4/24/2015. History of Reflux Surgery. Recent Innovations in the Surgical Treatment of Reflux

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1 Recent Innovations in the Surgical Treatment of Reflux Scott Carpenter, DO, FACOS, FACS Mercy Hospital Ardmore Ardmore, OK History of Reflux Surgery - 18 th century- first use of term heartburn Asher Winkelstein described GERD as the cause of esophagitis Rudolph Nissen's first fundoplication Belsey Mark IV Collis gastroplasty Dor fundoplication Toupet fundoplication Hill repair Cimetidine introduced Omeprazole introduced Laparoscopic Nissen fundoplication Angelchik Prosthesis 1

2 Angelchik Prosthesis Starling J, et al. Ann Surg patients, 8-20 month follow up - 25/28 patients (89%) asymptomatic - 2/28 patients (7%) significant improvement - 15/28 patients (53%) asymptomatic >1 year post surgery Evans et al. Ann R Coll Surg Engl patients, 19 for long term follow-up (median 54 months) - 4 early failures, 2 late failures - 4/19 (21%) reported mild reflux symptoms - Increase in LES pressure - Absence of reflux on 24 hour ph monitoring - Resolution of esophagitis Pathophysiology of Progressive GERD LES Deterioration Defective LES NS NS P=0.04 NS Acid Exposure P<0.05 NS P=0.03 P=0.03 Bilirubin Exposure NS NS NS P=0.02 Hiatal Hernia NS NS P=0.001 NS Normal Subjects NERD No Injury Healable Esophagitis Difficult to Heal Esophagitis Barrett s 2 to 20 years Lord et al. J Gastrointest Surg 2009;13: Used by permission of T DeMeester Criteria for a Surgical Procedure to Improve a Failing LES in Patients with Progressive GERD Safe Simple in design. Effective in augmenting LES function. Performed by laparoscopy Requires minimal tissue dissection. Done as an outpatient procedure Free of side effects Acceptable for application early in the course of GERD. Used by permission of T DeMeester 2

3 Used by permission of T DeMeester A loose ligature of expanding magnetic beads Distension Used by permission of T DeMeester Ganz et al. NEJM. Feb, patients, 5-year, prospective, multicenter, single group evaluation - Primary outcome - normalization of esophageal acid exposure, or - 50% reduction in exposure at 1 year - Secondary endpoints - Results: - 50 % improvement in QOL scores - 50% reduction in PPI use at 1 year - 64% pts achieved primary outcome - 93% pts 50% reduction in PPI use - 92% pts 50% imp in QOL scores Ganz RA, et al. Esophageal Sphincter Device for Gastroesophageal Reflux Disease. NEJM. 368:8. February 21,

4 Ganz et al. NEJM. Feb, 2013 Adverse Events: - Dysphagia- 68% postop, 11% 1 year, 4% 3 years - 16/19 improved with dilation - Serious events - Persistent dysphagia (3) - Severe Nausea and vomiting (2) - Persistent reflux symptoms (1) - Persistent chest pain (1) Ganz RA, et al. Esophageal Sphincter Device for Gastroesophageal Reflux Disease. NEJM. 368:8. February 21, Bonavina et al. JACS consecutive patients between 2007 and % pts off daily PPI - Significant improvement in QOL scores - Significant decrease in esophageal acid exposure - Adverse events: - 3 removals for persistent GERD, dysphagia or odynophagia - No erosions or migrations Bonavina L, et al. One Hundered Consecutive Patients Treated with Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease: 6 Years of Clinical Experience from a Single Center. JACS Lipham JC, et al. Diseases of the Esophagus patients, reporting safety data - Intra/perioperative complications- 0.1% - Hospital readmission rate- 1.3% - Dilation- 5.6% - Device removal- 3.4% - Dysphagia (34) - Erosion (1) - No migrations or malfunctions Lipham JC, et al. Safety Analysis of the first 1000 patients treated with magnetic sphincter aumentation for gastroesophageal reflux disease. Diseases of the Esophagus

5 Louie BE, et al. Ann Thorac Surg patients, 34 MSA, 32 LNF retrospective case-control study, 6 month follow up - HB, regurgitation, cough, aspiration, chest pain, ENT sx s improved significantly in both groups - QOL improved for both groups, with no difference between groups - DeMeester score normalized in both groups - 100% MSA pts off PPI - No migrations, erosions or device removals Louie BE, et al. Short-Term Outcomes Using Magnetic Sphincter Augmentation Versus Nissen Fundoplication for Medically Resistant Gastroesophageal Reflux Disease. Ann Thorac Surgery Endoscopic Fundoplication Endoscopic Fundoplication Bard Endocinch NDO Plicator Esophyx 5

6 Endoscopic Fundoplication J Arts, et al Dig Dis Sci patients, 12 month follow up - ph monitoring was normalized in 7 patients at 3 months - 13 patients were off PPI therapy - symptom score was significantly improved in all patients - by the end of 12 months, only 6 were free of PPI's MP Schwartz et al. Gut patients, 12 month follow up, sham-controlled trial - 3 months, reduced PPI use by >50%= 65% study, 25% sham - symptom improvement greater in study - no difference in esophageal acid exposure - 29% study patients retreated within 12 months Esophyx Esophyx Goal of Therapy: - Transoral approximation and full thickness fundoplication to narrow the GE junction and reestablish the angle of His. Patient Selection: - Indicated for the treatment of symptomatic GERD - Patients with GERD symptoms despite optimal medical treatment for >6 months - Patients who present with anatomic disintegration of the GE junction - Patients with a hiatal hernia < 2cm axially or transversely 6

7 Esophyx- US Registry Data -100 patients, prospective, multicenter trial - 6 month results (J Am Coll Surg 2012): - 89% elimination of regurgitation - 72% elimination of heartburn - 65% elimination of atypical symptoms - 80% completely off PPI therapy - 75% resolution of esophagitis - 12 month results (Surg Laparosc Endosc Percutan Tech 2014): - 83% elimination of regurgitation - 78% elimination of heartburn - 64% elimination of atypical symptoms - 74% completely off PPI therapy - 76% resolution of esophagitis - 24 month results (Am Surg 2014) - 75% resolution of esophagitis - Daily PPI use decreased from 91% preop to 29% Bell RC, et al. A prospective multicenter registry of chronic gastroesophageal disease receiving transoral incisionless fundoplpication. JACS Wilson EB, et al. The effects of transoral incisinoless fundoplication on chronic GERS p[atients: a 12-month prospective multicenter experience. Surg Laparosc Endosc Percutan Tech Bell RC, et al. Transoral Incisionless Fundoplication: 2 year results from prospective multicenter U.S. study. Am Surg 2014 Esophyx-TEMPO Trial - 63 patients, multicenter, randomized, controlled trial - Compare TF to high-dose PPI therapy - 6 month results (Surg Innov 2014): - Regurgitation- 97% TF vs 50% PPI - Regurgitation and atypical symptoms- 62% TF vs 5% PPI - Heartburn- 90% TF vs 13% PPI - Esophagitis healed/reduced- 90%TF vs 38% PPI Trad KS, et al. Transoral Incisionless Fundoplication effective in eliminating GERD symptoms in partial responders to Proton Pump Inhibitor therapy at 6 months: the TEMPO randomized clinical trial. Surg Innov month results (Gastroenterol 2014): - Original TF group - Regurgitation + atypical sx's: 77% TF - 82% complete cessation of PPI - 100% resolution of esophagitis - Crossover group: - Regurgitation + atypical sx's: 67% TF - 71% complete cessation of PPI - 85% resolution of esophagitis Trad KS, et al. Efficacy of Transoral Incisionless Fundoplication For Treatment of Chronic Gastroesophageal Reflux Disease Incompletely Controlled with high-dose PPI therapy: A Randomized, Multicenter, Open Label Crossover Study. Gastroenterol Esophyx- RESPECT Trial patients, multicenter, randomized, double-blind controlled trial - Compares TIF + placebo vs Sham+ PPI therapy - 6 month results (Gastroenterol 2015) - Regurgitation- 67% TF/placebo vs 45% Sham/PI - 77% TIF/placebo resolution esophagitis - 18 months, 72% TF/placebo off PPI - 71% Sham/PPI group elected to crossover Hunter JG, et al. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterol

8 Esophyx- Complications - Major complications <0.45% - Esophageal Perforation - PTX - Empyema - Intraluminal Bleeding - Failure Rate 12.5%-35% - Dysphagia 33% - Post-fundoplication SE <3% Endostim Endostim Rodriguez L., et al. Surg Endoscopy patients, 6 month follow up - 91% patients off PPI - Significant imp GERD-HRQL scores - No adverse events reports Rodriguez L, et al. Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: final results of open-label trial. Surg Endosc Rodriguez L., et al. Endoscopy patients, 12 month follow up - 96% off PPI - No adverse events reported Rodriguez L, et al. Long-term results of electrical stimulation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease. Endoscopy

9 Endostim Rodriguez L., et al. SPED patients, 3 year follow up - 85% normalization of distal esophageal ph - 78% cessation of PPI use Rodriguez L, et al. Eslectrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (LES) in Successful in Treating GERD- Long Term 3 Year Results. Digestive Diseases Pan-America Week (SPED) Siersma PD, et al. Gastroenterology patients, International, multicenter trial, 12 month follow-up - 79% off PPI, 3% improvement in PPI use, 10 % daily PPI - Significant imp in GERD-HRQl, physical and mental health scores - Normalization of distal esophageal ph- 75% female, 57% male - Adverse events: - Procedure-related - Dysphagia 14% Siersema PD, et al. Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (LES)- an Effective therapy for Refractory GERD- Interim Results of an International Multicenter Trial. Gastroenterology Questions? 9