other treatments for gerd… lee l swanstrom md, facs division of minimally invasive surgery legacy...
TRANSCRIPT
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Other treatments for GERD…
Lee L Swanstrom MD, FACS
Division of Minimally Invasive SurgeryLegacy Health System
Portland, OR
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Medical treatment of GERD is flawedflawed::
• It is palliative only
• It doesn’t always work
• It doesn’t stop reflux
• It doesn’t alter the progression of Barrett’s to cancer
• It is expensive
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PPI-associated Complications PPI-associated Complications Increase Over TimeIncrease Over Time
Increased risk of acute coronary syndrome when used with Plavix 1
Increased gallbladder motility 2
Increased bacterial gastroenteritis 3 Increased risk of Clostridium difficile colitis 4 Decreased innate immunity 5
1
5
10
Years on PPI
therapy
References1 Ho et al. JAMA 2009; 20:1364-7. 2 Cahan et al. Surg Endosc 2006; 20:1364-7. 3 Garcia Rodriguez et al. Clin Gastroenterol Hepatol 2007;
5:1418-23. 4 Cadle et al. Am J Health Pharm 2007; 64:2359-2363. 5 Alkim et al. Dig Dis Sci 2008; 53:347-51. 6 Jalving et al. Aliment Pharmacol Ther 2006; 24:1341-8. 7 Targownik et al. CMAJ 2008;179:319-26. 8 Geevasinga et al. Clin Gastroenterol Hepatol 2006; 4:597-4.
Increased renal failure 8
Increased risk of hip fracture 7
Increase of osteoporosis-associated
fractures 7
4x the risk of gastric polyps 6
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The problem with The problem with laparoscopic fundoplication…laparoscopic fundoplication…
• Can be dangerous
• Expensive ($13,500 at Legacy)
• Side effects can outweigh benefits for early or mild disease
• Not enough surgeons, ORs, time or energy to do lap Nissen on everyone
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Other options?
• Gastric bypass
• Endoluminal treatments
• Gastric emptying
• Laparoscopic Prosthesis
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Roux-en-Y Gastric Bypass• Most frequently performed
bariatric procedure in the US
• First done in 1967
• Some technical modifications since (stomach is cut)
• Laparoscopically since 1993
• 60 –80% loss EBW
• 75 – 80% effective control of reflux
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Endoluminal antireflux surgery:
• Radiofrequency ‘scarring’ of the LES (STRETTA)– FDA approved 2/20/00
• Bard Sewing machine “endoplication” (Endocynch)– FDA approved 2/20/00
• Endoscopic intramuscular injections (Enteryxx)– Approved under PMA 6/03
• Transgastric / endoscopic repair (N-do)– National trials 9/03
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Esophafix(Endogastric Solutions)
“World's First Endoluminal Fundoplication”Brussels team performs world's first endoluminal fundoplication (100%
trans-oral incision-less) with clinical aim of curing gastroesophageal reflux disease (GERD).
Nissen
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TIF HighlightsTIF Highlights• TIF has been used in eight unbiased clinical studies • Those clinical studies demonstrate that:
– TIF is safe
– TIF restores the GE valve anatomy and function
– Results have been proven measuring:
» Symptoms and quality of life
» Use of PPIs
» Impedance
» pH-metry
» Manometry
– TIF2 improves on TIF1
– TIF is more effective than EndoCinch or Plicator
• Additional clinical studies on the TIF Procedure are underway
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10 Clinical Studies = 6 10 Clinical Studies = 6 Completed + 4 In ProgressCompleted + 4 In Progress
Study (n) Available Data (n) Study Status Published
TIF1:
- Feasibility (19) 2 yrs (14) Completed Yes- Multicenter (86) 2 yrs (51) 3-yr in progress
No- Redo (15) 6 mo (15) Completed No- Registry Fraser (20) 7 mo (20) Completed No- Registry Bouvy (38) 10 mo (38) Completed No
TIF2: - Feasibility (10) 6 mo (10) Completed Yes- Randomized vs. PPIs (120) 6 mo (14) Enrolling n/a
- Feasibility in children (14) 3 mo (14) Completed n/a
- RCT vs. Sham (60) n/a EC review n/a
- RCT vs. LNF in children (300) n/a EC review n/aRCT –randomized controlled trial
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Current strategy
Chronic GERD symptoms
Comprehensive evaluation[EGD, 24 hr pH, motility]
Severe diseaseHigh DeMeester, esophagitis, Barrett’s, stricture, etc
Mild disease
Endoscopic ARSLaparoscopic ARS
Breakthrough reflux post lap ARS
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Highest Magnetic Resistance
Lowest Magnetic Resistance
Expands during swallow allowing food to enter stomach
Reinforces the LES restoring the barrier function
LINX™ Reflux Management System
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LINX™ Design
– Device Design
• Titanium beads with magnetic cores
• Linked together by titanium wires
– Links limit expansion distance between beads
– Resists sphincter relaxation while allowing normal physiological
function (swallowing, belching, etc)
– Mechanism of Action: Increased yield pressure of LES
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Barium Swallow: 1 Day Post-Op
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LINX™ Procedure
Dissect Size SecurePlace
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Healing Response: Porcine Explant (4 mo)
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Clinical Outcomes - Feasibility1
pH Normalization 79%No PPI Use 89%Median HRQL Reduction 96%
Median Total Acid Exposure
8.4
1.10
1
2
3
4
5
6
7
8
9
Baseline 3 month Follow Up
% T
ime
pH
< 4
1 – Bonavina, J Gastrointetinal Surg. 2008
87% Reduction
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Pivotal Trial
• Prospective, multi-center, single-arm study– Patient as their own control
• N=100 subjects
• Target Indication - subjects diagnosed with pathologic GERD as defined by abnormal pH scores and incomplete clinical response from medical therapy
• Primary endpoint – Normalized or >50% reduction in acid exposure @ 1 year
• Secondary Endpoints– >50% reduction in GERD HRQL @ 1 year– >50% reduction in PPI use @ 1 year
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Conclusions:
• Reflux is a disease – it presents in a continuum of symptoms and causes. It varies with individuals
• Treatments must be individualized to the patient’s psychology and physiology