A comparison of ibuprofen and indomethacin for closure of patent ductus arteriosus

went ASD closure with first, second or third generation button devices. Results: The fourth generation device was successfully deployed in 417/423 patients vs. 166/180 patients with earlier design devices (p ⫽ NS). “Unbuttoning” occurred in 4/423 patients (0.9%) compared with 13/180 patients (7.2%) who received earlier generation devices (p ⬍ 0.001). 90% of the patients with the double button occluder had no or trivial residual interatrial shunt at 24 hours by echocardiography as compared to 92% of patients with the single button device (p ⫽ NS). Reintervention to close residual ASD was required in 5% of patients with fourth generation devices at 23 ⫾ 15 months of follow-up vs. 14/166 (8%) patients with older devices at 46 ⫾ 20 months (p ⬍0.02). The actuarial reintervention-free rates at 1, 2 and 5 years were not different for the two designs of ASD occluder. Conclusions: Significantly less unbuttoning occurred with fourth generation (double button) ASD occluding devices than with earlier button occluders. Overall efficacy in closure of ASD’s with this device was comparable to earlier button-type ASD closure devices. Perspective: At this time, the FDA has not approved any of the available devices for percutaneous closure of ASDs. This fourth generation button device is added to a growing number of such devices that have been demonstrated to safely and effectively close simple secundum ASDs percutaneously. In this study, only simple secundum ASDs with Qp/Qs ⬎ 1.5 were closed. Whether these devices will be as effective in larger and/or more complicated ASDs has yet to be determined. JK

ischemia. Of these 12 children, seven died and five underwent heart transplantation. In this small group, there were no statistically significant predictors of sudden death. Conclusions: Myocardial ischemia is common in children with RCM. Although not a predictor of mode of death in this series, ischemia is associated with a very poor prognosis. Syncope may be an ominous sign in pediatric patients with RCM. Perspective: RCM is a rare but lethal disease in the pediatric population with a very brief time between diagnosis and death. Symptoms or signs of myocardial ischemia or syncope warrant rapid evaluation and consideration for cardiac transplantation. The role of medical therapy in these children is unknown. JK

A Comparison of Ibuprofen and Indomethacin for Closure of Patent Ductus Arteriosus Van Overmeire B, Smets K, Lecoutere D, et al. N Eng J Med 2000;343:674 – 681. Study Question: In animals, parenteral ibuprofen has been shown to have equivalent efficacy to indomethacin for closure of patent ductus arteriosus (PDA) without compromise of cerebral, gastrointestinal, or renal perfusion. The investigators asked: What is the efficacy and safety of ibuprofen compared to indomethacin for PDA closure in premature infants with respiratory distress syndrome (RDS)? Methods: Non-blinded, randomized, multicenter trial of ibuprofen vs. indomethacin for PDA closure in 148 premature infants (24 to 32 weeks gestational age) with RDS (and no major congenital abnormalities) in five neonatal ICUs. Ductal patency was assessed using echocardiography by readers blinded to treatment assignment. Indomethacin was given as rescue therapy to infants who failed the first randomized treatment. Results: The rate of PDA closure was similar in both groups (66% with indomethacin vs. 70% with ibuprofen, p ⫽ NS). Survival at one month was not different between the treatment groups. Oliguria occurring during treatment was more frequent (18.9 % vs. 6.8%, p ⫽ 0.03) and increase in serum creatinine greater in the indomethacin-treated infants. The development of necrotizing enterocolitis and intraventricular hemorrhage were not different between treatment groups, but the numbers of these complications were small. Conclusions: Parenteral ibuprofen has similar efficacy to indomethacin for closure of PDA in premature infants with a lower risk of developing renal dysfunction during treatment. Long-term effects of ibuprofen on the gastrointestinal and central nervous systems are unknown. Perspective: 70% of infants born at ⬍28 weeks gestational age have PDA that require closure. Therefore, this pilot study demonstrates potential benefit for a large number of infants. Unfortunately, as pointed out in the accompanying editorial, parenteral ibuprofen is currently not available in the United States for clinical trials or treatment. JK

Sudden Death and Cardiovascular Collapse in Children With Restrictive Cardiomyopathy Rivenes SM, Kearney DL, Smith EO, et al. Circulation 2000;102: 876 – 882. Study Question: The purpose of this study was to evaluate potential risk factors for sudden cardiac death (SCD) in children with restrictive cardiomyopathy (RCM). Methods: Retrospective review of all pediatric patients diagnosed with restrictive cardiomyopathy at Texas Children’s Hospital over a 31-year period. Holter monitors, electrocardiograms and pathologic specimens were evaluated for evidence of acute or chronic myocardial ischemia. Results: Seventeen children with RCM, ranging from 0.7 to 12.2 years old, had records available for review. Five died suddenly on average 1.0 ⫾ 0.6 years after initial diagnosis. Four of 5 deaths occurred within 6 months of diagnosis. Three of five patients presented with syncope, one with chest pain and one with a heart murmur. All five patients had evidence of acute ischemia with marked (5.4 to 12.7 mm) ST depression on both initial ECG and Holter monitors. None had congestive heart failure. Nine of 12 patients without SCD had congestive heart failure. None had syncope. Evidence of ischemia was also common in this group with 8/13 ECGs with definite ischemia and two with bundle-branch block precluding a diagnosis of

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