New and Emerging Treatments for
Benign Esophageal Disorders
Brian E. Louie MD, FACS, FRCSC, MHA, MPH
Director, Thoracic Research and Education
Co-Director, Minimally Invasive Thoracic Surgery Program
Asst. Program Director, MIS Thoracic and Foregut Fellowships
Division of Thoracic Surgery
Swedish Cancer Institute and Medical Center
Seattle, Washington
Missoula Medical Conference
September 11, 2015
Disclosures
Medical Advisory Board – Torax Medical
Objectives
• To compare and contrast the outcomes with antireflux
surgery and PPIs in the treatment of GERD
• To list the newer treatment options for GERD
• To review the construct and data related to magnetic
sphincter augmentation (LINX)
• To propose a new paradigm for GERD management
What is GERD?
…the passage of fluid and/or ingested
material from the stomach backwards
into the esophagus
…normal individuals experience some
GERD on a regular basis
The Reflux Barrier
Simple Concept
• allow passage of ingested
material into the stomach
• prevent retrograde
movement of stomach
contents into the
esophagus over a variety
of bodily positions and
pressure changes
Image Courtesy of Dr. Tom DeMeester
Fundamental Abnormality of GERD
Loss of an
effective sphincter
Composition of the
refluxed gastric
juice
Slide Courtesy of Dr. Tom DeMeester
Scope of the Problem
• 18.6 million Americans suffer from GERD
• Nearly 10 million office visits per year
• $5.8 billion in drug costs
• $3.5 billion in hospital and office costs
• $14.6 billion in lost productivity
American Gastroenterological Association, 2001
Scope of the Problem
• 40 – 50% of western populations have heartburn
monthly; 10% daily
• 50 million Americans have nighttime heartburn at least
once per week
• 65% of heartburn suffers had daytime and nighttime
symptoms
• 72% were taking prescription medications
• 45% reported the current treatments do not relieve all of
their symptoms
Gallup Poll for the American Gastroenterology Association, 2003
Typical Symptoms of GERD
Heartburn
• Burning sensation in the upper
abdomen that radiates toward
the head and felt beneath the
breast bone
• Made worse by meals, fatty
foods, caffeine containing
foods
• Often made better with
antacids (Tums) or medications
(Zantac, Prilosec)
Regurgitation
• Effortless return of acid or
bitter stomach contents into
the chest, throat or mouth
• Worse when lying down,
bending over
• Worse with bigger meals, fatty
meals
• Reduced volume with
medications
Atypical Symptoms of GERD
Respiratory
Chest Pain
• Chronic bronchitis
• Most commonly and
appropriately related to heart
problems
• 50% of severe chest pain with
normal heart tests related to
GERD
• Asthma and wheezing
• Also related to meal size
• Bronchiectasis
• Often pressure sensation
• Chronic cough
• Pneumonia
• Pulmonary fibrosis
• Difficult to define
Atypical Symptoms of GERD
ENT
•
Hoarseness
•
Sore or burning throat
•
Globus – lump in throat
•
Throat clearing
•
Trouble swallowing
•
Ear pain
•
Dysphonia
Other
• Dental erosions
Other Symptoms of GERD
• Dysphagia
– the sensation that food or liquid stick or do not pass from mouth to
stomach
• Bloating
– the sensation of fullness or distension of the upper abdomen
• Nausea and Vomiting
• Belching and hyperflatulence
The Spectrum of GERD
Type I
Normal
NERD
Hiatal Hernia
Type II
Type III
Healable
Esophagitis
Persistent
Esophagitis
Type IV
Barrett’s
Stricture (Schatzki to Fibrotic)
Shortened Esophagus
2 to 16
years
Adapted from Lord et al. J Gastrointest Surg 2009;13:602-610
GI Medicine
Surgical Reconstruction
>
Utilization of PPIs and H2RA
50
45
Rate per 1000 visits
40
35
30
25
20
15
10
5
0
1995
1996
1997
1998
1999
GERD Dx
2000
2001
PPI Use
Friedenberg et al. Digestive Disease and Science 2010; 55:1911-1917
2002
2003
H2RA Use
2004
2005
2006
Rise and fall of antireflux surgery
Finks Surg Endosc (2006) 20:1698-1701
Wang and Richter Diseases of the Esophagus (2011) 24:215-23
Continued (5-Year) Followup of a Randomized
Clinical Study Comparing Antireflux Surgery and
Omeprazole in Gastroesophageal Reflux Disease
L Lundell, MD, P Miettinen, MD, HE Myrvold, MD, SA Pedersen, MD, B Liedman, MD,
JG Hatlebakk, MD, R Julkonen, MD, K Levander, MD, J Carlsson, BSc, M Lamm, BSc, IWiklund, PhD
BACKGROUND: The efficacy of antireflux surgery (ARS) and proton pump inhibitor therapy in the
control of gastroesophageal reflux disease is well established. A direct comparison between these
therapiesis warranted to assess the benefits of respective therapies.
STUDY DESIGN: There were 310 patients with erosive esophagitis enrolled in the trial. There
were 155 patients randomized to continuous omeprazole therapy and 155 to open antireflux
surgery, of whom 144 later had an operation. Because of various withdrawals during the study
course, 122 patients originally having an antireflux operation completed the 5-year followup; the
corresponding figure in the omeprazole group was 133. Symptoms, endoscopy, and quality-of-life
questionnaireswere used to document clinical outcomes.Treatment failure was defined to occur if
at least one of the following criteria were fulfilled: Moderate or severe heartburn or acid
regurgitation during the last 7 days before the respective visit; Esophagitis of at least grade 2;
Moderate or severe dysphagia or odynophagia symptoms reported in combination with mild
heartburn or regurgitation; If randomized to surgery and subsequently required omeprazole for
more than 8 weeks to control symptoms, or having a reoperation; If randomized to omeprazole
and considered by the responsible physician to require antireflux surgery to control symptoms; If
randomized to omeprazole and the patient, for any reason, preferred antireflux surgery during the
course of the study. Treatment failure was the primary outcomes variable.
Continued (5-Year) Followup of a Randomized
Clinical Study Comparing Antireflux Surgery and
Omeprazole in Gastroesophageal Reflux Disease
• starting dose 20 mg, but
10% started at 40 mg/d
• mostly Nissen, some partial
fundos
• dose escalation to 40 mg,
but could go up to 60 mg
Continued (12-Year) Followup of a Randomized
Clinical Study Comparing Antireflux Surgery and
Omeprazole in Gastroesophageal Reflux Disease
• starting dose 20 mg, but
10% started at 40 mg/d
• dose escalation to 40 mg,
but could go up to 80 mg
BUT – a gradual deteriorations in the proportion of patients in remission in both groups
ORIGINAL CONTRIBUTION
CLINICIAN’S CORNER
Laparoscopic Antireflux Surgery vs
Esomeprazole Treatment for Chronic GERD
The LOTUS Randomized Clinical Trial
Jean-Paul Galmiche, MD, FRCP Context Gastroesophageal reflux disease (GERD) is a chronic,
Jan Hatlebakk, MD, PhD
Stephen Attwood, MD, PhD
Christian Ell, MD, PhD
Roberto Fiocca, MD, PhD
Stefan Eklund, MD, PhD
JAMA. 2011;305:1969-1977
relapsing disease with symptoms that have negative effects on daily
life. Two treatment options are long term medication or surgery.
Objective To evaluate optimized esomeprazole therapy vs
standardized laparoscopic antireflux surgery (LARS) in patients with
GERD.
Design, Setting, and Participants The LOTUS trial, a 5-year
exploratory randomized, open, parallel-group trial conducted in
academic hospitals in 11 European countries between October 2001
and April 2009 among 554 patients with well established chronic
GERD who initially responded to acid suppression. A total of 372
patients (esomeprazole, n=192; LARS, n=180) completed 5-year
follow-up.
Interventions Two hundred sixty-six patients were randomly
assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose
Treatment for chronic gastroesophageal
reflux (GERD)
=
1
Lundell et al. Clin Gastro Hep 2009
2 Galmiche et al. JAMA 2011
Continued Followup of a Randomized Clinical Study
Comparing Antireflux Surgery and Omeprazole in
Gastroesophageal Reflux Disease
Belching/Vomiting
Patterns of Fundoplication Failure
Richter, Clin Gastro Hep 2013
Effectiveness of PPIs for GERD
• AGA sponsored telephone survey
•
•
•
•
Oct – Nov 2010
N = 687/1004 on PPIs
55.3% continued to have disruptions from GERD
felt like nothing else could be done to control
GERD
• felt it difficult to get MD to understand symptom
severity
Gupta and Inadomi, DDW Abstract 1154. Gastro 2012
Symptom responsiveness to
acid suppression
Kahrilas et al. Clinical Gastroenterology And Hepatology Vol. 10, No. 6
Impact of PPIs on # of Reflux
Episodes
300
261
254
250
217
200
Total
150
100
Acid
119
98
Non-acid
50
7
0
No RX
Vela et al. Gastroenterology 2001; 120:1599-1606
On PPIs
Long Term Safety of PPIs
C-difficile Associated Disease2
Community Acquired
Pneumonia1
10
Odds Ratio
Odds Ration
2
1
8
6
4
2
0
0
H2RA Use
Past Use
H2RA Use
PPI Use
Odds Ratio
3
2
1
0
PPI, <
1.75
Antibiotic
use
Absorption of Vitamin B124
Risk of Hip Fracture3
H2RA, H2RA,
< 1.75 > 1.75
PPI Use
PPI >
1.75
1. Lehaj JAMA 2004; 2. Dial, CMAJ 2006; 3. Yang, JAMA 2006 4. Corley, JAMA 2013
Recent FDA response to PPI petition
Therapy Gap in GERD
PPI Therapy
Anti-reflux Surgery
GERD PATIENT POPULATION
100%
“invasiveness”
durability
side effects eg flatus,
reproducibility
Opportunity for new treatments
60%
40%
<1%
Satisfied with
PPI Therapy
Incomplete response to
PPI Therapy
Reflux
Surgery
Therapy Gap
Slide Courtesy of Dr. Tom DeMeester
Objectives
• To compare and contrast the outcomes with antireflux
surgery and PPIs in the treatment of GERD
• To list the newer treatment options for GERD
• To review the construct and data related to magnetic
sphincter augmentation (LINX)
• To propose a new paradigm for GERD management
New Treatment Options
Stretta
• Endoscopic balloon
mounted with prongs used
to delivery radiofrequency
energy to the GEJ
• Theory: energy remodels
the LES and gastric cardia
and results transient LES
relaxations
• Neural mediated vs tissue
fibrosis?
Stretta
• Indications:
•
•
•
•
•
hiatal hernia < 2 cm
normal motility
LESP 5 to 10 mm Hg
esophagitis < LA class B
no Barrett’s
• Technique:
•
•
•
•
EGD to measure to GEJ
Catheter positioned 2 cm
proximal to GEJ
Inflate to place electrodes
1 min, rotate 45 degrees,
repeat x 6
Stretta
30
25
20
15
10
5
0
Pre Stretta
Post
Stretta
50
45
40
35
30
25
20
15
10
5
0
PreStretta
PostStretta
Stretta
50
45
40
35
30
25
20
15
10
5
0
• 30% still required PPIs
• 11.9% required additional
treatment
Pre Stretta
Post
Stretta
•
•
Nissen
Repeat Stretta
• Minimal complications
•
•
•
chest pain
dyspepsia
bleeding
Transoral Incisionless Fundoplication
•
Over the scope device
•
Theory: creates a partial,
anterior fundoplication
•
Uses “H” fasteners made of
permanent suture
•
Indications:
•
•
•
•
Reducible hiatal hernia < 3
cm
Hill grade II or III
BMI < 35 kg/m2
No stricture, ulcer,
Transoral Incisionless Fundoplication
• Technique:
•
Complex
•
2 endoscopists
•
Uses a “screw” to grasp
tissue
•
Uses a “spatula” to push
and hold tissue
•
Stylets used to pierce tissue
for “H” fastener placement
100
90
80
70
60
50
40
30
20
10
0
Pre TIF
Post TIF
Enbright et al. Annals of Thoracic Surgery 2014
Transoral Incisionless Fundoplication
40
35
30
25
20
15
10
5
0
• 30% still required PPIs
• 13.5 to 37% required
additional treatment
Pre TIF
Pre TIF
Post
Post
Stretta
TIF
•
•
Nissen
reports of increased
complications
• Significant complications
•
•
esophageal perforation
bleeding
Objectives
• To compare and contrast the outcomes with antireflux
surgery and PPIs in the treatment of GERD
• To list the newer treatment options for GERD
• To review the construct and data related to magnetic
sphincter augmentation (LINX)
• To propose a new paradigm for GERD management
Sphincter Augmentation Device
(LINX™ System)
Titanium
wire
Titanium
case
Magnetic
core
Highest resistance when closed
(0.39N)
Roman Arch Design
assures that the device
is non-compressive
when closed
Lowest resistance when
expanded (0.07N))
Shortening of LES due to
gastric distension
Ayazi and DeMeester. Annals of Surgery 2010;252: 57–62
Transient -LES- Shortening
Distension
Nissen prevents LES shortening
30


LES Length, mm
25
20
 

 





















15
10
5
0
Mason, RJ et al.,
Arch Surg 1997;
132:719-726
0
200
400
600
800
Infused gastric volume (mL)
1000
A loose ligature prevents LES
opening
Samelson, Bombeck, Nyhus. Annals of Surgery (1983) 197:254
The LINX Sphincter Augmentation Device
A loose ligature
of expanding
magnetic
beads
Distension
Magnetic sphincter implantation
Use of a magnetic sphincter for the treatment of GERD:
a feasibility study
Robert A. Ganz, MD, FASGE, Christopher J. Gostout, MD, FASGE, Jerry Grudem, BS, William Swanson, BS,
Todd Berg, BS, Tom R. DeMeester, MD
Plymouth, Rochester, Maple Grove, Minnesota, Los Angeles, California, USA
Background: The success of fundoplication surgery varies widely; furthermore, complications after fundoplication
can be common. We introduced a new device to treat GERD: biomechanical augmentation of the lower esophageal
sphincter (LES) by use of a magnetic reinforcing appliance.
Objective: The aim was to determine whether a magnetic appliance could safely increase LES pressure, maintain a
closed sphincter except during swallowing and belching, and increase the gastric yield pressure in a porcine model.
Design: Ex vivo work-assessed design variables that would augment the reflux barrier yet still preserve swallow
function. Porcine acute and chronic (44 weeks) postimplant studies were also performed. A single animal
underwent planned device removal.
Main Outcome Measurements: Gastric yield pressure, animal behavior, endoscopy, barium studies, balloon
expansion studies, esophageal manometry, and histology.
Results: Gastric yield pressure correlated with increasing magnetic forces (R2 Z 0.5608, P!.001). The sphincter
augmentation device was safe in all animals, with no observed effect on eating behavior and normal weight
gain. The mucosa of the esophagus appeared normal at all intervals, and there was no device migration or
Ganz et al. Gastrointestinal Endoscopy 67:287-97 2008
Feasibility Trials
Bonavina et al. Annals of Surgery 2010
The
NEW ENGLAND JOURNAL o f MEDICINE
ORIGINAL ARTICLE
Esophageal Sphincter Device
for Gastroesophageal Reflux Disease
Robert A. Ganz, M.D., Jeffrey H. Peters, M.D., Santiago Horgan,
M.D., Willem A. Bemelman, M.D., Ph.D., Christy M. Dunst, M.D.,
Steven A. Edmundowicz, M.D., John C. Lipham, M.D., James D.
Luketich, M.D., W. Scott Melvin, M.D., Brant K. Oelschlager, M.D.,
Steven C. Schlack-Haerer, M.D., C. Daniel Smith, M.D., Christopher
C. Smith, M.D., Dan Dunn, M.D., and Paul A. Taiganides, M.D.
From
ABSTRACT
BACKGROUND
Patients with gastroesophageal reflux disease who have a partial
response to proton-pump inhibitors often seek alternative therapy.
We evaluated the safety and effectiveness of a new magnetic device
to augment the lower esophageal sphincter.
METHODS
We prospectively assessed 100 patients with gastroesophageal
reflux disease before
Ganz et al. N Engl J Med 2013;368:719-27
Components of pH Measurements
Baseline
No. of
Median
Patients
Value
1 Year
No. of
Median
Patients
Value
P
Value
pH < 4
Total %age of time
Percentage of time upright
Percentage of time supine
100
100
98
10.9
12.7
6.0
96
96
96
3.3
4.3
0.4
< 0.001
< 0.001
< 0.001
Total no. of reflux episodes
100
161.0
96
67
< 0.001
No. of reflux episodes lasting >
5 min
99
12.0
96
4.0
< 0.001
Longest reflux episode (min)
99
29
96
13.0
< 0.001
DeMeester score
97
36.6
96
13.5
< 0.001
Ganz et al. N Engl J Med 2013;368:719-27
Secondary Outcomes after LINX
Ganz et al. N Engl J Med 2013;368:719-27
One Hundred Consecutive Patients Treated
with Magnetic Sphincter Augmentation for
Gastroesophageal Reflux Disease: 6 Years
of Clinical Experience from a Single Center
Luigi Bonavina, MD, FACS, Greta Saino, MD, Davide Bona, MD, Andrea Sironi, MD,
Veronica Lazzari, MD
BACKGROUND:
This study was undertaken to evaluate our clinical experience during a 6-year period with an
implantable device that augments the lower esophageal sphincter for gastroesophageal reflux
disease (GERD). The device uses magnetic sphincter augmentation (MSA) to strengthen the
antireflux barrier.
STUDY DESIGN:
In a single-center, prospective case series, 100 consecutive patients underwent laparoscopic
MSA for GERD between March 2007 and February 2012. Clinical outcomes for each patient
were tracked post implantation and compared with presurgical data for esophageal pH
measurements, symptom scores, and proton pump inhibitor (PPI) use.
RESULTS:
Median implant duration was 3 years (range 378 days to 6 years). Median total acid exposure
time was reduced from 8.0% before implant to 3.2% post implant (p < 0.001). The median
GERD Health Related Quality of Life score at baseline was 16 on PPIs and 24 off PPIs and
improved to a score of 2 (p < 0.001). Freedom from daily dependence on PPIs was achieved
in 85% of patients. There have been no long-term complications, such as device migrations
or erosions. Three patients had the device laparoscopically removed for persistent GERD,
odynophagia, or dysphagia, with subsequent resolution of symptoms.
CONCLUSIONS:
Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term
reduction of esophageal acid exposure, substantial symptom improvement, and elimination of
daily PPI use. For candidates of antireflux surgery who have been carefully evaluated before
surgery to confirm indication for MSA, MSA has become a standard treatment at our
institution because control of reflux symptoms and pH normalization can be achieved with
minimal side effects and preservation of gastric anatomy. (J Am Coll Surg 2013;-:1e9.
2013 by the American College of Surgeons)
Diseases of the Esophagus (2014) ••, ••–••
DOI: 10.1111/dote.12199
Original article
Safety analysis of first 1000 patients treated with magnetic sphincter
augmentation for gastroesophageal reflux disease
J. C. Lipham,1 P. A. Taiganides,2 B. E. Louie,3 R. A. Ganz,4 T. R. DeMeester1
1Department
of Surgery, Keck Medical Center of USC, University of Southern California, Los Angeles,
California,
Community Hospital, Mount Vernon, Ohio, 3Division of Thoracic Surgery, Swedish Medical
Center and Cancer Institute, Seattle, Washington, and 4Minnesota Gastroenterology, Abbott-Northwestern
Hospital, Minneapolis, Minnesota, USA
2Knox
SUMMARY. Antireflux surgery with a magnetic sphincter augmentation device (MSAD) restores the competency
of the lower esophageal sphincter with a device rather than a tissue fundoplication. As a regulated device, safety
information from the published clinical literature can be supplemented by tracking under the Safe Medical
Devices Act. The aim of this study was to examine the safety profile of the MSAD in the first 1000 implanted
patients. We compiled safety data from all available sources as of July 1, 2013. The analysis included
intra/perioperative complications, hospital readmissions, procedure-related interventions, reoperations, and
device malfunctions leading to injury or inability to complete the procedure. Over 1000 patients worldwide have
been implanted with the MSAD at 82 institutions with median implant duration of 274 days. Event rates were
0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4%
reoperations. All reoperations were performed non-emergently for device removal, with no complications or
conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or
malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The safety analysis of the first
1000 patients treated with MSAD for gastroesophageal reflux disease confirms the safety of this device.
Short-Term Outcomes Using Magnetic Sphincter
Augmentation Versus Nissen Fundoplication
for Medically Resistant Gastroesophageal
Reflux Disease
Brian E. Louie, MD, Alexander S. Farivar, MD, Dale Shultz, BSc,
Christina Brennan, CCRP, Eric Vallières, MD, and Ralph W. Aye, MD
Division of Thoracic Surgery, Swedish Cancer Institute and Medical Center, Seattle, Washington
Background. In 2012 the United States Food and Drug
Administration approved implantation of a magnetic sphincter
to augment the native reflux barrier based on single-series
data. We sought to compare our initial experience with
magnetic sphincter augmentation (MSA) with laparoscopic
Nissen fundoplication (LNF).
Methods. A retrospective case-control study was performed of
consecutive patients undergoing either procedure who had
chronic gastrointestinal esophageal disease (GERD) and a
hiatal hernia of less than 3 cm.
Results. Sixty-six patients underwent operations (34 MSA
and 32 LNF). The groups were similar in reflux characteristics
and hernia size. Operative time was longer for LNF (118 vs 73
min) and resulted in 1 return to the operating room and 1
readmission. Preoperative symptoms were abolished in both
groups. At 6 months or longer postoperatively, scores on the
Gastroesophageal Reflux Disease Health Related Quality of
Annals of Thoracic Surgery 2014;98:498-504
scale improved from 20.6 to 5.0 for MSA vs 22.8 to 5.1 for
LNF. Postoperative DeMeester scores (14.2 vs 5.1, p [ 0.0001)
and the percentage of time pH was less than 4 (4.6 vs 1.1; p [
0.0001) were normalized in both groups but statistically
different. MSA resulted in improved gassy and bloated feelings
(1.32 vs 2.36; p [ 0.59) and enabled belching in 67% compared
with none of the LNFs.
Conclusions. MSA results in similar objective control of
GERD, symptom resolution, and improved quality of life
compared with LNF. MSA seems to restore a more physiologic
sphincter that allows physiologic reflux, facilitates belching,
and creates less bloating and flatulence. This device has the
potential to allow individualized treatment of patients with
GERD and increase the surgical treatment of GERD.
Quality of Life
QOLRAD
7
GERD-HRQL
45
25
6
LINX
20
Nissen
5
40
35
**
30
15
4
Swallowing
25
20
10
3
15
2
5
10
1
5
0
0
Pre
Op
Post Post
Op 6 Op 6
wks mths
Pre Op Post
Op 6
wks
LINX: N=23/34;mean follow up 6 m
Nissen: N=17/32; mean follow up 10 months
Post
Op 6
mths
0
Pre Post Post
Op Op 6 Op 6
** p=0.023 wks mths
Objective Measures of GERD
DeMeester Score
60
% time pH < 4
16
14
50
12
40
10
30
LINX
Nissen
20
}
10
0
14.7
p = 0.000
8
LINX
Nissen
6
4.9
4
}
2
0
Pre Op
Post Op 6
mths
LINX: N = 16/34; Nissen: N = 22/32
Pre Op
Post Op 6
mth
p = 0.000
LINX – More physiologic?
Total # refluxes
# refluxes - post prandial
Bloating/Belching
180
100
18
160
90
16
140
80
14
70
120
104
100
LINX
80
Nisse
n
60
50
40
30
40
20
20
10
0
0
Pre Op
12
60
Post Op
6 mths
LINX
10
Nisse
n
8
**
* p = 0.059
** p = 0.000
6
4
*
2
Pre Op
Post Op
6 mths
0
Bloat/Gas Belching
Multi Institutional Outcomes Using Magnetic
Sphincter Augmentation Versus Nissen
Fundoplication for Chronic Gastroesophageal
Reflux Disease
Heather F Warren, MD; Jessica L Reynolds, MD; Jody Mickley RN;
John C Lipham, MD; Paul A Taiganides, MD; Joerg Zehetner, MD; Nikolai A
Bildzukewicz, MD; Ralph W Aye, MD; Alexander S Farivar, MD; Brian E Louie, MD
Division of Thoracic Surgery, Swedish Cancer Institute; Seattle, WA
Keck Medical Center, University of Southern California, Los Angeles CA
Knox Community Hospital, Mount Vernon OH
Society of American Gastrointestinal and Endoscopic Surgeons
Nashville Tennessee
April 18, 2015
Methods
Antireflux
Surgery
(N=455)
Allocation
Comparative
Analysis
Propensity
matched
Magnetic
Sphincter
(N=201)
(N=214)
MSA
Nissen
N=169
N=185
MSA
Nissen
N=114
N=114
Nissen
GERD-HRQL after 1 year (N=331)
• MSA median follow up 12 months (0-57months)
• LNF median follow up 12 months (0-58 months)
20
21
19
15
10
5
0
P < 0.01
P < 0.01
3
MSA (N=153)
Baseline
4
LNF (N=178)
Follow up
Outcomes after 1 year (N=350)
MSA
N=169
NF
N=185
P Value
Postoperative PPI (Daily) (%)
19
14
0.18
Ability to Belch (%)
96
69
<0.01
Ability for Emesis (%)
95
43
<0.01
No Gas Bloat (%)
53
41
0.03
No Dysphagia
42
53
0.04
Propensity Matched Results (N=228)
MSA
NF
N=114 N=114
P
Value
Postoperative PPI (Daily) (%)
24
12
0.02
GERD-HRQL
6
5
0.53
Ability to Belch (%)
97
66
<0.01
No Gas Bloat (%)
53
41
0.03
No Dysphagia
42
53
0.04
Patient satisfied
88
89
0.61
Would have procedure again
93
83
0.01
Objectives
• To compare and contrast the outcomes with antireflux
surgery and PPIs in the treatment of GERD
• To list the newer treatment options for GERD
• To review the construct and data related to magnetic
sphincter augmentation (LINX)
• To propose a new paradigm for GERD management
The Spectrum of GERD
Type I
Normal
NERD
Hiatal Hernia
Type II
Type III
Healable
Esophagitis
Persistent
Esophagitis
Type IV
Barrett’s
Stricture (Schatzki to Fibrotic)
Shortened Esophagus
2 to 16
years
Adapted from Lord et al. J Gastrointest Surg 2009;13:602-610
When you have a hammer…
GI Medicine
Surgical Reconstruction
Indications for Antireflux Surgery
• Patient wishes to control symptoms without medication
• Medical therapy is no longer effective
• GERD with prominent regurgitation component
• Paraesophageal hiatal hernia
• Complications of reflux
– Esophagitis
– Bleeding
– Stricture
– Mucosal ulceration
Heitmiller and You. GERD in Cameron’s Current Surgical Therapy 10th ed, 2010
Proposed Indications for Antireflux
Surgery – GI view point
Vakil. Aliment Pharmacol Ther 25, 1365–1372, 2007
ACG – GERD Guidelines
Katz et al. AMJG, 2013
Management Decisions by Primary
Care
“A patient with typical GERD
symptoms experiences partial
but incomplete relief with a
PPI given once daily. He/she
still heartburn in the late
evening and at night. What
1. Increase dose or
switch PPI (15%)
2. Increase dose to bid
(40%)
3. Add H2RA qhs (31%)
would be your preferred
course of action?
Chey and Inadomi. Am J of Gastro 2005
4. Refer to GI (14%)
Management Decisions by Primary
Care
• 73% referred patient to GI before surgeon
• 83% referred to surgery for lack of response
to medical therapy
• 11% referred to surgery b/c patient refused
long term PPIs
Chey and Inadomi. Am J of Gastro 2005
Indications for Surgery
Surgery reserved for medical failure
• erosive esophagitis
• Patient wishes to control
symptoms without
medication
• peptic esophageal
ulcers
• Medical therapy is no
longer effective
• stricture
• GERD with prominent
regurgitation component
• Barrett’s esophagus
• Paraesophageal hiatal
hernia
Individualized and Tailored GERD
Treatment
PPI
Normal
NERD
MSA
Healable
Esophagitis
NF
Persistent
Esophagitis
Barrett’s
Conclusions
• PPIs and antireflux surgery are BOTH effective in
treating GERD
• PPIs and antireflux surgery BOTH have side effects
and issues with durability
• LINX is one of 4 new technologies for GERD that
appears to control GERD and minimize side effects
• The addition of LINX allows for individualized
treatment of GERD
New and Emerging Treatments for
Benign Esophageal Disorders
Brian E. Louie MD, FACS, FRCSC, MHA, MPH
Director, Thoracic Research and Education
Co-Director, Minimally Invasive Thoracic Surgery Program
Asst. Program Director, MIS Thoracic and Foregut Fellowships
Division of Thoracic Surgery
Swedish Cancer Institute and Medical Center
Seattle, Washington
Missoula Medical Conference
September 11, 2015
Swedish Digestive Health Network
The Swedish Digestive Health Network provides
patients and their hometown physicians seamless
access to quality providers who specialize in the
medical and surgical treatment of various digestive
disorders.
For consults, referrals and patient resources.
Debra Cadiente, RN, BC
Nurse Navigator
digestivehealth@swedish.org
1-855-411-MYGI (6344)
Fax: 206-215-3525
We believe the best outcomes can only occur when highly complex care at Swedish
is supported by local expertise and knowledge.