Obesity-related comorbidities significantly improved at 1 year after the implementation of aspiration therapy, according to results of a meta-analysis presented at the 2018 AGA James W. Freston Conference.
“AspireAssist was effective at treating hypertension, hyperlipidemia, diabetes and fatty liver,” Pichamol Jirapinyo, MD, MPH, an advanced endoscopy fellow at Brigham and Women’s Hospital, told Healio Gastroenterology and Liver Disease. “Additionally, patients with the AspireAssist device maintained their lost weight up to at least 4 years after device implantation with the amount of weight loss being approximately 20% of their initial weight.”
The AspireAssist (Aspire Bariatrics), an endoscopically placed gastrostomy tube with an external device that allows patients to drain approximately 30% of ingested calories after meals, has been effective at treating obesity class II and class III (BMI, 35-55 kg/m2), according to Jirapinyo.
Jirapinyo and colleagues conducted a systematic review and meta-analysis of 239 potential eligible studies that were published randomized controlled trials, cohort studies and conference abstracts that assessed outcomes of the weigh-loss device.
The aim of the study, according to Jirapinyo, was to assess the effect of the weight-loss system on obesity-related comorbidities and medium-term weight loss.
Six eligible studies were included in the meta-analysis, and authors from each study were contacted to provide additional data.
Changes in obesity-related comorbidities 1 year after implantation of the weight-loss device served as the primary endpoint.
Additional secondary outcomes included changes in weight at 1, 2 and 3 years, as well as pooled serious adverse events.
One of the studies included in the analysis had an overlapping patient cohort to another study and was used as a 3-year efficacy data analysis.
Mean baseline characteristics from the included studies were patients aged 39 to 49 years, and a BMI of 39.8 kg/m2 to 47.2 kg/m2.
Four studies (n = 168) reported the effect of the weight-loss device on obesity-related comorbidities.
Systolic blood pressure, diastolic BP, triglyceride, HDL and HbA1c significantly improved at 1 year after implantation on both per-protocol and intention-to-treat analyses.
Five studies (n = 466) demonstrated that total weight loss at 1 year was 17.8%, 19.7% at 2 years and 21.4% at 3 years after the implementation of the weight-loss device (P < .01 for all).
A subgroup analysis of two randomized controlled trials (n = 225; 148 weight-loss device vs. 77 lifestyle modification) demonstrated that the weight-loss device group lost 13.4 kg more than the patients in the control group (P < .0001). Additionally, patients within the subgroup who received the weight-loss device had a higher total weight loss (9.9%) and excess weight loss (25.6%) compared with the control group (P < .0001).
Serious adverse events were reported in eight patients across three studies. The most common adverse events included severe abdominal pain (n = 4), prepyloric ulceration (n = 1), product malfunction (n = 1) and intra-abdominal leak requiring ultrasound-guided drainage (n = 1).
“The AspireAssist is one of three endoscopic bariatric devices that are approved for weight loss in the U.S.,” Jirapinyo said. “Placement of the device is performed endoscopically and is less invasive than bariatric surgery. This study shows that, similar to bariatric surgery, the AspireAssist not only induces significant weight loss but also leads to improvement in obesity-related comorbidities.”
Jirapinyo noted that there are approximately 93 million adults in the U.S. who have obesity, which represents nearly 40% of the population.
“Currently, the most effective treatment modality for obesity is bariatric surgery,” she said. “However, studies show that only less than 2% of the patients who are eligible for bariatric surgery actually undergo the surgery. These results could potentially impact clinical practice by offering an alternative, less invasive method at treating patients with obesity.” – by Ryan McDonald
Jirapinyo P, et al. Effect of aspiration therapy on obesity-related comorbidities: Systematic review and meta-analysis. Presented at: 2018 AGA James W. Freston Conference; Arlington, Va.; Aug. 18-19, 2018.
Disclosure: Jirapinyo reports no relevant financial disclosures.