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Evaluation and Treatment of Gastric Stimulator Failure
Nancy Salloum*1, Micah R. Walker1, Patrick a. Williams1, Yana Nikitina1, Thomas S. Helling2, Thomas L. Abell1, Christopher J. Lahr2, James Griffith1 1Digestive Diseases, University of Mississippi Medical Center, Jackson, MS; 2Surgery, University of Mississippi Medical Center, Jackson, MS
Introduction: Some patients who undergo gastric electrical stimulation (GES) for gastroparesis (GP) develop recurrent symptoms i.e.: vomiting, nausea, early satiety, bloating, and abdominal pain despite an initial good result, replete with a functioning stimulator and unbroken leads. This study evaluates treatment for these patients, which includes temporary stimulation at a new gastric location and if symptoms are relieved this is followed by implantation of new leads and stimulator. We expect symptom scores to significantly decrease in the control group; we hypothesize that the symptom scores will also show a significant decrease in the replacement group.
Patients: 15 patients with recurrent symptoms after placement of GES have undergone surgical insertions of a new gastric electrical stimulation (GES) system. Of the 15 replacement surgeries, 10 (67%) were female, 5 were male (33%) (mean age of all: 45), and 3 (20%) had diabetes-induced gastroparesis; the remainder (80%) were either idiopathic, post-surgical, or sarcoidosis-induced.
Of 87 patients without recurrent symptoms after placement of GES who have not needed a replacement, 15 were selected as the control arm, matched by the three variables of investigator-derived independent outcome score (IDIOMS), baseline symptom scores before initial GES implantation, and etiology of disease (i.e. diabetic or idiopathic).
Methods: Each patient met specific indications to receive GES replacement surgery. All patients had a preoperative diagnosis of either diabetic or idiopathic, drug-refractory, or post-surgical gastroparesis, and disordered gastric emptying with significant weight change. Patients with failed GES were evaluated over a 1-2 week period with insertion of a temporary endoscopic gastric stimulator. Patients with a positive response to temporary stimulation undergo GES replacement surgery. Common gastroparesis symptoms were evaluated before and after gastric pacemaker replacement using the Likert score system 0-4. These symptoms include vomiting, nausea, epigastric pain, early satiety and bloating.
Results: See Tables 1 and 2. Total score of symptoms improved for 12 out of the 15 (80%) patients that underwent the GES replacement surgery. The frequency, amplitude, freq/amplitude ratio (FAR), and gastric emptying times (GET) are displayed to reinforce physiological similarity between the two groups.
Conclusion: Trial gastric mucosal electrical stimulation followed by implantation of new leads and stimulator successfully salvages the majority of patients whose gastric electrical stimulator is no longer relieving symptoms. Table 1 - Comparison of Mean Pre-Op and Mean Post-Op Symptom Scores Replacement(n=15) | Mean of Pre-Op Scores | Mean of Post-Op Scores | Difference in Symptom Scores | p-value of Difference | Vomiting ±SD | 3.2 ±1.3 | 2.1 ±1.3 | 1.2 | 0.001 | Nausea ±SD | 3.9 ±0.3 | 3.3 ±1.1 | 0.6 | 0.088 | Early satiety ±SD | 3.3 ±0.6 | 2.4 ±1.5 | 0.9 | 0.041 | Bloating ±SD | 3.3 ±0.6 | 2.5 ±1.5 | 0.8 | 0.057 | Epigastric pain ±SD | 3.6 ±0.6 | 3.3 ±1.4 | 0.3 | 0.24 | Total Score ±SD | 17.3 ±1.6 | 13.6 ±3.7 | 3.6 | 0.017 | | | | | | No Replacement (n=15) | Mean of Pre-Op Scores | Mean of Post-Op Scores | Difference in Symptom Scores | p-value of Difference | Vomiting ±SD | 3.0 ±0.9 | 2.0 ±1.5 | 1.0 | 0.019 | Nausea ±SD | 3.2 ±1.2 | 3.0 ±0.9 | 0.2 | 0.5 | Early satiety ±SD | 3.1 ±1.0 | 2.4 ±1.1 | 0.7 | 0.019 | Bloating ±SD | 2.8 ±1.2 | 2.6 ±1.1 | 0.2 | 0.7 | Epigastric pain ±SD | 3.1 ±1.4 | 3.0 ±1.2 | 0.1 | 0.88 | Total Score ±SD | 15.8 ±3.6 | 12.3 ±3.5 | 3.5 | 0.011 |
Table 2 - Comparison of Mean EGG Values | Replacement (n=15) | No Replacement (n=15) | p-value | Normal EGG values | Frequency ±SD | 5.5 ±3.0 | 5.8 ±1.5 | 0.73 | 2.7-3.3 | Amplitude ±SD | 0.44 ±0.6 | 0.6 ±0.6 | 0.54 | 0.5 | Freq/amp ratio ±SD | 31.2 ±31.5 | 32.4 ±42.3 | 0.94 | <10 | Gastric emptying time (GET), 1;2;4 hr (%) | 72, 49, 25 | 76, 48, 22 | 0.61, 0.96, 0.77 | | Total GET (%) ±SD | 146 ±59 | 146 ±60 | 0.99 | |
Table is displayed to reinforce physiological similarity between the two groups.
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