ENDOSCOPIC ANTERIOR FUNDOPLICATION WITH THE MEDIGUS SRS™ TRANSORAL SURGICAL STAPLER: A NOVEL TREATMENT FOR GASTROESOPHAGEAL REFLUX DISEASE
Johannes Zachaerl MD, Luigi Bonavina MD, Amol Babaye MD, Ralf Kiesslich MD, Sebastian Schoppmann MD, William Kessler MD, Don Selzer MD, Glen Lehman MD, Santiago Horgan MD
Submitted to SAGES 2014.
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.
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.
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.