背景:越来越多的反流患者选择磁性括约肌增强术(MSA)代替胃底折叠术。然而,很少有研究比较这些手术的中期疗效和安全性.
方法:我们对2015年1月至2020年6月期间的连续MSA和Nissen胃底折叠病例进行了回顾性单中心分析。患者接受了手术,包括组织成形术,用于食管裂孔疝引起的药物抵抗反流。手术翻修和质子泵抑制剂(PPI)再摄取率是主要结果。我们还比较了不良事件的发生率。患有严重术前吞咽困难/运动障碍的患者被分配了不同的治疗途径,并被排除在分析之外。我们使用倾向评分匹配来减少治疗之间的混淆。
结果:在411名符合条件的患者中,141例MSA患者和141例胃底折叠术患者的倾向评分相似,并进行了分析。平均而言,患者年龄55±12岁,超重(BMI:28±5)。平均随访3.9年,与胃底折叠术相比,MSA与较低的手术翻修风险相关(每年1.2%vs3.0%,分别;HR:0.38;95%CI0.15-0.96;p=0.04),PPI再摄取风险相似(每年2.6%vs4.2%;HR:0.59;95%CI0.30-1.16;p=0.12)。初次住院期间的不良事件发生率相似(MSA与胃底折叠术:1%vs.3%,p=0.68)。出院后MSA组发生不良事件的患者较少(24%vs.33%,p=0.11),受自限性吞咽困难发生率较高的驱动(1%vs.9%,p<0.01)和气体/腹胀(10%vs.18%,p=0.06)胃底折叠术后。需要诊断内镜检查的吞咽困难患者MSA和胃底折叠术之间的差异(11%与8%,p=0.54)或手术翻修(2%vs.1%,p=1.0)无显著性。装置外植率为4%(5/141)。
结论:与胃底折叠术相比,MSA降低了再次手术的风险,并且可以降低出院后的不良事件发生率。需要在可用的手术选择之间进行随机头对头研究。
BACKGROUND: An increasing number of reflux patients opt for magnetic sphincter augmentation (MSA) instead of
fundoplication. However, few studies compare the medium-term efficacy and safety of the procedures.
METHODS: We conducted a retrospective single-center analysis of consecutive MSA and Nissen fundoplication cases between 01/2015 and 06/2020. Patients underwent surgery, including hiatoplasty, for medical treatment-resistant reflux due to hiatal hernia. Surgical revision and proton pump inhibitor (PPI) reuptake rates were the primary outcomes. We also compared adverse event rates. Patients with severe preoperative dysphagia/motility disorders were assigned different treatment pathways and excluded from the analysis. We used propensity-score matching to reduce confounding between treatments.
RESULTS: Out of 411 eligible patients, 141 patients who underwent MSA and 141 with
fundoplication had similar propensity scores and were analyzed. On average, patients were 55 ± 12 years old and overweight (BMI: 28 ± 5). At 3.9 years of mean follow-up, MSA was associated with lower surgical revision risk as compared to fundoplication (1.2% vs 3.0% per year, respectively; HR: 0.38; 95% CI 0.15-0.96; p = 0.04), and similar PPI-reuptake risk (2.6% vs 4.2% per year; HR: 0.59; 95% CI 0.30-1.16; p = 0.12). Adverse event rates during primary stay were similar (MSA vs.
fundoplication: 1% vs. 3%, p = 0.68). Fewer patients experienced adverse events in the MSA group after discharge (24% vs. 33%, p = 0.11), driven by higher rates of self-limiting dysphagia (1% vs. 9%, p < 0.01) and gas/bloating (10% vs. 18%, p = 0.06) after fundoplication. Differences between MSA and
fundoplication in dysphagia requiring diagnostic endoscopy (11% vs. 8%, p = 0.54) or surgical revision (2% vs. 1%, p = 1.0) were non-significant. The device explantation rate was 4% (5/141).
CONCLUSIONS: MSA reduces the re-operation risk compared to
fundoplication and may decrease adverse event rates after discharge. Randomized head-to-head studies between available surgical options are needed.