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• W2024743553 abstract "Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97% of patients were in symptom remission (95% confidence interval, 89%–99%); symptom scores were reduced from 7 to 1 (P < .001) and lower esophageal sphincter pressures were reduced from 28 to 9 mm Hg (P < .001). The percentage of patients in symptom remission at 6 and 12 months was 89% and 82%, respectively. POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months. Clinical Trials Gov Registration number: NCT01405417. Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97% of patients were in symptom remission (95% confidence interval, 89%–99%); symptom scores were reduced from 7 to 1 (P < .001) and lower esophageal sphincter pressures were reduced from 28 to 9 mm Hg (P < .001). The percentage of patients in symptom remission at 6 and 12 months was 89% and 82%, respectively. POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months. Clinical Trials Gov Registration number: NCT01405417. See editorial on page 272. See editorial on page 272. Achalasia is a primary esophageal motility disorder leading to incomplete relaxation of the lower esophageal sphincter (LES), increased LES tone, and aperistalsis of the esophagus. Typical symptoms are dysphagia, regurgitation, and chest pain.1Francis D.L. et al.Gastroenterology. 2010; 139: 369-374Abstract Full Text Full Text PDF PubMed Scopus (157) Google Scholar Endoscopic therapy is facilitated by endoscopic balloon dilatation (EBD) or botulinum toxin injection (BTI) with 1-year remission rates of 68% and 41%, respectively.2Campos G.M. et al.Ann Surg. 2009; 249: 45-57Crossref PubMed Scopus (495) Google Scholar The surgical treatment is laparoscopic Heller myotomy (LHM) with remission rates of about 90%.2Campos G.M. et al.Ann Surg. 2009; 249: 45-57Crossref PubMed Scopus (495) Google Scholar, 3Boeckxstaens G.E. et al.N Engl J Med. 2011; 364: 1807-1816Crossref PubMed Scopus (581) Google Scholar Based on experimental research,4Pasricha P.J. et al.Endoscopy. 2007; 39: 761-764Crossref PubMed Scopus (347) Google Scholar an endoscopic technique to create the esophageal myotomy was developed5Inoue H. et al.Endoscopy. 2010; 42: 265-271Crossref PubMed Scopus (1127) Google Scholar and named peroral endoscopic myotomy (POEM).5Inoue H. et al.Endoscopy. 2010; 42: 265-271Crossref PubMed Scopus (1127) Google Scholar Pilot studies from Europe, Asia, and the United States have shown promising preliminary results for POEM.5Inoue H. et al.Endoscopy. 2010; 42: 265-271Crossref PubMed Scopus (1127) Google Scholar, 6Costamagna G. et al.Dig Liver Dis. 2012; 44: 827-832Abstract Full Text Full Text PDF PubMed Scopus (135) Google Scholar, 7von Renteln D. et al.Am J Gastroenterol. 2012; 107: 411-417Crossref PubMed Scopus (285) Google Scholar, 8Hungness E.S. et al.J Gastrointest Surg. 2013; 17: 228-235Crossref PubMed Scopus (197) Google Scholar, 9Ren Z. et al.Surg Endosc. 2012; 26: 3267-3272Crossref PubMed Scopus (163) Google Scholar, 10Swanstrom L.L. et al.Ann Surg. 2012; 256: 659-667Crossref PubMed Scopus (241) Google Scholar, 11Zhou P. et al.Endoscopy. 2013; 45: 161-166Crossref PubMed Scopus (132) Google Scholar This prospective study reports outcomes of an international multicenter POEM study in 70 achalasia patients from 5 centers in Europe and North America (Supplementary Tables 1 and 2). Patient data are shown in Supplementary Table 3; POEM was performed without technical difficulties under general anesthesia in all 70 patients. No conversions to laparoscopic or open surgery were required. The mean procedure time for POEM was 105 minutes (range, 54–240 min) and the mean length of the myotomy was 13 cm (range, 5–23 cm). In 57% of cases, full-thickness dissection into the peritoneal cavity at the cardia occurred, and in 69% of cases full-thickness dissection into the mediastinum was observed. After POEM, significant increases in C-reactive protein level (mean values, 4–49; P < .001) and leukocyte count (from 7.4 to 9.9; P < .001), and decreases in hemoglobin levels (from 13 to 12; P < .001) were observed. Symptom scores at 3 months were available for all 70 study patients. Treatment success was achieved in 97% of cases (95% confidence interval, 89–99). The mean pretreatment and post-treatment Eckhardt scores decreased from 7 to 1 (P < .001). Manometry assessments at 3 months were available for 61 of 70 study patients. Nine patients refused to undergo follow-up manometry because of discomfort related to the manometry procedure. Mean pretreatment compared with post-treatment LES pressures were 28 vs 9 mm Hg (P < .001). Study outcomes are summarized in Supplementary Table 4. Contact was established with all patients at the required follow-up periods for up to 1 year. No patient was lost to follow-up evaluation. The available number of patients at each of the follow-up intervals at the time of manuscript preparation was 70 (at 3 months), 61 (at 6 months), and 51 (at 1 year). The mean follow-up period for the entire patient group (n = 70) was 10.1 months (range, 3–12 mo). Follow-up evaluation at 6 and 12 months showed sustained treatment success of 88.5% and 82.4%, respectively (Figure 1). The mean Eckhardt score pretreatment was 6.9 compared with 1.3 at 6 months and 1.7 at 12 months (P < .001 for both comparisons). The incidence of gastroesophageal reflux after POEM is shown in Table 1. Multivariate analysis showed that neither age, previous treatment (Botox/dilatation), length of the myotomy, pre-procedure LES pressure, initial Eckardt score, sex, procedure duration, nor full-thickness dissection during POEM were significant predictors of treatment failure at 1 year. Complication rates are described in Supplementary Table 5.Table 1Gastroesophageal Reflux After POEM Treatment3 months6 months12 monthsClinical symptoms, % Overall rate333037 Daily1.56.67.8 Occasionally31.323.429.4PPI use, % Overall rate343929 Daily11.924.619.6 Occasionally22.414.89.8Endoscopic erosions, % Overall rate42 Grade A29.2 Grade B12.3 Grade CNone Grade DNone Open table in a new tab This international prospective multicenter study was able to reproduce the promising results of a POEM pilot series5Inoue H. et al.Endoscopy. 2010; 42: 265-271Crossref PubMed Scopus (1127) Google Scholar, 6Costamagna G. et al.Dig Liver Dis. 2012; 44: 827-832Abstract Full Text Full Text PDF PubMed Scopus (135) Google Scholar, 7von Renteln D. et al.Am J Gastroenterol. 2012; 107: 411-417Crossref PubMed Scopus (285) Google Scholar, 10Swanstrom L.L. et al.Ann Surg. 2012; 256: 659-667Crossref PubMed Scopus (241) Google Scholar in a substantially larger cohort and with a longer follow-up period. POEM appears to be a safe and effective treatment for achalasia, resulting in equivalent short-term symptom relief compared with LHM.2Campos G.M. et al.Ann Surg. 2009; 249: 45-57Crossref PubMed Scopus (495) Google Scholar, 3Boeckxstaens G.E. et al.N Engl J Med. 2011; 364: 1807-1816Crossref PubMed Scopus (581) Google Scholar With POEM it seems possible to emulate the surgical principles of LHM without the need for skin incisions and to reduce the procedural trauma. Treatment success for POEM declined moderately during follow-up evaluation with remission rates of 82% at 12 months. Thus, in the long term, POEM may be slightly less effective than LHM,2Campos G.M. et al.Ann Surg. 2009; 249: 45-57Crossref PubMed Scopus (495) Google Scholar, 3Boeckxstaens G.E. et al.N Engl J Med. 2011; 364: 1807-1816Crossref PubMed Scopus (581) Google Scholar but final conclusions can be drawn only after direct comparison in a randomized controlled trial. Comparing POEM with EBD also will require prospective randomized studies. Here, results will depend on the dilatation protocol: if only one initial EBD is performed then remission rates for POEM are likely to be higher.2Campos G.M. et al.Ann Surg. 2009; 249: 45-57Crossref PubMed Scopus (495) Google Scholar With an extended dilatation protocol that includes early re-treatments in therapy-naive patients, EBD can be equivalent to LHM at 2 years.3Boeckxstaens G.E. et al.N Engl J Med. 2011; 364: 1807-1816Crossref PubMed Scopus (581) Google Scholar In our study, approximately half of the patients had received previous endotherapies such as EBD or EBTI before POEM. This shows that POEM is safe and efficient after previous treatments. Studies have shown that treatment using EBD or BTI can be associated with decreased outcomes for subsequent LHM.12Smith C.D. et al.Ann Surg. 2006; 243: 579-584Crossref PubMed Scopus (186) Google Scholar However, after applying a multivariate analysis, neither previous Botox nor EBD treatment were identified as predictors of treatment failure after POEM. However, this might be owing to the limited number of POEM failures. Treatment failures after POEM underwent LHM (n = 3) or balloon dilatation (n = 5), and treatments were safe and effective. Because the target area for the myotomy during POEM is lateral (on the lesser curvature side) and the myotomy during LHM is anterior, subsequent LHM seem to be a feasible second-line treatment if POEM fails. Complications remain a matter of concern as with every new technique. Visible complete transmural openings into the mediastinum and into the peritoneal cavity occurred in the majority of patients. Therefore, POEM potentially carries the risk of mediastinitis/peritonitis and/or damage to surrounding organs. Full-thickness dissection into the mediastinum occurred because of the extremely thin layer of the longitudinal muscle and adventitia, and into the peritoneum because of intentional deep dissection and disappearance of the circular/longitudinal layer structure at the cardia. Occurrence of pneumoperitoneum and subcutaneous emphysema was not associated with any infectious complications. However, use of corrective procedures (ie, transabdominal relief of CO2 with a 16G needle) was required in a significant proportion of cases, and it is mandatory to secure the integrity of the overlying mucosal layer and to achieve sufficient closure of the mucosal entry site. Furthermore, precautions such as preoperative cleansing, sterile fluids, and perintervention antibiotics were used. The rate of gastroesophageal reflux appears to be higher compared with published literature for LHM and EBD, which is in the range of approximately 20%.3Boeckxstaens G.E. et al.N Engl J Med. 2011; 364: 1807-1816Crossref PubMed Scopus (581) Google Scholar At 3 months after POEM, esophagitis was observed in 42% of cases. However, the severity of esophagitis was only minor (grade A or B) and all patients could be managed adequately with proton pump inhibitor (PPI) therapy. At 3 months, 22% of patients required occasional and 12% required daily PPI therapy. The 1-year follow-up evaluation showed slightly increased clinical reflux rates (overall, 37%) but slightly reduced PPI use (overall, 29%). However, further assessment, especially pH-metry studies, comparing reflux rates after POEM with LHM and EBD remain warranted. Such study limitations are addressed in the randomized controlled trials that have been initiated. Another potential benefit of POEM is the option to extend the myotomy into the proximal esophagus. This could make POEM the preferred treatment approach for type III achalasia13Pandolfino J.E. et al.Gastroenterology. 2008; 135: 1526-1533Abstract Full Text Full Text PDF PubMed Scopus (595) Google Scholar or for patients with spastic disorders (ie, nutcracker esophagus). However, only classic achalasia patients were included in this study and the subgroup for patients identified with type III achalasia was too small to draw any conclusions on the efficacy of a very long myotomy. Studies evaluating POEM for such patient groups remains to be assessed in subsequent studies. In conclusion, this international prospective multicenter study showed that POEM is a safe and effective treatment for esophageal achalasia. Short- and long-term symptomatic relief is adequate and associated with an acceptable rate of gastroesophageal reflux. The authors would like to thank Tania Noder for data management and study follow-up evaluation, H. Inoue and H. Minami for training and helping to introduce peroral endoscopic myotomy for this study, Guy Boeckxstaens for advice with manuscript preparation, and John Cobain/Olympus Corp for invaluable technical and organizational assistance during the study. Adult patients with classic primary achalasia, diagnosed by standard methods (contrast studies, manometry and esophagogastroduodenoscopy) were enrolled into this multicenter study at 5 centers in Europe and North America (Hamburg n=33, Frankfurt n=12, Amsterdam n=14, Zurich n=7, and Montreal n=4). The inclusion and exclusion criteria are listed in the Supplementary Table 1. The study protocol was approved by the Ethics Committee of each institution (registration number PV3725 at the Hamburg Chamber of Physicians) and written informed consent was obtained from all patients. All patients underwent a preoperative assessment prior to peroral endoscopic myotomy (POEM) and were considered eligible to undergo general anesthesia. Before performing a POEM procedure independently, the endoscopist had to perform at least two procedures under direct guidance of an endoscopist with extensive POEM experience. The steps of the procedure, and the post-operative protocol have been previously described.1Von Renteln D. et al.Gastrointest Endosc. 2012; 75 (160): 160Abstract Full Text Full Text PDF Google Scholar All study sites used the exact same operative protocol and endotherapeutic material that has been described by our group previously.1Von Renteln D. et al.Gastrointest Endosc. 2012; 75 (160): 160Abstract Full Text Full Text PDF Google Scholar The primary outcome was treatment success defined as Eckhardt score of ≤3 at 3 months. Any patient requiring additional treatment after POEM for recurrent symptoms was defined as a treatment failure. All patients were scheduled for follow-up visits according to the schedule in Supplementary Table 2. Secondary outcomes included: procedure related adverse events, lower esophageal sphincter pressure (LESP), symptomatic reflux, and use of antacid medication. These data were obtained at 3 months, with further clinical follow-up conducted at 6 and 12 months. At 3 months, patients were re-assessed by endoscopy, manometry, and contrast radiography. Additional endoscopy, manometry, and contrast radiography was offered to patients in situations of persistent or recurrent symptoms. Procedure–specific parameters such as duration of the procedure, hospital stay, and length of the myotomy were also noted. A serious adverse event (SAE) incidence of less than 2% was established as the minimum safety standard. SAEs were defined as death, mediastinitis, peritonitis, or any complication requiring emergency/salvage surgery. The Ethics Comittee in Hamburg functioned as the safety monitoring board and received a report after each 10 consecutive patients completed the 3 month follow-up. We performed a prospective pilot study to establish the safety and preliminary efficacy for POEM1Von Renteln D. et al.Gastrointest Endosc. 2012; 75 (160): 160Abstract Full Text Full Text PDF Google Scholar and to determine the sample size calculation for this study. The sample size was calculated to demonstrate the non-inferiority of POEM compared with alternative therapies (LHM and EBD) with published success rates of about 90% for LHM and 68% for EBD.2Campos G.M. et al.Ann Surg. 2009; 249: 45-57Crossref PubMed Scopus (535) Google Scholar Calculations were based on the results of our POEM pilot study resulting in a 93.8% success rate after POEM. To demonstrate non-inferiority with a margin of equivalence of 14% and a power of 80% (α = .025 one-sided), 58 patients were required for the study. To account for possible attrition of up to 20%, 70 patients were recruited as per protocol. Prior to analysis the data were plotted to determine their distribution. Mean and 95% confidence intervals (95% CI) are shown. Mean values between baseline and follow-up were compared using Student’s t-test for paired samples. Success rates along with exact 95% CIs were calculated. Between groups comparisons were calculated with t-tests or Fisher's exact test as appropriate. Logistic regression with backward selection was used to identify predictors of treatment failure. Nominal P values are reported; P < .05, two-sided, were considered significant. In case of treatment failure requiring any second-line therapy, the last Eckhardt score prior to the second-line therapy is used for statistical assessment at all subsequent time points. R 2.15.2 was used for statistical analysis. All authors had access to the study data and have reviewed and approved the final manuscript.Supplementary Table 1Study inclusion and exclusion criteriaInclusion criteria•Patients with symptomatic achalasia and pre-op barium swallow, Manometry, and esophagogastroduodenoscopy which are consistent with the diagnosis•Age >18 years with medical indication for surgical myotomy or EBD•Signed written informed consent.Exclusion criteria•Patients with previous surgery of the stomach or esophagus•Patients with known coagulopathy•Previous surgical achalasia treatment•Patients with liver cirrhosis and/or esophageal varices•Active esophagitis•Eosinophilic esophagitis•Barrett’s esophagus•Pregnancy•Stricture of the esophagus•Malignant or premalignant esophageal lesion•Severe Candida esophagitis•Hiatal hernia > 1cm•Extensive, tortuous dilatation (>7cm luminal diameter, S shape) of the esophagus Open table in a new tab Supplement Table 2Study follow-upBaseline3 months6 months12 months2 yearsEckhardt Score√√√√√EGD√√——√Manometry√√———GERD Score√√√√√PPI use√√√√√ Open table in a new tab Supplement Table 3Patient and procedural characteristics of POEMPOEM (n=70)Age (y, CI)45(40.5–48.8)Female gender (n, %)30(42.9%)Previous treatment (n, %)24(34.3%)OR time (min, CI)105(95.1–114.2)Length of myotomy (cm, CI)13(11.9–13.5) Open table in a new tab Supplement Table 4Outcomes of POEM Pre- vs Post TreatmentPre-TreatmentPost-TreatmentP valueMean95% CIMean95% CIWeight72.8(68.8–76.9)75.6(71.3–79.8).005Eckhardt Score6.9(6.4–7.4)1(0.7–1.2)<.001LESP27.6(24.2–31.0)8.9(7.3–10.5)<.001CRP4.1(2.5–5.7)58.7(50.4–67.0)<.001WBC7.4(6.1–8.6)9.9(8.9–10.8)<.001Hb13(12.3–13.7)12(11.4–12.6)<.001 Open table in a new tab Supplement Table 5Complications of POEMComlicationn (%)Required additional treatment (n)SequelaClip dislocation at mucosal closure3 (4%)Endoscopic re-clipping (3)nonePeroration into mediatinum at mucosal entry site1 (1%)Endoscopic clipping, creation of a more distal entry into the submucosal tunnel (1)noneMucosal injury through electrocautery or laceration3 (4%)Endoscopic clipping (3)noneBleeding requiring intervention1 (1%)Endoscopic hemostatis (1)noneCap detached in submucosal tunnel1 (1%)Endoscopic removal (1)noneDelayed bleeding leading to mediastinal hematoma1 (1%)Hospital admission, monitoring, conservative management (1)none Open table in a new tab Poetry Is In the Air: First Multi-Institutional Results of the Per-Oral Endoscopic Myotomy Procedure for AchalasiaGastroenterologyVol. 145Issue 2PreviewVon Renteln and the Hamburg group1 bring us the results of a multicenter, multinational, and even trans-Atlantic, prospective registry of the relatively new achalasia therapy, per-oral endoscopic myotomy POEM). Five academic centers contributed a total of 70 patients and follow-up was a mean of 10 months. Although contribution from some centers was from well within their learning curve, early results were actually spectacular, with 97% of patients having not only dysphagia improvement from the treatments, but for the most part reporting complete remission of dysphagia and chest pain. Full-Text PDF" @default.
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• W2024743553 title "Peroral Endoscopic Myotomy for the Treatment of Achalasia: An International Prospective Multicenter Study" @default.
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