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

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
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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
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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
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4. Mechanical Sphincter Augmentation
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5. Mechanical Sphincter Augmentation
LINX
Bead
Fibrous
Capsule
In-tact
Muscular
Layer
Mucosa
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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
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7. Linx – Procedure
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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
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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
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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
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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
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12. Assessment – MSA Introduction
• Operative / procedure related complications
• PPI use
• GERD-HRQL
• Satisfaction with GERD condition
• Subsequent GI testing or interventions
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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. 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
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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%)
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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
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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
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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
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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
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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
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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
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