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Gastric Electrical Stimulation

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Presentation on theme: "Gastric Electrical Stimulation"— Presentation transcript:

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2 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

3 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

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

5 Gastroparesis: Incidence*
M = 2.5/ /yrs F = 9.8/ /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:

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

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

9 Gastroparesis: Treatment
Botulinum toxin GES

10 The History of Gastric Stimulation
1963 – Bilgutay et al.: The concept of electrical stimulation was born, when gastric stimulation was practiced for the treatment of postoperative ileus.

11 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

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

13 Gastric Electric Stimulation
? Neural sequential GES (experim. only) Gastric Neurostimulation (Enterra)  High Frequency (~ 4 x Slow Wave Freq) Low Energy with short pulse 12 bpm Frequency Gastric Pacing: 3 bpm  Low Frequency (~ Slow Wave Freq) High Energy with long pulse Energy

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

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 26 papers  13 excluded (duplicate series, case reports)
Gastric Electrical Stimulation for the Treatment of Gastroparesis: A Meta-Analysis 26 papers  13 excluded (duplicate series, case reports) 13 papers Author Year Pats. Study type Population Study quality Foster 2001 25 Prosp. case series Diab (19) Idiop (3) Post-Surg (3) Low Jones 2003 13 Diab (12) Idiop (1) Abell 33 RCT (2 mos)  Prosp. case series (10 mos.) Diab (17) Idiop (16) Moderate, then low Lin 2004 48 Diabetic (48) McCallum 2005 16 Post-Surgical (16) Mason 29 Retrosp. case series Diab (24) Idiop (5) Van der Voort 17 Diabetic (17) De Csepel 2006 Diab (7) Idiop (7) other (2) Gray 7 Diab (5) Idiop (2) Gourcerol 2007 15 Diab (5) Idiop (6) Post-Surg (4) Filichia 2008 Post-transplant (13) Maranki 28 Diab (12) Idiop (16) Velanovich 42 Diab (24) Idiop (17) Post-Surg (1) 302 O’Grady G, et al. World J Surg 2009; 33:

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

24 8.3 % Complications Infection 8 Skin erosion 6 Pain at site 4
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:

25 WAVESS*: Study Design Multicenter double blind crossover
March 14-15, 1997 WAVESS*: Study Design Multicenter double blind crossover ON Random Baseline 1/2 Implant 1/2 OFF Phase I Phase II 1 2 6 12 Months N= Patients 17 diabetic 16 idiopathic * Worldwide Anti-Vomiting Electrical Stimulation Study Study Initiation Meeting USA, Washington 13

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

27 Glucose Control in Diabetic Gastroparesis Patients
HbA1c Reduction at 6 and 12 months vs. Baseline Baseline 8.6% Baseline 9.4% Baseline 9.8% At 6 mths At 12 mths 8.5% 8.4% 6.5% Difference vs Baseline HbA1c Baseline 6 mths 12 mths 6m 12m Forster 2003 9.8% 9.0% 8.5% -0.8 -1.3* Lin 2004 9.4% 8.7% 8.4% -0.7 -1.0* Van der Voort 2005 8.6% 6.2% 6.5% -2.4 -2.1 * 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): 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

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

29 Post-Surgical Gastroparesis
Frequency Score 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) 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

30 # Musunuru S, et al. World J Surg 2010;34:1853-58 (n = 15)
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: (n = 28) # Musunuru S, et al. World J Surg 2010;34: (n = 15)

31 Unknown Gastric emptying not consistently improved
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

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

33 The Padua Experience Patient Age Ætiology Implant Outcome Notes
40 Idiopathic 9/05 & 10/05 No changes 5/07 removal 2, f CIIP 11/06 (open) Roux-Y  Total gastrectomy 3, f 24 Post-surgical (Nissen) 9/06 + Toupet Good 4, m 33 Diabetic 1/08 Good /fair 5, f 28 7/08 No changes x 3 mos. 6, f 35 9/09 Fair/good “off”  poor 7, f 36 Diabetic Pancreas Tx No surgical complications observed

34 27 implants: 7 10 diabetic 5 7 post-surgical 7 idiopathic 3 other 3 4
Gastric Electrical Stimulation for the Treatment of Gastroparesis: Italian preliminary experience 5 7 4 3 27 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
1 1 6 3 (Other n = 3) 3 5 1 6 16 6 3 >30% % <10% score reduction

36 Conclusions Gastric Electrical Stimulation improves: is safe:
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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