Johannes Zachaerl, Bonavina Luigi, Amol Babaye, Ralf Kiesslich, Sebastian Schoppmann, William Kessler, Don Selzer, Michael S Epstein, MD, Glen Lehman, Santiago Horgan, MD. University of California San Diego.
OBJECTIVE: Both long-term PPI use and surgical fundoplication have drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with the Medigus SRS™ video- and ultrasound-guided transoral surgical stapler.
DESCRIPTION OF TECHNOLOGY: The SRS™ device consists of a light source, control unit and single-use flexible endoscope that houses a video- and ultrasound-guided surgical stapler. This technology includes a handle with controls, a long (80 cm) flexible shaft, a short (5cm) rigid section holding a cartridge with 5 standard 4.8 mm titanium surgical staples, a ratchet controlling a one-way articulating section, and a distal tip (Figure 1a). The tip (Figure 1b) houses an anvil for bending the staples into a B shape, an ultrasonic transducer, a video camera, a light source, and two fine (~21 gauge) screws. The screws, secured by two nuts in the fixed section, compress tissues to allow for stapling and provide a counterforce for bending the staples. The tip also contains suction/air insufflation and irrigation channels. The control unit is a computer that interprets signals from the device and displays the resulting data on a video monitor, including the bending angle and screw position.
PRELIMINARY RESULTS: Of 72 patients enrolled at six sites, 69 underwent the procedure. Pre-procedure data was compared to data 6 months post procedural data available for 66 for the primary endpoint and 64 patients for pH testing. The primary endpoint was a ≥50% improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50% reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. Safety evaluation was performed at time 0 and weeks 1, 4, 12 and 24.
Six months after the procedure, the GERD-HRQL score improved by >50% off PPI in 73% (48/66) of patients (95% CI: 60%-83%). Forty-two patients (64.6%) were no longer using daily PPI medication. Of the 23 patients who continued to take daily PPI following the procedure, 10 (43.4%) reported a ≥50% reduction in dose. The mean percent of total time with esophageal pH < 4.0 decreased from baseline to 6 months (p<.001). The most common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events occurred, one a gastrointestinal bleed 8 days after procedure and one an esophageal leak requiring a chest tube. After procedural changes no further esophageal injury was reported.
CONCLUSION: Incisionless anterior surgical stapled fundoplication is a moderately safe and generally effective therapeutic option for patients with GERD. Continued assessment of durability and safety are ongoing in a three-year follow-up study. A next generation device has been designed and further study is planned.
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