An international multicenter study evaluating the clinical efficacy and safety of per-oral endoscopic myotomy in octogenarians.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) for achalasia is particularly appealing in the elderly because it is minimally invasive. However, data in patients aged ≥80 years are scarce. The aim of this study was to assess the clinical outcome of POEM in octogenarians. METHODS: This was a multicenter retrospective study at 8 centers. Consecutive octogenarians with achalasia who underwent POEM between 2010 and 2016 were included. Rates of technical success (completion of myotomy), clinical response (Eckardt score ≤3), and adverse events (severity graded as per American Society for Gastrointestinal Endoscopy lexicon) were assessed. RESULTS: A total of 76 patients (47.4% female, mean age 84 years) underwent POEM for treatment of achalasia: type I, 17.1%; type II, 35.5%; type III, 17.1%; and unspecified, 30.3%. Overall, 41.1% were treatment naïve, whereas others had previous botulinum toxin injection and/or pneumatic dilation. The mean (± standard deviation [SD]) age-adjusted Charlson comorbidity index score was 6.2 ± 2.4, with the majority of patients having American Society of Anesthesiologists Physical Status Classification System (ASA) scores of II/III. Technical success was 93.4%, with a median follow-up of 256 days. Fourteen adverse events occurred in 11 patients (14.5%). There were 3 inadvertent mucosotomies, 6 cases of symptomatic capnoperitoneum and/or capnomediastinum, 2 esophageal leaks, 1 cardiac arrhythmia, and 2 other). The severities of these adverse events were mild (78.6%), moderate (14.3%), and severe (7.1%). Clinical success was achieved in 90.8% of patients, with a mean (± SD) Eckardt score reduction from 7.0 ± 2.3 to 0.8 ± 0.1 (P < .001), a median follow-up of 256 days, and interquartile range of 66 to 547. CONCLUSION: Although the rate of technical success may be somewhat lower and the rate of adverse events slightly higher than previously reported, our data suggest that POEM in octogenarians is safe and effective, supporting its role as a primary modality for achalasia in this patient population.

Retraction notice to "Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter study": [YMGE 85 (2017) 927-933].

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted due to overlapping/duplicate material. Data from some patients from this study have previously been published in other journals without cross-referencing. Twenty patients overlap with a paper by Kumbhari et al.1 Thirty-five patients overlap with the study by Ngamruengphong et al.2.

Teaching peroral endoscopic myotomy (POEM) to surgeons in practice: an "into the fire" pre/post-test curriculum.

INTRODUCTION: With the increasing adoption of peroral endoscopic myotomy (POEM) as a first-line therapy for achalasia as well as a growing list of other indications, it is apparent that there is a need for effective training methods for both endoscopists in training and those already in practice. We present a hands-on-focused with pre- and post-testing methodology to teach these skills. METHODS: Six POEM courses were taught by 11 experienced POEM endoscopists at two independent simulation laboratories. The training curriculum included a pre-training test, lectures and discussion, mentored hands-on instruction using live porcine and ex-plant models, and a post-training test. The scoring sheet for the pre- and post-tests assessed the POEM performance with a Likert-like scale measuring equipment setup, mucosotomy creation, endoscope navigation, visualization, myotomy, and closure. Participants were stratified by their experience with upper-GI endoscopy (Novices <100 cases vs. Experts ≥100 cases), and their data were analyzed and compared. RESULTS: Sixty-five participants with varying degrees of experience in upper-GI endoscopy and laparoscopic achalasia cases completed the training curriculum. Participants improved knowledge scores from 69.7 ± 17.1 (pre-test) to 87.7 ± 10.8 (post-test) (p < 0.01). POEM performance increased from 15.1 ± 5.1 to 25.0 ± 5.5 (out of 30) (p < 0.01) with the greatest gains in mucosotomy [1.7-4.4 (out of 5), p < 0.01] and equipment (3.4-4.7, p < 0.01). Novices had significantly lower pre-test scores compared with Experts in upper-GI endoscopy (overall pre-score: 11.9 ± 5.6 vs. 16.3 ± 4.6, p < 0.01). Both groups improved significantly after the course, and there were no differences in post-test scores (overall post-score: 23.9 ± 6.6 vs. 25.4 ± 5.1, p = 0.34) between Novices and Experts. CONCLUSIONS: A multimodal curriculum with procedural practice was an effective curricular design for teaching POEM to practitioners. The curriculum was specifically helpful for training surgeons with less upper-GI endoscopy experience.

Efficacy and Safety of Peroral Endoscopic Myotomy for Treatment of Achalasia After Failed Heller Myotomy.

BACKGROUND & AIMS: In patients with persistent symptoms after Heller myotomy (HM), treatment options include repeat HM, pneumatic dilation, or peroral endoscopic myotomy (POEM). We evaluated the efficacy and safety of POEM in patients with achalasia with prior HM vs without prior HM. METHODS: We conducted a retrospective cohort study of 180 patients with achalasia who underwent POEM at 13 tertiary centers worldwide, from December 2009 through September 2015. Patients were divided into 2 groups: those with prior HM (HM group, exposure; n = 90) and those without prior HM (non-HM group; n = 90). Clinical response was defined by a decrease in Eckardt scores to 3 or less. Adverse events were graded according to criteria set by the American Society for Gastrointestinal Endoscopy. Technical success, clinical success, and rates of adverse events were compared between groups. Patients were followed up for a median of 8.5 months. RESULTS: POEM was technically successful in 98% of patients in the HM group and in 100% of patients in the non-HM group (P = .49). A significantly lower proportion of patients in the HM group had a clinical response to POEM (81%) than in the non-HM group (94%; P = .01). There were no significant differences in rates of adverse events between the groups (8% in the HM group vs 13% in the non-HM group; P = .23). Symptomatic reflux and reflux esophagitis after POEM were comparable between groups. CONCLUSIONS: POEM is safe and effective for patients with achalasia who were not treated successfully by prior HM. Although the rate of clinical success in patients with prior HM is lower than in those without prior HM, the safety profile of POEM is comparable between groups.

Comprehensive Analysis of Adverse Events Associated With Per Oral Endoscopic Myotomy in 1826 Patients: An International Multicenter Study.

OBJECTIVES: The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM. METHODS: Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders). RESULTS: A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs. CONCLUSIONS: This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.

Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter study.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) has shown promising safety and efficacy in short-term studies. However, long-term follow-up data are very limited. The aims of this study were to assess (1) clinical outcome of patients with a minimum post-POEM follow-up of 2 years and (2) factors associated with long-term clinical failure after POEM. METHODS: A retrospective chart review was performed that included all consecutive patients with achalasia who underwent POEM with a minimum follow-up of 2 years at 10 tertiary-care centers. Clinical response was defined by a decrease in Eckardt score to 3 or lower. RESULTS: A total of 205 patients (45.8% men; mean age, 49 years) were followed for a median of 31 months (interquartile range, 26-38 months). Of these, 81 patients (39.5%) had received previous treatment for achalasia before POEM. Clinical success was achieved in 98% (185/189), 98% (142/144), and 91% (187/205) of patients with follow-up within 6 months, at 12 months, and ≥24 months, respectively. Of 185 patients with clinical response at 6 months, 11 (6%) experienced recurrent symptoms at 2 years. History of previous pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23). Procedure-related adverse events occurred in 8.2% of patients and only 1 patient required surgical intervention. Abnormal esophageal acid exposure and reflux esophagitis were documented in 37.5% and 18% of patients, respectively. However, these rates are simply a reference number among a very selective group of patients. CONCLUSIONS: POEM is safe and provides high initial clinical success and excellent long-term outcomes. Among patients with confirmed clinical response within 6 months, 6% had recurrent symptoms by 2 years.

Outcomes in patients with over 1-year follow-up after peroral endoscopic myotomy (POEM).

BACKGROUND: Peroral endoscopic myotomy (POEM) is a promising therapy in the treatment of achalasia. The study was designed to report outcomes, including quality of life, in patients with at least 1-year follow-up. METHODS: Patients from an institutional review board-approved protocol underwent POEM and were followed prospectively. Health-related quality of life was measured preoperatively and 1 year post-operatively using Short Form-36 Health Survey version 2 (SF-36v2). Comparisons were made with patients from a prospective database who underwent laparoscopic Heller myotomy (LHM) over the same period. Paired t tests were used to analyze all normally distributed data, while Wilcoxon signed-rank tests were used to analyze SF-36 data, as it does not follow a normal distribution. RESULTS: We analyzed 41 consecutive POEM patients with at least 1-year follow-up. Significant improvements in quality of life between baseline and 1 year were found in role limitations due to physical health (81.8 ± 25.8 vs. 65.9 ± 31.6, p = 0.01) and social functioning (83 ± 19.1 vs. 64.6 ± 31.3, p = 0.01). When compared to 24 patients who underwent LHM, there was no difference in average Eckardt scores (0.9 ± 1.6 vs. 1.0 ± 1.3, p > 0.05) or incidence of PPI use (43.5 vs. 47.5 %, p = 0.71). However, when looking at just type III patients, POEM patients had a higher remission rate (100 vs. 62.5 %) and significantly lower post-operative Eckardt scores at 1 year (1.1 vs. 3.1, p < 0.05). The average myotomy length of type III achalasia patients undergoing POEM was 18.6 cm (±6.9) compared to 10.3 cm (±1.0) in LHM patients (p < 0.01), which may have contributed to this difference. CONCLUSION: POEM provides a significant quality of life benefit at 1 year while having similar relief of dysphagia and post-operative PPI use compared to LHM. Type III achalasia patients may have better outcomes with POEM compared to LHM.

Outcomes following 50 consecutive endoscopic gastrojejunal revisions for weight gain following Roux-en-Y gastric bypass: a comparison of endoscopic suturing techniques for stoma reduction.

BACKGROUND: Approximately 20-30 % of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) will experience significant weight regain in the years following surgery. Endoscopic gastrojejunal revision (EGJR) has been shown to be a safe, effective and less invasive alternative to revisional surgery, with promising weight loss outcomes. However, minimal data exist regarding how to perform the procedure most effectively and what factors may predict good outcomes. We compared weight loss outcomes between patients undergoing endoscopic stoma revision by one of two full-thickness suturing techniques. METHODS: A retrospective review of patients undergoing EGJR between 06/2012 and 09/2015 was performed. Included patients were adults 18-74 years of age who had experienced weight regain ≥2 years after initial RYGB with stoma dilation ≥15 mm in diameter. Revision was done with either an interrupted (IRT) or purse-string (PST) suture technique. A linear mixed effects model was constructed to predict postoperative weight loss. RESULTS: Fifty revisions (IRT = 36, PST = 14) were performed in 47 patients (92 % female, mean age of 50.9 ± 10.9 years and body mass index of 41.4 ± 7.1 kg/m2). Technical success (stoma diameter ≤10 mm) was achieved in all cases. Final diameter was significantly smaller in the PST group, 6.6 ± 2.2 mm versus 4.8 ± 1.8 mm (p < 0.01), resulting in a significantly greater % stoma reduction (76.8 ± 8.5 % vs. 84.2 ± 5.1 %, p < 0.01) versus the IRT group. PST resulted in greater % excess weight loss over time compared to IRT. Sixteen comorbid conditions resolved among 12 patients. No major complications occurred. CONCLUSION: Endoscopic revision of the gastric outlet results in meaningful weight loss and comorbidity resolution in select patients experiencing weight regain following RYGB. A PST revision likely results in higher and more sustainable weight loss when compared to IRT.

Long-term patterns and predictors of pain following laparoscopic inguinal hernia repair: a patient-centered analysis.

BACKGROUND: Laparoscopic inguinal hernia repair has been shown to offer patients the benefit of less postoperative pain as compared to traditional open techniques. However, the risk of experiencing significant postoperative pain may affect patient's decision making. We aimed to elucidate potential patterns of pain and the predictors of such, up to 2 years postoperatively, using both generic and specific quality of life tools. METHODS: Patients undergoing laparoscopic totally extra-peritoneal inguinal hernia repair were identified from a prospectively maintained database. Short form-36, Surgical Outcomes Measurement System (SOMS) and Carolinas Comfort Scale (CCS) surveys were administered pre- and postoperatively at 3 weeks, 6 months, 1 and 2 years. Patients with concomitant procedures were excluded. Significant pain was considered mild but bothersome or worse on either specific tool (SOMS scores ≥3/4, CCS scores ≥2). Predictors of significant pain were determined by logistic regression. RESULTS: From 2009 to 2015, 482 patients enrolled in our database underwent elective TEP repair of 626 hernias and completed an assessment tool. Mean age was 57 (±15) years, with 93 % male. Reported pain on all three tools improved significantly from baseline over time (p < 0.01). Significant pain on either specific tool, related or unrelated to surgery, was reported by 52 % of respondents (158/301) preoperatively, and postoperatively by 50 % at 3 weeks (111/220), 21 % at 6 months (15/70), 13 % at 1 year (14/108), and 25 % at 2 years (30/121). Significant pain at 6 months-2 years correlated more significantly with general health status than surgical factors. CONCLUSIONS: Significant pain can be as high as 50 % at 3 weeks on surgery-specific quality of life measures, but with significant improvement by 6 months which is maintained through 2 years. Poor quality of life and general health were the main predictors of pain after 6 months.

Barriers to Enhanced Recovery after Surgery after Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Enhanced Recovery after Surgery (ERAS) protocols lead to expedited discharges and decreased cost. Bariatric centers have adopted such programs for safely discharging patients after sleeve gastrectomy (LSG) on the first postoperative day (POD1). Despite pathways, some bariatric patients cannot be discharged on POD1. STUDY DESIGN: We performed a retrospective review of patients undergoing LSG, from 2013 through 2016, in a center of excellence, using a standardized enhanced recovery pathway. Patient variables and perioperative factors were analyzed, including multivariate regressions, for predictors of early discharge. RESULTS: There were 573 patients who underwent LSG (83% female, mean age of 46.3 ± 11.7 years, and BMI of 46.0 ± 6.6 kg/m2). Mean hospital stay was 1.7 days ± 1.0 SD. Early discharge occurred in 38.2% of patients. Independently, early operating room start times and treated obstructive sleep apnea were associated with earlier discharge (p < 0.05). In contrast, preoperative opioid use, history of psychiatric illness, chronic kidney disease, and revision cases delayed discharge (p < 0.05). Age, sex, American Society of Anesthesiologists (ASA) class, diabetes, congestive heart failure, hypertension, distance to home, and insurance status were not significant. On regression modeling, early operating room start time and treated obstructive sleep apnea (OSA) reduced length of stay (LOS) (p < 0.05), while creatinine >1.5 mg/dL, ejection fraction < 50%, and increased case duration increased LOS (p < 0.05). Fifteen patients were readmitted within 30 days (2.6%). CONCLUSIONS: Several clinical and operative factors affect early discharge after LSG. Knowing factors that enhance the success of ERAS as well as the causes and corrections for failed implementation allow teams to optimally direct care pathway resources.

Laparoscopic Totally Extraperitoneal Groin Hernia Repair and Quality of Life at 2-Year Follow-Up.

BACKGROUND: The lack of long-term data on quality of life after groin hernia repair presents a challenge in setting patients' postoperative expectations. This study aimed to describe quality of life outcomes after laparoscopic totally extraperitoneal groin hernia repair with a minimum of 2 years follow-up. STUDY DESIGN: We prospectively evaluated 293 patients who had laparoscopic totally extraperitoneal groin hernia repair in an IRB-approved study. The Short-Form 36-item Health Survey (version 2), Surgical Outcomes Measurement System, and Carolinas Comfort Scale were administered pre- and postoperatively. Pairwise comparisons using nonparametric Wilcoxon signed rank test were made between time points. RESULTS: Mean patient age was 56 ± 15 years and 93% were male; 80% of patients presented with painful hernias and 15% of hernias were recurrent. Mean operative time was 43 ± 16 minutes. No operative complications occurred. Mean duration of narcotic pain medication use was 2.5 ± 3.4 days, and daily activities were resumed and return to work occurred 5.4 ± 4.4 days and 5.4 ± 3.9 days post operation, respectively. Recurrence rate was 2%. The Short-Form 36-item Health Survey outcomes improved from baseline for domains of Physical Functioning, Role Limitations due to Physical Health, and Pain at 2 years post operation; Surgical Outcomes Measurement System outcomes improved for domains of Pain Impact on Quality of Life, Body Image, and Patient Satisfaction (p ≤ 0.05). The percentage of patients reporting no or mild but not bothersome symptoms on the Carolinas Comfort Scale at 2 years post operation for sensation of mesh, pain, and movement limitations were 98%, 95%, and 97%, respectively. CONCLUSIONS: Measuring both general and procedure-specific quality of life, patients' perceptions of health status improved significantly 2 years after laparoscopic totally extraperitoneal groin hernia repair.

Management of humeral and glenoid bone loss--associated with glenohumeral instability.

UNLABELLED: Anterior glenohumeral instability complicated by bone loss is a challenging problem and, when severe, may require surgical treatment with bone grafting. We review our institution's experience with humeral head and glenoid bone grafting for large Hill-Sachs lesions and glenoid defects. MATERIALS AND METHODS: Patients who underwent intra-articular bone reconstruction for Hill-Sachs and large glenoid defects for anterior instability at our institution during 2002-2008 were retrospectively reviewed. Those who had undergone concomitant humeral head replacement were excluded. Six patients were identified as having undergone allograft or autograft iliac crest bone graft reconstruction of the glenoid, with four available for full follow-up (average 39 months; range, 7 to 63). Five patients were identified as having undergone humeral head allograft reconstruction and four were available for full follow-up (average 28 months; range, 11 to 40). The remaining three patients were available for telephone follow-up. American Shoulder and Elbow Society (ASES) and University of California, Los Angles (UCLA) scores were recorded and radiographs obtained. RESULTS: Average postoperative ASES and UCLA scores for glenoid bone graft patients were 91 and 33, respectively. Average postoperative ASES and UCLA scores for humeral bone graft patients were 85.3 and 28.4, respectively. Glenoid bone graft shoulders, when compared to the opposite normal side, lost an average of 3° of forward flexion, 10° of external rotation, and two levels of internal rotation. Humeral head bone-grafted shoulders, lost an average of 23° of forward flexion, 8° of external rotation, and two levels of internal rotation. No episodes of recurrent subluxation or dislocations were reported. Radiographs showed no evidence of graft resorption or hardware prominence. CONCLUSIONS: Bone grafting procedures around the shoulder for the treatment of instability provided relief from recurrent instability and good functional results.