Adverse Events of SARS-CoV-2 Therapy: A Pharmacovigilance Study of the FAERS Database.

BACKGROUND: Over the past 2 years of the several strategies recommended to help fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 28 when compared with placebo. OBJECTIVE: Our study's aim was to explore the reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for COVID-19. METHOD: We conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir as the primary drug between January and June 2022. The primary outcome was the incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA database was queried using Python 3.10 to collect the AEs and Stata 17 was used to analyze the database. Adverse events were analyzed by associated medication, with "Covid-19" excluded. RESULTS: A total of 8098 reports were identified between January and June 2022. Most reported complaints in the AE system were COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, diarrhea, cough, fatigue, and headache. Event rates significantly rose between April and May. Disease recurrence and dysgeusia were the most commonly reported complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. CONCLUSIONS AND RELEVANCE: This is the first retrospective study done on reported AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease recurrence were the most reported AEs. Further monitoring of the FAERS database is warranted to periodically reassess the safety profile of this medication.

Acute Pancreatitis as an Unusual Culprit of Diabetic Ketoacidosis in a Nondiabetic: A Case-Based Review.

Acute pancreatitis has been associated with a multitude of complications including pancreatic necrosis, pseudocysts, abscesses, acute respiratory distress syndrome, disseminated intravascular coagulation, and hyperglycemia. To date, only rare case reports have demonstrated diabetic ketoacidosis (DKA) as a rare sequela of acute pancreatitis. We report a case of a 34-year-old female with no prior history of diabetes who was subsequently diagnosed with DKA after presenting with severe acute pancreatitis. This case serves as a framework to not only highlight DKA as a rare complication of acute pancreatitis but also to explore the potential pathophysiology that underlies this phenomenon including stress hyperglycemia and post-pancreatitis diabetes mellitus.

Intracardiac leadless versus transvenous permanent pacemaker implantation: Impact on clinical outcomes and healthcare utilization.

BACKGROUND: Transvenous permanent pacemakers are used frequently to treat cardiac rhythm disorders. Recently, intracardiac leadless pacemakers offer potential treatment using an alternative insertion procedure due to their novel design. Literature comparing outcomes between the two devices is scarce. We aim to assess the impact of intracardiac leadless pacemakers on readmissions and hospitalization trends. METHODS: We analyzed the National Readmissions Database from 2016 to 2019, seeking patients admitted for sick sinus syndrome, second-degree-, or third-degree atrioventricular block who received either a transvenous permanent pacemaker or an intracardiac leadless pacemaker. Patients were stratified by device type and assessed for 30-day readmissions, inpatient mortality, and healthcare utilization. Descriptive statistics, Cox proportional hazards, and multivariate regressions were used to compare the groups. RESULTS: Between 2016 and 2019, 21,782 patients met the inclusion criteria. The mean age was 81.07 years, and 45.52 % were female. No statistical difference was noted for 30-day readmissions (HR 1.14, 95 % CI 0.92-1.41, p = 0.225) and inpatient mortality (HR 1.36, 95 % CI 0.71-2.62, p = 0.352) between the transvenous and intracardiac groups. Multivariate linear regression revealed that length of stay was 0.54 (95 % CI 0.26-0.83, p < 0.001) days longer for the intracardiac group. CONCLUSION: Hospitalization outcomes associated with intracardiac leadless pacemakers are comparable to traditional transvenous permanent pacemakers. Patients may benefit from using this new device without incurring additional resource utilization. Further studies are needed to compare long-term outcomes between transvenous and intracardiac pacemakers.

Type 5 Cardiorenal Syndrome: An Underdiagnosed and Underrecognized Disease Process of the American Mother.

Cardiorenal syndrome (CRS) continues to be an area of concern due to the changing understanding of identification, pathophysiology and optimal management. Originally thought that diuretics were always the answer, recent literature has shed lights on the five major CRS subphenotypes, and while conceptual in their classifications, different strategies may be utilized to manage each type. The effect of CRS in pregnant women is largely under discussed and underappreciated as its own entity. Trials involving possible management, specifically utilizing serelaxin, a recombinant form of relaxin, have shown promising results but more data are needed to begin implementing it on a large scale.

Improving Hospital Length of Stay: Results of a Retrospective Cohort Study.

(1) Background: Jersey Shore University Medical Center (JSUMC) is a 646-bed tertiary medical center located in central New Jersey. Over the past several years, development and maturation of tertiary services at JSUMC has resulted in tremendous growth, with the inpatient volume increasing by 17% between 2016 and 2018. As hospital floors functioned at maximum capacity, the medical center was frequently forced into crisis mode with substantial increases in emergency department (ED) waiting times and a paradoxical increase in-hospital length of stay (hLOS). Prolonged hLOS can contribute to worse patient outcomes and satisfaction, as well as increased medical costs. (2) Methods: A root cause analysis was conducted to identify the factors leading to delays in providing in-hospital services. Four main bottlenecks were identified by the in-hospital phase sub-committee: incomplete orders, delays in placement to rehabilitation facilities, delays due to testing (mainly imaging), and delays in entering the discharge order. Similarly, the discharge process itself was analyzed, and obstacles were identified. Specific interventions to address each obstacle were implemented. Mean CMI-adjusted hospital LOS (CMI-hLOS) was the primary outcome measure. (3) Results: After interventions, CMI-hLOS decreased from 2.99 in 2017 to 2.84 and 2.76 days in 2018 and 2019, respectively. To correct for aberrations due to the COVID pandemic, we compared June-August 2019 to June-August 2020 and found a further decrease to 2.42 days after full implementation of all interventions. We estimate that the intervention led to an absolute reduction in costs of USD 3 million in the second half of 2019 and more than USD 7 million in 2020. On the other hand, the total expenses, represented by salaries for additional staffing, were USD 2,103,274, resulting in an estimated net saving for 2020 of USD 5,400,000. (4) Conclusions: At JSUMC, hLOS was found to be a complex and costly issue. A comprehensive approach, starting with the identification of all correctable delays followed by interventions to mitigate delays, led to a significant reduction in hLOS along with significant cost savings.

Chronic Kidney Disease in Patients Undergoing Cardiac Device Placement: Results of a Retrospective Study.

BACKGROUND: Cardiovascular issues (especially arrhythmia and sudden cardiac death) are one of the most common causes of mortality in patients with chronic kidney disease (CKD). To minimize cardiac mortality, these patients frequently require various cardiac devices, such as pacemakers, loop recorders, and defibrillators which can compromise their vascular access. In this study, we aim to determine the prevalence of CKD in patients undergoing cardiac device placement and their progression of CKD. METHODS: Institutional review board approval was obtained for this study. A total of 688 patients undergoing cardiac device placement were included in this study over a 3-year period at Jersey Shore University Medical Center. Demographic characteristics, comorbidities, base-line renal functions during the procedure, types of cardiac devices, sites of vascular access and follow-up renal function when available were assessed retrospectively. Patients were categorized into CKD stages 1 - 5 based on the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines. The patients who were already on hemodialysis were excluded in this study. RESULTS: The average age of the patient were 73.9 years with male predominance (60%). A total of 227 patients (33%) had estimated glomerular filtration rate (eGFR) < 60 mL/min consistent with the evidence of advanced-stage CKD (stages 3 - 5) at the time of cardiac device placement. The most common types of device placements were new insertion/replacement of atrial and ventricular leads (39.5%), loop recorder implantation (21.1%) and generator changes on an already implanted device (11%). Only 4% (28/688) had a leadless cardiac device placement. The most common access sites were subclavian (47.1%), axillary (32.3%) and femoral (12.2%). CONCLUSIONS: The present study demonstrated that nearly one-third of the patient undergoing cardiac device placement had an advanced degree of renal failure. Because CKD is a progressive disease, many of these patients might require renal replacement therapy in the future. Transvenous devices is not a good choice in this group of patients as they will ultimately require an arteriovenous fistula. Subcutaneous leadless cardiac device insertion might be a better option in patients with advanced CKD.

Concomitant Acute Hepatic Failure and Renal Failure Induced by Intravenous Amiodarone: A Case Report and Literature Review.

Hepatotoxicity caused by chronic oral amiodarone is well documented with around 15-20% incidence rate. However, acute liver failure due to intravenous (IV) amiodarone is rare clinical presentation with 3% incidence rate. Incidence of concomitant renal failure is even rarer. There is no full explanation for the underlying mechanism. Herein, we are presenting a rare case of concomitant acute hepatic failure and acute-on-chronic renal injury induced by use of IV amiodarone. A 67-year-old man with past medical history of coronary artery disease s/p coronary artery bypass graft (CABG), history of alcoholism, and chronic kidney disease stage 3 presented with chest pain for 1 week. In the emergency department (ED), he was found to have atrial flutter. Due to unresponsiveness to IV ß-blocker and diltiazem, the patient was loaded with IV amiodarone and continued IV amiodarone drip. His liver function tests (LFTs) and renal functions at the time of administration of IV amiodarone were aspartate transaminase (AST) 176 (10 - 42 IU/L) and alanine transaminase (ALT) 208 (10 - 60 IU/L), international normalized ratio (INR) 1.39 (reference value 2 - 3), blood urea nitrogen (BUN) 37 (5 - 25 mg/dL), and creatinine 1.85. Sixteen hours later patient developed acute hepatic failure with AST 4,250 (reference value 10 - 42 IU/L), ALT 2,422 (10 - 60 IU/L), INR 2.28, and acute renal failure with creatinine of 3.2 mg/dL (0.44 - 1.0 mg/dL), and BUN of 44 mg/d (5 - 25 mg/dL). Patient was intubated due to acute hepatic encephalopathy and sent to intensive care unit (ICU). IV amiodarone was stopped immediately. All workup for other causes of acute hepatic failure came back negative. He was started on IV N-acetylcysteine and required hemodialysis for acute-on-chronic renal failure. LFTs peaked 72 h after discontinuation of amiodarone. Kidney functions started to improve 5 days after discontinuation of amiodarone and patient came off hemodialysis. Acute hepatic failure as result of IV amiodarone is a rare presentation; however, it has a high mortality. Risk factors include low ejection fraction, hepatic congestion and pre-existing hepatic dysfunction. No obvious underlying mechanism to this presentation has been fully explained. Acute renal failure can be associated with this presentation which is even rarer. Stopping IV amiodarone, administering N-acetylcysteine and good supportive care can lead to favorable outcome.

Recurrence of Paget-Schroetter Syndrome: A Rare Case Report and Review of Literature.

Paget-Schroetter syndrome (PSS) is a primary upper extremity deep vein thrombosis (DVT) that occurs with no significant risk factors, mostly in a young and healthy patient. Treatment of this disease is discussed heavily in the literature and the optimal treatment method is still being debated. Here, we present a patient with PSS treated with balloon angioplasty, thrombolysis and treatment with an oral thrombin inhibitor (apixaban) who developed recurrence of PSS. A 38-year-old white male with no past medical history, presented to an urgent care center with sudden onset axillary pain and an axillary lump that was treated with outpatient antibiotics. Extensive deep venous thrombosis was diagnosed with computed tomography (CT) and ultrasound. He underwent percutaneous pharmacomechanical thrombectomy. Postprocedural angiogram showed significant improvement in the caliber of the axillary and subclavian veins where they crossed the first rib. He was discharged on apixaban and underwent removal of his first rib 1 month later. He returned 3 weeks later with recurrence of right arm pain and swelling. Repeat ultrasound showed thrombus in the right arm and venogram confirmed 80% stenosis at the subclavian vein as it enters the innominate vein. He was again treated with placement of a thrombolytic catheter and overnight thrombolysis of the central venous circulation on the right-side upper extremity balloon angioplasty of the subclavian vein, axillary vein, and basilic vein. He is disease-free for 6 months. Recurrence of PSS after surgical removal of rib, thrombectomy, thrombolysis while using apixaban is very rare. This is the first case to our knowledge presented with recurrent PSS treated with apixaban, early rib resection, balloon angioplasty and thrombectomy.

Varicella Zoster Meningitis with Hypoglycorrhachia on Cerebrospinal Fluid (CSF) Analysis in a Young Immunocompetent Host without a Rash.

BACKGROUND Varicella zoster virus (VZV) is a common viral infection, with primary infection presenting as fevers and pruritic vesicular rash. After staying dormant in the dorsal root ganglia, reactivation can lead to secondary infection. Meningitis is a rare a complication of VZV infection. CASE REPORT We report a case of a 44-year-old woman with no past medical history, presenting with severe frontal headache without meningeal signs or fevers, found to have VZV meningitis. CSF analysis revealed hypoglycorrhachia and she was treated successfully with combination of intravenous acyclovir and oral valacyclovir. CONCLUSIONS VZV meningitis can present with subtle clinical signs and symptoms and should be considered as a possible etiology for headaches without identifiable cause.

Relapsing Cutaneous Multiple Myeloma Responding to Immunochemotherapy: A Rare Case Report.

Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells. The diagnosis of this disease is often suspected through a constellation of clinical signs and symptoms of hypercalcemia, renal failure, anemia, and M-spike proteins. It is the second most common hematological malignancy after non-Hodgkin lymphomas. However, cutaneous MM is an extremely rare entity, and it is associated with poor prognosis. It presents as diffuse erythematous rash or violaceous nodules on the skin. Most common sites of involvement are chest, lower extremities and back. It can be triggered by a local extension of the tumor which is the most common way, surgical procedures and hematogenous spread. An 82-year-old African American male was diagnosed with MM since 2008. He underwent autologous peripheral stem cell transplantation (ASCT) twice in 2010 and 2014; and he had a history of multiple chemotherapy regimens in the past. He had violaceus chest nodules, and the biopsy confirmed the diagnosis of cutaneous MM in 2013. The patient was treated with pomalidomide, panobinostat and dexamethasone with a complete response (CR) to treatment. One year later, the patient developed new skin nodules. Repeat biopsy confirmed the diagnosis of MM again. Patient was treated with daratumumab and had CR to treatment without any new M-spike. Cutaneous lesion is an exceedingly rare presentation of MM. It either present as reddish rash or violaceous nodules involving chest, lower extremities and back. It has a poor prognosis and can be rapidly fatal. Our case is unique because our patient responded to the newer chemotherapy, and lesions resolved despite poor prognosis of this condition.