A prospective multicentre study of per-oral endoscopic myotomy (POEM) for achalasia in Australia.

OBJECTIVE: To describe the clinical and procedural outcomes of per-oral endoscopic myotomy (POEM) for achalasia in Australia. DESIGN, SETTING: Prospective observational study in three Australian tertiary referral centres, 5 May 2014 - 27 October 2019 (66 months). PARTICIPANTS: Patients who had undergone POEM for achalasia. MAJOR OUTCOME MEASURES: Eckardt scores calculated prior to POEM and six months, one year, and two years after POEM. The primary outcome was clinical success, defined as an Eckardt score of 3 or less without a second intervention. RESULTS: 142 patients underwent POEM for achalasia; their mean age was 52 years (SD, 18 years), 83 were men (58%), and the median length of hospital stay two days (IQR, 1-3 days). Their mean Eckardt score before POEM was 8.0 (SD, 2.4) and 1.1 (SD, 1.6) six months after POEM; it did not change significantly between six months and two years after POEM (mean monthly increase, 0.014 points; 95% CI, -0.001 to 0.029). A total of 127 patients (89%) improved clinically after POEM. Intra-procedural capnoperitoneum was the only risk factor associated with treatment failure (adjusted hazard ratio, 2.85; 95% CI, 1.08-7.51). Previous treatments - botulinum toxin injection (25 patients, 18%), endoscopic balloon dilatation (69, 49%), and Heller myotomy (14, 10%) - did not affect POEM outcomes. Five patients (4%) experienced major adverse events, including pneumonia, oesophageal leak, empyema and melaena, that were managed during admission and without sequelae. CONCLUSIONS: POEM is an effective treatment for achalasia. Significant reductions in Eckardt scores achieved by six months are sustained at two years. POEM can be both a first line definitive therapy and a salvage therapy for patients not helped by other treatments.

Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group.

BACKGROUND AND AIMS: Gastric peroral endoscopic myotomy (G-POEM) is a novel minimally invasive technique in endosurgery. Data is limited as to its efficacy, safety, and predictive factors. We conducted this meta-analysis to evaluate the clinical outcomes of G-POEM and used the outcomes of surgical pyloroplasty as a comparator group in the treatment of refractory gastroparesis. METHODS: We searched multiple databases from inception through March 2019 to identify studies that reported on G-POEM and pyloroplasty in gastroparesis. Our primary outcome was to analyze and compare the pooled rates of clinical success, in terms of Gastroparesis Cardinal Symptom Index (GCSI) score and 4-h gastric emptying study (GES) results, with G-POEM and pyloroplasty. RESULTS: Three hundred and thirty-two and 375 patients underwent G-POEM (11 studies) and surgical pyloroplasty (seven studies), respectively. The pooled rate of clinical success, based on the GCSI score, with G-POEM was 75.8% (95% CI 68.1-82.1, I2 = 50) and with surgical pyloroplasty was 77.3% (95% CI 66.4-85.4, I2 = 0), with no significance, p = 0.81. The pooled rate of clinical success, based on the 4-hour GES results, with G-POEM was 85.1% (95% CI 68.9-93.7, I2 = 74) and with surgical pyloroplasty was 84% (95% CI 64.4-93.8, I2 = 81), with no significance, p = 0.91. The overall adverse events were comparable. Based on meta-regression analysis, idiopathic gastroparesis, prior treatment with botulinum toxin and gastric stimulator seemed to predict clinical success with G-POEM. CONCLUSION: G-POEM demonstrates clinical success in treating refractory gastroparesis. Idiopathic gastroparesis, prior treatment with botulinum injections and gastric stimulator appear to have positive predictive effects on the 4-h GES results after G-POEM. Outcomes seem comparable to surgical pyloroplasty.

The Impact of Sociodemographic and Hospital Factors on Length of Stay Before and After Pyloromyotomy.

BACKGROUND: The aim of the study was to determine whether racial or ethnic and insurance disparities exist in pre- and post-operative length of stay (LOS) in patients with hypertrophic pyloric stenosis (HPS). MATERIALS AND METHODS: The Healthcare Cost and Utilization Project Kid's Inpatient Database database (years 2006, 2009, and 2012) was analyzed for patients aged <1 y with HPS with a primary procedure of pyloromyotomy. Multivariate logistic regression was performed to determine the association between race or ethnicity and insurance status with the primary outcomes of prolonged pre- and post-operative LOS (defined as >1 d). Odds ratios (ORs) and 95% confidence intervals (CIs) were tabulated using SPSS v24. RESULTS: A total of 13,706 cases were identified: 8503 (62%) non-Hispanic whites, 3143 (23%) Hispanics, 1007 (7%) non-Hispanic blacks (NHB), and 1053 (8%) non-Hispanic other race or ethnicity. NHB and Hispanics were 45% and 37%, respectively, more likely to have prolonged preoperative LOS compared with non-Hispanic whites (OR = 1.45, 95% CI: 1.19-1.77; OR = 1.37, 95% CI: 1.18-1.60, respectively). Children with public insurance had 21% increased odds of increased preoperative LOS (OR = 1.21, 95% CI: 1.06-1.38). All minority groups had increased odds of postoperative LOS (NHB OR 1.36, 95% CI: 1.17-1.54; Hispanic OR 1.14, 95% CI: 1.03-1.26; NHO OR 1.31, 95% CI: 1.15-1.51). CONCLUSIONS: We conclude that NHB, Hispanics, and other race or ethnicity were more likely to have prolonged pre- and post-operative LOS. In addition, children with public insurance were more likely to have prolonged preoperative LOS. Further work is needed to better characterize and eliminate disparities in the management and outcomes of children with HPS.

Pediatric Endoscopy Practice Patterns in the United States, Canada, and Mexico.

BACKGROUND AND AIMS: Endoscopic procedures are important for diagnosis and management of many gastrointestinal, liver, and biliary conditions in children. Therapeutic endoscopy procedures, including endoscopic retrograde cholangiopancreatography (ERCP), are performed less frequently in children relative to adults. A formal study to evaluate institutional volumes and practice patterns for advanced therapeutic pediatric endoscopy procedures has, however, not been previously undertaken. METHODS: A self-administered 16-question (5-minute) online survey assessing practice patterns for performance of pediatric endoscopy procedures was distributed to all registered North American Society for Pediatric Gastroenterology, Hepatology and Nutrition programs. Results were analyzed using descriptive statistics and thematic analysis of free-text comments. RESULTS: Respondents from 82.9% of North American Society for Pediatric Gastroenterology, Hepatology and Nutrition centers completed this survey. Responses revealed that esophagogastroduodenoscopy/colonoscopy are performed at the vast majority of centers (>90%), with most performing >50/year. Therapeutic endoscopy procedures are performed less frequently in the pediatric population, with 18.97% reporting that ERCP is not performed at their institution. Where ERCP is performed, 91.38% reported <25/year. Endoscopic ultrasound is not performed at more than half (53.33%) of institutions. Approximately 71.67% of respondents do not believe their institution's current arrangement for performing pediatric therapeutic endoscopy procedures is adequate. CONCLUSIONS: Although the range of endoscopic procedures performed in children parallels that performed in adults, there are notable differences in pediatric and adult gastroenterologists' endoscopy training and procedure volumes. Our results and respondent comments suggest that pediatric patients would benefit from a partnership between pediatric and adult gastroenterologists, with adult gastroenterologists performing more complex therapeutic endoscopic procedures.

Comparison of Military Health System Data Repository and American College of Surgeons National Surgical Quality Improvement Program-Pediatric.

BACKGROUND: Given the rarity of pediatric surgical disease, it is important to consider available large-scale data resources as a means to better study and understand relevant disease-processes and their treatments. The Military Health System Data Repository (MDR) includes claims-based information for > 3 million pediatric patients who are dependents of members and retirees of the United States Armed Services, but has not been externally validated. We hypothesized that demographics and selected outcome metrics would be similar between MDR and the previously validated American College of Surgeons National Surgical Quality Improvement Program-Pediatric (NSQIP-P) for several common pediatric surgical operations. METHODS: We selected five commonly performed pediatric surgical operations: appendectomy, pyeloplasty, pyloromyotomy, spinal arthrodesis for scoliosis, and facial reconstruction for cleft palate. Among children who underwent these operations, we compared demographics (age, sex, and race) and clinical outcomes (length of hospital stay [LOS] and mortality) in the MDR and NSQIP-P, including all available overlapping years (2012-2014). RESULTS: Age, sex, and race were generally similar between the NSQIP-P and MDR. Specifically, these demographics were generally similar between the resources for appendectomy (NSQIP-P, n = 20,602 vs. MDR, n = 4363; median age 11 vs. 12 years; female 40% vs. 41%; white 75% vs. 84%), pyeloplasty (NSQIP-P, n = 786 vs. MDR, n = 112; median age 0.9 vs. 2 years; female 28% vs. 28%; white 71% vs. 80%), pyloromyotomy, (NSQIP-P, n = 3827 vs. MDR, n = 227; median age 34 vs. < 1 year, female 17% vs. 16%; white 76% vs. 89%), scoliosis surgery (NSQIP-P, n = 5743 vs. MDR, n = 95; median age 14.2 vs. 14 years; female 75% vs. 67%; white 72% vs. 75%), and cleft lip/palate repair (NSQIP-P, n = 6202 vs. MDR, n = 749; median age, 1 vs. 1 year; female 42% vs. 45%; white 69% vs. 84%). Length of stay and 30-day mortality were similar between resources. LOS and 30-day mortality were also similar between datasets. CONCLUSION: For the selected common pediatric surgical operations, patients included in the MDR were comparable to those included in the validated NSQIP-P. The MDR may comprise a valuable clinical outcomes research resource, especially for studying infrequent diseases with follow-up beyond the 30-day peri-operative period.

Laparoscopic pyloromyotomy can be performed safely by senior pediatric surgery trainees without supervision at high volume centers.

AIM OF THE STUDY: Pediatric surgery trainees at our institution perform 15 to 20 supervised laparoscopic pyloromyotomies during their junior year, and are allowed to perform the operation independently without supervision during their senior year. We reviewed the outcomes of laparoscopic pyloromyotomies performed by senior trainees operating without supervision and compared them to experienced pediatric surgeons. METHOD: We did a retrospective reviewed of all unsupervised laparoscopic pyloromyotomies (n = 90) performed by the last 12 pediatric surgery fellows (2012-2018) during their senior year, and the most recent 90 consecutive laparoscopic pyloromyotomies performed by 9 experienced pediatric surgeons. Statistical significance was determined by T-test and Fisher's exact test. Data is expressed as mean (SD) or median (range). A p value of ≤0.05 was considered significant. RESULTS: Mean age at surgery was 4.7 (SD: 1.6) and 5 (SD: 2.3) weeks in the trainees and surgeons group, respectively (p = 0.38). Mean operative time was 28 (SD: 13) minutes in the trainees group vs. 25 (SD: 10) minutes in the surgeons group (p = 0.09). Intraoperative complications occurred in 3 of 90 (2.7%) cases in the trainees group (three mucosal perforations, all detected during the operation, one repaired laparoscopically, two repaired open), and none in the surgeons group (p = 0.11). One postoperative complication requiring reoperation occurred in the trainees group (omentum eviscerated through an incision site), while none occurred in the surgeons group (p = 0.36). No incomplete pyloromyotomies occurred in either group. The median length of postoperative hospital stay was 1 (1 to 10) and 1 (1 to 6) days in the trainees and surgeons group, respectively (p = 0.63). CONCLUSION: Senior trainees at high-volume training programs can perform unsupervised laparoscopic pyloromyotomies safely as a mean to promote surgical autonomy without compromising patient outcomes. LEVEL OF EVIDENCE: III.

Association between anemia and postoperative complications in infants undergoing pyloromyotomy.

BACKGROUND: Although preoperative anemia has been suggested to predict postsurgical morbidity and mortality among infants <1 year of age, the data were drawn from heterogeneous patient cohorts including severely ill infants undergoing complex, high-risk procedures. We aimed to determine whether untreated preoperative anemia was associated with increased risk of postoperative complications in infants <1 year of age who underwent pyloromyotomy, a common and relatively simple surgery. METHODS: Infants <1 year of age undergoing pyloromyotomy were identified from the American College of Surgeons (ACS) National Surgical Quality Improvement Program-Pediatric database. Preoperative anemia was defined as a hematocrit ≤40% for infants 0-30 days of age and ≤30% for infants more than 30 days of age. Patients who received pre- or postoperative blood transfusions were excluded. RESULTS: We identified 2948 patients who met our inclusion criteria, of whom 843 were anemic (29%). The overall rate of complications in this cohort was 6%. The most common postoperative complications were readmission (97 cases), surgical site infection (43), reoperation (39), prolonged hospital stay (24), urinary tract infection (3), 30-day mortality (3) and cardiac arrest (2). We found no differences in the incidence of complications in anemic versus nonanemic patients on bivariate analysis or multivariable logistic regression (adjusted odds ratio = 1.2; 95% confidence interval: 0.8-1.7; P = 0.319). CONCLUSIONS: In relatively healthy infants undergoing pyloromyotomy, untreated preoperative anemia was not associated with postoperative compilations and should not be considered a significant risk factor. Level of evidence III.

Assessment of Clinical Outcomes after Peroral Endoscopic Myotomy via Esophageal Distensibility Measurements with the Endoluminal Functional Lumen Imaging Probe.

Background/Aims: Endoluminal functional lumen imaging probe (EndoFLIP) is a modality that enables clinicians to measure volume-controlled distension of the esophagus. This study aimed to assess the utility of EndoFLIP in patients who had achalasia treated with peroral endoscopic myotomy (POEM). We hypothesized that improvement in the distensibility index (DI) is correlated with the postoperative clinical outcome of POEM. Methods: Patients who underwent POEM for achalasia at Cha Bundang Medical Center were included. Physiological measurements of the lower esophageal sphincter (LES) pressure before and after POEM were assessed using EndoFLIP. Patients' symptoms were recorded using the Eckardt score. Results: A total of 52 patients with achalasia were included in this study. Patients with a post-POEM DI below 7 (30 or 40 mL) had a significantly higher rate of incomplete response after POEM (p=0.001). Changes in LES pressure or integrated relaxation pressure after POEM were also significantly associated with an incomplete response (p=0.026 and p=0.016, respectively). Multivariate analysis showed that post-POEM DI ＜7 was the most important predictor of an incomplete response after POEM (p=0.004). Conclusions: Lower post-POEM DI values were associated with an incomplete post-POEM response. Therefore, post-POEM DI at the esophagogastric junction using EndoFLIP is a useful index for predicting the clinical outcome of POEM in patients with achalasia.

Implementation of a Quality Control System for Laparoscopic Pyloromyotomy in Hypertrophic Pyloric Stenosis: Hurdles and Pitfalls.

BACKGROUND: In 2011, we implemented a new video-based system for quality control of laparoscopic pyloromyotomy. More than 3 years later, we evaluated how the implementation had gone and assessed its usability in predicting postoperative outcomes. MATERIALS AND METHODS: Four key point images or short video-segments were to be recorded perioperatively: prepyloromyotomy, parallel-mobility testing, perforation testing, and postpyloromyotomy. Data of all 134 patients undergoing laparoscopic pyloromyotomy from September 2011 to December 2014 were analyzed retrospectively. Five pediatric surgeons independently assessed the anonymized operative images for predicting reoperation and time to full-enteral feeding. RESULTS: The percentage of operations during which images were recorded increased from 45% in 2012 to 75% in 2014. Over the study period, one or more images were recorded in 89 of the 134 (66%) patients. In only 17 of 89 patients (19%), all four images were documented. The key point images or videos were made for prepyloromyotomy in 49%, parallel-mobility testing in 85%, perforation testing in 42%, and postpyloromyotomy in 94% of 89 patients. Five patients (3.7%) were reoperated for incomplete pyloromyotomy (N = 4) or mucosal perforation (N = 1). Images were recorded during the first operation in four of the five reoperated patients. The need of reoperation was correctly predicted for two of the four patients. Full-enteral feeding within 24 hours was correctly predicted for 67% of the patients (range: 47-88%). CONCLUSION: The increase in recorded images over the years is promising. The implementation of the quality control system did not contribute to a significant decrease in the complication rate, which was already very low. Still, reoperation or a protracted postoperative course could only be predicted with moderate accuracy from the operative images, therefore, for now the use of perioperative images in a medicolegal setting should be advised against. Improved compliance with image recording and better instructions for evaluating the images might improve the usefulness of perioperative images in, e.g., telementoring, education, and medicolegal practice.

Gastric Peroral Endoscopic Myotomy (G-POEM) as a Treatment for Refractory Gastroparesis: Long-Term Outcomes.

Background and Aims: Gastric peroral endoscopic myotomy (G-POEM) has been regarded as a novel and minimally invasive therapy for refractory gastroparesis. This study reports the long-term outcomes and possible predictive factors for successful outcomes after G-POEM in an Asian population. Methods: This is a retrospective single-centre study of 16 patients who underwent G-POEM for refractory gastroparesis from August 2016 to October 2017. This study included 11 males and 5 females; in addition, 13 patients had postsurgical gastroparesis, and 3 patients had diabetes. The patients included had severe and refractory gastroparesis, as indicated by a Gastroparesis Cardinal Symptom Index (GCSI) score ≥20, and evidence of a delay on gastric emptying scintigraphy (GES). The primary outcome parameter was an assessment of the long-term clinical efficacy of the procedure. The secondary outcome parameter was the detection of possible predictive factors for success and the determination of cut-off values for such predictors. Results: Technical success was achieved in 100% of the patients, with a mean procedure time of 45.25±12.96 min. The long-term clinical response was assessed in all patients during a median follow-up of 14.5 months. Clinical success was achieved in 13 (81.25%) patients. There was a significant reduction in the GCSI scores and GES values after the procedure compared to the baseline values, with P values of <0.0001 and 0.012, respectively. Univariate regression analysis showed that the GCSI and GES had significant associations with the future clinical outcomes of the patients, but this finding was not confirmed in multivariate analysis. A GCSI cut-off score of ≤30 had a high sensitivity and a negative predictive value (NPV) of 100% for predicting a successful procedure. GES (half emptying time ≤221.6 min and 2-hour retention ≤78.6%) had a high specificity and a positive predictive value (PPV) of 100%. Conclusions: G-POEM is a safe and effective treatment option with a long-term efficacy of 81.6%. GCSI and GES could serve as good predictive measures.

Is all-cause readmission an appropriate performance measure for pediatric surgeons? A case study in pyloromyotomy.

INTRODUCTION: All cause readmissions are used as a surrogate metric for quality of care for both hospitals and physicians, and are considered in pay for performance initiatives. However, the integrity of using all cause readmissions as a benchmark for surgical outcomes has received little attention. Pyloromyotomy for hypertrophic pyloric stenosis is considered a safe pediatric surgical procedure with few complications or readmissions. The incidence of in hospital complications has been reported, however the rate of readmissions and specifically the proportion of readmissions related to surgical complications have not been previously reported. METHODS: Data were abstracted from the longitudinally linked Office of Statewide Health Planning and Development data from the State of California from 1995 to 2009, allowing patient tracking across all hospitals and years within California. Inclusion criteria were primary procedure code of pyloromyotomy, a diagnosis code of hypertrophic pyloric stenosis, and no prior record of any in-hospital admission. RESULTS: A total of 1900 patients were identified: 16.8% girls, 31.7% whites, 5.1% blacks, and 58.2% Hispanics. The median length of stay was 2days (IQR 2-3days). The in-hospital complication rate was 5.16% and overall complication rate was 6.84%; there were no deaths. The rate of 30-day all-cause readmission was 4.01%, with a median of 0% across hospitals (IQR 0%-1.1%); and 13.2% of readmissions occurred at a different hospital. Surgically-related readmission rate was 2.16%. Surgically-related readmission comprised 36% readmissions at 30days, but only 13% readmissions overall. The top three primary diagnoses on readmission were respiratory infections (43%), nonrespiratory infections (14%) and other nonsurgical GI indications (14%). All-cause readmissions at 60days, 90days, 180days, and 1year were 5.8%, 7.3%, 10.4%, and 13.7%, respectively. CONCLUSION: Thirty-day readmission for a surgical complication occurs in 1 of 50 patients undergoing a pyloromyotomy for hypertrophic pyloric stenosis but for all causes is twice as likely, 1 in 25 patients. All-cause readmission is an inadequate measure for the quality of surgical care and the performance of pediatric surgeons. This is a Prognostic Study with Level II Evidence.