Primary Achalasia : POEM Vs Heller's Myotomy AMOL BAPAYE MD (MS ), FAS GE

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1 Primary Achalasia : POEM Vs Heller's Myotomy AMOL BAPAYE MD (MS ), FAS GE SHIVANAND DESAI CENTER FOR DIG EST IVE DISOR DERS DEENANAT H MANGESHKAR HOSPITAL & R ESEAR C H C ENTER, PUNE, INDIA

2 What is Achalasia Cardia? Benign progressive disorder characterized by loss of esophageal motility & non relaxation of LES on wet swallows Therapy aims at Disruption / relaxation of circular muscle fibers at LES No method devised to improve esophageal body motility Therapeutic options Pharmacotherapy Endoscopic balloon dilatation Endoscopic Botox injection Laparoscopic Heller s myotomy (LHM) Per-oral endoscopic myotomy (POEM)

3 What Is POEM?

4 Pre POEM Post POEM 1 Minute 2 Minute

5 Is POEM effective? POEM : A Series of 500 Patients 3 yr or more follow up 61 pts Eckardt score - 1 Post-operative LES mm Hg Overall success rate was % Sigmoid Esophagus Failed LHM/ Endoscopic Inoue H et al. 2015

6 POEM Efficacy Continent N Mean Age Mean Length (cm) Eckardt Score Pre/Post LES pressure Pre/Post (mmhg) Efficacy ASIA / / % NORTH AMERICA / / % EUROPE / / % Weighted results for published series Mean follow up of 6 months (1-13 months) Stavropoulos et al, Ther Adv Gastroenterol 2013

7 Is POEM effective? POEM efficacy >90%

8 Long-term outcomes of per-oral endoscopic myotomy in achalasia patients with a minimum follow-up of 2 years: an international multicenter study Saowanee Ngamruengphong 1, Haruhiro Inoue 2, Philip Chiu 3, Hon-Chi Yip 3, Amol Bapaye 4, Michael Ujiki 5, et al. GIE 2016 (accepted for publication) N = 205, prior therapy = 81 (39.5%) Median follow up = 31 months (IQR 26 38) Clinical success = 98% (185/189), 98% (142/144), & 91% (187/205) at 6, 12 & 24-months 185 patients with clinical 6-months recurrent 2- years = 11 (6%) Prior PBD associated with long-term Conclusions Rx failure (OR, 3.41; 95% CI, ) POEM Procedure is safe and related provides AE = 8.2% high initial clinical success and excellent long-term Abnormal esophageal acid exposure outcomes and GERD = 37.5% and 18%

9 Is LHM Ideal? Safety and outcomes of laparoscopic reoperation for achalasia Recurrence of achalasia after LHM 20% Commonest cause is incomplete myotomy Zaninotto G Ann Surg 2002; 235: LHM although a gold standard for many years, IS NOT the IDEAL procedure for achalasia

10 Is LHM Ideal? National outcomes of laparoscopic LHM: Operative complications and risk factors for adverse events. Overall complications 59 / 1237 (4.8%) major 2.8%, deaths 4 Intra-operative mucosal injury 4% (not recorded as complication) Readmissions 3.1%, reoperations 2.3% LOS 2.8d +/- 5.5d Advanced age, co-morbid illness associated with increased operating time, complications & LOS Ross SW Surgical endoscopy 2015

11 Is LHM Ideal? Reasons and prevalence of reoperations after esophagomyotomy for achalasia. 18% re-interventions due to failure or complications 9% repeat operations due to incomplete myotomy Conclusions Early reoperations due to technical errors (mucosal injury) Late reoperations due to recurrence (incomplete myotomy) Li J Surg Laparosc Endosc Percutan Tech Oct;22(5):392-5.

12 POEM Vs LHM Seven Studies POEM (n) LHM (n) Type Bhayani et al, Prospective Vigneswaran et al, Retrospective Hungness et al, Retrospective Tietelbaum et al, Prospective Ujiki et al, Prospective Kumagai et al, Prospective Chan et al, Retrospective Last two studies have not been included in any of the published meta-analyses

13 POEM Vs LHM Two Abstracts POEM n LHM n Renteln V et al, Type of Comparison Prospective Kumbhari et al, Retrospective Von Renteln D, Fockens P et al. Gastrointest. Endosc. 2013; 77 (Supp 5): AB122. Kumbhari V et al. Gastrointes. Endosc. 2015; 81 (Supp 5): AB492.

14 Studies Comparing POEM Vs LHM Efficacy Complications a. Operative time b. Hospital stay Follow up Bhayani et al Equal Both Less in POEM 6 months Vigneswaran et al Equal - 5 months Hungness et al Equal a. Less in POEM b. Similar 6 months Tietelbaum et al Equal improvement in EGJ distensibility (FLIP) Ujiki et al Equal Equal in both 116/ 164 days

15 Studies Comparing POEM Vs LHM Kumagai et al Equal Equal Efficacy Efficacy Complications All Studies a.operative time b.hospital stay a.less in POEM b.equal Chan et al Differences Equal a. Less in POEM b. Equal Operative time Renteln V et al* Equal a. - - Pain/ Blood loss b. - Kumbhari et al** Similar adverse events - Hospital stay Equal a. Less in POEM - Early resumption b. to work Equal Follow up 3 months 6 months 3 months 4.3 months - Less cost *POEM - lower 3 month Eckhardt scores (1 vs. 1.4,p=0.05), lower post-op LESP (9 vs.12 mmhg, p=0.01) **POEM - less cost ($14,481 vs. $17,782)

16 Meta-analyses - POEM Vs LHM Four Meta-analyses Studies Total (Comparative) Talukdar et al, (5) Patel et al, (3) Wei et al, Zhang et al,

17 Meta-analyses - POEM Vs LHM Meta-analysis Main Outcome Studies Total (Comparative) Talukdar et al, 2014 All Meta-analyses Equal efficacy, pain, reflux, adverse events 19 (5) Patel et al, 2015 Equal Efficacy Similar adverse events, perforation, operative time Similar adverse events 22 (3) Wei et al, 2015 Comparable complications and recurrence 4 Differences Operative time Zhang et al, 2016 Equal efficacy, safety, stay and operation time 4

18 Redo LHM compared to primary LHM More complications due to scarring and fibrosis due to previous intervention Redo Heller: More conversion to open (up to 7%) Longer procedure time Lower efficacy More postoperative complications: gastrointestinal perforations (1.5% to 20%), pneumothorax (1.9% to 6.7%), pulmonary complications (1.3% to 4% of patients) Wang L, Li YM, World J Gastroenterol 2008; 14:7122e7126 Rosemurgy AS, J Am Coll Surg May;210(5):637 45, Lynch KL, Am J Gastroenterol, 107(12): James, D. R. Minim Invasive Ther Allied Technol 2012, 21 (3), 161-7

19 Author (year) Type Sample size Control/Cohorts Previous intervention Follow up (months) Outcome Onimaru (2013) Prospective 10 (11)/ 315 (total) Sharata (2013) Retrospective I: 12 NI: 28 All post Heller PBD failure Bo: 10 PBD: 2 Zhou (2013) Prospective 12 All failed Heller 10.4 ± 3.1 Vigneswaran (2014) Ornstein (2014) Retrospective, Prospective database 8 (all post Heller) (POEM:5 Heller:3) I:16 NI:24 Ling (2014) Prospective PBD: 21 NI: 30 All post Heller POEM: Bo 2, PBD 4, Fundopl 3 Heller: Bo 1, PBD 2, Fundopl 2 BO 9, PBD 9, HM 3, Fundopl2 All PBD failure 18.3 (3-13) Feasibility Procedure time Difficulty 6 Efficacy: Symptom relief Eckardt Score improvement 5 LES pressure reduction Complications GERD QOL Meds used prior & after POEM 10 POEM post intervention is effective in reduction of symptoms, dysphagia score, LES pressure with acceptable complication rate in short/medium follow up Comparable to data when performed without prior intervention POEM in post intervention setting is associated with QOL improvement 1 yr (I)/ yr (NI)

20 Advantages of POEM over LHM 1. Direct visual recognition of the submucosal layer, less perforations 2. POEM is submucosal, doesn t alter surrounding anatomy; possible less reflux, less severe reflux; further treatment options are safer 3. Less chances of fusion of the myotomy line in view of lateral dissection post POEM

21 Comparative Evaluation of Per Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia in Patients With Failed Heller Myotomy vs Patients Without a History of Surgical Myotomy: A Multicenter Retrospective Cohort Study Saowanee Ngamruengphong, Haruhiro Inoue, Michael Ujiki, Amol Bapaye, Pankaj N. Desai, Thierry Ponchon, et al GIE 2016 (Abstract) N = 181 (91 prior HM, 90 controls), 11 centers (4 US, 4 Europe, 3 Asia) Controls matched for age, achalasia subtype & Eckhardt scores Clinical response defined as post POEM Eckhardt scores <= 3 Technical success, clinical success & AE s compared between two groups Mean follow up = 8.5 months (IQR ) Technical success comparable 89/91 (98%) vs 100% (p=0.49) Procedure times similar Adverse events comparable 7 (8%) vs 12 (13%) (p=0.23)

22 Comparative Evaluation of Per Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia in Patients With Failed Heller Myotomy vs Patients Without a History of Surgical Myotomy: A Multicenter Retrospective Cohort Study Saowanee Ngamruengphong, Haruhiro Inoue, Michael Ujiki, Amol Bapaye, Pankaj N. Desai, Thierry Ponchon, et al GIE 2016 (Abstract) Clinical response significantly lower in HM group 80% vs 94% (p=0.02) Mean post POEM Eckhardt scores higher in HM group /- 2.5 vs /- 1.2 (p=0.002) Univariate analysis prior HM (OR 3.54, p 0.02) & prior PD (OR 3.36, p 0.01) were significantly associated with clinical failure Multivariate analysis prior HM (adjusted OR 2.91, p 0.05) was marginally associated with clinical failure after Conclusions POEM Although rate of clinical success in patients with prior HM is lower than those without, safety profile of POEM is comparable in both groups

23 Type III Achalasia/ SED s: Tailor-made myotomy according to requirement / indication Long segment LES Spastic contractions in lower third esophagus Rarest amongst all AC types Most difficult to treat Part of SED s DES, Jackhammer esophagus

24 Results of Rx for AC according to type

25 POEM for Type III AC Khashab et al GIE 2015 The only multicenter retrospective study N = 73, Includes all SED s Type III AC = 54 DES = 9 Jackhammer = 10 Outcome measure Eckhardt score < / = 3 Mean length of myotomy 16cm (6 26) Duration of procedure 118min (43 345)

26 POEM for Type III AC Khashab et al GIE 2015 Success = 93% (overall) Type III AC = 96.3% DES = 100% Jackhammer = 70% Relief of chest pain 87% Reduction in Eckhardt score Overall 6.73 to 1.13 (p < 0.01) Type III AC 6.4 to 0.86 (p < 0.01) AE = 8 / 73 (11%)

27 POEM vs. LHM for Type III AC Kumbhari et al EIO 2015 The only retrospective comparative study Multicenter N = 75 POEM 49 (multicenter) LHM + Dor / Toupet 26 (single center) Primary outcome symptom improvement & decrease in Eckhardt score 1 Secondary outcomes myotomy length, procedure duration, hospital stay, rate of AE

28 POEM vs. LHM for Type III AC Kumbhari et al EIO 2015 Clinical response 98 vs. 80.8% (p < 0.01) Mean procedure time 102 vs. 264min (p < 0.01) Myotomy length = 16 vs. 8cm (p < 0.01) AE = 6 vs. 27% (p < 0.01) Hospital stay = 3.3 vs. 3.2days (p = 0.68) Post procedure PPI = 38.8 vs. 46.1% (p = 0.7)

29 Sigmoid Achalasia POEM feasible, effective for sigmoid type (both S1 / S2) including advanced sigmoid achalasia (not amenable to LHM) Inoue Endoscopy 2010, Hu JW Surg endosc 2015, Eleftheriadis N Ann Gastroenterol 2014

30 POEM & GERD POEM has less or similar reflux / less severe reflux (12 35%) Chuah SK 2013 Cumulative Results of LHM Bhayani NH Annals of surgery 2014; 259: Inoue H Japanese Journal of clinical medicine 2010; 68: Bapaye et al J Gastroenterol Hepatol 2014 (Abstract)

31 Why GERD is a Problem in LHM: Hiatal dissection & post-op GERD Parameter Heller - Dor + Complete HD Heller - Dor + limited HD Heller only + limited HD P-value Median resting LES pressures Low High High < Median acid exposure time High Low Low < Abnormal De 3-yrs 23.1% 8.5% 9.1% < Prospective, randomized 3-yrs follow up 84 pts of LHM Conclusion Limited HD achieves better post op GERD control No Hiatal Dissection in POEM! Simic AP. J Gastrointest Surg 2010

32 Advantages of POEM: Summary

33 PD VS LHM Graded or on demand dilatation is equal to LHM in type I And Type II AC LHM better than Single dilatation PD VS POEM No comparative data

34 Individualized treatment PD LHM POEM TYPE I AC 63-65% 81% 91.4% TYPE II AC 90-93% % 93.6% TYPE III AC 33-40% 80-86% 98% Overall efficacy 44-84% % 80-97% Follow up > 5 years > 5 years 1-3 Years GER 4% 9-33% 15-30% Zaheer, Reddy DN, Ramchandani M, J Gastrointest Dig Syst 2016

35 Summary of available data LHM > Single Pneumatic dilatation LHM = Graded Dilatation (Type I, II) POEM = LHM POEM >= LHM (Type III, spastic disorders) POEM vs PD No literature

36 POEM Should it be the first line of treatment? Yes If I am in a institute where expertise is available If my patient is non compliant for repeated dilatation If patient desires minimally invasive & one time treatment If patient has type III achalasia No If patient has type II / type I achalasia & is willing for repeated dilatation (PBD) Severe sigmoidization Esophagectomy

37 Thank You!