Introducing Linx to Practice

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

Text of Introducing Linx to Practice

  • 1. LINX Reflux Management System: Best Practices MeetingFriday, May18, 2012

2. Establishing the LINX System as a SurgicalOfferingC. Daniel Smith, MDChair, Department of SurgerySurgeon-in-Chief Mayo Clinic in Florida 3. Disclosure- Co-PI for one of the sites who participated in thePivotal Trial- Advisor/consultant to Torax for preparation of thepresentation to FDA- Joined company for presentation to FDA- Paid consultant to company helping with safeand successful introduction of Linx to care ofGERD patients 4. Goals for This Portion of Discussion- Im not going to tell anyone in audience anythingthat they dont already know- Offer perspective on current surgical treatmentfor GERD (Nissen fundoplication)- Where would Linx fit in surgical practice- What is the Linx patient- Propose principles for use in our practices 5. Fundoplication- Great operation- Select patients do very well- Superior to PPIs- Significant positive impact on natural history ofGERD- Multiple studies have confirmed its effectivenessand role in treatment of GERD 6. Current Treatment Options for GERD FundoplicationSurgery PPI Therapy PPI TherapyNo. GERD PatientsFundoplicationSurgery Severity of Symptoms and DissatisfactionMild Severe 7. Fundoplication- Use of fundoplication for GERD has peaked, usehas been slowly declining- GIs have largely stopped referring patientsexcept for desperate or complicated cases- Most cases are done for complicated conditions(redo, large hiatal hernia, Barretts, severerefractory GERD- PPIs remain treatment of choice for all but themost severe cases of GERD 8. Fundoplication Why Not- Multifactorial- Technical failures inconsistent and questionable outcomes- Lack of standardized approach/technique- Inconsistent use patients still have fundoplication performedwithout objective confirmation fo GERD- Patients are afraid of the operation troubling side-effects ofgas bloat and excess flatus or perception that failure rate is50%- GIs refuse to refer all of the above and/or strong belief that itis a bad operation- Competing treatments primarily PPIs, some endolumenalapproaches 9. Two Predictors of Surgical OutcomeFundoplicationPatient SelectionOperative Technique Patients without objective 2 stitch, three stitch, four stitchconfirmation of GERD Esophageal stitch, how many andlocation Patients who fail to respond Pledgets for wrap or crural repairto 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 outcomespatient has been difficult 10. Current Treatment Options for GERD No standard treatment for Gap patients Targeted LinxPPI Therapy populationTherapy GapNo. GERD Patients Fundoplication SurgerySeverity of Symptoms and DissatisfactionMild Severe 11. Pivotal TrialKey Outcomes 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 use0 10 20 30 40 50 607080 90 100 13. Efficacy Endpointsby Baseline Hernia Assessment (3 cm)Primary Efficacy Endpoint Component No HerniaAll PatientsNormalization (pH 50% reduction from baseline 77% (33/43) 63.5% (61/96)Either normalization or > 50% reduction 79% (34/43) 66.7% (64/96) 14. PPI Free DaysAs of Last Follow-Up900800700600PPI Free Days500400300200100 0 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. Reduced Gas BloatSeverity of Gas BloatFREQUENTLYCONTINOUSLY100Percent of Patients Reporting806040200Baseline 12 Month Post LINX 24 Month Post LINXNote: As actively queried by Foregut Questionnaire 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. The Successful LINX Patient Post-LINXBaseline% of Pts% of PtsCharacteristic2 Years 100% Daily PPI dependence8%70% Reflux affecting their sleep on a daily basis 2%76% Reflux affecting their food tolerances on a daily 2%basis57% Moderate or severe regurgitation including1%aspirations55% Severe heartburn affecting their daily life 1%51% Experiencing extra esophageal symptoms in addition 12%to heartburn and/or regurgitation40% Esophagitis11% 19. How Were Good Results Achieved Rigorous adherence to patient selection and standardizedsurgical technique (arguably, even tighter adherence tostandardized surgical technique would have improvedoutcomes even further) pHGERD-HRQLPPI Use Hernia at BaselineNEndpointEndpoint Endpoint Success SuccessSuccess None44 77% 89%91% Yes repaired30 67% 100% 97% Yes not repaired26 39% 89%92%pH Endpoint Success95% CI No hernia or hernia repaired 73.0% (54 / 74)61.4, 82.7% 20. Two Predictors of Surgical OutcomeLINX Patient Selection Operative Technique Tight control on patient Device that results inselectionpredictable Dont go after extended response/performanceinclusion criteria patients Standard technique for Work closely with GI to assure placementfull diagnostic work-up andconsistent patient selection If any question of hiatal defect, approximate Consistent patient instructionsto establish expectationscrura with stitch(es)(dysphagia is common, dietprogression 21. Defining the LINX Patient 22. Key Pivotal IDE Eligibility CriteriaInclusion Age 18-75 years Typical GERD symptoms >6 months Pathologic GERD (esophageal pH4.5% of time) Daily PPI use Symptomatic improvement on PPIsExclusion Hiatal hernia (>3cm) Esophagitis Grade C or D (LA classification) Barretts esophagus Esophageal motility disorder 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 despitemaximum medical therapy for the treatment of reflux. 24. Patient Selection Per Labeling PRECAUTIONS1. Hiatal hernia >3 cm These2. Barretts esophagus PRECAUTIONS are3. Esophagitis grade C or D based on theinclusion/exclusion 4. Electrical implants or metallic abdominal implants criteria of the5. Major motility disorders pivotal study. 6. Scleroderma7. Esophageal or gastric cancerPatients outside of 8. Dysphagia greater than once per week within the last 3 months these9. Esophageal or gastric surgery or endoscopic interventionPRECAUTIONS have10. Distal amplitude 35) Linx with sleeve gastrectomy 26. Defining the LINX Patient Examples 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. 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 onPPIs LINX Patient? 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. Examples 58 year old female Heartburn is primary symptom Double dose PPI for last 10 years pH Bravo has failed twice and cant toleratecatheter-based pH Normal esophageal motility Normal EGD PPI controls most of symptoms, somebreakthrough, concerned about osteoporosis andreports of hip fracture when on PPIs No hiatal hernia LINX Patient? 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-dysplasticBarretts History of short segment Barretts with Haloablation 6 months earlier PPI does not control symptoms 3 hiatal hernia LINX Patient? 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. Examples 23 year old female Hoarseness and chronic cough are primarysymptoms Double dose PPI for last 5 years pH < 4.5 2% on PPIs, Impedence pH with non-acidreflux episodes without correlation to symptoms Esophageal motility with disordered peristalsis, but70% peristaltic and body pressure of 35 mm Hg EGD normal PPI helps some No hiatal hernia LINX Patient? 34. Summary / Principles Linx is a safe and effective tool for the management ofGERD In carefully selected patients outcomes are excellentand reproducible across a variety of settings The maintenance of these good outcomes will be criticalto gaining acceptance and reimbursement for thistreatment option Tight adherence to strict work-up, selection criteria andoperative technique is critical to achieving theconsistent and good outcomes achieved in the PivotalTrial and needed for the ongoing success of this offering 35. Summary / Principles We should agree as thought leaders in the field toadhere to these principles in offering Linx to ourpatients Extended inclusion criteria use should be done throughagreed upon study so as to segregate data andoutcomes if we do this we can help assure the advancement ofour field through responsible introduction of newtechniques to clinical practice 36. Discussion