Department of Pediatrics and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
J Thorac Cardiovasc Surg. 2012 Oct;144(4):915-21. doi: 10.1016/j.jtcvs.2012.05.021. Epub 2012 Jun 12.
In the Single Ventricle Reconstruction trial, infants undergoing the Norwood procedure were randomly allocated to undergo a right ventricle-to-pulmonary artery shunt or a modified Blalock-Taussig shunt. Apart from shunt type, subjects received the local standard of care. We evaluated variation in perioperative care during the Norwood hospitalization across 14 trial sites.
Data on preoperative, operative, and postoperative variables for 546 enrolled subjects who underwent the Norwood procedure were collected prospectively on standardized case report forms, and variation across the centers was described.
Gestational age, birth weight, and proportion with hypoplastic left heart syndrome were similar across sites. In contrast, all recorded variables related to preoperative care varied across centers, including fetal diagnosis (range, 55%-85%), preoperative intubation (range, 29%-91%), and enteral feeding. Perioperative and operative factors were also variable across sites, including median total support time (range, 74-189 minutes) and other perfusion variables, arch reconstruction technique, intraoperative medication use, and use of modified ultrafiltration (range, 48%-100%). Additional variation across centers was seen in variables related to postoperative care, including proportion with an open sternum (range, 35%-100%), median intensive care unit stay (range, 9-44 days), type of feeding at discharge, and enrollment in a home monitoring program (range, 1%-100%; 5 sites did not have a program). Overall, in-hospital death or transplant occurred in 18% (range across sites, 7%-39%).
Perioperative care during the Norwood hospitalization varies across centers. Further analysis evaluating the underlying causes and relationship of this variation to outcome is needed to inform future studies and quality improvement efforts.
在单心室重建试验中,接受 Norwood 手术的婴儿被随机分配接受右心室至肺动脉分流术或改良 Blalock-Taussig 分流术。除了分流类型外,受试者还接受了当地的标准治疗。我们评估了 14 个试验点在 Norwood 住院期间围手术期护理的变化。
前瞻性收集了 546 名接受 Norwood 手术的入组婴儿的术前、术中和术后变量数据,并记录在标准化病例报告表上,描述了各中心之间的差异。
各中心的胎龄、出生体重和左心发育不全综合征的比例相似。相比之下,所有与术前护理相关的记录变量在各中心之间均存在差异,包括胎儿诊断(范围 55%-85%)、术前插管(范围 29%-91%)和肠内喂养。围手术期和手术因素也存在差异,包括中位数总支持时间(范围 74-189 分钟)和其他灌注变量、弓部重建技术、术中药物使用以及使用改良超滤(范围 48%-100%)。术后护理相关的变量也存在额外的中心间差异,包括胸骨未闭合的比例(范围 35%-100%)、重症监护病房中位数住院时间(范围 9-44 天)、出院时的喂养类型以及参加家庭监测计划的比例(范围 1%-100%;5 个中心没有该计划)。总的来说,院内死亡或移植的发生率为 18%(各中心的范围为 7%-39%)。
Norwood 住院期间的围手术期护理在各中心之间存在差异。需要进一步分析评估这种差异的根本原因及其与结局的关系,以为未来的研究和质量改进工作提供信息。