Transoral Fundoplication, Linx and Other Technologies – Best Bet for the Future? Jon O Wee, MD Co‐Director of Minimally Invasive Thoracic Surgery Director of Robotics in Thoracic Surgery Brigham & Women’s Hospital Harvard Medical School [email protected] Gastroesophageal Reflux Disease 44% have heartburn at least once a month. 7‐10% of U.S. population experience heartburn daily. Increased Risk of Aspiration, COPD exacerbations, Pneumonias, Cancer PPI medication Increased risk of pneumonias, osteoporosis, C.diff infections, medication interactions. ( Jama 2004 292; 1955, Jama 2006 296; 2947) Gallop Organization National Survey. Heartburn Across America, Princeton, NJ. The Gallop Organization, Inc 1988 Gastroesophageal Reflux Disease • Medical failure in 40% of patients • 50 to 75% of patients recur following cessation of medication • Laparoscopic Nissen Fundoplication – Gold standard for anti‐reflux surgery – 30 Day Mortality 0.05% in < 70 yo, Complications 0.8% if < 50yo, 1.8% if 50‐69yo J Am Coll Surg 2012; 215: 61‐69 • • • • • • 85 pts with median follow‐up of 5 years 87% had no reflux ( 7 needed reoperation) 4 patients returned to daily medication 77% considered cured and 22% improved Overall 97% satisfied Low Grade dysplasia regressed in 7 of 16 patients ( 44%) Ann Surg Vol 234 No 4;532‐539 Antireflux surgery • 1696 patients with Barretts esophagus – 700 medical, 996 surgical • Incidence of Adenocarcinoma per 1000 patient years – 2.8 surgical vs 6.3 medical • Probability of regression of Barrett's – 15.4% in surgical group vs 1.9% in medical • Probability of progression to dysplasia – 2.9% in surgical group vs 6.8% in medical group Ann Surg 2007; 246: 11‐21 Antireflux surgery Patients who obtained antireflux surgery were less like have cancer, less likely to develop dysplasia, and more likely to have regression of their Barrett’s esophagus • 5 Year follow‐up of Lap Nissen vs Medical therapy • Surgery had better health outcomes • Surgery had better Quality of Life • Surgery More Cost Effective than Medicine BJS 2013 100: 1205‐1213 Alternative Surgical Options • Energy – STRETTA® Radiofrequency • Impantation/Injection – The Gatekeeper Reflux Repair System (Medtronic) – Enteryx (Boston Scientific) ® ® • Suture‐based – EndoCinch (Bard) – The Plicator (NDO Surgical) ® ® Alternative Surgical Options • Energy – STRETTA® Radiofrequency • Impantation/Injection – The Gatekeeper Reflux Repair System (Medtronic) – Enteryx (Boston Scientific) ® ® • Suture‐based – EndoCinch (Bard) – The Plicator (NDO Surgical) ® ® Transoral Incisionless Fundoplication •Three‐year results of a multicenter prospective study of transoral incisionless fundoplication. Muls V, Eckardt AJ, Marchese M, Bastens B, Buset M, Devière J, Louis H, Rajan A, Daniel MA, Costamagna G. • • • • • 100 patients, 10 centers 6 month f/u Improved Heartburn score 18 to 3 Improved Regurgitation score 15 to 0 80% of patients off of PPI Surg Innov. 2013 Aug;20(4):321‐30 A prospective multicenter registry of patients with chronic gastroesophageal reflux disease receiving transoral incisionless fundoplication. Bell RC, Mavrelis PG, Barnes WE, Dargis D, Carter BJ, Hoddinott KM, Sewell RW, Trad KS, DaCosta Gill B, Ihde GM. • 66 patients at 3 year f/u • 12 underwent revisional surgery • Of the remaining 54 patients – 61% remained off of daily PPI – 9 of 23 patients had normal pH study at 3 years (39%) J Am Coll Surg 2012; 251 (6) Transoral Incisionless Fundoplication Boston Medical Center 80 patients over 3 years 88% of patients used PPI pre‐op 51% of patients used PPI post‐op 6 patients required follow‐up procedures (including 5 Laparoscopic Nissen Fundoplications) • 19% of patients dissatisfied post‐ procedure • • • • • Ebright, Fernando, STSA 2013 TEMPO • TIF vs Medical PPI Management of Refractory GERD symptoms • Prospective, randomized TIF vs Maximal Med • Improved heartburn, regurgitation, globus sensation, hoarseness, and cough at 6 months • Daily heartburn eliminated 90% TIF vs 13% PPI • 90% of TIF completely ceased PPI use • Normalization of pH – 54% TIF – 52% PPI DDW 2013 RESPECT • Randomized EsophyX vs Sham/Placebo controlled trial • TIF + placebo vs Sham + PPI • 9 Centers. 129 patients • 15 General surgeons and 1 gastroenterologist • Results pending in 2014 LINX • LINX System is a small flexible band of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads is intended to help the LES resist opening to gastric pressures, preventing reflux from the stomach into the esophagus LINX LINX Bonavina, et al, Therap Adv Gastroenterol. 2013 Jul;6(4):261‐8. LINX Bonavina, et al, Therap Adv Gastroenterol. 2013 Jul;6(4):261‐8. • 14 Centers, 100 patients • Median DeMeester score 36.6 • 85 patients with 3 year follow‐up. • 64% of patients had < 50% reduction in acid exposure • 92% had greater than 50% reduction is QOL score • 93% with greater than 50% reduction in PPI use N Engl J Med 2013;368:719-727 Esophageal Sphincter Device for Gastroesophageal Reflux Disease • Satisfaction with reflux – 95% 1 yr, 90% 2 yr, 94% 3yr • Complete cessation of proton‐pump inhibitors – 86% 1 yr, 87% 2 yr, 87% 3 yr • Dysphagia in 68% of patients • Dysphagia 11% 1 yr, 5% 2 yrs, 4% 3 yr • 19 patients underwent dilation, 16 reported improvement after the procedure Conclusions • Laparoscopic Nissen remains the gold standard for anti‐reflux surgery • Multiple endoscopic devices have failed to provide long term relief • Transoral Incisionless fundoplication has some effect but falls short of Lap Nissen results. Need to await trial results • LINX is promising in early results for symptoms and acid control. Long term data is needed
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