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Dr. Elliot R Goodman Nuffield Health Leeds Dr. Elliot R Goodman Nuffield Health Leeds HospitalHospital

Transoral Incisionless Transoral Incisionless Fundoplication (TIF) Fundoplication (TIF) for the Treatment of for the Treatment of GORDGORD

Transoral Incisionless Transoral Incisionless Fundoplication (TIF) Fundoplication (TIF) for the Treatment of for the Treatment of GORDGORD

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The TRUE Cost of GORD is treating the Co-The TRUE Cost of GORD is treating the Co-MorbiditiesMorbidities

The TRUE Cost of GORD is treating the Co-The TRUE Cost of GORD is treating the Co-MorbiditiesMorbidities

Co-morbidity% of Patients

with GERD Comorbidities

Mean Drug Payments

Mean Medical Payments

Encounter for Preventive Health Services 59.29 % $2,344 $9,608Other 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 $9,494Other Respiratory Symptoms 24.72 % $2,840 $18,221

Essential Hypertension 23.89 % $3,057 $13,225Other Ear, Nose and Throat Disorders 20.49 % $2,622 $11,079Other 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 for Example: In this 2007 MarketScan, analysis of all patients claims for respiratory respiratory symptomssymptoms found that found 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 patients consumed $2,840 in GERD pharmaceutical These Respiratory/GERD patients consumed $2,840 in GERD pharmaceutical expenses, plus $18,221 in Medical payments to treat their respiratory condition which expenses, plus $18,221 in Medical payments to treat their respiratory condition which may be caused or aggravated by GORD.may be caused or aggravated by GORD.

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GORD is a progressive, deterioration of the OG junction

Hill Grade IV requires very invasive surgery that may involve a thoracotomy

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American Gastroenterological Association (AGA) recommendations for management of GORD:

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

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 His5. Augmenting high pressure zone of esophagus6. Closing the crural defect in the presence of a hiatal hernia.

Principles of Antireflux SurgeryPrinciples of Antireflux SurgeryPrinciples of Antireflux SurgeryPrinciples of Antireflux Surgery

Toupet repair & Nissen fundoplicationToupet 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)

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 His5. Augmenting high pressure zone of esophagus6. Closing the crural defect in the presence of a hiatal hernia.

Principles of Antireflux SurgeryPrinciples of Antireflux SurgeryPrinciples of Antireflux SurgeryPrinciples of Antireflux Surgery

TIFTIF

TIFTIFTIFTIF

TIFTIFTIFTIFTIFTIFTIFTIF

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

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 FundoplicationToupet 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.

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TIF repairs the underlying anatomic pathology of the disease by:

1. Wrapping of the fundus and cardia around the lower esophagus2. Full thickness plication with permanent suturing of esophagus and

stomach3. Restoring or lengthening the intra-abdominal esophageal length4. Recreating the angle of His5. Augmenting high pressure zone of esophagus6. Closing the crural defect in the presence of a hiatal hernia.

Endoscopic view of TIF3 weeks after procedure

St Joseph Pontiac

Endoscopic view of2X Nissen revisionDetroit Medical Center

Endoscopic view of TIFEndoscopic view of TIF

Text Book view of Nissen,Dr. B Jobe

RF Energy Injection/Implantation Plication/Suturing Surgical Implant

NDO Plicator

EndoCinch

Gatekeeper

EnteryxStrettaAngelchik

Endoluminal Therapies for GERD:

Unless a products or procedures produces an esophagogastric fundoplication, it is experimental.

TORAX Linx

FaileFaile

dd

New SAGES Position StatementNew 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

Surgery2. 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

American Society of General Surgeons American Society of General Surgeons

SurgerySurgery

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.

Sustained Long-term Effectiveness and SatisfactionSustained Long-term Effectiveness and SatisfactionSustained Long-term Effectiveness and SatisfactionSustained Long-term Effectiveness and Satisfaction

GERD-HRQL scoresimproved >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 PPIsReferences1 (n=58) Bouvy (unpublished) n=102 (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

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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

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TIF is Safer than Lap Anti-reflux Surgery (ARS)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 TIFBarnes (unpublished). Bell (unpublished). Cadiere (2008) Cadiere (2009). Demyttenaere (2009). Hoddinott (unpublished).Testoni (2010)

References for LARSFunch-Jensen (2008). Hahnloser (2002). Hunter (1996). Jobe (1997). Lind T (2000). Lundell (2004). Pearson (1997). Urschel (1993). Varin (2009). Waring (1999).

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Consistently 8 out of 10 patients remain off PPIs after TIF1Consistently 8 out of 10 patients remain off PPIs after TIF1

Single-center Multi-center Investigator-

initiated  1 yr

n=171

2 yrsn=142

(Hill I Tight)1 yr

n=79 (n=21) 3

2 yrsn=544

3 yrs n=45**4

6-10 mon=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

References1 Cadière, Rajan, Germay, et al. Surg Endosc 2008; 22: 333-42, 2 Cadière, Van Sante, Graves, et al. Surg Endosc 2009; 23: 957-943 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)

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Sustained Effectiveness and SatisfactionSustained Effectiveness and SatisfactionSustained 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-HRQLscores 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

References1 Cadière, Rajan, Germay, et al. Surg Endosc 2008; 22: 333-422 Cadière, Van Sante, Graves, et al. Surg Endosc 2009; 23: 957-643 Cadière, Buset, Muls, et al. World J Surg 2008; 32:1676-884 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

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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