Lack of effectiveness of Bebtelovimab monoclonal antibody among high-risk patients with SARS-Cov-2 Omicron during BA.2, BA.2.12.1 and BA.5 subvariants dominated era.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron subvariants are expected to be resistant to Bebtelovimab (BEB) monoclonal antibody (MAb) and the real-world experience regarding its effectiveness is scarce. This retrospective cohort study reports a data analysis in Banner Healthcare System (a large not-for-profit organization) between 4/5/2022 and 8/1/2022 and included 19,778 Coronavirus disease-19 (COVID-19) positive (by PCR or direct antigen testing) patients who were selected from Cerner-Electronic Health Record after the exclusions criteria were met. The study index date for cohort was determined as the date of BEB MAb administration or the date of the first positive COVID-19 testing. The cohort consist of COVID-19 infected patients who received BEB MAb (N = 1,091) compared to propensity score (PS) matched control (N = 1,091). The primary composite outcome was the incidence of 30-day all-cause hospitalization and/or mortality. All statistical analyses were conducted on the paired (matched) dataset. For the primary composite outcome, the event counts and percentages were reported. Ninety-five percent Clopper-Pearson confidence intervals for percentages were computed. The study cohorts were 1:1 propensity matched without replacement across 26 covariates using an optimal matching algorithm that minimizes the sum of absolute pairwise distance across the matched sample after fitting and using logistic regression as the distance function. The pairs were matched exactly on patient vaccination status, BMI group, age group and diabetes status. Compared to the PS matched control group (2.6%; 95% confidence interval [CI]: 1.7%, 3.7%), BEB MAb use (2.2%; 95% CI: 1.4%, 3.3%) did not significantly reduce the incidence of the primary outcome (p = 0.67). In the subgroup analysis, we observed similar no-difference trends regarding the primary outcomes for the propensity rematched BEB MAb treated and untreated groups, stratified by patient vaccination status, age (<65 years or ≥65), and immunocompromised status (patients with HIV/AIDS or solid organ transplants or malignancy including lymphoproliferative disorder). The number needed to treat (1/0.026-0.022) with BEB MAb was 250 to avoid one hospitalization and/or death over 30 days. The BEB MAb use lacked efficacy in patients with SARS-CoV-2 Omicron subvariants (mainly BA.2, BA.2.12.1, and BA.5) in the Banner Healthcare System in the Southwestern United States.

Safety and efficacy of balloon angioplasty compared to stent-based-strategies with pulmonary vein stenosis: A systematic review and meta-analysis.

BACKGROUND: Pulmonary vein stenosis (PVS) is an uncommon but known cause of morbidity and mortality in adults and children and can be managed with percutaneous re-vascularization strategies of pulmonary vein balloon angioplasty (PBA) or pulmonary vein stent implantation (PSI). AIM: To study the safety and efficacy outcomes of PBA vs PSI in all patient categories with PVS. METHODS: We performed a literature search of all studies comparing outcomes of patients evaluated by PBA vs PSI for PVS. We selected all published studies comparing PBA vs PSI for PVS with reported outcomes of restenosis and procedure-related complications in all patient categories. In adults, PVS following atrial fibrillation ablation and in children PVS related to congenital etiology or post-procedural PVS following total or partial anomalous pulmonary venous return repair were included. The patient-centered outcomes were risk of restenosis requiring re-intervention and procedural-related complications. The meta-analysis was performed by computing odds ratios (ORs) using the random effects model based on underlying statistical heterogeneity. RESULTS: Eight observational studies treating 768 severe PVS in 487 patients met our inclusion criteria. The age range of patients was 6 months to 70 years and 67% were males. The primary outcome of the re-stenosis requiring re-intervention occurred in 196 of 325 veins in the PBA group and 111 of 443 veins in the PSI group. Compared to PSI, PBA was associated with a significantly increased risk of re-stenosis (OR 2.91, 95%CI: 1.15-7.37, P = 0.025, I 2 = 79.2%). Secondary outcomes of the procedure-related complications occurred in 7 of 122 patients in the PBA group and 6 of 69 in the PSI group. There were no statistically significant differences in the safety outcomes between the two groups (OR: 0.94, 95%CI: 0.23-3.76, P = 0.929), I 2 = 0.0%). CONCLUSION: Across all patient categories with PVS, PSI is associated with reduced risk of re-intervention and is as safe as PBA and should be considered first-line therapy for PVS.

Severe Aplastic Anemia After Receiving SARS-CoV-2 Moderna mRNA Vaccination.

A 60-year-old male patient presented to the emergency department with complaints of easy bruising and worsening epistaxis after receiving severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Moderna mRNA vaccination. He had no personal or family history of hematological conditions. He had bruises in various stages involving the upper and lower extremities. Laboratory data revealed white blood cell count of 1.2 ×103/mm3, hemoglobin of 8.0 g/dL, platelet count of 1 ×103/mm3, immature platelet fraction of 0.7%, absolute neutrophil count of 0 ×103/µL, lymphocytes of 1.1 ×103/µL, neutrophils of 3% and lymphocytes of 93%. He had normal liver and renal function tests. Bone marrow biopsy confirmed very severe aplastic anemia with severely hypocellular bone marrow. His platelets continued to downtrend despite platelet transfusions and steroids. He was treated with immunosuppressive therapy with cyclosporine, anti-thymocyte globulin, eltrombopag and prednisone. The patient was discharged but was readmitted to the hospital secondary to recurrent neutropenic fever and pneumonia. He had high-grade vancomycin-resistant enterococcal infection and Clostridium difficile infection leading to septic shock and succumbing to cardiac arrest. This case demonstrates the possibility of very severe aplastic anemia following SARS-CoV-2 mRNA vaccination and clinicians need to be aware of this rare but serious side effect.

Impact of Intravascular Brachytherapy on Patient-Reported Outcomes in Patients with Coronary Artery Disease.

BACKGROUND: Intravascular brachytherapy (VBT) is an established treatment for the management of in-stent restenosis (ISR). However, whether VBT is associated with improved patient reported outcomes unknown. METHODS: We evaluated 51 consecutive patients undergoing VBT in one or more coronary arteries from January 2018 to September 2019. Data on baseline characteristics, procedural outcomes and adverse events were obtained. All patients completed the Seattle Angina Questionnaire - 7 (SAQ-7) form before and after VBT at 1 month and 6 months. RESULTS: The mean age was 69 ± 9 years and 29 (57%) of patients were males. Procedural success was 94.1%. The mean summary SAQ-7 score improved significantly (53.2 ± 21 vs. 83 ± 19, p < .001) at 30-days. The median Quality of Life (QoL) component of SAQ-7 score was 31.3 (Interquartile Range [IQR]: 18.8, 62.5) and improved to 82.5 (IQR: 62.5, 100), p < .001 at 30 days and 87.5 [IQR: 75, 100), p < .001 at last follow up. Likewise, the median angina frequency component of the SQL-7 score pre-VBT was 55 (IQR: 45, 80) and improved significantly to 90 (IQR: 60, 100) at 30-days, p < .001 and 100 [IQR: 68.8, 100], p = .02 at last follow up. Lastly, the median activity component of the SAQ-7 score improved from 83.3 (IQR: 60-100) to 100 (IQR: 83, 100), p = .01 at 30-days. Thus, results were evident as early as 1 month and sustained at median follow up of 17 months. CONCLUSION: VBT is associated with improvement in patient reported outcome measures at short term and long term follow up.

Comparison of Rotational with Orbital Atherectomy During Percutaneous Coronary Intervention for Coronary Artery Calcification: A Systematic Review and Meta-Analysis.

BACKGROUND: Percutaneous coronary intervention (PCI) outcomes for patients with significant calcification have been consistently inferior compared to patients without significant calcification. Procedural success and long-term outcomes after PCI have been worse in patients with severe coronary calcium. OBJECTIVE: A Bayesian meta-analysis of outcomes comparing rotational atherectomy (RA) with orbital atherectomy (OA) was performed. METHODS: PubMed, Embase, and Cochrane Library databases were searched through 30th November 2018 and identified 4 observational studies. RESULTS: The primary end-point, Major Adverse Cardiac Event (MACE) composing of death, MI and stroke at 1 year was more likely with RA (OR = 1.61; 95% CI: 1.11-2.33; p = 0.01) as compared to OA. The driver of the difference in MACE between the two groups was a statistically significant difference in mortality favoring OA (OR = 4.65; 95% CI: 1.36-15.87; p = 0.01). Peri-procedural MI, the other component of the primary end-point was 1.3 times more likely in the RA arm (OR = 1.35; 95% CI 0.95-1.92; p-0.09) and was not statistically different between the groups. The odds of a vascular complication were not different in the two groups (OR = 1.26; 95% CI: 0.73-2.17; p = 0.41). In an adjusted Bayesian analysis, mortality (OR = 3.69; 95% CI: 0.30-38.51), MACE (OR = 1.68; 95% CI: 0.55-5.49), MI (OR = 1.42; 95% CI: 0.50-4.29) and dissections/perforations (OR = 0.38; 95% CI: 0.10-1.38) were not different in RA and OA groups. CONCLUSION: Our study is the first published Bayesian meta-analysis comparing MACE and peri-procedural outcomes in RA compared to OA. These findings lay the foundation for a randomized comparison between the two competing technologies.

Operator Experience and Outcomes after Transcatheter Left Atrial Appendage Occlusion with the Watchman Device.

BACKGROUND: Transcatheter left atrial appendage occlusion (LAAO) has become a suitable alternative to anticoagulation in patients with atrial fibrillation (AF). However, volume-outcome relationships at the individual operator level have not been studied. METHODS: Study population included 425 consecutive patients with AF undergoing LAAO from August 2015 to November 2018 by seven operators at BUMC-Phoenix. Operator volume was divided in tertiles by those with <40 cases/year (2 operators), 41-80 cases/year (3 operators) and >80 cases/year (2 operators). Patient data including comorbidities, labs, medications, procedural characteristics and outcomes were collected. The primary composite outcome was major adverse cardiac events (MACE) including mortality, stroke, bleeding and vascular complications. RESULTS: Mean age was 75 ±â€¯8 years and 251 (59%) were males. Mean CHA2DS2-VASc score was 4.5 ±â€¯1.3 points and mean HASBLED score was 3.9 ±â€¯1.0 points. MACE outcome was similar in the three operator groups in both unadjusted (p = 0.83) and adjusted (OR = 0.59: 95% Confidence Interval [CI]: 0.15-2.29, p = 0.45) analysis. The occurrence MACE was also similar between Interventional Cardiologist (IC) and Electrophysiologist (EP) operators in an unadjusted (p = 0.24) and adjusted (OR = 0.60: 95% CI: 0.21-1.68, p = 0.33) analysis. The secondary outcome of technical success did not differ among the three tertiles (p = 0.37) and among IC & EP operators respectively (p = 0.24) as well. CONCLUSION: Operator experience does not affect MACE and technical success even after adjusting for comorbidities. These results suggest a lower learning curve for LAAO with high technical success achievable even by low volume operators.

Balloon-assisted Tracking of Guide Extension Catheter: A Novel Technique to Retrieve a Carotid Embolic Protection Device.

Embolic protection devices are used to minimize the risk of stroke by preventing the migration of emboli during carotid artery stenting (CAS). After the successful conclusion of the CAS procedure, these devices are meant to be retrieved. Sometimes retrieval of the filter can be difficult. This difficulty in retrieval can be due to multiple factors such as incomplete stent expansion, stent fracture, vasospasm, and vessel tortuosity causing pseudostenoses. In this case report, an under-expanded proximal carotid stent strut contributed to the filter not being retrievable in spite of maneuvers to retrieve the filter. An innovative approach was used; a coronary guide extension catheter was used to enhance support and balloon-assisted tracking of the extension catheter then permitted advancement of the retrieval device and ultimate retrieval of the filter. This technique to retrieve a carotid filter has not been previously described in the literature.

Prognostic value of frontal QRS-T angle in predicting survival after primary percutaneous coronary revascularization/coronary artery bypass grafting for ST-elevation myocardial infarction.

BACKGROUND: Frontal QRS-T angle (FQRST) has previously been correlated with mortality in patients with stable coronary artery disease, but its role as survival predictor after ST-elevation myocardial infarction (STEMI) remains unknown. METHODS: We evaluated 267 consecutive patients with STEMI undergoing reperfusion or coronary artery bypass grafting. Data assessed included demographics, clinical presentation, electrocardiograms, medical therapy, and one-year mortality. RESULTS: Of 267 patients, 187 (70%) were males and most (49.4%) patients were Caucasian. All-cause mortality was significantly higher among patients with the highest (101-180°) FQRST [28% vs. 15%, p = 0.02]. Patients with FQRST 1-50° had higher survival (85.6%) compared with FQRST = 51-100° (72.3%) and FQRST = 101-180° (67.9%), [log rank, p = 0.01]. Adjusting for significant variables identified during univariate analysis, FQRST (OR = 2.04 [95% CI: 1.31-13.50]) remained an independent predictor of one-year mortality. FQRST-based risk score (1-50° = 0 points, 51-100° = 2 points, 101-180° = 5 points) had excellent discriminatory ability for one-year mortality when combined with Mayo Clinic Risk Score (C statistic = 0.875 [95%CI: 0.813-0.937]. A high (>4 points) FQRST risk score was associated with greater mortality (32% vs. 19%, p = 0.02) and longer length of stay (6 vs. 2 days, p < 0.001). CONCLUSION: FQRST represents a novel independent predictor of one-year mortality in patients with STEMI undergoing reperfusion. A high FQRST-based risk score was associated with greater mortality and longer length of stay and, after combining with Mayo Clinic Risk Score, improved discriminatory ability for one-year mortality.

Superior safety of direct oral anticoagulants compared to Warfarin in patients with atrial fibrillation and underlying cancer: a national veterans affairs database study.

BACKGROUND: Studies evaluating safety of warfarin and direct oral anticoagulants (DOACs) for prevention of stroke in patients with atrial fibrillation (AF) are lacking. METHODS & RESULTS: All patients (n = 196,521) receiving care at veteran's affairs with active cancer and AF from 2010-2015 were included. One-year mortality was significantly higher in unadjusted analysis with warfarin (44.9%) compared to dabigatran (25%, P < 0.001), rivaroxaban (24.4%, P < 0.001) and apixaban (30%, P < 0.001) and after adjusting for age, sex and type of cancer mortality (OR = 2.66, 95% CI: 2.52-2.82, P < 0.001). Risk of ischemic stroke (13.5% vs. 11.1%, 12.0%, 14.0%) was similar, however risk of hemorrhagic stroke was significantly higher among patients receiving warfarin (1.2%) compared to patients receiving dabigatran (0.5%), rivaroxaban (0.7%) and apixaban (0.8%) respectively, P = 0.04. CONCLUSIONS: We demonstrated the superior safety profile of DOACs compared to warfarin among patients with underlying cancer and AF. Warfarin was associated with higher mortality, similar ischemic stroke risk but higher risk of hemorrhagic stroke.

Medical and Ethical Concerns Regarding Pacemaker Implantation in a Patient with Substance Use Disorder.

Medical and ethical dilemmas surrounding endocarditis and cardiac valve replacements related to intravenous drug use have been described often. Less well-described are dilemmas associated with pacemaker implantation in such patients. We describe a patient with a substance use disorder for whom a pacemaker was medically indicated.

Positive Murphy's Sign in Pericardial Hematoma from a Right Atrial Tear.

A positive Murphy's sign in a patient with right upper quadrant abdominal pain is the arrest of inspiration during deep palpation of the quadrant. It is usually suggestive of acute cholecystitis. We report an unusual case of a positive Murphy's sign not due to acute cholecystitis, but rather from a pericardial hematoma from a right atrial tear causing right heart failure. The patient required an atrial tear repair to prevent a cardiac tamponade.

A rare case of alpha 1-antitrypsin deficiency associated with hypogammaglobulinemia and recurrent pulmonary thrombosis.

Alpha 1-antitrypsin (AAT) belongs to the family of serpins (serine protease inhibitors). Loop sheet polymerization is the pathology behind serpinopathies which encompasses AAT, anti-thrombin III and neuroserpin deficiency. To the best of our knowledge, we report the first case of alpha 1-antitrypsin deficiency associated with hypogammaglobulinemia and recurrent pulmonary thrombosis without any concomitant use of drugs.