目的:磁括约肌增强术(MSA)是FDA批准的抗反流程序,其结果与胃底折叠术相当。然而,有关其使用的大多数数据仅限于单中心或小型多中心研究,这可能会限制其疗效的普遍性。这项研究的目的是在国家数据库中评估MSA与胃底折叠术患者的预后。
方法:利用2017-2020年美国外科医生学会国家外科质量改善计划(ACS-NSQIP)注册来评估接受MSA或胃底折叠术的患者。需要科利斯胃成形术的病人,食管旁疝修补术,和紧急情况,被排除在外。患者结果包括总体并发症发生率,再入院,重新操作,和死亡率。
结果:共有7,882例患者接受了MSA(n=597)或胃底折叠术(n=7285)。MSA患者较年轻(51vs57,p<0.001),更常见的是男性(49.6对34.3%,p<0.001)。虽然接受MSA的患者经历了相似的再手术率(1.0vs2.0%,p=0.095),他们经历了较少的再入院(2.2%对4.7%,p=0.005),并发症(0.6vs4.0%,p<0.001),较短的平均(SD)住院时间(天)(0.4±4.3vs1.8±4.6,p<0.001)和手术时间(min)(80.8±36.1vs118.7±63.7,p<0.001)。组间死亡率相似(0vs0.3%,p=0.175)。在多变量分析中,MSA与术后并发症减少独立相关(OR0.23,CI0.08至0.61,p=0.002),再入院(OR0.53,CI0.30至0.94,p=0.02),手术时间(RC-36.56,CI-41.62至-31.49。p<0.001)和住院时间(RC-1.22,CI-1.61至-0.84p<0.001)。
结论:在这项国家数据库研究中,与胃底折叠术相比,MSA与减少术后并发症有关,更少的再入院,手术时间和住院时间更短。虽然MSA和胃底折叠术之间缺乏随机试验,机构和国家数据库研究都继续支持将MSA用作安全的抗反流手术.
OBJECTIVE: Magnetic Sphincter Augmentation (
MSA) is an FDA-approved anti-reflux procedure with comparable outcomes to fundoplication. However, most data regarding its use are limited to single or small multicenter studies which may limit the generalizability of its efficacy. The purpose of this study is to evaluate the outcomes of patients undergoing
MSA vs fundoplication in a national database.
METHODS: The 2017-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Registry was utilized to evaluate patients undergoing MSA or fundoplication. Patients requiring Collis gastroplasty, paraesophageal hernia repair, and emergency cases, were excluded. Patient outcomes included overall complication rates, readmissions, reoperations, and mortality.
RESULTS: A total of 7,882 patients underwent
MSA (n = 597) or fundoplication (n = 7285).
MSA patients were younger (51 vs 57, p < 0.001), and more often male (49.6 vs 34.3%, p < 0.001). While patients undergoing MSA experienced similar rates of reoperation (1.0 vs 2.0%, p = 0.095), they experienced fewer readmissions (2.2 vs 4.7%, p = 0.005), complications (0.6 vs 4.0%, p < 0.001), shorter mean (SD) hospital length of stay(days) (0.4 ± 4.3 vs 1.8 ± 4.6, p < 0.001) and operative time(min) (80.8 ± 36.1 vs 118.7 ± 63.7, p < 0.001). Mortality was similar between groups (0 vs 0.3%, p = 0.175). On multivariable analysis, MSA was independently associated with reduced postoperative complications (OR 0.23, CI 0.08 to 0.61, p = 0.002), readmissions (OR 0.53, CI 0.30 to 0.94, p = 0.02), operative time (RC - 36.56, CI - 41.62 to - 31.49. p < 0.001) and length of stay (RC - 1.22, CI - 1.61 to - 0.84 p < 0.001).
CONCLUSIONS: In this national database study, compared to fundoplication MSA was associated with reduced postoperative complications, fewer readmissions, and shorter operative time and hospital length of stay. While randomized trials are lacking between MSA and fundoplication, both institutional and national database studies continue to support the use of
MSA as a safe anti-reflux operation.