Novel Approaches for Managing Reflux. Marcus Reddy Consultant General and Upper GI surgeon

Transcription

1 Novel Approaches for Managing Reflux Marcus Reddy Consultant General and Upper GI surgeon

2 Medigus SRS Endoscope (TIFS) EsophyX STRETTA LINX

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6 Persistent GORD

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13 RF delivery for GORD RF fits in the algorithm between drugs and surgery Only technique FDA/MEA approved on effectiveness and reproducibility Symptoms, Qol and acid-exposure improvement Double blind sham controlled randomised trials Durability at 4 years and beyond

14 Clinical Spotlight Review 2/2013 SAGES Is considered appropriate for patients being treated for GERD with symptoms of heartburn, regurgitation or both for 6 months or more who have been partially or completely responsive to drugs, and who have declined anti-reflux surgery Reasonable to propose STRETTA for bridge therapy between continuous PPIs and surgery.

15 LINX

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18 Persistent GORD

19 Non-ablative Radiofrequency (RF) Therapy for the Treatment of GERD AN EFFECTIVE ENDOLUMINAL BRIDGE BETWEEN MEDICATIONS FOR GERD AND INVASIVE SURGERY OR IMPLANTS

20 14 Years of Data Stretta Highlights >21,000 STRETTA PROCEDURES 15-Years of peer reviewed clinical data Multiple 4-year studies with consistent outcomes 10-year follow-up, Surgical Endoscopy Aug year follow-up, Gastroenterology Research & Practice May ,000+ patients studied in clinical trials Safety profile <1% complication rate Level I Evidence 3 randomized sham control trials, plus 1 randomized vs. PPI SAGES Society of American Gastrointestinal and Endoscopic Surgeons Society support 2013 Grade Analysis Recommendation Strong/Quality of Evidence ++++ Over 34 published clinical studies Consistency of reported results Meta-Analysis (Perry 2012) 18 studies/1441 patients - Both objective and subjective outcomes significantly improved

21 SAGES Strongest Grade Recommendation

22 ASGE Guidelines: June 2015 ENDOSCOPIC MANAGEMENT OF GERD Statements on Stretta: Adverse events were infrequent and typically minor. The technique appears to durably relieve GERD symptoms for up to 10 years in the majority of patients This technique uses RF energy delivery to the distal esophagus and appears to reduce GERD by decreasing tissue compliance and reducing transient lower esophageal relaxations. Summary: Endoscopic antireflux therapy may be considered for select GERD patients.

23 Stretta is Effective Meta-analysis - 18 Studies 1,441 Patients Outcome Variable Studies (n) SUBJECTIVE MEASUREMENTS Patients (n) Mean Followup (mo.) Pre- Stretta Post- Stretta P-value GERD-HRQL QOLRAD SF-36 Physical SF-36 Mental Heartburn Score Satisfaction Score OBJECTIVE MEASUREMENTS Esophageal Acid Exposure (%PH.<4) DeMeester score LES pressure Radiofrequency Energy Delivery to the Lower Esophageal Sphincter Reduces Esophageal Acid Exposure and Improves GERD Symptoms: A Systematic Review and Meta-analysis. Kyle A. Perry, MD, Ambar Banerjee, MD, and William Scott Melvin, MD. Surg Laparosc Endosc Percutan Tech 2012;22:

24 Improvement In Health Outcomes LONG TERM OUTCOME STUDIES 10 year (Noar 2014) 72% of patients normalized GERD HRQL 41% of patients off PPIs 8 year (Dughera 2014) 76% of patients off all meds 4 year (Dughera 2011) 92% improved heartburn scores 72% completely off PPIs 4 year (Noar 2007) GERD-HRQL scores improved from 27.8 to % of patients off daily meds 4 year (Reymunde 2007) 86% of patients off daily meds

25 Stretta How it Works Low power RF energy delivered to tissue Multi-level treatment at muscle depth improves muscle in the LES and Gastric Cardia Function improved, reduced compliance, fewer TLESRs Stretta therapy remodels the musculature of the lower esophageal sphincter (LES) and gastric cardia. Clinical studies demonstrate that the Stretta RF treatment results in significant reductions in tissue compliance and transient LES relaxations. These mechanisms act to restore the natural barrier function of the LES as well as to significantly reduce spontaneous regurgitation caused by transient inappropriate relaxations of the sphincter. Edward D. Auyang, Patrice Carter, Thomas Rauth, Robert D. Fanelli, SAGES Guidelines Committee, Endoluminal Treatments for GERD, May 2013

26 ASGE Guidelines: June 2015 ENDOSCOPIC MANAGEMENT OF GERD Statements on Stretta: Adverse events were infrequent and typically minor. The technique appears to durably relieve GERD symptoms for up to 10 years in the majority of patients This technique uses RF energy delivery to the distal esophagus and appears to reduce GERD by decreasing tissue compliance and reducing transient lower esophageal relaxations. Summary: Endoscopic antireflux therapy may be considered for select GERD patients.

27 Increased Thickness CANINES HUMANS Before Stretta Baseline controluntreated 5.2 mm ± months post-treatment 7.8 mm ± % mean increase in thickness of the GE junction (p<0.0001) After Stretta 3 Months Kim M, GI Endoscopy 2003 De Angelis C, Repici A, Dughera L. UEGW 2004

28 UNTREATED RF TREATMENT Herman et al, Colorectal Disease April 2015 Demonstrating a thinner muscularis propria in the untreated group, compared to thicker in the RF group.

29 The Stretta Patient Profile Because Stretta doesn t alter the anatomy or introduce foreign substances, it can be utilized in a variety of patient groups, and doesn t preclude other treatment options. Stretta fills an unmet need in: Patients who don t respond to, or are intolerant of PPIs Patients who don t wish to have surgery or an implant Non-erosive reflux (NERD) patients Laryngopharyngeal reflux (LPR) patients, and those with other extra-esophageal symptoms of GERD Post-Nissen patients with recurring reflux Post-gastric sleeve/bypass patients with GERD Pre-Post Lung Transplant patients with GERD

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31 Stretta in Bariatric Patients with GERD Many patients who have had bariatric surgery have GERD post procedure. Non-surgical options for this patient population are limited...to Stretta. Because Stretta is performed trans orally and doesn t further alter the anatomy it is an ideal option to provide relief from GERD symptoms in the bariatric patient. Stretta Therapy offers an alternative that permits further surgery if necessary, and leaves the gastric sleeve unaffected. A study of Stretta in bariatric patients with GERD showed 71% were symptom free with ph normalization (Mattar et al).

32 Stretta Contraindications There are no known absolute contraindications to the use of radiofrequency (RF) in humans. The use of the Stretta System is contraindicated when, in the judgment of the physician, RF surgical procedures would be contrary to the best interests of the patient. The following is a list of patient groups in whom the use of the Stretta System for the treatment of GERD may be contraindicated. 1. Subjects under the age of Pregnant women 3. Patients without a diagnosis of GERD 4. Hiatal hernia > 3 cm 5. Achalasia or incomplete LES relaxation in response to swallow 6. Poor surgical candidate