Gastric Electrical Stimulation for Gastroparesis

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


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


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.


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%


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™

3 • Applica-on for Funding

4 • Temporary Enterra™ ≈ 2 weeks • Gastroparesis Symptom Diary

5 • Permanent Enterra™ if ≥50% symptom-‐improvement with Temporary Enterra™


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)


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


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


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


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


Outcome Data January 2012 N=31

Median FU: 10 months (1-‐28)

≥50% Symptom-‐Improvement N=22 (71%)

<50% Symptom-‐Improvement N=9 (29%)

Results Outcomes with Permanent Enterra


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


Gastric Electrical Stimulation for Gastroparesis

Health & Medicine

Transcript of Gastric Electrical Stimulation for Gastroparesis