Background

Endoscopy has evolved to become first-line therapy for the treatment of post-bariatric leaks; however, many sessions are often required with variable success rates. Due to these limitations, the use of the cardiac septal defect occluder (CSDO) has recently been reported in this population.

Methods

The study population was a multicenter retrospective series of patients with post-bariatric surgical leaks who underwent treatment with CSDO placement. Data on the type of surgery, previous treatment details, fistula dimensions, success rate, and adverse events were collected. Leaks were grouped according to the International Sleeve Gastrectomy Expert Panel Consensus. Outcomes included technical and clinical success and safety of the CSDO. Regression analysis was performed to determine the predictors of response.

Results

Forty-three patients with leaks were included (31 sleeve gastrectomy and 12 Roux-en-Y gastric bypass). They were divided into acute (n = 3), early (n = 5), late (n = 23), and chronic (n = 12). Forty patients had failed previous endoscopic treatment and 3 patients had CSDO as the primary treatment. Median follow-up was 34 weeks. Technical success was achieved in all patients and clinical success in 39 patients (90.7%). All chronic, late, and early leaks were successfully closed, except one undrained late leak. The 5 patients with early leaks had an initial satisfactory response, but within 30 days, drainage recurred. The CSDOs were removed and replaced with larger-diameter devices leading to permanent defect closure. Acute leaks were not successfully closed in all 3 patients. Regression analysis showed that chronicity and previous treatment were associated with fistula closure; success rates for late/chronic leaks versus acute/early leaks were 97.1% and 62.5%, respectively (P = .0023).

Conclusion

This observational study found that the CSDO had a high efficacy rate in patients with non-acute leaks, with no adverse events. All early, late, and chronic leaks were successfully closed, except for one undrained late leak. However, early leaks required a second placement of a larger CSDO in all cases. These results suggest that the CSDO should be considered for non-acute fistula and that traditional closure methods are likely preferred in the acute and early settings.

中文翻译：

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心脏中隔封堵器在重症外科手术后渗漏和瘘管治疗中的功效

背景

内窥镜检查已发展成为治疗重金属后泄漏的一线治疗方法。但是，通常需要多次会议，而成功率却各不相同。由于这些限制，最近在该人群中报告了心脏间隔缺损封堵器（CSDO）的使用。

方法

研究人群是多中心回顾性系列患者，这些患者经过CSDO放置治疗后出现了aria门术后漏气。收集有关手术类型，先前治疗细节，瘘管尺寸，成功率和不良事件的数据。根据国际袖套胃切除术专家小组共识对泄漏进行分组。结果包括CSDO的技术和临床成功以及安全性。进行回归分析以确定反应的预测因子。

结果

包括四十三例有渗漏的患者（31例胃切除术和12例Roux-en-Y胃旁路手术）。他们分为急性（n = 3），早期（n = 5），晚期（n = 23）和慢性（n = 12）。40例先前的内镜治疗失败，3例以CSDO为主要治疗方法。中位随访时间为34周。所有患者均获得技术成功，其中39例（90.7％）获得临床成功。除一次不排水的晚期泄漏外，所有慢性，晚期和早期泄漏均已成功关闭。5例早期渗漏的患者最初的反应满意，但在30天内再次引流。移除了CSDO，并用大直径设备替换，从而永久性关闭了缺陷。所有3例患者均未成功关闭急性渗漏。回归分析表明，慢性病和既往治疗与瘘管闭合有关。晚期/慢性渗漏与急性/早期渗漏的成功率分别为97.1％和62.5％（P  = .0023）。

结论

这项观察性研究发现CSDO在非急性渗漏患者中有很高的疗效，没有不良事件。除一次不排水的晚期泄漏外，所有早期，晚期和慢性泄漏均已成功关闭。但是，在所有情况下，早期泄漏都需要第二次放置较大的CSDO。这些结果表明，对于非急性瘘管应考虑CSDO，在急性和早期环境中，传统的闭合方法可能更可取。