LONGER TERM FOLLOW UP AFTER ENDOSCOPIC TREATMENT OF GERD WITH THE MEDIGUS SRS™ ENDOSCOPIC STAPLING DEVICE
Kessler, William R.; McNulty, Gail; Selzer, Don J.; Lehman, Glen A.
Medicine - Gastroenterology & Hepatology, Indiana University Medical Center, Indianapolis, IN, United States. / Department of Surgery, Indiana University Medical Center, Indianapolis, IN, United States.
Presented at DDW 2014.
Gastroesophageal Reflux Disease (GERD) is a common problem. While the majority of patients are well controlled with medical therapy, surgical approaches are the mainstay for refractory disease and for patients wishing to avoid adverse effects and costs of long-term use of proton pump inhibitor therapy (PPI). Endoscopic approaches to the treatment of GERD include the Medigus SRS™ stapling device which is a flexible surgical stapler, coupled with an endoscopic video camera and an endoscopic range finder, used to create an anterior fundoplication. Preliminary data from the multi-center pivotal trial has been published (Gastroenterology 2012; 142(5):S1076) and resulted in FDA approval [510(k):K120299; 5/18/12]. We report three year results of patients treated with the SRS™ System at our institution.
In this prospective trial, patients with pH probe documented GERD with good response to PPI were treated with the SRS™ device. Under general anesthesia, the Medigus SRS™ was used to place 2-3 staple quintuplets to create an anterior fundoplication. A minimum of three years post-procedure GERD-HRQL scores, use of PPIs, H2RAs and antacids, and overall satisfaction were obtained by phone interview. No additional pH or endoscopic studies were done.
Twenty-two patients were treated at Indiana University with the SRS™ device. One patient experienced a GI bleed 8 days after the procedure requiring blood transfusion. Bleeding stopped spontaneously and no therapy was required. Mean follow up GERD-HRQL scores, with baseline score measurement (on or off PPI, determined by PPI use at selected time point - year 1, 2 or 3) improved (See Table 1; Figure 1). The majority of patients were satisfied at 1, 2 and 3 years and remained off of daily PPI at all-time points. Of patients taking any PPI post-stapling, mean omeprazole equivalent doses were decreased from baseline of 47.7 mg/d to 26.8 mg/day at one year, 19.7 mg/d at 2 years and 15.9 mg/d at 3 years.
At our institution the Medigus SRS™ stapling device proved relatively safe and efficacious for patients with PPI-responsive, moderate-to-severe GERD. Fewer than 5% of patients experienced complications and 74% of patients remained off daily PPI at 3 years post-procedure. Further studies involving multiple centers, larger numbers of patients and appropriate control groups are required to better understand the future role of the Medigus SRS™ device in endoluminal GERD therapy.
Table 1: HRQL scores, patient satisfaction and PPI use after Medigus SRS™stapling device.
Figure 1: HRQL scores at baseline, years 1, 2 and 3 after Medigus SRS™ stapling device.