Minimally Invasive Techniques for GERD Joseph P. Regan, M.D.

GERD: Definitions Reflux of gastric contents above GE junction Associated with incompetent valve, hiatal hernia Chronic disease involving symptoms at least twice per week Heartburn is most common symptom Chest pain, regurgitation, cough, asthma symptoms, dysphagia also common

GERD: Anatomy

GERD: Definitions Associated with obesity, pregnancy, smoking, consumption of chocolate, caffeine, alcohol, and peppermint Complications can include esophagitis, esophageal stricture, respiratory issues, Barrett’s esophagus, adenocarcinoma of esophagus

GERD: Definitions 60 million adults have symptoms once per month 15 million adults have daily symptoms 15% of adults have chronic symptoms 20 million adults take PPI regularly 50% increase in double dose PPI scripts in last 7 years 42% PPI users supplement their scripts 30% PPI users dissatisfied with therapy $15 billion in direct healthcare costs for GERD

GERD: Definitions Lifestyle changes Medications Decrease meal size Eliminate late eating Weight control Quit smoking Elevate bed from below Medications Antacids H2 blockers PPIs

GERD: Definitions Patient concerns regarding GERD Quality of life issues Use of internet Increasing rates of Barrett’s and adenocarcinoma at GE junction – 2.5-fold increase in incidence since 1970 Long term and inappropriate use of PPIs Recent reports on osteoporosis, chronic renal failure, dementia

GERD: Diagnosis Abnormal EGD Typical symptoms Abnormal pH study

Hiatal Hernia

Hiatal Hernia and Hill Grade

GERD: Anatomical Considerations

GERD: Montreal Definition/Classification

GERD: Historical Perspective 1800s - confusion regarding reflux disease Examples include heartburn, cardia portion of stomach, cardiospasm, biliousness, dyspepsia Early 1900s - recognized relationship of acid and esophagitis Winkelstein - 1930s - gastroenterologist at Mount Sinai in NYC - first detailed description of esophagitis Barrett - 1950s in London - first description of peptic esophagitis and ectopic gastric mucosa

GERD: Historical Perspective Development of diagnostic and treatment stategies Early 1900s – barium studies and rigid endoscopy 1960s – flexible endosocopy 1970s – manometry and pH probes, use of H2 blockers 1980s – use of PPIs 1950s – first Nissen fundoplication in Germany 1991 – first laparoscopic Nissen in Canada and Belgium

GERD Procedures Laparoscopic Nissen fundoplication TIF procedure – transoral incisionless fundoplication LINX procedure – laparoscopic magnetic augmentation of GE junction

Nissen Fundoplication

Toupet Fundoplication

Nissen Fundoplication National Inpatient Sample 9,173 procedures in 1993 32,980 procedures in 2000 19,668 procedures in 2006 Concern for postop complications and durability, increase in bariatric surgery, new endoscopic techniques, PPIs available over the counter Patients undergoing Nissen fundoplication are older, have longer LOS, and higher morbidity and mortality Dis Esophagus 2011;24:215-23.

TIF Procedure Endoscopic device (EsophyX2) used to create 2-3cm 270 degree fundoplication EndoGastric Solutions based in Redmond, WA Uses deployment of polypropylene H-shaped fasteners Under direct vision using endoscope

TIF Procedure First developed in Belgium – Prof. Cadiere FDA approved in September 2007 17,000 cases world-wide AMA granted level 1 CPT code 43210 as of January 1, 2016 Requires general anesthesia with less than 1 hour length of procedure Discharge same day versus overnight stay

TIF Procedure

TIF Procedure

TIF Procedure

TIF Procedure

TIF Procedure Candidates for TIF Failure of medical management Fear of long term PPI use Breakthrough symptoms Hiatal hernia <2cm BMI <38 Classic symptoms including regurgitation, response to PPI Atypical symptoms

TIF Procedure Confirmation of GERD EGD pH study – Bravo/impedance Lack of motility disorder Manometry Barium study

TIF Procedure Two-year outcomes from 127 patients at 14 centers No serious adverse events Quality of life and regurgitation scores improved by 50% or greater in 66% of patients Reflux symptom index score improved in 65% of patients Daily PPI use decreased from 91% to 29% 2/3 patients had symptom control 75% (12/16) had resolution of esophagitis and 57% (8/14) had normal esophageal acid exposure Am Surg 2014;80:1093-105.

LINX Procedure Laparoscopically placed magnetic augmentation of the lower esophageal sphincter Torax Medical based in Shoreview, MN 5 different sizes of linked magnets

LINX Procedure Company founded in 2002 FDA approved in 2012 Over 4000 cases in 6 countries AMA granted level 1 CPT code to take effect January 1, 2017 Requires general anesthesia with less than 1 hour length of procedure Discharge same day versus overnight stay

LINX Procedure

LINX Procedure

LINX Procedure

LINX Procedure Candidates for LINX Failure of medical management Fear of long term PPI use Breakthrough symptoms Hiatal hernia repair at same time BMI <38 Classic symptoms including regurgitation, response to PPI Atypical symptoms

LINX Procedure Confirmation of GERD EGD pH study – Bravo/impedance Lack of motility disorder Manometry Barium study

LINX Procedure Easily explanted Device is MR Conditional with static magnetic field up to 1.5-Tesla Goal is to improve the barrier function of the esophageal sphincter without altering gastric or hiatal anatomy or interfering with swallowing, belching, or vomiting

LINX Procedure Five-year results from 100 patients No adverse events Significant improvement in quality of life scores 85% off PPI Moderate to severe regurgitation rates decreased from 57% at baseline to 1.2% at 5 years Dysphagia present in 6% at 5 years Gas bloat decreased from 52% at baseline to 8% at 5 years Clinical Gastroenterology and Hepatology 2015;15:763-6.

Sleeve Gastrectomy

Roux-en-Y Gastric Bypass

Development of Sleeve Gastrectomy 2008 U.S. bariatric surgery 67% gastric bypass 24% Lap-Band 1% sleeve gastrectomy 2012 U.S. bariatric surgery 56% gastric bypass 36% sleeve gastrectomy 4% Lap-Band

Sleeve Gastrectomy and GERD 919 patients underwent sleeve gastrectomy 4% diagnosed with postop GERD 3% with de novo GERD 1% with pre-existing GERD 96% with de novo GERD responded to meds 77% with pre-existing GERD responded to meds 4 total patients converted to gastric bypass secondary to GERD Surg Obes Relat Dis 2015 (Epub).

Summary GERD is increasing in incidence Dramatic increase in PPI use, but with concerns for long term use Minimally invasive options for GERD to improve barrier function at the esophageal sphincter include Nissen/Toupet fundoplication, TIF, and LINX TIF and LINX have both been shown to be safe and provide durable symptom relief over short term Appropriate patient selection and work-up are critical Obese patient with GERD may require bariatric surgery

Development of CSM Reflux Center Centralized phone number – (414)962-2274 Website development Nurse coordinator Preoperative GI conference Coordinated insurance preauthorization Informational seminars Dietitian support Plan for marketing and promotion