Management strategies of adverse reactions to magnetic sphincter augmentation for gastroesophageal reflux disease

doi:10.3877/cma.j.issn.2095-8773.2022.03.08

Abstract

Abstract:

Objective

Magnetic sphincter augmentation (MSA) is a new surgical treatment for gastroesophageal reflux disease (GERD) . This study aimed to explore the postoperative complications and management strategies of Chinese MSA in the treatment of GERD.

Methods

According to the enrollment criteria for the SS-MSA clinical trial, 43 GERD patients were treated with MSA from August 2018 to October 2021. SS-MSA, jointly developed by ShengJieKang Co. and Shanghai Chest Hospital, was implanted via laparoscopy. The primary evaluation index of postoperative efficacy included the total time of acid exposure within 24 h, the average daily dose of PPI medications and GERD-Health Related Quality of Life (GERD-Q) improvement after MSA implantation. The complications were recorded. This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-16009512) .

Results

Among the 43 GERD patients undergoing SS-MSA surgery, 23 cases were followed up for 1 year. The total time of acid exposure within 24 h [9% (6.2%–13.4%) vs 0.4% (0.1%–2.4%) , P<0.001] and GERD-Q score [11 (8–14) vs 6 (6–11) , P=0.001] were improved after operation significantly. All subjects took proton pump inhibitor (PPI) drugs before surgery, while 5 patients (21.7%) needed long-term administration of PPI postoperatively. The patients could belch normally. The most common complication after the operation was dysphagia (37/43, 86%) , of which 95% (35/37 cases) were mild to moderate and were relieved within 1–3 months. Two patients developed severe dysphagia one month after the operation with the size of MSA 13 and 14, both of which were removed. Other postoperative adverse events included diarrhea, abdominal pain, constipation, and nausea. All patients received symptomatic therapy and were relieved within 3 months, except for one case of diarrhea with readmission. Twenty-seven patients underwent persistent acid reflux symptoms postoperatively. The symptoms disappeared within 3 months in 13 patients and mild to moderate symptoms persisted in 14 patients, with intermittent or continuous use of PPI drugs and one patient had the device removed due to serious reflux. One patient had the device removed due to chest pain.

Conclusions

The main complication was dysphagia after SS-MSA implantation, which could be relieved in a short time. Proper selection of MSA devices, good preoperative education and postoperative diet guidance will ensure the success rate of the operation.

Key words: Gastroesophageal reflux disease, Magnetic sphincter augmentation, Surgery, Complication

Yifeng Sun, Haoyao Jiang, Haiyong Gu, Yang Yang, Yi He, Bin Li, Zhigang Li. Management strategies of adverse reactions to magnetic sphincter augmentation for gastroesophageal reflux disease[J]. Chinese Journal of Thoracic Surgery(Electronic Edition), 2022, 09(03): 173-180.

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Figures/Tables 5

References 35

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监测指标	术前（n＝43）	术后1年（n＝23）	P
酸暴露总时间（%）	9（6.2～13.4）	0.4（0.1～2.4）	<0.001
直立位反流总时长（%）	10.8（7.5～18.1）	0.5（0.1～1.6）	<0.001
平躺位反流总时长（%）	5.6（1.9～14.2）	0（0～0.44）	<0.001
反流总次数	158（87～204）	69（43～120）	0.004
>5 min的反流次数	5（2～7）	0（0～0）	0.004
最长反流时长（min）	12.5（7.9～24.3）	1.7（0.4～4.0）	<0.001
DeMeester评分	35.69（23.72～48.91）	1.65（0.69～6.87）	<0.001
LES静息压（mmHg）	7.1（5～12.2）	21.9（13.25～28.85）	0.005

监测指标	术前（n＝43）	术后1年（n＝23）	P
酸暴露总时间（%）	9（6.2～13.4）	0.4（0.1～2.4）	<0.001
直立位反流总时长（%）	10.8（7.5～18.1）	0.5（0.1～1.6）	<0.001
平躺位反流总时长（%）	5.6（1.9～14.2）	0（0～0.44）	<0.001
反流总次数	158（87～204）	69（43～120）	0.004
>5 min的反流次数	5（2～7）	0（0～0）	0.004
最长反流时长（min）	12.5（7.9～24.3）	1.7（0.4～4.0）	<0.001
DeMeester评分	35.69（23.72～48.91）	1.65（0.69～6.87）	<0.001
LES静息压（mmHg）	7.1（5～12.2）	21.9（13.25～28.85）	0.005

内镜检查结果		例数
食管炎
	A级	4
	B级	1
慢性浅表性胃炎伴胃底糜烂		1
慢性浅表性胃炎		30
慢性非萎缩性胃炎		2
慢性浅表性胃炎伴胆汁反流		2
糜烂性胃炎		1
慢性萎缩性胃炎		1
轻度糜烂性胃窦炎）		1
裂孔疝（2 cm裂孔疝）		1

内镜检查结果		例数
食管炎
	A级	4
	B级	1
慢性浅表性胃炎伴胃底糜烂		1
慢性浅表性胃炎		30
慢性非萎缩性胃炎		2
慢性浅表性胃炎伴胆汁反流		2
糜烂性胃炎		1
慢性萎缩性胃炎		1
轻度糜烂性胃窦炎）		1
裂孔疝（2 cm裂孔疝）		1

不良事件	n	程度			缓解或消失	持续	移除
不良事件	n	Ⅰ级	Ⅱ级	Ⅲ级	缓解或消失	持续	移除
吞咽困难	37	19	16	2	28	7	2
烧心或反酸	27	17	8	2	13	13	1
胸背痛	11	5	5	1	4	6	1
腹痛	10	5	5	0	5	5	0
恶心	8	3	5	0	4	4	0
腹胀	6	4	2	0	6	0	0
失眠	5	1	4	0	1	4	0
腹泻	4	2	1	1	4	0	0
呕吐	3	2	0	1	3	0	0
低热	3	3	0	0	3	0	0
咳嗽	2	2	0	0	2	0	0
便秘	1	1	0	0	1	0	0
胸闷	1	0	1	0	1	0	0
焦虑	1	0	1	0	0	1	0

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