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AspireAssist device linked to improved weight loss in patients with obesity
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The AspireAssist system along with lifestyle counseling was associated with greater weight loss in patients with obesity compared with lifestyle counseling alone, according to data from a multicenter randomized controlled trial.
AspireAssist (Aspire Bariatrics) is an FDA-approved endoscopic weight loss device indicated for patients with a BMI of 35 to 55, which involves an endoscopically placed percutaneous gastrostomy tube connected to an external device that enables drainage of an estimated 30% of calories from a meal. The device is implanted in a 15-minute, outpatient procedure, which does not alter a patient’s internal anatomy and is fully reversible, according to a press release.
“The PATHWAY study showed that AspireAssist procedure is a viable alternative to bariatric surgery for patients with Class II or Class III obesity, with both significant weight loss and excellent safety,” Christopher C. Thompson, MD, associate professor of medicine at Harvard Medical School, and director of therapeutic endoscopy at Brigham and Women’s Hospital, said in the press release. “Side effects such as nausea and vomiting are rare, and, notably, the treatment group showed improvement in eating habits, with better food choices and more thorough chewing. This is partly due to the procedure mandating follow-up with the health care team for ongoing use, or the device shuts off.”
Thompson and colleagues randomly assigned 207 individuals with a BMI of 35 to 55 kg/m2 to undergo the AspireAssist procedure with lifestyle counseling (n = 137; mean BMI, 42.2 ± 5.1 kg/m2) or lifestyle counseling alone (n = 70; mean BMI, 40.9 ± 3.9 kg/m2) at 10 U.S. sites. Mean percentage of excess weight loss and the percentage of patients with at least 25% excess weight loss at 52 weeks served as the co-primary endpoints.
The procedure was successful 97% of the time.
Based on a modified intent-to-treat analysis, patients who underwent the AspireAssist procedure lost a mean of 31.5% ± 26.7% excess body weight and 12.1% ± 9.6% total body weight compared with a respective 9.8% ± 15.5% and 3.5% ± 6% in patients who received lifestyle counseling alone (P < .001).
Further, 58.6% of patients who underwent the procedure lost at least 25% of their excess body weight compared with 15.3% of those who received lifestyle counseling alone (P < .001).
Perioperative abdominal pain and discomfort, and postoperative peristomal granulation tissue and peristomal irritation were the most common adverse events, and 3.6% of patients who underwent the procedure experienced a serious adverse event.
“With less than 1% of the 29 million Americans with BMIs over 35 availing themselves of bariatric surgery each year, there is a significant unmet need for a non-surgical weight loss procedure that is effective, safe, and reversible,” Katherine Crothall, PhD, president and CEO of Aspire Bariatrics, said in the press release. “AspireAssist therapy satisfies this need and additionally offers a lower cost solution to the health care system. Publication of the PATHWAY results should help facilitate insurance coverage.” – by Adam Leitenberger
Disclosures: Two of the researchers and Crothall are employed by Aspire Bariatrics.
Perspective
Back to TopNeil Floch, MD, FACS
Most experienced bariatric health professionals strive to use the techniques of diet change and mental support first, resorting to medications and bariatric surgery in a step like fashion according to need. When surgery is indicated, healthy eating habits and diet change continue to be supported as part of the treatment. Non-traditional surgical procedures that do not support the teaching of proper eating, undermine the ultimate goal of bariatric surgery which is a change in eating behavior.
The AspireAssist appears to reward any type of eating by allowing the patient to remove food from the stomach. Being allowed to eat an entire cake and simply being able to empty it from the stomach encourages poor eating. Although temporarily successful, according to studies, this device does not support a healthy change in eating behavior.
Perspective
Back to Top
Zachary L. Smith, DO
Many new endoscopic bariatric therapies (EBTs) have emerged during the last several years, four of which have gained FDA approval. Among these, the device that evokes the most polarizing opinions and viewpoints is aspiration therapy via the AspireAssist device (Aspire Bariatrics). This therapy has been referred to by some as “medical bulimia,” and has garnered a lot of negative media attention. It is vital however, to put one’s own personal opinions and biases aside when critically assessing medical research.
Dr. Chris Thompson and colleagues from several institutions performed a randomized controlled trial (RCT) aiming to study aspiration therapy in combination with lifestyle counseling — which included ongoing instruction on nutrition and eating habits — vs. lifestyle counseling alone. At 52 weeks, patients in the intervention arm — aspiration therapy plus lifestyle counseling — demonstrated an average of 31.5% excess weight loss (EWL) and 12.1% total body weight loss (TBWL). This was compared to 9.8% EWL and 3.5% TBWL in the control arm of lifestyle counseling alone. Serious adverse events occurred in 3.6% of patients. These 52-week weight loss levels well exceed the previously described thresholds for EBTs set forth by the American Society for Gastrointestinal Endoscopy (ASGE) and the American Society for Metabolic and Bariatric Surgery (ASMBS) with acceptable adverse event rates.
Further, despite criticism toward the device arguing that it encourages binging and poor eating behaviors, the presence of the aspiration device in this trial was not associated with over-eating, or over-use of the aspiration tube over the course of the 52-week study period. Patients in this study were screened for binge eating disorders using validated metrics and excluded if a binge eating disorder was present. As with any bariatric therapy, surgery included, patient selection is paramount to optimizing success. In the case of bariatric surgery, patients with binge eating disorders demonstrate lower rates of weight loss and higher rates of weight re-gain than those without this condition and therefore, current guidelines advise caution when assessing this patient population for a bariatric surgical procedure.
Regardless of the opinion of an individual health care provider, we must recall that our patients may not in fact share these same opinions as to what constitutes as “gross” or “revolting.” In this study, nearly three quarters of subjects completed the 52-week study in the aspiration therapy arm, owing to its tolerability in appropriately selected and motivated individuals. When presenting all viable weight loss options to our patients, we should not allow our own opinions and biases to skew this conversation and instead, should objectively present the data in a manner that allows the patient to make an informed decision. Dr. Yoni Freedhoff from the University of Ottawa said it best on his blog Weighty Matters stating, “I’m pretty sure that safety and efficacy, not grossness, are what determine the utility of an intervention.” In this well-designed multi-center RCT, AspireAssist demonstrates this safety and efficacy that ultimately led to its FDA-approval.
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