Comparison of Shunt Types in the Norwood Procedure for Single-Ventricle Lesions.

被引:684
作者
Ohye, Richard G. [1 ]
Sleeper, Lynn A. [2 ]
Mahony, Lynn [3 ]
Newburger, Jane W. [4 ]
Pearson, Gail D. [5 ]
Lu, Minmin [2 ]
Goldberg, Caren S. [1 ]
Tabbutt, Sarah [6 ]
Frommelt, Peter C. [7 ,8 ]
Ghanayem, Nancy S. [7 ,8 ]
Laussen, Peter C. [4 ]
Rhodes, John F. [9 ]
Lewis, Alan B. [10 ]
Mital, Seema [11 ]
Ravishankar, Chitra [6 ]
Williams, Ismee A. [12 ]
Dunbar-Masterson, Carolyn [4 ]
Atz, Andrew M. [13 ]
Colan, Steven [4 ]
Minich, L. LuAnn [14 ,15 ]
Pizarro, Christian [16 ]
Kanter, Kirk R. [17 ]
Jaggers, James [9 ]
Jacobs, Jeffrey P. [18 ]
Krawczeski, Catherine Dent [19 ]
Pike, Nancy [10 ]
McCrindle, Brian W. [11 ]
Virzi, Lisa [2 ]
Gaynor, J. William [6 ]
机构
[1] Univ Michigan, Sch Med, Ann Arbor, MI USA
[2] New England Res Inst, Watertown, MA 02172 USA
[3] Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USA
[4] Childrens Hosp Boston, Boston, MA USA
[5] NHLBI, Bethesda, MD 20892 USA
[6] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA
[7] Childrens Hosp Wisconsin, Milwaukee, WI 53201 USA
[8] Med Coll Wisconsin, Milwaukee, WI 53226 USA
[9] Wake Forest Univ, Winston Salem, NC 27109 USA
[10] Childrens Hosp Los Angeles, Los Angeles, CA 90027 USA
[11] Hosp Sick Children, Toronto, ON M5G 1X8, Canada
[12] Childrens Hosp New York, New York, NY USA
[13] Med Univ S Carolina, Charleston, SC 29425 USA
[14] Univ Utah, Salt Lake City, UT USA
[15] Primary Childrens Med Ctr, Salt Lake City, UT 84103 USA
[16] Nemours Cardiac Ctr, Wilmington, DE USA
[17] Emory Univ, Atlanta, GA 30322 USA
[18] Congenital Heart Inst Florida, St Petersburg, FL USA
[19] Cincinnati Childrens Med Ctr, Cincinnati, OH USA
关键词
PULMONARY-ARTERY CONDUIT; LEFT-HEART SYNDROME; BLALOCK-TAUSSIG SHUNT; OPERATION; OUTCOMES; PALLIATION; EXPERIENCE; RECONSTRUCTION; HEMODYNAMICS; CHILDREN;
D O I
10.1056/NEJMoa0912461
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: The Norwood procedure with a modified Blalock-Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction, is associated with high mortality. The right ventricle-pulmonary artery (RVPA) shunt may improve coronary flow but requires a ventriculotomy. We compared the two shunts in infants with hypoplastic heart syndrome or related anomalies. Methods: Infants undergoing the Norwood procedure were randomly assigned to the MBT shunt (275 infants) or the RVPA shunt (274 infants) at 15 North American centers. The primary outcome was death or cardiac transplantation 12 months after randomization. Secondary outcomes included unintended cardiovascular interventions and right ventricular size and function at 14 months and transplantation-free survival until the last subject reached 14 months of age. Results: Transplantation-free survival 12 months after randomization was higher with the RVPA shunt than with the MBT shunt (74% vs. 64%, P=0.01). However, the RVPA shunt group had more unintended interventions (P=0.003) and complications (P=0.002). Right ventricular size and function at the age of 14 months and the rate of nonfatal serious adverse events at the age of 12 months were similar in the two groups. Data collected over a mean (+/-SD) follow-up period of 32+/-11 months showed a nonsignificant difference in transplantation-free survival between the two groups (P=0.06). On nonproportional-hazards analysis, the size of the treatment effect differed before and after 12 months (P=0.02). Conclusions: In children undergoing the Norwood procedure, transplantation-free survival at 12 months was better with the RVPA shunt than with the MBT shunt. After 12 months, available data showed no significant difference in transplantation-free survival between the two groups. (ClinicalTrials.gov number, NCT00115934.) N Engl J Med 2010;362:1980-92.
引用
收藏
页码:1980 / 1992
页数:13
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