The AspireAssist Device for Weight Loss

Two surgeons preparing for surgery; patient lying down
Surgical endoscopy. XiXinXing/Getty Images

A number of options now exist for the treatment of obesity. These include diet and lifestyle changes, weight-loss drugs, and devices and procedures that range from full bariatric surgery to newer, minimally invasive devices.

In the summer of 2016, the U.S. Food and Drug Administration (FDA) approved the weight-loss device called AspireAssist, marketed by Aspire Bariatrics.

What Is AspireAssist?

AspireAssist is a weight-loss device approved for the treatment of obesity in adults who are at least 22 years of age and who have a body mass index (BMI) of 35 to 55.

The device makes it possible for users to drain a portion of their stomach contents through a stomach tube (known as a gastrostomy tube) into a toilet after each meal.

The AspireAssist device is intended for long-term use in eligible adults who have not been able to achieve adequate weight loss through nonsurgical methods such as lifestyle changes and weight-loss medications.

How Does It Work?

As noted above, AspireAssist makes use of a tube placed through an opening in the stomach, allowing partial drainage of stomach contents after a meal. In a pilot study by Sullivan and colleagues, this was found to result in a reduction in the total amount of absorbed calories by about 30 percent.

The AspireAssist device contains a gastrostomy tube, as noted above, as well as a port valve, an external device containing a connector, a water reservoir, and a drainage tube with a clamp.

About 20 to 30 minutes following a meal, the user of the AspireAssist device attaches the gastrostomy tube to the external device and opens the port valve, thereby allowing stomach contents to drain into a toilet by force of gravity.

It is important to note that food must have been chewed thoroughly during the preceding meal in order for it to fit through the drainage tube, which is only 6 millimeters in diameter.

Once drainage ceases, the AspireAssist user is supposed to flush the tube and the stomach with clean, potable water from the water reservoir that comes with the device.

The whole process is estimated to take approximately 5 to 10 minutes.

If you are a user of this device, keep in mind that it will be necessary to keep regular follow-up appointments with your doctor, since the connector must be replaced after 115 cycles (approximately 5 to 6 weeks).

It is also necessary at these follow-up visits to confirm that the AspireAssist device is working properly. The length of the tube may also need to be adjusted as you lose weight. Your doctor will also continue to provide diet and lifestyle counseling at each follow-up visit.

How Much Does It Cost?

According to the Medical Letter on Drugs and Therapeutics, based on information from the manufacturer, the combined costs of the initial procedure plus the first year of follow-up are expected to be $8,000 to $13,000.

How Effective Is It?

In an abstract published in a supplement to the journal Gastroenterology, researchers for the PATHWAY trial found that those patients who were assigned to treatment with AspireAssist plus lifestyle counseling for approximately a year achieved a weight loss total of 31.5 percent of excess weight, compared to only 9.8 percent of excess weight lost in the group that was assigned to lifestyle counseling alone.

Further results from longer-term studies are not available, so it is difficult to determine what the long-term effects on weight loss and quality of life would be with AspireAssist.

Are There Any Side Effects?

In the PATHWAY trial mentioned above, at least 5 percent of patients had side effects associated with the AspireAssist device.

The reported side effects included abdominal pain, nausea and/or vomiting, change in bowel habits, and inflammation or irritation around the area of the gastrostomy tube. Other side effects that were noted included infection, bleeding, and/or discharge around the opening to the stomach. Most of these side effects appeared to resolve within 30 days.

In 4 of the 111 patients treated with AspireAssist in the PATHWAY trial, the device was associated with serious adverse events, such as need for replacement of the gastrostomy tube, abdominal infection, and ulceration.

Notably, in its review of the device, the Medical Letter on Drugs and Therapeutics concluded: “The AspireAssist device is less invasive than bariatric surgery for treatment of obesity and might be effective for some patients, but available data are limited and the list of contraindications is extensive.”

What Are Other Medical-Device Options for Weight Loss?

Another device has been on the market for the treatment of obesity since January 2015. This FDA-approved device, known as the Maestro Rechargeable System, works by targeting the nerve pathway between the brain and the stomach that exerts control over feelings of hunger and fullness. It consists of an electrical pulse generator that is rechargeable, along with wire leads and electrodes. These are implanted surgically into the abdomen. It then sends electrical impulses to the vagus nerve, which helps regulate stomach emptying and sends signals to the brain that the stomach is either feeling empty or full.

According to EnteroMedics Inc., the company that makes the device, the Maestro Rechargeable System blocks signals that the vagus nerve would ordinarily send to the brain, thus reducing feelings of hunger and making patients feel full earlier than they would otherwise.

On July 28, 2015, the FDA announced approval of yet another device for the treatment of obesity: the temporary balloon device known as the ReShape Integrated Dual Balloon System (ReShape Dual Balloon.

Like the AspireAssist device, the ReShape Dual Balloon also requires an endoscopic procedure to place the device, which is inserted into the stomach through the mouth and esophagus. As noted by the FDA, “The device does not change or alter the stomach’s natural anatomy,” and patients are encouraged to “follow a medically supervised diet and exercise plan to augment their weight loss efforts” while using the device. This helps to ensure that patients are able to maintain their weight loss once the device is removed.

The device is meant to be temporary and, according to the FDA, should be removed six months after it is first inserted.

It is thought that the ReShape Dual Balloon works by taking up space in the stomach, which likely triggers feelings of fullness, but there may be other mechanisms at work that are not yet understood.

What Are Surgical Options for Weight Loss?

More invasive and traditional surgical options generally fall under the category of bariatric surgery, and may include gastric bypass surgery, gastric banding (lap band), and sleeve gastrectomy (gastric sleeve), among others.

To be a candidate for bariatric surgery, a person must have a BMI of 40 or greater, or a BMI of 35 or greater in a person who has other medical conditions (known as “comorbid conditions”) caused by obesity..

The most popular weight-loss surgery turns out to be the gastric sleeve procedure, or sleeve gastrectomy. In fact, largely due to its effectiveness and safety as compared with other procedures, according to Bariatric Surgery Source, the gastric sleeve procedure now appears to be overtaking gastric bypass as the new “gold standard” procedure.

The sleeve gastrectomy operation aims to enable patients to reduce food intake, thereby inducing weight loss. In this procedure, approximately 60 percent of the stomach is removed (usually laparoscopically), such that the remaining portion of the stomach takes on the shape of a tube or sleeve.

Because the stomach is smaller after the operation, the gastric sleeve patient will feel fuller faster and with less food. For these reasons, the gastric sleeve procedure is known as a “restrictive” type of bariatric surgery.

Discussion With Your Physician

If you have obesity and feel you have already tried several medical options as well as diet and lifestyle changes, and these have not worked for you, discuss your further options with your physician. It is important to put a lot of thought and consideration into any decision to proceed with elective surgery, particularly a weight-loss surgery or procedure.

Your doctor can discuss with you what options might be a good choice for you as an individual, given your particular BMI and any other chronic diseases you may have. In this discussion, you can both weigh the pros and cons of any potential weight-loss surgery or procedure.

It is also very important to be sure you discuss and are aware of the side effects of any procedure, surgery, or device you are considering, since each option does come with at least some side effects, some of which may be serious.

On the other hand, if you are a good candidate for a particular weight-loss surgery or procedure, and you are well-informed and prepared to follow up with your medical or surgical team at regularly scheduled intervals following the procedure, weight-loss surgery can have a number of health benefits, including treatment of diabetes and high blood pressure as well as reduction of heart disease risk.

Sources:

AspireAssist—a new device for weight loss. Med Lett Drugs Ther. 2016;58:109-110.

Durkin M. Weighing the options for bariatric surgery. ACP Internist 2016;36(1):1.

FDA News Release. FDA approves non-surgical temporary balloon device to treat obesity. Accessed online at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm on July 29, 2015.

Sullivan S, Stein R, Jonnalagadda S, Mullady D. Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013;145:1245.

Thompson CC et al. The AspireAssist is an effective tool in the treatment of class II and class III obesity: results of a one-year clinical trial. Gastroenterology. 2016;150(suppl1):S86, abstract 381.

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