Transcript Current Status of Antireflux Surgery

Current Trends and Updates on
Diagnosis and Management of GERD
Jeraldine S. Orlina, MD
Grand Rounds
January 11, 2006
Pathophysiology
• Lower esophageal
sphincter
• Intrinsic muscle of
distal esophagus
• Sling fibers of cardia
• Diaphragm
• Transmitted pressure
of abdominal cavity
• Reflux occurs when the high-pressure
zone in distal esophagus is too low or
when sphincter with normal pressure
undergoes spontaneous relaxation
Absite Question
• An operation is the primary initial
management for:
• A) Achalasia
• B) a large sliding esophageal hiatal
hernia
• C) an epiphrenic esophageal
diverticulum
• D) gastroesophageal reflux
• E) a paraesophageal hiatal hernia
Symptoms
Symptom
Heartburn
Regurgitation
Abdominal Pain
Cough
Dysphagia for solids
Hoarseness
Belching
Aspiration
Wheezing
Globus
Predominance (%)
80
54
29
27
23
21
15
14
7
4
Symptoms -- Heartburn
• Epigastric and retrosternal
• Caustic or stinging sensation
• Does not radiate to the back, is not
pressurelike
• Can be confused with symptoms of
PUD, bilary colic, or CAD
Symptoms -- Regurgitation
• Indicates progression of disease
• Distinguish between digested and
undigested food
Diagnostic Studies
• Empirical Therapy
• Upper Gastrointestinal Endoscopy
(EGD)
• Upper Gastrointestinal Fluoroscopy
with Barium
• 24-hour pH testing
• Esophageal Manometry
EGD
• Allows examination of the esophageal
mucosa
• Identifies presence of esophagitis and
grading of severity
• Can identify other pathology, such as
diverticula, hiatal hernia, webs, rings,
or strictures
• Tissue biopsies to screen for Barrett’s
esophagus
Absite Question
• Four hours following upper esophagogastric
endoscopy for gastroesophageal reflux, a
62 year-old man returns to the emergency
room with chills, chest pain, and dyspnea.
Cardiac work-up is normal, but
esophagography shows a distal esophageal
perforation. The most appropriate
management is
•
•
•
•
•
A) nasogastric suction and TPN
B) reinforced primary esophageal repair
C) drainage and esophageal diversion
D) esophagectomy with gastric pull-through
E) fluoroscopic esophageal stent placement
Absite Question
• A 60 year-old otherwise healthy man
has symptomatic GERD that has not
responded to medical therapy,
including PPIs. Esophagoscopy shows
moderately severe esophagitis.
Multiple biopsies of the esophageal
mucosa in the area of esophagitis
show columnar epithelium replacing
the normal squamous epithelium. As
the patient’s treatment is being
planned, a biopsy report shows highgrade dysplasia.
(cont)
• Treatment should be
A. Continued medical treatment with
yearly esophagoscopy and biopsies
B. Laparoscopic Nissen fundoplication
C. Photodynamic therapy
D. Esophagectomy
E. Laser ablation of normal mucosa
24-hour pH test
• Gold Standard for
presence of
pathologic reflux
• Parameters
measured include:
total # of reflux
episodes, duration
of longest reflux
episode,
percentage of time
pH is less than 4
Ambulatory pH testing – Recent Advances
• Combined
impedance and
acid testing
• Allows for the
measurement of
both acid and
nonacid (volume)
reflux.
• Important in pt with
persistent symptoms
despite an
adequate medical
trial
Ambulatory pH testing – Recent Advances
• Tubeless method– Bravo
System
• Allows a radiotelemetry
capsule to be attached
to the esophageal
mucosa
• Decreases patient
discomfort, allows for
longer (48h) monitoring,
and may improve
accuracy by allowing the
patient to carry out their
usual activities
Esophageal Manometry
• Lower Esophageal
Sphincter (LES)
• Mean resting
pressure
• Total length
• Esophageal Body
• To determine
effectiveness of
peristalsis
• Amplitude of
esophageal wave
Esophagram
• Useful when
operation is
planned—shows
anatomy of
esophagus and
proximal stomach
• Demonstrates
presence and size
of hiatal hernia if
present
Treatment – Lifestyle Modification
• May benefit many patients with GERD,
although these changes alone are
unlikely to control symptoms in the
majority of patients
• Elevation of the head of the bed,
decreased fat intake, cessation of
smoking, avoiding recumbency for 3h
postprandially, avoidance of certain
foods (chocolate, EtOH, peppermint)
• No data reflecting the efficacy of
these maneuvers
Treatment – Patient Directed Therapy
• Antacids
• H2 receptor antagonists
• If symptoms persist, continuous therapy
is required, or alarm symptoms/signs
develop – pt should have additional
evaluation and treatment
Treatment – Acid Suppression
• 6-week course of acid-suppression
therapy
• Double dose of a proton pump
inhibitor
• Irreversible bind the proton pump in
parietal cells of the stomach
• Maximal effect 4 days after initiation of
therapy and lasts for the life of the
parietal cell
• More effective than other
antacid regimens
Absite Question
• Proton pump inhibitors used in the
treatment of GERD
A. Cause regression of Barrett’s epithelium
B. Inhibit progression of dysplasia
C. Increase squamous islands in Barrett’s
segments
D. Reverse intestinal metaplasia
E. Are effective only if gastric acidity is
normalized
Treatment – Promotility Therapy
• May be used as an adjunct to acid
suppression therapy in patients with
demonstrated defects in
esophagogastric motility (LES
incompetence, poor esophageal
clearance, delayed gastric emptying)
Absite Question
•
Five years after a myocardial infarction, a 55
year-old woman with HTN and DM has
symptomatic esophagogastric reflux. Medical
treatment for the last year has not been
successful. Her BMI is 55. Esophagoscopy
shows severe esophagitis. Multiple biopsies
show inflammatory changes but no columnar
epithelium or cancer. The best treatment
would be:
A.
B.
C.
D.
E.
Nissen fundoplication
Gastric bypass procedure
Gastric banding procedure
Vertical banded gastroplasty
Biliary-pancreatic diversion with duodenal switch
Surgical Therapy
• Indications
• Pt w/ evidence of severe esophageal
injury (ulcer, stricture, or Barrett’s)
• Incomplete resolution of symptoms or
relapses while on medical therapy
• Long duration of symptoms
• Younger patients
• Ideal patient: more than 10-year life
expectancy and are in need of lifelong
therapy due to a mechanically defective
sphincter
Trends in the use of surgery for gastroesophageal reflux
disease in Ontario, 1988-2000
Urbach, D. R. et al. CMAJ 2004;170:219-221
Copyright ©2004 CMA Media Inc. or its licensors
Laparoscopic Nissen Fundoplication
• Lafullarde T, Watson DI, Jamieson GG, Myers
JC, Game PA, Devitt PG. Laparoscopic
Nissen fundoplication: five-year results and
beyond. Arch Surg. 2001 Feb;136(2):180-4
• 87% of the 176 patients remained free of
significant reflux. The long-term outcome
was considered "good or excellent" by
90% of patients.
Laparoscopic Nissen Fundoplication
• Success rate of greater than 90%
• Procedure of choice
Absite Question
• A 56 year-old man is seen 2 years after
a laparoscopic Nissen fundoplication
for GERD. His pre-operative work-up 2
years ago demonstrated normal
esophageal motility, and pH probe
testing showed that reflux was the
cause of his symptoms. He now has
recurrent symptoms of GE reflux.
A Barium swallow is performed.
• Which is not true about
this patient?
A. Redo operation is as
effective as primary
antireflux operation for
ameliorationg reflux
symptoms
B. Transabdominal
laparoscopic redo
operation is
contraindicated
C. Redo operation has an
increased complication
rate
D. The cause is related to
technical performance
of the initial operation
E. Manometry is helpful in
planning operative
therapy
Absite Question
• Four years ago, a 47 year-old woman had a
laparoscopic fundoplication. It failed after
three years and she had severe, recurrent
gastroesophageal symptoms. Through a
celiotomy incision, the surgeon performed a
redo-fundoplication with a 360-degree, 2 cm
wrap around a 56 Fr dilator. For the past three
months she has had severe early satiety,
postprandial epigastric pain, and weight loss.
The most likely cause of these symptoms is:
A. The wrap is too tight
B. The wrap is too loose
C. Vagal injury
D. Irritable bowel syndrome
E. Esophageal motor disorder
Absite Question
• Barrett’s esophagus
• A) will usually regress after Nissen
fundoplication
• B) carries an increased risk of squamous
cell carcinoma
• C) is an indication for esophagectomy
• D) should be followed by endoscopic
surveillance
• E) is a contraindication to laparoscopic
Nissen fundoplication
Endoscopic Therapy
• Attempt to augment the LES by
1. Suturing – EndoCinch
2. Radiofrequency energy – Stretta
3. Plexiglass injection –
polymethylmethacrylate
4. Biocompatible polymer injection -Enteryx
Plication/Sewing Techniques
• First developed in the mid ’80’s
• Allow placement of sutures into the
gastric cardia, thereby augmenting
the barrier effect of the GEJ
• Bard EndoCinch
EndoCinch
• Filipi CJ, Lehman GA, Rothstein RI et al.
“Transoral, flexible endoscopic suturing
for treatment of GERD: a multicenter
trial.” Gastrointestinal Endoscopy 2001;
53: 416-22.
• Suggested that endoscopic gastric
plication is a safe procedure and, at a 6month follow-up, that 2/3 of pts
undergoing the procedure were
successfully treated.
EndoCinch (cont)
• Inclusion Criteria
• Three or more episodes of heartburn a week
when off antisecretory meds
• Successful response to and reliance upon
antisecretory meds for GERD
• Abnormal acid reflux on ambulatory pH
monitoring
• Exclusion Criteria
•
•
•
•
Dysphagia
BMI greater than 40
GERD refractory to PPIs
Hiatal hernia greater than 2 cm in length
EndoCinch (cont)
• Treatment success defined as a decrease in
the heartburn severity score by 50% in
addition to a reduction in the use of
antireflux medications to fewer to 4 doses
per month.
• 64 patients were enrolled
• 33 pts (52%) – gastroplication in a linear
configuration
• 31 (48%) – gastroplication in a circumferential
plication
• No difference in outcomes between the 2
groups
• Results:
• Mean heartburn scores fell from a preprocedure
score of 62.7 to mean scores of 16.7 and 17 and
3 and 6 months postprocedure
• Percent total time the pH was < 4, total number
of reflux episodes, and percent upright pH time
was lower than 4 were all significantly improved,
but none returned to normal range
• Regurgitation scores improved significantly
• Quality of life scores were improved for social
functioning and bodily pain and 62% of pts at 3
and 6 month f/u were taking less than 4 doses of
medication per month
• Results (cont)
• No significant change found in LES resting
pressure or length
• No significant effect on mucosal healing
• Adverse events included pharyngitis
(31%), vomiting (14%), and abdominal
pain (14%), and chest pain (16%)
• One patient experienced a suture
microperforation that was treated
conservatively with IV antibiotics and brief
hospitalization
EndoCinch (cont)
• Chen YK, Raijman I, Ben-Menachem T
et al. “Long-term outcomes of
endoluminal gastroplication: a U.S.
multicenter trial.” Gastrointestinal
Endoscopy 2003. 61: 434-440
• Prospective, multicenter trial which
enrolled 85 patients to be treated with
endoluminal gastroplication followed over
2 years
• Results:
• 51% of patients had no or occasional GERD
symptoms
• 73% and 69% were completely off PPIs or at 12 and
24 months postprocedure
• Reduction in the mean annual medication cost
from $1564 per year preprocedure to $157 one
year postprocedure (cost redux of 88%)
• Shortcomings of study
• Does not contain a
nonplication sham group
• Trends toward increased
symptoms over time
suggestive of degradation
of repair over time
EndoCinch (cont)
• Schiefke I et al. “Long term failure of
endoscopic gastroplication
(EndoCinch)”. Gut 2005; 54: 752-758
• Evaluated prospectively long term
outcome after EndoCinch
• 70 patients at a single referral center
• Patients interviewed with a standard
questionaire regarding symptoms,
medication use, in addition to f/u with
endoscopy, 24h pH monitoring, and
esophageal manometry
• Results:
• 18 months after EndoCinch 56/70 patients
(80%) were considered treatment failures
as their heartburn symptoms did not
improve or PPI medication exceeded 50%
of initial dose
• Endoscopy showed all sutures in situ in
12/70 (17%), while no sutures remained in
18/70 (26%)
• No significant changes in 24h pH
monitoring or LES pressure
• Conclusion:
• Long term outcome is disappointing
probably due to suture loss in the majority
of patients
Radiofrequency Thermal Therapy -- Stretta
• Delivery of low-power, temperaturecontrolled radiofrequency energy to
the GEJ
• Two mechanisms
1. mechanically altering the GEJ
2. inducing the ablation of nerves that
trigger transient lower esophageal
relaxation
Radiofrequency Thermal Therapy -- Stretta
Stretta
• Wolfsen HC and Richards WO. “The
Stretta Procedure for the Treatment of
GERD: A registry of 558 patients.”
Journal of Laparoendoscopic and
Advanced Surgical Techniques 2002
• 558 patients, 33 institutions
• 6 months of follow-up
• Survey administered which assessed GERD
severity, percentage of GERD symptom
control, satisfaction, and antisecretory
medication use
• Results
• At baseline, the median percentage of
GERD symptom control while on drugs
was 50%, compared with 90% after Stretta
• Satisfaction with symptom control was
26% versus 77% after Stretta
• Median requirement at baseline was
double dose of PPI versus antacids prn
after Stretta
• Most subjects (90%) would recommend
Stretta to a friend
Stretta
• Triadafilopolous et al: reported 6- and 12month results of an open label trial of
Stretta
• Prospective multicenter trial involving 118
patients who had chronic heartburn or
regurgitation, abnormal esophageal acid
exposure, hiatal hernia less than 2 cm, and
mild esophagitis
• At 12 mo: improvement in heartburn score,
GERD score, and quality of life. PPI use
decreased from 88% to 30%. Esophageal acid
exposure improved significantly, although no
improvement in the incidence and severity of
esophagitis
• randomized, double-blinded, sham
controlled trial of radiofrequency
energy to the gastroesophageal
junction for the treatment of GERD
Patient Criteria
• heartburn or acid regurgitation at least partially
responsive to and requiring daily antacid
medications
• age 18 years
• 24-hour pH study (off medications) showing
abnormal esophageal acid exposure (4%) or a
DeMeester score of 14.7
• esophageal manometry showing normal
esophageal peristalsis and sphincter relaxation
• EGD, on medications, showing no esophagitis
worse than grade II (i.e., no substantial
ulcerations), no hiatal hernia 2 cm long, and no
Barrett’s esophagus
• no coagulation disorders, mechanical prostheses,
prominent dysphagia, or unstable disorders.
Stretta
• Patients were offered the Stretta procedure if
they had documented GERD and did not have
a hiatal hernia larger than 2 cm, LES pressure less
than 8 mmHg, or Barrett’s esophagus.
• Patients with larger hiatal hernias, LES pressure
less than 8 mmHg, or Barrett’s were offered LF.
Stretta
• Conclusions – Although the incidence
of complications is decreased
compared with operative intervention,
success of therapy does not approach
that of surgical intervention
• After Stretta 30-50% of patients still
require PPI therapy
Injection/implantation techniques -- Enteryx
• Injectable biocompatible solution
consisting of 8% ethylene vinyl alcohol
copolymer mixed in dimethyl sulfoxide
• When injected into the LES, the solution
interacts with the surrounding fluid to
become an inert spongy solid mass
• Mechanism: may impart an alteration
in the compliance of tissues preventing
sphincter shortening and improving the
barrier function of the GEJ
Enteryx
Enteryx
• Cohen LB, Johnson DA, Ganz RA et al
“Enteryx implantation for GERD:
expanded multicenter trial results and
interim postapproval follow-up to 24
months.” Gastrointestinal Endoscopy
May 2005
• Open-label, international clinical trial
conducted in 144 PPI—dependent patients
with GERD with f/u at 6 and 12 months
• Primary outcome: PPI use
• Secondary outcome: GERD health-related
quality of life and esophageal acid
exposure
• Results:
• At 12 months PPI use was reduced by
greater than 50% in 84% of treated pts
• GERD health-related quality of life < 11% in
78% of patients
• Esophageal acid exposure was reduced
by 31%
Enteryx
Conclusions on Endoscopic Mgmt of GERD
• Techniques need to be further studied in shamcontrolled protocol
• Long term follow-up suggest a declining effect
of treatment with pts returning to PPI use -more long term f/u studies necessary
• Future studies should improve targeting of
which patients benefit, further elucidate the
mechanisms of action, and provide detailed
comparisons to alternative treatments.
Future of Endoscopic Therapy
• As a substitute for long-term medical
therapy for the pt with mildly
symptomatic GERD
• As adjuncts to ongoing
pharmacologic treatment
• In patients with a failed surgical
fundoplication