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Primary Achalasia : POEM Vs Heller's Myotomy AMOL BAPAYE MD (MS ), FAS GE
SHIVANAND DESAI CENT ER FOR DIG EST IVE DISOR DER S
DEENANAT H MANG ESHKAR HOSPITAL & R ESEAR CH CENT ER , PUNE, INDIA
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)
Is POEM effective?
POEM : A Series of 500 Patients
3 yr or more follow up – 61 pts
Eckardt score - 1
Post-operative LES - 11.7 mm Hg
Overall success rate was - 88.5%
Inoue H et al. 2015 Sigmoid Esophagus
Failed LHM/ Endoscopic
POEM Efficacy
Weighted results for published series
Mean follow up of 6 months (1-13 months)
Stavropoulos et al , Ther Adv Gastroenterol 2013
Continent N Mean Age Mean Length (cm)
Eckardt Score Pre/Post
LES pressure Pre/Post (mmHg)
Efficacy
ASIA 374 45 13.5 6.33/1.19 32.5/4.9 97.9%
NORTH AMERICA
107 50.4 9.1 7.4/0.3 38.6/14.3 95.3%
EUROPE 128 43.5 12.4 7.1/1.0 34.1/12.5 88.6%
Long-term outcomes of per-oral endoscopic myotomy in achalasia patients with a minimum follow-up of 2 years: an international multicenter study Saowanee Ngamruengphong1, Haruhiro Inoue2, Philip Chiu3, Hon-Chi Yip3, Amol Bapaye4, Michael Ujiki5, 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 response @ 6-months – recurrent symptoms @ 2-years = 11 (6%)
• Prior PBD associated with long-term Rx failure (OR, 3.41; 95% CI, 1.25 – 9.23)
• Procedure related AE = 8.2%
• Abnormal esophageal acid exposure and GERD = 37.5% and 18%
Conclusions
POEM is safe and provides high initial clinical success and excellent long-term outcomes
• Recurrence of achalasia after LHM – 20% • Commonest cause is incomplete myotomy
LHM although a gold standard for many years, IS NOT the IDEAL procedure for achalasia
Safety and outcomes of laparoscopic re-operation for achalasia
Zaninotto G Ann Surg 2002; 235: 186 – 192
Is LHM Ideal ?
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
National outcomes of laparoscopic LHM: Operative complications and risk factors for adverse events.
Is LHM Ideal ?
Ross SW Surgical endoscopy 2015
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)
Is LHM Ideal ?
Li J Surg Laparosc Endosc Percutan Tech. 2012 Oct;22(5):392-5 .
POEM Vs LHM Seven Studies POEM (n) LHM (n) Type
Bhayani et al, 2014 37 64 Prospective
Vigneswaran et al, 2014 5 3 Retrospective
Hungness et al, 2014 18 55 Retrospective
Tietelbaum et al, 2013 12 17 Prospective
Ujiki et al, 2013 18 21 Prospective
Kumagai et al, 2015 42 41 Prospective
Chan et al, 2015 33 23 Retrospective
Last two studies have not been included in any of the published meta-analyses
POEM Vs LHM
Two Abstracts POEM n
LHM n
Type of Comparison
Renteln V et al, 2013 70 110 Prospective
Kumbhari et al, 2015 52 52 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.
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
Studies Comparing POEM Vs LHM
Efficacy Complications
a.Operative time b.Hospital stay
Follow up
Kumagai et al Equal a.Less in POEM b.Equal
3 months
Chan et al Equal a. Less in POEM b. Equal
6 months
Renteln V et al* Equal a. - b. -
3 months
Kumbhari et al** Equal a. Less in POEM b. Equal
4.3 months
*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)
All Studies
Equal Efficacy
Similar adverse events
Differences
– Operative time
- Pain/ Blood loss
- Hospital stay
- Early resumption to work
- Less cost
Meta-analyses - POEM Vs LHM
Four Meta-analyses Studies
Total (Comparative)
Talukdar et al, 2014 19 (5)
Patel et al, 2015 22 (3)
Wei et al, 2015 4
Zhang et al, 2016 4
Meta-analyses - POEM Vs LHM Meta-analysis Main Outcome Studies
Total (Comparative)
Talukdar et al, 2014 Equal efficacy, pain, reflux, adverse events 19 (5)
Patel et al, 2015 Similar adverse events, perforation, operative time 22 (3)
Wei et al, 2015 Comparable complications and recurrence 4
Zhang et al, 2016 Equal efficacy, safety, stay and operation time 4
All Meta-analyses
Equal Efficacy
Similar adverse events
Differences – Operative time
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. 2010 May;210(5):637– 45, 645–7
Lynch KL, Am J Gastroenterol, 107(12):1817-25
James, D. R. Minim Invasive Ther Allied Technol 2012, 21 (3), 161-7
Author (year) Type Sample size Control/Cohorts
Previous intervention
Follow up (months)
Outcome
Onimaru (2013) Prospective 10 (11)/ 315 (total)
All post Heller➡ ️PBD failure
18.3 (3-13) Feasibility Procedure time Difficulty Efficacy: • Symptom relief • Eckardt Score
improvement • LES pressure
reduction Complications GERD QOL Meds used prior & after POEM
Sharata (2013) Retrospective I: 12 NI: 28
Bo: 10 PBD: 2
6
Zhou (2013) Prospective 12 All failed Heller 10.4 ± 3.1
Vigneswaran (2014)
8 (all post Heller) (POEM:5 Heller:3)
All post Heller POEM: Bo 2, PBD 4, Fundopl 3 Heller: Bo 1, PBD 2, Fundopl 2
5
Ornstein (2014) Retrospective, Prospective database
I:16 NI:24
BO 9, PBD 9, HM 3, Fundopl2
10
Ling (2014) Prospective PBD: 21 NI: 30
All PBD failure 1 yr (I)/1.2+0.2 yr (NI)
Jones (2015) Prospective database
I: 15 NI: 25
BO 7, PBD 5, HM 3 10 (5-17)
• 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
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
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 3.2 – 14.7)
• 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)
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 - 2.09 +/- 2.5 vs 1.08 +/- 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 POEM Conclusions
Although rate of clinical success in patients with prior HM is lower than those without, safety profile of POEM is comparable in both groups
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
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)
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%)
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
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)
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
POEM & GERD
Chuah SK 2013 Cumulative Results of LHM Bhayani NH Annals of surgery 2014; 259: 1098-1103
Inoue H Japanese Journal of clinical medicine 2010; 68: 1749-1752 Bapaye et al J Gastroenterol Hepatol 2014 (Abstract)
POEM has less or similar reflux / less severe reflux (12 – 35%)
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 < 0.001
Median acid exposure time High Low Low < 0.001
Abnormal De Meester @ 3-yrs 23.1% 8.5% 9.1% < 0.001
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
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
Individualized treatment
PD LHM POEM
TYPE I AC 63-65% 81% 91.4%
TYPE II AC 90-93% 93-100% 93.6%
TYPE III AC 33-40% 80-86% 98%
Overall efficacy 44-84% 57-89.3% 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
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
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