Gastric Electrical Stimulation for Abdominal Pain in Patients with Symptoms of Gastroparesis CHRISTOPHER J

Gastric Electrical Stimulation for Abdominal Pain in Patients with Symptoms of Gastroparesis CHRISTOPHER J

Delivered by Publishing Technology to: Universita' studi di Torino IP: 130.192.119.93 on: Wed, 15 May 2013 20:20:35 Copyright Southeastern Surgical Congress. All rights reserved. Gastric Electrical Stimulation for Abdominal Pain in Patients with Symptoms of Gastroparesis CHRISTOPHER J. LAHR, M.D.,* JAMES GRIFFITH, B.S.,§ CHARU SUBRAMONY, M.D.,† LINDSEY HALLEY, M.D.,§ KRISTEN ADAMS, M.D.,§ ELIZABETH R. PAINE, M.D.,‡ ROBERT SCHMIEG, M.D.,* SALEEM ISLAM, M.D.,k JAY SALAMEH, M.D.,{ DANIELLE SPREE, F.N.P.,‡ TRUPTESH KOTHARI, M.D.,** ARCHANA KEDAR, M.D.,‡ YANA NIKITINA, M.D.,‡ THOMAS ABELL, M.D.‡ From the Departments of *Surgery, †Pathology, and ‡Medicine, and the §Division of Digestive Diseases, School of Medicine, University of Mississippi Medical Center, Jackson, Mississippi; the kDepartment of Surgery, University of Florida, Gainesville, Florida; {George Washington Hospital, Arlington, Virginia; and **Gastroenterology/Hepatology, State University of New York Downstate Medical Center, Brooklyn, New York Abdominal pain physiology may be better understood studying electrophysiology, histology, and symptom scores in patients with the symptoms of gastroparesis (Gp) treated with gastric electrical stimulation (GES). Ninety-five Gp patients’ symptoms were recorded at baseline and during temporary and permanent GES. Gastric-emptying times and cutaneous, mucosal, and serosal electrogastrograms were obtained. S100-stained, full-thickness gastric biopsies were compared with autopsy controls. Sixty-eight patients reported severe pain at baseline. Severe pain patients’ mean pain scores decreased with temporary GES from 3.62 to 1.29 (P \ 0.001) and nonsevere pain from 1.26 to 0.67 (P 5 0.01). With permanent GES, severe mean pain scores fell to 2.30 (P \ 0.001); nonsevere pain changed to 1.60 (P 5 0.221). Mean follow-up was 275 days. Mean cutaneous, mucosal, and serosal frequencies and frequency-to-amplitude ratios were markedly higher than literature controls. For patients with Gp overall and subdivided by etiology and severity of pain, S-100 neuronal fibers were significantly reduced in both muscularis propria layers. GES improved severe pain associated with symptoms of Gp. This severe pain is associated with abnormal electrogastrographic activity and loss of S100 neuronal fibers in the stomach’s inner and outer muscularis propria and, therefore, could be the result of gastric neuropathy. HRONIC, SEVERE ABDOMINAL pain in patients with relief. With neither identified cause nor a reliable C the symptoms of gastroparesis (Gp) is a common treatment option for chronic abdominal pain, physi- medical reason for frequent physician and emergency cians often face the dilemma of treating innumerable department visits. Despite a complete evaluation, in- symptomatic, complaining patients without relying on cluding upper and lower endoscopy, contrast comput- chronic narcotic use. erized tomography, abdominal and pelvic ultrasound, Efforts to resolve many types of pain have included and blood work, a definitive cause for this pain often is recourse to electrical stimulation. Such use for chronic, not identified. Patients with Gp symptoms who have severe abdominal pain associated not with the symptoms a history of abdominal surgery may be told that their of gastroparesis, however, has largely been confined pain is the result of adhesions. Unfortunately, the use to spinal stimulation. In recent years, direct electrical of diagnostic laparoscopy with therapeutic lysis of stimulation of the stomach, or gastric electrical stimu- adhesions as a potential diagnostic and therapeutic op- lation(GES),hasbeenusedasaneffectivetreatmentfor tion has not led overwhelmingly to successful symptom reducing Gp symptoms including chronic abdominal pain in patients with drug-refractory Gp, including those who on a modified Likert scale report their chronic ab- Presented at the Southeastern Surgical Congress 2010 Annual Scientific Meeting, February 2010, Savannah, Georgia. dominal pain as either a 3 or 4 out of 4, severe or ex- 1 Address correspondence and reprint requests to Christopher tremely severe. J. Lahr, M.D., Department of Surgery, University of Mississippi Gastroparesis is a motility or physiologic failure of Medical Center, Jackson, MS 39216. E-mail: CHRISLAHR@AOL. the stomach to fill and empty properly. This disorder COM, [email protected]. results in symptoms of nausea, vomiting, early satiety Thomas Abell is a licensee, consultant, and investigator for Medtronic. and bloating, and pain may often be a symptom as 2 The University of Mississippi has filed an intellectual property well. However, relatively little has been done to study claim regarding aspects of the technology used in this study. the effects of GES on the subgroup of patients with Gp 457 Delivered by Publishing Technology to: Universita' studi di Torino IP: 130.192.119.93 on: Wed, 15 May 2013 20:20:35 Copyright Southeastern Surgical Congress. All rights reserved. 458 THE AMERICAN SURGEON May 2013 Vol. 79 symptoms who experience severe, chronic abdominal a result of prior gastric resection or scarring. The bi- pain. Our study was undertaken in an effort to correlate opsy specimen was obtained by using an end-to-end pain with physiologic and histologic parameters in anastomosis circular stapler placed tangentially at ap- patients with Gp symptoms as well as to contribute to proximately 5 cm proximal to the pylorus along the a better understanding of other instances of chronic midline of the anterior surface of the stomach. A dime- abdominal pain such as that associated with hollow sized, full-thickness biopsy was removed, leaving the viscous pain in the absence of malignancy, infection, staple line on the serosal surface without entering the inflammation, and distension or obstruction. lumen. This line was imbricated with monofilament, absorbable suture to reduce adhesions. Patients and Methods Symptoms The Institutional Review Board at the University of Mississippi Medical Center approved this study. Pa- Patient-reported measures of Gp symptoms de- tient consent was obtained before enrollment. scribing the frequency and severity of nausea, vomit- ing, bloating, early satiety, and epigastric pain were Patients quantified (0 to 4) with a modified Likert scale tool.7 These symptom reports were collected at baseline Ninety-five consecutive drug-refractory patients with (before electrical stimulation), at least four days after the symptoms of Gp at baseline were evaluated and activation of temporary GES, and during the three- consented to a series of investigational and humanitar- month and one-year follow-up visits after implantation ian use protocols for GES treatment. Most patients also of a pGES. Patients with suboptimal symptom re- had to demonstrate drug refractoriness and stomach sponse to stimulation had their devices adjusted by mobility dysfunction through a solid-phase gastric- a previously published energy algorithm during these emptying study through standardized scintigraphy and visits.8 a low-fat test meal, as previously reported.3, 4 For the purpose of this analysis, patients, who sub- Physiology jectively stated their baseline abdominal pain as 0 to 2 out of 4 (no pain or mild to moderate pain), were con- Gastric-emptying time (GET) and electrogastrogram sidered the nonsevere pain group; those with scores of (EGG) were also performed and recorded.3 Gastric re- 3 or 4, severe or extremely severe, were considered the tention was documented at one-, two-, and four-hour severe pain group. increments by nuclear scintigraphy with delayed GET Ofthe95patientswithGpwhoelectedtounder defined as a greater than 10 per cent retention (95th permanent gastric stimulator implantation (pGES), percentile) of a Tc 99m radionuclide-labeled meal four 27 (six male, 21 female; age range, 11 to 71 years; mean hours after ingestion.2 EGG measures of amplitude and age, 43.9 years; 11 diabetic, 16 idiopathic) had non- frequency were assessed by using cutaneous leads at severe pain before treatment. Another 68 (nine male, baseline, mucosal leads at temporary stimulation, and 59 female; age range, 19 to 69 years; average age, seromuscular leads during implantation of the perma- 44.6 years; 22 diabetic, 46 idiopathic) had severe pain. nent gastric stimulator. Baseline mucosal and seromus- Of the original 95 patients, 82 patients (58 with severe cular EGG values were collected before the temporary pain and 24 with nonsevere pain) were available for or permanent GES was activated, respectively. follow-up at least one month after pGES with a mean latest follow-up at 275 days after pGES implantation. Histopathology The study pathologist examined each full-thickness Intervention gastric biopsy after the sample had been immunohis- Patients underwent at least a four-day trial of tem- tologically stained with S-100 to permit identification porary gastric stimulation (Enterra, trademark of of nerve fibers. These fibers were counted in the inner Medtronic) through an endoscopically placed gastric and outer muscle layers of the muscularis propria mucosal lead.5 Patients who had lead dislodgment as a across 10 high-power fields (hpf). The counts for all result of emesis or could not complete the temporary 10 hpf were averaged to obtain a mean. All histologic trial were excluded. Patients with a successful trial pro- findings were compared with findings from 17 autopsy ceeded with placement of a permanent gastric electrical controls. stimulator (Enterra) through laparotomy.6 Evaluation of gastric neuronal histology as well as of

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