Gastric pacing
This is a new procedure which is in FDA test presently.
In the trials it appears that only small groups of patients are being tested
(15-20 in each group). For the first six months of each trial, half the
patients do not have their pacer "turned on", and results are studied.
From then on, all the patients have the pacer turned on. Testing this
device is going on in 10 hospitals across the USA.
At one hospital, of the three groups of 15 participating in
the trials, all the members of the first group did not lose weight well, had a
lot of trouble with adjusting the pacer and have converted to other Weight Loss
Surgery procedures. Weight loss in the two other groups ranges from 5 to
30 lbs with only one patient losing more weight. The average weight loss
in the 3rd group (over a year) was 10 lbs per patient.
The pacer is very similar to a
heart pacemaker, lies just below the skin. The electronic leads of the
pacer are sutured into the outside of the stomach as electrical impulses are
sent to work on the smooth muscles of the stomach. The pacer can be
programmed by a device which lays on top of the skin. The device which
turns it on and off and adjusts the intensity looks something like a small
hairdryer. Transneuronix.com is the corporations manufacturing this
device. It's a worldwide corporation.
Programming the pacer for the trials has been, at least in
some places, a sort of hit and miss operation.
If the batteries in the pacer go dead (happens every so often)
the patient must be opened up again to replace the batteries. Also the
leads can come loose (has happened with a few of the study participants.
The device can travel in the body as well, if the leads come loose.
Surgeons are warned in the directions to the surgery, that the leads must be
placed very carefully or else, perforation of the stomach can occur. They are
told to immediately scope for this after placing each lead.
All patients in the trial are supposed to be given a diet and exercise regime to
follow and also are supposed to be followed up by the surgeon in charge of each
trial, at least once a month. However, at least in one of the trials, the
patients were neither given any help in dieting or exercising nor has the
surgeon even SEEN the patients on a regular basis after surgery, unless they
needed surgical revision (they finally assigned a nurse to answer questions).
What the pacer surgery does, send electronic impulses to the
smooth muscles of the stomach, causing a stoppage of the natural movement
of food from the stomach to the small bowel. (Called peristalsis).
This is supposed to make the patient feel "full" with lowered food intake.
But the reality is, with a 40 oz stomach, even one which does
not empty well, a person can eat more than 2 days worth of calories at one meal
if the person eats high fat food (read that as the typical American diet).
Patients are complaining about a lot of acid reflux. No
wonder, one of the more prevalent causes of GERD (acid reflux disorder) is a
hiatal hernia which ALSO slows down the emptying of the stomach. As the
food stays in the stomach, the stomach continues to produce an overage of
stomach acid. Another name for acid reflux disorder is GERD and it is often a
very ugly thing to fight. It can cause the following:
- Aspiration of acid laced stomach contents at night
(EXTREMELY PAINFUL)
- Stricture i.e. the narrowing of the esophagus - caused by
the scarring from the injury of stomach acid refluxing
- Heartburn and other discomfort
- Stomach acid refluxing at night to cause the eating away of
the enamel on your teeth - can cause tooth decay and eventually lose of teeth
And in a small percentage of cases, the granddaddy of all -
Barrett's esophagus, a pre cancerous condition.
The treatment of GERD has been the PPI drugs like Prevacid
which shut down the stomach acid. They also shut down the digestion of protein,
the sanitizing of the incoming food and a lot of other good things stomach acid
does.
The pacer is apparently being marketed as for people not
qualified for gastric bypass surgery (those with BMI's lower than 40) but the
news releases seen lately say it's good for people who are qualified for gastric
bypass as well.
It's sold as a safe and effective technology. But upon a closer look and
contact with participants in the study, it appears that this so called "safe"
non invasive device may be neither safe nor non-invasive.
Ironically they are using the pacer quite successfully to
CAUSE The emptying of the stomach in disorders like gastroparesis etc.
Media coverage of the trials portrays them as promising:
The first gastric
stimulator for the treatment of morbid obesity was implanted by Dr. Valerio
Cigaina in 1995. That patient lost 80% of her excess weight over the first 21
months of treatment. A second study was initiated by Cigaina in 1998,
involving 10 patients who received Transneuronix’ first-generation Prelude®
IGS. The 1998 patient group has lost a mean of 25% of its excess weight at
nearly three years after initiation of gastric stimulation as shown in the
graphic below.
Food intake was
reduced due to an early and increased satiety reported by the patients. In
conclusion, long-term studies continue to show that gastric pacing can be a
safe and effective procedure to treat morbid obesity.
And of course, we have the studies like this one
which appeared in Obesity Surgery Journal
in April of 2002:
Gastric pacing as
therapy for morbid obesity: preliminary results.
Cigaina V
Obes Surg 2002 Apr 12 Suppl 1:12S-16S
Abstract
BACKGROUND: A novel method to treat morbid obesity is presented--gastric
electrical pacing. Following animal research, human investigation in a total of
24 patients in three cohorts began in 1995. METHODS: Morbidly obese subjects
(BMI > or = 40) received electrical stimulation devices in 1995/6 (n = 4), 1998
(n = 10) and 2000 (n = 10). Electrodes were positioned intramuscularly on the
anterior gastric wall at the lesser curvature. BMI = body mass index; %EBL = %
excess BMI (> 25) lost. RESULTS: Patients reported satiety for food with less
food. The 2 patients from the first study followed for > 5 years have achieved
38 and 67 %EBL. In the second study, every patient lost weight. At 36 months
follow-up, the mean %EBL was 24 +/- 10 SD (n = 10). CONCLUSIONS: Implantable
gastric pacing is a safe procedure and causes changes in eating habits in
morbidly obese humans, resulting in decreased food intake and weight loss.
Like many other things, the reality is less exciting.
This device is available in Europe but extremely expensive.
Here are some further links:
Manufacturer:
www.transneuronix.com
See
the surgery photos and description
Dr. Owens (one of those involved in the trial) appeared on Good
Morning America, recently, to discuss the procedure.
To see the interview, go to
www.coastalobesity.com and go to
the video library section. You will need Real One Player to view the video.
Healthread!