Abstract
INTRODUCTION
Intra-gastric balloons have been in use as an aide to weight loss. Since its introduction, it has evolved from air filled to saline filled intra-gastric balloons. The SPATZ-ABS is a new adjustable saline filled balloon.
PRESENTATION OF CASE
Three patients have presented to our hospital as emergencies due to complications arising from this balloon. Two of these patients required emergency laparotomy and resection of small bowel due to pressure necrosis effects of the anchoring device. One patient had migration of the device into the duodenum that was removed endoscopically. Of the 2 patients who underwent a laparotomy, one patient did not have any symptoms or signs that correlated with the intra-operative findings.
DISCUSSION
The anchoring device meant to prevent the intra-gastric balloon from migrating distally has migrated in three patients. To our knowledge, there has been no reported incident of migration of this device. These serious complications pose a risk to patients having these balloons fitted.
CONCLUSION
There is a need to study our experience with a larger population of patients who have had this device inserted. Its safety needs to be questioned and its design may need to be addressed.
Keywords: Intra-gastric adjustable balloon system, Anchoring device, Migration, Infarction, Resection
1. Introduction
Obesity has been a growing concern worldwide. There is a spectrum of measures to aid with weight loss, ranging from dietary modulation to surgical measures. Intra-gastric balloons are one of the modalities studied and currently in practice. Intra-gastric balloons have been in use since the 1980s. During the evolution of its use, complications arose from air filled balloons, including balloon deflation and passage from the stomach into the small bowel subsequently causing bowel obstruction. It went out of favour for several years before being reintroduced as fluid filled intra-gastric balloons. We report three cases of intra-gastric SPATZ balloon complications. All three patients presented with symptoms of proximal small bowel obstruction. Two patients had jejunal resection as a result of pressure necrosis to the bowel by the anchoring device of the SPATZ balloon. One patient had gastric ulceration with the anchoring device migrating into the second part of the duodenum. In all three cases, the balloon was intact and had not deflated. In all cases the balloon was in the stomach for less than the recommended one year period. We recommend further studies to study the experience with these adjustable balloons with anchoring devices in a larger series of patients. There is a need to relook at the design again or even the recommended duration.
2. Case series
2.1. Case 1
A 31 year old lady with a history of asthma and a previous gastric band that had been removed. She underwent an insertion of a SPATZ-ABS intra-gastric balloon in a private hospital, seven months prior to presentation to our hospital. She developed a ‘burning’ epigastric and left upper quadrant abdominal pain, which had been progressively worsening. One week prior to admission, she had started vomiting. Clinically she was mildly tender over the left upper quadrant of her abdomen, but not peritonitic. An urgent gastroscopy was performed. This demonstrated the gastric balloon itself to be in the stomach but the anchoring device had migrated into the 3rd and 4th part of the duodenum, and could not be retrieved endoscopically. She underwent an exploratory laparotomy after a failed second attempt to remove the balloon device under a general anaesthetic. The intact balloon was delivered by a gastrotomy. However the anchoring device had migrated to the duodeno-jejunal flexure causing pressure necrotic changes to the mesenteric and anti-mesenteric borders of the jejunal wall. This device was retrieved at the time of resection of the non-viable jejunum. A functional anastomoses was created. The patient recovered and was discharged on the 6th post-operative day.
2.2. Case 2
A 42 year old lady with a previous history of curative surgery for cervical cancer, sought to decrease weight. She had a SPATZ-ABS intra-gastric balloon inserted in a private hospital. Towards the end of the 11th month, she had a planned endoscopy to remove the balloon. However, during the procedure to remove the intra-gastric balloon, the anchoring device had migrated to the 3rd and 4th part of the duodenum. The intra-gastric balloon itself was deflated and the patient was referred to the emergency surgical admissions of the hospital for an open retrieval of the device. She did not have any abdominal symptoms or signs prior to surgery, except for a rise in her CRP. She underwent an emergency laparotomy to retrieve the device.
At laparotomy, it was noted that the balloon device had migrated further into the duodeno-jejunal flexure. There was evidence of pressure necrosis to this segment of bowel. This segment was resected and a functional anastomoses was created. She made an uneventful recovery and was discharged on the 7th postoperative day.
2.3. Case 3
A 50 year old lady who was fit and well, had a SPATZ-ABS intra-gastric balloon inserted in a private hospital. In the seventh month, she started developing symptoms of vomiting 2–3 h after eating. These symptoms lasted for a week. Additionally, she developed epigastric and right upper quadrant pain before presenting to the hospital with abdominal discomfort and acute kidney injury. She was adequately resuscitated, and underwent an urgent gastroscopy, which demonstrated that the balloon was still intact but the anchoring device had migrated into the first and second part of the duodenum. There was evidence of a gastric ulcer at the incisura. The gastric balloon was deflated at the time of the first gastroscopy, but the device could not be retrieved on the same day. The patient underwent a repeat endoscopy the following day, when the device was completely removed. She was started on antacids and was discharged on the same day.
3. Discussion
There is no doubt that obesity is a growing problem worldwide. In 2010, the World Health Organization reported that 43 million children (35 million in developing countries) were estimated to be overweight and obese.1 The key findings of the Heath Survey of England in 2011, demonstrated that 24% men and 26% women were obese, with 41% of men and 33% of women being overweight.2
There are different management options available to these patients, ranging from lifestyle and dietary modifications, gastric banding, sleeve gastrectomy and intra-gastric balloons. Intra-gastric balloons have been in practice since the 1980s when it was first introduced.3 It was suggested that patients who had intra-gastric balloons would have an increased sense of satiety and a reduced oral intake. As it is easy to insert, modify and retrieve, it proved attractive to doctors and patients. This however has been subject to debate, with some papers suggesting that the weight loss for patients with intra-gastric balloons is comparable to those who had dietary manipulation alone.4,5 These initial studies were conducted in the 1980s, and the intra-gastric balloons has evolved since.
The initial intra-gastric balloon models were filled with air. With time, it was noticed that the balloons did not come without complications. There were side effects associated with these balloons. The most common side effects were nausea, difficulty with inflating or deflating the balloon, deflation and migration of the balloon, which in some cases may lead to obstruction.6 To address this concern, experts convened at a conference to determine the ideal characteristics of a safe and effective intra-gastric balloon.6 Based on research and evidence available at the time, it was agreed that balloons should be filled with fluid instead of air, and that methylene blue should be present in this fluid, as any leakage of fluid would be identified by excretion of methylene blue by the patient.7 Since then, various other fluid and air filled intra-gastric balloons have been in use worldwide.
Some of the known complications of the intra-gastric balloons are gastric ulceration in 2.5%, intolerance in 5%, difficulty in inflating or deflating the balloon in 28.7% and spontaneous deflation of the balloon causing subsequent obstruction.8 There have been many reports of intra-gastric balloons that have deflated and migrated leading to bowel obstruction of variable degree. Balloons have passed uneventfully,9,10 or caused gastric outlet obstruction symptoms,11 spontaneous deflation of the balloon and even partial bowel obstruction.12 In most of these reports, there was balloon deflation in about 80%, which again defers from our series.
The general recommendation for most intra-gastric balloons, is that it should be removed in 6 months, to reduce complications. In 2011, a pilot trial of the use of the intra-gastric SPATZ Adjustable Balloon System (SPATZ-ABS) in 18 patients was performed.13 Seven of the eighteen patients had premature removal of the balloon for gastritis (1), valve malfunction (1), Mallory-Weiss tear (1), balloon deflation (1), NSAID perforating ulcer (1) and 2 patients who had a catheter shear from the chain (one passed uneventfully and the other causing esophageal laceration without perforation). The follow up at one year for these patients demonstrated that only one patient had a perforated ulcer, and this patient was on NSAIDs. However, the study population is small and a conclusion on the safety of leaving the balloon in for one year cannot be assumed.
The SPATZ-ABS anchoring device is unique in its aim to prevent the migration of the balloon. However this anchoring device has had serious complications to these three patients. To our knowledge, there have been no reports on the migration of an anchoring device. In our case series, two patients had bowel resection as a result of the migration of the anchoring device, despite the intra-gastric balloon being intact in the stomach. With the reversal of roles between the anchoring device and the balloon, the balloon may act as an anchor whilst allowing the anchoring device to cause pressure necrosis on the proximal small intestine, and eventually perforation. This is especially so at acute angles where the metal anchoring device may not pass easily. Even with the balloon deflated, this anchoring device has caused irreparable damage to the proximal small bowel which in these patients, was near the duodeno-jejunal flexure. What is of more concern is that, in the case of one patient where there were no symptoms or signs. With our experience from the first two patients, the last patients symptoms were identified early and the patient was treated before further damage was done warranting emergency surgery. In all three cases, the recommended duration of one year had not been exceeded. Two patients developed complications that were life threatening, with one patient treated before the anchoring device migrated any further distally.
4. Conclusion
Though intra-gastric balloons are safe and the SPATZ – Adjustable Balloon System (ABS) is more amenable to modifications once inserted with adequate weight loss, we question its safety. We suggest larger studies to report on experiences with these balloons. We urge the manufacturers to rectify this risk by either modification of either the design or the duration it is left in situ.
Conflict of interest
None.
Funding
None.
Ethical approval
Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal on request.
Author contributions
Ramesh Yap Kannan – Lead Author.
Michael Nutt – Consultant Upper GI Surgeon overseeing patient care.
Footnotes
This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-No Derivative Works License, which permits non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited.
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