Abstract This clinical review on the treatment of patients with gastroparesis is a consensus document developed by the American Motility Society Task Force on Gastroparesis. It is a multidisciplinary effort with input from gastroenterologists and other specialists who are involved in the care of patients with gastroparesis. To provide practical guidelines for treatment, this document covers results of published research studies in the literature and areas developed by consensus agreement where clinical research trials remain lacking in the field of gastroparesis.
Abstract The aims were to investigate the effects of gastric electrical stimulation (GES) on autonomic function, gastric distention and tone, and central control mechanisms in gastroparetic patients. Ten gastroparetic patients refractory to standard medical therapy participated in this study and data were collected at baseline, within two weeks before surgery for implantation of GES system, and at follow-up sessions between 6 and 12 weeks after GES therapy was initiated. In each session, electrocardiogram, electrogastrogram (EGG) and gastric barostat measurements were conducted before and after a caloric liquid meal. Positron Emission Tomography (PET) brain scans were performed on a separate day. During GES therapy there was a significant increase in the discomfort threshold for mean pressure from 21 mmHg at baseline to 25 mmHg at follow-up, and for mean volume from 561 mL to 713 mL. A significant increase in the postprandial EGG power (amplitude) was observed between baseline and follow up. The sympathovagal balance was significantly decreased after GES therapy, indicating a significant increase in vagal activity. The cumulative PET data showed an increase in quantitative radioactive counts relative to the standardized data base in both the thalamic and caudate nuclei after chronic GES therapy. We conclude that our data suggest that the symptomatic improvement achieved by GES in gastroparesis is best explained by activation of vagal afferent pathways to influence CNS control mechanisms for nausea and vomiting accompanied by enhanced vagal efferent autonomic function and decreased gastric sensitivity to volume distention which enhances postprandial gastric accommodation.
Abstract The aims were to determine symptom responses and long‐term outcomes in gastroparetic patients receiving gastric electrical stimulation (GES) therapy beyond 3 years by presenting per protocol analysis and intention‐to‐treat (ITT) analysis. Data collected at baseline, 1 year and beyond 3 years in 55 patients included total symptom scores (TSS), nutritional status, weight, hospitalizations, the use of prokinetic and/or antiemetic medications, HbA1c in diabetics and adverse events. Of the 55 patients, 10 died of non‐pacemaker‐related complications, six had the devices removed and two could not be reached. The remaining 37 patients had the device activated for a mean of 45 months. Both per protocol and ITT analysis demonstrated that TSS, hospitalization days and the use of medications were all significantly reduced at 1 year and were sustained beyond 3 years. Average TSS decreased by 62.5% for the 37 patients completing 3 years of GES. At implantation, 15/37 patients required nutritional support and only five continued beyond 3 years. Mean HbA1c level in diabetics was significantly reduced from 9.5 to 7.9% at 3 years. We conclude that a significant improvement in symptoms and all measures of clinical outcome can be maintained for greater than 3 years with GES in patients with refractory gastroparesis.
Chronic high‐frequency gastric electrical stimulation (GES) has been shown to improve gastroparetic symptoms and quality of life (QOL) in up to 70% of patients with refractory gastroparesis (Gastroenterology 2003; 125:421–8). Little is known about factors associated with treatment failure. Clinical and gastric function data (gastric emptying test, GET; electrogastrogram, EGG) were extracted from a retrospective analysis of 87 gastroparetic patients (48 diabetic, 20 idiopathic and 19 postsurgical) who completed GES therapy (Enterra™ System, Medtronic) for at least 1 year. Total symptom score (TSS) (sum of severity of nausea, vomiting, early satiety, bloating, postprandial fullness, epigastric pain and burning using a 5‐point scale, 0 = non, 4 = extremely severe), quality of life (SF‐36 Health Status Survey questionnaire including physical composite score (PCS) and mental composite score (MCS)) and GET (4‐hour scintigraphy of a low‐fat meal) were examined at baseline and 1 year follow‐up. A non‐responder had <25% reduction in TSS and a responder was defined as having a ≥ 50% reduction in TSS after 1 year of GES therapy. Results: Overall the non‐responder rate was 23% (10% in diabetic vs. 16% in postsurgical vs. 35% in idiopathic subgroup). Non‐responder rates were similar for men (22%) and women (23%) and age was not a factor. Compared to responders of GES therapy, non‐responders had similar mean baseline vomiting (2.6 vs. 3.2) and nausea scores (3.3 vs. 3.6) but a lower TSS (17.6 vs. 20.1, P < 0.05). Also non‐responders had less improvements in mean gastric retention both at 2 hours (+5.4 vs. 8.7%) and at 4 hours (+4.0 vs. 10.5%), less improvement in mean PCS (+2.0 vs. +12.4, P < 0.05) and gained less weight (0.4 kg vs. +3.7 kg) than responders. 67% of non‐responders had an abnormal EGG (dysrhythmia >30% or decrease in postprandial EGG power) vs. 33% in responders. Non‐responders had more baseline mean tachygastria both in the fasting state vs. responders (26% vs. 11%, P < 0.05) and in the fed state (24% vs. 11%, P < 0.05) and less increase in postprandial EGG power (1.3 dB vs. 1.6 dB, P < 0.05). Conclusions: The best symptom improvement achieved by high‐frequency GES therapy in refractory gastroparesis is in diabetics (10% treatment failure rate) and postsurgical (16% failure) while the worst results are in idiopathics (35% non‐responder rate). Baseline EGG abnormalities are predictors of poor symptomatic response to GES therapy and may be useful in developing a patient profile to optimize selection and expectations for GES therapy.
Gastric electrical stimulation (GES) is a new therapeutic option for treatment of gastroparesis. We report our experience with the 4 diabetic patients (2M, 2F, mean age: 32 years) who received both low frequency stimulation (LFS) and high frequency stimulation (HFS) for 2 months to 2 years. LFS always preceded the HFS. LFS was applied at the stomach's intrinsic frequency of 3 cycles/min (cam) via a pair of electrodes surgically placed on the serosa of the mid-body of the stomach and connected to an external stimulator. HFS (12 cpm) was applied to the electrodes surgically positioned at 9 to 10 cm from the pylorus on the greater curvature of the ant rum and connected to a neurostimulator implanted in a pocket under the abdomen. In addition, 2 to 3 pairs of temporary pacing wires were placed on the serosa of the stomach along the greater curvature for measuring myoelectric activity of the stomach. Severity of nausea and vomiting were graded using a 5-point scale (0 to 4) and gastric emptying was evaluated using a 4-hour scintigraphy at baseline and during GES. Spectral analysis of the serosal recordings of gastric myoelectric activity showed that LFS not HFS entrained the gastric slow waves. Both LFS and HFS increased the amplitude of gastric slow waves. Mean total symptom score reduced from 5.5 to 2.25 by LFS and from 6.35 to 2.5 by HFS. The improvement in GE is 62% by LFS and overall no change by HFS. The following conclusions were drawn: 1) LFS improved GE by 60%, entrained gastric slow waves and reduced symptoms by 60%, 2) High frequency GES improved nausea and vomiting (60%) without changing GE or frequency of electric activity, 3) Important differences exist between these 2 methods of GES.
Improvement of gastroparesis (GP) symptoms has been documented in patients treated with gastric electrical stimulation (GES), but acceleration of gastric emptying (GET) is unpredictable. The aim of our study was to evaluate the advantage of adding surgical pyloroplasty (PP) to GES for improvement of GET and control of symptoms in diabetes mellitus (DM), idiopathic (ID), and postvagotomy (P-V) GP.A total of 49 (17 - DM, 9 - ID, 23 - P-V) consecutive GP patients: 38 female; mean age 42 (21-73 years); mean weight 158 lbs (102-245), underwent GES implantation, and 26 (53%) additionally received PP. Total Symptoms Score, 4-h GET, adverse events (AEs), and days of hospitalizations were captured at baseline and at the last visit.The mean follow-up was 7 months. Total Symptoms Score in patients who received Enterra and PP or GES alone significantly improved compared to their baseline scores (P < 0.001). GET improved by 64% at 4 h (P < 0.001) in patients with Enterra and PP, compared to 7% observed after GES therapy alone (ns). The most impressive acceleration of GET was seen in the P-V group, who received both therapies (P = 0.004) and 8 (60%) of them normalized GET. No AEs accompanied the addition of PP to the Enterra surgery.(i) In drug-refractory GP the addition of PP to GES substantially accelerated GET; (ii) The GET response in P-V group was the most impressive; (iii) Significant symptom reductions were achieved by both procedures; and (iv) PP added to GES may sustain better long-term symptoms control particularly in the P-V setting.
