View Presentation - American Association for Thoracic Surgery

AATS Focus on Thoracic Surgery :
Esophageal Disease
November 15, 2013
Session I:Esophageal Physiology Testing and GERD
New Surgical Options for GERD: Lynx (the
Magnetic Ring), and the Fate of Stretta,
Enteryx, Endocinch, etc
James D. Luketich MD, FACS
Henry T. Bahnson Professor and Chairman,
Department of Cardiothoracic Surgery
University of Pittsburgh Medical Center
Disclosure
• Participant in the multicenter trial of
Magnetic Sphincter Augmentation with
Linx Device (Torax Medical)
Overview
• The results of various anti-reflux
operations for GERD have been
inconsistent and the popularity has
suffered
• Endoscopic Therapies for GERD were
developed to compete with PPI’s and
surgery but largely have failed
• Linx (Magnetic Sphincter Augmentation
for GERD) is one of the newest and
more promising devices
“The Rise and Fall of Antireflux
Surgery in the United States”
• Data from the Nationwide Inpatient Sample
• Peak in 1999 at 31,700 cases (15.7 cases per
100,000 adults)
• Steady decline thereafter
• 30% decrease by 2003 to 24,000 cases (11
cases per 100,000 adults)
• Reasons?
Finks JF, Wei Y, Birkmeyer JD. Surg Endosc 2006;20:1698-1701
J Am Coll Surg 2012;215:61-69. © 2012 by the American College of Surgeons
Perioperative Risk of Laparoscopic
Fundoplication: Safer then Previously Reported –
Analysis of the American College of Surgeons
National Surgical Quality Improvement Program
2005 to 2009
Stefan Niebisch, MD, Fergal J Fleming, MD, Kelly M Galey, MD, Candice L Wilshire, MD,
Carolyn E Jones, MD, FACS, Virginia R Litle, MD, FACS, Thomas J Watson, MD, FACS,
Jeffrey H Peters, MD, FACS
Results (n = 7,531):
- 30-day mortality rare (0.05%) if < 70 y/o;
- Serious complications in: 0.8% if < 50 y/o;
1.8% if 50-69 y/o
Laparoscopic fundoplication is a safe operation!
Problems with Antireflux Surgery
Realities that Surgeons Must
Acknowledge…
• Inconsistent patient selection
• Inconsistent delineation of expectations
• Inconsistent operative techniques
• These all lead to inconsistent results across
centers!
The Need:
• An easy, safe, minimally invasive, reproducible,
cost-effective means to control chronic GERD
Endoscopic Therapies
• Energy based
• STRETTA® Radiofrequency (Curon), Now acquired
by Mederi Therapeutics
• Injection-based
• The Gatekeeper Reflux Repair System® (Medtronic)
• Enteryx® (Boston Scientific)
• Suture-based
• EndoCinch® (Bard)
• The Plicator® (NDO Surgical)
Stretta RF Delivery.
: RFA to deliver a controlled coagulation inflammation and fibrosis
-leads to neurolysis of the vagal fibers locally, reduced frequency of TLESRs
improves gastric emptying, and reduces esophageal sensitivity, and increases
LES resistance
GI Motility online (May 2006) | doi:10.1038/gimo55
Stretta Meta Analysis
• Analysis of Twenty studies
• Gastroesophageal reflux disease
(GERD) symptom assessment,
• Quality of life, esophageal pH, and
esophageal manometry.
Perry et al. Surg Laparosc Endosc Percutan Tech 2012;22:283–288
Stretta Meta Analysis:
Results
• Results: A total of 1441 patients from 18
studies were included.
• Radiofrequency treatment improved
heartburn scores (P=0.001),
• Improvements in quality of life as
measured by GERD–health-related
quality-of-life scale (P=0.001) and
quality of life in reflux and dyspepsia
score (P=0.001).
Perry et al. Surg Laparosc Endosc Percutan Tech 2012;22:283–288
Stretta Meta Analysis:
Results and Conclusions
• DeMeester score decreased from 44.4 to 28.5
(P=0.007) but failed to normalize acid reflux
• Conclusions: RFA of the lower esophageal sphincter
produces an improvement in reflux symptoms with
unclear mechanism
• Many patients still have symptomatic reflux
symptoms thus fell out of favor
• Currently not actively being performed
• Recent takeover by another company, lowered of
RFA, attempting to further market this technology
Perry et al. Surg Laparosc Endosc Percutan Tech 2012;22:283–288
Enteryx: Inject polymer into submucosa of the LES
area during EGD to result in a “bulk” effect and
increase tone of the LES Valve
Complications: aortic injection with death, mediastinitis, renal failure led
to removal from the market
EndoCinch: Create an internal
valve flap at LES area
This product led to variable success, intermediate and long-term GERD
Recurrences and little current enthusiasm.
This had initial interest but again failure to deliver consistent good clinical results,
Retrieved from the market in 2008 due to poor financial performance.
Transoral Incisionless
Fundoplication (TIF)
– An “endoscopic” fundoplication
– Prior studies; Safety and initial
effectiveness
– Longer-term durability less clear
From Ebright, Fernando ,HC Presented at STSA 2013
From Ebright, Fernando ,HC Presented at STSA 2013
Results
•
•
•
•
•
80 patients treated over a three-year period
Mean age 48 years; 48% female
Mean procedure time 75 minutes
Mean length of stay 1 day; median 1.4 days
Adverse Events
– Seven grade II (urinary retention most common);
– one grade III (aspiration pneumonia)
– No grade V (death)
From Ebright, Fernando ,HC Presented at STSA 2013
Results: Efficacy Analysis
• 57 pts had at
least 3 month
follow-up
• Mean followup 14 months
at time of last
GERD-HRQL
assessment
80 pts
57 pts
(>= 3m
f/u)
MOTILI
TY
HIATAL
HERNIA
From Ebright, Fernando ,HC Presented at STSA 2013
HILL
GRADE
Results: Additional Endpoints
• PPI Use
– 50 (88%) using PPIs preoperatively
– 29 (51%) using PPIs postoperatively procedure.
• BUT majority had reduced their dose.
• Satisfaction (Graded from 1-3)
•
•
•
•
Pre-TIF = 2.96
Post-TIF = 1.60
p <0.001
19% dissatisfied post-procedure
• Six patients, repeat procedures
– (4 laparoscopic Nissen, 2 TIF)
From Ebright, Fernando ,HC Presented at STSA 2013
Conclusions
• TIF safe and effective at reducing GERD
symptoms
• Small hiatal hernias, high Hill grade, impaired
motility did not predict poor outcome
• However many patients remain on PPIs
• Suggesting improvement in GERD rather than resolution
• TIF retains ability to perform subsequent lap Nissen
• Future studies needed to determine
• Relative role of laparoscopic fundoplication, LINX, and TIF
in GERD treatment algorithm
• Long-term durability
Makes Laparoscopic Nissen salvage surgery much more
difficult and risk of microfistulae at fastener sites!
From Ebright, Fernando ,HC Presented at STSA 2013
Summary of Endoscopic Control of
GERD is pretty Dismal.
Injection /
Bulking
Therapies
? Radiofrequency
-Stretta
-Enteryx
Suturing
-Endocinch
(Bard)
-Wilson-Cook
-Gatekeeper
? Endoluminal fundoplication
-Plicator
-Medigus
- TIF: EsophyX
Laparoscopic Magnetic Ring
Augmentation of LES: Linx
LINX™ System Design Goals:
Fix the Anatomy
Cure the Disease
 Restoration of the sphincter barrier
 Address primary GERD symptoms; stop all reflux including bile
and acid
 Preserve physiologic esophageal functions; minimal side effects
 Procedural simplicity
 Provide durable effectiveness and safety
 Reversible
LINX Design and Engineering
Normal Swallow
Pressures
35-80 mm Hg
LINX® System “Barrier
Function”
10-15 mm Hg
Gastric Pressures
5-10 mm Hg
CLOSED to Reflux
Courtesy Torax
OPEN to Swallowing
Magnetic Device for Augmentation of the Lower Esophageal Sphincter
Ganz RA et al. N Engl J Med 2013;368:719-727
29
Steps in the Preferred Method of
Implantation
• Mobilize the posterior fundic wall off the lateral surface of the left crus
• Identify and free 1-3 cm along the anterior edge of the left crus just above the
crural decussation
• Open the gastrohepatic ligament above and below the hepatic branch of the
anterior vagus nerve
• Identify and free 1-3 cm along the anterior edge of the right crus just above the
crural decussation
• Delicately tunnel from the right crus towards the left crus just above the crural
decussation
• Identify the posterior vagus nerve and tunnel between it and the posterior
esophageal wall
• Complete the tunnel by delicately dissecting over the anterior edge of the left
crus into the free space behind the previously mobilized gastric fundus
Steps in the Preferred Method of
Implantation
• Pull a half-inch Penrose drain through the tunnel in a left to right direction
• Measure the esophagus for the proper size LINX device
• Pass the appropriately sized LINX device through the tunnel in a left to right
direction
• If necessary, reflect the esophageal fat pad by mobilizing it in an inferior
direction
• If necessary, make a trench through the areolar tissue on the anterior surface of
the esophagus in a transverse direction below the insertion of the inferior leaf
of the phreno-esophageal ligament and just superior to the reflected esophageal
fat pad
• Connect the ends of the LINX device together, position the device in the trench
and confirm that no fat or connective tissue is between the device and the
esophagus
Laparoscopic Insertion of Linx Device
Median Operative Time: 36 minutes (range 7 to 125 minutes)
N Engl J Med 2013;368:719-727
J Am Coll Surg 2013
Esophageal
Acid Exposure
14
12
10
8
Pathologic
6
4
2
0
Published
Studies
Surgical
Endoscopy
New England Journal
of Med.
American College
Surgeons
Patients
44
100
100
Centers
4
14
1
Mean F/U
48 months
36 months
36 months
Pre-LINX
Median GERD-Symptom
Score
30
25
20
Pre-LINX
15
10
5
0
Published
Studies
Surgical
Endoscopy
New England Journal
of Med.
American College
Surgeons
Patients
44
100
100
Centers
4
14
1
Mean F/U
48 months
36 months
36 months
PPI Use (% patients taking
any
PPI’s)
100
90
80
70
60
Pre-LINX
50
40
30
20
10
0
Published
Studies
Surgical
Endoscopy
New England Journal
of Med.
American College
Surgeons
Patients
44
100
100
Centers
4
14
1
Mean F/U
48 months
36 months
36 months
Patient Satisfaction (%
Satisfied)
100
90
80
70
60
Pre-LINX
50
40
30
20
10
0
Published
Studies
0%
0%
Surgical
Endoscopy
New England Journal
of Med.
American College
Surgeons
Patients
44
100
100
Centers
4
14
1
Mean F/U
48 months
36 months
36 months
Linx Conclusions
• In these studies, before and after lower esophageal sphincter
augmentation with a magnetic device
– 1 exposure to esophageal acid decreased
– 2 reflux symptoms improved
– 3 use of proton-pump inhibitors decreased.
• Patients retain ability to burp, vomit and have minimal
other side effects
•
Follow-up studies are needed to assess long-term
safety but 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
Overall Conclusions
• Surgical Fundoplication remains the gold standard for
acid reflux control
• Among recent technologies, Linx magnetic sphincter
augmentation appears most promising
• Further investigations needed for TIF, Stretta staging
a comeback, no new data
• In selected patients, magnetic sphincter
augmentation with Linx magnetic device decreases
acid exposure, improves symptom control,
associated with decrease in PPI use
• Side-effects with the Linx (Bloating, inability to belch
or vomit) appear to be rare
• Follow-up studies are underway to assess long-term
safety.