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Gastric Electrical Stimulation for Gastroparesis

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Gastric Electrical Stimulation for Gastroparesis

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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  

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