Aspiration therapy was implemented in 25 adults with average body mass index 40. BMI decreased to 32 in one year and 31 in two years. No electrolyte anomalies or major side effects were noted. Stomach was drained 20 min after each meal, 3 times a day. Adherence to procedure was 80% in 12 months and 60% in 24 months.
Could this be a future viable therapy for obesity?
Prospective Observational Study
Background: This study evaluated the efficacy and safety of the novel AspireAssist® Aspiration Therapy System for treatment of obesity, and its effect on patient’s quality of life.
Methods: A prospective observational study with 25 obese subjects, mean age 48 years (range 33–65), was performed. A custom gastrostomy tube (A-tube, Aspire Bariatrics) was percutaneously inserted during a gastroscopy performed under conscious sedation. Drainage and irrigation of the stomach were performed 3 times daily, 20 min after each meal, for 1–2 years. Efficient aspiration required thorough chewing of ingested food. Treatment included a cognitive behavioral weight loss program.
Results: Mean BMI at inclusion was 39.8 kg/m2. After 1 year mean BMI was 32.1 kg/m2, p < 0.01, and excess weight loss was 54.4%, p < 0.01. Quality of life, as measured with EQ-5D, improved from 0.73 to 0.88, p < 0.01. After 2 years BMI was 31.0 kg/m2, p < 0.01, and excess weight loss was 61.5%, p < 0.01. There were no serious adverse events or electrolyte disorders. Compliance was 80% after 1 year and 60% after 2 years.
Conclusions: Aspiration therapy is an efficient and safe treatment for obesity, and weight reduction improves quality of life. Excess weight was approximately halved in a year, with weight stability if treatment was continued.
Trial registration: Trial Register ISRCTN 49958132. Retrospectively registered 28/02/2014.
MORE INFORMATION FROM THE PUBLICATION:
Obesity, as defined by World Health Organization as BMI >30, is a major global health problem with increasing prevalence. Obesity has more than doubled worldwide since 1980. In 2014, more than 1.9 billion adults, of 18 years and older, were overweight. Most of the world’s population live in countries where overweight and obesity cause higher mortality than underweight. There is a well-established association between obesity and decreased quality of life as well as morbidity from diabetes type 2, elevated blood pressure, dyslipidemia and cardiovascular complications as coronary artery disease and cerebrovascular insult. It has recently been shown that obesity also is an avoidable cause of some specific forms of cancer.
Alarmingly, it has been shown that obese mothers affect the phenotype of their offspring, rendering the child more susceptible to obesity. This effect is irreversible but preventable by bariatric surgery prior to pregnancy. On the other hand, bariatric surgery before pregnancy increases risk of preterm and small for gestational age births.
Successful long-term weight loss is rarely achieved through conservative treatment alone, even though there are evidence of the moderate effectiveness of combination of psychological intervention, exercise and dietary strategies. Bariatric surgery is the most effective therapy available today, with proven effects on long term weight loss, mortality, morbidity and incidence of cancer in women.
We evaluated a new device for treating obesity, the AspireAssist® Aspiration Therapy System (Aspire Bariatrics, King of Prussa, PA), which consists of an endoscopically placed gastrostomy tube and siphon assembly. AspireAssist® allows patients to aspirate gastric contents 20 min after meal consumption three times daily. Aspiration takes about 10 min to perform and removes approximately 30% of ingested calories.
Irrigation and aspiration of gastric content can possibly lead to chronic loss of hydrogen and chloride ions. The physiologic response is renal secretion of potassium ions and resorption of hydrogen ions, resulting in hypochloremic hypokalemic metabolic alkalosis. Loss of potassium ions cause hypokalemia and risk of cardiac arrhythmia.
This weight loss surpassed our expectation and is nearly at the level of gastric bypass procedure and other major abdominal surgery for obesity. The subjects reported improved quality of life during treatment. There was neither mortality nor any event more severe than grade III-a according to Clavien-Dindo grading system.
The hypothesis of a possible compensatory increase in potassium secretion into urine, which could lead to chronic hypokalemia and subsequent risk of cardiac arrhythmia, was examined and rejected. We therefore conclude that prophylactic administration of potassium or proton pump inhibitors is unnecessary, if the patient does not use any potassium lowering medication (as for example diuretics). We also observed that aspiration therapy caused alkalization of urine and a reduced urinary secretion of chloride and sodium. We interpret this as a compensatory response due to loss of some hydrochloric acid.
Drainage of stomach content is only possible if the patient eats slowly and chews thoroughly. The patient gets a direct feedback regarding how well he or she chewed when attempting aspiration. Many subjects reported that the treatment has changed their eating habits, with slower eating and smaller meals. This change may in itself lead to a reduction in caloric intake. The previous study by Sullivan and his colleges indicates that the treatment does not lead to increase in caloric intake.
Bariatric surgery is currently regarded as a golden standard for obesity treatment. Aspiration therapy provides a reversible, easily performed outpatient procedure that does not entail the risks associated with major abdominal surgery. AspireAssist® does not alter the anatomy of the gastrointestinal tract. In our experience so far, the AspireAssist® gastrostomy tube placement has not complicated subsequent laparoscopic bariatric surgery. One subject in our study underwent a gastric bypass procedure without any problems related to the prior gastrostomy stoma.
Limitation of this study is the combination of aspiration therapy and CBT without any control group. This study only encompasses treatment during 1-2 years. Long term patency is still unknown. It is our belief that once the desired weight goal is achieved many, if not most, patients will need to continue aspiration therapy, albeit possibly at a reduced frequency, to maintain weight stability. In order to determine this we have started a prospective study in which we will follow 50 patients with AspireAssist® and 50 patients with laparoscopic gastric bypass procedure for 5 years.