A Novel Gastric Pacing Device to Modulate Slow Waves and Assessment by High-Resolution Mapping

Objective: The use of electrical pacing in the gastrointestinal field continues to advance clinical and basic science; however, the efficacy and effectiveness of gastric stimulation and pacing remains limited. In the stomach, rhythmic bioelectrical events, known as slow waves, coordinate the muscular contractions that aid digestion. A range of slow wave abnormalities have been shown to be associated with functional motility disorders, such as gastroparesis, chronic unexplained nausea and vomiting, and functional dyspepsia. Pacing is an attractive therapeutic approach to revert slow wave abnormalities. However, there are currently no clinical gastric pacing devices in active use. In this study, a novel battery-powered pacing device was developed, implementing wireless control and tissue electrical parameter monitoring. Methods: The pacing device was applied in five pigs in vivo along with high-resolution (HR) mapping to validate the device and to elucidate the pacing response of slow waves. The pacing leads were placed in the middle of the HR array to determine any changes to the propagation pattern. The pacing period range was 14-30 s. Results: In all studies, the novel pacing device initiated slow wave activation from a location near the pacing leads at the specified period. Slow wave propagation speed increased after pacing (from 6.4 ± 2.0 to 8.1 ± 3.2 mm/s; P <; 0.001), commensurate with induction of paced anisotropic propagation. Conclusion: This study introduces a novel gastric pacing system suitable for clinical trials, achieving reliable induction of slow wave pacing at specific location and periods. The device is now available to be trialed as a therapeutic application for motility disorders and obesity.