Transcript Diabetic Gastroparesis

Enterra® Therapy
Understanding
Gastroparesis
Anatomical Overview
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What is Gastroparesis?
– A symptomatic chronic disorder of the stomach
characterized by delayed gastric emptying in the
absence of mechanical obstruction.
– In a healthy digestive system, strong muscular
contractions move food from the stomach through the
digestive tract.
– With gastroparesis, stomach muscles work poorly (or
not at all), thus preventing the stomach from emptying
properly.
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Symptoms
Most patients present with upper-gastrointestinal symptoms or
with symptoms related to disordered gastric motor function.
These include:
– Nausea and vomiting
– Abdominal bloating
– Abdominal pain
– Feelings of fullness after only a few bites of food (early
satiety)
– Heartburn or gastroesophageal reflux disease (GERD)
– Changes in blood sugar levels
– Lack of appetite
– Excessive weight loss
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Prevalence
• The true prevalence of gastroparesis is not known; however, it
has been estimated that up to 5 million people in the US may
suffer from this condition.*
• In a survey patients with documented chronic gastroparesis
patients, it was found that the origins were about 36 percent
idiopathic and 29 percent diabetic, with the remaining amount
attributed to several other causes.**
* Abell T, et al.. Nutrition in Clinical Practice 2006.
** Soykan I, et al.Dig Dis Sci. 1998.
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Causes and Risk Factors
The most common causes of gastroparesis are:
– Idiopathic
– Diabetes, either type 1 or type 2
The impact of gastroparesis on physical well-being can be
devastating. It can cause chronic nausea and vomiting and
lead to malnutrition and inadequate blood sugar levels.
Living with gastroparesis also affects emotional well-being –
the constant discomfort of chronic nausea and vomiting can
have an impact on school and work performance, family and
personal relationships, and social activities.
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Etiologies
In a study of 146 patients, the most common origins were:
–
–
–
–
Idiopathic (35%)
Diabetic (29%)
Postsurgical (13%)
Others: Parkinson’s disease, vascular disease, pseudo-obstruction
4%
6%
Idiopathic - 35%
5%
Diabetic - 29%
35%
8%
Post-surgical - 13%
Parkinson's - 8%
Vascular Disease - 5%
13%
Pseudo-obstruction - 4%
Miscellaneous - 6%
29%
Soykan I et al. Dig Dis Sci 1998.
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Idiopathic Gastroparesis
Delayed gastric emptying without apparent cause or
underlying abnormality may be the most common form of
gastroparesis
Symptoms fluctuate: patient may have episodes of
pronounced symptoms interspersed with relatively symptomfree intervals
Patients are frequently young or middle-aged women
Kendall, McCallum. Gastroenterology 1993.
Parkman et al. Gastroenterology 2004.
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Idiopathic Gastroparesis
Symptoms may resolve after months or even years
– Patients with a viral trigger tend to have slow resolution of
their symptoms over several years
– Patients without a viral trigger tend to show less
improvement over time
Parkman et al. Gastroenterology 2004.
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Idiopathic Gastroparesis
In a study of 146 patients, 52 patients had idiopathic
gastroparesis:
–
–
–
–
–
23% had sudden onset of symptoms after viral
syndrome, suggesting a potential viral etiology
48% had severe abdominal pain
19% had gastroesophageal reflux disease and nonulcerative dyspepsia
23% had depression
8% had onset post-cholecystectomy
Soykan I et al. Dig Dis Sci 1998,
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Diabetic Gastroparesis
Gastroparesis is a recognized complication of diabetes mellitus
–
Primarily among patients with long-standing type 1
diabetes and other associated complications
Gastroparesis affects:
–
40-50% of people with Type 1 diabetes
–
30-40% of people with Type 2 diabetes
Parkman. Gastroenterology 2004.
Diabetes Institute Foundation Website. 2005
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Diabetic Gastroparesis
Likely to result from impaired neural control of gastric motility,
possibly at the level of the vagus nerve
Problems with blood glucose control may be the first
indication that a diabetic patient is developing gastroparesis
– Gastroparesis contributes to poor glycemic control
because of unpredictable delivery of food into the
duodenum
– Delayed gastric emptying with continued insulin
administration may produce hypoglycemia
Parkman. Gastroenterology 2004.
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Post-surgical* Gastroparesis
Any surgery of the upper intestinal tract (esophagus, stomach
or duodenum) may result in injury to the vagus nerve**
Gastroparesis may occur as a complication of a variety of
surgical procedures***
–
–
–
–
Post-vagotomy - Most often peptic ulcer surgery with vagotomy
Post-fundoplication - Complication of fundoplication to treat GERD
Post-bariatric - Most commonly Roux-en-Y gastric bypass for obesity
Post lung and heart-lung transplantation
* Use of gastric electrical stimulation for post-surgical gastroparesis is not an approved indication for
Enterra® Therapy.
**American College of Gastroenterolgy Website. 2005
***Parkman et al. Gastroenterology 2004.
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Complications of Gastroparesis
• Esophagitis: an inflamation of the esophagus
• Mallory-Weiss tear: Tear in mucosal layer at the
junction of the esophagus and stomach
• Vegetable-laden bezoars: an accumulation of undigested
food that cannot pass through the pylorus
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Effects of Gastroparesis
• Severe nausea and vomiting can:
–
–
–
be debilitating
Compromise quality of life
Lead to the inability to work or go to school
• If not controlled, patients can suffer from potentially
life-threatening complications that may require
hospitalization, such as:
–
–
–
–
Electrolyte imbalances
Dehydration
Malnutrition
Poor glycemic control (diabetics)
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Costs for Gastroparesis
• Health care expenditures for gastroparesis care
are significant*
• One study estimated healthcare costs for a
gastroparesis patient at $6972/month**, which
includes
– Hospitalization
– Total parental nutrition
• Better glycemic control may result in significant
cost savings per diabetic patient per year***
* Parkman et al. Gastroenterology 2004.
** Abell et al. Am J Gastroenterol 2001..
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Economic Impact
• Better glycemic control may result in significant
• Patients with gastroparesis often have prolonged hospital
cost
per diabetic
patient
pernutritional
year*** support*
stays savings
due to dehydration
and the
need for
*** Ordog et al. Diabetes 2000.
Wagner et al. JAMA 2001.
* Parkman et al. Gastroenterology 2004.
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Impact on Quality of Life
For patients with gastroparesis:
• Meal times must be carefully timed and portions
controlled, which may make dining out difficult, if
not impossible.
• May not know when nausea and vomiting
episodes will occur.
• Feeding tubes or intravenous feedings can be
restrictive which may limit patient activity and have
serious medical complications.
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Diagnosing
The diagnosis of gastroparesis is confirmed through the following test:
– Radioisotope gastric-emptying scan: The patient eats food
containing a radioisotope, which is a slightly radioactive
substance (not dangerous) that shows up on the scan. After
eating, the patient lies under a machine (at set time periods) that
detects the radioisotope and shows an image of food in and
leaving the stomach. If greater than 60 percent of the food
remains at 2 hours or greater than 10 percent after 4 hours then
gastroparesis may be diagnosed.
– a physician may do an upper endoscopy or an ultrasound to rule
out other causes for delayed gastric emptying.
During endoscopy the lining of the stomach is checked for any
abnormalities.
An ultrasound is used to examine the outline and shape of the
gallbladder and pancreas to rule out gallbladder disease or
pancreatitis.
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Treatment Options
• Treatment options for both diabetic and non-diabetic patients
include, changes in eating habits, oral medications and, in
severe cases, feeding tubes and intravenous feeding.
• An innovative treatment option from Medtronic is Enterra®
Therapy which uses mild electrical pulses for gastric
stimulation to help control the chronic, drug refractory
nausea and vomiting secondary with gastroparesis of
diabetic and idiopathic origin (see Enterra fact sheet).
– Gastric electrical stimulation (GES) therapy was approved by
the FDA in 2000 as a humanitarian use device based on a
finding of safety and probable benefit. However, the
effectiveness of Enterra Therapy for this use has not been
demonstrated.
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References
• Abell TL et al. Gastric electrical stimulation is superior to standard pharmacological
treatment in reducing health care costs and hospital stays and in improving quality of life in
patients with severe upper GI motor disorders (abst). Am J Gastroenterol 2001;235:s258.
• Abell T, Malinowski S, Minocha A. Nutrition Aspects of Gastroparesis and Therapies for
Drug-Refractory Patients. Nutrition in Clinical Practice 2006;21:23-33.
• Cutts TF, Lou J, Starkebaum W, Rashed H, Abell TL.Is gastric electrical stimulation superior
to standard pharmacologic therapy in improving GI symptoms, healthcare resources, and
long-term healthcare benefits? Neurogastroenterol Motil (2005) 17, 35-43.
• Parkman HP et al. American Gastroenterological Association technical review on the
diagnosis and treatment of gastroparesis. Gastroenterology 2004 Nov;127(5):1592-1622.
• Parkman HP et al. American Gastroenterological Association medical position statement:
diagnosis and treatment of gastroparesis. Gastroenterology 2004 Nov;127(5):1589-9.
• Ordog T et al. Remodeling of networks of interstitial cells of Cajal in a murine model of
diabetic gastroparesis. Diabetes. 2000 Oct;49(10):1731-9.
Wagner EH et al. Effect of improved glycemic control on health care costs and utilization.
JAMA 2001 Apr 18:285(15):1963-64.
• Soykan I, Sivri B, Sarosiek I, Kiernan B, McCallum RW. Demography, clinical characteristics,
psychological and abuse profiles, treatment, and long-term follow-up of patients with
gastroparesis. Dig Dis Sci. 1998;43(11):2398-2404.
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Enterra Therapy for Gastroparesis: Product technical manual must be reviewed prior to use for detailed disclosure.
Indications: The Medtronic Enterra Therapy System for gastric electrical stimulation (GES) is indicated for use in the treatment of chronic,
intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Contraindications: The Enterra Therapy System is contraindicated in patients whom the physician determines are not candidates for surgical
procedures and/or anesthesia due to physical or mental health conditions. Do not use shortwave diathermy, microwave diathermy or therapeutic
ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be
transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or
death. Diathermy is further prohibited because it can also damage the neurostimulation system components resulting in loss of therapy, requiring
additional surgery for system explantation and replacement.
Warnings: This system has not been evaluated for pregnancy, pediatric use, or patients under the age of 18, or over the age of 70. Strong sources
of electromagnetic interference (EMI) can result in serious injury, system damage, or operational changes to the system. Strong sources of EMI
include MRI, electrocautery, radiofrequency (RF)/microwave ablation, external defibrillators, ultrasonic equipment, radiation therapy, and theft
detectors. Patients on anticoagulation therapy may be at a greater risk for post-operative complications. The system may be affected by or adversely
affect other implantable devices such as cardiac pacemakers and cardioverters/defibrillators. Rupture or piercing of the neurostimulator can result in
severe burns. The use of non-Medtronic components with this system may result in damage to Medtronic components, loss of therapy, or patient
injury. When possible, identify and treat any infections remote to the implant site prior to surgery. It is recommended that the neurostimulator implant
site be irrigated with antibiotic solution during surgery and that IV antibiotics be administered perioperatively. Infections at the implant site almost
always require the surgical removal of the implanted system. Avoid excess lead slack in the abdominal cavity. The lead can become entangled with
or erode into the bowel, which may result in bowel obstruction, bowel perforation, intra-abdominal infection, bowel resection and may require system
revision.
Precautions: Clinicians and patients should follow programming guidelines and precautions provided in product manuals. Patients should avoid
manipulating or rubbing the neurostimulator system components, which can cause component damage, skin erosion, or stimulation at the implant
site. Patients should be detoxified from narcotics prior to implant so that the effects of stimulation can be properly assessed. Patients should avoid
activities that may put undue stress on the implanted neurostimulation system components. Patients should not scuba dive below 10 meters of water
or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other activities may cause
shocking or jolting.
Adverse Events: Adverse events related to the system include infection, stomach wall perforation, migration/erosion of the neurostimulator,
programming difficulty, undesirable change in stimulation, implant site pain, hemorrhage, hematoma, migration/dislodgement of the lead, extraabdominal pain, seroma, concomitant muscle stimulation, allergenic or immune system response to implanted materials, loss of therapeutic effect,
and gastrointestinal complications including upper and lower gastro-intestinal (GI) symptoms.
Humanitarian Device: Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to
gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
USA Rx Only. Rev 0709
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