This document summarizes a study on using temporary gastric electrical stimulation (GES) to select patients for permanent GES treatment for intractable gastroparesis. 71 patients underwent temporary GES, and 51 experienced over 50% symptom improvement, making them candidates for permanent GES. Of those, 35 received permanent implants. The study found temporary GES effective for selecting patients likely to benefit from permanent GES treatment for severe gastroparesis refractory to other therapies.

1. Diges-ve
Diseases
Federa-on
Mee-ng,
Liverpool,
UK
Associa-on
of
Upper
GI
Surgeons
of
UK
Prize
Session
19-­‐06-­‐2012
Gastric
Electrical
S-mula-on
for
Intractable
Gastroparesis
Abeezar
I.
Sarela,
Simon
P.
Dexter,
Fahmid
Chowdhury,
Mark
Denyer
for
The
Leeds
Gastroparesis
Mul--­‐Disciplinary
Team
Departments
of
Upper
GI
Surgery,
Nuclear
Medicine
&
Gastroenterology
St
James’s
University
Hospital,
Leeds
www.foregutsurgeon.com

2. Gastroparesis
Chronic
delayed
gastric
emptying
in
the
absence
of
mechanical
obstruc-on
of
the
stomach
American
Gastroenterological
Associa-on
medical
posi-on
statement:
diagnosis
and
treatment
of
gastroparesis.
Parkman
et
al.
Gastroenterology
2004;127:1589-­‐1591
www.foregutsurgeon.com

3. Gastric
Electrical
S-mula-on
Enterra™
from
Medtronics
• FDA:
2000
• NICE:
IPG
103,
2004
• RCTs
1. Abell
et
al.
2003
2. McCallum
et
al.
2011
www.foregutsurgeon.com

4. Can
Symptoma-c
Response
be
Predicted
in
Advance
of
Permanent
Implanta-on
of
Enterra™?
• 54%
of
pa-ents
had
>50%
symptom-­‐reduc-on
Gastric
electrical
s-mula-on
improves
outcomes
of
pa-ents
with
gastroparesis
for
up
to
10
years.
McCallum
et
al.
Clin
Gastroenterol
Hepatol.
2010;9:314-­‐319
• Symptom-­‐profile,
ae-ology
&
opiod
analgesia
help
to
predict
the
response
to
Enterra™
Predic-ve
factors
for
clinical
improvement
with
Enterra
gastric
electric
s-mula-on
treatment
for
refractory
gastroparesis.
Maranki
et
al.
Dig
Dis
Sci.
2007;53:2072-­‐2078
• Response
to
temporary
s-mula-on
can
improve
selec-on
for
implanta-on
of
permanent
Enterra™
Temporary
gastric
electrical
s-mula-on
with
orally
or
PEG-­‐placed
electrodes
in
pa-ents
with
drug
refractory
gastroparesis.
Ayinala
(Abell)
et
al.
Gastro
Endos
2005;61:455-­‐461
www.foregutsurgeon.com

5. Aim
To
evaluate
symptoma-c
benefit
in
pa-ents
with
severe,
drug-­‐resistant
gastroparesis
to
gastric
electrical
s-mula-on
with
Enterra™,
using
rou-ne
temporary
s-mula-on
for
pa-ent
selec-on.
www.foregutsurgeon.com

6. Pa-ents
&
Methods
Diagnosis
of
Gastroparesis:
Nuclear
Medicine
Gastric
Emptying
Scan
Normal
Reten-on
of
Ac-vity
1
hour
<90%
2
hours
<60%
3
hours
<30%
4
hours
<10%
www.foregutsurgeon.com

7. Pa-ent
&
Methods
Selec-on
for
Temporary
S-mula-on
Cardinal
Symptoms
of
Severe
Gastroparesis/
Gastroparesis
Gastric
Pump
Failure
1. Nausea
• Drug-­‐unresponsive
2. Vomi-ng
• Inability
to
maintain
oral
nutri-on
3. Excessive
fullness
• Frequent
A&E
visits/
4. Bloa-ng
hospitalisa-on
5. Pain
• Poor
diabetes
control
www.foregutsurgeon.com

8. • Diagnosis
of
Gastroparesis
1
• Evalua-on
of
Clinical
Severity
• MDT
Discussion
2
• Selec-on
for
Temporary
Enterra™
• Applica-on
for
Funding
3
• Temporary
Enterra™
≈
2
weeks
4
• Gastroparesis
Symptom
Diary
• Permanent
Enterra™
if
≥50%
symptom-­‐
5
improvement
with
Temporary
Enterra™
www.foregutsurgeon.com

9. Results
• Period:
March
2009
–
Jan.
2012
• Senng:
St
James’s
University
Hospital,
Leeds
• No.
of
pa-ents
selected
for
temporary
gastric
electrical
s-mula-on
=
71
• Women:
51
(72%)
• Age:
42
y
(14-­‐69)
www.foregutsurgeon.com

10. Results:
Ae-ology
Overall
Ae-ology
Post-­‐Surgical
Gastroparesis
An--­‐Reflux
13,
Idiopathic
Gastric
Bypass
18%
1
1
14,
Diabetes
1
6
Cardiomyotomy
20%
44,
62%
Post-­‐Surgery
Splenectomy
4
Unclear
www.foregutsurgeon.com

11. Results:
Pa-ent
Characteris-cs
Route
of
Nutri-on
Previous
Treatment-­‐
Interven-on
10%
Naso-­‐Jejunal
Botox
11%
1%
Jejunostomy
Pyloroplasty
23%
Parenteral
3%
78%
Gastrectomy
1%
Oral
72%
Supplements
1%
Gastrojejunostomy
None
www.foregutsurgeon.com

12. Selected
Results
N=71
(January,
2012)
Permanent
Enterra
Temporary
Enterra
Awai-ng
Enterra
N=4
N=51
N=16
≥
50%
symptom-­‐ <
50%
symptom-­‐
improvement
improvement
N=39
(77%)
N=12
(33%)
Temporary
Permanent
Enterra
Gastric
Electrical
S-mula-on
N=35
as
a
Selec-on
Tool
www.foregutsurgeon.com

13. Program-­‐Adjustment
of
Enterra
Therapy
• 6-­‐8
weekly
follow-­‐up
• Impedance:
200-­‐800
Ω
• Current:
5
mA
–
15
mA
• Cycle
on:
0.1
s
–
1
s
An
energy
algorithm
improves
symptoms
in
some
pa-ents
with
gastroparesis
and
treated
with
gastric
electrical
s-mula-on.
Ayinala
et
al.
Neurogastroenterol
Mo-l
2006;18:334-­‐338
www.foregutsurgeon.com

14. Results
Outcomes
with
Permanent
Enterra
N=35
Permanent
Enterra
Outcome
Data
January
2012
N=31
Median
FU:
10
months
(1-­‐28)
≥50%
Symptom-­‐ <50%
Symptom-­‐
Improvement
Improvement
N=22
(71%)
N=9
(29%)
www.foregutsurgeon.com

15. Conclusion
Pa-ent-­‐selec-on
by
rou-ne
use
of
a
trial
of
temporary
s-mula-on
is
associated
with
clinically
meaningful
(≥
50%)
symptom-­‐
improvement
from
permanent
Enterra™
therapy
in
71%
of
pa-ents
with
severe
gastroparesis
www.foregutsurgeon.com