Early Results With Linx and Lessons for Implementation in Practice

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Paper delivered at 2013 annual meeting of the Southern Surgical Association in Hot S

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  • Our goals when deliver healthcare should be to provide the right care, to the right patient, at the right time. It is critical that we do that will maintaining or increasing the value of the healthcare we deliver. In doing this variability is the enemy.
  • Early Results With Linx and Lessons for Implementation in Practice

    1. 1. Introduction of Mechanical Sphincter Augmentation for GERD into Practice: Early Clinical Outcomes and Keys to Successful Adoption Southern Surgical Association 125th Annual Session December 3, 2012 The Homestead Hot Springs, Virginia C. Daniel Smith, MD 1
    2. 2. Conflict of Interest / Disclosures • Co-PI for Pivotal Trial Implanting Center • Advisor to Torax for preparation of presentation to FDA Advisory Panel • Presented clinical outcomes data to FDA Advisory Panel • Paid consultant to Torax helping guide safe and successful introduction to practice 2
    3. 3. Mechanical Sphincter Augmentation • FDA approved March 22, 2012 • Developed and tested over 10 years • In US 621 implants at 41 centers (1325 world wide)* • To date, 5 publications covering 244 patients (100 U.S.) followed for up to 6 years *as of October 31, 3013 3
    4. 4. Mechanical Sphincter Augmentation 4
    5. 5. Mechanical Sphincter Augmentation LINX Bead Fibrous Capsule In-tact Muscular Layer Mucosa 5
    6. 6. Mechanical Sphincter Augmentation Normal Peristaltic Pressures 35-80 mm Hg Mechanical Sphincter Opening Pressure 20-25 mm Hg Gastric Pressures 5-10 mm Hg CLOSED to Reflux OPEN to Swallowing 6
    7. 7. Linx – Procedure 7
    8. 8. Study Aims – MSA Introduction • Review early experience of introduction of MSA to mature foregut practice • Assess peri-operative & early clinical outcomes • Analyze patient selection & post-operative management seeking to optimize successful introduction into practice 8
    9. 9. Background – MSA Introduction • Managed within a well established foregut surgery program • Senior gastroenterologist and senior GI surgeon (20+ years of experience each) • All patients underwent standardized evaluation pH testing Esophageal motility EGD Barium swallow • Gastroenterologist consultation with all candidates early, selectively later in series 9
    10. 10. Patient Selection – MSA Introduction • Abnormal reflux study (abnormal pH or non-acid reflux on impedance pH testing) • Adequate esophageal motility • No active esophagitis or significant Barrett’s (LS) • Hiatal hernia < 3cm • PPI responsive GERD • No prior esophageal surgery • Comfortable with new device / technology 10
    11. 11. Peri-operative Care – MSA Introduction All foregut patients follow clinical pathway • Discharge when recovered form anesthesia and comfortable* • Regular diet immediately post-op* • Return to regular activity immediately unless cruroplasty* FUNDOPLICATION • One month POV / contact Overnight stay • PRN contact (phone, email) 30 days of liquid/soft diet 30 days restricted activity *Deviation from pathway for fundoplication patients 11
    12. 12. Assessment – MSA Introduction • Operative / procedure related complications • PPI use • GERD-HRQL • Satisfaction with GERD condition • Subsequent GI testing or interventions 12
    13. 13. Study Population – MSA Introduction 150 10/01/11 – 09/10/13 (interested) 82 68 (not candidate) (implanted) 04/01/12 – 09/26/13 2 (ineligible for study) 218 fundo pts • GERD • hiatal hernia • redo 66 (study patients) 1 65 (lost to followup) (studied)
    14. 14. Methods – MSA Introduction PATIENT DEMOGRAPHICS No. patients Age (yrs) Age > 60 Male:Female BMI BMI>30 Clinical History Hiatal hernia Barretts esophagus 66 53.7 (18-86) 10 (29%) 28:38 26.0 (17.6-34.1) 16 (24%) 44 3 pH % time < 4.0* DeMeester Score 9.7 (0.4-31.6) 32.3 (1.4-67) *9 patients with normal pH while on PPIs, and documented non-acid reflux 14
    15. 15. Results – MSA Introduction PERI-OPERATIVE DATA Successful Implantation Complications Cruroplasty 1st ½ of series 2nd ½ of series No. crural sutures (per case) 1st ½ of series 2nd ½ of series Length of stay Same day discharge 66 0 37 (56%) 26/33 (79%) 12/33 (36%) 1.0 (1-4) 1.0 (1-3) 2.0 (1-4) 0.75 17 (25%) 15
    16. 16. Results – MSA Introduction CLINICAL OUTCOMES Overall < 6 mon > 6 mon Follow-up in 65* (mon) 5.8 (1-18.6) 39 (60%) 26 (40%) Off PPI 54/65 (83%) PPI Dose (none, PRN, QD, BID) GERD-HRQL Satisfaction (satisfied or neutral) 38/46 (83%) 21/26 (81%) 54,1,7,3 38,2,3,3 21,0,5,0 6 8 2 60/65 (92%) 37/42 (88%) 23/25 (92%) *1 patient lost to follow-up 16
    17. 17. Results – MSA Introduction ADDITIONAL TESTING / INTERVENTIONS Total Contrast Swallow EGD Dilation pH test* Esophageal motility Ulcers or Erosions Device removal 13 (20%) 12 9 4 5 1 0 0 *4 of 5 normalized, 1 significantly decreased 17
    18. 18. Results – MSA Introduction Response Over Time 120 Satisfaction Off PPIs 100 80 % 60 40 20 0 Overall < 6 Months 6-12 Months > 12 Months 18
    19. 19. 3-6 Month Issues – MSA Introduction • Dysphagia Delayed yet steady recovery of bolus transit “Be patient” • Esophageal clearance of saliva/liquid Steady & progressive improvement “Be Patient” Use saltine crackers to help absorb and form bolus 19
    20. 20. Not a Fundoplcation – MSA Introduction • Minimal dissection and device under posterior vagus • Regular diet immediately – expect dysphagia and coach patients and nurses about this • Consistent augmentation pressure results in longer recovery time until esophageal bolus transit normal • More pooling of saliva and liquids in distal esophagus leading to perception of GERD and some frothy regurgitation • These patients are more sensitive to symptoms due newness of procedure & device versus natural tissue • “Hand holding” for up to a year before declaring failure 20
    21. 21. Conclusion - MSA • Promising new offering for GERD • Introduction to practice will require changes from how fundoplication candidates and patients are managed • Improved patient education and postoperative management should facilitate optimal use and patient response • IF one decides to use MSA, thoughtful patient selection and differentiation from fundoplication patients will be important for TEAM providing care 21

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