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随机对照试验双胎输血综合征激光手术:序贯试验。

Randomized controlled trial of twin-twin transfusion syndrome laser surgery: the sequential trial.

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA.

Childbirth Research Associates, LLC, North Hollywood, CA.

出版信息

Am J Obstet Gynecol. 2024 Sep;231(3):365.e1-365.e15. doi: 10.1016/j.ajog.2024.06.009. Epub 2024 Jun 17.

Abstract

BACKGROUND

Intraoperative blood transfer between twins during laser surgery for twin-twin transfusion syndrome can vary by surgical technique and has been proposed to explain differences in donor twin survival.

OBJECTIVE

This trial compared donor twin survival with 2 laser techniques: the sequential technique, in which the arteriovenous communications from the volume-depleted donor to the volume-overloaded recipient are laser-occluded before those from recipient to donor, and the selective technique, in which the occlusion of the vascular communications is performed in no particular order.

STUDY DESIGN

A single-center, open-label, randomized controlled trial was conducted in which twin-twin transfusion syndrome patients were randomized to sequential vs selective laser surgery. Nested within the trial, a second trial randomized patients with superficial anastomoses (arterioarterial and venovenous) to ablation of these connections first (before ablating the arteriovenous anastomoses) vs last. The primary outcome measure was donor twin survival at birth.

RESULTS

A total of 642 patients were randomized. Overall donor twin survival was similar between the 2 groups (274 of 320 [85.6%] vs 271 of 322 [84.2%]; odds ratio, 1.12 [95% confidence interval, 0.73-1.73]; P=.605). Superficial anastomoses occurred in 177 of 642 cases (27.6%). Donor survival was lower in the superficial anastomosis group vs those with only arteriovenous communications (125 of 177 [70.6%] vs 420 of 465 [90.3%]; adjusted odds ratio, 0.33 [95% confidence interval, 0.20-0.54]; P<.001). In cases with superficial anastomoses, donor survival was independent of the timing of ablation or surgical technique. The postoperative mean middle cerebral artery peak systolic velocity was lower in the sequential vs selective group (1.00±0.30 vs 1.06±0.30 multiples of the median; P=.003). Post hoc analyses showed 2 factors that were associated with poor overall donor twin survival: the presence or absence of donor twin preoperative critical abnormal Doppler parameters and the presence or absence of arterioarterial anastomoses. Depending on these factors, 4 categories of patients resulted: (1) Category 1 (347 of 642 [54%]), no donor twin critical abnormal Doppler + no arterioarterial anastomoses: donor twin survival was 91.2% in the sequential and 93.8% in the selective groups; (2) Category 2 (143 of 642 [22%]), critical abnormal Doppler present + no arterioarterial anastomoses: donor survival was 89.9% vs 75.7%; (3) Category 3 (73 of 642 [11%]), no critical abnormal Doppler + arterioarterial anastomoses present: donor survival was 94.7% vs 74.3%; and (4) Category 4 (79 of 642 [12%]), critical abnormal Doppler present + arterioarterial anastomoses present: donor survival was 47.6% vs 64.9%.

CONCLUSION

Donor twin survival did not differ between the sequential vs selective laser techniques and did not differ if superficial anastomoses were ablated first vs last. The donor twin's postoperative middle cerebral artery peak systolic velocity was improved with the sequential vs the selective approach. Post hoc analyses suggest that donor twin survival may be associated with the choice of laser technique according to high-risk factors. Further study is needed to determine whether using these categories to guide the choice of surgical technique will improve outcomes.

摘要

背景

在激光治疗双胎输血综合征期间,双胞胎之间的术中血液转移可能因手术技术而异,并被提议解释供体双胞胎存活率的差异。

目的

本试验比较了两种激光技术的供体双胞胎存活率:序贯技术,其中先闭塞从体积不足的供体到体积过多的受体的动静脉交通,然后闭塞从受体到供体的动静脉交通;选择性技术,其中血管交通的闭塞没有特定的顺序。

研究设计

这是一项单中心、开放标签、随机对照试验,其中双胎输血综合征患者被随机分为序贯与选择性激光手术组。在试验中嵌套了第二个试验,将有浅表吻合(动-动脉和静-静脉)的患者随机分为首先消融这些连接(在消融动静脉吻合之前)与最后消融这些连接。主要结局指标是出生时供体双胞胎的存活率。

结果

共随机分配了 642 例患者。两组供体双胞胎的存活率相似(320 例中的 274 例[85.6%]与 322 例中的 271 例[84.2%];优势比,1.12[95%置信区间,0.73-1.73];P=.605)。在 642 例中,有 177 例(27.6%)存在浅表吻合。与只有动静脉交通的患者相比,浅表吻合组的供体存活率较低(177 例中的 125 例[70.6%]与 465 例中的 420 例[90.3%];调整后的优势比,0.33[95%置信区间,0.20-0.54];P<.001)。在有浅表吻合的情况下,供体存活率与消融或手术技术的时间无关。与选择性组相比,序贯组的术后大脑中动脉收缩期峰值速度较低(1.00±0.30 与 1.06±0.30 中位数倍数;P=.003)。事后分析显示,有两个因素与整体供体双胞胎存活率差有关:供体双胞胎术前多普勒参数是否存在临界异常和是否存在动-动脉吻合。根据这些因素,有 4 类患者:(1)类别 1(642 例中的 347 例[54%]),无供体双胞胎临界异常多普勒+无动-动脉吻合:序贯组的供体双胞胎存活率为 91.2%,选择性组为 93.8%;(2)类别 2(642 例中的 143 例[22%]),存在临界异常多普勒+无动-动脉吻合:供体存活率为 89.9%与 75.7%;(3)类别 3(642 例中的 73 例[11%]),无临界异常多普勒+存在动-动脉吻合:供体存活率为 94.7%与 74.3%;(4)类别 4(642 例中的 79 例[12%]),存在临界异常多普勒+存在动-动脉吻合:供体存活率为 47.6%与 64.9%。

结论

序贯与选择性激光技术之间的供体双胞胎存活率无差异,如果先消融浅表吻合而不是最后消融,存活率也没有差异。与选择性方法相比,序贯方法可改善供体双胞胎的术后大脑中动脉收缩期峰值速度。事后分析表明,供体双胞胎的存活率可能与根据高危因素选择激光技术有关。需要进一步的研究来确定是否使用这些类别来指导手术技术的选择是否会改善结果。

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