Aspiration therapy is a weight loss therapy in the United States for patients with a body mass index between 35 kg/m 2 and 55 kg/m 2 . Aspiration therapy allows patients to remove up to one-third of calories consumed at a meal and causes patients to eat fewer calories than prior to starting treatment. Studies demonstrate 14.2% to 21.5% total body weight loss in participants who complete 1 year of treatment and maintenance of weight loss in patients treated for 2 years. Aspiration therapy is a safe and effective new treatment of obesity.
Key points
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The AspireAssist System was recently approved by the Food and Drug Administration (FDA) to perform aspiration therapy.
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Aspiration therapy removes up to 30% of calories consumed at a meal but also induces a decrease in food intake and improved eating behaviors.
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Percent total body weight loss (%TBWL) across trials in patients completing 52 weeks of therapy is 14.2% to 21.4%.
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Serious adverse event (SAE) rates are low, no deaths have occurred, and no patients have developed binge eating disorder or bulimia as a result of aspiration therapy.
Introduction
One of the key components in the pathophysiology of obesity is the intake of calories in excess of energy expenditure resulting in storage of energy, mainly in the form of triglycerides. The physiologic control of eating by the adipose tissue–gut–brain axis has been extensively studied. Humans eat for a variety of reasons, however, including hedonic likability of food, social influences, emotional stress, and environmental cues that are less well understood and may over-ride physiologic mechanisms for appetite regulation. Moreover, lifestyle interventions aimed at modifying behaviors related to these psychosocial factors yield only modest weight loss. Aspiration therapy, an endoscopic bariatric therapy (EBT) that removes up to 30% of calories in a meal, may overcome the limitations of lifestyle intervention alone in reducing food intake to level required for greater weight loss. This review details aspiration therapy with the recently FDA-approved AspireAssist System (Aspire Bariatrics, King of Prussia, Pennsylvania).
Introduction
One of the key components in the pathophysiology of obesity is the intake of calories in excess of energy expenditure resulting in storage of energy, mainly in the form of triglycerides. The physiologic control of eating by the adipose tissue–gut–brain axis has been extensively studied. Humans eat for a variety of reasons, however, including hedonic likability of food, social influences, emotional stress, and environmental cues that are less well understood and may over-ride physiologic mechanisms for appetite regulation. Moreover, lifestyle interventions aimed at modifying behaviors related to these psychosocial factors yield only modest weight loss. Aspiration therapy, an endoscopic bariatric therapy (EBT) that removes up to 30% of calories in a meal, may overcome the limitations of lifestyle intervention alone in reducing food intake to level required for greater weight loss. This review details aspiration therapy with the recently FDA-approved AspireAssist System (Aspire Bariatrics, King of Prussia, Pennsylvania).
Aspiration and the components of the AspireAssist System
Aspiration therapy involves the aspiration of gastric contents after a meal to reduce total calorie absorption for weight loss. The therapy requires the use of the AspireAssist System, which is seen in Fig. 1 and described.
Permanent Components
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A-Tube: a 42-cm silicone tube attached to a dilator and metal cable loop used to attach the A-Tube to a flexible guide wire for placement through the abdominal wall with the standard pull percutaneous endoscopic gastrostomy (PEG) tube technique (see Fig. 1 A). After implantation, the delivery tube portion of the A-Tube with the dilator and metal loop are cut and discarded. The remaining A-Tube has an intragastric bumper that prevents migration through the gastrocutaneous tract. Unlike a standard PEG tube, the A-Tube also contains a 15-cm intragastric portion lined with fenestrations to facilitate the flow of gastric contents into the A-tube.
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Skin-Port: a 3.5-cm disk with a height of less than 1 cm, which is connected to the external portion of the A-Tube. The Skin-Port contains a valve that can be opened to allow gastric contents to flow out when opened with the Connector (discussed later)
Components Only Attached During Aspiration
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Connector: a disk that attaches to the Skin-Port and opens the valve in the Skin-Port (see Fig. 1 B). The Connector also contains a counter that tracks the number of times the Skin-Port is opened. After 115 uses, or the equivalent of 5 weeks to 6 weeks of therapy, the Connector locks and can no longer be used to open the Skin-Port.
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Patient Line: a flexible silicone tube that connects the Connector to the Companion (discussed later)
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Companion: a passive siphon with that allows for flow of water into the Patient Line through the Connector into the A-Tube to facilitate aspiration of gastric contents and flow of gastric contents out of the stomach into the Patient Line and out of the Companion
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Reservoir: a 600-mL soft water bottle that can be filled with tap water and attaches to the Companion to infuse into the stomach to facilitate aspiration of gastric contents
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Drain Tube: silicone tube that attaches to the bottom of the Companion and provides a clean exit of gastric contents into the toilet
Patient evaluation overview
The indications for use of the AspireAssist System as listed in the FDA Summary of Safety and Effectiveness Data document, include patients age 22 and older with a body mass index (BMI) of 35.0 kg/m 2 to 55.0 kg/m 2 who have not been able to lose or maintain a weight loss with nonsurgical weight loss therapy. The FDA summary specifically includes lifestyle therapy and continuous medical monitoring as components of the AspireAssist System. These are consistent with medical society position statements, which confirm that EBTs are intended to be used in conjunction with a lifestyle therapy program and medical monitoring.
Contraindications for use are listed in Box 1 . Most contraindications can be determined by standard medical history and physical examination, laboratory evaluation, or endoscopy. Diagnosing bulimia, binge eating disorder, or night eating syndrome using Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) ( DSM-5 ) criteria may pose more of a challenge to endoscopists who likely have not been trained in making these diagnoses. The FDA does not require patients to be seen by a psychologist for evaluation; however, the author suggests that if patients exhibit signs of an eating disorder on history or on eating disorder questionnaires, referral should be made to a psychologist or psychiatrist with expertise in eating disorders. The most common questionnaire assessments of eating behaviors used in the preoperative bariatric surgical patient, which are also appropriate for preprocedural aspiration therapy patients, include
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Questionnaire on Eating and Weight Patterns-5
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Three-Factor Eating Questionnaire
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Eating Disorder Examination Questionnaire
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Binge Eating Scale
Previous abdominal surgery that increases the risk of gastrostomy tube placement
Esophageal stricture, pseudo-obstruction, severe gastroparesis, gastric outlet obstruction
Inflammatory bowel disease
History of refractory gastric ulcers
Ulcers, bleeding lesions, or tumors discovered during endoscopic examination
Uncontrolled hypertension (blood pressure >160/100 mm Hg)
History or evidence of serious pulmonary or cardiovascular disease (acute coronary syndrome, New York Heart Association class III or IV heart failure
Coagulation disorder (platelets <50,000, prothrombin time >2 seconds above control or international normalized ratio >1.5)
Anemia (hemoglobin <8.0 g/dL in women and <10.0 g/dL in men)
Pregnancy or lactation
Diagnosed bulimia or diagnosed binge eating disorder using DSM-5 criteria
Night eating syndrome
Chronic abdominal pain that potentially complicates the management of the device
Physical or mental disability or psychologic illness that could interfere with the compliance of therapy
At high risk for having a medical complication from the endoscopic procedure or the AspireAssist weight loss program for any reason, including general poor health or severe organ dysfunction, such as cirrhosis or renal dysfunction
In addition to the FDA-labeled contraindications, treating physicians should review the requirements for successful aspiration therapy prior to device placement. Patients need the flexibility to be able to go to a restroom or other facility where they are able to perform aspiration 20 minutes after a meal. Total time for aspiration, including set-up and clean-up, takes 10 minutes to 15 minutes on average. Patients who are unable to reliably perform aspiration are not likely to achieve significant weight loss.
Outcomes
Weight Loss
Four studies have investigated the effects of aspiration therapy one weight loss in subjects with a BMI between 35 kg/m 2 and 55 kg/m 2 :
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Mexico pilot study: 26-week pilot study in Mexico
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US pilot study: 52-week randomized controlled pilot trial in the United States
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Swedish pilot study: 26-week pilot trial in Sweden
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Pivotal Aspiration Therapy with Adjusted Lifestyle Therapy Study (PATHWAY): 52-week multicenter randomized controlled trial in the United States
Additionally, 1 multicenter European trial evaluated the effects of aspiration therapy on subjects with a BMI greater than 55 kg/m 2 (European superobesity pilot study). Details of subject characteristics are in Table 1 . The Mexico pilot study and part of the US pilot study were performed with the first generation of the AspireAssist System. The major difference between the first-generation and second-generation devices is the A-Tube. The extragastric portion of the original A-Tube was made of an expanded polytetrafluoroethylene (ePTFE) tube and was reinforced with a helical ePTFE wire with the intragastric portion made of silicone. The redesign to the all-silicone tube occurred during the US pilot trial in response to patient discomfort with the ePTFE portion of the A-Tube.
| Study Group | Number (Male/Female) | Age (y) | Weight (kg) | Body Mass Index (kg/m 2 ) |
|---|---|---|---|---|
| Mexico pilot study , a | 9 (0/9) | 41.6 ± 0.1 | 110.1 ± 14.9 | 40.0 ± 3.1 |
| US pilot study control group a | 4 (1/3) | 45.3 ± 2.8 | 105.3 ± 2.5 | 39.3 ± 1.1 |
| US pilot study aspiration therapy group a | 10 (0/10) | 38.7 ± 2.3 | 112.2 ± 4.6 | 42.0 ± 1.4 |
| Sweden pilot study a | 22 (2/20) | 49.8 ± 7.7 | 109.8 ± 18.6 | 40.3 ± 4.3 |
| PATHWAY control group | 60 (7/53) | 46.8 ± 11.6 | 112.8 ± 16.1 | 40.9 ± 3.9 |
| PATHWAY aspiration therapy group | 111 (15/96) | 42.4 ± 10.0 | 116.9 ± 21.2 | 42.0 ± 5.1 |
| European superobesity pilot study | 11 (8/3) | 44.9 (32–63) | 196.1 (143.0–290.0) | 66.5 (55.0–80.4) |
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