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Gastroparesis and Gastric Electrical Stimulation

Gastroparesis and Gastric Electrical Stimulation. Dr. Mario Costantini Clinica Chirurgica 1 Università ed Azienda Ospedaliera di Padova U.O.S. Fisiopatologia Esofago-Gastrica. Gastroparesis.

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Gastroparesis and Gastric Electrical Stimulation

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  1. Gastroparesis and Gastric Electrical Stimulation Dr. Mario Costantini Clinica Chirurgica 1 Università ed Azienda Ospedaliera di Padova U.O.S. Fisiopatologia Esofago-Gastrica

  2. Gastroparesis A chronic disorder of gastric motility characterized by delayed gastric emptying in the absence of mechanical obstruction. • Main symptoms: • Nausea, vomiting • Early satiety, bloating • Post-prandial fullness • Abdominal pain • Weight loss, dehydration • Difficult glycaemic control

  3. Gastroparesis: Ætiology (post-infective) Kendall and McCallum. Gastroenterology 1993. Soykan et al. Dig Dis Sci 1998.

  4. Gastroparesis: Incidence* M = 2.5/100.000/yrs F = 9.8/100.000/yrs 5-yr survival 80% “Gastroparesis is an uncommon condition in the community, but is associated with a poor outcome” *Olmsted County Jung H-K et al. Gastroenterology 2009;136:1225-33

  5. Gastroparesis: Pathophysiology Excessive relaxation Poor antro-pyloro-duodeno synchronization Antral hypomotility Abnormal duodenum motility

  6. Gastroparesis: a proposed classification Ad da Abell TL et al, Neurogastroenterol Motil 2006

  7. Gastroparesis: Treatment Botulinum toxin GES

  8. 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

  9. 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

  10. XIth International Symposium on Gastrointestinal Motility Oxford, September 7-11, 1987

  11. 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 Gastric Electric Stimulation ? Neural sequential GES (experim. only) 12 bpm Frequency Gastric Pacing: 3 bpm Energy

  12. 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

  13. 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

  14. 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

  15. Surgery • Laparoscopy (Laparotomy) • 3-4 Ports • Upper right port becomes stimulator pocket • Length of stay: 2-3 days • Evaluate neurostimulator parameters before discharge

  16. Lead Location • Greater curvature • Leads placed 10cm from pylorus • Utilize measuring tape or 10cm suture length • Leads 1cm apart

  17. Lead Placement Proximal anchoring point utilizing winged/trumpet anchor One centimeter electrode length in stomach wall

  18. Lead Fixation • Disc sutured to stomach wall • 1-2 sutures • Lead suture wire clipped to disc • 1-2 clips

  19. Lead Connection • Leads connected and tightened • Stimulator placed engraving up • Extra lead length wound behind stimulator

  20. Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis 13 papers 302 26 papers  13 excluded (duplicate series, case reports) O’Grady G, et al. World J Surg 2009; 33:1693-1701

  21. Requirement for Enteral or Parenteral Nutritional Support SF-36 Physical Composite Score Total Symptom Severity Score Vomiting Symptom Severity Score Nausea Symptom Severity Score SF-36 Mental Composite Score Change in Weight (kg) Gastric Electrical Stimulationfor the Treatment of Gastroparesis: A Meta-Analysis 13 papers O’Grady G, et al. World J Surg 2009; 33:1693-1701

  22. Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis 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 O’Grady G, et al. World J Surg 2009; 33:1693-1701

  23. WAVESS*: Study DesignMulticenter double blind crossover ON Random Baseline 1/2 Implant 1/2 OFF Phase I Phase II Months 12 6 0 1 2 N= 33 33 33 27 24 Patients 17 diabetic 16 idiopathic * Worldwide Anti-Vomiting Electrical Stimulation Study

  24. WAVESS Outcomes • 77% efficacy in idiopathic patients • 70% efficacy in diabetic patients

  25. Baseline 9.8% Baseline 9.4% At 6 mths At 6 mths Baseline 8.6% At 12 mths 8.5% At 12 mths 8.4% At 12 mths 6.5% At 6 mths Glucose Control in DiabeticGastroparesis Patients HbA1c Reduction at 6 and 12 months vs. Baseline * P < 0.05  P < 0.01 • 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 DerVoort et al: Gastric Electrical Stimulation Results in Improved Metabolic Control in Diabetic Patients Suffering From Gastroparesis. Exp ClinEndocrinol Diabetes 2005; 113:38-42

  26. Nutritional Support Lin et al: Treatment of Diabetic Gastroparesis by High-Frequency Gastric Electrical Stimulation. Diabetes Care 2004; 27(5), 1071-1076

  27. Post-Surgical Gastroparesis Frequency Score • 16 post-Surgical patients • Nissenfundoplication (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) 1-Year Average Hospitalization Days • 63% efficacy at 12 months • 50% of patients required no hospitalizations after implant McCallum et al, Clin J Gastro Hep 2005; Clinical Response to Gastric Electrical Stimulation in Patients With Postsurgical Gastroparesis

  28. Gastric Electrical Stimulation for the Treatment of Gastroparesis: Predictive factors • 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 * * Maranki JL, et al. Dig Dis Sci 2008;53:2072-78 (n = 28) # Musunuru S, et al. World J Surg 2010;34:1853-58 (n = 15)

  29. Gastric Electrical Stimulation for the Treatment of Gastroparesis: Mechanisms of action Unknown • Gastric emptying not consistently improved • Gastric dysrhythmias not normalized • Increased gastric accommodation • Increased vagal afferent activity • Increased thalamic activity McCallum RW et al. Neurogastroenterol & Motil 2010;22:161-e51

  30. Temporary Percutaneous Gastric Electrical Stimulation Abdominal wall 27 Pats.  22 “responders”  20 permanent GES Andersson S et al. Digestion 2011;83:3-12

  31. The Padua Experience No surgical complications observed

  32. 3 7 5 5 3 4 Gastric Electrical Stimulation for the Treatment of Gastroparesis:Italian preliminary experience • 27 implants: • 10 diabetic • 7 post-surgical • 7 idiopathic • 3 other • neuromuscular dis. 2 • post-viral 1 7 male – 20 female Medinage 42 years (24-68) Follow-up 25 mos. (1-84)

  33. Gastric Electrical Stimulation for the Treatment of Gastroparesis: Results n=27 n=10 n=7 n=7 1 1 6 3 (Other n = 3) 3 5 1 6 16 6 3 >30% 10 - 30% <10% score reduction

  34. 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)

  35. 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

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