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(Circulation. 2007;116:293-297.)
© 2007 American Heart Association, Inc.

Pediatric Cardiology

Clinical Outcomes of Palliative Surgery Including a Systemic-to-Pulmonary Artery Shunt in Infants With Cyanotic Congenital Heart Disease

Does Aspirin Make a Difference?

Jennifer S. Li, MD, MHS; Eric Yow, MS; Katherine Y. Berezny, MPH; John F. Rhodes, MD; Paula M. Bokesch, MD; John R. Charpie, MD; Geoffrey A. Forbus, MD; Lynn Mahony, MD; Lynn Boshkov, MD; Virginie Lambert, MD; Damien Bonnet, MD; Ina Michel-Behnke, MD; Thomas P. Graham, MD; Masato Takahashi, MD; James Jaggers, MD; Robert M. Califf, MD; Amit Rakhit, MD; Sylvie Fontecave, MD; Stephen P. Sanders, MD

From the Division of Pediatric Cardiology, Department of Pediatrics, Duke University Medical Center, Durham, NC (J.S.L., J.F.R., J.J.); Duke Clinical Research Institute, Durham, NC (J.S.L., E.Y., K.Y.B., R.M.C.); Emory University, Atlanta, Ga (P.M.B.); Michigan Congenital Heart Center, C.S. Mott Children’s Hospital, Ann Arbor (J.R.C.); Medical University of South Carolina, Charleston (G.A.F.); Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (L.M.); Oregon Health Sciences University Medical Center, Portland (L.B.); Hopital Marie-Lannelongue, Le Plessis Robinson, France (V.L.); Hopital Necker Enfants Malades, Paris, France (D.B.); Pediatric Heart Center University–Giessen, Giessen, Germany (I.M.-B.); Vanderbilt Medical Center, Nashville, Tenn (T.P.G.); Children’s Hospital Los Angeles, Los Angeles, Calif (M.T.); Bristol-Myers Squibb, Princeton, NJ (A.R.); sanofi-aventis, Paris, France (S.F.); and Ospedale Pediatrico Bambino Gesu, Rome, Italy (S.P.S.).

Correspondence to Jennifer S. Li, MD, MHS, PO Box 17969, Duke Clinical Research Institute, Durham, NC 27705. E-mail jennifer.li{at}duke.edu

Received July 17, 2006; accepted April 9, 2007.

Background— Aspirin (ASA) often is used to prevent thrombosis in infants with congenital heart disease after placement of a systemic-to–pulmonary artery shunt, but its effect on outcomes is unknown.

Methods and Results— The present multicenter study prospectively collected data on 1-year postoperative rates of death, shunt thrombosis, or hospitalization age <4 months for bidirectional Glenn/hemi-Fontan surgery in 1004 infants. The use and dose of ASA were recorded. Kaplan-Meier event rates were calculated for each event and the composite outcome, and a Cox regression model was constructed for time to event. Model terms were ASA use and type of surgery, with adjustment for age at surgery. Diagnoses were hypoplastic left heart syndrome (n=346), tricuspid atresia (n=103), tetralogy of Fallot (n=127), pulmonary atresia (n=177), heterotaxy syndrome (n=38), and other (n=213). There were 344 shunts placed without cardiopulmonary bypass (closed shunt), 287 shunts with bypass (open shunt), 323 Norwood procedures, and 50 Sano procedures. Overall, 80% of patients received ASA. One-year postoperative events rates were high: 38% for the composite end point, 26% for death, and 12% for shunt thrombosis. After the exclusion of patients with early mortality, patients receiving ASA had a lower risk of shunt thrombosis (hazard ratio, 0.13; P=0.008) and death (closed shunt: hazard ratio, 0.41, P=0.057; open shunt: hazard ratio, 0.10, P<0.001; Norwood: hazard ratio, 0.34, P<0.001; Sano: hazard ratio, 0.68, P=NS) compared with those not receiving ASA.

Conclusions— The morbidity and mortality for infants after surgical placement of a systemic-to–pulmonary artery shunt are high. ASA appears to lower the risk of death and shunt thrombosis in the present observational study.

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