Emerging Technology: Latest Anti-reflux Endoscopic procedures & Surgeries

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1 Emerging Technology: Latest Anti-reflux Endoscopic procedures & Surgeries Simi Jesto Joseph, DNP, RN, APN, NP-C Director of Research & Clinical Services Gastroenterology Nurse Practitioner GI Solutions of IL Objectives 1) Describe types of reflux diseases 2) Identify the current diagnostic technology to distinguish GERD vs NERD 3) Describe briefly the current medical & surgical treatment for GERD 4) Identify the right patient for anti-reflux procedures Reflux Diseases GERD LPRD DGR NERD Reflux Diseases 1) GERD Gastroesophageal Reflux 2) LPRD Laryngopharyngeal Reflux! Backflow of stomach contents up the esophagus and into the throat 3) DGR Duodeno-Gastric Reflux! Duodenal contents (bile acids; pancreatic juice)! Also called bile reflux 4) NERD Non-Erosive Reflux! Typical reflux symptoms caused by the intraesophageal reflux of gastric contents! No visible esophageal mucosal injury

2 GERD A condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications (Montreal Consensus) (AGA, 2008) GERD Overview! Gastroesophageal reflux disease (GERD) is a chronic disease which affects an estimated 38 million patients in the U.S! Weekly in approximately 20-25% of adults 2! Only 19 million are diagnosed annually! 35% of affected individuals do not seek medical care, preferring to self- medicate! The most common gastrointestinal diagnosis recorded on outpatient visits since 2006, surpassing abdominal pain 3! Increasing prevalence 4! Aging population! Obesity! Changes in diet & physical activity! Over-prescription of pharmaceutical therapies (PPIs) 5! Americans spend in excess of $10 billion per year on Proton Pump Inhibitors (PPIs)! The number of PPI prescriptions/year in the United States has doubled since 1999 Lewis, (2006); Pandalfino & Kwialek (2008); Shaheen et al (2006); Vakil et al (2006; Moore et al. 2016) Pathophysiology of GERD permission from (GI Solutions/ Arun Ohri, MD) GERD: Symptoms Typical Atypical Heartburn Chest Pain Excessive Salivation Regurgitation Gas Bloating Trouble Sleeping Sensitive To Some Foods & Liquids Typical symptoms have been associated with Barrett s Esophagus--a condition that increases risk for cancer.* And Or Persistent cough Chronic sore throat Difficulty swallowing Frequent swallowing Asthma Hoarseness Excessive throat clearing Bad breath Dental erosions or gum disease Discomfort in ears & nose 6 million suffer from GERD and asthma GERD is Deceptively Complex

3 GERD Clinical Progression Progression of GERD Physiological Reflux Symptomatic GERD Esophagitis (Infrequent & Mild) (Frequent & Intense) Complex Esophagitis Symptoms: Typical Heartburn Regurgitation Atypical Chest pain Difficulty swallowing Cough Asthma Laryngitis Esophagitis is inflammation of the esophagus. It may be acute or chronic. Complications: Ulceration Hemorrhage Strictures Barrett s Esophagus Adenocarcinom a (Cancer) Esophagogastroduodenoscopy Extend of esophagitis H-pylori gastritis Ulcers Barrett s esophagus Strictures Varices Angiodysplasias Mallory-Weiss tear Tumors Gastric polyps permission from (GI Solutions/ Arun Ohri, MD) Bravo ph Monitoring System! Catheter-free ph monitoring system! ph capsule attached to the esophageal wall transmits data to pager-sized receiver! Allows normal activities such as dietary habits, showering, and exercise and does not interfere with sleeping! 48 to 72 hour PH reading of the esophagus! Supine reflux! Night time reflux! Symptom correlation! Monitor reflux on PPI as well as Off PPI permission from (GI Solutions/ Arun Ohri, MD) Esophageal Manometry! To accurately define esophageal motor function! For preoperative assessment of patients being considered for antireflux surgery! Note: Esophageal manometry is not indicated for making or confirming a suspected diagnosis of GERD! Indications:! Achalasia! Nutcracker esophagus! Cricopharyngeal Achalasia! Simultaneous swallows! Abnormal co-ordination permission from (GI Solutions/ Arun Ohri, MD)

4 Esophageal Impedance Testing! 24 hour catheter-based test! Patient carry the catheter and resume normal activities! Allowing recognition of both acidic and weakly acidic reflux episodes! The results of several studies suggest that impedance-ph monitoring is useful in the evaluation of patients with PPI-resistant typical reflux symptoms, and atypical symptoms:! Chronic unexplained cough! Excessive belching! Rumination! Motility disorders! Non-acid reflux Pritchett, Aslam, Slaughter (2009); permission from (GI Solutions/Arun Ohri, MD) Barium x-ray X-ray examination of the esophagus, stomach, and first part of the small intestine Images obtained using fluoroscopy and oral barium Evaluate the anatomy and function Air-contrast or double-contrast upper GI Iodine contrast is used if recent GI surgery or barium allergy Indications: Difficulty swallowing An alternative to EGD or manometry if needed GERD: Esophagitis, NERD, Functional Heartburn? GERD Endoscopy + Los Angeles A-D - esophagitis ph monitoring excess esophageal acid exposure - + NERD ph monitoring + Hypersensitive symptom correlation esophagus - Functional heartburn non-acid reflux Lifestyle Modifications Eliminate Triggering Foods & Drink Rigorously Timed Meals GERD Associated Quality of Life Parameters* Unable to enjoy meals Sleep disturbances Fatigue Reduced overall productivity Altered social well-being Altered emotional wellbeing Inclined Sleeping Position Sleeping in Chair Weight Loss Eliminate Smoking No Pressure On Stomach

5 Medical Management Escalated dosing of more complex medications until pills stop working. PPIs H2 Blockers Blocks the secretion of acid into the stomach Antacids Neutralize or buffer stomach acid Blocks the body s signal to the stomach to produce acid and medications come with side-effects and complications GERD Suffering is Widespread 19 Million Daily 42 Million Weekly 20 Million Monthly 134 Millon OTC & Rx 81 Million Total ¼ of Americans Only And But 0.05 Million 10.2 Million 6.3 Million Receive Tests Receive Treatment Visit a Doctor to Diagnose with a Procedure Risks Associated With PPI Use Vitamin B12 Deficiency 1 PPI Interaction with Plavix 5 Increased Risk of Fundic Gland Polyps 6 Increased Pneumonia Risk 2 Increased Risk of Bacterial Gastroenteritis 7 Increased Risk of Osteoporosis Fractures 3 Magnesium deficiency 8 Reduced Gallbladder Motility 4 Increased Risk of C. diff, Small Intestine Bacterial Overgrowth 9 GERD Symptom and Treatment Continuum Endoscopic Repair

6 Anti-Reflux Surgery-Decision! Anti-reflux surgeries are an effective alternative to medical treatment! Increases Transient Lower Esophageal relaxation period! Indications (SAGE Guideline)! Symptoms refractory to pharmacological therapy! Have complications of GERD! Barrett s esophagus,! peptic stricture,! large Hiatal hernia,! Atypical symptoms,! and reflux documented on 24hr PH monitoring Pre-op work up! 1) Upper Endoscopy! Visual and histopathological changes! 2) PH monitoring! Gold standard for pathologic acid reflux! 3) Esophageal Manometry! To identify dysmotility of esophagus! 4) Barium Swallow! To determine the anatomy Anti-reflux procedures Normal Anatomy Abnormal Anatomy Solution: Restore anatomy to normal Closed; no reflux Functional Valve Vs. Can t close; contents reflux Dysfunctional Valve by Repairing valve Tight to the scope Physiological Reflux (Infrequent & Mild) Loose to the scope Symptomatic GERD (Frequent & Intense) to Resolve symptoms permission from (Endogastric Solutions) Laparoscopic (LNF) vs Open technique for GERD (CNF)! Laparoscopic NISSEN Fundopliction vs Conventional NISSEN Fundoplication! Aim: re-create and restore normal physiologic function of LES, reconstruction of the Hiatus, and repair of hernia! LNF-Preferred approach and gold standard for surgical treatment! Longer operative time! Shorted hospital stay! Low perioperative morbidity! Decreased pain! Low rate of abdominal hernias! Low rate of infections

7 Partial Vs Total Fundoplication Toupet! Partial-270 degree! Fewer symptoms of bloating! Able to vomit Nissen! Total-360 degree! High rate of dysphagia! Flatulance! Bloating Toupet vs Nissen! Toupet done in 3.0 cm and 1.5 cm valve length! 3.0 is superior in controlling reflux! Dysphagia is higher in 3.0! More studies required Anterior (DOR) vs Nissen! 120 degree anterior fundoplication! Less post operative dysphagia! Shown less effective in controlling reflux! Most patients required re operation Comparison Nissen DOR Advantages Effective in reflux control Less post-op Dysphagia Disadvantages Flatulance, bloating, dysphagia More re opertaions Toupet Less Post-op dysphagia Length of the wrap determines the quality of reflux control

8 Stomach Intestinal Pylorus Sparing Surgery (SIPS)! Modified approach for morbidly obese pts! Modified duodenal switch! Involves sleeve gastrectomy and attach pylorus to the midgut located 3 meters from the terminal Ileum! Novel technique for both obesity and GERD! Early results are encouraging (Zaveri et al. 2015) Anti-reflux surgery-conclusion! LNF is the gold standard procedure! Failure rate-3%-16%! Etiology-Slipped fundoplication or herniation of the wrap! Re-operation is safe! High complication rates-gastric or esophageal perforation! Longer operative times! Higher conversion to open approach Antireflux Endoscopic Procedures (History)! Implanting Technique - Enteryx! Radio Frequency - Stretta! Suturing Devices: - Endocinch - Plicator permission from (Endogastric Solutions) Patient Selection Criteria! Inclusion Criteria:! years of age for adults or > 12 years and 25 kg for children! Chronic symptomatic GERD for > 6 months! Persistent GERD symptoms despite PPI therapy! Demonstrated reflux (48-h ph metry, UGI radiography or esophagitis B or C)! Deteriorated gastroesophageal junction (Hill grade II-III) - Patient willing to comply with post-operative dietary recommendations! Exclusion Criteria:! BMI > 35! Irreducible hiatal hernia > 2 cm! Esophagitis grade D! Esophageal ulcer, fixed stricture or motility disorders! Dysphagia

9 TIF ( Transoral Incisionless Fundoplication) No incisions No scarring No incisional herniation Less nosocomial infection No dysphagia permission from (Endogastric Solutions) TIF permission from (Endogastric Solutions) TIF! 3 rd generation in reflux surgery Surgical reconstruction transorally Sterile, single use device An evolution of current surgical procedure Based on long standing surgical principles Physiologically less invasive Future options open-adjustable Adaptive to patients anatomy permission from (Endogastric Solutions) Endoscopic Retroflex View Before & After TIF Procedure permission from (GI Solutions/Arun Ohri, MD)

10 TIF Evidence Experienc e Outcomes Safety Studied in over 40 peer-reviewed publications with outcomes for over 700 individual patients. Over 15,000 patients treated consecutively over 10 years. High level of efficacy in improving subjective and objective measures of GERD. Commercial SAE rate less than 0.4% Absent long-term side-effects associated with other treatment options. Level 1 and 2 Clinical Studies Detailed RESPECT A multi-center, randomized, singleblind, controlled TIF/Placebo vs. Sham/PPIs trial TEMPO A multi-center, randomized, openlabel, controlled TIF vs. PPI trial TIF REGISTRY A multi-center, prospective, openlabel, post market registry STAR REGISTRY (AGA) A multi-center, prospective, openlabel, post market registry To compare safety and effectiveness of TIF vs. Sham/ PPIs in patients with troublesome symptoms specifically regurgitation To compare safety and efficacy of TIF vs. PPIs for the treatment of chronic medically refractory GERD To evaluate the safety and efficacy of TIF in a broad range of GERD patients treated in routine clinical practice To compare the safety and efficacy of TIF procedure vs. Laparoscopic Nissen Fundoplication Surgery (LNF) 2:1 ratio TIF/ Placebo group ( n=80) vs. Sham/ PPI group (n=40) 2:1 ratio TIF group (n=28) vs. PPIs group (n=14) 274 patients treated with TIF procedure 1:1 ratio TIF group (n=250) vs. LNF group (n=250) (Trad et al, 2014; Bell et al, 2012) In the TEMPO randomized, controlled trial comparing the TIF 2.0 procedure to maximum dose PPI therapy, outcomes at 6 months: VS of patients eliminated daily regurgitation 50% in the PPI group 97% VS of patients had esophagitis healed 38% for PPI group 90% VS of patients eliminated all symptoms 5% for PPI group 62% VS of patients had esophageal ph normalized 52% in the PPI group 54% Trad et al(2014) Endoscopic Fundoplication! All outcome measures of TIF were sustained and statistically unchanged between 6- and 12 M follow-up! 84% of TIF patients remained completely off PPI at 12-M vs. 90% at 6-M follow-up! Esophagitis was healed or reduced in 100% of TIF patients at 12-M vs. 90% at 6-M! 77% of TIF patients experienced global elimination of regurgitation and atypical symptoms off PPIs at 12- M! In the crossover group of patients, 71% were completely off PPIs 6 months post-tif! In crossover patients, TIF was superior to high-dose PPIs in eliminating typical and atypical GERD symptoms

11 Endoscopic Fundoplication! TIF provides significant control of regurgitation, atypical symptoms and healing of esophagitis in patients with small hiatal hernias and an incomplete response to PPIs! TIF avoids the undesirable post-fundoplication side-effects (dysphagia, gas-bloat and flatulence) commonly associated with laparoscopic anti-reflux procedures! In a well selected patient population, TIF is a safe, viable endoscopic alternative to existing anti-reflux procedures! TIF may also be viewed as an adjunct to PPI therapy in patients with incomplete control of regurgitation and atypical symptoms! Outcomes of this study are consistent with other recently published data and demonstrate durability of results 12 months following TIF TIF vs Nissen or Toupet! Safe and efficacious in symptom control! TIF is a paradigm shift in tx of GERD! TIF has shorter operative time and length of stay! No complications or no conversions! High patient satisfaction (Toomey et al. 2014) Conclusion Transoral fundoplication achieved elimination of daily dependence on PPI-75-80% (6 yrs data) Troublesome regurgitation was resolved in a greater proportion of patients treated with TIF than with omeprazole TIF appears to be safe, without fundoplication side effects Intra-esophageal acid control improved following TIF TIF should be considered in GERD patients with small or absent hiatal hernia who suffer from troublesome regurgitation, despite PPI therapy (Testoni, Testoni, mazzoleni, Vailati, & Passaretti, 2015) Linx! Minimally invasive laparoscopic procedure! Linx is implanted outside the LES! Preserves normal function-can belch and vomit! Designed for lifetime, quarter in size, made of Titanium! One type is safe in MRI scanning

12 LINX Reflux Management System! FDA approved in 2012! Proven safe and effective! Minimally invasive procedure! Designed to be a permanent solution for GERD! Long term 5 year data published in Clinical Gastroenterology & Hepatology May Journal Support 46 Add Practice Name to Slide Master Add Practice Logo to Slide Master Layout LINX Procedure Laparoscopic, minimally invasive procedure Generally completed in less than one hour Patients typically go home the same day and resume a normal diet as soon as tolerated No alteration to the stomach Patients generally retain ability to belch and vomit; reduces gas bloat Removable 47 Add Practice Name to Slide Master Add Practice Logo to Slide Master Layout LINX Benefits! 87% of patients completely eliminated medication use 1! 98% of patients reported no bothersome heartburn affecting their nightly sleep 2! 98% of patients required no daily change to their diet from heartburn 2! 94% of patients were satisfied with their overall condition after LINX 1 1. Ganz, et al., Esophageal Sphincter Device for Gastroesophageal Reflux Disease. The New England Journal of Medicine; 368; 8: Data on File, Torax Medical. 48

13 ! ( How LINX Works LINX helps keep the LES closed to prevent reflux LINX expands to allow for normal swallowing 49 How LINX Works! FDA approved-2014 MUSE- EndostaplerSystem! The innovative endoscopy system is for the treatment of Gastroesophageal Reflux Disease (GERD).! It performs an anterior fundoplication in lieu of current surgical procedures, without opening the abdominal cavity.! SRS endoscope distal section including several sophisticated innovative technologies such as a surgical stapler, miniature camera and an ultrasound sensor! The SRS system has the following principal advantages: Provides the same results as in gold standard laparoscopic surgery.! Faster than laparoscopic surgery.! A more attractive treatment than either surgery or lifelong medication.! A more efficient and cost effective procedure.! Less trauma to patient with no incisions.! The entire endoscope is disposable.! (

14 ! AGA (2008). American Gastroenterology Association medical position statement on the management of Gastroesophageal Reflux Disease. Gastroenterology, 135: ! Bell, R.C, Mavrelis, P.G., Barnes, W.E., Dargis, D., Carter, B.J.,.Ihde, G.M. (2012). A prospective multicentered registry of chronic gastroesophageal disease receiving transoral incisionless fundoplication. Americal College of Surgery, 215(6): ! De Vault, K.R. & Castell, D.O. (2005). Updated guidelines for the diagnosis & treatment of Gastroesophageal Reflux Disease. American Journal of Gastroenterology, 100: ! Lewis, JV. (2009) (Editorial). Gastroesophageal Reflux Disease and Obesity. Southern Medical Journal, 102(10); ! Pandalfino,J.E. & Kwialek, M.A. (2008). Use and utility of the Bravo Ph capsule. Journal of Clinical Gastroenterology, 42: ! Shaheen, N.J., Hansen, R.A., Morgan, D.R., Gangarosa, L.M., Ringel, Y., Thiny, M.T., Russo, M.W., Sandler, R.S. (2006). The burden of gastrointestinal and liver disease. American journal of Gastroenterology, 101: ! Moore, M., Afaneh, C., benhuri, D., Antonacci, C., Abelson, J., & Zarnegar, R. (2016). Gastroesophageal reflux disease: A review of surgical decision making., World Journal of gastrointestinal Surgery, 8 (1): 77-83! MUSE endostapler system Photography: Retrieved from Pritchett, J.M., Aslam, M., Slaughter, J.C. (2009). Efficacy of esophageal impedence/ph monitoring in patients with refractory gasroesophageal reflux disease, on and off PPI therapy. Clinical Gastroenterology & Hepatology, 7: ! Toomey, P., Teta, A., Patel, K, Ross, S., Sukharamwala, P., & Rosemurgy, A.S. (2014). Transoral Incisionless Fundoplication: Is it as safe and efficacious as a Nissen or Toupet Fundoplication?. The American Surgeon, 9(80): ! Testoni, P.A., Testoni, S., Mazzoleni, G., Vailati, C., & Passaretti, S. (2015). Long-term efficacy of tranoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-centered study, 29: ! Trad,K.S., Barnes, W.E, Simoni, G., Shughoury, A.B., Marvelis, P.G., Heise, J.A., Turgeon, D.G., & Fox, M.A. (2014). 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, 22 (1): 26-40! permission from (GI Solutions/Arun Ohri, MD)! permission from (Endogastric Solutions)! Vakil,N., Vanzanten, S.V, Kahrilas, P., dent, J., Jones, R. & Global consensus group. The Montreal definition and classification of Gastroesophageal Reflux Disease: A global evidence-based consensus (2006). American Journal of Gastroenterology, 101: ! Zaveri, H., Surve, A., Cottam, D., Richards, C., Medlin, W., Belnap, L., Cottam, S., & Cottam, A. (2015). Stomach intestinal pylorus sparing surgery (SIPS) with laparoscopic fundoplication (LF): a new approach to gastroesophageal reflux disease 9GERD) in the setting of morbid obesity. 4: 596 Endostim Therapy Bipolar lead delivers low energy electrical impulses to LES Implanted through laparoscopic procedure Single-center (Chile) and International multicenter open-label trials Prospective pilot studies evaluating safety and efficacy 6-M and 12-M follow-up results published for single-center study Initial studies have demonstrated safety and efficacy at 12 months follow-up in PPI-refractory sufferers Still upstream, but a potential treatment option for GERD Ideal GERD Treatment Provider Wish List Subjective Improvement: Symptom control QOL scores Medication use Satisfaction Durability Objective Improvement: ph-metry Esophagitis Safe, few and minor complications Minimal side-effects Patient Wish List I wish I could feel normal again. I need a decent night s sleep. I don t want to take pills anymore. I want to avoid an invasive surgery. I don t want side-effects. Thank you GI SOLUTIONS References