Other treatments for GERD…

Lee L Swanstrom MD, FACS

Division of Minimally Invasive SurgeryLegacy Health System

Portland, OR

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

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

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

Other options?

• Gastric bypass

• Endoluminal treatments

• Gastric emptying

• Laparoscopic Prosthesis

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

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

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

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

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

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

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

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

Barium Swallow: 1 Day Post-Op

LINX™ Procedure

Dissect Size SecurePlace

Healing Response: Porcine Explant (4 mo)

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

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

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