we attempted to determine the cutfoff level of cTnT to diagnose acute myocarditis in children. Pediatric patients with clinically suspected myocarditis or dilated cardiomyopathy (DCM) and a control group were recruited. History, physical examination, elctrocardiogram, chest roentgenogram, echocardiogram, cTnT level, and/or endomyocardial biopsy and clinical course were studied. The gold standard to diagnose acute myocarditis was endomyocardial biopsy proved according to the Dallas criteria and/or recovery from cardiovascular problems within 6 months of follow-up. Forty-three patients were admitted due to cardiovascular problems from primary myocardial dysfunction. Twenty-four patients were diagnosed as acute myocarditis (group 1), 19 were idiopathic chronic DCM (group 2), and 21 patients had moderate to large ventricular septal defect and congestive heart failure (group 3). Median cTnT level was statistically higher in (group 1) compared to groups 2 and 3. Ejection fraction (EF) and left ventricular end diastolic dimension (LVEDd) z score of acute myocarditis were 38.5% (range, 21-67) and 1.3 (range, -0.8-3.0), respectively, which were significantly better than DCM [28.0% (range, 17-45) and 6.0 (range, 2.0-10.0)]. The cutoff point of cTnT level to diagnose acute myocarditis was 0.052 ng/ml (sensitivity, 71%; specificity, 86%). cTnT level, EF, and LVEDd z score did not predict short-term outcomes of patients. In acute myocarditis, cTnT level and EF were significantly higher and LVEDd z score was significantly lower than in DCM. However, the three parameters had no significant effect on outcomes of the patients. Our data show that cardiac a cTnT level of 0.052 ng/ml is an appropriate cutoff point for the diagnosis of acute myocarditis.

Predictors of successful transcatheter closure of atrial septal defect by cardiac magnetic resonance imaging.

The location, size, and rim of an atrial septal defect (ASD) are major determining factors for transcatheter closure. We compared the measurements of ASD size and the characteristics of atrial septal rim using cardiac magnetic resonance imaging (MRI) with those obtained using transesophageal echocardiography (TEE). Patients with an ASD that met established criteria were selected for evaluation by cardiac MRI and TEE. There were 66 patients who underwent both TEE and cardiac MRI. Bland-Altman comparative analysis was performed to demonstrate agreement between measurement of ASD by MRI and balloon sizing compared to measurement of ASD by TEE and balloon sizing. Twelve patients were excluded from transcatheter closure of ASD. TEE did not demonstrate an adequate measurement of the posterior inferior rim in 10 of 66 patients. Fifty-four patients underwent transcatheter closure using the Amplatzer septal occluder. Of these, 52 patients had successful closure (ASD measurements of 25.9 +/- 5.6 mm using MRI and 21.9 +/- 5.8 mm using TEE). The median device size was 28 mm (range, 11-38). Patients who had successful closure had a significantly smaller major axis of ASD and larger posterior inferior rim compared to those of patients who were excluded from the closure procedure. Cardiac MRI showed a better correlation of ASD diameter measurement to balloon sizing compared to TEE. We believe that the most important predictive factor for successful transcatheter closure of an ASD is an adequate posterior inferior rim, which is best visualized using cardiac MRI.

Immunoglobulin failure and retreatment in Kawasaki disease.

Several cases of Kawasaki disease (KD) were unresponsive to the initial treatment with intravenous immunoglobulin (IVIG). We retrospectively analyzed all children admitted with KD to determine the occurrence and variables associated with the initial IVIG treatment failure. All patients who fulfilled the criteria for KD and were treated with a single dose (2 g/kg) of IVIG between January 1995 and August 2001 were enrolled. An analysis of the patients who had initially failed to respond to IVIG was performed. A total of 120 patients were enrolled during the study period. There were 68 boys (56.7%). Fourteen patients (11.6%) were found to be unresponsive to initial IVIG treatment. Patients who were anemic (Hb<10 G/DL), had a high neutrophil count (> 75%), a high band count, and low albumin were at risk of failure to respond to a single dose of IVIG. We found no correlation among age, gender, days since starting IVIG treatment, and erythrocyte sedimentation rate (ESR) with failure of the initial IVIG treatment. There were 12 patients (10%) who developed coronary artery aneurysms. The failure of a single dose of IVIG treatment occured in up to 11.6% of our Kawasaki patients. We found that low hemoglobin (<10 G/DL), high neutrophil count (> 75%), high band count, and a low albumin were associated with the requirement for retreatment with a second dose of IVIG.

Cardiac troponin T: its role in the diagnosis of clinically suspected acute myocarditis and chronic dilated cardiomyopathy in children.

This study was conducted to assess the use of the serum cardiac troponin T (cTnT) level as a noninvasive indicator to differentiate acute myocarditis and chronic dilated cardiomyopathy in pediatric patients. Myocarditis and dilated cardiomyopathy are clinically difficult to differentiate. Endomyocardial biopsy proved to be quite useful. However, the nature of the procedure--invasiveness, time-consuming, and limited sensitivity--caused some concerns, especially in pediatric patients. Hence, we attempted to find an alternative method that could give a prompt diagnosis of acute myocarditis. Twenty cases with clinically suspected myocarditis or dilated cardiomyopathy and a control group of 21 cases with moderate left-to-right shunt and congestive heart failure were recruited. History, physical examination, electrocardiogram, chest roentgenogram, echocardiogram, cTnT, creatine kinase MB isoenzyme (CK-MB mass), and/or endomyocardial biopsy were compared. The gold standard used to diagnose myocarditis is endomyocardial biopsy (Dallas criteria) and/or recovery from cardiovascular problems within 6 months of follow-up. Ten patients were diagnosed as having myocarditis (group 1) and 10 with chronic dilated cardiomyopathy (group 2). The control group of 21 cases was designated as group 3. The median serum cTnT levels were 0.088 (0.04-3.11), 0.010 (0.010-0.990), and 0.010 (0.010-0.550) ng/ml in groups 1, 2, and 3, respectively. The mean CK-MB mass level for groups, 1, 2, and 3 were 18.35 (7.14-70.00), 4.80 (0.54-108.00), and 2.26 (0.95-7.06) ng/ml. The study showed that both the cTnT and CK-MB mass levels were significantly higher in group 1 than either group 2 or group 3. Histopathology was studied in 9 cases. In 2 of 5 cases and in all 4 cases in group 1 and group 2 histopathology was pathologically proved. Levels of cTnT and CK-MB were significantly higher for myocarditis than for dilated cardiomyopathy and left-to-right shunt with CHF. Further study is needed to assess the optimum cTnT level for differentiating both conditions.

Comparison of atrial septal defect closure using amplatzer septal occluder with surgery.

Our study reports the results of a comparison of closure of atrial septal defect (ASD) surgically with transcatheter closure using the Amplatzer septal occluder. Patients having an ASD and a surgical closure or transcatheter closure between January 1999 and July 2000 were selected. There were 103 patients who had ASD. All 64 patients in group 1 (surgery) had a successful operation, with only 2 patients with a mild residual shunt. There were 39 patients enrolled for transcatheter closure of the ASD (group 2). Four patients were excluded initially. The median age for group 1 was 25 years (range 2.3-64 years) compared to 11.7 years (range 2-69 years) in group 2 (p = 0.035). In group 1, the mean ASD diameter measured was 28.4 +/- 10.2 mm compared to 23.4 +/- 5.7 mm in group 2 (p = 0.003). In 29 patients, devices were deployed with sizes from 10 mm to 30 mm (median 24 mm). Three patients were excluded because a larger device (>30 mm) was not available and devices were not successfully deployed in another 3 patients. One patient had a device embolized into the right ventricle (surgical removal and closure of the ASD). Complications occurred in 13 patients in group 1 and 4 patients in group 2. Complete occlusion occurred in 27 of 28 group 2 patients (96.4%) during the follow-up period (10.2 +/- 5.4 months). The Amplatzer septal occluder is a new device for closure of different-sized ASDs. The intermediate-term follow-up demonstrated excellent closure results. The benefit for each patient was demonstrated in less morbidity and less time spent in the hospital.

Intermediate term follow-up on transcatheter closure of atrial septal defects by Amplatzer septal occluder.

BACKGROUND: Surgical repair of secundum atrial septal defect (ASD) is a safe, widely accepted procedure with negligible mortality. However, it is associated with morbidity, discomfort and a thoracotomy scar. As an alternative to surgery, a variety of devices for transcatheter closure of ASD have been developed. OBJECTIVES: We report our clinical experience with transcatheter closure of ASD using the Amplatzer Septal Occluder, a new occlusion device with intermediate term follow-up. PATIENTS & METHOD: Patients having ASD met established two-dimensional echocardiographic criteria for transcatheter closure were selected. ASD size was measured by transesophageal echocardiogram (TEE) and balloon occlusion catheter (stretched diameter). The Amplatzer's size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a guiding sheath and deployed under fluoroscopic and TEE guidance. Once its position was optimal, it was released. TEE was undertaken to demonstrate the residual shunt. RESULTS: There were 26 patients with a mean age of 17.2 +/- 15.9 years old (2 to 60) and a mean weight of 22 +/- 37.5 kg. (10.7 to 62.5). The mean ASD diameter measured by TEE was 18.3 +/- 5.2 mm. and by stretched diameter was 22 +/- 7.5 mm. Four patients who had ASD stretched diameter over 32 mm were excluded because a larger device was not available. Devices were deployed in 22 patients with sizes from 9 to 30 mm (median = 22mm). Immediately after closure a tiny residual shunt was observed at the core of the device in each case. At 24 hours only two patients had a small (< 2 mm) shunt. One patient with fenestrated ASD had a device embolized into the right ventricle with successful removal and surgical closure. Patients were followed-up for a mean duration of 8 +/- 3.5 months (from 3 to 12 months). Complete occlusion was found in 20 out of 21 patients (95%). CONCLUSION: The Amplatzer Septal Occluder is a new device designed for closure of different sizes of ASD and can be easily and safely deployed. Our experience showed that this device could be used to close an ASD as large as 30 mm. The intermediate term follow-up also demonstrated an excellent closure result. Caution should be undertaken with patients who have a fenestrated atrial septal defect particularly at the septal rim.

The Fontan operation: experience at Siriraj Hospital.

Seventy five patients underwent modified Fontan operation at Siriraj Hospital from October 1987 to December 1998. Cardiology data was analyzed retrospectively. Four patients' data was unavailable. Median age at operation was 9.7 (1.8-34) years old. Tricuspid atresia accounted for 38 per cent of the patients. Ten patients (14.1%) died in the acute post operative period due to consequence of low cardiac output. Another 3 patients (4.2%) expired in the intermediate and late post operative period. Age at operation, pulmonary artery size, pre-operative oxygen saturation, and mean pre-operative pulmonary artery pressure were not different between those who survived and those who died. Abnormal pulmonary vein, atrioventricular valve regurgitation, and underlying ventricular morphology statistically affected the acute survival of modified Fontan operation. Intraoperative aortic cross clamp time, and post operative mean pulmonary artery pressure on day 0, 1 and 2 post operation were found statistically shorter and lower in the survival group. Survival rate at 5 years was 83 per cent. Modified Fontan operation is the final palliative operation of choice for low risk single ventricle physiology in our institution with acceptable outcome. Thorough pre-operative hemodynamic and anatomic studies and staging modified Fontan procedure may include a higher number of candidates and improve the outcome of the operation.

Limitation of transthoracic echocardiography in the diagnosis of congenital heart diseases.

Nowadays, it has been widely accepted that echocardiography is the most efficient, non invasive diagnostic tool to diagnose congenital heart diseases. However, cardiac catheterization remains the gold standard to diagnose and obtain hemodynamic data prior to cardiovascular surgery. In order to find out the accuracy of transthoracic echocardiography in relation to the anatomical diagnosis of congenital heart diseases, 175 consecutive patients who underwent diagnostic cardiac catheterization during January 1999 to December 1999 were reviewed. All of them had complete echocardiographic studies prior to the procedure. The male to female ratio was 1.06:1. The median age at the time of echocardiography was 3.36 (0.01-28.8) years old. The indications of the cardiac catheterization were to demonstrate cardiovascular anatomy 64 per cent, to obtain pulmonary artery pressure and pulmonary vascular resistance 13.7 per cent, and to get both information 22.3 per cent. Tetralogy of Fallot (23.4%) was the most frequent cardiac malformation, followed by complex congenital heart diseases (22.3%), simple left to right shunt (12%), pulmonary atresia with ventricular septal defect (8.6%), tricuspid atresia (5.7%), simple d-transposition of great arteries (4%), etc. From cardiac catheterization; 49 cases (28%) revealed additional data which were surgically important, 3 cases (1.7%) resulted in different diagnoses, and 3 cases (1.7%) revealed additional information which was not surgically important. Inadequate imaging technique (36 cases, 65.5%) and limitation of technique (19 cases, 34.5%) were the reasons for missing anatomical findings of transthoracic echocardiography. Age at the time of echocardiography was not a significant factor affecting the accuracy. Persistent left superior vena cava, multiple aorto-pulmonary collateral arteries, pulmonary artery anatomy, and coronary artery anatomy were the most frequent cardiac lesions misdiagnosed by transthoracic echocardiography that were somewhat surgically important. The incorrect echocardiographic diagnoses were aorto-pulmonary window, patent ductus arteriosus, and vascular ring. Thorough and extensive echocardiographic scanning coupled with cooperative or adequately sedated patients by an experienced operator using an efficient echocardiographic machine might improve the accuracy of transthoracic echocardiography in the diagnosis of congenital heart diseases.

Utility of intraoperative transesophageal echocardiogram in congenital heart disease.

Intraoperative transesophageal echocardiogram (TEE) has improved the perioperative outcome in adult patients. The purpose of the current study was to assess the benefit of intraoperative TEE in patients with congenital heart disease undergoing surgical correction (repair). The results of the patients who had consecutively undergone intraoperative TEE during their congenital heart surgery between January 1998 to June 2000 were reviewed. There were 104 patients (whose ages ranged from one week old to 50 years old (median 5 years old) and their weights from 3 kg to 79 kg (median 15 kg). A significant impact was said to have occurred if these findings prompted a change in surgical procedure following a prebypass study or rebypass for repair of a residual defect. Prebypass TEE had a significant impact in seven patients (6.7%). TEE could be used as a guide to help repair in three patients. The postbypass TEE examination had a significant impact in 15 patients (14.4%). Of these 15 patients, eight were detected primarily by TEE examination. The group of patients in whom TEE had the most significant impact was in patients who had surgery related to the repair of the atrioventricular valve (complete or partial atrioventricular (AV) canal repair, Ebstein's anomaly; 9 out of 22 patients; 41%). A less significant impact was found in surgery for other complex congenital defects (single ventricle or complete transposition of great arteries; eight out of 46 patients; 17.4%). TEE had limited impact in simple congenital lesion. Intraoperative TEE is valuable in the perioperative care of patients with congenital heart defects. We found the most benefit in patients with complete or partial AV canal and Ebstein's anomaly.

Coarctation of the aorta in children at Siriraj Hospital.

A retrospective analysis of 33 children who were diagnosed to have coarctation of aorta at Siriraj Hospital between January 1989 and December 1998 was undertaken. There were 21 males (64%) and 12 females (36%). Their ages ranged from one day to 11 years (median 2 months). The majority of the patients (78.8%) were presented early within the first year of life. The predominant clinical manifestations were congestive heart failure (69.6%), systemic hypertension of the upper extremities (36.3%) and decreased femoral pulses. Chest roentgenogram revealed cardiomegaly (70%) and increased pulmonary blood flow (84%), reflecting congestive heart failure and associated left-to-right shunting. Electrocardiogram showed normal pattern (33.3%), right ventricular hypertrophy (33.3%), left ventricular hypertrophy (22.2%) and biventricular hypertrophy (11.2%). The younger the patient is, the more right ventricular predominance is demonstrated. According to the echocardiogram and/or aortogram, juxtaductal type was found in 51.5 per cent, postductal type in 27.3 per cent and preductal type in 21.2 per cent. Medical management included prostaglandin E1 infusion in a newborn baby presented with low-cardiac output state, anticongestion and antihypertension, if indicated, followed by surgical correction. The result of coarctectomy with end-to-end anastomosis with or without arch augmentation was good. The operative mortality rate was 5 per cent. The overall mortality in the present study was 9 per cent. The most common causes of death were multiorgan failure and pulmonary infection. Residual coarctation was found in 5 per cent.

Predictors of early- and late-onset supraventricular tachyarrhythmias after Fontan operation.

BACKGROUND: The objectives of our study were to determine the frequency of supraventricular tachyarrhythmias (SVTAs) among modifications of the Fontan operation and identify risk factors for developing SVTA. METHODS AND RESULTS: The population consisted of all patients who had any modification of the Fontan operation at the Mayo Clinic between 1985 and 1993. Clinically significant SVTAs were those requiring initiation or change of antiarrhythmic treatment, and they were divided into early SVTAs (<30 days after the operation) and late SVTAs (>/=30 days after the operation). Clinical histories were reviewed, and health status questionnaires were sent. Four hundred ninety-nine patients had various modifications of the Fontan operation. Frequency of early SVTA was 15%. Risk factors identified by multivariate analysis for early SVTA were AV valve regurgitation, abnormal AV valve, and preoperative SVTA. Frequency of late SVTA was 6% by 1 year, 12% by 3 years, and 17% by 5 years. Risk factors for late SVTA were age at operation (<3 or >/=10 years) and systemic AV valve replacement. By univariate and multivariate analysis, the type of Fontan operation was not a significant risk factor for late SVTA when all 6 modifications were considered. However, when we analyzed the frequency of late SVTA for the 2 recently used modifications, we found a lower frequency of late SVTA in patients with atriopulmonary connection with lateral tunnel compared with those with total cavopulmonary connection. CONCLUSIONS: Postoperative SVTA continues to be a significant problem. Risk factors for SVTA are AV valve regurgitation, abnormal AV valve, preoperative SVTA, and age at operation. Frequency of SVTA does not appear to be related to type of Fontan procedure except for slightly lower frequency in patients with atriopulmonary connection with lateral tunnel compared with those with total cavopulmonary connection.

Diastolic ventricular function in children: a Doppler echocardiographic study establishing normal values and predictors of increased ventricular end-diastolic pressure.

OBJECTIVE: To extend noninvasive assessment of diastolic cardiac function into the pediatric age-group. DESIGN: This study was divided into two phases, the first of which was designed to provide an age-appropriate set of normal diastolic Doppler echocardiographic data for children and adolescents and the second of which was to determine whether these Doppler techniques could be used to identify children with increased ventricular end-diastolic pressure (EDP). MATERIAL AND METHODS: Complete echocardiographic studies focusing on Doppler variables of diastolic ventricular function were performed on 223 normal children. Values observed were analyzed for dependence on age, heart rate, and gender. Results from the normal group were then compared with Doppler values observed in a group of 24 children with catheterization-substantiated increases in ventricular EDP. RESULTS: Normal values for the Doppler factors studied vary with both age and heart rate. The variables that most confidently distinguished children with increased EDP from normal subjects were the ratio of and the difference between the durations of pulmonary vein atrial reversal and the mitral A wave. A ratio of 1.2 or more or a difference of 29 ms or more identified those children with increased EDP with sensitivities of 88 and 90% and specificities of 86 and 86%, respectively. CONCLUSION: Use of the normal data and the Doppler techniques described in this study will allow confident assessment of diastolic function in children as well as in adults.

Cardiorespiratory response to exercise after modified Fontan operation: determinants of performance.

OBJECTIVES: This study sought to measure the cardiorespiratory responses to exercise and to identify the perioperative determinants of exercise performance in children, adolescents and young adults who underwent the modified Fontan operation. BACKGROUND: Several studies of the cardiorespiratory responses to exercise after the Fontan operation have demonstrated subnormal maximal oxygen uptake and exercise heart rate, but the perioperative variables that ultimately affect exercise responses have not been assessed systematically. METHODS: The study included 59 of the 548 patients who underwent a modified Fontan operation between January 1, 1984 and December 31, 1993 at the Mayo Clinic. Spirometry was performed at rest in all patients before exercise testing. The patients then exercised using a previously calibrated cycle ergometer and a 3-min incremental cycle exercise protocol. Multiple linear regression analysis was used to determine a subset of variables associated with oxygen uptake at peak exercise (VO2max), blood oxygen saturation (O2sat) and heart rate at peak exercise (HRmax). RESULTS: VO2max ranged from 29% to 95% of normal value; O2sat at peak exercise ranged from 77% to 96%; and HRmax ranged from 39.7% to 97.4% of normal value. Multivariate analysis showed that log VO2max/kg2/3 was associated with age at exercise, male gender, body surface area, preoperative confluent pulmonary arteries and rest VO2max/kg2/3. Preoperative left pulmonary artery stenosis, the presence of a classic Glenn anastomosis at exercise and rest O2sat were associated with O2sat at peak exercise. Age, body surface area at exercise, heart rate at rest and diastolic blood pressure were associated with HRmax at exercise. CONCLUSIONS: Subnormal VO2max and HRmax values were demonstrated at peak exercise. Several perioperative variables were associated with VO2max and O2sat at peak exercise. The presence of a classic Glenn anastomosis was associated with decreased O2sat at peak exercise, suggesting intrapulmonary shunting with the classic Glenn anastomosis.

The appropriateness of early discharge of hospitalized children with suspected sepsis.

BACKGROUND: Febrile children with suspected sepsis are often hospitalized and empirically treated with parenteral antibiotics pending results of bacterial cultures. The question of just how long such children should be observed and treated following initial negative culture reports has not been adequately addressed. This study was designed to determine the appropriateness of discharging hospitalized culture-negative children with suspected sepsis at the end of 48 hours. METHODS: All children admitted with a diagnosis of "suspected sepsis" over an 8-month period were prospectively evaluated. Based on initial culture data, children were divided into two groups: group A with positive bacterial cultures and group B with negative bacterial cultures. Clinical assessment and review of cerebrospinal fluid, blood, and urine culture data were made at 24 hours, 48 hours, and until discharge, and at 2 weeks following discharge of all group B patients. RESULTS: Of the 83 children enrolled in the study, 8 (9.5%) patients had a culture positive for bacterial infection (group A): meningitis in two, bacteremia in six, and urinary tract infection in two. All cultures were positive within 48 hours. Cultures were negative at 48 hours in the remaining 75 (90.4%) children (group B), and remained negative until discharge and at 2-week follow-up. Eight (10.6%) patients had received antibiotics prior to admission. After the workup, 37 of 73 (50.6%) children received antibiotics for less than 48 hours, while 36 (49.4%) children did so for more than 48 hours. Clinical assessment was normal at 48 hours in 71 of the 75 children. Sixty-three (84%) children available for follow-up continued to do well after discharge. No statistical distinction could be made between those children who remained hospitalized after 48 hours and those children who were dismissed at 48 hours. CONCLUSIONS: Although our study data suggest that culture-negative children hospitalized for suspected sepsis who meet the criteria for normal clinical assessment can be safely discharged at 48 hours, a stronger statistical validation of this approach can be made if a larger sample size is studied.

The prevention of coronary artery aneurysm in Kawasaki disease: a meta-analysis on the efficacy of aspirin and immunoglobulin treatment.

OBJECTIVE: Varying observations have been made concerning the use of aspirin (ASA) and/or intravenous immunoglobulin (IVIG) in the prevention of coronary artery aneurysm (CAA) in children with Kawasaki disease. A meta-analysis of published articles on the subject was conducted to evaluate the reported efficacy of these therapies. METHODS: All published studies in all languages from 1967 through 1993 obtained from MEDLINE and EMBASE were considered, and a defined set of inclusion and exclusion criteria selected the studies for analysis. These studies were grouped based on whether the children in the studies received: (1) ASA alone, (2) low IVIG (< or = 1 g/kg) and ASA, (3) high IVIG (> 1 g/kg) and ASA, (4) single IVIG (> 1 g/kg) and ASA, (5) high IVIG and low ASA (< or = 80 mg/kg), or (6) high IVIG and high ASA (> 80 mg/kg). Studies that satisfied the test for homogeneity were subjected to further analysis. The best estimate of the true proportion of CAA as well as the 95% confidence interval for each group were calculated at 30 and 60 days. Hypothesis testing was conducted to determine the statistical significance of the calculated difference in each compared treatment group. RESULTS: The best estimate of true proportion of CAA and the 95% confidence interval in each group at 30 and 60 days were: (1) ASA group, 30 days, 22.8% (20.6%, 25%); 60 days, 17.1% (13.6%, 20.7%); (2) low-IVIG group, 30 days, 17.3% (14.3%, 20.2%); 60 days, 11.1% (8.7%, 13.6%); (3) high-IVIG group, 30 days, 10.3% (8.3%, 12.3%); 60 days, 4.4% (2.8%, 6%); (4) single-IVIG group, 30 days, 2.3% (0.5%, 4.2%); 60 days, 2.4% (0.5%, 4.2%); (5) high-IVIG-low-ASA group, 30 days, 13% (9%, 17%); 60 days, 4.8% (2.3%, 7.4%); and (6) high-IVIG-high-ASA group, 30 days, 9.1% (6.9%, 11.4%); 60 days, 4% (2%, 6.1%). CONCLUSION: The incidence of CAA both at 30 and 60 days was significantly lower in low-IVIG than in ASA and in high-IVIG than in low-IVIG groups. Also, the incidence was lower in the single-IVIG than in the high-IVIG group, but this was noted at 30 days and not at 60 days. There was no statistically significant difference in the incidence of CAA both at 30 and 60 days between the high-IVIG-low-ASA and high-IVIG-high-ASA groups.