Background
Per oral endoscopic myotomy (POEM) represents a Natural Orifice Transluminal Endoscopic Surgery (NOTES) approach to Heller myotomy. Even though we are now entering an exponential phase of ...growth with a large number of centers interested in POEM, published data to guide them are limited. As part of the July 2012 NOSCAR meeting, a conference was organized to review POEM and develop a consensus document. Authors SNS and TS who chaired the NOSCAR panel recognized the dearth of published data, which also may lag the rapid developments in POEM. Therefore, they undertook a survey of early POEM adopters around the world to rapidly obtain global, extensive, and current data on POEM. The raw survey data were made available to NOSCAR panel participants to assist with their presentations. We summarize the salient findings of the survey.
Methods
A comprehensive POEM survey was created and tested. The final survey instrument consisted of 197 questions that covered all aspects of POEM, including operator discipline, prior training, patient selection, setting, technique preference, results, adverse events, regulatory requirements, and perspectives on the future. An automated online response collector was used.
Results
The International Per Oral Endoscopic Myotomy Survey (IPOEMS) involved 16 expert centers, 7 in North America, 5 in Asia, 4 in Europe, including all high-volume centers (≥30 POEMs per center), as of July 2012. These centers had performed 841 POEMs. There were modest variations among centers in technique and periprocedural management, but all centers uniformly reported excellent efficacy and safety outcomes.
Conclusions
The international POEM survey provides a “global snapshot” of the experience of early adopters. The excellent outcomes over a large cumulative volume of procedures are in line with those of published small series and lend further support to the notion that POEM represents a paradigm shift in the treatment of achalasia.
Background Per oral endoscopic myotomy (POEM) represents a natural orifice transluminal endoscopic surgery approach to Heller myotomy. Our center was the first to offer POEM outside of Japan, ...allowing us to accumulate what is likely the highest single-operator POEM volume in the United States. Objective To define the POEM learning curve of a gastroenterologist by using a larger data set and more detailed statistical analysis than used in 2 other reports of POEM performed by surgeons. Design Prospective cohort study. Setting Tertiary-care academic medical center. Patients We analyzed the first 93 consecutive POEMs on patients with achalasia aged >18 years without contraindications to POEM performed by a single operator from October 2009 to November 2013. Interventions (1) Efficiency estimation via cumulative sum (CUSUM) analysis, (2) mastery estimation via penalized basis-spline regression and CUSUM analysis, (3) correlation of operator experience with clinical outcomes (Eckardt score improvement, lower esophageal sphincter pressure reduction) and technical errors (accidental mucosotomy rate), and (4) unadjusted and adjusted regression analysis to assess how patient characteristics affected procedure time by using a generalized linear model. Main Outcome Measurements Clinical outcomes, procedure time, technical errors. Results Efficiency was attained after 40 POEMs and mastery after 60 POEMs. When we used the adjusted regression analysis, only case number (operator experience) significantly affected procedure time ( P < .0001). Improvements in clinical outcomes were excellent but not significantly affected by operator experience, as was the case with accidental mucosotomies. Procedure time was not significantly affected by age, sex, achalasia stage, baseline lower esophageal sphincter pressure, baseline Eckardt score, prior treatment of achalasia, prior botulinum toxin injection, incidence of accidental mucosotomies, length of myotomy, or type of knife used (all P > .05). Limitations Our analysis may underestimate the number of POEMs required to achieve mastery for operators with limited or no endoscopic submucosal dissection experience. Conclusion These results offer thresholds for efficiency and mastery of a single gastroenterologist operator that may guide the efforts of novice POEM operators.
Background and study aims:
Type III achalasia is characterized by rapidly propagating pressurization attributable to spastic contractions. Although laparoscopic Heller myotomy (LHM) is the current ...gold standard management for type III achalasia, peroral endoscopic myotomy (POEM) is conceivably superior because it allows for a longer myotomy. Our aims were to compare the efficacy and safety of POEM with LHM for type III achalasia patients.
Patients and methods:
A retrospective study of 49 patients who underwent POEM for type III achalasia across eight centers were compared to 26 patients who underwent LHM at a single institution. Procedural data were abstracted and pre- and post-procedural symptoms were recorded. Clinical response was defined by improvement of symptoms and decrease in Eckardt stage to ≤ 1. Secondary outcomes included length of myotomy, procedure duration, length of hospital stay, and rate of adverse events.
Results:
Clinical response was significantly more frequent in the POEM cohort (98.0 % vs 80.8 %;
P =
0.01). POEM patients had significantly shorter mean procedure time than LHM patients (102 min vs 264 min;
P <
0.01) despite longer length of myotomy (16 cm vs 8 cm;
P <
0.01). There was no significant difference between POEM and LHM in the length of hospital stay (3.3 days vs 3.2 days;
P =
0.68), respectively. Rate of adverse events was significantly less in the POEM group (6 % vs 27 %;
P <
0.01).
Conclusions:
POEM allows for a longer myotomy than LHM, which may result in improved clinical outcomes. POEM appears to be an effective and safe alternative to LHM in patients with type III achalasia.
Peroral endoscopic myotomy (POEM) is becoming the treatment of choice for achalasia. Data beyond 3 years are emerging but are limited. We herein report our 10-year experience, focusing on long-term ...efficacy and safety including the prevalence, management, and sequelae of postoperative reflux.
This was a single-center prospective cohort study.
Six hundred ten consecutive patients received POEM from October 2009 to October 2019, 160 for type 1 achalasia (26.2%), 307 for type II (50.3%), 93 for type III (15.6%), 25 for untyped achalasia (4.1%), and 23 for nonachalasia disorders (3.8%). Two hundred ninety-two patients (47.9%) had prior treatment(s). There was no aborted POEM. Median operation time was 54 minutes. Accidental mucosotomies occurred in 64 patients (10.5%) and clinically significant adverse events in 21 patients (3.4%). No adverse events led to death, surgery, interventional radiology interventions/drains, or altered functional status. At a median follow-up of 30 months, 29 failures occurred, defined as postoperative Eckardt score >3 or need for additional treatment. The Kaplan-Meier clinical success estimates at years 1, 2, 3, 4, 5, 6, and 7 were 98%, 96%, 96%, 94%, 92%, 91%, and 91%, respectively. These are highly accurate estimates because only 13 patients (2%) were missing follow-up assessments. One hundred twenty-five patients (20.5%) had reflux symptoms more than once per week. At a median of 4 months, the pH study was completed in 406 patients (66.6%) and was positive in 232 (57.1%), and endoscopy was completed in 438 patients (71.8%) and showed reflux esophagitis in 218 (49.8%), mostly mild.
POEM is exceptionally safe and highly effective on long-term follow-up, with >90% clinical success at ≥5 years.
Background Limited data exist on the use of peroral endoscopic myotomy (POEM) for therapy of spastic esophageal disorders (SEDs). Objective To study the efficacy and safety of POEM for the treatment ...of patients with diffuse esophageal spasm, jackhammer esophagus, or type III (spastic) achalasia. Design Retrospective study. Setting International, multicenter, academic institutions. Patients All patients who underwent POEM for treatment of SEDs refractory to medical therapy at 11 centers were included. Interventions POEM. Main Outcome Measurements Eckardt score and adverse events. Results A total of 73 patients underwent POEM for treatment of SEDs (diffuse esophageal spasm 9, jackhammer esophagus 10, spastic achalasia 54). POEM was successfully completed in all patients, with a mean procedural time of 118 minutes. The mean length of the submucosal tunnel was 19 cm, and the mean myotomy length was 16 cm. A total of 8 adverse events (11%) occurred, with 5 rated as mild, 3 moderate, and 0 severe. The mean length of hospital stay was 3.4 days. There was a significant decrease in Eckardt scores after POEM (6.71 vs 1.13; P = .0001). Overall, clinical response was observed in 93% of patients during a mean follow-up of 234 days. Chest pain significantly improved in 87% of patients who reported chest pain before POEM. Repeat manometry after POEM was available in 44 patients and showed resolution of initial manometric abnormalities in all cases. Limitations Retrospective design and selection bias. Conclusion POEM offers a logical therapeutic modality for patients with SEDs refractory to medical therapy. Results from this international study suggest POEM as an effective and safe platform for these patients.
Background
Gastric per oral endoscopic myotomy (G-POEM) of the pylorus is a technique that is recently being used to treat gastroparesis. Our aim was to report our experience in performing G-POEM for ...refractory gastroparesis of different etiologies and determine symptom improvement.
Methods
Thirteen patients undergoing G-POEM are reported. Pre- and post-procedure gastric emptying study (GES) and PAGI-SYM for symptom severity were obtained. Patients underwent G-POEM by creating a submucosal tunnel starting in the greater curvature of the distal antrum and extending it to the beginning of the duodenal bulb, followed by a full thickness pyloromyotomy.
Results
All 13 gastroparesis patients successfully underwent G-POEM (one diabetic DGp, four idiopathic IGp, eight postsurgical PSGp). Postsurgical patients included 4 s/p esophagectomy for esophageal cancer, 3 s/p Nissen fundoplication, and 1 s/p esophagectomy for achalasia. There were no procedure-related side effects. Of 11 patients completing follow-up questionnaires, eight were improved subjectively (four patients reported considerably better, four patients somewhat better, one unchanged, and two worse). Individual symptom severity scores tended to improve, particularly vomiting, retching, and loss of appetite. Of six patients that had post-G-POEM GES; GES improved in four, unchanged in one, and worsened in one).
Conclusions
G-POEM for treatment of refractory gastroparesis appears to be a feasible and safe technique that can be successfully performed in patients with a variety of etiologies including different types of postsurgical gastroparesis. Our initial experience suggests that the majority of patients report some improvement in symptoms, particularly symptoms of vomiting, retching, and loss of appetite. Further experience is needed to determine the efficacy and safety of G-POEM and predict those who best respond to this treatment.
Background EUS-guided biliary drainage (EGBD) can be performed via direct transluminal or rendezvous techniques. It is unknown how both techniques compare in terms of efficacy and adverse events. ...Objective To describe outcomes of EGBD performed by using a standardized approach and compare outcomes of rendezvous and transluminal techniques. Design Retrospective analysis of prospectively collected data. Setting Two tertiary-care centers. Patients Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EGBD after failed ERCP between July 2006 and December 2012 were included. Intervention EGBD by using a standardized algorithm. Main Outcome Measurements Technical success, clinical success, and adverse events. Results During the study period, 35 patients underwent EGBD (rendezvous n = 13, transluminal n = 20). Technical success was achieved in 33 patients (94%), and clinical success was attained in 32 of 33 patients (97.0%). The mean postprocedure bilirubin level was 1.38 mg/dL in the rendezvous group and 1.33 mg/dL in the transluminal group ( P = .88). Similarly, length of hospital stay was not different between groups ( P = .23). There was no significant difference in adverse event rate between rendezvous and transluminal groups (15.4% vs 10%; P = .64). Long-term outcomes were comparable between groups, with 1 stent migration in the rendezvous group at 62 days and 1 stent occlusion in the transluminal group at 42 days after EGBD. Limitations Retrospective analysis, small number of patients, and selection bias. Conclusion EGBD is safe and effective when the described standardized approach is used. Stent occlusion is not common during long-term follow-up. Both rendezvous and direct transluminal techniques seem to be equally effective and safe. The latter approach is a reasonable alternative to rendezvous EGBD.
Heller’s myotomy (HM) is one of the most effective treatments for esophageal achalasia. However, failures do exist, and the success rate tends to decrease with time. The efficacy of rescue treatments ...for patients with failed HM is limited. A few small-scale studies have reported outcomes of per-oral endoscopic myotomy (POEM) in these patients. We conducted this study to systematically assess feasibility, safety, and efficacy of POEM on patients who have had HM.
Patients at least 3 months out from POEM were selected from our prospective database: 318 consecutive POEMs performed from October 2009 to October 2016. The efficacy and safety of POEM were compared between the 46 patients with prior HM and the remaining 272 patients.
Patients with prior HM had longer disease history, more advanced disease, more type I and less type II achalasia, lower before-POEM Eckardt scores, and lower before-POEM lower esophageal sphincter (LES) pressure (all P < .01). Procedure parameters and follow-up results (clinical success rate, Eckardt score, LES pressure, GERD score, esophagitis, and pH testing) showed no significant difference between the 2 groups. For the 46 HM-POEM patients, no clinically significant perioperative adverse events occurred. Their overall clinical success rate (Eckardt score ≤3 and no other treatment needed) was 95.7% at a median follow-up of 28 months.
POEM as a rescue treatment for patients with achalasia who failed HM is feasible, safe, and highly effective. It should be the treatment of choice in managing these challenging cases at centers with a high level of experience with POEM.
Background The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC ...closure of GI defects. Objective To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. Design Multicenter, retrospective study. Setting Multiple, international, academic centers. Patients Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. Interventions OTSC placement to attempt closure of GI defects. Main Outcome Measurements Long-term success of the procedure. Results A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) ( P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). Limitations Retrospective design and multiple operators with variable expertise with the OTSC device. Conclusion OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.
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