emerging technology: latest anti-reflux endoscopic ......gerd vs nerd 3) describe briefly the...
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Emerging Technology: Latest Anti-reflux Endoscopic procedures & Surgeries
Simi Jesto Joseph, DNP, RN, APN, NP-C Director of Research & Clinical Services
Gastroenterology Nurse Practitioner GI Solutions of IL
Objectives
1) Describe types of reflux diseases 2) Identify the current diagnostic technology to distinguish
GERD vs NERD 3) Describe briefly the current medical & surgical treatment for
GERD 4) Identify the right patient for anti-reflux procedures
Reflux Diseases
GERD LPRD DGR NERD
Reflux Diseases
1) GERD – Gastroesophageal Reflux
2) LPRD – Laryngopharyngeal Reflux
! Backflow of stomach contents up the esophagus and into the throat 3) DGR – Duodeno-Gastric Reflux
! Duodenal contents (bile acids; pancreatic juice) ! Also called bile reflux
4) NERD – Non-Erosive Reflux
! Typical reflux symptoms caused by the intraesophageal reflux of gastric contents
! No visible esophageal mucosal injury
GERD“ A condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications” (Montreal Consensus)
(AGA, 2008)
GERD Overview
! Gastroesophageal reflux disease (GERD) is a chronic disease which affects an estimated 38 million patients in the U.S
! Weekly in approximately 20-25% of adults2
! Only 19 million are diagnosed annually
! 35% of affected individuals do not seek medical care, preferring to self- medicate
! The most common gastrointestinal diagnosis recorded on outpatient visits since 2006, surpassing abdominal pain3
! Increasing prevalence4
! Aging population
! Obesity
! Changes in diet & physical activity
! Over-prescription of pharmaceutical therapies (PPIs)5
! Americans spend in excess of $10 billion per year on Proton Pump Inhibitors (PPIs)
! The number of PPI prescriptions/year in the United States has doubled since 1999
Lewis, (2006); Pandalfino & Kwialek (2008); Shaheen et al (2006); Vakil et al (2006; Moore et al. 2016)
Pathophysiology of GERD
Photography: Used with permission from (GI Solutions/Arun Ohri, MD)
Typical symptoms have been associated with Barrett’s Esophagus--a condition that increases risk for cancer.*
GERD is Deceptively Complex
Typical Atypical
• Persistent cough • Chronic sore throat • Difficulty swallowing • Frequent swallowing • Asthma • Hoarseness • Excessive throat clearing • Bad breath • Dental erosions or gum
disease • Discomfort in ears & nose
• Heartburn • Chest Pain • Excessive Salivation • Regurgitation • Gas • Bloating • Trouble Sleeping • Sensitive To Some Foods
& Liquids
And
Or
6 million suffer from GERD and asthma
GERD: Symptoms
GERD Clinical Progression
Progression of GERD…
Complications: • Ulceration • Hemorrhage • Strictures • Barrett’s
Esophagus • Adenocarcinom
a (Cancer)
Esophagitis is inflammation of the esophagus. It may be acute or chronic.
Physiological Reflux (Infrequent & Mild)
Symptomatic GERD (Frequent & Intense)
Esophagitis Complex Esophagitis
Symptoms: Typical • Heartburn • Regurgitation Atypical • Chest pain • Difficulty
swallowing • Cough • Asthma • Laryngitis
Esophagogastroduodenoscopy
• Extend of esophagitis • H-pylori gastritis • Ulcers
• Barrett’s esophagus
• Strictures
• Varices
• Angiodysplasias • Mallory-Weiss tear • Tumors
• Gastric polyps
Photography: Used with permission from (GI Solutions/Arun Ohri, MD)
Bravo pH Monitoring System! Catheter-free pH monitoring system ! pH capsule attached to the esophageal wall transmits data
to pager-sized receiver ! Allows normal activities such as dietary habits, showering,
and exercise and does not interfere with sleeping ! 48 to 72 hour PH reading of the esophagus
! Supine reflux
! Night time reflux ! Symptom correlation
! Monitor reflux on PPI as well as
Off PPI
Photography: Used with permission from (GI Solutions/Arun Ohri, MD)
Esophageal Manometry! To accurately define esophageal motor function
! For preoperative assessment of patients being considered for antireflux surgery
! Note: Esophageal manometry is not indicated for making or confirming a suspected diagnosis of GERD
! Indications:
! Achalasia
! Nutcracker esophagus
! Cricopharyngeal Achalasia
! Simultaneous swallows
! Abnormal co-ordination
Photography: Used with permission from (GI Solutions/Arun Ohri, MD)
Esophageal Impedance Testing! 24 hour catheter-based test ! Patient carry the catheter and resume normal activities ! Allowing recognition of both acidic and weakly acidic reflux episodes ! The results of several studies suggest that impedance-pH monitoring is useful in the
evaluation of patients with PPI-resistant typical reflux symptoms, and atypical symptoms: ! Chronic unexplained cough ! Excessive belching ! Rumination ! Motility disorders
! Non-acid reflux
Pritchett, Aslam, Slaughter (2009); Photography: Used with permission from (GI Solutions/Arun Ohri, MD)
Barium x-ray
• X-ray examination of the esophagus, stomach, and first part of the small intestine • Images obtained using fluoroscopy and oral barium • Evaluate the anatomy and function • Air-contrast or double-contrast upper GI • Iodine contrast is used if recent GI surgery or barium allergy • Indications:
• Difficulty swallowing
• An alternative to EGD or manometry if needed
GERD: Esophagitis, NERD, Functional Heartburn?
GERD Endoscopy + Los Angeles A-D esophagitis
-
pH monitoring excess esophageal
acid exposure+ NERD
-
pH monitoring symptom correlation
+ Hypersensitive esophagus
-
Functional heartburn
non-acid reflux
Lifestyle Modifications
GERD Associated Quality of Life Parameters*
Rigorously Timed Meals
Weight Loss Eliminate Smoking
No Pressure On
Stomach
Sleeping in Chair
Inclined Sleeping Position
• Unable to enjoy meals • Sleep disturbances • Fatigue • Reduced overall
productivity • Altered social well-being • Altered emotional well-
being
Eliminate Triggering Foods &
Drink
PPIs
Blocks the secretion of acid into the
stomach
Escalated dosing of more complex medications
…until pills stop working.
H2 Blockers
Blocks the body’s signal to the stomach to produce acid
Antacids
Neutralize or buffer stomach
acid
…and medications come with side-effects and complications
Medical Management
GERD Suffering is Widespread
19 Million Daily
42 Million Weekly
20 Million Monthly
81 Million Total ¼ of Americans
Only And But
10.2 Million Visit a Doctor
6.3 Million Receive Tests to Diagnose
0.05 Million Receive Treatment with a Procedure
134 Millon OTC & Rx
Vitamin B12 Deficiency1
Increased Pneumonia
Risk2
Increased Risk of Osteoporosis
Fractures3
Reduced Gallbladder
Motility4
PPI Interaction with Plavix5 Increased Risk
of Fundic Gland Polyps6
Increased Risk of Bacterial
Gastroenteritis7
Magnesium deficiency8
Increased Risk of C. diff , Small Intestine
Bacterial Overgrowth9
Risks Associated With PPI Use
GERD Symptom and Treatment Continuum
Endoscopic Repair
Anti-Reflux Surgery-Decision
! Anti-reflux surgeries are an effective alternative to medical treatment ! Increases Transient Lower Esophageal relaxation period
! Indications (SAGE Guideline)
! Symptoms refractory to pharmacological therapy
! Have complications of GERD
! Barrett’s esophagus,
! peptic stricture,
! large Hiatal hernia, ! Atypical symptoms, ! and reflux documented on 24hr PH monitoring
(Moore et al. 2016)
Pre-op work up
! 1) Upper Endoscopy
! Visual and histopathological changes
! 2) PH monitoring ! Gold standard for pathologic acid reflux
! 3) Esophageal Manometry
! To identify dysmotility of esophagus
! 4) Barium Swallow ! To determine the anatomy
(Moore et al. 2016)
Anti-reflux procedures
Closed; no reflux
Can’t close; contents reflux
Tight to the scope
Loose to the scope
Normal Anatomy Abnormal Anatomy
Functional Valve Dysfunctional Valve
Physiological Reflux (Infrequent & Mild)
Symptomatic GERD (Frequent & Intense)
Vs.
Solution:
Restore anatomy to
normal
by
Repairing valve
to
Resolve symptoms
Photography: Used with permission from (Endogastric Solutions)
Laparoscopic (LNF) vs Open technique for GERD (CNF)
! Laparoscopic NISSEN Fundopliction vs Conventional NISSEN Fundoplication
! Aim: re-create and restore normal physiologic function of LES, reconstruction of the Hiatus, and repair of hernia
! LNF-Preferred approach and gold standard for surgical treatment
! Longer operative time ! Shorted hospital stay ! Low perioperative morbidity
! Decreased pain
! Low rate of abdominal hernias ! Low rate of infections
(Moore et al. 2016)
Partial Vs Total FundoplicationToupet ! Partial-270 degree ! Fewer symptoms of bloating ! Able to vomit
Nissen ! Total-360 degree ! High rate of dysphagia ! Flatulance ! Bloating
(Moore et al. 2016)
Toupet vs Nissen
! Toupet done in 3.0 cm and 1.5 cm valve length ! 3.0 is superior in controlling reflux ! Dysphagia is higher in 3.0
! More studies required
(Moore et al. 2016)
Anterior (DOR) vs Nissen
! 120 degree anterior fundoplication
! Less post operative dysphagia ! Shown less effective in controlling reflux ! Most patients required re operation
(Moore et al. 2016)
Comparison
Nissen
DOR
Toupet
Advantages Disadvantages
Effective in reflux control
Less post-op Dysphagia
Less Post-op dysphagia
Flatulance, bloating, dysphagia
More re opertaions
Length of the wrap determines the quality of reflux control
(Moore et al. 2016)
Stomach Intestinal Pylorus Sparing Surgery (SIPS)
! Modified approach for morbidly obese pts ! Modified duodenal switch
! Involves sleeve gastrectomy and attach pylorus to the midgut located 3 meters from the terminal Ileum
! Novel technique for both obesity and GERD ! Early results are encouraging
(Zaveri et al. 2015)
Anti-reflux surgery-conclusion
! LNF is the gold standard procedure
! Failure rate-3%-16%
! Etiology-Slipped fundoplication or herniation of the wrap ! Re-operation is safe ! High complication rates-gastric or esophageal perforation
! Longer operative times
! Higher conversion to open approach
(Moore et al. 2016)
Antireflux Endoscopic Procedures (History)
! Implanting Technique - Enteryx
! Radio Frequency - Stretta
! Suturing Devices: - Endocinch
- Plicator
Photography: Used with permission from (Endogastric Solutions)
! Inclusion Criteria: ! 18-80 years of age for adults or > 12 years and 25 kg for children
! Chronic symptomatic GERD for > 6 months
! Persistent GERD symptoms despite PPI therapy
! Demonstrated reflux (48-h pH metry, UGI radiography or esophagitis B or C)
! Deteriorated gastroesophageal junction (Hill grade II-III)
- Patient willing to comply with post-operative dietary recommendations
! Exclusion Criteria: ! BMI > 35
! Irreducible hiatal hernia > 2 cm
! Esophagitis grade D
! Esophageal ulcer, fixed stricture or motility disorders
! Dysphagia
Patient Selection Criteria
TIF ( Transoral Incisionless Fundoplication)
➢ No incisions
➢ No scarring
➢ No incisional
herniation
➢ Less nosocomial
infection
➢ No dysphagia
Photography: Used with permission from (Endogastric Solutions)
TIF
Photography: Used with permission from (Endogastric Solutions)
TIF
! 3rd generation in reflux surgery ➢ Surgical reconstruction transorally ➢ Sterile, single use device
➢ An evolution of current surgical procedure
➢ Based on long standing surgical principles
➢ Physiologically less invasive
➢ Future options open-adjustable
➢ Adaptive to patients
anatomy
Photography: Used with permission from (Endogastric Solutions)
Endoscopic Retroflex View Before & After TIF Procedure
Photography: Used with permission
from (GI Solutions/Arun Ohri, MD)
TIF
EvidenceOutcomes
Experience
Studied in over 40 peer-reviewed publications with
outcomes for over 700 individual
patients.
Safety
Over 15,000 patients treated
consecutively over 10 years.
High level of efficacy in improving
subjective and objective measures
of GERD.
Commercial SAE rate less than
0.4% Absent long-term
side-effects associated with other treatment
options.
RESPECT
• A multi-center, randomized, single-blind, controlled TIF/Placebo vs. Sham/PPIs trial
• To compare safety and effectiveness of TIF vs. Sham/PPIs in patients with “troublesome symptoms” specifically regurgitation
• 2:1 ratio TIF/Placebo group ( n=80) vs. Sham/PPI group (n=40)
TEMPO
• A multi-center, randomized, open-label, controlled TIF vs. PPI trial
• To compare safety and efficacy of TIF vs. PPIs for the treatment of chronic medically refractory GERD
• 2:1 ratio TIF group (n=28) vs. PPIs group (n=14)
TIF REGISTRY
• A multi-center, prospective, open-label, post market registry
• To evaluate the safety and efficacy of TIF in a broad range of GERD patients treated in routine clinical practice
• 274 patients treated with TIF procedure
STAR REGISTRY (AGA)
• A multi-center, prospective, open-label, post market registry
• To compare the safety and efficacy of TIF procedure vs. Laparoscopic Nissen Fundoplication Surgery (LNF)
• 1:1 ratio TIF group (n=250) vs. LNF group (n=250)
Level 1 and 2 Clinical Studies Detailed
(Trad et al, 2014; Bell et al, 2012)
In the TEMPO randomized, controlled trial comparing the TIF 2.0 procedure to maximum dose PPI therapy, outcomes at 6 months:
97%of patients eliminated daily
regurgitation 50% in the PPI group VS
90%of patients had esophagitis
healed 38% for PPI groupVS
62%of patients eliminated all
symptoms 5% for PPI groupVS
54%of patients had esophageal pH
normalized 52% in the PPI groupVS
Trad et al(2014)
Endoscopic Fundoplication! All outcome measures of TIF were sustained and statistically unchanged between 6- and 12–M follow-up
! 84% of TIF patients remained completely off PPI at 12-M vs. 90% at 6-M follow-up
! Esophagitis was healed or reduced in 100% of TIF patients at 12-M vs. 90% at 6-M
! 77% of TIF patients experienced global elimination of regurgitation and atypical symptoms off PPIs at 12-M
! In the crossover group of patients, 71% were completely off PPIs 6 months post-TIF
! In crossover patients, TIF was superior to high-dose PPIs in eliminating typical and atypical GERD symptoms
Endoscopic Fundoplication
! TIF provides significant control of regurgitation, atypical symptoms and healing of esophagitis in patients with small hiatal hernias and an incomplete response to PPIs
! TIF avoids the undesirable post-fundoplication side-effects (dysphagia, gas-bloat and flatulence) commonly associated with laparoscopic anti-reflux procedures
! In a well selected patient population, TIF is a safe, viable endoscopic alternative to existing anti-reflux procedures
! TIF may also be viewed as an adjunct to PPI therapy in patients with incomplete control of regurgitation and atypical symptoms
! Outcomes of this study are consistent with other recently published data and demonstrate durability of results 12 months following TIF
TIF vs Nissen or Toupet
! Safe and efficacious in symptom control
! TIF is a paradigm shift in tx of GERD
! TIF has shorter operative time and length of stay
! No complications or no conversions
! High patient satisfaction
(Toomey et al. 2014)
Conclusion• Transoral fundoplication achieved elimination of daily dependence on
PPI-75-80% (6 yrs data)
• Troublesome regurgitation was resolved in a greater proportion of patients treated with TIF than with omeprazole
• TIF appears to be safe, without fundoplication side effects
• Intra-esophageal acid control improved following TIF
• TIF should be considered in GERD patients with small or absent hiatal hernia who suffer from troublesome regurgitation, despite PPI therapy
(Testoni, Testoni, mazzoleni, Vailati, & Passaretti, 2015)
Linx
! Minimally invasive laparoscopic procedure
! Linx is implanted outside the LES
! Preserves normal function-can belch and vomit
! Designed for lifetime, quarter in size, made of Titanium
! One type is safe in MRI scanning
LINX® Reflux Management System
! FDA approved in 2012 ! Proven safe and effective ! Minimally invasive procedure ! Designed to be a permanent solution for GERD ! Long term 5 – year data published in Clinical Gastroenterology & Hepatology May 2016
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LINX® Procedure
►Laparoscopic, minimally invasive procedure
►Generally completed in less than one hour
►Patients typically go home the same day and resume a normal diet as soon as tolerated
►No alteration to the stomach
►Patients generally retain ability to belch and vomit; reduces gas bloat
►Removable
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LINX® Benefits
! 87% of patients completely eliminated medication use1
! 98% of patients reported no bothersome heartburn affecting their nightly sleep2
! 98% of patients required no daily change to their diet from heartburn2
! 94% of patients were satisfied with their overall condition after LINX1
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1. Ganz, et al., Esophageal Sphincter Device for Gastroesophageal Reflux Disease. The New England Journal of Medicine; 368; 8: 719-727. 2. Data on File, Torax Medical.
How LINX® Works
LINX helps keep the LES closed to prevent reflux
LINX expands to allow for normal swallowing
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How LINX® Works
MUSE- EndostaplerSystem! FDA approved-2014
! The innovative endoscopy system is for the treatment of Gastroesophageal Reflux Disease (GERD).
! It performs an anterior fundoplication in lieu of current surgical procedures, without opening the abdominal cavity.
! SRS™ endoscope distal section including several sophisticated innovative technologies such as a surgical stapler, miniature camera and an ultrasound sensor
! (http://www.medigus.com)
! The SRS system has the following principal advantages: Provides the same results as in gold standard laparoscopic surgery.
! Faster than laparoscopic surgery. ! A more attractive treatment than either surgery or lifelong medication. ! A more efficient and cost effective procedure. ! Less trauma to patient with no incisions. ! The entire endoscope is disposable.
! (http://www.medigus.com)
Endostim Therapy
✓ Bipolar lead delivers low energy electrical impulses to LES ✓ Implanted through laparoscopic procedure ✓ Single-center (Chile) and International multicenter open-label trials
• Prospective pilot studies evaluating safety and efficacy • 6-M and 12-M follow-up results published for single-center study
✓ Initial studies have demonstrated safety and efficacy at 12 months follow-up in PPI-refractory sufferers
✓ Still upstream, but a potential treatment option for GERD
Ideal GERD Treatment
Provider Wish List Patient Wish List
“I wish I could feel normal again.” “I need a decent night’s sleep.”
“I don’t want to take pills anymore.”
“I want to avoid an invasive surgery.”
“I don’t want side-effects.”
• Subjective Improvement: – Symptom control – QOL scores
– Medication use – Satisfaction
– Durability
• Objective Improvement: – pH-metry – Esophagitis – Safe, few and minor complications – Minimal side-effects
Thank you
GI SOLUTIONS
References! AGA (2008). American Gastroenterology Association medical position statement on the management of Gastroesophageal Reflux Disease. Gastroenterology, 135: 1383-1391
!Bell, R.C, Mavrelis, P.G., Barnes, W.E., Dargis, D., Carter, B.J.,….Ihde, G.M. (2012). A prospective multicentered registry of chronic gastroesophageal disease receiving transoral incisionless fundoplication. Americal College of Surgery, 215(6):794-809
! De Vault, K.R. & Castell, D.O. (2005). Updated guidelines for the diagnosis & treatment of Gastroesophageal Reflux Disease. American Journal of Gastroenterology, 100:190-200
! Lewis, JV. (2009) (Editorial). Gastroesophageal Reflux Disease and Obesity. Southern Medical Journal, 102(10); 995-996
! Pandalfino,J.E. & Kwialek, M.A. (2008). Use and utility of the Bravo Ph capsule. Journal of Clinical Gastroenterology, 42:571-578
! Shaheen, N.J., Hansen, R.A., Morgan, D.R., Gangarosa, L.M., Ringel, Y., Thiny, M.T., Russo, M.W., Sandler, R.S. (2006). The burden of gastrointestinal and liver disease. American journal of Gastroenterology, 101:2128-2138.
!Moore, M., Afaneh, C., benhuri, D., Antonacci, C., Abelson, J., & Zarnegar, R. (2016). Gastroesophageal reflux disease: A review of surgical decision making., World Journal of gastrointestinal Surgery, 8 (1): 77-83
! MUSE endostapler system Photography: Retrieved from http://www.medigus.com ! Pritchett, J.M., Aslam, M., Slaughter, J.C. (2009). Efficacy of esophageal impedence/PH monitoring in patients with refractory gasroesophageal reflux disease, on and off PPI therapy. Clinical Gastroenterology & Hepatology,
7: 743-748
! Toomey, P., Teta, A., Patel, K, Ross, S., Sukharamwala, P., & Rosemurgy, A.S. (2014). Transoral Incisionless Fundoplication: Is it as safe and efficacious as a Nissen or Toupet Fundoplication?. The American Surgeon, 9(80): 860-867
!Testoni, P.A., Testoni, S., Mazzoleni, G., Vailati, C., & Passaretti, S. (2015). Long-term efficacy of tranoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-centered study, 29: 2770-2780
! Trad,K.S., Barnes, W.E, Simoni, G., Shughoury, A.B., Marvelis, P.G., Heise, J.A., Turgeon, D.G., & Fox, M.A. (2014). Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: The TEMPO randomized clinical trial. Surg Innov, 22 (1): 26-40
! Photography: Used with permission from (GI Solutions/Arun Ohri, MD)
! Photography: Used with permission from (Endogastric Solutions)
! Vakil,N., Vanzanten, S.V, Kahrilas, P., dent, J., Jones, R. & Global consensus group. The Montreal definition and classification of Gastroesophageal Reflux Disease: A global evidence-based consensus (2006). American Journal of Gastroenterology, 101:1900-1920
! Zaveri, H., Surve, A., Cottam, D., Richards, C., Medlin, W., Belnap, L., Cottam, S., & Cottam, A. (2015). Stomach intestinal pylorus sparing surgery (SIPS) with laparoscopic fundoplication (LF): a new approach to gastroesophageal reflux disease 9GERD) in the setting of morbid obesity. 4: 596