A Systematic Review and Meta-Analysis: A Prior Appendectomy Does Not Increase the Risk of Severe Clostridioides difficile Infection or Recurrence.

BACKGROUND AND OBJECTIVES: There is conflicting evidence regarding the association between a prior appendectomy and severity of Clostridioides difficile infection. The aim of this study was to perform a systematic review and meta-analysis to evaluate this association. PATIENTS AND METHODS: Comprehensive review of multiple databases was performed up to May 2022. The primary outcome assessed was the rate of severe Clostridioides difficile infection in patients with a prior appendectomy compared to patients with an appendix. The secondary outcomes assessed were recurrence, mortality, and colectomy rates associated with Clostridioides difficile infection in patients with a prior appendectomy compared to patients with an appendix. RESULTS: Eight studies with 666 patients with a prior appendectomy and 3580 patients without an appendectomy were included. The odds ratio of severe Clostridioides difficile infection in patients who underwent prior appendectomy was 1.03 (95% CI 0.6-1.78, p = 0.92). The odds ratio of recurrence in patients who underwent prior appendectomy was 1.29 (95% CI 0.82-2.02, p = 0.28). The odds ratio of colectomy due to Clostridioides difficile infection in patients who underwent prior appendectomy was 2.16 (95% CI 1.27-3.67, p = 0.004). The odds ratio of mortality due to Clostridioides difficile infection in patients with a prior appendectomy was 0.92 (95% CI 0.62-1.37, p = 0.68). CONCLUSION: Patients with appendectomy are not at increased risk for developing severe Clostridioides difficile infection or recurrence. Further prospective studies are needed to establish these associations.

New Alternative? Self-Assembling Peptide in Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

BACKGROUND: Gastrointestinal bleeding (GIB) is a common and potentially fatal condition with all-cause mortality ranging from 3 to 10%. Endoscopic therapy traditionally involves mechanical, thermal, and injection therapies. Recently, self-assembling peptide (SAP) has become increasingly available in the United States. When applied to an affected area, this gel forms an extracellular matrix-type structure allowing for hemostasis. This is the first systematic review and meta-analysis to assess the safety and efficacy of this modality in GIB. METHODS: We performed a comprehensive literature search of major databases from inception to Nov 2022. The primary outcomes assessed were the success of hemostasis, rebleeding rates, and adverse events. The secondary outcomes assessed were successful hemostasis with monotherapy with SAP and combined therapy, which may include mechanical, injection, and thermal therapies. Pooled estimates were calculated using random-effects models with a 95% confidence interval (CI). RESULTS: The analysis included 7 studies with 427 patients. 34% of the patients were on anticoagulation or antiplatelet agents. SAP application was technically successful in all patients. The calculated pooled rate of successful hemostasis was 93.1% (95% confidence interval (CI) 84.7-97.0, I2 = 73.6), and rebleeding rates were 8.9% (95% CI 5.3-14.4, I2 = 55.8). The pooled rates of hemostasis with SAP monotherapy and combined therapy were similar. No adverse events were noted related to SAP. CONCLUSION: SAP appears to be a safe and effective treatment modality for patients with GIB. This modality provides an added advantage of improved visualization over the novel spray-based modalities. Further, prospective, or randomized controlled trials are needed to validate our findings.

Safety of endoscopic pancreatic necrosectomy compared with percutaneous and surgical necrosectomy: a nationwide inpatient study.

Background and study aims Pancreatic necrosis is an independent predictor of morbidity and mortality among patients with acute pancreatitis. We compared the safety and outcomes of three techniques including endoscopic necrosectomy, fluoroscopy-guided percutaneous necrosectomy by an interventional radiologist, and surgical necrosectomy. Patients and methods Using the Nationwide Readmissions Database, we identified hospitalized patients who underwent pancreatic necrosectomy from 2016 to 2019. They were identified using the International Classification of Diseases, 10th Revision, Procedure Coding System. Results: Of the 2,281 patients meeting the selection criteria, the method of pancreatic necrosectomy was as follows: endoscopy (n = 672), percutaneous (n = 1,338), and surgery (n = 271). Compared to surgery, the rate of mortality was lowest for endoscopy (hazard ratio (HR) 0.27; 95 % CI 0.08-0.90; P  = 0.033) followed by percutaneous (HR 0.44; 95 % CI, 0.20-0.98; P  = 0.045). Endoscopy was associated with less post-procedure bleeding compared to percutaneous and surgical necrosectomy ( P  < 0.001), as well as lower rates of post-procedure renal failure ( P  < 0.001) and respiratory failure ( P  = 0.002). Endoscopy was associated with average shorter lengths of stay and total hospital costs when compared with percutaneous and surgical approaches, respectively (20.1 vs 25.8 vs 38.3 days; P  < 0.001) and ($ 57K vs $ 76K vs $ 123K; P  < 0.001). Conclusions Endoscopic necrosectomy is associated with significantly lower risk of inpatient mortality, adverse events, length of stay, and cost when compared to percutaneous and surgical approaches.

Single-incision needle-knife biopsy for the diagnosis of GI subepithelial tumors: a systematic review and meta-analysis.

BACKGROUND AND AIMS: A histologic diagnosis of GI subepithelial tumors (SETs) is important because of the malignant potential of these lesions. The current modalities of choice, including EUS-guided FNA and biopsy (EUS-FNA/FNB) have demonstrated suboptimal diagnostic success. Single-incision with needle-knife (SINK) biopsy has emerged as an alternative diagnostic approach to increase tissue acquisition and diagnostic success. The aim of this study was to perform a systematic review and meta-analysis to evaluate the technical success, diagnostic success, and adverse events of SINK biopsy. METHODS: We searched multiple databases including PubMed, EMBASE, CINAHL, Cochrane, Web of Science, and Google Scholar from inception to July 2022. The primary outcomes assessed were the technical success and diagnostic success of SINK in GI SETs. The secondary outcomes assessed were adverse events and whether immunohistochemical analysis could be successfully performed on tissue samples obtained via SINK. RESULTS: Seven studies with a total of 219 SINK biopsy procedures were included in this meta-analysis. The technical success rate was 98.1% (95% CI, 94.9%-99.3%; P = .000; I2 = .0%), and the diagnostic success rate was 87.9% (95% CI, 82.6%-91.7%; P = .000; I2 = .0%). The immunohistochemical success rate was 88.3% (95% CI, 78.7%-93.9%; P = .000; I2 = 3.5%). The rate of adverse events was 7.5% (95% CI, 4.3%-12.7%; P = .00; I2 = 7.2%), and bleeding was the most common adverse event. CONCLUSION: SINK biopsy is a safe diagnostic procedure with a high technical and diagnostic success in patients with GI SET. Further randomized controlled trials and direct comparison studies are needed to validate these findings.

Medications and the risk of perforated appendicitis: an adverse event report system (FAERS) database analysis.

OBJECTIVE: Different classes of medication have been reported in the literature to be associated with an increased risk of gastrointestinal perforation. However, little is known about the risk of drug-induced perforated appendicitis. METHODS: We analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS), a large national database of reported adverse events associated with post-market FDA-approved medications from January 2011 to October 2021. Patients of any age group with appendiceal perforation were included. Duplicated reports and other anatomical areas of gastrointestinal tract perforation outside the appendix were excluded. RESULTS: During the study period, 474 event cases met inclusion criteria, of which 284 were females. Most reports of perforation occurred in patients 40-49 years (n = 110) and 50-59 years (n = 144). Cases of perforated appendicitis occurred in patients being treated for multiple sclerosis (31.5%) and rheumatoid arthritis (17.1%). Perforation occurred in patients receiving interferon beta 1a (23.6%), adalimumab (17.9%), etanercept (14.1%), natalizumab (12.2%), clozapine (10.1%), infliximab (9.9%), bevacizumab (7.2%), and calcium chloride (4.9%). Sixteen fatal outcomes were reported. CONCLUSION: Findings from the FAERS database highlight the risk of appendiceal perforation in the context of different classes of drugs. Larger pharmacovigilance studies are needed to confirm these observations.

Safety and efficacy of EUS-guided ablation of pancreatic lesions with ethanol versus ethanol with paclitaxel: A systematic review and meta-analysis.

Background and Objectives: EUS-guided ethanol ablation has emerged as an alternative method for pancreatic lesions. Recently, paclitaxel was added to ethanol to assess ablative effects in pancreatic lesions. We performed a systematic review and meta-analysis on EUS-guided ethanol ablation (EUS E) versus EUS-guided ethanol with paclitaxel (EUS EP) ablation for the management of pancreatic lesions. Methods: Comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, Google Scholar, and Web of Science databases (from inception to May 2020). The primary outcome evaluated complete ablation of the lesions radiologically and the secondary outcome evaluated adverse events (AEs). Results: Fifteen studies on 524 patients were included in our analysis. The pooled complete ablation rate was 58.89% (95% confidence interval (CI) = 38.72-77.80, I2 = 91.76%) and 55.99% (95% CI = 44.66-67.05, I2 = 0) in the EUS E and EUS EP groups (P = 0.796), respectively. The pooled AE rates were 13.92% (95% CI = 4.71-26.01, I2 = 83.43%) and 31.62% (95% CI = 3.36-68.95, I2 = 87.9%) in the EUS E and EUS EP groups (P = 0.299), respectively. The most common AE was abdominal pain at 7.27% (95% CI = 1.97-14.6, I2 = 68.2%) and 12.44% (95% CI = 0.00-39.24, I2 = 81.1%) in the EUS E and EUS EP groups (P = 0.583), respectively. Correlation coefficient (r) was ‒0.719 (P = 0.008) between complete ablation and lesion size. Conclusion: Complete ablation rates were comparable among both groups. AE rates were higher in the EUS EP group. Further randomized controlled trials are needed to validate our findings.

Impact of utilization of hepatitis C positive organs in liver transplant: Analysis of united network for organ sharing database.

BACKGROUND: The utility of hepatitis C virus (HCV) organs has increased after the Food and Drug Administration approval of direct acting anti-viral (DAA) medications for the HCV treatment. The efficacy of DAA in treating HCV is nearly 100%. AIM: To analyze the United Network for Organ Sharing (UNOS) database to compare the survival rates between the hepatitis C positive donors and negative recipients and hepatitis C negative donors and recipients. METHODS: We analyzed the adult patients in UNOS database who underwent deceased donor liver transplant from January 2014 to December 2017. The primary endpoint was to compare the survival rates among the four groups with different hepatitis C donor and recipient status: (Group 1) Both donor and recipient negative for HCV (Group 2) Negative donor and positive recipient for HCV (Group 3) Positive donor and negative recipient for HCV (Group 4) Both positive donor and recipient for HCV. SAS 9.4 software was used for the data analysis. Kaplan Meier log rank test was used to analyze the estimated survival rates among the four groups. RESULTS: A total of 24512 patients were included: Group 1: 16436, Group 2: 6174, Group 3: 253 and Group 4: 1649. The 1-year (Group 1: 91.8%, Group 2: 92.12%, Group 3: 87%, Group 4: 92.8%), 2-year (Group 1: 88.4%, Group 2: 88.1%, Group 3: 84.3%, Group 4: 87.5%), 3-year (Group 1: 84.9%, Group 2: 84.3%, Group 3: 75.9%, Group 4: 83.2%) survival rates showed no statistical significance among the four groups. Kaplan Meier log rank test did not show any statistical significance difference in the estimated survival rates between Group 3 vs all the other groups. CONCLUSION: The survival rates in hepatitis C positive donors and negative recipients are similar as compared to both hepatitis C negative donors and recipients. This could be due to the use of DAA therapy with cure rates of nearly 100%. This study supports the use of hepatitis C positive organs in the selected group of recipients with and without HCV infection. Further long-term studies are needed to further validate these findings.

A comparison of balloon- versus stent-based approach for dominant strictures in primary sclerosing cholangitis: a meta-analysis.

Background: Approximately 10-62% of patients with primary sclerosing cholangitis (PSC) will develop dominant strictures at some point during their disease. Because of the paucity of available data, optimal endoscopic therapeutic strategies remain unclear. We performed a systematic review and meta-analysis of endoscopic balloon dilation vs. balloon dilation plus stenting of dominant strictures in PSC. Methods: A comprehensive literature search from inception to November 2020 was performed. Primary outcomes were clinical and technical success. Secondary outcomes reported were adverse events (AE). Clinical success was defined in most studies as improvement in symptoms such as fever, abdominal pain, pruritus, fatigue and/or liver enzymes. The statistical analysis was done using comprehensive meta-analysis (CMA Version 3). Results: The technical success rates for balloon and balloon plus stent were 96.8% and 91.9%, respectively. The clinical success rates for balloon and balloon plus stent were 86.5% and 70.8%, respectively. The overall AE rates for balloon and balloon plus stent were 11.2% and 26.9%, respectively. Other AE rates in balloon and balloon plus stent were cholangitis (4.8% vs. 11.4%), bile duct perforation (1.3% vs. 1.6%), post-procedural pancreatitis (2.2% vs. 9.8%), and bleeding (1.5% vs. 1.2%), respectively. Low to considerable heterogeneity was noted in our meta-analysis. Conclusions: Balloon dilation appears to be superior in terms of clinical and technical successes, with overall lower rates of AE compared to balloon dilation plus stenting for the management of PSC dominant strictures. Further trials are needed to validate our findings.

Endoscopic cryotherapy: Indications, techniques, and outcomes involving the gastrointestinal tract.

Endoscopic cryotherapy is a technique utilized for the ablation of target tissue within the gastrointestinal tract. A cryotherapy system utilizes the endoscopic application of cryogen such as liquid nitrogen, carbon dioxide or liquid nitrous oxide. This leads to disruption of cell membranes, apoptosis, and thrombosis of local blood vessels within the target tissue. Several trials utilizing cryotherapy for Barrett's esophagus (BE) with variable dysplasia, gastric antral vascular ectasia (GAVE), esophageal carcinoma, radiation proctitis, and metastatic esophageal carcinomas have shown safety and efficacy. More recently, liquid nitrogen cryotherapy (cryodilation) was shown to be safe and effective for the treatment of a benign esophageal stricture which was refractory to dilations, steroid injections, and stenting. Moreover, liquid nitrogen cryotherapy is associated with less post procedure pain as compared to radiofrequency ablation in BE with comparable ablation rates. In patients with GAVE, cryotherapy was found to be less tedious as compared to argon plasma coagulation. Adverse events from cryotherapy most commonly include chest pain, esophageal strictures, and bleeding. Gastric perforations did occur as well, but less often. In summary, endoscopic cryotherapy is a promising and growing field, which was first demonstrated in BE, but the use now spans for several other disease processes. Larger randomized controlled trials are needed before its role can be established for these different diseases.

Efficacy of EUS-guided needle-based confocal laser endomicroscopy in the diagnosis of pancreatic lesions: A systematic review and meta-analysis.

Background and Objectives: Needle-based confocal laser endomicroscopy (nCLE) is a procedure in which an AQ-Flex nCLE mini-probe is passed through an EUS-FNA needle into a pancreatic lesion to enable subsurface in vivo tissue analysis. In this study, we conducted a systematic review and meta-analysis of nCLE for the diagnosis of pancreatic lesions. Materials and Methods: We conducted a comprehensive search of several databases and conference proceedings, including PubMed, EMBASE, Google-Scholar, MEDLINE, SCOPUS, and Web of Science databases (earliest inception to March 2020). The primary outcomes assessed the pooled rate of diagnostic accuracy for nCLE and the secondary outcomes assessed the pooled rate of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and adverse events (AE) of nCLE to diagnose premalignant/malignant pancreatic lesions. Results: Eleven studies on 443 patients were included in our analysis. The pooled rate of diagnostic accuracy of EUS nCLE was 83% (95 confidence interval [CI] = 79-87; I 2 = 0). The pooled rate of sensitivity, specificity, PPV and NPV of EUS nCLE was 85.29% (95% CI = 76.9-93.68; I 2 = 85%), 90.49% (95% CI = 82.24-98.74; I 2 = 64%), 94.15% (95% CI = 88.55-99.76; I 2 = 68%), and 73.44% (95% CI = 60.16-86.72; I 2 = 93%), respectively. The total AE rate was 5.41% (±5.92) with postprocedure pancreatitis being the most common AE at 2.28% (±3.73). Conclusion: In summary, this study highlights the rate of diagnostic accuracy, sensitivity, specificity, and PPV for distinguishing premalignant/malignant lesions. Pancreatic lesions need to be further defined with more validation studies to characterize CLE diagnosis criteria and to evaluate its use as an adjunct to EUS-FNA.

Predictors of Lymph Node Metastasis in T1 Colorectal Cancer in Young Patients: Results from a National Cancer Registry.

The objective of this study is to fill the knowledge gap by examining predictors of lymph node metastasis (LNM) in young patients, less than 45 years, using a national cancer registry. Methods: Patients diagnosed with T1 colorectal cancer were identified in the Surveillance, Epidemiology, and End Results registry. In total, 692 patients with T1 colorectal cancer were identified. Most tumors occurred in white race (77.7%), between 40 and 44 years of age (49.4%), with grade III tumor differentiation (59.8%) and 1 to 1.9 cm size (32.2%), and were left-sided tumors (61.1%). The overall rate of LNM was 22.5% (n = 149). LNM was associated with tumor grade IV (undifferentiated) (odds ratio (OR) 2.94, CI: 1.06-8.12; p = 0.038), and increasing tumor size (1 cm-1.9 cm: OR 2.92, CI: 1.71-4.97, p < 0.001; 2.0 cm-2.9 cm: OR 2.00, CI: 1.05-3.77, p = 0.034; and ≥3.0 cm: OR 2.68, CI: 1.43-5.01, p = 0.002). Five-year cancer-specific survival for patients with LNM was 91% and for patients without LNM this was 98%. Adjusted cox proportion models showed that LNM was associated with a four times higher rate of mortality (hazard ratio (HR) 4.43, CI: 1.27-15.52, p = 0.020). In this population-based analysis of patients with T1 colorectal cancer, tumor size and grade were significant predictors of LNM.

Choice of sedation in endoscopic retrograde cholangiopancreatography: is monitored anesthesia care as safe as general anesthesia? A systematic review and meta-analysis.

BACKGROUND: Monitored anesthesia care (MAC) and general anesthesia (GA) are the 2 most common methods of sedation used for endoscopic retrograde cholangiopancreatography (ERCP). We performed a systematic review and meta-analysis to compare the overall safety between MAC vs. GA in ERCP. METHODS: We conducted a comprehensive search of electronic databases to identify studies reporting the use of MAC or GA as a choice of sedation for ERCP. The primary outcome was to compare the overall rate of sedation-related adverse events in MAC vs. GA groups. The secondary endpoint was to investigate the total duration of the procedure, recovery time, ERCP cannulation rates, and conversion rate of MAC to GA. The meta-analysis was performed using a Der Simonian and Laird random-effects model. RESULTS: A total of 21 studies reporting on 11,592 patients were included. The overall sedation-related side-effects were similar in the GA (12.76%, 95% confidence interval [CI] 5.80-21.73; I2=95%) and MAC (12.08%, 95%CI 5.38-20.89; I2=99%) groups (P=0.956). Hypoxia, arrhythmias, hypotension, aspiration and other sedation-related side-effects were similar between the 2 groups. The mean duration of the procedure was longer in the MAC group, but the mean recovery time was shorter. Significant heterogeneity was noted in our meta-analysis. CONCLUSIONS: In our meta-analysis, the overall sedation-related side-effects were similar between the MAC and GA groups. MAC could be used as a safer alternative to GA when performing ERCP. However, large multicenter randomized control trials are needed to further validate our findings.

Comparison of left versus right lateral starting position on colonoscopy: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Modifying patient position during colonoscopy has been proposed as a simple and inexpensive technique to increase luminal distention and improve navigation through the large bowel. The left lateral (LL) decubitus starting position is commonly used during colonoscopy. However, reports indicate that other starting positions may offer additional benefit. We aimed to determine if the right lateral (RL) starting position compared to the standard LL starting position could improve outcomes in colonoscopy. METHODS: We searched PubMed, Medline, and EMBASE through June 2020 to identify studies comparing RL and LL starting positions during colonoscopy. The primary outcomes included mean cecal insertion time and cecal intubation rate, and adverse events were assessed by pooling data using a random-effects model expressed in terms of odds ratio (OR), mean difference, and 95% confidence interval (CI). RESULTS: We identified 5 randomized controlled trials, including 809 participants, that compared LL vs. RL colonoscopy. The pooled OR for cecal intubation rate was 1.3 (95%CI 0.8-2.3; P=0.3). The mean difference in mean cecal insertion time was 0.08 (95%CI -0.09 to 0.26; P=0.4). Heterogeneity between studies was low (I 2=0%). No complications were reported in either arm of the study. Pain scores assessed using a visual analog scale were comparable among both arms of the study. CONCLUSION: The RL starting position for colonoscopy was comparable to the LL and offered no additional benefit in terms of cecal intubation time, intubation rate, or patient discomfort.

Endo-sponge in management of anastomotic colorectal leaks: a systematic review and meta-analysis.

Background and study aims Following colorectal surgery, anastomotic dehiscence and leak formation has an incidence of 2 % to 7 %. Endo-SPONGE has been applied in the management of anastomatic leaks (ALs) after colorectal surgery. This is the first systematic review and meta analysis to evaluate the efficacy and safety of Endo-SPONGE in the management of colorectal ALs. Patients and methods The primary outcomes assessed were the technical and clinical success of Endo-SPONGE placement in colorectal ALs. The secondary outcomes assessed were the overall adverse events (AEs) and the AE subtypes. Pooled estimates were calculated using random-effects models with 95 % confidence interval (C. I.). The statistical analysis was done using STATA v16.1 software (StataCorp, LLC College Station, Texas, United States). Results The analysis included 17 independent cohort studies with a total of 384 patients. The rate of technical success was 99.86 % (95 % CI: 99.2 %, 100 %; P  = 0.00; I 2  = 70.69 %) and the calculated pooled rate of clinical success was 84.99 % (95 % CI: 77.4 %, 91.41 %; P  = 0.00; I 2  = 68.02 %). The calculated pooled rate of adverse events was 7.6 % (95 % CI: 3.99 %, 12.21 %; P  = 0.03; I 2  = 42.5 %) with recurrent abscess formation and bleeding being the most common AEs. Moderate to substantial heterogeneity was noted in our meta-analysis. Conclusions Endoscopic vacuum therapy appears to be a minimally invasive, safe, and effective treatment modality for patients with a significant colorectal leak without any generalized peritonitis with high clinical and technical success rates and a low rate of adverse events. Further prospective or randomized controlled trials are needed to validate our findings.

Wet- versus dry-suction techniques for EUS-FNA of solid lesions: A systematic review and meta-analysis.

The optimal sampling techniques for EUS-FNA remain unclear and have not been standardized. To improve diagnostic accuracy, suction techniques for EUS-FNA have been developed and are widely used among endoscopists. The aim of this study was to compare wet-suction and dry-suction EUS-FNA techniques for sampling solid lesions. We performed a comprehensive literature search of major databases (from inception to June 2020) to identify prospective studies comparing wet-suction EUS-FNA and dry-suction EUS-FNA. Specimen adequacy, sample contamination, and histologic accuracy were assessed by pooling data using a random-effects model expressed in terms of odds ratio (OR) and 95% confidence interval (CI). Six studies including a total of 418 patients (365 wet suction vs. 377 dry suction) were included in our final analysis. The study included a total of 535 lesions (332 pancreatic lesions and 203 nonpancreatic lesions). The pooled odds of sample adequacy was 3.18 (CI: 1.82-5.54, P = 0.001) comparing wet- and dry-suction cohorts. The pooled odds of blood contamination was 1.18 (CI: 0.75-1.86, P = 0.1). The pooled rate for blood contamination was 58.33% (CI: 53.65%-62.90%) in the wet-suction cohort and 54.60% (CI 49.90%- 59.24%) in the dry-suction cohort (P = 0.256). The pooled odds of histological diagnosis was 3.68 (CI 0.82-16.42, P = 0.1). Very few adverse events were observed and did not have an impact on patient outcomes using either method. EUS-FNA using the wet-suction technique offers higher specimen quality through comparable rates of blood contamination and histological accuracy compared to dry-suction EUS-FNA.

Population-Based Long-term Cardiac-Specific Mortality Among Patients With Major Gastrointestinal Cancers.

Importance: Patients with major gastrointestinal (GI) cancers are at long-term risk for cardiac disease and mortality. Objective: To investigate the cardiac-specific mortality rate among individuals with major GI cancers and the association of radiation and chemotherapy with survival outcomes in the United States. Design, Setting, and Participants: This US cohort study included individual patient-level data of men and women older than 18 years with 5 major gastrointestinal cancers, including colorectal, esophageal, gastric, pancreatic, and hepatocellular cancer from 1990 to 2016. Data was extracted from the Surveillance, Epidemiology, and End Results (SEER) national cancer database. Data cleaning and analyses were conducted between November 2020 and March 2021. Exposures: Patients received chemotherapy, radiotherapy, or a combination of adjuvant therapy for major GI cancers. Main Outcomes and Measures: The primary outcome was cardiac-specific mortality. Examined factors associated with cardiac mortality included age, sex, race, tumor location, tumor grade, SEER stage, TNM (seventh edition) staging criteria, cancer treatment (ie, the use of radiation, chemotherapy, or surgery), survival months, and cause of death. Results: A total of 359 032 patients (mean [SD] age at baseline, 65.1 [12.9] years; 186 921 [52.1%] men) with GI cancers were analyzed, including 313 940 patients (87.4%) with colorectal cancer, 7613 patients (2.1%) with esophageal cancer, 21 048 patients (5.9%) with gastric cancer, 7227 patients (2.0%) with pancreatic cancer, and 9204 patients (2.6%) with hepatocellular cancer. Most cancers were localized except pancreatic cancer, which presented with regional and distant involvement (3680 cancers [50.9%]). Overall, all major gastrointestinal tumors were associated with increased risk of cardiac mortality compared with noncardiac mortality (median survival time: 121 [95% CI, 120-122] months vs 287 [95% CI, 284.44-290] months). Patients with hepatocellular cancer had the lowest cardiac-specific median survival time (98 [95% CI, 90-106] months), followed by pancreatic cancer (105 [95% CI, 98-112] months), esophageal cancer (113 [95% CI, 107-119] months), gastric cancer (113 [95% CI, 110-116] months), and colorectal cancer (122 [95% CI, 121-123] months). At 15 years of follow up, the use of only chemotherapy, only radiation, or radiation and chemotherapy combined was associated with poor survival rates from cardiac causes of death (eg, colorectal: chemotherapy, 0 patients; radiation, 1 patient [1.9%]; radiation and chemotherapy, 3 patients [2.7%]). Conclusions and Relevance: These findings suggest that among patients with major gastrointestinal cancers, cardiac disease is a significant cause of mortality. The use of only chemotherapy, only radiation, or both was associated with higher cardiac mortality.

Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.

Intragastric balloons have been used to bridge the obesity treatment gap. We aim to investigate the number and type of complications associated with intragastric balloons using public-access governmental databanks. We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2017 through Nov 2020. During the study period, approximately 773 cases with 830 device issues and 1134 patient complications were identified. Most balloon complications were due to leaks (33.4%). The most reported adverse events were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%). Findings from the MAUDE database highlight patient and device adverse outcomes that should be addressed to improve clinical success.