Gastric Electrical Stimulator for Treatment of Gastroparesis

Atassi, Hadi; Abell, Thomas L.

doi:10.1016/j.giec.2018.08.013

Cited by 32 publications

(29 citation statements)

References 30 publications

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“…The strong correlation between duration of treatment and responder status may reflect a natural bias of responders to continue therapy beyond the minimum 4 weeks, and the inverse for non‐responders. It is still unclear whether long‐term therapy may have a higher response rate, as has become evident for GES therapy where symptomatic improvement requires months . Because of the small sample size, a relationship between voltage dosing and likelihood of response could not be determined.…”

Section: Discussionsupporting

confidence: 75%

“…Currently, several agents are under various stages of clinical trials including selective serotonin 5‐HT4 receptor agonists, neurokinin‐1 receptor antagonists, and ghrelin receptor agonists . GES through continuous high‐frequency/low‐energy pulses is offered as a last resource for medically refractory patients and significantly decreases vomiting frequency and gastrointestinal symptoms in patients with severe gastroparesis . Several mechanisms have been proposed to explain the symptomatic benefit of gastric neurostimulation including fundic relaxation, increases in vagal efferent and afferent activity, and central nervous system plasticity in the thalamic and caudate nuclei .…”

Section: Discussionmentioning

confidence: 99%

“…Follow-up placebo-controlled, larger trials will be instrumental in determining if nVNS will become a clinical modality for gastroparesis therapy. 22 Several mechanisms have been proposed to explain the symptomatic benefit of gastric neurostimulation including fundic relaxation, increases in vagal efferent and afferent activity, and central nervous system plasticity in the thalamic and caudate nuclei. 23 A central role for the vagus has been invoked based on (a) spectral analysis of heart rate variability showing that GES increases vagal activity in both rats and humans 24,25 ; (b) vagotomy blocks its antiemetic effect in dogs 26 ; and denervation of vagal afferents abolishes its enhancive effect on vagal efferent activity.…”

Section: Discussionmentioning

confidence: 99%

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Open‐label pilot study: Non‐invasive vagal nerve stimulation improves symptoms and gastric emptying in patients with idiopathic gastroparesis

Gottfried-Blackmore

Adler

Fernandez‐Becker

et al. 2019

Neurogastroenterology Motil

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Background Gastroparesis, a chronic motility disorder characterized by delayed gastric emptying, abdominal pain, nausea, and vomiting, remains largely unexplained. Medical therapy is limited, reflecting the complex physiology of gastric sensorimotor function. Vagus nerve stimulation is an attractive therapeutic modality for gastroparesis, but prior methods required invasive surgery. In this open‐label pilot study, we aimed to assess the benefit of non‐invasive vagal nerve stimulation in patients with mild to moderate idiopathic gastroparesis. Methods Patients self‐administered the gammaCore vagal nerve stimulator for 4 weeks. The gastroparesis cardinal symptom index daily diary (GCSI‐dd) was assessed during a two‐week run‐in period, ≥4 weeks of therapy, and 4 weeks after therapy was completed. Gastric emptying and autonomic function testing were also performed. The primary endpoint was an absolute reduction in CGSI‐dd of 0.75 after nVNS. Results There was a total improvement in symptom scores (2.56 ± 0.76 to 1.87 ± 1.05; P = .01), with 6/15 (40%) participants meeting our primary endpoint. Therapy was associated with a reduction in gastric emptying (T1/2 155 vs 129 minutes; P = .053, CI −0.4 to 45). Therapy did not correct autonomic function abnormalities, but was associated with modulation of reflex parasympathetic activity. Conclusions Short‐term non‐invasive vagal nerve stimulation led to improved cardinal symptoms and accelerated gastric emptying in a subset of patients with idiopathic gastroparesis. Responders had more severe gastric delay at baseline and clinical improvement correlated with duration of therapy, but not with improvements in gastric emptying. Larger randomized sham‐controlled trials of greater duration are needed to confirm the results of this pilot study.

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Section: Discussionsupporting

confidence: 75%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Open‐label pilot study: Non‐invasive vagal nerve stimulation improves symptoms and gastric emptying in patients with idiopathic gastroparesis

Gottfried-Blackmore

Adler

Fernandez‐Becker

et al. 2019

Neurogastroenterology Motil

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“…Temporary GES, using non‐surgical leads placed on the gastrointestinal mucosa, has been used for a number of years on a variety of patients, including those of pediatric age, but is an off‐label use in the US . A recent publication has presented long‐term follow‐up of GES in patients who received temporary GES first, and which suggests that temporary GES may be able to predict permanent GES response …”

Section: Discussionmentioning

confidence: 99%

“…In addition, a number of patients in the GpCRC have the symptoms of gastroparesis but do not have delayed solid gastric emptying, and thus, with the current approach to pyloric therapy, would not have been considered for that intervention. In terms of GES and pyloric therapy, recent publication has presented an algorithmic approach that could be considered as a way to integrate GES and pyloric (and other) therapies . However, long‐term follow‐up data on this proposed approach is not yet available.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries

Abell

Yamada

McCallum

et al. 2019

Neurogastroenterology Motil

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Background Gastric electrical stimulation (GES) for treating gastroparesis symptoms is controversial. Methods We studied 319 idiopathic or diabetic gastroparesis symptom patients from the Gastroparesis Clinical Research Consortium (GpCRC) observational studies: 238 without GES and 81 with GES. We assessed the effects of GES using change in GCSI total score and nausea/vomiting subscales between baseline and 48 weeks. We used propensity score methods to control for imbalances in patient characteristics between comparison groups. Key Results GES patients were clinically worse (40% severe vs. 18% for non‐GES; P < .001); worse PAGI‐QOL (2.2. vs. 2.6; P = .003); and worse GCSI total scores (3.5 vs. 2.8; P < .001). We observed improvements in 48‐week GCSI total scores for GES vs. non‐GES: improvement by ≥ 1‐point (RR = 1.63; 95% CI = (1.14, 2.33); P = .01) and change from enrollment (difference = −0.5 (−0.8, −0.3); P < .001). When adjusting for patient characteristics, symptom scores were smaller and not statistically significant: improvement by ≥ 1‐point (RR = 1.29 (0.88, 1.90); P = .20) and change from the enrollment (difference = −0.3 (−0.6, 0.0); P = .07). Of the individual items, the nausea improved by ≥ 1 point (RR = 1.31 (1.03, 1.67); P = .04). Patients with GCSI score ≥ 3.0 tended to improve more than those with score < 3.0. (Adjusted P = 0.02). Conclusions and Inferences This multicenter study of gastroparesis patients found significant improvements in gastroparesis symptoms among GES patients. Accounting for imbalances in patient characteristics, only nausea remained significant. Patients with greater symptoms at baseline improved more after GES. A much larger sample of patients is needed to fully evaluate symptomatic responses and to identify patients likely to respond to GES.

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Outcome of gastric electrical stimulator with and without pyloromyotomy for refractory gastroparesis

Aeschbacher,

Garcia,

Dourado

et al. 2024

Surg Endosc

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Background Surgical treatments of refractory gastroparesis include pyloromyotomy and gastric electrical stimulator (GES). It is unclear if patients may benefit from a combined approach with concomitant GES and pyloromyotomy. Methods Retrospective cohort analysis of all patients with refractory gastroparesis treated with GES implantation with and without concomitant pyloromyotomy at Cleveland Clinic Florida from January 2003 to January 2023. Primary endpoint was efficacy (clinical response duration and success rate) and secondary endpoints included safety (postoperative morbidity) and length of stay. Success rate was defined as the absence of one of the following reinterventions during follow-up: Roux-en-Y gastric bypass (RYGB), pyloromyotomy, GES removal. Results During a period of 20 years, 134 patients were treated with GES implantation. Three patients with history of previous surgical pyloromyotomy or RYGB were excluded from the analysis. Median follow-up was 31 months (IQR 10, 72). Forty patients (30.5%) had GES with pyloromyotomy, whereas 91 (69.5%) did not have pyloromyotomy. Most of the patients had idiopathic (n = 68, 51.9%) or diabetic (n = 58, 43.3%) gastroparesis. Except for preoperative use of opioids (47.5 vs 14.3%; p < 0.001), patient’s characteristics were similar in both groups. There were no significant differences between the two groups in terms of overall postoperative complications (17.5% vs 14.3%; p = 0.610), major postoperative complications (0% vs 2.2%; p = 1), and length of stay (2(IQR 1, 2) vs 2(IQR 1, 3) days; p = 0.068). At 5 years, success rate was higher in patients with than without pyloromyotomy however not statistically significant (82% versus 62%, p = 0.066). Especially patients with diabetic gastroparesis seemed to benefit from pyloromyotomy during GES (100% versus 67%, p = 0.053). In an adjusted Cox regression, GES implantation without pyloromyotomy was associated with a 2.66 times higher risk of treatment failure compared to GES implantation with pyloromyotomy (HR 2.66, 95% CI 1.03–6.94, p = 0.044). Conclusion Pyloromyotomy during GES implantation for gastroparesis seems to be associated with a longer clinical response with similar postoperative morbidity and length of hospital stay than GES without pyloromyotomy. Patient with diabetic gastroparesis might benefit from a combination of GES implantation and pyloromyotomy.

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Gastric Electrical Stimulator for Treatment of Gastroparesis

Cited by 32 publications

References 30 publications

Open‐label pilot study: Non‐invasive vagal nerve stimulation improves symptoms and gastric emptying in patients with idiopathic gastroparesis

Open‐label pilot study: Non‐invasive vagal nerve stimulation improves symptoms and gastric emptying in patients with idiopathic gastroparesis

Effectiveness of gastric electrical stimulation in gastroparesis: Results from a large prospectively collected database of national gastroparesis registries

Outcome of gastric electrical stimulator with and without pyloromyotomy for refractory gastroparesis

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