Peroral endoscopic myotomy: 10-year outcomes from a large, single-center U.S. series with high follow-up completion and comprehensive analysis of long-term efficacy, safety, objective GERD, and endoscopic functional luminal assessment.

BACKGROUND AND AIMS: 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. METHODS: This was a single-center prospective cohort study. RESULTS: 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. CONCLUSIONS: POEM is exceptionally safe and highly effective on long-term follow-up, with >90% clinical success at ≥5 years.

Learning Curve for Endoscopic Submucosal Dissection With an Untutored, Prevalence-Based Approach in the United States.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is widely used in Asia to resect early-stage gastrointestinal neoplasms, but use of ESD in Western countries is limited. We collected data on the learning curve for ESD at a high-volume referral center in the United States to guide development of training programs in the Americas and Europe. METHODS: We performed a retrospective analysis of consecutive ESDs performed by a single operator at a high-volume referral center in the United States from 2009 through 2017. ESD was performed in 540 lesions: 449 mucosal (10% esophageal, 13% gastric, 5% duodenal, 62% colonic, and 10% rectal) and 91 submucosal. We estimated case volumes required to achieve accepted proficiency benchmarks (>90% for en bloc resection and >80% for histologic margin-negative (R0) resection) and resection speeds >9cm2/hr. RESULTS: Pathology analysis of mucosal lesions identified 95 carcinomas, 346 premalignant lesions, and 8 others; the rate of en bloc resection increased from 76% in block 1 (50 cases) to a plateau of 98% after block 5 (250 cases). The rate of R0 resection improved from 45% in block 1 to >80% after block 5 (250 cases) and ∼95% after block 8 (400 cases). Based on cumulative sum analysis, approximately 170, 150, and 280 ESDs are required to consistently achieve a resection speed >9cm2/hr in esophagus, stomach, and colon, respectively. CONCLUSIONS: In an analysis of ESDs performed at a large referral center in the United States, we found that an untutored, prevalence-based approach allowed operators to achieve all proficiency benchmarks after ∼250 cases. Compared with Asia, ESD requires more time to learn in the West, where the untutored, prevalence-based approach requires resection of challenging lesions, such as colon lesions and previously manipulated lesions, in early stages of training.

A novel technique of endoscopic submucosal dissection for circumferential ileocecal valve adenomas with terminal ileum involvement: the "doughnut resection" (with videos).

BACKGROUND: Ileocecal valve (ICV) lesions are difficult to resect endoscopically and patients are often referred for laparoscopic colectomy. ICV involvement has been shown to be related to technical failure and tumor recurrence after endoscopic mucosal resection (EMR) and represents a challenge for endoscopic submucosal dissection (ESD). Few publications have focused specifically on endoscopic management of ICV lesions. METHODS: We developed a novel ESD technique, the "doughnut resection," for circumferential ICV adenomas with terminal ileum involvement. Two circumferential mucosal incisions are performed, one in the ileum and the other in the cecum, followed by submucosal dissection of the disk of tissue between the two incisions around a guiding stent placed across the valve that helps guide the dissection as it crosses the valve orifice. The lesion is removed en bloc in the shape of a "doughnut" with two concentric assessable lateral margins. The underwater ESD technique and a gastroscope were used to facilitate the resection. RESULTS: Seven patients received the doughnut resection. The median patient age was 67 years. All patients had prior biopsy and three had prior endoscopic resection (1-6 times). The median specimen diameter was 4.5 cm (range 3-8). All resections were en bloc and R0. There was no perforation, delayed bleeding, or other clinically significant adverse events. After a median follow-up of 21 months (range 12-32), there was no tumor recurrence. CONCLUSION: The "doughnut resection" is a feasible, safe, and effective method to remove circumferential ICV lesions endoscopically even for patients with multiple prior tumor manipulations.

Spiral enteroscopy-assisted ERCP in bariatric-length Roux-en-Y anatomy: a large single-center series and review of the literature (with video).

BACKGROUND: Deep enteroscopy-assisted ERCP (DEA-ERCP) in post-bariatric Roux-en-Y (RY) anatomy is challenging. Laparoscopy-assisted ERCP (LA-ERCP) and EUS-directed transgastric ERCP (EDGE) are technically easier and faster but are more invasive and morbid procedures. Therefore, we have used DEA-ERCP as our first-line approach, reserving EDGE and LA-ERCP for cases in which adjunctive techniques that cannot be performed through an enteroscope are required (eg, EUS-FNA, sleeve sphincter of Oddi manometry), or DEA-ERCP failures. The 2 main methods for DEA-ERCP are balloon- and spirus-assisted. Current literature on spiral enteroscopy ERCP (SE-ERCP) in bariatric RY anatomy is scant with low success rates reported. Our center has nearly exclusively used SE-ERCP for bariatric patients. Here, we report one of the largest such series to date. METHODS: This is a retrospective cohort study of consecutive patients with bariatric-length RY anatomy who had SE-ERCP from December 2009 to October 2016 at a tertiary care center, by one operator (S.N.S.). Primary outcomes included success at reaching the papilla, cannulation success, success of desired therapeutic intervention, and overall SE-ERCP success. RESULTS: Thirty-five SE-ERCPs were performed (28 in bariatric RY gastric bypass and 7 other long-limb RY surgical reconstructions). The papilla was reached in 86% (30/35) of cases. Cannulation success in patients in whom deep cannulation was indicated (28/30) was 100% (28/28 cases, including the 24 cases with native papilla). Therapeutic ERCP success was 100% (28/28). Overall SE-ERCP success was 86% (30/35). Median length of stay was 3 days. Median procedure time was 189 minutes. Reasons for SE-ERCP failures included RY anastomosis stricture, adhesions (2), long Roux limb, and redundant small bowel. Two of these patients underwent interventional radiology-guided percutaneous biliary drainage, 2 patients had laparoscopy-assisted ERCP, and 1 patient had EUS-guided antegrade cholangioscopy with sphincteroplasty and stone clearance. There were no adverse events. CONCLUSION: With sufficient allotted time (median procedure time ∼3 hours) and high operator experience (a single-operator volume that exceeds that of other published series), SE-ERCP is safe and effective in bariatric, long-limb RY patients with an overall success rate of 86%, which is higher than previously reported.

Per-oral endoscopic myotomy in patients with or without prior Heller's myotomy: comparing long-term outcomes in a large U.S. single-center cohort (with videos).

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Gastric Per Oral Endoscopic Myotomy (G-POEM) for the Treatment of Refractory Gastroparesis: Early Experience.

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.

Per oral endoscopic myotomy for the treatment of achalasia.

Per oral endoscopic myotomy (POEM) represents the culmination of natural orifice transluminal endoscopic surgery (NOTES) research, and its most successful application to date. Over a thousand POEMs have been performed globally with remarkable results in terms of clinical efficacy and safety. PURPOSE OF REVIEW: We examine the most recent literature concerning POEM since the last two comprehensive analyses [Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) White Paper, ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI)], and integrate this literature in the consensus POEM guidelines and perspective. These current works are largely centered on POEM operator learning curve, comparison of POEM and laparoscopic Heller myotomy (LHM) and extended application of POEM. RECENT FINDINGS: POEM and LHM are comparable in terms of efficacy (diminished dysphagia and Eckardt score) and complications including GERD. POEM has been successfully performed in a wide variety of patients including children, those with prior achalasia therapy and those with spastic esophageal disorders. SUMMARY: POEM has been validated as a treatment for achalasia. Issues remain regarding its longer term efficacy in comparison with LHM. Subsequent comparison trials are needed. VIDEO ABSTRACT: http://links.lww.com/COG/A14.

The light at the end of the tunnel: a single-operator learning curve analysis for per oral endoscopic myotomy.

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.

International multicenter experience with peroral endoscopic myotomy for the treatment of spastic esophageal disorders refractory to medical therapy (with video).

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.

International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video).

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.

EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos).

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.

The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience.

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.

Endoscopic diverticulotomy for Killian-Jamieson diverticulum: mid-term outcome and description of an ultra-short tunnel technique.

Background and study aims Killian-Jamieson Diverticulum (KJD) is a rarer and more recently described upper pharyngeal diverticulum than Zenker's diverticulum (ZD). KJD is more difficult to manage than ZD because it tends to extend lower into the upper mediastinum and the diverticulum neck is in close proximity to the recurrent laryngeal nerve. There is limited literature on KJD management and transcervical surgical diverticulectomy is the mainstay of therapy. Patients and methods Here we describe two methods of endoscopic diverticulotomy to treat KJD - direct and tunneling diverticulotomy (with hypopharyngeal tunnel or ultra-short tunnel - the latter being our preferred technique). Results This was a retrospective study including 13 consecutive patients between March 2015 and April 2018. Three patients received direct and 10 received tunneling diverticulotomy (7 with the hypopharyngeal tunnel and 3 with the ultra-short tunnel). All procedures were completed in 16 to 52 minutes. There was no incidence of bleeding, mediastinitis, or sign of recurrent laryngeal nerve injury. At follow up of 9 to 79 months (median 33), the clinical success rate was 92 % (12/13); 11 patients had complete symptom resolution (post-operative symptom score = 0) and one patient had near-complete symptom resolution (occasional residual dysphagia). One patient receiving direct myotomy had limited symptom relief (frequent residual dysphagia and occasional residual regurgitation), possibly related to incomplete myotomy. Conclusions Endoscopic tunneling diverticulotomy is a feasible, safe, and effective method to treat KJD.

The appendix may protect against Clostridium difficile recurrence.

BACKGROUND & AIMS: Several risk factors have been identified for the development of recurrent Clostridium difficile infection (CDI) that alter host immunity and disrupt colonic flora. Although the function of the appendix has been debated, its active, gut-associated lymphoid tissue and biofilm production indicate potential roles in recovery from initial CDI and protection against recurrent CDI. We investigated whether the presence or absence of an appendix is associated with CDI recurrence. METHODS: We reviewed the medical records of adult inpatients with CDI who were admitted to a tertiary-care teaching hospital from 2005 to 2007 to identify those with and without an appendix. The primary dependent variable for statistical analysis was CDI recurrence. RESULTS: In a multivariate analysis of 11 clinical variables, the presence of an appendix was associated inversely with CDI recurrence (P < .0001; adjusted relative risk, .398). Age older than 60 years also was associated with CDI recurrence (P = .0280; adjusted relative risk, 2.44). CONCLUSIONS: The presence of an appendix has a significant and independent, inverse association with CDI recurrence, but this finding requires validation in a prospective study. Assessing the presence or absence of an appendix might be useful in predicting CDI recurrence.