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 Diges-ve Diseases Federa-on Mee-ng, Liverpool, UK Associa-on of Upper GI Surgeons of UK Prize Session 19062012
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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
Diges-ve Diseases Federa-on Mee-ng, Liverpool, UK Associa-on of Upper GI Surgeons of UK
Prize Session 19-‐06-‐2012
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
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
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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
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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.
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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%
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Pa-ent & Methods Selec-on for Temporary S-mula-on
Cardinal Symptoms of Gastroparesis
1. Nausea
2. Vomi-ng
3. Excessive fullness
4. Bloa-ng
5. Pain
Severe Gastroparesis/Gastric Pump Failure
• Drug-‐unresponsive
• Inability to maintain oral nutri-on
• Frequent A&E visits/hospitalisa-on
• Poor diabetes control www.foregutsurgeon.com
1 • Diagnosis of Gastroparesis • Evalua-on of Clinical Severity
2 • MDT Discussion • Selec-on for Temporary Enterra™
5 • Permanent Enterra™ if ≥50% symptom-‐improvement with Temporary Enterra™
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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)
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Results: Ae-ology
44, 62%
14, 20%
13, 18%
Overall Ae-ology
Idiopathic
Diabetes
Post-‐Surgery
6
4
1 1
1
Post-‐Surgical Gastroparesis
An--‐Reflux
Gastric Bypass
Cardiomyotomy
Splenectomy
Unclear
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Results: Pa-ent Characteris-cs
10%
11% 1%
78%
Route of Nutri-on
Naso-‐Jejunal
Jejunostomy
Parenteral
Oral Supplements
23% 3% 1%
1% 72%
Previous Treatment-‐Interven-on
Botox
Pyloroplasty
Gastrectomy
Gastrojejunostomy
None
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Selected N=71
(January, 2012)
Awai-ng Enterra N=16
Temporary Enterra N=51
< 50% symptom-‐improvement N=12 (33%)
≥ 50% symptom-‐improvement N=39 (77%)
Permanent Enterra N=35
Permanent Enterra N=4
Results
Temporary Gastric Electrical S-mula-on
as a Selec-on Tool www.foregutsurgeon.com
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