scholarly journals Characterization of American Teduglutide Consumers from 2015–2020: A Large Database Study

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1429-1429
Author(s):  
Michael Kurin ◽  
Raj Shah ◽  
Perica Davitkov

Abstract Objectives The glucagon-like peptide 2 (GLP-2) analog teduglutide (TED) is a novel therapy for intestinal failure that reduces need for parenteral support. Degree of response may correlate to location of surgical anastomoses. TED may worsen heart failure (HF) and gastrointestinal (GI) neoplasms. Using a large database we characterize American patients prescribed TED. Methods The Explorys national database (Cleveland, OH, USA) is an aggregate of de-identified patient data from 26 US healthcare systems. SNOMED classification was used to identify consecutive patients prescribed TED, 2015–2020. Demographics and comorbidities were collected. Preceding surgeries, suspected inciting conditions, and incident symptoms/events post TED were searched using the temporal attributes feature on Explorys. Results Of 72 million patients, 170 are prescribed TED. Age range of majority was 45–69 years. 70% were female, 82% caucasian and 12% African American. 70 used medicare, and 70 private insurance. In 50 patients, initial BMI was > 30, 40 had BMI < 19, and majority had BMI 19–29. 10 had opioid dependence, and 70 tobacco use. 30 started TED with comorbid HF; 10 had prior GI malignancy. Common underlying conditions: bowel obstruction (N = 80), Crohn's (N = 70; 50 fistulizing, 10 abscess-forming), congenital gut malformation (N = 30), mesenteric ischemia (N = 30), and perforation (N = 20). <10 had radiation enteritis, traumatic intestinal injury and intestinal dysmotility. Prior surgeries: 60 had ileostomy, and 40 colostomy. 90 had partial colonic resection and 30 partial excisions of small bowel. Only 10 had jejunal bypass, and <10 esophagojejunostomy, gastrojejunostomy, pancreaticojejunostomy, jejunojejunostomy, ileocolic anastomosis, and small bowel transplant. Common incident symptoms/events: abdominal pain (N = 70), nausea (N = 40), intestinal obstruction (N = 30), stoma complications (N = 20), ≤10 had colon polyps, duodenal neoplasm, biliary disorder, pancreatitis, flatulence, and fluid overload. Conclusions In 26 US centers, TED use is rare and associated with several known indications for intestinal surgery. Most were not underweight, and many were obese at initiation. Serious adverse events appear rare. Increased awareness of TED is needed, but careful risk-benefit analysis is needed prior to prescribing TED in patients with GI neoplasms and HF. Funding Sources None.

2020 ◽  
Vol 8 (4_suppl3) ◽  
pp. 2325967120S0024
Author(s):  
Tyler B. Hall ◽  
Max J. Hyman ◽  
Neeraj M. Patel

Background: A number of surgical options are available for sizeable articular cartilage lesions of the knee. These include osteochondral autograft (OAU) or allograft (OAL) transfer, or autologous chondrocyte implantation (ACI). In the pediatric population, there is little data on the patients undergoing these procedures or evidence to support one technique over another, which may lead to variation in preferred practice. Hypothesis/Purpose: The purpose of this study is to analyze the epidemiology of children and adolescents undergoing OAU, OAL, and ACI in the United States, with attention to variation along the lines of demographic and geographic factors. Methods: The Pediatric Health Information System, a national database consisting of 49 children’s hospitals, was queried for all patients undergoing OAU, OAL, and ACI between 2012 and 2018. Demographic information was collected for each subject. United States Census guidelines were used to categorize hospitals geographically into regions. Univariate analysis was followed by purposeful entry multivariate regression to adjust for confounding factors. Results: A total of 809 subjects with a mean age of 15.4±2.4 years were included in the analysis. Of these, 393 (48.6%) underwent OAL, 339 (41.9%) underwent OAU, and 77 (9.5%) underwent ACI. The most common diagnosis at the time of surgery was osteochondritis dissecans in 360 patients (44.5%) followed by an associated cruciate ligament injury in 126 (15.6%) and patellar instability in 98 (12.1%). After adjusting for confounders in a multivariate model, ACI was more 3.4 times more likely to be performed in patients with private insurance than those that were publicly insured (95% CI 1.5-7.5, p=0.002). Furthermore, a patient in this Northeast was 29.3 times more likely to undergo ACI than in the West (95% CI 4.0-217.4, p=0.001). OAU was performed most frequently in the West and Midwest (52.4% and 51.8% of the time, respectively; p<0.001). Univariate analysis also revealed differences along the lines of race, but these findings did not maintain statistical significance in multivariate analysis. Conclusion: In the United States, there is substantial variation in the procedures performed for cartilage restoration in children and adolescents. Though ACI is the least commonly selected operation overall, it is significantly more likely to be performed on patients with private insurance and those in the Northeast. OAU is the most commonly performed procedure in the West and Midwest.


2021 ◽  
Author(s):  
Lisa Vitale ◽  
Briana Rodriguez ◽  
Anne Baetzel ◽  
Robert Christensen ◽  
Bishr Haydar

Abstract Background: Previous studies examining removal of endotracheal tubes and supraglottic devices under deep anesthesia were underpowered to identify rare complications. This study sought to report all adverse events associated with this practice found in a large national database of pediatric anesthesia adverse events.Methods: An extract of an adverse events database created by the Wake Up Safe database, a multi-institutional pediatric anesthesia quality improvement initiative, was performed for this study. It was screened to identify anesthetics with variables indicating removal of airway devices under deep anesthesia. Three anesthesiologists screened the data to identify events where this practice possibly contributed to the event. Event data was extracted and collated. Results: 102 events met screening criteria and 66 met inclusion criteria. Two cardiac etiology events were identified, one of which resulted in the patient’s demise. The remaining 97% of events were respiratory in nature (64 events), including airway obstruction, laryngospasm, bronchospasm and aspiration. Some respiratory events consisted of multiple distinct events in series. Nineteen respiratory events resulted in cardiac arrest (29.7%) of which 15 (78.9%) were deemed preventable by local anesthesiologists performing independent review. Respiratory events resulted in intensive care unit admission (37.5%), prolonged intubation and temporary neurologic injury but no permanent harm. Provider and patient factors were root causes in most events. Upon investigation, areas for improvement identified included improving patient selection, ensuring monitoring, availability of intravenous access, and access to emergency drugs and equipment until emergence.Conclusions: Serious adverse events have been associated with this practice, but no respiratory events were associated with long-term harm.


2018 ◽  
Vol 43 (2) ◽  
pp. 263-270 ◽  
Author(s):  
David Galloway ◽  
Ethan Mezoff ◽  
Wujuan Zhang ◽  
Melissa Byrd ◽  
Conrad Cole ◽  
...  

2020 ◽  
Vol 14 (11) ◽  
pp. 1558-1564 ◽  
Author(s):  
Mattias Soop ◽  
Haroon Khan ◽  
Emma Nixon ◽  
Antje Teubner ◽  
Arun Abraham ◽  
...  

Abstract Background and Aims Intestinal failure [IF] is a feared complication of Crohn’s disease [CD]. Although cumulative loss of small bowel due to bowel resections is thought to be the dominant cause, the causes and outcomes have not been reported. Methods Consecutive adult patients referred to a national intestinal failure unit over 2000–2018 with a diagnosis of CD, and subsequently treated with parenteral nutrition during at least 12 months, were included in this longitudinal cohort study. Data were extracted from a prospective institutional clinical database and patient records. Results A total of 121 patients were included. Of these, 62 [51%] of patients developed IF as a consequence of abdominal sepsis complicating abdominal surgery; small bowel resection, primary disease activity, and proximal stoma were less common causes [31%, 12%, and 6%, respectively]. Further, 32 had perianastomotic sepsis, and 15 of those had documented risk factors for anastomotic dehiscence. On Kaplan-Meier analysis, 40% of all patients regained nutritional autonomy within 10 years and none did subsequently; 14% of patients developed intestinal failure-associated liver disease. On Kaplan-Meier analysis, projected mean age of death was 74 years.2 Conclusions IF is a severe complication of CD, with 60% of patients permanently dependent on parenteral nutrition. The most frequent event leading directly to IF was a septic complication following abdominal surgery, in many cases following intestinal anastomosis in the presence of significant risk factors for anastomotic dehiscence. A reduced need for abdominal surgery, an increased awareness of perioperative risk factors, and structured pre-operative optimisation may reduce the incidence of IF in CD.


2009 ◽  
Vol 54 (No. 5) ◽  
pp. 215-222 ◽  
Author(s):  
E. Honsova ◽  
A. Lodererova ◽  
P. Balaz ◽  
M. Oliverius

Small bowel transplantations (SBT) are increasingly performed to treat patients with irreversible intestinal failure or short-bowel syndrome. Histologic evaluation of small bowel allograft biopsies is important for the diagnosis of acute cellular rejection (ACR). A reliable serological marker of ACR after SBT is still unknown. Recently, citrulline was identified as a potential biomarker of reduced enterocyte mass. The aim of our study was to analyze rejection and plasma citrulline levels early after SBT in pigs. 24 pigs were used and divided into four groups. Group A, autologous SBT (<I>n</I> = 3) as a control group; Group B, allogeneic SBT with tacrolimus monotherapy (<I>n</I> = 7); Group C, allogeneic SBT immunosuppressed with tacrolimus and sirolimus (<I>n</I> = 8); and Group D, without immunosuppresion (<I>n</I> = 6). The observation period was 30 days. Mucosal biopsies were obtained on Days 0, 3, 5, 7, 10, 14, 20, 28 and simultaneously plasma citrulline levels were measured. ACR was classified according to standardized grading schema on a scale of indeterminate, mild, moderate, and severe. There were no significant differences in citrulline plasma levels between cases with mild ACR and indeterminate for ACR. A significant decline in plasma citrulline levels occurred in cases of moderate and severe rejection. Plasma citrulline levels constituted a marker of more advanced injury of small bowel epithelium.


2019 ◽  
Vol 67 (7) ◽  
pp. 1092-1094
Author(s):  
Kwabena Oware Adu-Gyamfi ◽  
Chaitanya Pant ◽  
Abhishek Deshpande ◽  
Mojtaba Olyaee

While short bowel syndrome (SBS) is the leading cause of intestinal failure in children, little objective data are available regarding hospital readmissions for children with SBS. This study sought to investigate rehospitalizations related to SBS in young children. Data for study were obtained from the 2013 Nationwide Readmissions Database (NRD). Using data from the 2013 NRD, we identified a total of 1898 hospitalizations in children with SBS aged 1–4 years. A total of 901 index cases and 997 rehospitalizations were noted. Of these, 425 children (47.2%) underwent rehospitalizations. The most frequent diagnoses and procedures associated with readmission of children with SBS were related to infections and intravenous catheter placement. This is the first study to use US nationwide data to report on the incidence of readmissions in children with SBS. The results from this study indicate that improving central line care and providing home healthcare resources to families at discharge may help in preventing SBS-related rehospitalizations.


Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1376
Author(s):  
Denis Picot ◽  
Sabrina Layec ◽  
Eloi Seynhaeve ◽  
Laurence Dussaulx ◽  
Florence Trivin ◽  
...  

Some temporary double enterostomies (DES) or entero-atmospheric fistulas (EAF) have high output and are responsible for Type 2 intestinal failure. Intravenous supplementations (IVS) for parenteral nutrition and hydration compensate for intestinal losses. Chyme reinfusion (CR) artificially restores continuity pending surgical closure. CR treats intestinal failure and is recommended by European Society for Clinical Nutrition and Metabolism (ESPEN) and American Society for Parenteral and Enteral Nutrition (ASPEN) when possible. The objective of this study was to show changes in nutritional status, intestinal function, liver tests, IVS needs during CR, and the feasibility of continuing it at home. A retrospective study of 306 admitted patients treated with CR from 2000 to 2018 was conducted. CR was permanent such that a peristaltic pump sucked the upstream chyme and reinfused it immediately in a tube inserted into the downstream intestine. Weight, plasma albumin, daily volumes of intestinal and fecal losses, intestinal nitrogen, and lipid absorption coefficients, plasma citrulline, liver tests, and calculated indices were compared before and during CR in patients who had both measurements. The patients included 185 males and 121 females and were 63 ± 15 years old. There were 37 (12%), 269 (88%) patients with EAF and DES, respectively. The proximal small bowel length from the duodeno-jejunal angle was 108 ± 67 cm (n = 232), and the length of distal small intestine was 117 ± 72 cm (n = 253). The median CR start was 5 d (quartile 25–75%, 2–10) after admission and continued for 64 d (45–95), including 81 patients at home for 47 d (28–74). Oral feeding was exclusive 171(56%), with enteral supplement 122 (42%), or with IVS 23 (7%). Before CR, 211 (69%) patients had IVS for nutrition (77%) or for hydration (23%). IVS were stopped in 188 (89%) 2 d (0–7) after the beginning of CR and continued in 23 (11%) with lower volumes. Nutritional status improved with respect to weight gain (+3.5 ± 8.4%) and albumin (+5.4 ± 5.8 g/L). Intestinal failure was cured in the majority of cases as evidenced by the decrease in intestinal losses by 2096 ± 959 mL/d, the increase in absorption of nitrogen 32 ± 20%, of lipids 43 ± 30%, and the improvement of citrulline 13.1 ± 8.1 µmol/L. The citrulline increase was correlated with the length of the distal intestine. The number of patients with at least one liver test >2N decreased from 84–40%. In cases of Type 2 intestinal failure related to DES or FAE with an accessible and functional distal small bowel segment, CR restored intestinal functions, reduced the need of IVS by 89% and helped improve nutritional status and liver tests. There were no vital complications or infectious diarrhea described to date. CR can become the first-line treatment for intestinal failure related to double enterostomy and high output fistulas.


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