L ANELLO MAGNETICO NELLA TERAPIA DEL REFLUSSO

L ANELLO MAGNETICO NELLA TERAPIA DEL REFLUSSO GASTROESOFAGEO Greta Saino University of Milan Department of Biomedical Sciences for Health Division of General Surgery IRCCS Policlinico San Donato TOP TEN IN GASTROENTEROLOGIA TOP TEN IN GASTROENTEROLOGIA ISEO, 13-14 MARZO 2015

The burden of gastroesophageal reflux disease in the world North America: 18-27% Europe: 9-25% South America: 23% Australia: 11% East Asia: 3-8% PJ P.J. Kahrilas Symptomatic reflux disease: the present, the past and the future Postgrad Med J,2015 NJ Shaheen N.J. Shaheen Burden of Gastrointestinal Disease in the United States Gastroenterology, 2012

THE GAP BETWEEN MEDICAL AND SURGICAL THERAPY MEDICAL THERAPY SURGICAL THERAPY (FUNDO) > 90% 60% < 10% The rise and fall of antireflux surgery in the United States JF Finks, 2006, Surgical Endoscopy

EVOLUTION OF ANTIREFLUX SURGERY: PIONEERS The esophagogastric p g g angle should be reconstituted by fixing the cardia below the diaphragm and so allowing the fundus of stomach to ballon up under the dome Philip Allison, S rg Gynecol Surg G necol Obstet, Obstet 1951 Norman Barrett Br J Surg, 1954 Ronald Belsey J Thorac Cardiovasc Surg, 1961

EVOLUTION OF ANTIREFLUX SURGERY: THE DOGMA SINCE A HALF OF CENTURY Andrè Toupet Mem Acad Chir 1963 Rudolf Nissen Schweiz Med Wochenschr, 1956

ANTIREFLUX SURGERY (2001 2014) 2014) n = 782 18,2 % 4,1 % 21,4 % 56,3 % NISSEN (n=417) TOUPET (n=182) LINX (n=143) OTHER (n=40) IRCCS Policlinico San Donato

DISTRIBUTION OF ANTIREFLUX PROCEDURES (2001 2013) 2013) No. pts 140 120 100 80 Nissen 60 40 20 Toupet Linx 0 2001 2003 2004 2006 2007 2010 2011 2013 IRCCS Policlinico San Donato

ISSUES WITH NISSEN FUNDOPLICATION Technically complex Alters gastricanatomy ti anatomy Operator-dependent Side effects Variable success rate Not reversible reserved for severe GERD Vakil et al, Am JMed 2003

WHICH IS THE IDEAL GERD TREATMENT? Restore LES barrier function Preserve normal physiology (ability to swallow belch and vomit) Minimally invasive Standardize efficacy and outcomes Reversible if necessary Outpatient procedure

FEASIBILITY TRIAL: FIRST IMPLANT Policlinico san Donato, March, 17 TH, 2007

MAGNETIC SPHINCTER AUGMENTATION: CLINICAL EXPERIENCE Feasibility trial 30 Policlinico San Donato, Milano. 7 Northwestern t Hospital, Minneapolis, Minnesota 3 Chapman Medical Center, Orange, California (Bonavina L et al, J Gastrointest Surg 2008; Bonavina L et al, Ann Surg 2010; Lipham J et al,surg Endosc 2012) Pivotal trial (Ganz R et al, New Engl J Med 2013) Italian registry (Bonavina L et al, J Am Coll Surg, 2013)

All devices implanted laparoscopically No intra-operative complications Median operative time 40 minutes (range19-104) 43/44 patients discharged within 48 hours post-implant No serious adverse events during hospitalization Patients resumed normal diet post-implant Dysphagia most common adverse event, motly miold and resolved by 3 months No device erosins or migrations

30 N=44 PI (Mean n) RQL Sco ore Off P GERD H 25 20 15 10 5 N=37 N=33 N=27 N=23 p<0.001 p=0.003 p<0.001 p<0.001 0 BL Off PPI Year 1 Year 2 Year 3 Year >=4

Clinical Outcomes by Implant Group GERD-HRQL Score (Median) 30 25 20 Group 1 (Pts 1 25) 15 Group 2 (Pts 26 50) 10 Group 3 (Pts 51 75) 5 Group 4 (Pts 76 100) 0 Baseline Last Follow up 100 %of Patients ate tswith PPI Use 80 60 40 20 0 Baseline Last Follow up Group 1 (Pts 1 25) Group 2 (Pts 26 50) Group 3 (Pts 51 75) Group 4 (Pts 76 100)

100 80 60 40 20 0 Daily PPI Use N=44 N=35 N=32 N=25 N=39 Baseline Year 1 Year 2 Year 3 Year >=4 Patients Reporting Daily PP PI Use (% %)

No. pts Sex Implant date Crural repair Size Time to explant (mos.) Reason Associated procedure POZZI R 002 M 12/2009 yes 13 12 DARDANO R 006 F 01/2010 no 14 24 Odynophagia &chest pain Heartburn &regurgitation (previous MR) Dor Toupet (+crura repair) PERFETTI R 081 M 11/2011 yes 12 13 Dysphagia Lortat-Jacob DI PIETRO R 102 M 04/2012 no 12 11 Heartburn Toupet (+crura repair) DI GREGORI O R 101 M 04/2012 no 12 14 Dysphagia FERRARI R 076 M 09/2011 yes 13 24 Heartburn &regurgitation Toupet (+crura repair) Nissen (+crura repair) BAIETTA R 093 M 02/2012 yes 12 20 Dysphagia&vomiting yp g Dor CAGNI R 110 F 05/2012 yes 11 20 Regurgitation Toupet ROSSI R 125 M 03/2013 yes 12 19 Dysphagia Dor BARBERO R118 M 12/2012 yes 13 27 Heartburn & epigastric pain Toupet

MAGNETIC RESONANCE AND LINX 8 (8,3%) patients underwent postop. MR 5 pts (1,5 Tesla); l) 2pts (0,5 Tesla);1 l) pt (0,2 Tesla) l) 2/5 1,5 T experienced level 8 discomfort

PREGNANCY TESTED DEVICE Pre-pregnancy p g y R 079 Post-pregnancy p g y R 079

CONCLUSIONS LINX can improve reflux symptoms and allow discontinuation of PPI with minimal side effects in patients with early-stage GERD. LINX can reduce the variability in outcomes observed with traditional antireflux surgery. A more pragmatic rather than dogmatic surgical approach in GERD is probably worthwhile. pp p y

Whether justified or not, it is clear that fewer patients with GERD are undergoing surgical intervention. i Whichh therapeutic approachmedical, surgical or endoscopic- is best suited for which patients is an important question that remains unanswered. The rise and fall of antireflux surgery in the The rise and fall of antireflux surgery in the United States J.F. Finks, Surgical Endoscopy, 2006