Design and rationale of a randomized trial comparing the Blalock-Taussig and right ventricle-pulmonary artery shunts in the Norwood procedure

被引：105

作者：

Ohye, Richard G. ^{[1
]}

Gaynor, J. William ^{[2
]}

Ghanayem, Nancy S. ^{[3
]}

Goldberg, Caren S. ^{[1
]}

Laussen, Peter C. ^{[4
,5
]}

Frommelt, Peter C. ^{[3
]}

Newburger, Jane W. ^{[4
,5
]}

Pearson, Gail D. ^{[6
]}

Tabbutt, Sarah ^{[2
]}

Wernovsky, Gil ^{[2
]}

Wruck, Lisa M. ^{[7
]}

Atz, Andrew M. ^{[8
]}

Colan, Steve D. ^{[4
,5
]}

Jaggers, James ^{[9
]}

McCrindle, Brian W. ^{[10
]}

Prakash, Ashwin ^{[11
]}

Puchalski, Michael D. ^{[12
]}

Sleeper, Lynn A. ^{[7
]}

Stylianou, Mario P. ^{[6
]}

Mahony, Lynn ^{[13
]}

机构：

[1] Univ Michigan, Sch Med, Ann Arbor, MI USA

[2] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA

[3] Childrens Hosp Wisconsin, Herma Heart Ctr, Milwaukee, WI 53201 USA

[4] Childrens Hosp, Boston, MA 02115 USA

[5] Harvard Univ, Sch Med, Boston, MA USA

[6] NHLBI, NIH, Bethesda, MD 20892 USA

[7] New England Res Inst, Watertown, MA 02172 USA

[8] Med Univ S Carolina, Charleston, SC 29425 USA

[9] Duke Univ, Med Ctr, Durham, NC USA

[10] Hosp Sick Children, Toronto, ON M5G 1X8, Canada

[11] Columbia Univ, Med Ctr, New York, NY USA

[12] Primary Childrens Med Ctr, Salt Lake City, UT 84103 USA

[13] Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USA

来源：

JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY | 2008年 / 136卷 / 04期

基金：

美国国家卫生研究院;

关键词：

D O I：

10.1016/j.jtcvs.2008.01.013

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective: The initial palliative procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood procedure, remains among the highest risk procedures in congenital heart surgery. The classic Norwood procedure provides pulmonary blood flow with a modified Blalock-Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood procedure that uses a right ventricle-pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques. Methods: The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood procedure with either the right ventricle -pulmonary artery or modified Blalock-Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups. Conclusion: This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.

引用

页码：968 / 975

页数：8

共 30 条

[1] New developments in the treatment of hypoplastic left heart syndrome [J].