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Gastric Electrical Stimulation for Gastroparesis
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
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
