Refractory GERD: What s a Gastroenterologist To Do? Philip O. Katz, MD, FACG Chairman, Division of Gastroenterology Einstein Medical Center Clinical Professor of Medicine Jefferson Medical College Philadelphia, PA
The Easy Patient Heartburn, typical Regurgitation Sleep disturbed On PPI twice a day, heartburn 85% better, still with regurgitation post prandial Never had a test
The Real Hard Patient Chronic Cough (5 years) Non smoker Normal Chest xray/ct Voice disturbance ENT says LPR, pulmonary says no asthma Dexlansoprazole once a day/h2 at bedtime no perceived improvement
What Do We Need to Know Does the patient REALLY have GERD If so how do we prove it. What is a reasonable approach? If truly refractory what are the options? If not GERD what to do (if you keep the patient)
Potential Causes of Continued Symptoms on PPI The patient has GERD but: Acid is not controlled Healing/symptom relief not complete despite good antisecretory therapy The patient has weakly acidic or non-acid reflux Hatlebakk JG, et al. Gastroenterol Clin North Am 1999;28:847-60.
Potential Causes for Continued Symptoms on PPI The patient does not have GERD (medication, eosinophilic esophagitis, functional heartburn) The response to PPI is impacted by concurrent functional medical illness (IBS, migraine, anxiety, chest pain) Some people really have more than one problem
Patients Still Do Not Optimize PPI 3.7 Therapy 27.8 29.6 38.9 > 60 minutes before meals As needed After meals At bedtime Gunaratnam NT, et al. Aliment Pharmacol Ther 2006;23:1473.
Options for the Work Up Perform EGD Ambulatory monitoring ph Impedance Esophageal function testing (manometry, impedance) Kahrilas P, et al. Gastroenterology 2008; 135:1392-1413. DeVault KR, et al. Am J Gastroenterol 2005 Jan;100(1):190-200.
Prolonged ph (Reflux) Monitoring Allows clinician to determine: The amount and timing of acid reflux The association between acid reflux and symptoms (does reflux precede symptom?) The effect of therapy on acid reflux Non-acid reflux (impedance) Reflux Height DeVault K, et al. Am J Gastroenterol 2005;100(1):190-200. Hirano I, Richter JE. Am J Gastroentrol 2007;102:668-85.
Should ph (Reflux) Monitoring Be Performed Off or On Therapy Low pre test probability of GERD at baseline/no diagnostic tests done OFF Medication (7-10 days) GERD likely OR known. EGD done ON Medication (impedance/ph) Kahrilas P, et al. Gastroenterology 2008; 135:1392-1413. Hirano I, Richter JE. Am J Gastroentrol 2007;102:668-85.
Patients with positive symptom index (%) 100% 90% 80% 70% Non Acid Reflux and Positive 72% Symptom Index 60% 50% 40% 30% 20% 10% 35% 32% 16% 14% 10% 22% 0% Regurgitation 18 Heartburn 20 Cough 22 Chest pain 25 Abdominal Sx 7 ENT symptoms 21 Others 37 Katz P, personal data from approx 1500 patients
Non Acid Reflux Options Baclofen Imipramine (functional) Surgery
No. Reflux Episodes Number of Reflux Episodes: Effect of Baclofen 250 200 206 Acid Nonacid Rereflux 150 100 89 73 50 0 32 19 3 Placebo Baclofen Vela MF, et al. Aliment Pharmacol Ther 2003; 17:243-251
No. symptom events Effect Of Baclofen On Number Of 120 100 80 97 Symptom Events 70 Placebo Baclofen 60 40 20 0 21 * 15 20 * 5 * 7 1 Total Acid-related Nonacidrelated * Noncorrelated * p<0.05 (Vela et al. Al Pharm Ther 2003)
Symptom improvement and resolution after LARS among those presenting with the symptom 100 80 23 22 60 40 18 29 22 Improved % Resolution % 20 0 67 70 57 47 40 Heartburn Regurgitation Dysphagia Cough Hoarseness Oelschlager BK, et al. Am J Gastroenterol 2008; 103:280-287.
Reflux on PPI with Positive Symptom Index: Surgery Outcome 19 Patients Heartburn-2 Regurgitation-3 NAR Acid Symptoms not associated with reflux Cough-7 Throat Clearing-1 Hoarseness-1 Heartburn-3 Nausea-1 Heartburn-1
Esophageal Manometry Recommended by AGA technical review if GERD not present by above testing Especially helpful with dysphagia Rarely will find Achalasia/Spasm Upper sphincter abnormalities seen in >50% of ENT referrals. Significance unknown AGA Technical Review. Gastroenterology 2008
Ambulatory reflux testing OFF PPI Primary outcome is focused on acid reflux Prolonged wireless ph monitoring (48 hours) Or 24 hour catheter (ph alone or ph impedance)
Normal esophageal acid exposure Negative symptom-reflux association Likelihood of GERD: Low Typical Extraesophageal Diagnosis c/w Functional Heartburn/ Chest Pain Look for alternate diagnosis
Pathological esophageal acid exposure Positive symptom-reflux association Likelihood of GERD: High Treatment optimization - Escalation of acid suppression - Document compliance No response
Ambulatory reflux testing ON PPI (Can be first test in several circumstances) 24 hour phimpedance Persistent Acid Non-acid Hypersensitive Not associated with GERD Escalation of reflux therapy is reasonable Escalation of reflux therapy may be based on symptoms/mechanism Look for alternate diagnosis
Referral for Antireflux Procedure Without a previous confirmed diagnosis of Pathologic acid gastroesophageal reflux Ambulatory reflux testing OFF PPI primary outcome is focused on acid reflux Prolonged wireless ph monitoring (48 hours) or 24 hour catheter (ph alone/or ph-impedance) Normal esophageal acid exposure Negative symptom-reflux association Pathological esophageal acid exposure Positive symptom-reflux association Likelihood of GERD: Low Likelihood of GERD: High Response to antireflux procedure is poor PPI responder or intolerant to PPI Response to antireflux procedure is good No response to PPI Consider further testing ON therapy if a functional /alternative diagnosis is possible