Duodeno-ileal magnetic compression anastomoses in metabolic surgery: a systematic review and meta-analysis.

IF 3.8
Patrick Noel, Laurent Biertho, Jaime Ponce, Pierre Garneau, Rami Lutfi, Michel Gagner
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引用次数: 0

Abstract

Background: Sutureless duodeno-ileal magnetic compression anastomosis (DI-MCA) is a novel technology for metabolic and bariatric surgery, but pooled evidence on feasibility, safety, and early efficacy is lacking.

Objectives: To systematically review feasibility, safety, and early efficacy of DI-MCA across device classes and procedural contexts.

Setting: International; prospective clinical studies.

Methods: MEDLINE, EMBASE, CENTRAL, Web of Science, and ClinicalTrials.gov were searched to 31 March 2026. Eligible studies reported DI-MCA using linear (LMAS), biofragmentable (BMAS), self-forming (SNAP/SNAP-S), or immediately-patent (IMPA-DI) devices. Cohort overlap was resolved by investigator correspondence. Proportions were pooled with Freeman-Tukey transformation; continuous outcomes with REML and Hartung-Knapp correction. Bias: MINORS; certainty: Grading of Recommendations, Assessment, Development, and Evaluations.

Results: Twelve prospective studies (220 enrolled, 218 implanted) met inclusion criteria; after de-duplication, 153 enrolled adults (151 implanted) were verified-unique. The pooled device-related leak rate was .0% (95% confidence interval [CI] .0-1.7), with zero 30-day mortality. Efficacy is reported descriptively by procedural context. Primary DI-MCA with concurrent sleeve gastrectomy: 6-month percent total weight loss (%TWL) 28.1% (n = 24, LMAS 1.9 cm) and 10.7% (n = 17, BMAS 4-5 cm), with 12-month data in 5 patients (%TWL 34.0%). Revisional solo DI-MCA: %TWL 5.4% at 6 months (n = 24) and 5.3% at 12 months (n = 23). Solo biofragmentable DI-MCA in mild obesity with type 2 diabetes: 12-month %TWL 8.7% (n = 8/15); HbA1c 8.2%→6.6%. Protein-energy malnutrition (9.3%, 5/54) was confined to the SNAP subset. Certainty of evidence was low to very low.

Conclusions: DI-MCA is feasible, with no device-related anastomotic leak and no 30-day mortality; early efficacy is device- and context-dependent. All available data are derived from small, industry-sponsored single-arm studies in highly selected patients at experienced investigational centers, and support feasibility and early safety rather than comparative effectiveness or generalizability to routine practice. Larger comparative studies with longer follow-up are needed; the SNAP malnutrition signal warrants prospective surveillance.

十二指肠-回肠磁压缩吻合术在代谢手术中的应用:一项系统综述和荟萃分析。
背景:无缝合十二指肠-回肠磁压吻合术(DI-MCA)是一种用于代谢和减肥手术的新技术,但缺乏可行性、安全性和早期疗效的综合证据。目的:系统地回顾DI-MCA的可行性、安全性和早期疗效,跨越器械类别和程序背景。背景:国际;前瞻性临床研究。方法:检索MEDLINE、EMBASE、CENTRAL、Web of Science和ClinicalTrials.gov至2026年3月31日。符合条件的研究报告了使用线性(LMAS)、生物可分解(BMAS)、自形成(SNAP/SNAP- s)或立即专利(IMPA-DI)装置的DI-MCA。通过研究者通信解决队列重叠问题。比例与Freeman-Tukey变换合并;REML和Hartung-Knapp校正的持续结果。偏见:未成年人;确定性:建议、评估、发展和评估的分级。结果:12项前瞻性研究(220项入组研究,218项植入研究)符合纳入标准;在去重复后,153名入组的成年人(151名植入)被证实是独一无二的。池化设备相关泄漏率为。0%(95%可信区间[CI] .0-1.7), 30天死亡率为零。疗效是通过程序语境来描述的。原发性DI-MCA合并袖胃切除术:6个月总体重减轻(%TWL) 28.1% (n = 24, LMAS 1.9 cm)和10.7% (n = 17, BMAS 4-5 cm),其中5例患者12个月数据(%TWL 34.0%)。修正单独DI-MCA: %TWL: 6个月时5.4% (n = 24), 12个月时5.3% (n = 23)。轻度肥胖合并2型糖尿病患者单发生物可降解DI-MCA: 12个月TWL为8.7% (n = 8/15);糖化血红蛋白8.2%→6.6%。蛋白质能量营养不良(9.3%,5/54)仅限于SNAP亚组。证据的确定性很低甚至很低。结论:DI-MCA是可行的,无器械相关吻合口漏,无30天死亡率;早期疗效依赖于设备和环境。所有可用的数据都来自小型的、行业赞助的单臂研究,在经验丰富的研究中心,在高度选择的患者中进行,并支持可行性和早期安全性,而不是比较有效性或推广到常规实践。需要更大规模的比较研究和更长时间的随访;SNAP的营养不良信号值得进行前瞻性监测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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