Gastroparesis and Gastric Electrical Stimulation Dr. Mario Costantini Clinica Chirurgica 1...
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Transcript of Gastroparesis and Gastric Electrical Stimulation Dr. Mario Costantini Clinica Chirurgica 1...
Gastroparesis and Gastric Electrical Stimulation
Dr. Mario CostantiniClinica Chirurgica 1
Università ed Azienda Ospedaliera di Padova
U.O.S. Fisiopatologia Esofago-Gastrica
A chronic disorder of gastric motility characterized by delayed gastric emptying in the absence of mechanical obstruction.
Gastroparesis
Main symptoms:• Nausea, vomiting• Early satiety, bloating • Post-prandial fullness• Abdominal pain • Weight loss, dehydration• Difficult glycaemic control
Gastroparesis: Ætiology
Idiopathic35.5%
Diabetic29.0%
Postsurgical13.0%
Miscellaneouscauses6.0%
Parkinson'sdisease
7.6%
Intestinalpseudoobstruction
4.1%
CollagenVascular disease
4.8%
(post-infective)
Kendall and McCallum. Gastroenterology 1993.Soykan et al. Dig Dis Sci 1998.
Gastroparesis: Incidence*
“Gastroparesis is an uncommon condition in the community, but is associated with a poor outcome”
Jung H-K et al. Gastroenterology 2009;136:1225-33
M = 2.5/100.000/yrs F = 9.8/100.000/yrs 5-yr survival 80%
*Olmsted County
Excessive relaxation
Abnormal duodenum
motility
Poorantro-pyloro-duodeno
synchronization
Antral hypomotility
Gastroparesis: Pathophysiology
Ad da Abell TL et al, Neurogastroenterol Motil 2006
Gastroparesis: a proposed classification
Gastroparesis: Treatment
Botulinum toxin GES
1963 – Bilgutay et al.: The concept of electrical stimulation was born, when gastric stimulation was practiced for the treatment of postoperative ileus.
The History of Gastric Stimulation
The History of Gastric Stimulation
1972: Kelly and Laforce at Mayo Clinic induced antegrade and retrograde conduction of slow waves in canines with gastric stimulation.
1988: McCallum et al. at University of Virginia showed increased gastric emptying in canines with vagotomy
1997: Familoni et al. reported improved peristalsis in canines with GES
1998: The WAVESS Study Group demonstrated the feasibility of GES, leading to Enterra Therapy
XIth International Symposiumon Gastrointestinal MotilityOxford, September 7-11, 1987
Energy
Fre
quen
cyGastric Electric Stimulation
3 bpm
12 bpm
Gastric Pacing:
Gastric Neurostimulation (Enterra) High Frequency (~ 4 x Slow Wave Freq)
Low Energy with short pulse
Low Frequency (~ Slow Wave Freq) High Energy with long pulse
? Neural sequential GES (experim. only)
Gastric Pacing vs. Neurostimulation Pacing is an application of an electrical stimulus that activates contraction
of gastric smooth muscle, entraining at that rate of the intrinsic slow wave by a low-frequency, high-energy, long pulse stimulation
too large and heavy batteries to be implanted
Neurostimulation activates a nausea- and vomiting-control mechanism, utilizing a high-frequency, low-energy, short pulse stimulation to achieve symptomatic relief
miniaturization and possible implantation
Enterra Therapy: Humanitarian Device Exemption
Enterra Therapy was granted approval as a HUD (humanitarian use device) to be used
in patients with refractory diabetic or idiopathic gastroparesis, restricted to
Institutions where Institutional Review Board approval has been obtained.
FDA, 2000
Enterra Therapy CE mark Indication
“Enterra Therapy is indicated for the treatment of patients with chronic,
intractable (drug refractory) nausea and vomiting secondary to gastroparesis.”
August 2002
Surgery
Laparoscopy (Laparotomy) 3-4 Ports Upper right port becomes
stimulator pocket Length of stay: 2-3 days Evaluate neurostimulator
parameters before discharge
Lead Location
Greater curvature Leads placed
10cm from pylorus Utilize measuring tape
or 10cm suture length Leads 1cm apart
Lead Placement
One centimeter electrode length in
stomach wall
Proximal anchoring point utilizing
winged/trumpet anchor
Lead Fixation
Disc sutured to stomach wall
1-2 sutures Lead suture wire
clipped to disc 1-2 clips
Lead Connection Leads connected and
tightened Stimulator placed
engraving up Extra lead length wound behind
stimulator
Gastric Electrical Stimulation
for the Treatment of Gastroparesis: A Meta-Analysis
O’Grady G, et al. World J Surg 2009; 33:1693-1701
26 papers 13 excluded (duplicate series, case reports)
Author Year Pats. Study type Population Study quality
Foster 2001 25 Prosp. case series Diab (19) Idiop (3) Post-Surg (3) Low
Jones 2003 13 Prosp. case series Diab (12) Idiop (1) Low
Abell 2003 33 RCT (2 mos)
Prosp. case series (10 mos.)
Diab (17) Idiop (16) Moderate,
then low
Lin 2004 48 Prosp. case series Diabetic (48) Low
McCallum 2005 16 Prosp. case series Post-Surgical (16) Low
Mason 2005 29 Retrosp. case series Diab (24) Idiop (5) Low
Van der Voort 2005 17 Prosp. case series Diabetic (17) Low
De Csepel 2006 16 Prosp. case series Diab (7) Idiop (7) other (2) Low
Gray 2006 7 Retrosp. case series Diab (5) Idiop (2) Low
Gourcerol 2007 15 Prosp. case series Diab (5) Idiop (6) Post-Surg (4) Low
Filichia 2008 13 Retrosp. case series Post-transplant (13) Low
Maranki 2008 28 Prosp. case series Diab (12) Idiop (16) Low
Velanovich 2008 42 Prosp. case series Diab (24) Idiop (17) Post-Surg (1) Low
13 papers
302
Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis
O’Grady G, et al. World J Surg 2009; 33:1693-1701
Total Symptom Severity Score
SF-36 Physical Composite Score
SF-36 Mental Composite Score
Requirement for Enteral or Parenteral Nutritional Support
Change in Weight (kg)
Vomiting Symptom Severity Score
Nausea Symptom Severity Score
13 papers
Gastric Electrical Stimulation
for the Treatment of Gastroparesis: A Meta-Analysis
O’Grady G, et al. World J Surg 2009; 33:1693-1701
Complications
8.3 % (22/265 patients, 10/13 studies)
Infection 8
Skin erosion 6
Pain at site 4
Gastric perforation 2
Device migration 1
Volvulus 1
Baseline
ON
Implant
1/2
1/2
OFF
Random
1 20 Months6 12
WAVESS*: Study DesignMulticenter double blind crossover
* Worldwide Anti-Vomiting Electrical Stimulation Study
Phase I Phase II
N= 33 33 33 27 24 Patients17 diabetic16 idiopathic
HQOL SF-36 Score Improvements (All patients)
0
1020
30
4050
60
7080
90
PF RP BP GH VT SF RE MH
Me
an
US norms
12 mths
Baseline
*
** * *
*
*
* p < 0.005
n = 24
WAVESS OutcomesVomiting frequency reduction
0
5
10
15
20
25
30
Baseline OFF (1mth) ON (1mth) 6 mths 12 mths
Ep
iso
de
s /
We
ek
All
Diabetic
Idiopathic†
* **
* * *
* p < 0.05 vs. baseline† p < 0.05 on vs. off
33, 17, 16 33, 17, 16 33, 17, 16 27, 13, 14 24, 11, 13 n
77% efficacy in idiopathic patients
70% efficacy in diabetic patients
Glucose Control in Diabetic Gastroparesis Patients
Difference vs Baseline
HbA1c Baseline 6 mths 12 mths 6m 12m
Forster 2003 9.8% 9.0% 8.5% -0.8 -1.3*
Lin 2004 9.4% 8.7% 8.4% -0.7 -1.0*
Van der Voort 2005
8.6% 6.2% 6.5% -2.4 -2.1
•Forster et al: Further experience with gastric stimulation to treat drug refractory gastroparesis. Am J Surgery 2003; 186(6): 690-695
•Lin et al: Treatment of Diabetic Gastroparesis by High-Frequency Gastric Electrical Stimulation. Diabetes Care 2004; 27(5), 1071-1076.
•Van Der Voort et al: Gastric Electrical Stimulation Results in Improved Metabolic Control in Diabetic Patients Suffering From Gastroparesis. Exp Clin Endocrinol Diabetes 2005; 113:38-42
* P < 0.05 P < 0.01
Baseline 8.6%
Baseline 9.4%
Baseline 9.8%
At 6 mths
At 12 mths8.5%
At 12 mths8.4%
At 12 mths6.5%
At 6 mths
At 6 mths
HbA1c Reduction at 6 and 12 months vs. Baseline
Lin et al: Treatment of Diabetic Gastroparesis by High-Frequency Gastric Electrical Stimulation. Diabetes Care 2004; 27(5), 1071-1076
Nutritional Support
Nutritional Support Reduction
13
9
5*0
5
10
15
20
25
Baseline 12 mths
Pat
ien
t N
um
ber
TPN
J-tubes
48 28 n
* p < 0.05
McCallum et al, Clin J Gastro Hep 2005; Clinical Response to Gastric Electrical Stimulation in Patients With Postsurgical Gastroparesis
Post-Surgical Gastroparesis16 post-Surgical patients Nissen fundoplication (5) Vagotomy and pyloroplasty (3) Billroth I and vagotomy (2) Billroth II and vagotomy (2) Cholecystectomy (1) Spinal surgery (2) Esophagectomy with colonic
interposition (2)
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Vomiting Nausea EarlySatiety
Bloating PostprandialFullness
EpigastricPain
Baseline
6 months
12 months
Frequency Score
31
6*0
5
10
15
20
25
30
35
40
45
Baseline 12 months
Day
s
n= 16 16
1-Year Average Hospitalization Days
63% efficacy at 12 months 50% of patients required no
hospitalizations after implant
Gastric Electrical Stimulation for the Treatment of Gastroparesis:
Predictive factors
* Maranki JL, et al. Dig Dis Sci 2008;53:2072-78 (n = 28)
Diabetic vs Idiopathic * # Main symptom:
Nausea/vomiting vs Abdominal pain * #
No narcotic use vs Narcotic use *
No effect of gender, BMI, gastric emptying test or
HbA1c at baseline *
# Musunuru S, et al. World J Surg 2010;34:1853-58 (n = 15)
Gastric Electrical Stimulation for the Treatment of Gastroparesis:
Mechanisms of action
McCallum RW et al. Neurogastroenterol & Motil 2010;22:161-e51
Gastric emptying not consistently improved
Gastric dysrhythmias not normalized
Increased gastric accommodation
Increased vagal afferent activity
Increased thalamic activity
Unknown
Temporary Percutaneous Gastric Electrical Stimulation
Andersson S et al. Digestion 2011;83:3-12
27 Pats. 22 “responders” 20 permanent GES
Abdominal wall
The Padua Experience
Patient Age Ætiology Implant Outcome Notes
1, m 40 Idiopathic 9/05 & 10/05
No changes 5/07 removal
2, f 40 CIIP 11/06 (open)
No changes Roux-Y Total gastrectomy
3, f 24 Post-surgical (Nissen)
9/06 + Toupet
Good
4, m 33 Diabetic 1/08 Good /fair
5, f 28 Diabetic 7/08 Good No changes x 3 mos.
6, f 35 Diabetic 9/09 Fair/good “off” poor
7, f 36 Diabetic Pancreas Tx
9/09 No changes
No surgical complications observed
Gastric Electrical Stimulation for the Treatment of Gastroparesis: Italian preliminary experience
5 7
4
3
3
5
27 implants:
10 diabetic 7 post-surgical 7 idiopathic 3 other
neuromuscular dis. 2post-viral 1
7 male – 20 femaleMedin age 42 years (24-68)Follow-up 25 mos. (1-84)
Gastric Electrical Stimulation for the Treatment of Gastroparesis:
Results
0%
20%
40%
60%
80%
100%
TOTAL Diabetic Post-surgical
Idiopathic
Good Fair No changes
n=10 n=7 n=7
6
6
3
13
1
1
3
n=27
>30% score reduction10 - 30% <10%
16
6
5(Other n = 3)
Conclusions
Gastric Electrical Stimulation
• improves:• Nausea and vomiting symptoms• Quality-of-life• Glycemic control (HbA1c)• Nutritional status
• is safe:• Low adverse events• No cardiac side effect
• is reversible:• Device can be removed (laparoscopically)
Conclusions
Gastric Electrical Stimulation
• Lack of EBM studies (Grade “C” recommendation)
• Only (but 1) observational and uncontrolled studies
• Costs ( ~ USD 20,000) - Complications
• Temporary stimulation ?
• In Italy: sporadic implants and disomogeneous patients (etiology, work up, follow up)
• Need for a National Registry (GISMAD ?)
It may represent the only way to treat these patients