GES

Gastric Electrical Stimulation (GES)

Enterra^®Therapy for the Treatment of Gastroparesis, And Other Neuro-modulating Therapies

For more information on gastric electrical stimulation (GES) and a wide variety of treatments (Tx)  for gastroparesis/dyspepsia, please also see our section: Understanding GP

Here you will find some general facts and common Questions & Answers related to gastric electrical stimulation.

Gastric electrical stimulation (GES), or Enterra^® Therapy, also known as the stomach pacemaker, has revolutionized the symptom management of both diabetic and idiopathic gastroparesis.

Many diabetics gain a robust response with this implantable device, which greatly diminishes their symptoms of nausea, vomiting, an early feeling of fullness, and heartburn. About half of all diabetics, who, because of unrelenting digestive symptoms, were feeding tube-dependent, are able, with GES, to eat more normally and thus, can come off of this feeding method. Furthermore, these patients who were underweight due to their gastroparesis, show improvements and stabilization of their weights and blood glucose levels.

Facts about GES:

• To date it is the only treatment on the market specifically developed for gastroparesis.

• GES is a low-energy/high-frequency neuro-stimulating system, very similar to spinal cord and sacral nerve stimulation. Due to its low-energy features, it does not “pace” the stomach or induce it to contract and empty. Scientists believe it works by modulating the autonomic nervous system, blunting sympathetic outflow and thus, reducing symptoms of nausea and vomiting related to gastroparesis.

• Over one thousand patients have been implanted with GES devices in the United States.

• Ten years of data on GES have been collected, from 3 treatment centres. Ten years of experience show persistent, enduring, anti-vomiting/anti-nauseant properties.

• No deaths have occurred from GES. Deaths are documented for jejunostomy procedures and other surgical interventions performed to treat gastroparesis.

• GES saves money by decreasing hospital visits for intravenous rehydration. Cost savings are further gained due to the fact that greater than half the patients who are dependent on enteral or parenteral nutrition are able to discontinue this form of feeding because GES allows them to eat normally.

• There is more published research on Enterra^® Therapy (GES) than on the other surgical treatment options used for treating severe gastroparesis.

• When Enterra^® Therapy is compared and contrasted with other traditional treatment approaches for severe, drug-refractory gastroparesis, Enterra^® Therapy remains the safest, most effective treatment option.

• GES is a derivative of the neuro-stimulators used for treating neuropathic pain and for sacral stimulation to treat bladder paresis. These stimulating devices have been in use in humans for over 40 years.

• The published papers on GES all report symptom reduction and, in some cases, the discontinuation of enteral/parenteral nutrition for patients, some of whom had been nutritionally dependent on feeding tubes for over half a decade.

• Lack of access to GES costs more money than treatment with GES and greatly impairs patients' quality of life.

• GES is the most effective treatment to date for gastroparesis, a disorder that is so very difficult to manage; it should, therefore, be applied early in the treatment phase so that patients do not experience weight loss to the degree that jejunostomy placement is needed.

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Questions and Answers about Enterra^® Therapy (stomach pacer):

1. Is the surgery painful when the permanent pacer is implanted?
YES. Normally, an incision—approximately 4 to 5 inches long—is made from below the breastbone, extending downward toward the naval. Layers of muscle and nerves that are cut need time to heal. The incision is in an area that you use a lot in the course of normal activities. However, most patients begin to feel better after a few days. Painkillers are prescribed as needed to ensure your comfort.

2. Can you see and/or feel the pacer?
Normally, only a small bulge will be visible. If you are thin, with a small amount of body mass, the pacer may be a little more noticeable; however, it's not something that protrudes from the abdomen. Most obese patients have trouble locating their pacers.

3. Can I use my computer or other electrical appliances?
YES. We have only heard of a couple of instances where a pacer was turned off when passing through airport security. No damage was done to the pacer and the patient was able to have it reprogrammed simply by making a physician visit. There have been a few cases in which a pacemaker activated a store's theft detector. Medtronic, the company that manufactures Enterra^® Therapy, issues an ID card to all patients implanted with their device to show if this occurs.

4. How soon will I be able to eat "real" food?
Enterra^® Therapy is a treatment—not a cure. Remember how long it's been since you were able to eat normally and give your body time to heal. Most patients have found that mini-meals are still better tolerated than large ones. You will still have some pre-pacer symptoms but overall you should see some significant improvement. Everyone responds differently—and what works for one person may or may not work for you.

5. Can the pacer be implanted laproscopically?
YES. However, this is not the best approach for all patients. Your surgeon will discuss your options with you.

6. Will my insurance pay for it?
Medicare will cover the cost; however, private insurance companies vary in their coverage. Most cases are initially denied—mainly because private insurance companies consider the pacer experimental—and a lengthy appeal process ensues.

7. Why aren't there more doctors that know about the pacer?
Because the pacer is approved as a humanitarian device, most physicians are reluctant to prescribe this treatment option. That is why patient/physician education and awareness is so vital.

8. How soon will the clinical trials be completed so that the HDE can be removed from the pacer?
Enrollment is currently under way at several implanting centres. After enrollment is completed, follow-up and FDA submission will require approximately 12 to 24 months.

9. I can't feel my pacer. How do I know if it's working or not?
Being unable to feel the pacer is common. If you think it's not working, compare the way you are feeling now with the way you were PRIOR to having it implanted. If your symptoms are the same or worse, then call your physician. It's possible that you just need a minor adjustment in the settings.

10. How often will I need to have an adjustment?
Your physician will schedule follow-up appointments. However, if your symptoms do not improve over time, you need to call for an appointment. It is recommended that you wait at least 3 to 4 weeks between adjustments to give your body time to get used to the new settings.

11. Can my primary physician do my adjustments?
Adjustments can be made in your primary physician's office IF he/she agrees and IF a Medtronic therapy consultant is in attendance. This is a joint effort with the adjustments being made ONLY after consulting with the physician who implanted the pacer.

12. Why can't I buy a “programmer” and do my own adjustments?
Enterra^® settings are based on impedance and each patient’s response to the therapy. It requires a physician to oversee the therapy in order to protect the safety of the patient.

13. What if I don't like it, have complications, or am not pleased with the results. Can the pacer be removed?
YES. The pacer can be removed at any time; however, remember you will have to undergo another major surgery in order to have the leads removed from the inside wall of your stomach. We would like to offer this tidbit before you take this drastic action: If you think the pacer is not working for you, ask your physician to turn it off for a few days— then make your decision.

14. How long does the battery last?
Anticipated battery life is 5 to 10 years; however, the higher the rate of stimulation, the sooner the battery will run down. Think of your pacer as a flashlight. If you turn it on for short periods, the battery lasts longer; if you leave it on for extended periods, then the battery will run down sooner. The same thing applies, if it is constantly turned on and off. Your battery (pacer) will run down sooner if it is constantly turned up and down without a reasonable amount of time between adjustments.

15. How is the battery replaced?
A shallow incision (usually reusing the one from your original surgery) is made under local anesthesia to access the pacer, which is located just under your skin. The old one is removed, a new one inserted; the lead wires are then re-attached and the incision is closed. This is all performed as same-day surgery. You will need to take it easy for a couple of days but recovery time is usually not extended.

16. Why do some physicians do a temporary pacer first?
It's considered major surgery when the permanent pacemaker is implanted. Unfortunately, like any mechanical device, the pacer may or may not work for some patients. By testing with a temporary pacemaker first, physicians have been able to determine if a patient may possibly benefit from Enterra^® Therapy. In the rare instances where patients don't respond to the pacemaker, they are spared from undergoing major surgery.

17. How is the temporary pacer inserted?
Two lead wires are lightly attached via endoscopy to the inside wall of your stomach. The wires then come up through your esophagus and throat, into your mouth, around your back tooth, along the side of your mouth between your teeth and cheek, and extend from the corner of your mouth. The lead ends are attached to the pacer unit, which is then placed in a pouch (for safety) that can either be worn around your waist or neck. The wires are held in place by a small adhesive bandage placed on your cheek. Some people may experience some throat discomfort and/or gag reflex. The main thing to remember is to try not to dislodge the wires. If the wires come out, then usually the whole procedure will have to be redone.

18. What if I bite the wires in two?
Unfortunately, this has happened on rare occasions. If it happens to you, the outer end of the wires (attached to the pacer) will just slid out. Notify your physician if this occurs; even though it's usually not an emergency, he or she needs to be aware that problems have occurred in order to give you instructions on what to do about the remaining ends of the leads.

Occasionally the wires are broken (usually when the patient is chewing) and the patient—especially one with crowns—receives a mild “shock” inside the mouth. If this happens— and it bothers you—please call your physician who will advise you about what needs to be done.

Also, you need to advise your physician if the leads are removed; however, this is not an emergency situation and can be done during normal business hours.

19. My urologist wants me to have a sacral nerve stimulator and my GI specialist wants me to have the stomach pacer. Is it possible for me to have two implanted devices?
YES. Diabetic gastroparesis and, in many cases, idiopathic gastroparesis are often the result of a poorly functioning autonomic nervous system. The impact of the autonomic nerve dysfunction means that other organs, besides the stomach, are also affected. Often, GP is found to be associated with bladder/ voiding (emptying) problems. Sacral nerve stimulation, similar to Enterra^® Therapy, works well for correcting bladder problems. It helps to decrease recurrent bladder infections and improves overall quality of life.

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