The EndoBarrier gastrointestinal liner (GI Dynamics, Lexington, Massachusetts, USA)
([Fig. 1]) is an endoscopically deployed and fully reversible treatment modality for type
2 diabetes and/or obesity [1]. Adverse events related to its use include transient abdominal pain, nausea, and
vomiting, which typically occur within the first 2 weeks after implantation. We present
the first case of premature explantation of the EndoBarrier after recurrent abdominal
pain, nausea, and vomiting due to invagination of the sleeve.
Fig. 1 The EndoBarrier gastrointestinal liner consists of a 60-cm fluoropolymer “sleeve”
that is anchored in the duodenal bulb. It creates a duodenal–jejunal bypass by internally
lining the mucosa of the proximal small intestine. The device is implanted and explanted
endoscopically while the patient receives general anesthesia or conscious sedation.
The EndoBarrier is CE-marked for up to 12 months of use in the treatment of obese
patients with or without type 2 diabetes.
Following implantation, a 25-year-old obese woman experienced recurrent epigastric
pain and nausea with occasional vomiting. The severity of the symptoms led to hospitalization
4 weeks after implantation. Abdominal computed tomography revealed no migration or
signs of obstruction of the device ([Fig. 2]), and a biochemical profile showed the following elevated values: plasma alanine
transaminase, 84 U/L (normal range 10 – 45); aspartate transaminase, 53 U/L (normal
range 10 – 35); amylase, 205 U/L (normal range 10 – 65). The white blood cell count
remained normal, but the C-reactive protein level fluctuated up to 58 mg/L (normal
values < 10). Upper gastrointestinal endoscopy revealed invagination of the device
([Fig. 3]), which was uneventfully explanted. The patient was discharged well and with normalized
blood values.
Fig. 2 Contrast-enhanced computed tomographic scan of the abdomen shows no migration or
signs of obstruction of the device. The anchor is correctly situated in the duodenal
bulb (arrow). a Coronal projection. b Sagittal projection.
Fig. 3 Appearance of the EndoBarrier gastrointestinal liner after explantation because of
the patient’s recurrent episodes of epigastric pain, nausea, and vomiting. The “anchor”
is seen from above; the “sleeve” is invaginated (arrowhead) and tinged by bile. The
two drawstrings (arrow), which were used to collapse the anchor during the explantation
procedure, are located at the top of the anchor.
Abdominal pain, nausea, and/or vomiting are common symptoms within the first 2 weeks
after implantation [2]. Similar symptoms have been reported in association with device obstruction [3], but also without obstruction [4]. Other adverse events, which may result in abdominal symptoms, include device-related
ulceration [5] and device migration. However, the latter have also been reported in asymptomatic
patients [4]. Invagination of the EndoBarrier has not previously been reported. Computed tomography
may be employed for diagnosis, but upper gastrointestinal endoscopy seems preferable
because it allows device explantation, depending on the findings.
Obstruction of the EndoBarrier due to invagination may be the cause of recurrent epigastric
pain. Therefore, it should be emphasized that patients experiencing epigastric pain,
nausea, and/or vomiting beyond the first 2 weeks should be thoroughly examined with
regard to the function and location of the device.
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