Treatment of Achalasia in 2013: Dilation, Heller, or POEM?
Treatment of Achalasia in 2013: Dilation, Heller, or POEM? AATS, Nov. 15, 2013 Nathaniel J. Soper, M.D., FACS Northwestern Medicine Department of Surgery Chicago, IL Presenter Disclosure Nathaniel J. Soper, MD, FACS The following relationships exist related to this presentation: No Relationships to Disclose Achalasia • Rare, idiopathic disease of esophageal motility • Failure of esophagogastric junction (EGJ) relaxation and aperistalsis of the esophageal body • Results in dysphagia, regurgitation, and esophageal dilation Diagnosis • Based on history and manometry • Upper endoscopy – rule out pseudoachalasia • Esophagram – define anatomy High-resolution manometry Pressure mmHg ≥110 Clouse Plot 90 70 50 30 Manometric port 10 -10 0 2.5 4.5 5.6 7.1 8.5 8.8 11.0 13.0 Achalasia HRM criteria 1. Impaired relaxation 2. Absent peristalsis Normal Achalasia Achalasia Subtypes: Chicago Classification** • Type I (‘classic achalasia’): absence of esophageal pressurization • Type II: panesophageal pressurization • Type III: spastic contractions • **Pandolfino and Kahrilas Achalasia: Historical Aspects • Thomas Willis (1672) - pt. starving, unable to swallow - whalebone dilator • Von Mikulicz (1881)– “cardiospasm” • Einhorn (1888) – impairment of normal reflex relaxation of the cardiac sphincter • Hurst (1913) – “achalasia”- (a, not; χαλάω, I relax) -coined by Sir Cooper Perry Achalasia: Historical Aspects •Heller (1913) – Extramukose cardioplastik belm chronischen cardiospasmus mit dilatation des Ösophagus. Mitt Grenzgeb Med Chir 27: 141-5 •Zaaijer (1923) – Anterior myotomy only • Rake (1927) - progressive destruction of the cells of Auerbach’s plexus (post-mortem) Current Treatment of Achalasia Medical • Pharmacotherapy: Nitrates/Ca-channel blockers – ~20% partial response • Endoscopic Botox (botulinum toxin A) injection* Mechanical • Endoscopic pneumatic dilation* • Esophagomyotomy (Heller or POEM) (Excisional • End-stage disease) *Renders subsequent myotomy more difficult Botox® Advantages Easy Safe Reversible (with time) PJK Disadvantages Temporary Relatively ineffective Expensive • Considering limited efficacy No physiological improvement Doesn’t halt progression May impede myotomy Pneumatic Dilators used for Treating Achalasia Microvasive® Dilator (3.0, 3.5, or 4.0 cm) Passed over guidewire, imaged with fluoroscopy PJK Pneumatic Dilation 35 mm dilator PJK Pneumatic Dilation 35 mm dilator “Waist” locating the LES PJK Pneumatic Dilation 35 mm dilator Effacement of “Waist” PJK Pneumatic dilation Advantages Outpatient procedure Can be repeated Potentially long-term solution Halts disease progression Rare post-Rx reflux Disadvantages 2-4% perforation risk-may require thoracotomy Less efficacious than myotomy • 58% SI >3 years – Campos et al 2008 (meta) May need 2 or even 3 successive dilations • 44% SI at 6 years – Vela et al 2006 • 72% excellent or good at 6 years – Hulselmans et al 2010 – serial and graded Modified from PJK The European Achalasia Trial: 2 year results All patient without previous treatment Successful treatment (%) (Eckardt score < 3) Eckardt score (n=97) Pneumatic dilation (n=85) 90% 86% 1.1 ± 0.1 1.5 ± 0.1 (p = 0.06) LES pressure (mmHg) 10 12 Timed barium swallow (cm) 1.9 3.7 23% 15% Abnormal pH PJK Heller myotomy Boeckxstaens GE, et al. NEJM 2011; 364(19):19 The European Achalasia Trial: Concerns • Surgeon experience: > 5cases • 106 cases at 14 sites over 5 years = 1.5 cases/site/year • 12% perforation rate during LHM • Myotomy only 1-1.5 cm onto stomach •30% initial perforation rate •4% perf for PD after protocol revision •Less experience among U.S. GIs Adverse Events Response Rates Heller vs. Pneumatic Dilation; Meta-analysis of RCTs (Yaghoobi, et al, GI Endosc 2013) Esophageal myotomy Advantages The most effective treatment The most definitive treatment Halts disease progression PJK Disadvantages Requires hospitalization and general anesthetic Operative morbidity and mortality Expensive Post-Rx reflux Surgical Myotomy: Which Approach? Open vs Laparoscopic • Laparoscopic myotomy resulted in shorter LOS, less pain and more rapid recuperation along with similar symptomatic outcome compared to open myotomy (Dempsey, et al, Surg Endosc, ‘99) Laparoscopic vs Thoracoscopic • Laparoscopic associated with shorter OR time, fewer conversions and shorter LOS along with better symptomatic outcome than thoracoscopic myotomy (Stewart, et al, JACS, ‘99) Fundoplication? • Partial fundoplication decreases pathologic reflux -47 vs. 9% (Richards et al, Ann Surg 2004) • No difference between Dor or Toupet (small PRT) - GERD in 42% vs. 21% [p=NS] (Rawlings et al, Surg Endosc 2011) •Nissen fundoplication results in higher rates of dysphagia compared with partial fundoplication - 15 vs. 2.8% (Rebecchi et al, Ann Surg 2008) • Laparoscopic Myotomy Current Preferred Approach Heller-Dor: Minimal posterior dissection; anterior 1800 fundoplication; covers exposed mucosa, but may ‘close the door’ OR Heller-Toupet: Full fundal/esophageal mobilization; posterior ~1800 fundoplication to edges of myotomy; may hold myotomy open From Hunter Partial Fundoplication Toupet Dor From Mastery of Surgery, Chap 62. Swanstrom LL. Surg Endosc 1995 Outcomes of Heller Myotomy: Meta-analysis Symptomatic improvement (%) GERD (%) Laparotomy (732, 87) 84.5 12 Thoracotomy (842, 102) 83.3 24.6 Thoracoscopy (211, 36) 77.6 28.3 Laparoscopy (3086, 35) 89.3 14.9 - without fundo 89.0 41.5 - with fundo 90.3 14.5 (n, mean follow-up months) Campos, et al, Ann Surg 2009 Long-Term Outcomes of Heller Myotomy Treatment failures in 7% at 2 yrs, 10% at 5 yrs and 18% at 10 yrs—failure associated with lower preop LESP and sigmoid esophagus – Zaninotto, et al Ann Surg 2008: 248: 986 Satisfactory results >90% at 5 years75% at 15 yrs – Ortiz, et al Ann Surg 2008; 247: 258 Excellent/good results in 80% at 10 yrs and 65% at 20 yrs—failures due to GERD (Visick scores) – Csendes, et al Ann Surg 2006; 243: 196 Effect of endoscopic treatments before myotomy Prior Botox resulted in increased symptoms of dysphagia, regurgitation and heartburn after laparoscopic Heller • Finley et al 2010 Prior treatment increased failure rate: • 3.7% to 16.8% (Schuchert et al 2008) • 10.1% to 19.5% (Smith et al 2006) ―At this time in history, the best primary therapy for achalasia in a fit patient is a laparoscopic Heller myotomy and fundoplication.‖ John Dent, Professor of Medicine, University of Adelaide – ISDE state of the art lecture-1998 Per-Oral Esophagomyotomy (POEM） …Pasricha initially reported a method of submucosal endoscopic myotomy with no skin incision in an experimental model [1]. Subsequently, Inoue modified the technique and applied it clinically…[2]. １. Pasricha, et al. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy 2007;39(9): 761-4. ２. Inoue H, et al. First clinical experience of submucosal endoscopic myotomy for esophageal achalasia with no skin incision. Gastrointest Endosc 2009;69: A122 POEM (1) Enter into the submucosa in the mid esophagus View through transparent distal cap on endoscope Triangle tip knife Courtesy of H. Inoue POEM (2) Creation of submucosal tunnel ≈ half esophageal circumference mucosal layer palisade vessels Courtesy of H. POEM (3) Myotomy begun ≈ 3 cm distal to entry, ≈ 6 cm above EGJ Courtesy of H. POEM (3) Myotomy completion Courtesy of H. Inoue POEM (4) Clip mucosotomy Courtesy of H. Inoue Northwestern Protocol IRB – >70 cases to date Exclusion criteria: • Prior Botox or dilation for first 10 cases • Sigmoid esophagus for first 20 cases Pre-op multidisciplinary evaluation • HRM • FLIP • Questionnaires Esophagram on POD #1 EndoFLIP Pre/post POEM Technical differences between POEM and Heller 1) No skin incisions 2) Myotomy of only the circular muscle layer 3) No disruption of the diaphragmatic hiatus 4) No concurrent anti-reflux procedure from Inoue et. al. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71 from Vaziri, Soper. Laparoscopic Heller myotomy: technical aspects and operative pitfalls. J Gastrointest Surg. 2008 Sep;12(9):1586-91. Do the differences matter? 1) Perioperative safety and outcomes 2) Resulting anatomy 3) EGJ physiology 4) Learning curve for POEM 5) Long term outcomes after POEM from Inoue et. al. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71 from Vaziri, Soper. Laparoscopic Heller myotomy: technical aspects and operative pitfalls. J Gastrointest Surg. 2008 Sep;12(9):1586-91. Perioperative outcomes • Comparison of intraoperative and immediate postoperative outcomes at Northwestern • Limited to treatment naïve patients Baseline Characteristics – Treatment Naïve Patients POEM LHM p-value Number Female Age 26 28% 42 55 48% 50 BMI ASA classification I 27 28 11% 8% 67% 68% 22% 3.1 24% 2.3 NS 29 27 NS II III Duration of symptoms (years) Preoperative EGJ relaxation pressure (mmHg) NS .02 NS NS Perioperative Outcomes p-value POEM LHM Number 26 55 Operative time (mins) 110 126 .01 Myotomy length (cm) 9.2 8.5 .03 EBL (ml) <10 91 <.001 Major complications 1 (6%) 1 (2%) NS Minor complications 4 (15%) 7 (13%) NS Length of stay (days) 1.6 1.5 NS Pain Scores and Narcotic Requirements POEM LHM POEM LHM p-value Narcotic requirements (mg morphine equivalents) Day of surgery POD #1 Ketorolac usage 10 4 28% 8 5 80% NS NS <.001 POEM Follow-up Manometry * * * : p < .008 POEM Follow-up Esophagram and Endoscopy * * * Pre : p < .001 * Post Long-term Results at NU* • 27 patients >1 yr followup • Eckardt score 7.5 +-2.11.5 +/-2.1; 2 failures (7%; E.S.>3) • 2 failures underwent laparoscopic Heller myotomy • IRP 28 +/-1211 +/-4 mmHg • TBE column height at 5 min. 15 +/-85 +/-4 cm • On EGD (N=14), Grade A esophagitis in 57% (40% with retained clips!), but only one pt with abnormal 24 hr pH test (N=7) ∆ Symptomatic success in 93%, objective reflux in only one patient *Unpublished results Published POEM Results Inoue et al: n=17 (mean f/u 5 months) • Decreased dysphagia symptom score from 10 to 1.3 • Reduced mean LES from 52.4mmHg to 19.9mmHg • 1/17 with reflux esophagitis (LA grade B) Inoue, et al, Endoscopy 2010 Swanstrom et al: n=18 (mean f/u 11 mos) • 3 minor complications • Median LOS 1 day, return to normal activity 3 days • Relief of dysphagia in all • Mean IRP 8.5 mm Hg • 50% with some return of peristalsis • 50% with evidence of acid reflux Swanstrom, et al, Ann Surg 2012 POEM Results (cont) International Prospective Registry 70 pts, multiple centers Symptomatic remission in 97% at 3 months, 89% at 6 months, but in only 82% at 12 months von Renteln, et al, Gastroenterology 2013 Shanghai Group N = 234 Symptomatic success in 95% at 6-12 mos Circular and full-thickness myotomy—no difference in longterm outcome Li, et al, JACS 2013 Response Rates of Achalasia Treatments categorized by pressure topography subtype Type I Classic Type II, with compression Type III spastic Botulinum toxin 0% (0/2) 86% (6/7) 22% (2/9) 39% (7/18) Pneumatic dilation 38% (3/8) 73% (19/26) 0% (0/11) 53% (24/45) Heller Myotomy 67% (4/6) 100% (13/13) 0% (0/1) 85% (17/20) All (any) interventions 44% (7/16) 83% (38/46) 9% (2/21) 56% (47/83) Achalasia subtype First Intervention All types Pandolfino JE et al, Gastroenterology 2008;135:1526 Heller myotomy (n=246) 85.4% (82/96) 95.3% (121/127) 69.6% (16/23) p<0.007 Salvador R et al, J Gastrointest Surg 2010;14:1635 POEM: Utility in Type III Achalasia? LHM limited in proximal extent of myotomy (S.I. <70%) Trans-thoracic extended myotomy not tested Targeted extended myotomy via POEM: 65 y.o. F with dysphagia and chest pain; HRM: • Type III • Spasms to ~ 8 cm prox to EGJ Preoperative Postoperative POEM; myotomy 9 cm prox to EGJ; currently asymptomatic Clinical experience China > 500 cases Japan >375 cases Germany >200 cases United States >250 cases • • • • • • • Legacy – 110 Northwestern – >70 Long Island > 50 (?) Case Western - 40 UCSD - 25 Hopkins - 20 Misc. groups Summary—POEM* • Per-oral esophageal myotomy (POEM) is a feasible procedure for creating an endoscopic myotomy across the EGJ in patients with achalasia • Published results have been variable and short-term, and most have included the learning curve • POEM is a difficult procedure, requiring both advanced endoscopic and surgical skills • POEM may be particularly useful for Type III achalasia • Further investigation is needed regarding long-term symptomatic and physiologic outcomes after POEM • *Acknowledge: Eric Hungness, Ezra Teitelbaum, Peter Kahrilas, John Pandolfino Conclusions—Achalasia Treatment 2013 • Botox should only be used as a temporizing measure • Pneumatic dilation highly operator dependent and inferior to myotomy • Laparoscopic Heller myotomy with partial fundoplication is time-tested option with good long-term symptom control • POEM is emerging as a promising alternative and may be especially useful for Type III achalasia
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