Curbing the Delta Surge: Clinical Outcomes After Treatment With Bamlanivimab-Etesevimab,Casirivimab-Imdevimab,or Sotrovimab for Mild to Moderate Coronavirus Disease 2019

ObjectiveTo describe and compare the clinical outcomes of bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab treatment of mild to moderate coronavirus disease 2019 (COVID-19) during the severe acute respiratory coronavirus 2 (SARS-CoV-2) B.1.617.2 Delta surge.MethodsThis is a retrospective study of high-risk patients who received bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab for mild to moderate COVID-19 between August 1, 2021, and December 1, 2021. Rates of severe disease, hospitalization, intensive care unit admission, and death were assessed.ResultsAmong 10,775 high-risk patients who received bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab for mild to moderate COVID-19 during the Delta surge, 287 patients (2.7%) developed severe disease that led to hospitalization, oxygen supplementation, or death within 30 days after treatment. The rates of severe disease were low among patients treated with bamlanivimab-etesevimab (1.2%), casirivimab-imdevimab (2.9%), and sotrovimab (1.6%; P<.01). The higher rate of severe outcomes among patients treated with casirivimab-imdevimab may be related to a significantly lower COVID-19 vaccination rate in that cohort. Intensive care unit admission was comparable among patients treated bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab (1.0%, 1.0%, and 0.4%, respectively).ConclusionThis real-world study of a large cohort of high-risk patients shows low rates of severe disease, hospitalization, intensive care unit admission, and mortality after treatment with bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab for mild to moderate COVID-19 during the SARS-CoV-2 Delta surge.     

Coronavirus Disease 2019–Associated Coagulopathy

Patients with the severe form of coronavirus disease 2019 (COVID-19) have been frequently found to suffer from both arterial and venous thrombotic events due to the perpetuation of a hypercoagulable state. This phenomenon, termed COVID-19–associated coagulopathy, is now considered a major component of the pathophysiology of this novel infectious disease, leading to widespread thrombosis. While at first, the vascular insults may be limited to the pulmonary microvasculature, as the disease progresses, systemic involvement occurs, culminating in distant organ thrombosis and multiorgan dysfunction syndrome. In this review article, we discuss recent insights into the pathophysiologic mechanisms of COVID-19–associated coagulopathy and review the clinical, histopathologic, and laboratory evidence, which leads us to conclude that COVID-19 is both a pulmonary and vascular disorder.     

Sex Differences in Management and Outcomes Among Patients With High-Risk Pulmonary Embolism: A Nationwide Analysis

ObjectiveTo examine the sex differences in management and outcomes among patients with high-risk acute pulmonary embolism (PE).Patients and MethodsThe Nationwide Readmissions Database was used to identify hospitalizations with high-risk PE from January 1, 2016, to December 31, 2018. Differences in use of advanced therapies, in-hospital mortality, and bleeding events were compared between men and women.ResultsA total of 125,901 weighted hospitalizations with high-risk PE were identified during the study period; 46.3% were women (n=58,253). Women were older and had a higher prevalence of several comorbidities and risk factors of PE such as morbid obesity, diabetes mellitus, chronic pulmonary disease, heart failure, and metastatic cancer. Systemic thrombolysis and catheter-directed interventions were more commonly used among women; however, mechanical circulatory support was less frequently used. In-hospital mortality was higher among women in the unadjusted analysis (30.7% vs 27.8%, P<.001) and after propensity score matching (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.08 to 1.25; P<.001), whereas the rates of intracranial hemorrhage and non–intracranial hemorrhage were not different. On multivariate regression analysis, female sex (OR, 1.18; 95% CI, 1.15 to 1.21; P<.001) was independently associated with increased odds of in-hospital mortality.ConclusionIn this contemporary observational cohort of patients admitted with high-risk PE, women had higher rates of in-hospital mortality despite receiving advanced therapies more frequently, whereas the rate of major bleeding events was not different from men. Efforts are needed to minimize the excess mortality observed among women.     

A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model

The administration of spike monoclonal antibody treatment to patients with mild to moderate COVID-19 is very challenging. This article summarizes essential components and processes in establishing an effective spike monoclonal antibody infusion program. Rapid identification of a dedicated physical infrastructure was essential to circumvent the logistical challenges of caring for infectious patients while maintaining compliance with regulations and ensuring the safety of our personnel and other patients. Our partnerships and collaborations among multiple different specialties and disciplines enabled contributions from personnel with specific expertise in medicine, nursing, pharmacy, infection prevention and control, electronic health record (EHR) informatics, compliance, legal, medical ethics, engineering, administration, and other critical areas. Clear communication and a culture in which all roles are welcomed at the planning and operational tables are critical to the rapid development and refinement needed to adapt and thrive in providing this time-sensitive beneficial therapy. Our partnerships with leaders and providers outside our institutions, including those who care for underserved populations, have promoted equity in the access of monoclonal antibodies in our regions. Strong support from institutional leadership facilitated expedited action when needed, from a physical, personnel, and system infrastructure standpoint. Our ongoing real-time assessment and monitoring of our clinical program allowed us to improve and optimize our processes to ensure that the needs of our patients with COVID-19 in the outpatient setting are met.     

Outcomes and Echocardiographic Follow-up After Surgical Management of Tricuspid Regurgitation in Patients With Transvenous Right Ventricular Leads

ObjectiveTo evaluate outcomes of elective surgical management of tricuspid regurgitation (TR) in patients with transvenous right ventricular leads, and compare results between non–lead-induced and lead-induced TR patients.Patients and MethodsWe studied patients with right ventricular leads who underwent tricuspid valve surgery from January 1, 1993, through December 31, 2015, and categorized them as non–lead-induced and lead-induced TR. Propensity score (PS) for the tendency to have lead-induced TR was estimated from logistic regression and was used to adjust for group differences.ResultsFrom the initial cohort of 470 patients, 444 were included in PS-adjustment analyses (174 non–lead-induced TRs [123 repairs, 51 replacements], 270 lead-induced TRs [129 repairs, 141 replacements]). In PS-adjusted multivariable analysis, lead-induced TR was not associated with mortality (P=.73), but tricuspid valve replacement was (hazard ratio, 1.59; 95% CI, 1.13 to 2.25; P=.008). Five-year freedom from tricuspid valve re-intervention was 100% for non–lead-induced TR and 92.3% for lead-induced TR; rates adjusted for PS differed between groups (P=.005). There was significant improvement in TR postoperatively in each group (P<.001). In patients having tricuspid valve repair, TR grades tended to worsen over time, but the difference in trends was not significantly different between groups.ConclusionLead-induced TR did not affect long-term survival after elective tricuspid valve surgery. In patients with lead-induced TR, tricuspid valve re-intervention was more common. Improvement in TR was achieved in both groups after surgery; however, severity of TR tended to increase over follow-up after tricuspid valve repair.     

Clinical Characteristics,Treatment, and Outcomes of Critically Ill Patients With COVID-19: A Scoping Review

A growing number of studies on coronavirus disease 2019 (COVID-19) are becoming available, but a synthesis of available data focusing on the critically ill population has not been conducted. We performed a scoping review to synthesize clinical characteristics, treatment, and clinical outcomes among critically ill patients with COVID-19. Between January 1, 2020, and May 15, 2020, we identified high-quality clinical studies describing critically ill patients with a sample size of greater than 20 patients by performing daily searches of the World Health Organization and LitCovid databases on COVID-19. Two reviewers independently reviewed all abstracts (2785 unique articles), full text (218 articles), and abstracted data (92 studies). The 92 studies included 61 from Asia, 16 from Europe, 10 from North and South America, and 5 multinational studies. Notable similarities among critically ill populations across all regions included a higher proportion of older males infected and with severe illness, high frequency of comorbidities (hypertension, diabetes, and cardiovascular disease), abnormal chest imaging findings, and death secondary to respiratory failure. Differences in regions included newly identified complications (eg, pulmonary embolism) and epidemiological risk factors (eg, obesity), less chest computed tomography performed, and increased use of invasive mechanical ventilation (70% to 100% vs 15% to 47% of intensive care unit patients) in Europe and the United States compared with Asia. Future research directions should include proof-of-mechanism studies to better understand organ injuries and large-scale collaborative clinical studies to evaluate the efficacy and safety of antivirals, antibiotics, interleukin 6 receptor blockers, and interferon. The current established predictive models require further verification in other regions outside China.     

Continuous Renal Replacement Therapy Liberation and Outcomes of Critically Ill Patients With Acute Kidney Injury

ObjectiveTo examine the association between continuous renal replacement therapy (CRRT) liberation and clinical outcomes among patients with acute kidney injury (AKI) requiring CRRT.MethodsThis single-center, retrospective cohort study included adult patients admitted to intensive care units with AKI and treated with CRRT from January 1, 2007, to May 4, 2018. Based on the survival and renal replacement therapy (RRT) status at 72 hours after the first CRRT liberation, we classified patients into liberated, reinstituted, and those who died. We observed patients for 90 days after CRRT initiation to compare the major adverse kidney events (MAKE₉₀).ResultsOf 1135 patients with AKI, 228 (20%), 437 (39%), and 470 (41%) were assigned to liberated, reinstituted, and nonsurvival groups, respectively. The MAKE₉₀, mortality, and RRT independence rates of the cohort were 62% (707 cases), 59% (674 cases), and 40% (453 cases), respectively. Compared with reinstituted patients, the liberated group had a lower MAKE₉₀ (29% vs 39%; P=.009) and higher RRT independence rate (73% vs 65%; P=.04) on day 90, but without significant difference in 90-day mortality (26% vs 33%; P=.05). After adjustments for confounders, successful CRRT liberation was not associated with lower MAKE₉₀ (odds ratio, 0.71; 95% CI, 0.48 to 1.04; P=.08) but was independently associated with improved kidney recovery at 90-day follow-up (hazard ratio, 1.81; 95% CI, 1.41 to 2.32; P<.001).ConclusionOur study demonstrated a high occurrence of CRRT liberation failure and poor 90-day outcomes in a cohort of AKI patients treated with CRRT.     

Falls Efficacy Is Associated With Better Gait and Functional Outcomes After Rehabilitation in Older Patients

ObjectiveTo examine the relationship between falls efficacy and the change in gait speed and functional status in older patients undergoing postacute rehabilitation.DesignProspective cohort study.SettingPostacute rehabilitation facility.ParticipantsPatients (N=180) aged 65 years and older (mean age ± SD, 81.3±7.1y).InterventionsNot applicable.Main Outcome MeasuresData on demographics; functional, cognitive, and affective status; and falls efficacy using a 10-item version of the Falls Efficacy Scale (FES; range, 0-100) were collected upon admission. Data about gait speed and functional status (Barthel Index and Basic Activities of Daily Living [BADL]) were measured at admission and discharge. In addition, BADL performance was self-reported 1 month after discharge.ResultsCompared with admission, all rehabilitation outcomes improved at discharge: gait speed (0.41±0.15 m/s vs 0.50±0.16 m/s; P<.001), Barthel Index score (68.4±16.3 vs 82.5±13.6; P<.001), and BADL (3.5±1.6 vs 4.7±1.3; P<.001). Adjusting for baseline status and other potential confounders, baseline FES independently predicted gait speed (adjusted coefficient: 0.002; 95% confidence interval [CI], 0.000-0.004; P=.025) and Barthel index (adjusted coefficient: 0.225; 95% CI, 0.014-0.435; P=.037) at discharge, with higher confidence at baseline predicting greater improvement. Baseline FES was also independently associated with self-reported BADL performance at the 1-month follow-up (adjusted coefficient: 0.020; 95% CI, 0.010-0.031; P<.001).ConclusionsIn older patients, higher falls efficacy predicted better gait and functional rehabilitation outcomes, independently of baseline performance. These results suggest that interventions aiming at falls efficacy improvement during rehabilitation might also contribute to enhancing gait speed and functional status in patients admitted to this setting.     

Prevalence and Prognostic Implications of Moderate or Severe Mitral Regurgitation in Patients with Bicuspid Aortic Valve

1. Download : Download high-res image (169KB)
2. Download : Download full-size image

     

Sex Differences in Outcomes of Patients With Chronic Aortic Regurgitation: Closing the Mortality Gap

ObjectiveTo examine contemporary clinical differences between men and women with hemodynamically significant chronic aortic regurgitation (AR).Patients and MethodsWe retrospectively identified 1072 consecutive patients with moderate to severe or severe AR diagnosed between February 21, 2004, and April 29, 2019. Echocardiographic data, aortic valve surgical intervention (AVS), and all-cause death were analyzed.ResultsAt baseline, the 189 women in the study group were older than the 883 men (mean ± SD age, 64±18 years vs 58±17 years), had more advanced symptoms, and had larger left ventricular end-systolic dimension index (LVESDi) (all P<.001) despite similar AR severity. An LVESDi of greater than 20 mm/m² was noted in 60 of 92 asymptomatic women (65%) vs 225 of 559 asymptomatic men (40%) (P<.001). Median follow-up was 5.6 years (interquartile range, 2.5 to 10.0 years). Female sex was associated with less AVS (P=.009), and overall 10-year survival was better in men (76%±2%) than in women (64%±5%) (P=.004). However, 10-year post-AVS survival was similar between the sexes (P=.86), and women had better left ventricular reverse remodeling than men regarding end-diastolic dimension (P=.02). Multivariable independent predictors of death were age, advanced symptoms, LVESDi, ejection fraction, and AVS (all P≤.03) but not female sex. When compared with the age-matched US population, women exhibited a 1.3-fold increased relative risk of death (P=.0383) while men had similar survival (P=.11).ConclusionIn contemporary practice, women with AR continue to exhibit an overall survival penalty not related to female sex but to late referral markers, including more advanced symptoms, larger LVESDi, and less AVS. Nonetheless, women in our study exhibited outstanding post-AVS left ventricular remodeling and had good post-AVS survival, a step forward toward closing the sex-related mortality gap. The high percentage of LVESDi of 20 mm/m² or greater in asymptomatic women represents a window of opportunity for advanced-symptom prevention and timely AR surgical correction that may close the mortality gap.     

Similarities and Differences of Gait Patterns in Women and Men With Parkinson Disease With Mild Disability

ObjectiveThis study aimed to quantitatively investigate the existence of differences in spatiotemporal and kinematic parameters of gait in men and women with Parkinson disease (PD) using computerized 3-dimensional gait analysis.DesignRetrospective cohort study.SettingLaboratory of Biomechanics.ParticipantsIndividuals with PD (N=35; 17 female, 18 male) of mean age 70.7 years characterized by mild disability (Hoehn and Yahr ≤2.5) who were tested in On medication state approximately 60 to 90 minutes after intake of the usual morning Levodopa dose.InterventionNot applicable.Main Outcome MeasuresSpatiotemporal parameters of gait (speed, stride length, cadence, step width, duration of stance, swing, double support phases) and kinematics of hip, knee, and ankle joints in the sagittal plane.ResultsMen and women exhibit similar spatiotemporal parameters, except for step width (wider in men). In contrast, relevant differences were found in terms of ankle kinematics. In particular, women presented increased ankle dorsiflexion through all the stance phase and mid to late swing phase, and reduced plantarflexion at the stance-swing phase transition.ConclusionsGait patterns of men and women with PD with mild disability are similar in terms of spatiotemporal parameters but characterized by marked differences regarding the ankle kinematics on the sagittal plane. The findings of the present study support the concept that investigations seeking to clarify the complex pathophysiology of PD-related gait disturbances should consider the role played by an individual's sex, thereby achieving more effective designing of physical and rehabilitative treatments.     

Clinical Characteristics and Outcomes of Patients With Primary Plasma Cell Leukemia in the Era of Novel Agent Therapy

ObjectiveTo evaluate the clinical outcomes of patients with primary plasma cell leukemia (pPCL) defined by 5% or greater clonal circulating plasma cells on peripheral blood smear and treated with novel agent induction therapies.Patients and MethodsA cohort of 68 patients with pPCL diagnosed at the Mayo Clinic in Rochester, Minnesota, from January 1, 2000, to December 31, 2019, and treated with novel agent induction therapies was evaluated.ResultsThe median follow-up was 46 (95% CI, 41 to 90) months. The median bone marrow plasma cell content was 85% (range, 10% to 100%) and median clonal circulaitng plasma cell percentage on the peripheral blood smear was 26% (range, 5% to 93%). There was a preponderance of t(11;14) primary cytogenetic abnormality in this cohort. The median time to next therapy (TTNT) and overall survival (OS) for all patients with pPCL patients in this cohort was 13 (95% CI, 9 to 17) and 23 (95% CI, 19 to 38) months, respectively. However, when stratified by cytogenetic risk, the median TTNT and OS were 16 and 51 months for standard risk vs 9 and 19 months for high risk (P=.01 for OS).ConclusionPrimary plasma cell leukemia remains an aggressive disease with poor prognosis despite novel agent–based therapies. Some patients have better than expected survival and this phenomenon may be influenced by the absence of high-risk cytogenetics. Newer treatment regimens are needed to improve the prognosis of this devastating disease.     

Clinical Characteristics,Management Strategies and Outcomes of Acute Myocardial Infarction Patients With Prior Coronary Artery Bypass Grafting

ObjectiveTo investigate the management strategies, temporal trends, and clinical outcomes of patients with a history of coronary artery bypass graft (CABG) surgery and presenting with acute myocardial infarction (MI).Patients and MethodsWe undertook a retrospective cohort study using the National Inpatient Sample database from the United States (January 2004–September 2015), identified all inpatient MI admissions (7,250,768 records) and stratified according to history of CABG (group 1, CABG-naive [94%]; group 2, prior CABG [6%]).ResultsPatients in group 2 were older, less likely to be female, had more comorbidities, and were more likely to present with non-ST-elevation myocardial infarction compared with group 1. More patients underwent coronary angiography (68% vs 48%) and percutaneous coronary intervention (PCI) (44% vs 26%) in group 1 compared with group 2. Following multivariable logistic regression analyses, the adjusted odd ratio (OR) of in-hospital major adverse cardiovascular and cerebrovascular events (OR, 0.98; 95% CI, 0.95 to 1.005; P=.11), all-cause mortality (OR, 1; 95% CI, 0.98 to 1.04; P=.6) and major bleeding (OR, 0.99; 95% CI, 0.94 to 1.03; P=.54) were similar to group 1. Lower adjusted odds of in-hospital major adverse cardiovascular and cerebrovascular events (OR, 0.64; 95% CI, 0.57 to 0.72; P<.001), all-cause mortality (OR, 0.45; 95% CI, 0.38 to 0.53; P<.001), and acute ischemic stroke (OR, 0.71; 95% CI, 0.59 to 0.86; P<.001) were observed in group 2 patients who underwent PCI compared with those managed medically without any increased risk of major bleeding (OR, 1.08; 95% CI, 0.94 to 1.23; P=.26).ConclusionsIn this national cohort, MI patients with prior-CABG had a higher risk profile, but similar in-hospital adverse outcomes compared with CABG-naive patients. Prior-CABG patients who received PCI had better in-hospital clinical outcomes compared to those who received medical management.     

Outcomes of Patients With Type 2 Myocardial Infarction Complicating Acute Ischemic Stroke

ObjectiveTo study the patient profiles and the prognostic impact of type 2 myocardial infarction (MI) on outcomes of acute ischemic stroke (AIS).MethodsThe National Readmission Database 2018 was queried for patients with primary AIS hospitalizations with and without type 2 MI. Baseline characteristics, inpatient outcomes, and 30-day all-cause readmissions between cohorts were compared.ResultsOf 587,550 AIS hospitalizations included in the study, 4182 (0.71%) had type 2 MI. Patients with type 2 MI were older (73.6 years vs 70.1 years; P<.001) and more likely to be female (52% vs 49.7%; P<.001), and they had a higher prevalence of heart failure (32.6% vs 15.5%; P<.001), atrial fibrillation (38.5% vs 24.2%; P<.001), prior MI (8.8% vs 7.7%; P<.001), valvular heart disease (17% vs 9.8%; P<.001), peripheral vascular disease (12.2% vs 9.2%; P<.001), and chronic kidney disease (24.4% vs 16.7%; P<.001). Compared with patients without type 2 MI, AIS patients with type 2 MI had significantly higher in-hospital mortality (adjusted odds ratio [aOR], 1.96; 95% CI, 1.65 to 2.32), poor functional outcome (aOR, 1.80; 95% CI, 1.62 to 2.00), more hospital costs (adjusted parameter estimate, $5618; 95% CI, $4480 to $6755), higher rate of discharge to a facility (aOR, 1.70; 95% CI, 1.52 to 1.90), increased length of stay (adjusted parameter estimate, 2.22; 95% CI, 1.72 to 2.72), and higher rate of 30-day all-cause readmissions (aOR, 1.38; 95% CI, 1.18 to 1.60).ConclusionType 2 MI in patients hospitalized with AIS is associated with poor prognosis and higher resource utilization.