Adverse events related to AtriCure EPi-Sense Coagulation Device-Analysis of the FDA MAUDE database

INTRODUCTION: The AtriCure EPi-Sense Device is used for the hybrid convergent procedure, an emerging treatment for persistent atrial fibrillation (AF) and long-standing persistent AF. However, data on the AE related to the EPi-Sense device are scarce. METHODS: Keyword EPI-SENSE was searched on the MAUDE database. There were 80 device reports from 2016 to 2020. After excluding reports when the device was not returned for evaluation, 79 device reports were included for final analysis. RESULTS: The adverse events (AE) were broadly classified into 11 categories. The most common complications were pericardial effusion (25.3%), stroke (17.7%), and atrioesophageal fistula (AEF) (8.9%). Death was reported in 15 (19%) cases, 3 of which were due to pulmonary embolism, 6 due to AEF, 3 due to unknown cause, 1 due to sepsis, 2 due to events related to acute renal failure. DISCUSSION: Pericardial effusion is a common AE reported in patients with convergence procedures and is well documented in the CONVERGE trial. The convergent procedure is unique in that the epicardial ablations are performed on the posterior wall with the radiofrequency probe directed towards the heart and away from the esophagus which in theory should reduce esophageal injuries. Despite that, a high number of AEF were noticed. Finally, there were also some reports of saline perfusion malfunction which can lead to injuries due to overheating. CONCLUSION: This analysis of the AE related to the EPi-Sense device highlights several major AE that are previously unreported

Can glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors help in mitigating the risk of atrial fibrillation in patients with diabetes?

The role of glucagon-like peptide-1 receptor agonists (GLP-1 RA) and dipeptidyl peptidase-4 inhibitors (DPP-4i) in mitigating the risk of atrial fibrillation (AF) remains unknown. We interrogated the Food and Drug Administration\u27s Adverse Event Reporting System (FAERS) database to study the association between AF-related adverse events and the use of GLP-1 RA and DPP-4i. A signal of disproportionate reporting of AF was detected with the DPP-4i group compared with all the other drugs in the FAERS database [ROR, 2.56; 95% confidence interval (CI), 2.10-3.12], whereas there was no disproportionality signal detected with the GLP-1 RA group (ROR, 0.90; 95% CI, 0.78-1.03) although liraglutide showed a significant disproportionality signal (ROR, 2.51; 95% CI, 2.00-3.15). Our analysis supports the existing body of literature demonstrating the cardiac safety of GLP-1 RA but raises concerns about the apparent increase in the risk of AF associated with DPP-4i. Further clinical and translational studies are needed to validate these findings

Possible mechanisms responsible for acute coronary events in COVID-19

The novel coronavirus (SARS-CoV-2) is primarily a respiratory pathogen and its clinical manifestations are dominated by respiratory symptoms, the most severe of which is acute respiratory distress syndrome (ARDS). However, COVID-19 is increasingly recognized to cause an overwhelming inflammatory response and cytokine storm leading to end organ damage. End organ damage to heart is one of the most severe complications of COVID-19 that increases the risk of death. We proposed a two-fold mechanism responsible for causing acute coronary events in patients with COVID-19 infection: Cytokine storm leading to rapid onset formation of new coronary plaques along with destabilization of pre-existing plaques and direct myocardial injury secondary to acute systemic viral infection. A well-coordinated immune response is the first line innate immunity against a viral infection. However, an uncoordinated response and hypersecretion of cytokines and chemokines lead to immune related damage to the human body. Human Coronavirus (HCoV) infection causes infiltration of inflammatory cells that cause excessive production of cytokines, proteases, coagulation factors, oxygen radicals and vasoactive molecules causing endothelial damage, disruption of fibrous cap and initiation of formation of thrombus. Systemic viral infections also cause vasoconstriction leading to narrowing of vascular lumen and stimulation of platelet activation via shear stress. The resultant cytokine storm causes secretion of hypercoagulable tissue factor without consequential increase in counter-regulatory pathways such as AT-III, activated protein C and plasminogen activator type 1. Lastly, influx of CD4+ T-cells in cardiac vasculature results in an increased production of cytokines that stimulate smooth muscle cells to migrate into the intima and generate collagen and other fibrous products leading to advancement of fatty streaks to advanced atherosclerotic lesions. Direct myocardial damage and cytokine storm leading to destabilization of pre-existing plaques and accelerated formation of new plaques are the two instigating mechanisms for acute coronary syndromes in COVID-19

Analysis of the impact of COVID-19 pandemic on house-staff in the USA: addressing the ripple effects

Background: The novel corona virus has changed the way individuals interact with each other and society. In the medical sector, this has affected the residents and fellows who spend the majority of their time on the front lines. Methods: We conducted a cross-sectional survey to assess the impact of the COVID-19 pandemic on the lives and training of house-staff across the USA. Respondents in our survey reported feeling significantly overwhelmed by the ongoing pandemic. Results: The majority of house-staff were significantly concerned about the lack of protective equipment, inability to safeguard themselves from infection and inability to look after their families. Concerns regarding contracting the infection and transmitting it to their loved ones were reported as a cause of mental distress among resident physicians. Increasing patient load, lack of protective equipment, and disruption of educational and academic activities during the COVID-19 pandemic have all reportedly affected the training and overall well-being of resident physicians. Conslusion: Our study adds further support for measures to safeguard house-staff with proper protective equipment and ensure adequate support for both mental and physical well-being during these challenging times

Inpatient cardiovascular outcomes in patients with cancer affected by viral influenza infection

Background: Influenza disproportionately affects individuals with underlying comorbidities. Long-term follow-up studies have shown that patients with cancer with influenza have higher mortality. However, very little is known about the in-hospital mortality and cardiovascular outcomes of influenza infection in cancer hospitalisations. Methods: We compared the in-hospital mortality and cardiovascular outcomes in patients with cancer with and without influenza by screening the National Inpatient Sample from 2015 to 2017. A total of 9 443 421 hospitalisations with any cancer were identified, out of which 14 634 had influenza while 9 252 007 did not. A two-level hierarchical multivariate logistic regression analysis adjusted for age, sex, race, hospital type and relevant comorbidities was performed. Results: The group with cancer and influenza had higher in-hospital mortality (OR 1.08; 95% CI 1.003 to 1.16; p=0.04), acute coronary syndromes (OR 1.74; 95% CI 1.57 to 1.93; p\u3c 0.0001), atrial fibrillation (OR 1.24; 95% CI 1.18 to 1.29; p\u3c 0.0001) and acute heart failure (OR 1.41; 95% CI 1.32 to 1.51; p\u3c 0.0001). Conclusion: Patients with cancer affected by influenza have higher in-hospital mortality and a higher prevalence of acute coronary syndrome, atrial fibrillation and acute heart failure

Arrhythmias in patients with in-hospital alcohol withdrawal are associated with increased mortality: Insights from 1.5 million hospitalizations for alcohol withdrawal syndrome

Background: Atrial arrhythmias are commonly noted in patients with alcohol withdrawal syndrome (AWS), requiring inpatient admission. Objective: The burden of arrhythmias and the association with in-hospital outcomes are incompletely defined in patients hospitalized with AWS. Methods: The nationwide inpatient sample database was accessed from September 2015 to December 2018 to identify hospitalizations for AWS. We studied a cohort of patients with arrhythmias noted during hospitalization using the appropriate International Classification of Diseases, Tenth Revision billing codes. We compared patient characteristics, outcomes, and hospitalization costs between alcohol withdrawal hospitalizations with and without documented arrhythmias. Propensity score matching (PSM) and multivariate regression were performed to control confounders and develop odds ratios (OR), respectively. Results: Among 1,511,155 hospitalization with AWS, 146,825 (9.72%) had concurrent arrhythmias. After PSM, we identified 135,540 cases in each group. Hospitalizations with AWS and concurrent arrhythmias had higher in-hospital mortality (4.19% vs 1.95%, OR 1.76, confidence interval [CI] 1.67-1.85, \u3c .0001). The most common arrhythmia was atrial fibrillation (66.7%). Arrhythmias in AWS were also associated with poorer in-hospital outcomes, including a higher risk of acute heart failure (8.40% vs 4.58%, OR 1.97, CI 1.90-2.05, \u3c .0001), acute kidney injury (21.32% vs 15.27%, OR 1.39, CI 1.36-1.43, \u3c .0001), and acute respiratory failure (9.19% vs 5.49%, OR 1.70, CI 1.64-1.76, \u3c .0001) requiring intubation. The length of hospital stay (6 days vs 4 days \u3c .0001) and cost of hospital care ($12,615 [$6683-$27,330] vs$7860 [$4482-$15,868], \u3c .0001) were higher in AWS with arrhythmias. Conclusion: Arrhythmia in AWS is associated with higher in-hospital mortality and poorer in-hospital outcomes

Meta-analysis of Safety and Efficacy of Anticoagulation versus no Anticoagulation in Octogenarians and Nonagenarians with Atrial Fibrillation

Introduction: The role of anticoagulation in octogenarians and nonagenarians with atrial fibrillation (AF) is controversial due to the lack of evidence from randomized controlled trials (RCTs), owing to the under representation of these patients in clinical trials. Aim: In the present meta-analysis we aim at comparing the clinical benefits and risk of anticoagulation (AC) with no AC in octogenarians and nonagenarians. Methods: We systematically searched MEDLINE/PubMed, EMBASE/Ovid, and Web of Science databases from the inception to October, 2020. Studies were eligible for inclusion if they met the following criteria: studies comparing AC with no AC in patients aged 80 or more for AF and reported thromboembolic events (TE) and bleeding outcomes. We used Mantel-Haenszel method with a Paule-Mandel estimator of Tau2 with Hartung Knapp-Sidik-Jonkman adjustment to estimate risk ratio (RR) with a 95% confidence interval (CI). Outlier analysis was used to adjust for statistical heterogeneity. Results: A total of 10 observation studies and 1 RCT were included in the final analysis. There was no difference in the risk of TE with AC in octogenarians and nonagenarians compared with no AC, before [RR: 0.87, 95% CI 0.62-1.23, I2: 71%, GRADE confidence very low ] and after [RR: 0.83, 95% CI 0.66-1.04, I2: 55.5%] adjusting for statistical heterogeneity among studies. In the unadjusted analysis, no difference in the risk of bleeding events was observed between both groups [RR: 1.05, 95% CI 0.62-1.77, I2: 86%, GRADE confidence very low ]. After adjusting for heterogeneity, AC was associated with an increased risk of bleeding compared with those not receiving AC [RR: 1.57, 95% CI 1.44-1.71, I2: 0%]. AC in octogenarians was not associated with a net clinical benefit compared with no AC. Conclusions: This meta-analysis did not demonstrate any difference in the risk TE in octogenarians and nonagenarians with AF on AC vs. no AC, in both the adjusted and unadjusted analyses. Also, the risk of bleeding events in the unadjusted analysis was similar between both groups. The adjusted analysis showed an increased risk of bleeding in the AC group compared with no AC group. More data is needed to establish safety and efficacy of AC in this vulnerable patient population. The results of this analysis should be interpreted with caution due to the observational nature of most studies included, and the only RCT reported lower rates of TE and similar risk of bleeding

Impact of Chronic Kidney Disease on In-Hospital Outcomes of Hospitalizations With Acute Limb Ischemia Undergoing Endovascular Therapy.

Purpose: Studies on outcomes related to endovascular treatment (EVT) in advanced stages of chronic kidney disease (CKD) and end-stage renal disease (ESRD) among hospitalizations with acute limb ischemia (ALI) are limited. Methods: The Nationwide Inpatient Sample was quarried from October 2015 to December 2017 to identify the hospitalizations with ALI and undergoing EVT. The study population was subdivided into 3 groups based on their CKD stages: group 1 (No CKD, stage I, stage II), group 2 (CKD stage III, stage IV), and group 3 (CKD stage V and ESRD). The primary outcome was all-cause in-hospital mortality. Results: A total of 51 995 hospitalizations with ALI undergoing EVT were identified. The in-hospital mortality was significantly higher in group 2 (OR = 1.17; 95% CI 1.04 - 1.32, p=0.009) and group 3 (OR = 3.18; 95% CI 2.74-3.69, p\u3c 0.0001) compared with group 1. Odds of minor amputation, vascular complication, atherectomy, and blood transfusion were higher among groups 2 and 3 compared with group 1. Group 2 had higher odds of access site hemorrhage compared with groups 1 and 3, whereas group 3 had higher odds of major amputation, postprocedural infection, and postoperative hemorrhage compared with groups 1 and 2. Besides, groups 2 and 3 had lower odds of discharge to home compared with group 1. Finally, the length of hospital stay and cost of care was significantly higher with the advancing CKD stages. Conclusion: Advanced CKD stages and ESRD are associated with higher mortality, worse in-hospital outcomes and higher resource utilization among ALI hospitalizations undergoing EVT. Clinical impact: Current guidelines are not clear for the optimum first line treatment of acute limb ischemia, especially in patients with advanced kidney disease as compared to normal/mild kidney disease patients. We found that advanced kidney disease is a significant risk factor for worse in-hospital morbidity and mortality. Furthermore, patients with acute limb ischemia and advanced kidney disease is associated with significantly higher resource utilization as compared to patients with normal/mild kidney disease. This study suggests shared decision making between treating physician and patients when considering endovascular therapy for the treatment of acute limb ischemia in patients with advanced kidney disease