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

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Presentation on theme: "Gastroparesis and Gastric Electrical Stimulation Dr. Mario Costantini Clinica Chirurgica 1 Università ed Azienda Ospedaliera di Padova U.O.S. Fisiopatologia."— Presentation transcript:

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

3 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

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

5 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: M = 2.5 / /yrs F = 9.8 / /yrs 5-yr survival 80% *Olmsted County

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

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

9 Gastroparesis: Treatment Botulinum toxin GES

10 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

11 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

12 XI th International Symposium on Gastrointestinal Motility Oxford, September 7-11, 1987

13 Energy Frequency Gastric 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)

14 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

15 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

16 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

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

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

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

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

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

22 Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis OGrady G, et al. World J Surg 2009; 33: papers 13 excluded (duplicate series, case reports) AuthorYearPats.Study typePopulationStudy quality Foster200125Prosp. case seriesDiab (19) Idiop (3) Post-Surg (3)Low Jones200313Prosp. case seriesDiab (12) Idiop (1)Low Abell RCT (2 mos) Prosp. case series (10 mos.) Diab (17) Idiop (16)Moderate, then low Lin200448Prosp. case seriesDiabetic (48)Low McCallum200516Prosp. case seriesPost-Surgical (16)Low Mason200529Retrosp. case seriesDiab (24) Idiop (5)Low Van der Voort200517Prosp. case seriesDiabetic (17)Low De Csepel200616Prosp. case seriesDiab (7) Idiop (7) other (2)Low Gray20067Retrosp. case seriesDiab (5) Idiop (2)Low Gourcerol200715Prosp. case seriesDiab (5) Idiop (6) Post-Surg (4)Low Filichia200813Retrosp. case seriesPost-transplant (13)Low Maranki200828Prosp. case seriesDiab (12) Idiop (16)Low Velanovich200842Prosp. case seriesDiab (24) Idiop (17) Post-Surg (1)Low 13 papers 302

23 Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis OGrady G, et al. World J Surg 2009; 33: 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

24 Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis OGrady G, et al. World J Surg 2009; 33: Complications 8.3 % (22/265 patients, 10/13 studies) Infection8 Skin erosion6 Pain at site4 Gastric perforation2 Device migration1 Volvulus1

25 Baseline ON Implant 1/2 OFF RandomRandom 120 Months 6 12 WAVESS*: Study Design Multicenter double blind crossover * Worldwide Anti-Vomiting Electrical Stimulation Study Phase IPhase II N= Patients 17diabetic 16idiopathic

26 WAVESS Outcomes 77% efficacy in idiopathic patients 70% efficacy in diabetic patients

27 Glucose Control in Diabetic Gastroparesis Patients Difference vs Baseline HbA1cBaseline6 mths12 mths6m12m Forster %9.0%8.5% * Lin %8.7%8.4% * Van der Voort %6.2%6.5% Forster et al: Further experience with gastric stimulation to treat drug refractory gastroparesis. Am J Surgery 2003; 186(6): Lin et al: Treatment of Diabetic Gastroparesis by High-Frequency Gastric Electrical Stimulation. Diabetes Care 2004; 27(5), 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 mths 8.5% At 12 mths 8.4% At 12 mths 6.5% At 6 mths HbA1c Reduction at 6 and 12 months vs. Baseline

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

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

30 Gastric Electrical Stimulation for the Treatment of Gastroparesis: Predictive factors * Maranki JL, et al. Dig Dis Sci 2008;53: (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: (n = 15)

31 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

32 Temporary Percutaneous Gastric Electrical Stimulation Andersson S et al. Digestion 2011;83: Pats. 22 responders 20 permanent GES Abdominal wall

33 The Padua Experience PatientAgeÆtiologyImplantOutcomeNotes 1, m40Idiopathic9/05 & 10/05 No changes5/07 removal 2, f40CIIP11/06 (open) No changes Roux-Y Total gastrectomy 3, f24Post-surgical (Nissen) 9/06 + Toupet Good 4, m33Diabetic1/08Good /fair 5, f28Diabetic7/08GoodNo changes x 3 mos. 6, f35Diabetic9/09Fair/good off poor 7, f36Diabetic Pancreas Tx 9/09No changes No surgical complications observed

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

35 Gastric Electrical Stimulation for the Treatment of Gastroparesis: Results n=10n= n=27 >30%score reduction %<10% (Other n = 3)

36 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)

37 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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