PPT presentation on endoluminal anti-reflux surgery to be given at International Conference on the Stomach, Mumbai (India) Dec 5th 2010

1. 1
Dr. Elliot R Goodman Nuffield Health Leeds HospitalDr. Elliot R Goodman Nuffield Health Leeds Hospital
Transoral IncisionlessTransoral Incisionless
Fundoplication (TIF)Fundoplication (TIF)
for the Treatment of GORDfor the Treatment of GORD

2. 2
The TRUE Cost of GORD is treating the Co-MorbiditiesThe TRUE Cost of GORD is treating the Co-Morbidities
Co-morbidity
% of Patients with
GERD
Comorbidities
Mean Drug Payments
Mean Medical
Payments
Encounter for Preventive Health
Services 59.29 % $2,344 $9,608
Other Gastrointestinal or Abdominal
Symptoms 35.60 % $2,423 $14,308
Other Arthropathies, Bone and Joint
Disorders 29.78 % $2,980 $14,223
General Signs, Symptoms, and
Ill-Defined Conditions
27.26 % $2,897 $16,581
Lipid Abnormalities 27.18 % $2,779 $9,494
Other Respiratory Symptoms 24.72 % $2,840 $18,221
Essential Hypertension 23.89 % $3,057 $13,225
Other Ear, Nose and Throat Disorders 20.49 % $2,622 $11,079
Other Inflammations and Infections of
Skin and Subcutaneous Tissue 18.42 % $2,733 $11,428
MarketScan 2007 Commercial – Thompson Reuters
Example: In this 2007 MarketScan, analysis of all patients claims forExample: In this 2007 MarketScan, analysis of all patients claims for respiratory symptomsrespiratory symptoms
found thatfound that 24.72% of these patients also had a diagnosis of GERD24.72% of these patients also had a diagnosis of GERD. These Respiratory/GERD. These Respiratory/GERD
patients consumed $2,840 in GERD pharmaceutical expenses, plus $18,221 in Medical paymentspatients consumed $2,840 in GERD pharmaceutical expenses, plus $18,221 in Medical payments
to treat their respiratory condition which may be caused or aggravated by GORD.to treat their respiratory condition which may be caused or aggravated by GORD.

3. 3
GORD is a progressive, deterioration of the
OG junction
Hill Grade IV
requires very
invasive surgery
that may involve a
thoracotomy

4. 4
American Gastroenterological Association (AGA)
recommendations for management of GORD:
 Diet
 Activity
 Medication
 Surgery
– antireflux operations
• Belsey Mark IV operation - 270 degree wrap, left thoracotomy,
transthoracic fundoplication
• Nissen (transabdominal) fundoplication - 360 degree wrap via
abdomen, also done via laparoscopic or thoracic approach
• Hill (transabdominal) repair (posterior gastropexy) - uses arcuate
ligament to re-establish intra-abdominal position of distal esophagus,
270 degree wrap
• Toupet (laparoscopic) fundoplication - 270 degree posterior wrap

5. Repairs the underlying anatomic pathology of the disease by:
1. Wrapping of the fundus and cardia around the lower esophagus
2. Full thickness plication with permanent suturing of esophagus and
stomach
3. Restoring or lengthening the intra-abdominal esophageal length
4. Recreating the angle of His
5. Augmenting high pressure zone of esophagus
6. Closing the crural defect in the presence of a hiatal hernia.
Principles of Antireflux SurgeryPrinciples of Antireflux Surgery

6. Toupet repair & Nissen fundoplication
In the Toupet repair, the fundus is wrapped 270 degrees around
the distal esophagus. Securing the fundoplication entails
suturing the fundus on either side of the esophagus.
Identification of the anterior vagal branch helps prevent
incorporation into a suture. Suturing the lateral aspects of the
wrap to the crural edges stabilizes the repair. (Source: Peters,
JH, DeMeester, T (eds). Minimally Invasive Surgery of the
Foregut. St Louis, MO: Quality Medical Publishing; 1994, with
permission)

7. Repairs the underlying anatomic pathology of the disease by:
1. Wrapping of the fundus and cardia around the lower esophagus
2. Full thickness plication with permanent suturing of esophagus and
stomach
3. Restoring or lengthening the intra-abdominal esophageal length
4. Recreating the angle of His
5. Augmenting high pressure zone of esophagus
6. Closing the crural defect in the presence of a hiatal hernia.
Principles of Antireflux SurgeryPrinciples of Antireflux Surgery
TIFTIF
TIFTIF
TIFTIF
TIFTIF
TIFTIF
TIFTIF
TIFTIF
Patients with less than 2 cm hiatal hernia are TIF candidates.Patients with less than 2 cm hiatal hernia are TIF candidates.
Larger hiatal defects require invasive surgical interventionLarger hiatal defects require invasive surgical intervention

8. Toupet repair & TIF
• Tighten ARB
• Lengthening of HPZ
• Reducing distal esophageal perimeter
• Recreating the mechanical dynamics of the
Angle of His
• 270 degree wrap around the esophagus
• Hiatal hernia reduced 2cm or less
Toupet repair & Transoral Fundoplication
In the Toupet repair, the fundus is wrapped 270 degrees around
the distal esophagus. Securing the fundoplication entails
suturing the fundus on either side of the esophagus.
Identification of the anterior vagal branch helps prevent
incorporation into a suture. Suturing the lateral aspects of the
wrap to the crural edges stabilizes the repair. (Source: Peters,
JH, DeMeester, T (eds). Minimally Invasive Surgery of the
Foregut. St Louis, MO: Quality Medical Publishing; 1994, with
permission)
o TIF Leverages the experience and success of Endoscopy with the gold standard treatment for
GERD.
o TIF is a full thickness, Esophagogastric fundoplication utilizing poly-propylene suture
material.
o TIF is the next logical step in the progression for a fundoplication from a thoracic, to
abdominal, to laparoscopic and now endoscopic.

9. 9
TIF repairs the underlying anatomic pathology of the disease by:
1. Wrapping of the fundus and cardia around the lower esophagus
2. Full thickness plication with permanent suturing of esophagus and stomach
3. Restoring or lengthening the intra-abdominal esophageal length
4. Recreating the angle of His
5. Augmenting high pressure zone of esophagus
6. Closing the crural defect in the presence of a hiatal hernia.

10. Endoscopic view of TIF
3 weeks after procedure
St Joseph Pontiac
Endoscopic view of
2X Nissen revision
Detroit Medical Center
Endoscopic view of TIF
Text Book view of Nissen,
Dr. B Jobe

11. RF Energy Injection/Implantation Plication/Suturing Surgical Implant
NDO Plicator
EndoCinch
Gatekeeper
EnteryxStretta
Angelchik
Endoluminal Therapies for GERD:
Unless a products or procedures produces an esophagogastric
fundoplication, it is experimental.
TORAX Linx
Faile
Faile

12. New SAGES Position Statement
 Endolumenal Therapy (ELT)
– Transoral incisionless approach for
reconstructive surgical procedures
 SAGES position statement on ELT
1. Positions ELT as the Future of
Surgery
2. Endorses ELT approach as a
benefit in safety and recovery
time of patients and their
employers
3. Represents ELT as the up-in-
coming procedure of choice for
GORD patients
4. Aggressively supports the
reimbursement of these
procedures

13. American Society of General Surgeons

14. Surgery
 Surgery
– antireflux operations
• in general - increases lower esophageal sphincter (LES) tone, involves
vagotomy, fundoplication = create ring around LES (wrap with gastric
fundus)
• Belsey Mark IV operation - 270 degree wrap, left thoracotomy,
transthoracic fundoplication
• Nissen (transabdominal) fundoplication - 360 degree wrap via
abdomen, also done via laparoscopic or thoracic approach
• Hill (transabdominal) repair (posterior gastropexy) - uses arcuate
ligament to re-establish intra-abdominal position of distal esophagus,
270 degree wrap
• Toupet (laparoscopic) fundoplication - 270 degree posterior wrap
• Transoral Incisionless Fundoplication – 270-310 degree wrap,
Transoral Fundoplication for patients with hiatal defect of less than
2cm.

15. Sustained Long-term Effectiveness and SatisfactionSustained Long-term Effectiveness and Satisfaction
GERD-HRQL scores
improved >50%
88% 66%-75% 53%* 73% (86%) 64%* 84%
Off daily PPIs 80% 79%-82% 82% 85% (86%) 79% 84%
Acid exposure
normalized
67% 42%-50% 63% 37% (48%) N/A N/A
Esophagitis
reduced
67% 50%-53% N/A 62% (80%) 50% N/A
Hiatal hernia
reduced
89% 75%-85% 62% 60% (89%) 60% N/A
Satisfaction 80% 50%-70% 82% 65% (89%) 86% 78%
* vs. baseline ON PPIsReferences
1
(n=58) Bouvy (unpublished) n=10
2
(n=20) Youd, Sivanesan, Emmanuel, et al. Endosc (in preparation)
3
(n=38) Bouvy (unpublished)
4
(n=17) Cadière, Rajan, Germay, et al. Surg Endosc 2008; 22: 333-342.
5
(n=79) Cadière, Buset, Muls, et al. World J Surg 2008; 32:1676-1688.
6
(n=14) Cadière, Van Sante, Graves, et al. Surg Endosc 2009; 23: 957-964.
7
(n=51) Costamagna, Marchese, Eckardt, et al. Surg Endosc (in preparation).
6 mo 7-10 mo 1 yr 2 yrs

16. 16
 Adverse Events:
– Few, mild and transient
– Throat, left-shoulder and abdomen pain most commonly reported
– Resolve in 100% of patients within 2-3 weeks
 Serious Adverse Events (rates per 2,150 cases world-wide):
– 3 (0.14%) Perforations upon device insertion
– 3 (0.14%) Pleural effusion
– 3 (0.14%) Esophageal leak
– 3 (0.14%) Intraluminal bleeding
– 2 (0.09%) Mediastinal abscess
Studies Showed that TIF is SafeStudies Showed that TIF is Safe

17. 17
TIF is Safer than Lap Anti-reflux Surgery (ARS)
TIF
(2,150 cases)
Lap ARS
 Intraoperative complications:
- Perforations
- Esophageal leaks
- Intraluminal bleeding
- Pleural effusion
- Mediastinal abscess
- Splenectomy
- Mortality
0.1%
0.1%
0.1%
0.1%
0.1%
0.0%
0.0%
1-4%
2%
1-6%
1%
1%
0.9%
0.5-3%
 Postoperative complications:
- Abdominal pain
- Dysphagia
- Diarrhea
- Gas bloat
- Nausea
- Herniation
9-14%
4-11%
0-5%
3-59%
2-11%
0.0%
10-40%
44-90%
18-20%
10-82%
8-21%
1-14%
 Long-term complications:
- Chronic dysphagia
- Gas bloat syndrome
0%
0%
2-6%
9-62%
References for TIF
Barnes (unpublished). Bell
(unpublished). Cadiere (2008)
Cadiere (2009). Demyttenaere
(2009). Hoddinott
(unpublished).Testoni (2010)
References for LARS
Funch-Jensen (2008). Hahnloser
(2002). Hunter (1996). Jobe (1997).
Lind T (2000). Lundell (2004).
Pearson (1997). Urschel (1993).
Varin (2009). Waring (1999).

18. 19
Consistently 8 out of 10 patients remain off PPIs after TIF1
Single-center Multi-center Investigator-
initiated
1 yr
n=171
2 yrs
n=142
(Hill I Tight)
1 yr
n=79 (n=21) 3
2 yrs
n=544
3 yrs
n=45**4
6-10 mo
n=20-385-9
GERD-HRQL
Scores improved >50%
53%* 64%* 73% (86%) 83% 85%** 66-75%
Off daily PPIs 82% 79% 85% (86%) 80% 72%** 53-82%
Acid exposure
normalized
63% N/A 37% (48%) N/A 100%
(6/6)
31-42%
Esophagitis
reduced
N/A 50% 62% (80%) N/A 62%** 50-53%
Hiatal hernia
reduced
62% 60% 60% (89%) N/A 60%** 75%-81%
* vs. Pre-TIF ON PPIs; N/A - not available
** Partial results - Follow-up in progress
References
1
Cadière, Rajan, Germay, et al. Surg Endosc 2008; 22: 333-42, 2
Cadière, Van Sante, Graves, et al. Surg Endosc 2009; 23: 957-94
3
Cadière, Buset, Muls, et al. World J Surg 2008; 32:1676-88, 4
Muls, Marchese, Eckardt, et al. GI Endosc (in preparation)
5
Bouvy (unpublished), 6
Demyttenaere, Pham, Anderson, et al. Surg Endosc 2009 (ePub), 7
Repici, Fumagalli, Malesci, et al. J Gastrointest Surg
2009 (ePub) 8
Testoni, Corsetti, Di Pietro, et al. World J Surg (in press),9
Youd, Emmanuel, Sivanesan, et al. Endosc (submitted)

19. 20
Sustained Effectiveness and SatisfactionSustained Effectiveness and Satisfaction
1 yr 2 yrs 1 yr 2 yrs 3 yrs
n=17 1
n=14 2 n=79 3
n=54 4
n=45 4
GERD-HRQL
scores improved >50%
53%* 64%* 73% 84% 85%*
Off daily PPIs 82% 79% 85% 80% 72%*
Acid exposure
normalized
63% n/a 37% n/a 100%
(6/6)*
Satisfaction 82% 86% 65% 72% 70%*
* vs. baseline ON PPIs
References
1
Cadière, Rajan, Germay, et al. Surg Endosc 2008; 22: 333-42
2
Cadière, Van Sante, Graves, et al. Surg Endosc 2009; 23: 957-64
3
Cadière, Buset, Muls, et al. World J Surg 2008; 32:1676-88
4
Muls, Marchese, Eckardt, et al. Gastrointest Endosc (to be submitted in Apr 2010)
N/A - not available, * Partial results - Follow-up in progress
Single-center Multi-center

20. 22
 Inclusion Criteria:
– Chronic symptomatic GERD for > 6 months
– Controlled or persistent typical or atypical GERD symptoms on PPI therapy
– Reflux confirmed by:
• Moderate to severe GERD symptoms while off or on PPIs and
• Pathologic esophageal pH testing or
• Esophagitis (Los Angeles grade A, B or C)
– Deteriorated gastroesophageal junction (Hill grade II or III)
 Exclusion Criteria:
– BMI > 35
– Irreducible hiatal hernia > 2 cm
– Esophagitis grade D
– Esophageal ulcer, fixed stricture or motility disorders
– Dysphagia
– Pregnancy or plans of pregnancy in the next 12 months
Patient Selection Criteria for TIFPatient Selection Criteria for TIF