J Gastrointest Surg DOI 10.1007/s11605-007-0331-8
Refractory Gastroparesis After Roux-en-Y Gastric Bypass: Surgical Treatment with Implantable Pacemaker J. R. Salameh & Robert E. Schmieg Jr. & J. Matt Runnels & Thomas L. Abell
Received: 19 May 2007 / Accepted: 5 September 2007 # 2007 The Society for Surgery of the Alimentary Tract
Abstract Background Gastroparesis is a rare complication of Roux-en-Y gastric bypass. We evaluate the role of gastric electrical stimulation in medically refractory gastroparesis. Methods Patients with refractory gastroparesis after gastric bypass for morbid obesity were studied. After behavioral and anatomic problems were ruled out, the diagnosis of disordered gastric emptying was confirmed by radionuclide gastric emptying. Temporary endoscopic stimulation was used first to assess response before implanting a permanent device. Results Six patients, all women with mean age of 42 years, were identified. Two patients ultimately had reversal of their surgery with gastro-gastrostomy, while another had a total gastrectomy with persistence of symptoms in all three. Five of the patients evaluated had insertion of a permanent gastric pacemaker, with pacing lead implanted on the gastric pouch (2), the antrum of the reconstructed stomach (1), or the proximal Roux limb (2). Nausea and emesis improved significantly postoperatively; mean total symptom score decreased from 15 to 11 out of 20. There was also a persistent improvement in gastric emptying postoperatively based on radionuclide testing. Conclusion If medical therapy fails, electrical stimulation is a viable option in selected patients with gastroparesis symptoms complicating gastric bypass and should be considered in lieu of reversal surgery or gastrectomy. Keywords Gastroparesis . Bariatric surgery . Pacemaker
Introduction Nausea and vomiting are the most common complaints after Roux-en-Y gastric bypass. When these symptoms Presented at SSAT meeting, Washington, DC, May 2007. J. R. Salameh : R. E. Schmieg Jr. Department of Surgery, University of Mississippi Medical Center, Jackson, MS, USA J. M. Runnels : T. L. Abell Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA J. R. Salameh (*) 2500 North State Street, Jackson, MS 39216, USA e-mail:
[email protected]
persist, patients should be investigated to rule out a variety of possible etiologies, including anatomic problems such as anastomotic stricture and small bowel obstruction or behavioral problems such as disordered eating. Gastroparesis is a motility disorder of the stomach, defined by delayed gastric emptying of a solid meal in the absence of mechanical obstruction and is a diagnosis of exclusion. It can occasionally be responsible for severe, persisting nausea, and vomiting symptoms in some of these patients, which can be difficult to treat and is often refractory to medical therapy. Gastric electrical stimulation (GES) has received FDA Humanitarian Use Device approval in 2000 and has been shown to be an effective treatment alternative in patients with medically refractory diabetic or idiopathic gastroparesis.1 We have used GES in postsurgical or surgery-associated gastroparesis with significant clinical improvements at long term follow-up.2 In this study, we evaluate the role of electric stimulation therapy in patients with severe gastroparesis complicating Roux-en-Y gastric bypass for morbid obesity.
J Gastrointest Surg
Material and Methods All patients with refractory gastroparesis after Roux-en-Y gastric bypass surgery for morbid obesity were identified. Chart review was conducted including records from the referring institution. Behavioral problems are ruled out by careful nutritional assessments and structured psychiatric interviews. Anatomic problems are ruled out using numerous diagnostic studies including upper gastrointestinal contrast studies, computed tomography (CT) scan of the abdomen and pelvis and upper endoscopy. Diagnosis of disordered gastric emptying was confirmed by radionuclide gastric emptying showing either significant gastric retention at 4 h or rapid emptying of the stomach at 1 h, and this test was repeated after the institution of GES therapy. GES uses low energy stimuli administered at a frequency higher than the intrinsic slow-wave frequency of the normal stomach. Temporary endoscopically placed stimulation is used first to assess response to stimulation before surgically implanting a permanent device. Permanent GES is implanted surgically via laparotomy: two stimulating electrodes (Medtronic Model 4351 or 4300, Medtronic, Minneapolis, MN) are inserted into the muscularis propria 1 cm apart in the gastric pouch or in the gastric antrum, 10 cm proximal to the pylorus, in cases of reversal of the gastric bypass. When a total gastrectomy with esophago-jejunostomy was performed, electrodes are inserted in the proximal Roux limb. Intraoperative endoscopy is used in all cases to verify that the electrodes placed in the stomach or small bowel wall have not penetrated the mucosa. The electrodes are tunneled through the fascia and connected to a battery-powered neurostimulator (Medtronic ITREL 3 Model 7425G or Enterra, Medtronic, Minneapolis, MN) placed in a subcutaneous pocket. The neurostimulator is programmed and turned on after verifying adequate impedance. GES implantation follows a study protocol approved by our institutional review board. All patients were assessed sequentially during regularly scheduled office visits and as needed. Symptoms of nausea, vomiting, bloating/distension, early satiety, and abdominal pain are assessed at all stages of treatment and follow-up and are each scored on a
scale from 1 to 4 based on severity, 4 being most severe. The sum of all five symptom scores constitutes the total symptom score (TSS), 20 being the highest and worst score possible. Quality of life was assessed on a −3 to +3, worse to best, scale for the temporary GES and by an investigatorderived independent outcome score on a 0 to 30 scale, best to worse, for the permanent GES and compared by t tests.3
Results Six patients were referred to our institution for refractory gastroparesis after prior Roux-en-Y gastric bypass (Table 1). Two patients had a concomitant hiatal hernia repair and truncal vagotomy at the time of their bariatric surgery. All six patients were women with mean age of 42 years. Mean total symptom score at presentation was 15. The onset of symptoms varied among the patients, from immediately postoperatively to 16 years after the surgery. All of these patients lost a various amount of weight after their bariatric surgery. Preoperative weights were not available to us, but body mass indexes upon presentation to our institution ranged from 20 to 39 with a mean of 31. In addition to the many diagnostic studies to rule out anatomic problems, most patients had a surgical reexploration that was normal. All patients did not respond to various prokinetic and antiemetic agents. Two patients ultimately had reversal of their surgery with gastro-gastrostomy, while another had a total gastrectomy with persistence of the symptoms in all three of them. All patients had markedly abnormal radionuclide gastric emptying with four of six patients showing slow gastric emptying with mean gastric retention of 78% at 4 h and two of six patients with rapid gastric emptying with mean gastric retention of 27% at 1 h. Temporary endoscopic pacing was performed on all six patients with improvement in their total symptom scores to a mean of 8; in addition, gastric emptying improved to 35% at 4 h in the delayed group and to 30% at 1 h in the rapid group. Five of the patients evaluated had insertion of a permanent gastric pacemaker, with implantation of the pacing leads on the gastric pouch (two patients), the
Table 1 Patient Demographics, Prior Procedures Performed, and Location of Implanted Leads Patient
Age/gender
Procedure(s)
1 2 3 4 5 6
44 52 35 50 23 48
Roux-en-Y Roux-en-Y Roux-en-Y Roux-en-Y Roux-en-Y Roux-en-Y
F F F F F F
gastric gastric gastric gastric gastric gastric
Lead location bypass, followed by total gastrectomy bypass bypass, followed by reversal bypass and hiatal hernia repair/truncal vagotomy followed by reversal bypass and hiatal hernia repair/truncal vagotomy bypass
Roux limb Gastric pouch – Gastric Antrum Gastric pouch Roux limb
J Gastrointest Surg
antrum of the reconstructed stomach (one), or the proximal Roux limb (two patients). Mean follow-up for these patients was 16 months. Symptoms improved significantly postoperatively with mean nausea score of 1.8/4, mean emesis score of 2.2/4, and mean total symptom score of 11/20. There was also a persistent improvement in gastric emptying postoperatively based on radionuclide testing; the delayed emptying group improved to 28% at 4 h and the rapid emptying group improved to 57% at 1 h. Quality of life changed from mean −3.0 to mean +1.2 after temporary GES (p
