Analysis of Reported Adverse Events Related to Hemospray: An FDA MAUDE Database Study.

BACKGROUND: Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database. METHODS: We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events. RESULTS: Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5). CONCLUSION: Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.

Cold snare endoscopic mucosal resection for colon polyps: a systematic review and meta-analysis.

BACKGROUND: Cold snare endoscopic mucosal resection (CS-EMR) can reduce the risks associated with electrocautery during colon polyp resection. Data on efficacy are variable. This systematic review and meta-analysis aimed to estimate the pooled efficacy and safety rates of CS-EMR. METHODS: We conducted a comprehensive literature search of multiple databases, from inception to March 2023, for studies addressing outcomes of CS-EMR for colon polyps. The weighted pooled estimates with 95 %CIs were calculated using the random effects model. I2 statistics were used to evaluate heterogeneity. RESULTS: 4137 articles were reviewed, and 16 studies, including 2592 polyps in 1922 patients (51.4 % female), were included. Overall, 54.4 % of polyps were adenomas, 45 % were sessile serrated lesions (SSLs), and 0.6 % were invasive carcinomas. Polyp recurrence after CS-EMR was 6.7 % (95 %CI 2.4 %-17.4 %, I2  = 94 %). The recurrence rate was 12.3 % (95 %CI 3.4 %-35.7 %, I2  = 94 %) for polyps ≥ 20 mm, 17.1 % (95 %CI 4.6 %-46.7 %, I2  = 93 %) for adenomas, and 5.7 % (95 %CI 3.2 %-9.9 %, I2  = 50 %) for SSLs. The pooled intraprocedural bleeding rate was 2.6 % (95 %CI 1.5 %-4.5 %, I2  = 51 %), the delayed bleeding rate was 1.5 % (95 %CI 0.8 %-2.7 %, I2  = 18 %), and no perforations or post-polypectomy syndromes were reported, with estimated rates of 0.6 % (95 %CI 0.3 %-1.3 %, I2  = 0 %) and 0.6 % (95 %CI 0.3 %-1.4 %, I2  = 0 %), respectively. CONCLUSION: CS-EMR demonstrated an excellent safety profile for colon polyps, with variable recurrence rates based on polyp size and histology. Large prospective studies are needed to validate these findings.

Outcome benefit of arterial duplex stent imaging after superficial femoral artery stent implantation.

OBJECTIVE: In-stent stenosis is a frequent complication of superficial femoral artery (SFA) endovascular intervention and can lead to stent occlusion or symptom recurrence. Arterial duplex stent imaging (ADSI) can be used in the surveillance for recurrent stenosis; however, its uniform application is controversial. In this study, we aimed to determine, in patients undergoing SFA stent implantation, whether surveillance with ADSI yielded a better outcome than in those with only ankle-brachial index (ABI) follow-up. METHODS: We performed a retrospective analysis of all patients undergoing SFA stent implantation for occlusive disease at a tertiary care referral center between 2009 and 2016. The patients were divided into those with ADSI and those with ABI follow-up only. Life-table analysis comparing stent patency, major adverse limb events (MALEs), limb salvage, and mortality between groups was performed. RESULTS: There were 248 patients with SFA stent implantation included, 160 in the ADSI group and 88 in the ABI group. Groups were homogeneous in clinical indications of claudication and critical limb-threatening ischemia (for ADSI, 39% and 61%; for ABI, 38% and 62%; P = .982) and TransAtlantic Inter-Society Consensus class A, B, C, and D lesions (for ADSI, 17%, 45%, 16%, and 22%; for ABI, 21%, 43%, 16%, and 20%; P = .874). Primary patency was similar between groups at 12, 36, and 56 months (ADSI, 65%, 43%, and 32%; ABI, 69%, 34%, and 34%; P = .770), whereas ADSI patients showed an improved assisted primary patency (84%, 68%, and 54%) vs ABI patients (76%, 38%, and 38%; P = .008) and secondary patency. There was greater freedom from MALEs in the ADSI group (91%, 76%, and 64%) vs the ABI group (79%, 46%, and 46%; P < .001) at 12, 36, and 56 months of follow-up. ADSI patients were more likely to undergo an endovascular procedure as their initial post-SFA stent implantation intervention (P = .001), whereas ABI patients were more likely to undergo an amputation (P < .001). CONCLUSIONS: In SFA stent implantation, patients with ADSI follow-up demonstrate an advantage in assisted primary patency and secondary patency and are more likely to undergo an endovascular reintervention. These factors are likely to have effected a decrease in MALEs, indicating the benefit of a more universal adoption of post-SFA stent implantation follow-up ADSI.

Extracorporeal Membrane Oxygenation Rescue for Severe Aspiration Pneumonitis in Two Patients after Roux-en-y Gastric Bypass Procedure.

Roux-en-y gastric bypass (RYGB) is one of the most common weight loss surgical procedures performed in the United States. Early post-operative small bowel obstruction is a rare but potentially morbid, complication of RYGB. We report two patients who underwent RYGB and required subsequent treatment for a post-operative small bowel obstruction. Their post-operative course was complicated by severe aspiration pneumonitis leading to hypoxemic respiratory failure requiring rescue with femoral veno-venous extracorporeal membrane oxygenation (V-V ECMO). Both patients were successfully extubated, weaned off V-V ECMO support, and discharged to home. These cases highlight the potential role of V-V ECMO for patients who have undergone RYGB and develop severe aspiration pneumonitis. They also highlight the need for cautionary use of gastrografin in RYGB patients. Early engagement of a multidisciplinary team experienced with adult ECMO is vital for favorable patient outcomes.

Extrahepatic Health Effects of Alcohol Use and Alcohol-associated Liver Disease.

PURPOSE: Alcohol use disorder (AUD) is a growing public health concern and an important contributor to global morbidity and mortality. While the hepatotoxic effects of alcohol are well known, the adverse effects of alcohol are manifested in almost every organ system. With the growing public health impact of AUD, the aim of this narrative review is to highlight the epidemiology and burden of AUD and its association with extrahepatic diseases including malignancy and disorders of the gastrointestinal (GI), cardiovascular, immunologic, neurologic, endocrine, and hematologic systems. METHODS: A narrative review of the literature was performed to identify studies addressing the epidemiology, pathophysiology, clinical manifestations, and therapy of extrahepatic health manifestations of alcohol use. FINDINGS: In the United States, an estimated 14.5 million people have AUD and approximately 88,000 adults die yearly due to alcohol-related causes. The consumption of alcohol and AUD is associated with injuries, violence, cancers, nonmalignant conditions of the GI system, infections, effects on the cardiovascular system, and neurodegenerative diseases. These conditions contribute to the increased mortality associated with AUD and are burdensome to patients and caregivers. IMPLICATIONS: Increased awareness of the extrahepatic manifestations of AUD, screening for AUD using validated screening tools, such as the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score, and offering evidence-based interventions to patients with AUD is imperative to reduce the public health burden of AUD. Although historically controversial, recent evidence suggests that any level of alcohol consumption can have negative health consequences. Further research is warranted to determine if any amount of alcohol is safe for consumption. Public health efforts are warranted to help curtail the growing burden of AUD.

Liver transplantation from a SARS-COV-2-positive donor: A road ahead or not.

The COVID-19 pandemic has had a remarkable impact on the field of liver transplantation. Increasing evidence demonstrates a minimal risk of transmission of SARS-CoV-2 from non-lung donors who test positive for SARS-CoV-2; however, the risks of donor-derived SARS-CoV-2 from liver donors are unknown. We present our experience with two cases in which a liver was transplanted successfully from a brain-dead donor with incidental SARS-CoV-2 infection. Both donors were asymptomatic SARS-CoV-2-positive with negative bronchoalveolar lavage polymerase chain reaction (BAL PCR) and mechanism of death unrelated to COVID-19. Both the recipients did well after transplant and went home with a well-functioning liver. One patient did get readmitted and was found to be SARS-CoV-2-positive; however, it was probably related to hospital exposure rather than donor-derived. SARS-CoV-2-positive donors in select cases may be used for organ donation and liver transplant is safe for recipients.

Elevated Liver Enzymes in a Patient With Hepatocellular Carcinoma on Immune Checkpoint Inhibitor Therapy: A Diagnostic and Therapeutic Challenge.

We present a patient with untreated hepatitis C virus and metastatic hepatocellular carcinoma treated with combination immunotherapy who developed elevated liver enzymes. The immunotherapy was withheld, and the liver enzymes continued to rise. A liver biopsy was performed, which demonstrated findings consistent with chronic viral hepatitis. Direct-acting antiviral treatment was initiated, and the liver enzymes returned to normal limits. This case demonstrates the diagnostic dilemmas raised among patients with hepatocellular carcinoma on immunotherapy who develop elevated liver enzymes and some of the challenges regarding the use of these medications in patients with viremic hepatitis C virus.

Not every pancreatic mass is cancer: a case of a large intra-pancreatic splenule.

We report a case of a 72-year-old man who was referred to our tertiary medical center for endoscopic ultrasound (EUS) evaluation for an incidental 2-cm mass in the tail of the pancreas seen on computed tomography (CT). On EUS, a 22 mm by 13 mm, well-defined hypoechoic mass was identified within the pancreatic tail, and a fine-needle biopsy was performed. Histopathology revealed benign pancreatic parenchyma and the presence of lymphocytes. A technetium-99m sulfur colloid scan was performed, which demonstrated uptake in the pancreatic tail lesion consistent with an intra-pancreatic splenule. This case demonstrates that a splenule or accessory splenic tissue should remain in the differential diagnosis of a pancreatic mass. An accurate diagnosis of pancreatic splenule can preclude surgical resection.

Identifying the broken heart: predictors of mortality and morbidity in suspected blunt cardiac injury.

BACKGROUND: Blunt cardiac injury (BCI) is an infrequent but potentially fatal finding in thoracic trauma. Its clinical presentation is highly variable and patient characteristics and injury pattern have never been described in trauma patients. The aim of this study was to identify predictors of mortality in BCI patients. METHODS: We performed an 8-year retrospective analysis of all trauma patients diagnosed with BCI at our Level 1 trauma center. Patients older than 18 years, blunt chest trauma, and a suspected diagnosis of BCI were included. BCI was diagnosed based on the presence of electrocardiography (EKG), echocardiography, biochemical cardiac markers, and/or radionuclide imaging studies. Elevated troponin I was defined as more than 2 recordings of greater than or equal to .2. Abnormal EKG findings were defined as the presence of bundle branch block, ST segment, and t-wave abnormalities. Univariate and multivariate regression analyses were performed. RESULTS: A total of 117 patients with BCI were identified. The mean age was 51 ± 22 years, 65% were male, mean systolic blood pressure was 93 ± 65, and overall mortality rate was 44%. Patients who died were more likely to have a lactate greater than 2.5 (68% vs 31%, P = .02), hypotension (systolic blood pressure < 90) (86% vs 14%, P = .001), and elevated troponin I (86% vs 11%, P = .01). There was no difference in the rib fracture (58% vs 56%, P = .8), sternal fracture (11% vs 21%, P = .2), and abnormal EKG (89% vs 90%, P = .6) findings. Hypotension and lactate greater than 2.5 were the strongest predictors of mortality in BCI. CONCLUSIONS: BCI remains an important diagnostic and management challenge. However, once diagnosed resuscitative therapy focused on correction of hypotension and lactate may prove beneficial. Although the role of troponin in diagnosing BCI remains controversial, elevated troponin may have prognostic significance.