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Current Trends and Updates on Diagnosis and Management of GERD Jeraldine S. Orlina, MD Current Trends and Updates on Diagnosis and Management of GERD Jeraldine S. Orlina, MD Grand Rounds January 11, 2006

Pathophysiology • Lower esophageal sphincter • Intrinsic muscle of distal esophagus • Sling fibers Pathophysiology • Lower esophageal sphincter • Intrinsic muscle of distal esophagus • Sling fibers of cardia • Diaphragm • Transmitted pressure of abdominal cavity • Reflux occurs when the high-pressure zone in distal esophagus is too low or when sphincter with normal pressure undergoes spontaneous relaxation

Absite Question • An operation is the primary initial management for: • A) Achalasia Absite Question • An operation is the primary initial management for: • A) Achalasia • B) a large sliding esophageal hiatal hernia • C) an epiphrenic esophageal diverticulum • D) gastroesophageal reflux • E) a paraesophageal hiatal hernia

Symptoms Symptom Heartburn Regurgitation Abdominal Pain Cough Dysphagia for solids Hoarseness Belching Aspiration Wheezing Symptoms Symptom Heartburn Regurgitation Abdominal Pain Cough Dysphagia for solids Hoarseness Belching Aspiration Wheezing Globus Predominance (%) 80 54 29 27 23 21 15 14 7 4

Symptoms -- Heartburn • Epigastric and retrosternal • Caustic or stinging sensation • Does Symptoms -- Heartburn • Epigastric and retrosternal • Caustic or stinging sensation • Does not radiate to the back, is not pressurelike • Can be confused with symptoms of PUD, bilary colic, or CAD

Symptoms -- Regurgitation • Indicates progression of disease • Distinguish between digested and undigested Symptoms -- Regurgitation • Indicates progression of disease • Distinguish between digested and undigested food

Diagnostic Studies • Empirical Therapy • Upper Gastrointestinal Endoscopy (EGD) • Upper Gastrointestinal Fluoroscopy Diagnostic Studies • Empirical Therapy • Upper Gastrointestinal Endoscopy (EGD) • Upper Gastrointestinal Fluoroscopy with Barium • 24 -hour p. H testing • Esophageal Manometry

EGD • Allows examination of the esophageal mucosa • Identifies presence of esophagitis and EGD • Allows examination of the esophageal mucosa • Identifies presence of esophagitis and grading of severity • Can identify other pathology, such as diverticula, hiatal hernia, webs, rings, or strictures • Tissue biopsies to screen for Barrett’s esophagus

Absite Question • Four hours following upper esophagogastric endoscopy for gastroesophageal reflux, a 62 Absite Question • Four hours following upper esophagogastric endoscopy for gastroesophageal reflux, a 62 year-old man returns to the emergency room with chills, chest pain, and dyspnea. Cardiac work-up is normal, but esophagography shows a distal esophageal perforation. The most appropriate management is • • • A) nasogastric suction and TPN B) reinforced primary esophageal repair C) drainage and esophageal diversion D) esophagectomy with gastric pull-through E) fluoroscopic esophageal stent placement

Absite Question • A 60 year-old otherwise healthy man has symptomatic GERD that has Absite Question • A 60 year-old otherwise healthy man has symptomatic GERD that has not responded to medical therapy, including PPIs. Esophagoscopy shows moderately severe esophagitis. Multiple biopsies of the esophageal mucosa in the area of esophagitis show columnar epithelium replacing the normal squamous epithelium. As the patient’s treatment is being planned, a biopsy report shows highgrade dysplasia.

(cont) • Treatment should be A. Continued medical treatment with yearly esophagoscopy and biopsies (cont) • Treatment should be A. Continued medical treatment with yearly esophagoscopy and biopsies B. Laparoscopic Nissen fundoplication C. Photodynamic therapy D. Esophagectomy E. Laser ablation of normal mucosa

24 -hour p. H test • Gold Standard for presence of pathologic reflux • 24 -hour p. H test • Gold Standard for presence of pathologic reflux • Parameters measured include: total # of reflux episodes, duration of longest reflux episode, percentage of time p. H is less than 4

Ambulatory p. H testing – Recent Advances • Combined impedance and acid testing • Ambulatory p. H testing – Recent Advances • Combined impedance and acid testing • Allows for the measurement of both acid and nonacid (volume) reflux. • Important in pt with persistent symptoms despite an adequate medical trial

Ambulatory p. H testing – Recent Advances • Tubeless method– Bravo System • Allows Ambulatory p. H testing – Recent Advances • Tubeless method– Bravo System • Allows a radiotelemetry capsule to be attached to the esophageal mucosa • Decreases patient discomfort, allows for longer (48 h) monitoring, and may improve accuracy by allowing the patient to carry out their usual activities

Esophageal Manometry • Lower Esophageal Sphincter (LES) • Mean resting pressure • Total length Esophageal Manometry • Lower Esophageal Sphincter (LES) • Mean resting pressure • Total length • Esophageal Body • To determine effectiveness of peristalsis • Amplitude of esophageal wave

Esophagram • Useful when operation is planned—shows anatomy of esophagus and proximal stomach • Esophagram • Useful when operation is planned—shows anatomy of esophagus and proximal stomach • Demonstrates presence and size of hiatal hernia if present

Treatment – Lifestyle Modification • May benefit many patients with GERD, although these changes Treatment – Lifestyle Modification • May benefit many patients with GERD, although these changes alone are unlikely to control symptoms in the majority of patients • Elevation of the head of the bed, decreased fat intake, cessation of smoking, avoiding recumbency for 3 h postprandially, avoidance of certain foods (chocolate, Et. OH, peppermint) • No data reflecting the efficacy of these maneuvers

Treatment – Patient Directed Therapy • Antacids • H 2 receptor antagonists • If Treatment – Patient Directed Therapy • Antacids • H 2 receptor antagonists • If symptoms persist, continuous therapy is required, or alarm symptoms/signs develop – pt should have additional evaluation and treatment

Treatment – Acid Suppression • 6 -week course of acid-suppression therapy • Double dose Treatment – Acid Suppression • 6 -week course of acid-suppression therapy • Double dose of a proton pump inhibitor • Irreversible bind the proton pump in parietal cells of the stomach • Maximal effect 4 days after initiation of therapy and lasts for the life of the parietal cell • More effective than other antacid regimens

Absite Question • Proton pump inhibitors used in the treatment of GERD A. Cause Absite Question • Proton pump inhibitors used in the treatment of GERD A. Cause regression of Barrett’s epithelium B. Inhibit progression of dysplasia C. Increase squamous islands in Barrett’s segments D. Reverse intestinal metaplasia E. Are effective only if gastric acidity is normalized

Treatment – Promotility Therapy • May be used as an adjunct to acid suppression Treatment – Promotility Therapy • May be used as an adjunct to acid suppression therapy in patients with demonstrated defects in esophagogastric motility (LES incompetence, poor esophageal clearance, delayed gastric emptying)

Absite Question • Five years after a myocardial infarction, a 55 year-old woman with Absite Question • Five years after a myocardial infarction, a 55 year-old woman with HTN and DM has symptomatic esophagogastric reflux. Medical treatment for the last year has not been successful. Her BMI is 55. Esophagoscopy shows severe esophagitis. Multiple biopsies show inflammatory changes but no columnar epithelium or cancer. The best treatment would be: A. B. C. D. E. Nissen fundoplication Gastric bypass procedure Gastric banding procedure Vertical banded gastroplasty Biliary-pancreatic diversion with duodenal switch

Surgical Therapy • Indications • Pt w/ evidence of severe esophageal injury (ulcer, stricture, Surgical Therapy • Indications • Pt w/ evidence of severe esophageal injury (ulcer, stricture, or Barrett’s) • Incomplete resolution of symptoms or relapses while on medical therapy • Long duration of symptoms • Younger patients • Ideal patient: more than 10 -year life expectancy and are in need of lifelong therapy due to a mechanically defective sphincter

Trends in the use of surgery for gastroesophageal reflux disease in Ontario, 1988 -2000 Trends in the use of surgery for gastroesophageal reflux disease in Ontario, 1988 -2000 Urbach, D. R. et al. CMAJ 2004; 170: 219 -221 Copyright © 2004 CMA Media Inc. or its licensors

Laparoscopic Nissen Fundoplication • Lafullarde T, Watson DI, Jamieson GG, Myers JC, Game PA, Laparoscopic Nissen Fundoplication • Lafullarde T, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG. Laparoscopic Nissen fundoplication: five-year results and beyond. Arch Surg. 2001 Feb; 136(2): 180 -4 • 87% of the 176 patients remained free of significant reflux. The long-term outcome was considered "good or excellent" by 90% of patients.

Laparoscopic Nissen Fundoplication • Success rate of greater than 90% • Procedure of choice Laparoscopic Nissen Fundoplication • Success rate of greater than 90% • Procedure of choice

Absite Question • A 56 year-old man is seen 2 years after a laparoscopic Absite Question • A 56 year-old man is seen 2 years after a laparoscopic Nissen fundoplication for GERD. His pre-operative work-up 2 years ago demonstrated normal esophageal motility, and p. H probe testing showed that reflux was the cause of his symptoms. He now has recurrent symptoms of GE reflux. A Barium swallow is performed.

 • Which is not true about this patient? A. Redo operation is as • Which is not true about this patient? A. Redo operation is as effective as primary antireflux operation for ameliorationg reflux symptoms B. Transabdominal laparoscopic redo operation is contraindicated C. Redo operation has an increased complication rate D. The cause is related to technical performance of the initial operation E. Manometry is helpful in planning operative therapy

Absite Question • Four years ago, a 47 year-old woman had a laparoscopic fundoplication. Absite Question • Four years ago, a 47 year-old woman had a laparoscopic fundoplication. It failed after three years and she had severe, recurrent gastroesophageal symptoms. Through a celiotomy incision, the surgeon performed a redo-fundoplication with a 360 -degree, 2 cm wrap around a 56 Fr dilator. For the past three months she has had severe early satiety, postprandial epigastric pain, and weight loss. The most likely cause of these symptoms is: A. The wrap is too tight B. The wrap is too loose C. Vagal injury D. Irritable bowel syndrome E. Esophageal motor disorder

Absite Question • Barrett’s esophagus • A) will usually regress after Nissen fundoplication • Absite Question • Barrett’s esophagus • A) will usually regress after Nissen fundoplication • B) carries an increased risk of squamous cell carcinoma • C) is an indication for esophagectomy • D) should be followed by endoscopic surveillance • E) is a contraindication to laparoscopic Nissen fundoplication

Endoscopic Therapy • Attempt to augment the LES by 1. Suturing – Endo. Cinch Endoscopic Therapy • Attempt to augment the LES by 1. Suturing – Endo. Cinch 2. Radiofrequency energy – Stretta 3. Plexiglass injection – polymethylmethacrylate 4. Biocompatible polymer injection -Enteryx

Plication/Sewing Techniques • First developed in the mid ’ 80’s • Allow placement of Plication/Sewing Techniques • First developed in the mid ’ 80’s • Allow placement of sutures into the gastric cardia, thereby augmenting the barrier effect of the GEJ • Bard Endo. Cinch

Endo. Cinch • Filipi CJ, Lehman GA, Rothstein RI et al. “Transoral, flexible endoscopic Endo. Cinch • Filipi CJ, Lehman GA, Rothstein RI et al. “Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. ” Gastrointestinal Endoscopy 2001; 53: 416 -22. • Suggested that endoscopic gastric plication is a safe procedure and, at a 6 month follow-up, that 2/3 of pts undergoing the procedure were successfully treated.

Endo. Cinch (cont) • Inclusion Criteria • Three or more episodes of heartburn a Endo. Cinch (cont) • Inclusion Criteria • Three or more episodes of heartburn a week when off antisecretory meds • Successful response to and reliance upon antisecretory meds for GERD • Abnormal acid reflux on ambulatory p. H monitoring • Exclusion Criteria • • Dysphagia BMI greater than 40 GERD refractory to PPIs Hiatal hernia greater than 2 cm in length

Endo. Cinch (cont) • Treatment success defined as a decrease in the heartburn severity Endo. Cinch (cont) • Treatment success defined as a decrease in the heartburn severity score by 50% in addition to a reduction in the use of antireflux medications to fewer to 4 doses per month. • 64 patients were enrolled • 33 pts (52%) – gastroplication in a linear configuration • 31 (48%) – gastroplication in a circumferential plication • No difference in outcomes between the 2 groups

 • Results: • Mean heartburn scores fell from a preprocedure score of 62. • Results: • Mean heartburn scores fell from a preprocedure score of 62. 7 to mean scores of 16. 7 and 17 and 3 and 6 months postprocedure • Percent total time the p. H was < 4, total number of reflux episodes, and percent upright p. H time was lower than 4 were all significantly improved, but none returned to normal range • Regurgitation scores improved significantly • Quality of life scores were improved for social functioning and bodily pain and 62% of pts at 3 and 6 month f/u were taking less than 4 doses of medication per month

 • Results (cont) • No significant change found in LES resting pressure or • Results (cont) • No significant change found in LES resting pressure or length • No significant effect on mucosal healing • Adverse events included pharyngitis (31%), vomiting (14%), and abdominal pain (14%), and chest pain (16%) • One patient experienced a suture microperforation that was treated conservatively with IV antibiotics and brief hospitalization

Endo. Cinch (cont) • Chen YK, Raijman I, Ben-Menachem T et al. “Long-term outcomes Endo. Cinch (cont) • Chen YK, Raijman I, Ben-Menachem T et al. “Long-term outcomes of endoluminal gastroplication: a U. S. multicenter trial. ” Gastrointestinal Endoscopy 2003. 61: 434 -440 • Prospective, multicenter trial which enrolled 85 patients to be treated with endoluminal gastroplication followed over 2 years

 • Results: • 51% of patients had no or occasional GERD symptoms • • Results: • 51% of patients had no or occasional GERD symptoms • 73% and 69% were completely off PPIs or at 12 and 24 months postprocedure • Reduction in the mean annual medication cost from $1564 per year preprocedure to $157 one year postprocedure (cost redux of 88%) • Shortcomings of study • Does not contain a sham group • Trends toward increased symptoms over time of degradation over time nonplication suggestive of repair

Endo. Cinch (cont) • Schiefke I et al. “Long term failure of endoscopic gastroplication Endo. Cinch (cont) • Schiefke I et al. “Long term failure of endoscopic gastroplication (Endo. Cinch)”. Gut 2005; 54: 752 -758 • Evaluated prospectively long term outcome after Endo. Cinch • 70 patients at a single referral center • Patients interviewed with a standard questionaire regarding symptoms, medication use, in addition to f/u with endoscopy, 24 h p. H monitoring, and esophageal manometry

 • Results: • 18 months after Endo. Cinch 56/70 patients (80%) were considered • Results: • 18 months after Endo. Cinch 56/70 patients (80%) were considered treatment failures as their heartburn symptoms did not improve or PPI medication exceeded 50% of initial dose • Endoscopy showed all sutures in situ in 12/70 (17%), while no sutures remained in 18/70 (26%) • No significant changes in 24 h p. H monitoring or LES pressure

 • Conclusion: • Long term outcome is disappointing probably due to suture loss • Conclusion: • Long term outcome is disappointing probably due to suture loss in the majority of patients

Radiofrequency Thermal Therapy -- Stretta • Delivery of low-power, temperaturecontrolled radiofrequency energy to the Radiofrequency Thermal Therapy -- Stretta • Delivery of low-power, temperaturecontrolled radiofrequency energy to the GEJ • Two mechanisms 1. mechanically altering the GEJ 2. inducing the ablation of nerves that trigger transient lower esophageal relaxation

Radiofrequency Thermal Therapy -- Stretta Radiofrequency Thermal Therapy -- Stretta

Stretta • Wolfsen HC and Richards WO. “The Stretta Procedure for the Treatment of Stretta • Wolfsen HC and Richards WO. “The Stretta Procedure for the Treatment of GERD: A registry of 558 patients. ” Journal of Laparoendoscopic and Advanced Surgical Techniques 2002 • 558 patients, 33 institutions • 6 months of follow-up • Survey administered which assessed GERD severity, percentage of GERD symptom control, satisfaction, and antisecretory medication use

 • Results • At baseline, the median percentage of GERD symptom control while • Results • At baseline, the median percentage of GERD symptom control while on drugs was 50%, compared with 90% after Stretta • Satisfaction with symptom control was 26% versus 77% after Stretta • Median requirement at baseline was double dose of PPI versus antacids prn after Stretta • Most subjects (90%) would recommend Stretta to a friend

Stretta • Triadafilopolous et al: reported 6 - and 12 month results of an Stretta • Triadafilopolous et al: reported 6 - and 12 month results of an open label trial of Stretta • Prospective multicenter trial involving 118 patients who had chronic heartburn or regurgitation, abnormal esophageal acid exposure, hiatal hernia less than 2 cm, and mild esophagitis • At 12 mo: improvement in heartburn score, GERD score, and quality of life. PPI use decreased from 88% to 30%. Esophageal acid exposure improved significantly, although no improvement in the incidence and severity of esophagitis

 • randomized, double-blinded, sham controlled trial of radiofrequency energy to the gastroesophageal junction • randomized, double-blinded, sham controlled trial of radiofrequency energy to the gastroesophageal junction for the treatment of GERD

Patient Criteria • heartburn or acid regurgitation at least partially responsive to and requiring Patient Criteria • heartburn or acid regurgitation at least partially responsive to and requiring daily antacid medications • age 18 years • 24 -hour p. H study (off medications) showing abnormal esophageal acid exposure (4%) or a De. Meester score of 14. 7 • esophageal manometry showing normal esophageal peristalsis and sphincter relaxation • EGD, on medications, showing no esophagitis worse than grade II (i. e. , no substantial ulcerations), no hiatal hernia 2 cm long, and no Barrett’s esophagus • no coagulation disorders, mechanical prostheses, prominent dysphagia, or unstable disorders.

Stretta • Patients were offered the Stretta procedure if they had documented GERD and Stretta • Patients were offered the Stretta procedure if they had documented GERD and did not have a hiatal hernia larger than 2 cm, LES pressure less than 8 mm. Hg, or Barrett’s esophagus. • Patients with larger hiatal hernias, LES pressure less than 8 mm. Hg, or Barrett’s were offered LF.

Stretta • Conclusions – Although the incidence of complications is decreased compared with operative Stretta • Conclusions – Although the incidence of complications is decreased compared with operative intervention, success of therapy does not approach that of surgical intervention • After Stretta 30 -50% of patients still require PPI therapy

Injection/implantation techniques -- Enteryx • Injectable biocompatible solution consisting of 8% ethylene vinyl alcohol Injection/implantation techniques -- Enteryx • Injectable biocompatible solution consisting of 8% ethylene vinyl alcohol copolymer mixed in dimethyl sulfoxide • When injected into the LES, the solution interacts with the surrounding fluid to become an inert spongy solid mass • Mechanism: may impart an alteration in the compliance of tissues preventing sphincter shortening and improving the barrier function of the GEJ

Enteryx Enteryx

Enteryx • Cohen LB, Johnson DA, Ganz RA et al “Enteryx implantation for GERD: Enteryx • Cohen LB, Johnson DA, Ganz RA et al “Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months. ” Gastrointestinal Endoscopy May 2005 • Open-label, international clinical trial conducted in 144 PPI—dependent patients with GERD with f/u at 6 and 12 months • Primary outcome: PPI use • Secondary outcome: GERD health-related quality of life and esophageal acid exposure

 • Results: • At 12 months PPI use was reduced by greater than • Results: • At 12 months PPI use was reduced by greater than 50% in 84% of treated pts • GERD health-related quality of life < 11% in 78% of patients • Esophageal acid exposure was reduced by 31%

Enteryx Enteryx

Conclusions on Endoscopic Mgmt of GERD • Techniques need to be further studied in Conclusions on Endoscopic Mgmt of GERD • Techniques need to be further studied in shamcontrolled protocol • Long term follow-up suggest a declining effect of treatment with pts returning to PPI use -more long term f/u studies necessary • Future studies should improve targeting of which patients benefit, further elucidate the mechanisms of action, and provide detailed comparisons to alternative treatments.

Future of Endoscopic Therapy • As a substitute for long-term medical therapy for the Future of Endoscopic Therapy • As a substitute for long-term medical therapy for the pt with mildly symptomatic GERD • As adjuncts to ongoing pharmacologic treatment • In patients with a failed surgical fundoplication