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Selecting the Right Patient for Gastric Electrical Stimulation: Using Blinded Temporary Stimulation Trials in
Andrea Geleni Gongora1, Christel Gharby1, Madison Wnuk1
1Department of Surgery, University of Florida College of Medicine, Gainesville, FL, USA.
Background:
Gastric electrical stimulation (GES) has been shown to relieve symptoms in children with gastroparesis (GP). Currently, trials with temporary gastric stimulation (tGES) guide selection for permanent implantation; however, there remain several nonresponders and early failures requiring early device explant. This study reports our experience with patient selection with "blinding" during their tGES trial.
Materials And Methods:
A cohort study was conducted in patients aged four to 26 years who underwent blinded (B) and nonblinded (NB) tGES for GP from January 2014 to April 2022. B cases began the trial as either ON or OFF and then crossed over. Gastroparesis Cardinal Symptom Index (GCSI), nutritional intake, and permanent stimulator implant outcomes were measured and compared between the groups using Fisher exact test.
Results:
A total of 84 patients underwent tGES, of whom 57 were NB and 27 B. Of the NB, 55 (96.5%) had improved GCSI, of whom 49 (86%) underwent permanent implantation. In the B group, 14 (51.9%) showed improvement when ON and worsened when OFF (concordant), whereas the others had either discordant or no response to the ON/OFF phase; 12 of 27 B cases (44.4%) were implanted. Early failures were noted in one of 12 B vs nine of 49 in NB cases (p = 0.67).
Conclusions:
Overall, GES remains an effective therapy for severe GP in children and adolescents. Blinded tGES trials appeared to allow improved patient selection for those with concordant responses with lower implant rates and fewer early failures. Long-term outcomes of patients who were blinded and received a permanent implant need to be further studied.
