1. Endoscopic Diagnosis of Hiatal Hernia Gilbert Simoni, MD Advanced Gastroenterology, Inc And Chief, division of gastroenterology Los Robles Hospital and Medical Center West Coast Reflux Society- Inaugural Meeting November 10 th, 2012

2. GI Motility online (May 2006) | doi:10.1038/gimo52 Figure 1 Lower esophageal sphincter (LES) fibers.

4. Ways to “skin a cat”? Text book definitions Typical EGD diagnosis Hill Grade The “Simoni” method Imaging

5. Text book There are four types of hiatal hernia: ◦ Type I hiatal hernia ◦ Type II (paraesophageal) hiatal hernia ◦ Type III hiatal hernia ◦ Type IV hiatal hernia

6. Type I hiatal hernia: Type I hiatal hernia:

7. Type II (paraesophageal) hiatal hernia:

8. Type III hiatal hernia:

9. Type IV hiatal hernia:

10. Typical EGD reports Incompetent GEJ Small Medium (moderate) Large

11. A normal valve (No Hiatal Hernia)

12. Incompetent GEJ

13. Small Hiatal Hernia

14. Medium size Hiatal Hernia

15. Large Hiatal Hernia

16. Hill Grade

17. Axial measurement

18. Transverse measurement

19. Imaging Upper GI: Axial height from diaphragm to uppermost gastric folds

20. The “Simoni” Method The best of all worlds?

27. Hill 2 Endoscopic and Lap View

28. Hill 3 Endoscopic and Lap View

29. A little bit of anatomy

31. GI Motility online (May 2006) | doi:10.1038/gimo56 Figure 2 An endoscopic view of a 360-degree fundoplication.

35. Impelementing BRAVO pH System

36. - Considered the best test for the diagnosis of gastroesophageal reflux disease (GERD) - Greater sensitivity than endoscopy and greater specificity than an empiric trial of proton pump inhibitor (PPI) therapy.

37. Indications GERD Chronic Cough Laryngitis LPR Chest pain (non-cardiac) Regurgitation Post-ARS evaluation Failure to respond to PPIs

38. Current Technology and it’s Limitations Catheter Based Systems: Patient Intolerance ◦ Uncomfortable ◦ Pharyngeal and Throat Discomfort ◦ Runny Nose Artifact Prone ◦ Alters Regular Diet and Activity Requires Manometry?

40. Catheter-Free pH Monitoring System pH Capsule attached to the esophageal wall transmits data to pager-sized Receiver Eliminates uncomfortable 24-hr trans-nasal catheter Allows normal activities, showering and does not interfere with sleeping Bravo pH System™

41. Bravo pH System Components 1) Bravo Calibration Stand 2) Bravo pH Receiver 3) Bravo pH Capsule with Delivery System 4) Bravo pH Capsule 5) Bravo DataLink 6) Lithium AA Battery 7) Calibration Solutions (pH 7.01 & 1.07) 8) POLYGRAM NET pH Testing Application Optional: Vacuum Pump

42. pH Capsule Catheter Handle For trans-nasal or trans-oral placement Single-Use item One-handed operation 100 cm long with working length of 80 cm Distance marks every 5 cm up to 60 cm Bravo pH Capsule with Delivery System

43. Bravo pH Capsule placed via nose or mouth Trans-nasal placement relative to manometrically identified LES upper boarder Trans-orally placement relative to endoscopically identified Scuama- Columnar Junction pH Capsule Flexible Tip Bravo pH Capsule with Delivery System

44. pH Capsule measures esophageal pH with Antimony pH sensor Uses Radio-Telemetry to send data to Receiver Dimensions: 6 x 6.3 x 26 mm Contains: suction chamber, locking pin, 2 batteries, PCB, transmitter and pH sensor+ref. pH Capsule Bravo pH Capsule

45. Step 1 Position Bravo Capsule Step 2 Apply Suction Step 3 Advance Pin Step 5 Begin pH Recording Step 4 Release Capsule Capsule Attachment

46. pH Capsule transmits data to pager-sized Receiver Eliminates uncomfortable 24-hr trans-nasal catheter Allows showering and does not interfere with sleeping pH Capsule Receiver Bravo pH Receiver

47. Use Digital Radio- Telemetry Capsule measures pH every 6 sec and transmits data to receiver every 12 sec Keep the receiver within 1m to prevent data loss (range up to 3m) Digital Radio-Telemetry

48. FeatureBenefit Catheter-Free Enhances Patient Comfort Eliminates Pharyngeal & Throat Discomfort, not Socially Embarrassing Patients are Less Likely to Miss Work Increases Freedom Patients Carry True Physiologic Data Reduces Chance of Artifact Increases Accuracy Easy to Perform Perform Same Time as EGD Available to All GI Docs Increase Physician Revenue Opportunity Features and Benefits

49. FeatureBenefit 48-Hour Study Double the Diagnostic Information Bravo Designed for “Atypical” Patients - ENT, Pulmonary, Chest Pain Patient Acceptance Pre/Post Treatment Clinically Document Therapeutic Outcome or Drug Effectiveness Features and Benefits, cont’

50. Bravo Performs Clinically - Summary Bravo Market Studies Confirm/Validate Clinical Performance Bravo’s Capsule is Comparable to the Conventional Catheter in Quantifying Esophageal pH* The Bravo “Catheter-Free System” should Lead to Increased Patient Acceptance and Compliance of this Test for GERD*

51. Report Templates Report TypeDescription Basic Study summary graph, Reflux Table summary, Normal Values Table, DeMeester Score, SAP Table (Symptom Association Probability), and SI Table (Symptom Index) Basic No DeMeester Same as Basic but without DeMeester Score or SI Table Advanced Study summary graph, Reflux Table by symptom, Normal Values Table, DeMeester Score, SAP Table (Symptom Association Probability), and SI Table (Symptom Index) Detailed Study summary graph, Reflux Table by upright and supine, Normal Values Table, DeMeester Score, SAP Table (Symptom Association Probability), SI Table (Symptom Index), Detailed Graphs, and Diary Events

52. RAPID pH Summary Simplified User Interface ◦ Intuitive software navigation ◦ Streamlined pH monitoring workflow Easy Study Management Reporting Options to Meet Your Needs ◦ Multiple options for graphically displaying study data ◦ Multiple templates enable customized reporting Flexible Integration Solutions ◦ Enables network printing and email options for reporting ◦ Enables study management and storage on network drives

53. Gilbert Simoni, MD 805-719-0244 gsimoni@AGImedical.com