ASPIREASSIST – A NEW APPROACH TO CONTROLLING OBESITY

As of today, obesity is a problem for lots of people around the world. Every year, the number of people suffering from obesity is rapidly increasing. The research, conducted by Food and Agriculture Organization of the United Nations in 2013, clearly highlights the significance of this problem (see the table below).

Country                   

population % of obese people

Mexico

32,8

USA

31,8

Syria

31,6

Venezuela, Libya

30,8

Trinidad and Tobago

30,0

Vanuatu

29,8

Iraq, Argentina

29,4

Turkey

29,3

Chile

29,1

Czech Republic

28,7

Lebanon

28,2

New Zealand, Slovenia

28,0

Salvador

27,9

Malta

27,6

Panama, Antigua

26,8

Israel

26,5

Australia, Saint Vincent and the Grenadines

26,1

Dominica

26,0

Great Britain, Russia

24,9

Hungary

24,8

The main causes of obesity development:

       1) Genetic factors:

  • Lipolysis enzymatic activity reduction;
  • Lithogenesis enzymatic activity increase.

       2) Endocrine disorders (hypogenitalism, hypothyroidism and diabetes).

       3) Sedentary lifestyle.

       4) Psychoemotional disorders.

Obesity is classified according to BMI (body mass index) calculated using a formula  where m is weight in kilograms, h is height in meters. Results interpretation is presented in the table below:

BMI 

Classification

< 18,5

underweight

18,5–24,9

normal weight

25,0–29,9

overweight

30,0–34,9

class I obesity

35,0–39,9

class II obesity

≥40,0

class III obesity

For class I or II obesity patients treatment, drugs, physiotherapy, diet therapy and psychotherapy are widely used. Unfortunately, these methods often do not produce results for class III obesity treatment, so, such patients have to agree to surgical modalities.

In July 2016, FDA (Food & Drug Administration, the Department of medicines and food quality control of the US Department of Health) approved the use of the presented Aspire Assist device be the American company Aspire Bariatrics Inc. Using this device, patients are able to drain their gastric cavity unaided, reducing the volume of nutrients uptake by the body.

The device itself consists of a tube with one end inserted surgically into the stomach and the other one is brought out to the anterior abdominal wall as a skin valve port. All patients shall have the mandatory gastrointestinal tract endoscopic examination before the device is installed.

The catheter replacement should be performed once per month to prevent infection. The catheter can be installed either temporarily or for the entire life. After removing the catheter, the fistula heals by itself and does not require additional surgery.

In about 20-30 minutes after every meal, the patient will attach the connector with the reservoir to the port and opens the valve. That will result in undigested food leaving the stomach and consequently washing it down the toilet. Once the stomach is completely freed of the food the patient will squeeze the water reservoir to rinse out the stomach from any food remains. With the help of this device, the patient will be able to reduce calorie intake by about 30%.

AspireAssit device also has some indications for use, namely:

  1. patient’s age over 22 years;
  2. BMI ranges from 35.0 to 55.0 kg/m2;
  3. conservative treatment (diet, sports, drug therapy) ineffectiveness

171 persons from 10 American states took part in AspireAssist™ device clinical investigations. 110 patients of the total number of the partakers were implanted with the device. The other 60 were in the control group. The Patients with AspireAssist™ device implanted lost about 14 kg during 52 test weeks (31.5% of overweight or 12.1% of total weight). The control group patients could manage to lose only 4 kg (9.8% of overweight or 2.5% of total weight).

Unfortunately, in addition to many benefits, AspireAssist™ system also has its weaknesses, namely:

  1. focal skin reaction to the skin-port;
  2. possible surgical wound infections;
  3. dyspeptic disorders;
  4. stomach irritation by the catheter tip

During a short system utilization period, it received its supporters and critics. In particular, some critics consider the device to stimulate nervous bulimia, and it can lead to anorexia in severe cases. Supporters claim such cases were not reported during the clinical investigations, and AspireAssist™ is a real alternative to extensive surgical interference (vertical banded gastroplasty, gastric banding, Roux-en-Y gastric bypass, biliopancreatic diversion) for class III obesity patients, who are not subject to other treatments. Hope still remains that the wider device utilization will provide more opportunities to analyze its advantages and disadvantages, as well as to get doctors’ clinical guidelines and advice to patients.

Roman Vernyk, urologist, BiMedis Company