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LINX® Reflux Management System:     Best Practices Meeting        Friday, May18, 2012
Establishing the LINX® System as a Surgical                  Offering            C. Daniel Smith, MD              Chair, D...
Disclosure- Co-PI for one of the sites who participated in the  Pivotal Trial- Advisor/consultant to Torax for preparation...
Goals for This Portion of Discussion- I’m not going to tell anyone in audience anything  that they don’t already know- Off...
Fundoplication- Great operation- Select patients do very well- Superior to PPIs- Significant positive impact on natural hi...
Current Treatment Options for GERD                                           Fundoplication                               ...
Fundoplication- Use of fundoplication for GERD has peaked, use  has been slowly declining- GIs have largely stopped referr...
Fundoplication – Why Not- Multifactorial- Technical failures – inconsistent and questionable outcomes- Lack of standardize...
Two Predictors of Surgical Outcome                        Fundoplication    Patient Selection                    Operative...
Current Treatment Options for GERD                           No standard treatment for Gap patients                       ...
Pivotal TrialKey Outcomes
Summary of Efficacy Endpoints         Percent Successful (95% Binomial Exact Confidence Limits)Primary: pH Normalization o...
Efficacy Endpointsby Baseline Hernia Assessment (≤3 cm)Primary Efficacy Endpoint Component       No Hernia      All Patien...
PPI Free Days                      As of Last Follow-Up                900                800                700          ...
Minimal Side EffectsAbility to Belch   •   99% of patients throughout study periodInability to Vomit   •   0% at 12 months...
Reduced Gas Bloat                                              Severity of Gas Bloat                                      ...
Overall Acceptable Safety Risk   144 patients implanted between 2-4 years   No deaths   No intra-operative complication...
The Successful LINX Patient                                                                 Post-LINXBaseline             ...
How Were Good Results Achieved• Rigorous adherence to patient selection and standardized  surgical technique (arguably, ev...
Two Predictors of Surgical Outcome                                LINX Patient Selection                     Operative Tec...
Defining the LINX® Patient
Key Pivotal IDE Eligibility CriteriaInclusion      Age 18-75 years      Typical GERD symptoms >6 months      Pathologic...
Patient Selection Per Labeling                         INDICATION   The LINX Reflux Management System is indicated for pat...
Patient Selection Per Labeling                                               PRECAUTIONS                      1. Hiatal he...
Extended Criteria Use• Linx in hiatal hernia > 3 cm• Linx in Barretts• Linx in morbid obesity (BMI > 35)• Linx with sleeve...
Defining the LINX® Patient         Examples
Examples•   45 year old male•   Heartburn is primary symptom•   Double dose PPI for last 3 years•   pH < 4.5 10%•   Normal...
Examples•   24 year old female•   Chest pain is primary symptom•   Single dose PPI for last 6 months•   pH < 4.5 - 6%•   N...
Examples•   51 year old male•   Heartburn is primary symptom•   Single dose PPI for last 10 years•   pH < 4.5 - 11%•   Nor...
Examples•   58 year old female•   Heartburn is primary symptom•   Double dose PPI for last 10 years•   pH – Bravo has fail...
Examples• 72 year old male• Chest pain and regurgitation are primary symptoms• Double dose PPI for last 15 years• pH < 4.5...
Examples•   18 year old male•   Chest pain and heartburn•   Single dose PPI for last 2 years•   pH < 4.5 – 8%•   Normal es...
Examples• 23 year old female• Hoarseness and chronic cough are primary  symptoms• Double dose PPI for last 5 years• pH < 4...
Summary / Principles• Linx is a safe and effective tool for the management of  GERD• In carefully selected patients outcom...
Summary / Principles• We should agree as thought leaders in the field to  adhere to these principles in offering Linx to o...
Discussion
Introducing Linx to Practice
Introducing Linx to Practice
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Introducing Linx to Practice

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Presentation given as part of Best Practices Meeting during 2012 DDW meeting in San Diego

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Introducing Linx to Practice

  1. 1. LINX® Reflux Management System: Best Practices Meeting Friday, May18, 2012
  2. 2. Establishing the LINX® System as a Surgical Offering C. Daniel Smith, MD Chair, Department of Surgery Surgeon-in-Chief Mayo Clinic in Florida
  3. 3. Disclosure- Co-PI for one of the sites who participated in the Pivotal Trial- Advisor/consultant to Torax for preparation of the presentation to FDA- Joined company for presentation to FDA- Paid consultant to company helping with safe and successful introduction of Linx to care of GERD patients
  4. 4. Goals for This Portion of Discussion- I’m not going to tell anyone in audience anything that they don’t already know- Offer perspective on current surgical treatment for GERD (Nissen fundoplication)- Where would Linx fit in surgical practice- What is the Linx patient- Propose principles for use in our practices
  5. 5. Fundoplication- Great operation- Select patients do very well- Superior to PPIs- Significant positive impact on natural history of GERD- Multiple studies have confirmed its effectiveness and role in treatment of GERD
  6. 6. Current Treatment Options for GERD Fundoplication Surgery PPI Therapy PPI TherapyNo. GERD Patients Fundoplication Surgery Severity of Symptoms and Dissatisfaction Mild Severe
  7. 7. Fundoplication- Use of fundoplication for GERD has peaked, use has been slowly declining- GIs have largely stopped referring patients except for desperate or complicated cases- Most cases are done for complicated conditions (redo, large hiatal hernia, Barretts, severe refractory GERD- PPIs remain treatment of choice for all but the most severe cases of GERD
  8. 8. Fundoplication – Why Not- Multifactorial- Technical failures – inconsistent and questionable outcomes- Lack of standardized approach/technique- Inconsistent use – patients still have fundoplication performed without objective confirmation fo GERD- Patients are afraid of the operation – troubling side-effects of gas bloat and excess flatus or perception that failure rate is 50%- GIs refuse to refer – all of the above and/or strong belief that it is a bad operation- Competing treatments – primarily PPIs, some endolumenal approaches
  9. 9. Two Predictors of Surgical Outcome Fundoplication Patient Selection Operative Technique• Patients without objective • 2 stitch, three stitch, four stitch confirmation of GERD • Esophageal stitch, how many and location• Patients who fail to respond • Pledgets for wrap or crural repair to PPIs • Divide short gastrics or not• Patients with BMI >35 • Anchor wrap to diaphragm/crura• Atypical symptoms? • Extensive esophageal mobilization • Calibrate wrap and to what size• Occasional antireflux surgeon • Occasional antireflux surgeon• Patient selection can be tricky • Tricky operation • Not everyone can get good• Defining the typical GERD outcomes patient has been difficult
  10. 10. Current Treatment Options for GERD No standard treatment for Gap patients Targeted Linx PPI Therapy population Therapy GapNo. GERD Patients Fundoplication Surgery Severity of Symptoms and Dissatisfaction Mild Severe
  11. 11. Pivotal TrialKey Outcomes
  12. 12. Summary of Efficacy Endpoints Percent Successful (95% Binomial Exact Confidence Limits)Primary: pH Normalization or ≥ 64% (:54, 73%) 50% reductionSecondary: GERD ≥ 50% reduction in 92% (85, 97%) GERD-HRQLSecondary: PPI ≥ 50% reduction in 93% (86, 97%) daily PPI use 0 10 20 30 40 50 60 70 80 90 100
  13. 13. Efficacy Endpointsby Baseline Hernia Assessment (≤3 cm)Primary Efficacy Endpoint Component No Hernia All PatientsNormalization (pH<4.5%) 67% (29/43) 58.3% (56/96)> 50% reduction from baseline 77% (33/43) 63.5% (61/96)Either normalization or > 50% reduction 79% (34/43) 66.7% (64/96)
  14. 14. PPI Free Days As of Last Follow-Up 900 800 700 600PPI Free Days 500 400 300 200 100 0
  15. 15. Minimal Side EffectsAbility to Belch • 99% of patients throughout study periodInability to Vomit • 0% at 12 months • 1% at 24 months Note: As actively queried by Foregut Questionnaire
  16. 16. Reduced Gas Bloat Severity of Gas Bloat FREQUENTLY CONTINOUSLY 100Percent of Patients Reporting 80 60 40 20 0 Baseline 12 Month Post LINX 24 Month Post LINX Note: As actively queried by Foregut Questionnaire
  17. 17. Overall Acceptable Safety Risk 144 patients implanted between 2-4 years No deaths No intra-operative complications No device failures No device erosions or migrations Serious Adverse Events  6% (8/144)  No late onset (>1 year)
  18. 18. The Successful LINX Patient Post-LINXBaseline % of Pts% of Pts Characteristic 2 Years 100% Daily PPI dependence 8% 70% Reflux affecting their sleep on a daily basis 2% 76% Reflux affecting their food tolerances on a daily 2% basis 57% Moderate or severe regurgitation including 1% aspirations 55% Severe heartburn affecting their daily life 1% 51% Experiencing extra esophageal symptoms in addition 12% to heartburn and/or regurgitation 40% Esophagitis 11%
  19. 19. How Were Good Results Achieved• Rigorous adherence to patient selection and standardized surgical technique (arguably, even tighter adherence to standardized surgical technique would have improved outcomes even further) pH GERD-HRQL PPI Use Hernia at Baseline N Endpoint Endpoint Endpoint Success Success Success None 44 77% 89% 91% Yes – repaired 30 67% 100% 97% Yes – not repaired 26 39% 89% 92% pH Endpoint Success 95% CI No hernia or hernia repaired 73.0% (54 / 74) 61.4, 82.7%
  20. 20. Two Predictors of Surgical Outcome LINX Patient Selection Operative Technique• Tight control on patient • Device that results in selection predictable• Don’t go after extended response/performance inclusion criteria patients • Standard technique for• Work closely with GI to assure placement full diagnostic work-up and consistent patient selection • If any question of hiatal defect, approximate• Consistent patient instructions to establish expectations crura with stitch(es) (dysphagia is common, diet progression
  21. 21. Defining the LINX® Patient
  22. 22. Key Pivotal IDE Eligibility CriteriaInclusion  Age 18-75 years  Typical GERD symptoms >6 months  Pathologic GERD – (esophageal pH<4 for >4.5% of time)  Daily PPI use  Symptomatic improvement on PPIsExclusion  Hiatal hernia (>3cm)  Esophagitis Grade C or D (LA classification)  Barrett’s esophagus  Esophageal motility disorder
  23. 23. Patient Selection Per Labeling INDICATION The LINX Reflux Management System is indicated for patientsdiagnosed with GERD as defined by abnormal pH testing, who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
  24. 24. Patient Selection Per Labeling PRECAUTIONS 1. Hiatal hernia >3 cm These 2. Barrett’s esophagus PRECAUTIONS are 3. Esophagitis grade C or D based on theinclusion/exclusion 4. Electrical implants or metallic abdominal implants criteria of the 5. Major motility disorders pivotal study. 6. Scleroderma 7. Esophageal or gastric cancerPatients outside of 8. Dysphagia greater than once per week within the last 3 months these 9. Esophageal or gastric surgery or endoscopic interventionPRECAUTIONS have 10. Distal amplitude <35 mmHg or <70% peristaltic sequences not been studied. 11. Esophageal stricture or gross anatomic abnormalities 12. Esophageal or gastric varices 13. Lactating, pregnant or plan to become pregnant 14. Morbid obesity (BMI >35) 15. Age <21 years
  25. 25. Extended Criteria Use• Linx in hiatal hernia > 3 cm• Linx in Barretts• Linx in morbid obesity (BMI > 35)• Linx with sleeve gastrectomy
  26. 26. Defining the LINX® Patient Examples
  27. 27. Examples• 45 year old male• Heartburn is primary symptom• Double dose PPI for last 3 years• pH < 4.5 10%• Normal esophageal motility• Normal EGD• 2 cm sliding hiatal hernia• Completely satisfied on current PPI regimen• LINX Patient?
  28. 28. Examples• 24 year old female• Chest pain is primary symptom• Single dose PPI for last 6 months• pH < 4.5 - 6%• Normal esophageal motility• Normal EGD• Carries diagnosis of fibromyalgia• Absolutely no improvement in GERD symptoms on PPIs• LINX Patient?
  29. 29. Examples• 51 year old male• Heartburn is primary symptom• Single dose PPI for last 10 years• pH < 4.5 - 11%• Normal esophageal motility• Normal EGD• PPI controls heartburn symptom• Recent onset of night time regurgitation• 3 cm hiatal hernia• LINX Patient?
  30. 30. Examples• 58 year old female• Heartburn is primary symptom• Double dose PPI for last 10 years• pH – Bravo has failed twice and can’t tolerate catheter-based pH• Normal esophageal motility• Normal EGD• PPI controls most of symptoms, some breakthrough, concerned about osteoporosis and reports of hip fracture when on PPIs• No hiatal hernia• LINX Patient?
  31. 31. Examples• 72 year old male• Chest pain and regurgitation are primary symptoms• Double dose PPI for last 15 years• pH < 4.5 – 8%• Normal esophageal motility• EGD with irregular SCJ – biopsy with non-dysplastic Barretts• History of short segment Barretts with – Halo ablation 6 months earlier• PPI does not control symptoms• 3 hiatal hernia• LINX Patient?
  32. 32. Examples• 18 year old male• Chest pain and heartburn• Single dose PPI for last 2 years• pH < 4.5 – 8%• Normal esophageal motility• EGD with eosinophilic esophagitis• PPI does not control symptoms• No hiatal hernia• LINX Patient?
  33. 33. Examples• 23 year old female• Hoarseness and chronic cough are primary symptoms• Double dose PPI for last 5 years• pH < 4.5 – 2% on PPIs, Impedence pH with non-acid reflux episodes without correlation to symptoms• Esophageal motility with disordered peristalsis, but 70% peristaltic and body pressure of 35 mm Hg• EGD normal• PPI helps some• No hiatal hernia• LINX Patient?
  34. 34. Summary / Principles• Linx is a safe and effective tool for the management of GERD• In carefully selected patients outcomes are excellent and reproducible across a variety of settings• The maintenance of these good outcomes will be critical to gaining acceptance and reimbursement for this treatment option• Tight adherence to strict work-up, selection criteria and operative technique is critical to achieving the consistent and good outcomes achieved in the Pivotal Trial and needed for the ongoing success of this offering
  35. 35. Summary / Principles• We should agree as thought leaders in the field to adhere to these principles in offering Linx to our patients• Extended inclusion criteria use should be done through agreed upon study so as to segregate data and outcomes• if we do this we can help assure the advancement of our field through responsible introduction of new techniques to clinical practice
  36. 36. Discussion

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