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Effectiveness, Safety and Feasibility of Robotic-assisted Gastric Neurostimulator Placement

Jaskiran Kaur, MD, Francisco Igor Macedo, MD, Ramachandra Kolachalam, MD. Providence Hospital and Medical Centers/ Michigan State University

Background: Gastric neurostimulation with Enterra® therapy device (Medtronic, Minneapolis, MN) provides the last resort for patients with refractory gastroparesis. Currently, the device has Humanitarian Use status by Food and Drug Administration (FDA), thereby requiring further investigation. We aim to describe the feasibility and clinical outcomes with device placement using robotic technique in patients with refractory gastroparesis.

Methods: From June 2014 to September 2016, 15 patients underwent robotic-assisted insertion of Enterra® gastric neurostimulator device. Patient demographics, comorbidities, and clinical outcomes including mortality, length of stay (LOS), readmission rates, reoperation and complications were retrospectively described. Patients were followed up and assessed based on a validated 14-point questionnaire regarding satisfaction with the operation, quality of life and symptomatic relief. The answers were scored 0-4 based on 2 categories: severity (absent to extremely severe requesting bed rest) and frequency (absent to extremely frequent, >7times/week).

Results: Mean age was 41.6 years ± 13.8 (25-81) and there were 11 females (73.3%). Ethnicity included African-American (53.3%), Caucasian (40%), and Middle-eastern (6.7%). Etiology of gastroparesis included idiopathic (46.7%), diabetic (46.7%) and Arnold-Chiari type I malformation (6.7%). Most frequent comorbidities were gastroesophageal reflux (33.3%) chronic kidney disease (26.7%), anxiety disorder (26.7%) and depression (13.3%) and five (33.3%) patients had prior cholecystectomy. Four (26.7%) patients required readmission within 30 days of placement. No mortality was reported and length of stay was 2.3 days ± 1.9. There was statistically significant reduction in the number of hospital admissions per year after gastric neurostimulator (2.5 ± 4.1 vs. 3.6 ± 4.4, p<0.05). Two (13.3%) patients opted for device removal laparoscopically after 6 months and 1 year due to lack of symptomatic relief. During the follow-up, a statistically significant decrease was noted regarding the severity of emesis (p=0.03), postprandial fullness (p=0.03), and abdominal bloating (p=0.01). The frequency of nausea (p=0.03), early satiety (p=0.02), postprandial fullness (p=0.02), and abdominal bloating (p=0.01) was also decreased after device placement.

Conclusion: This is the first report to describe the clinical experience with gastric neurostimulator device placed robotically. This approach is safe and feasible and seems to have similar outcomes as laparoscopic technique. Potential advantages to robotic technique include enhanced dexterity and suturing of the device within gastric wall. Further experience with large comparative studies and clinical trials are warranted.


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 79751

Program Number: P679

Presentation Session: Poster (Non CME)

Presentation Type: Poster

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