The NewYork-Presbyterian Hospital is a nonprofit academic medical center in New York City affiliated with two Ivy League medical schools: Columbia University Vagelos College of Physicians and Surgeons and Weill Cornell Medicine. It is composed of two distinct medical centers, Columbia University Irving Medical Center and Weill Cornell Medical Center. As of 2020, the hospital is ranked as the 4th best hospital in the United States and 1st in the New York City metropolitan area by U.S. News & World Report. The hospital has around 20,000 employees and 2,678 beds in total, and is one of the largest hospitals in the world.
Background and study aims The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2–5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester > 14.72), and in one case, there was evidence of esophagitis. Conclusions Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.
Introduction: Several predictive factors for Barrett’s esophagus (BE) have been demonstrated, including age, ethnicity, BMI and others. However, thus far there are no studies that evaluated the degree of the relationship between esophageal motility disorders and long or short segment BE. The aim of this study was to determine which type of esophageal motor disorders is a risk factor for long (≥ 3 cm) versus short segment BE (≤ 3 cm). Methods: This was a multicenter international cohort study that included 5 major hospitals. Patients with BE diagnosis who underwent HREM between 01/2013 and 12/2019 were included. Demographics, endoscopic findings and esophageal manometry results were collected. A multivariable logistic regression modeling was used to calculate the odds of being diagnosed with long segment BE (≥ 3 cm) relative to short segment BE (< 3 cm) for the following variables: demographics, comorbidities, medication use, endoscopic findings, and presence of hypertensive (diffuse esophageal spasm, jackhammer esophagus, esophagogastric junction outflow obstruction, achalasia or hypotensive motility disorders (absent contractility, ineffective motility, hypotensive lower esophageal sphincter, fragmented peristalsis). Results: A total of 149 patients with BE were identified. Of those, 91 (61.07%) had short segment BE (SSBE) and 58 (38.93%) long segments BE (LSBE). For SSBE mean age was 57.7 and 52.3% were females, and for LSBE, mean age was 56 years and 56.9% were females. Presence of hiatal hernia was associated with a 44% increase in the odds of having long segment BE for every 1 cm increase in hernia size. In addition, the presence of a hypotensive motility disorder increased the odds of long segment BE by 256%. There was no statistically significant correlation between the other tested variables and LSBE. Conclusion: the presence of hypotensive esophageal motor disorders increases patients’ risk of having long segment BE.Table 1.: Multivariable Analysis of the Predictors of Long-Segment Barrett's Esophagus.
Cytomegalovirus (CMV) infection is a common complication of allogeneic hematopoietic cell transplantation (HCT). In this trial, we randomized adult CMV-seropositive HCT recipients without CMV viremia at screening 2:1 to receive brincidofovir or placebo until week 14 post-HCT. Randomization was stratified by center and risk of CMV infection. Patients were assessed weekly through week 15 and every third week thereafter through week 24 post-HCT. Patients who developed clinically significant CMV infection (CS-CMVi; CMV viremia requiring preemptive therapy or CMV disease) discontinued the study drug and began anti-CMV treatment. The primary endpoint was the proportion of patients with CS-CMVi through week 24 post-HCT; patients who discontinued the trial or with missing data were imputed as primary endpoint events. Between August 2013 and June 2015, 452 patients were randomized at a median of 15 days after HCT and received study drug. The proportion of patients who developed CS-CMVi or were imputed as having a primary endpoint event through week 24 was similar between brincidofovir-treated patients and placebo recipients (155 of 303 [51.2%] versus 78 of 149 [52.3%]; odds ratio, .95 [95% confidence interval, .64 to 1.41]; P = .805); fewer brincidofovir recipients developed CMV viremia through week 14 compared with placebo recipients (41.6%; P < .001). Serious adverse events were more frequent among brincidofovir recipients (57.1% versus 37.6%), driven by acute graft-versus-host disease (32.3% versus 6.0%) and diarrhea (6.9% versus 2.7%). Week 24 all-cause mortality was 15.5% among brincidofovir recipients and 10.1% among placebo recipients. Brincidofovir did not reduce CS-CMVi by week 24 post-HCT and was associated with gastrointestinal toxicity.
BACKGROUNDIn 2014, Ontario augmented its publicly funded multiple-marker screening program for prenatal aneuploidy by incorporating cell-free fetal DNA (cffDNA) analysis for high-risk pregnancies. We assessed trends in the use of multiple-marker screening, cffDNA screening and prenatal diagnostic testing before and after implementation of public funding.METHODSWe conducted a descriptive study based on data from the Better Outcomes Registry & Network (BORN) Ontario. The study population included all pregnant women in Ontario with a singleton pregnancy and an expected date of delivery between July 1, 2012, and Mar. 31, 2016, with pregnancy data captured in BORN. Pregnancy losses and terminations before 20 weeks' gestation not captured in BORN were excluded. We generated descriptive statistics to show trends and regional variations in use.RESULTSThe study sample included 534 210 singleton pregnancies. After cffDNA screening was funded for specific indications, uptake of multiple-marker screening increased slightly, from 66.5% to 68.1% (p < 0.001). Uptake of cffDNA screening among women with a positive multiple-marker screening result increased substantially, from 3.2% to 48.8% (p < 0.001). In contrast, the rate of prenatal diagnostic testing in this group decreased from 54.8% to 30.8% (p < 0.001). Although women aged 40 years or older are eligible for primary cffDNA screening, only a small decrease in the use of multiple-marker screening was observed in this group. The greatest use of cffDNA screening and greatest decline in prenatal diagnostic testing were seen in women with a level of risk for trisomy 21 of 1:101-1:200 based on multiple-marker screening.INTERPRETATIONAfter public funding of cffDNA screening was implemented in Ontario, there was a significant increase in cffDNA screening and a significant decrease in prenatal diagnostic testing among women with a positive multiple-marker screening result. These changing patterns show the significant impact of public policy and funding decisions on women's choices regarding prenatal testing.
