Endovascular thrombectomy for acute ischemic stroke with a large infarct area: an updated systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Since the efficacy and safety of endovascular thrombectomy (EVT) in patients with acute ischemic stroke with a large infarct area is still inconclusive, we sought to compare functional and neurological outcomes with the use of endovascular thrombectomy versus medical care alone. METHODS: We searched MEDLINE (via PubMed), Embase, Cochrane Library, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) to retrieve all the relevant randomized controlled trials (RCTs) on this topic. Review manager (RevMan) was used to perform meta-analyses using a random-effect model. Dichotomous outcomes were pooled using risk ratios (RR) with 95% confidence intervals (CIs). RESULTS: Our meta-analysis included 6 RCTs with a total of 1665 patients. Most studies included patients with an ASPECTS score of 3-5. Our results demonstrate that endovascular thrombectomy significantly increased the rates of functional independence (mRS ≤ 2) (RR, 2.49; 95% CI, 1.89-3.29) and moderate neurological outcome (mRS ≤ 3) (RR, 1.90; 95% CI, 1.50-2.40) at 90 days. The benefit of EVT for these outcomes remained the same at 1-year follow-up. Endovascular thrombectomy was associated with increased rates of early neurological improvement (RR, 2.22; 95% CI, 1.53-3.22), excellent neurological recovery (mRS ≤ 1) (RR, 1.75; 95% CI, 1.02-3.03), and decreased rate of poor neurological recovery (mRS 4-6) (RR, 0.81; 95% CI, 0.76-0.86). No significant difference was found between the two groups regarding all-cause mortality (RR, 0.86; 95% CI, 0.72-1.02), decompressive craniectomy (RR, 1.32; 95% CI, 0.89-1.94), and the incidence of serious adverse effects (RR, 1.39; 95% CI, 0.83-2.32) between the two groups. Endovascular thrombectomy significantly increased the rates of any intracranial hemorrhage (RR, 1.94; 95% CI, 1.48-2.53) and symptomatic intracranial hemorrhage (RR, 1.73; 95% CI, 1.11-2.69). CONCLUSION: Endovascular thrombectomy (EVT) significantly improves neurological and functional outcomes in patients who present within 6 hours of stroke onset with ICA and proximal M1 occlusions, and ASPECTS scores ranging from 3 to 5, compared to medical therapy alone, with an increased risk of symptomatic intracranial hemorrhage.

Oral Nirmatrelvir and Ritonavir for Coronavirus Disease 2019 in Vaccinated, Nonhospitalized Adults Aged 18-50 Years.

BACKGROUND: The effects of nirmatrelvir/ritonavir (NMV/r [Paxlovid]) on coronavirus disease 2019 (COVID-19) outcomes in younger vaccinated adults are unclear. The objective of this study was to assess if NMV/r use in vaccinated adults aged ≤50 years is associated with improved outcomes and to identify beneficial and nonbeneficial subgroups. METHODS: In this cohort study, we generated 2 propensity-matched cohorts of 2547 patients from an 86 119-person cohort assembled from the TriNetX database. Patients in 1 cohort received NMV/r, and patients in the matched control cohort did not. The main outcome was composite of all-cause emergency department visits, hospitalization, and mortality. RESULTS: The composite outcome was detected in 4.9% of the NMV/r cohort and 7.0% of the non-NMV/r cohort (odds ratio, 0.683 [95% confidence interval, .540-.864]; P = .001), indicating a 30% relative risk reduction. The number needed to treat (NNT) for the primary outcome was 47. Subgroup analyses found significant associations for patients with cancer (NNT = 45), cardiovascular disease (NNT = 30), and both conditions (NNT = 16). No benefit was found for patients with only chronic lower respiratory disorders (asthma/chronic obstructive pulmonary disease [COPD]) or without serious comorbidities. Thirty-two percent of NMV/r prescriptions in the overall database were for 18- to 50-year-olds. CONCLUSIONS: NMV/r use in vaccinated adults aged 18-50 years, especially with serious comorbidities, was associated with reduced all-cause hospital visits, hospitalization, and mortality in the first 30 days of COVID-19 illness. However, NMV/r in patients without significant comorbidities or with only asthma/COPD had no association of benefit. Therefore, identifying high-risk patients should be a priority and overprescription should be avoided.

Oral Nirmatrelvir and Ritonavir in Nonhospitalized Vaccinated Patients With Coronavirus Disease 2019.

BACKGROUND: Treatment of coronavirus disease 2019 (COVID-19) with nirmatrelvir plus ritonavir (NMV-r) in high-risk nonhospitalized unvaccinated patients reduced the risk of progression to severe disease. However, the potential benefits of NMV-r among vaccinated patients are unclear. METHODS: We conducted a comparative retrospective cohort study using the TriNetX research network. Patients ≥18 years of age who were vaccinated and subsequently developed COVID-19 between 1 December 2021 and 18 April 2022 were included. Cohorts were developed based on the use of NMV-r within 5 days of diagnosis. The primary composite outcome was all-cause emergency room (ER) visit, hospitalization, or death at a 30-day follow-up. Secondary outcomes included individual components of primary outcomes, multisystem symptoms, COVID-19-associated complications, and diagnostic test utilization. RESULTS: After propensity score matching, 1130 patients remained in each cohort. A primary composite outcome of all-cause ER visits, hospitalization, or death in 30 days occurred in 89 (7.87%) patients in the NMV-r cohort compared with 163 (14.4%) patients in the non-NMV-r cohort (odds ratio: .5; 95% confidence interval: .39-.67; P < .005) consistent with 45% relative risk reduction. A significant reduction in multisystem symptom burden and subsequent complications, such as lower respiratory tract infection, cardiac arrhythmia, and diagnostic radiology testing, were noted in NMV-r-treated patients. There was no apparent increase in serious complications between days 10 and 30. CONCLUSIONS: Treatment with NMV-r in nonhospitalized vaccinated patients with COVID-19 was associated with a reduced likelihood of ER visits, hospitalization, or death. Complications and overall resource utilization were also decreased.

Expectant management of patent ductus arteriosus for preterm infants: A meta-analysis of randomized controlled trials.

We conducted this meta-analysis to compare expectant management of patent ductus arteriosus (PDA) with active treatment for PDA closure in preterm infants. Data from 7 randomized controlled trials (RCTs) showed that all-cause mortality and other clinical adverse outcomes did not differ between expectant management of PDA and active treatment. Future large-scale and double-blinded RCTs with a consistent definition for hemodynamically significant PDA, and focusing on clearly delineated high-risk subgroups or later selective treatment are needed to further evaluate the role of expectant management.

Perioperative prophylactic corticosteroids for cardiac surgery in children: A systematic review and meta-analysis.

OBJECTIVE: Perioperative corticosteroids have been used for pediatric cardiac surgery for decades, but the underlying evidence is conflicting. We aimed to investigate the efficacy and safety of perioperative prophylactic corticosteroids in pediatric heart surgeries. METHODS: We searched electronic databases until March 2023 to retrieve all randomized controlled trials (RCTs) that administered perioperative prophylactic corticosteroids to children undergoing heart surgery. We used RevMan 5.4 to pool risk ratios (RRs) and mean differences (MDs). RESULTS: A total of 12 RCTs (2,209 patients) were included in our review. Corticosteroids administration was associated with a nonsignificant reduction in all-cause mortality (RR 0.62; 95% CI: 0.37-1.02, I2 = 0%; moderate certainty); however, it was associated with a lower duration of mechanical ventilation (MV) (MD -0.63 days; 95% CI: -1.16 to -0.09 days, I2 = 41%; high certainty). Corticosteroids did not affect the length of ICU and hospital stay but significantly reduced the incidence of postoperative low cardiac output syndrome (LCOS) (RR 0.76; 95% CI: 0.60-0.96, I2 = 0%; moderate certainty) and reoperation (RR 0.37; 95% CI: 0.19-0.74, I2 = 0%; moderate certainty). There was no increase in adverse events except a higher risk of hyperglycemia and postoperative insulin use. CONCLUSIONS: The use of perioperative corticosteroids in pediatric heart surgeries is associated with a trend toward reduced all-cause mortality without attaining statistical significance. Corticosteroids reduced MV duration, and probably decrease the incidence of LCOS, and reoperations. The choice of corticosteroid agent and dose is highly variable and further larger studies may help determine the ideal agent, dose, and patient population for this prophylactic therapy.

Association of Hospital Procedural Volume With Outcomes of Left Ventricular Assist Device Placement.

BACKGROUND: With the advancement in device technology, the use of durable left ventricular assist devices (LVADs) has increased significantly in recent years. However, there is a dearth of evidence to conclude whether patients who undergo LVAD implantation at high-volume centers have better clinical outcomes than those receiving care at low- or medium-volume centers. METHODS: We analyzed the hospitalizations using the Nationwide Readmission Database for the year 2019 for new LVAD implantation. Baseline comorbidities and hospital characteristics were compared among low- (1-5 procedures/year), medium- (6-16 procedures/year) and high-volume (17-72 procedures/year) hospitals. The volume/outcome relationship was analyzed using the annualized hospital volume as a categorical variable (tertiles) as well as a continuous variable. Multilevel mixed-effect logistic regression and negative binomial regression models were used to determine the association of hospital volume and outcomes, with tertile 1 (low-volume hospitals) as the reference category. RESULTS: A total of 1533 new LVAD procedures were included in the analysis. The inpatient mortality rate was lower in the high-volume centers compared with the low-volume centers (9.04% vs 18.49%, aOR 0.41, CI0.21-0.80; P = 0.009). There was a trend toward lower mortality rates in medium-volume centers compared with low-volume centers; however, it did not reach statistical significance (13.27% vs 18.49%, aOR 0.57, CI0.27-1.23; P = 0.153). Similar results were seen for major adverse events (composite of stroke/transient ischemic attack and in-hospital mortality). There was no significant difference in bleeding/transfusion, acute kidney injury, vascular complications, pericardial effusion/hemopericardium/tamponade, length of stay, cost, or 30-day readmission rates between medium- and high-volume centers compared to low-volume centers. CONCLUSION: Our findings indicate lower inpatient mortality rates in high-volume LVAD implantation centers and a trend toward lower mortality rates in medium-volume LVAD implantation centers compared to lower-volume centers.

Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease.

PURPOSE: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database. MATERIALS AND METHODS: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival. RESULTS: A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69-0.79]; P <.05, and HR, 0.89 [95% CI, 0.77-1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76-0.87]; P =.02, and HR, 0.77 [95% CI, 0.67-0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years. CONCLUSIONS: In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.

One-year outcomes of catheter ablation for atrial fibrillation in young patients.

BACKGROUND: Atrial fibrillation (AF) is relatively less frequent in younger patients (age < 50). Recently, studies have suggested that early restoration of sinus rhythm may lead to improved outcomes compared with rate control, however the efficacy of catheter ablation for AF in young is scarce. METHODS: We included all hospitalized patients between 18 and 50 years with a diagnosis of AF from the Nationwide Readmission Database 2016-2017 from the Healthcare Cost and Utilization Project. Demographic and comorbidity data were collected and analyzed. Outcomes assessed included one-year AF readmission rates, all-cause readmission, ischemic stroke, and all-cause mortality. Subgroup analyses were performed for all demographic and comorbidity variables. RESULTS: Overall, 52,598 patients (medium age 44, interquartile range 38-48, female 25.7%) were included in the study, including 2,146 (4.0%) who underwent catheter ablation for AF. Patients who underwent catheter ablation had a significantly lower rate of readmission for AF or any cause at one year (adjusted hazard ratios (HR) of 0.52 [95% confidence interval (CI): 0.43-0.63] and HR of 0.81 [95% CI: 0.72-0.89], respectively). There was no difference in 1-year readmission for stroke or all-cause mortality between the two groups. Subgroup analyses showed a consistent reduction in the risk of AF readmission among major demographic and comorbidity subgroups. CONCLUSION: Catheter ablation in young patients with AF was associated with a reduction in 1-year AF related and all-cause readmissions. These data merit further prospective investigation for validation, through dedicated registries and multicenter collaborations to include young AF from diverse population.

Extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest: A meta-analysis of randomized controlled trials.

INTRODUCTION: Extracorporeal cardiopulmonary resuscitation (ECPR) is a resuscitation method for patients with refractory out-of-hospital cardiac arrest (OHCA). However, evidence from randomized controlled trials (RCTs) is lacking. METHODS: We searched several electronic databases until March 2023 for RCTs comparing ECPR with conventional CPR in OHCA patients. RevMan 5.4 was used to pool risk ratios (RR) with 95% confidence intervals (CIs). RESULTS: A total of four RCTs were included. The results of our meta-analysis showed no statistically significant benefit of ECPR regarding mid-term survival (RR 1.21; 95% CI 0.64 to 2.28; I2 = 48%; p = .55). We found a significant improvement with ECPR in mid-term favorable neurological outcome (RR 1.59; 95% CI 1.09 to 2.33; I2 = 0%; p = .02). There was no significant difference between ECPR and conventional CPR in long-term survival (RR 1.32; 95% CI 0.18 to 9.50; I2 = 64%; p = .79), and long-term favorable neurological outcome (RR 1.47; 95% CI 0.89 to 2.43; I2 = 25%; p = .13). There was an increased incidence of adverse events in the ECPR group (RR 3.22; 95% CI 1.18 to 8.80; I2 = 63%; p = .02). CONCLUSION: ECPR in OHCA patients was not associated with improved survival or long-term favorable neurological outcome but did improve favorable neurological outcome in the mid-term. However, these results are likely underpowered due to the small number of available RCTs. Large-scale confirmatory RCTs are needed to provide definitive conclusions.

Social Vulnerability and Premature Cardiovascular Mortality Among US Counties, 2014 to 2018.

BACKGROUND: Substantial differences exist between United States counties with regards to premature (<65 years of age) cardiovascular disease (CVD) mortality. Whether underlying social vulnerabilities of counties influence premature CVD mortality is uncertain. METHODS: In this cross-sectional study (2014-2018), we linked county-level CDC/ATSDR SVI (Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry Social Vulnerability Index) data with county-level CDC WONDER (Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiological Research) mortality data. We calculated scores for overall SVI and its 4 subcomponents (ie, socioeconomic status; household composition and disability; minority status and language; and housing type and transportation) using 15 social attributes. Scores were presented as percentile rankings by county, further classified as quartiles on the basis of their distribution among all US counties (1st [least vulnerable] = 0 to 0.25; 4th [most vulnerable = 0.75 to 1.00]). We grouped age-adjusted mortality rates per 100 000 person-years for overall CVD and its subtypes (ischemic heart disease, stroke, hypertension, and heart failure) for nonelderly (<65 years of age) adults across SVI quartiles. RESULTS: Overall, the age-adjusted CVD mortality rate per 100 000 person-years was 47.0 (ischemic heart disease, 28.3; stroke, 7.9; hypertension, 8.4; and heart failure, 2.4). The largest concentration of counties with more social vulnerabilities and CVD mortality were clustered across the southwestern and southeastern parts of the United States. The age-adjusted CVD mortality rates increased in a stepwise manner from 1st to 4th SVI quartiles. Counties in the 4th SVI quartile had significantly higher mortality for CVD (rate ratio, 1.84 [95% CI, 1.43-2.36]), ischemic heart disease (1.52 [1.09-2.13]), stroke (2.03 [1.12-3.70]), hypertension (2.71 [1.54-4.75]), and heart failure (3.38 [1.32-8.61]) than those in the 1st SVI quartile. The relative risks varied considerably by demographic characteristics. For example, among all ethnicities/races, non-Hispanic Black adults in the 4th SVI quartile versus the 1st SVI quartile exclusively had significantly higher relative risks of stroke (1.65 [1.07-2.54]) and heart failure (2.42 [1.29-4.55]) mortality. Rural counties with more social vulnerabilities had 2- to 5-fold higher mortality attributable to CVD and subtypes. CONCLUSIONS: In this analysis, US counties with more social vulnerabilities had higher premature CVD mortality, varied by demographic characteristics and rurality. Focused public health interventions should address the socioeconomic disparities faced by underserved communities to curb the growing burden of premature CVD.

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2022 American College of Cardiology Scientific Sessions.

PURPOSE OF REVIEW: Focused review highlighting select studies presented at the 2022 American College of Cardiology (ACC) Scientific Sessions. RECENT FINDINGS: Included studies assessed the impact of a low-sodium diet on heart failure outcomes (SODIUM-HF); outcomes of pregnant patients with chronic hypertension treated with antihypertensive therapies (CHAP); cardiovascular outcomes in patients with type 2 diabetes and renal impairment treated with sotagliflozin (SCORED); a safety and efficacy study investigating SLN360, a short interfering RNA targeting lipoprotein(a) (APOLLO); a supermarket and web-based intervention targeting nutrition for cardiovascular risk reduction (SuperWIN); a superiority trial comparing myocardial injury following very mild perioperative hypothermia versus aggressive warming after non-cardiac surgery (PROTECT); and 3-year efficacy outcomes of renal denervation on blood pressure reduction from the SPYRAL HTN-ON MED pilot study. Research presented at the 2022 ACC Scientific Sessions underscores the new potential and meaningful impact of cardiovascular disease prevention and management interventions.

Five Years of Sacubitril/Valsartan-a Safety Analysis of Randomized Clinical Trials and Real-World Pharmacovigilance.

PURPOSE: In PARADIGM-HF, sacubitril/valsartan showed a significant reduction in mortality and hospitalization for patients with heart failure with reduced ejection fraction. Despite proven efficacy, sacubitril/valsartan has moderate uptake in clinical practice. This study explores the safety profile of sacubitril/valsartan by comparing adverse events in RCT and real-world use. METHODS: We studied hypotension, renal dysfunction, hyperkalemia, and angioedema associated with sacubitril/valsartan in RCTs and pharmacovigilance databases. A random-effects meta-analysis was performed with six RCTs investigating sacubitril/valsartan vs. control/comparators in heart failure patients. WHO's VigiBase, FAERS, and EMA's EudraVigilance were mined to obtain spontaneously reported real-world adverse events. Disproportionality analysis was performed with the FDA's OpenVigil 2.0. RESULTS: Six RCTs enrolled 15,538 patients with heart failure with reduced and preserved ejection fractions. There was no statistical difference for the composite of hypotension, renal dysfunction, hyperkalemia, and angioedema between sacubitril/valsartan and its comparators viz. ACEi or ARBs (OR 1.23, CI 0.98-1.56; p = 0.08). A total of 103,038 adverse events were registered in the spontaneous reporting systems. Hypotension was the most reported adverse event. Proportions of composite adverse events were 20% in VigiBase, 17% in FAERS, and 39% with EudraVigilance. Disproportionality analysis showed a lower risk of adverse events with sacubitril/valsartan than other guideline-directed heart failure medications used in clinical practice. CONCLUSION: With increased uptake of sacubitril/valsartan, risks of hypotension, renal dysfunction, hyperkalemia, and angioedema appear low and acceptable in RCTs and global clinical practice.

The cross-section of routine practice of echocardiographic diastolic evaluation in atrial fibrillation in a community hospital: A quality improvement project.

BACKGROUND: The echocardiographic assessment of diastolic function in the context of atrial fibrillation (AF) has been controversial and can be challenging and labor-intensive. We aimed to assess the actual practice of diastolic evaluation in AF in our community hospital echocardiography laboratory and to improve clinical performance by a quality improvement project. METHODS: We reviewed 244 echocardiograms in patients with AF at the time of echocardiography from November 2019 to November 2020 (pre-intervention phase). We classified cases into a complete versus incomplete evaluation group according to the completeness of diastolic parameter measurement. After an educational intervention, we reviewed 68 echocardiograms in patients with AF from August 2021 to October 2021 (post-intervention phase). RESULTS: Our results demonstrated an improvement in a complete diastolic assessment from 69% to 91% after intervention (p < .001). In the pre-intervention phase, the four parameters (mitral inflow pulsed wave Doppler image, left atrium volume index, mitral annular tissue Doppler image [TDI], and tricuspid regurgitation Vmax), mitral annular TDI was not acquired in 71 out of 244 cases (29.1%) and those cases were classified as incomplete evaluation group. Interestingly, in the pre-intervention phase, 57 out of 162 cases (35%) with preserved EF (≥50%) received significantly more incomplete diastolic evaluation than 14 out of 82 patients (17%) with reduced EF (<50%) (p = .004). There were no statistically significant differences in age, BMI, the reason for requesting echocardiography, and patient level of care between the complete and incomplete evaluation groups. In the post-intervention phase, completeness of diastolic measurement in AF was significantly improved compared to the pre-intervention phase (29% vs. 9%, p < .001, respectively). CONCLUSION: A quality improvement project effectively improved the clinical performance of diastolic evaluation in AF in our community echocardiography laboratory. After the intervention, we decreased an incomplete evaluation from 30% to 9%. More efforts should be needed to increase awareness and familiarity in evaluating diastolic function in AF.

Disparities in Cardio-oncology: Effects On Outcomes and Opportunities for Improvement.

PURPOSE OF REVIEW: The purpose of this article is to provide a comprehensive review of available data on health disparities and the interconnected social determinants of health (SDOH) in cardio-oncology. We identify the gaps in the literature and suggest areas for future research. In addition, we propose strategies to address these disparities at various levels. RECENT FINDINGS: There has been increasing recognition of health disparities and the role of SODH on an individual's access to health care, quality of care, and outcomes of the illness. There is growing evidence of sex and race-based differences in cancer therapy-related cardiotoxicity. Recent studies have shown how access and quality of health care are affected by financial stability and rurality. Our recent study utilizing the social vulnerability index (SVI) and county-level patient data found graded increase in county-level cardio-oncology mortality with greater social vulnerability. The incremental impact of social vulnerability was higher for cardio-oncology mortality than for mortality related to either cancer or CVD alone. The mortality rates in these patients were higher in rural areas compared to urban areas regardless of social vulnerability. Additionally, for those within the counties within highest social vulnerability, Black individuals had significantly higher cardio-oncology mortality compared with White individuals. Disparities in the cardio-oncology population are deep-rooted and widespread, leading to poor quality of life and increased mortality. It is crucial to integrate SDOH, not only in clinical care delivery but also in future research, and registry data to improve our understanding and the outcomes in our unique subset of cardio-oncology patients.

Cardiotoxicity of Immune Checkpoint Inhibitors.

PURPOSE OF REVIEW: Immune checkpoint inhibitors (ICIs) have improved the survival of several cancers. However, they may cause a wide range of immune-related adverse events (irAEs). While most irAEs are manageable with temporary cessation of ICI and immunosuppression, cardiovascular toxicity can be associated with high rates of morbidity and mortality. As ICIs evolve to include high-risk patients with preexisting cardiovascular risk factors and disease, the risk and relevance of ICI-associated cardiotoxicity may be even higher. RECENT FINDINGS: Several cardiovascular toxicities such as myocarditis, stress cardiomyopathy, and pericardial disease have been reported in association with ICIs. Recent findings also suggest an increased risk of atherosclerosis with ICI use. ICI-associated myocarditis usually occurs early after initiation and can be fulminant. A high index of suspicion is required for timely diagnosis. Prompt treatment with high-dose corticosteroids is shown to improve outcomes. Although the overall incidence is rare, ICI cardiotoxicity, particularly myocarditis, is associated with significant morbidity and mortality, making it a major therapy-limiting adverse event. Early recognition and prompt treatment with the cessation of ICI therapy and initiation of high-dose corticosteroids are crucial to improve outcomes. Cardio-oncologists will need to play an important role not just in the management of acute cardiotoxicity but also to reduce the risk of long-term sequelae.

Outcomes of COVID-19 in Patients With a History of Cancer and Comorbid Cardiovascular Disease.

BACKGROUND: Cancer and cardiovascular disease (CVD) are independently associated with adverse outcomes in patients with COVID-19. However, outcomes in patients with COVID-19 with both cancer and comorbid CVD are unknown. METHODS: This retrospective study included 2,476 patients who tested positive for SARS-CoV-2 at 4 Massachusetts hospitals between March 11 and May 21, 2020. Patients were stratified by a history of either cancer (n=195) or CVD (n=414) and subsequently by the presence of both cancer and CVD (n=82). We compared outcomes between patients with and without cancer and patients with both cancer and CVD compared with patients with either condition alone. The primary endpoint was COVID-19-associated severe disease, defined as a composite of the need for mechanical ventilation, shock, or death. Secondary endpoints included death, shock, need for mechanical ventilation, need for supplemental oxygen, arrhythmia, venous thromboembolism, encephalopathy, abnormal troponin level, and length of stay. RESULTS: Multivariable analysis identified cancer as an independent predictor of COVID-19-associated severe disease among all infected patients. Patients with cancer were more likely to develop COVID-19-associated severe disease than were those without cancer (hazard ratio [HR], 2.02; 95% CI, 1.53-2.68; P<.001). Furthermore, patients with both cancer and CVD had a higher likelihood of COVID-19-associated severe disease compared with those with either cancer (HR, 1.86; 95% CI, 1.11-3.10; P=.02) or CVD (HR, 1.79; 95% CI, 1.21-2.66; P=.004) alone. Patients died more frequently if they had both cancer and CVD compared with either cancer (35% vs 17%; P=.004) or CVD (35% vs 21%; P=.009) alone. Arrhythmias and encephalopathy were also more frequent in patients with both cancer and CVD compared with those with cancer alone. CONCLUSIONS: Patients with a history of both cancer and CVD are at significantly higher risk of experiencing COVID-19-associated adverse outcomes. Aggressive public health measures are needed to mitigate the risks of COVID-19 infection in this vulnerable patient population.

Pharmacovigilance study for SGLT 2 inhibitors- Safety review of real-world data & randomized clinical trials.

PURPOSE: Despite effectiveness of sodium-glucose cotransporter 2 (SGLT 2) inhibitors, concerns have been raised about the potential side effects of these drugs. Thus, a pharmaco-vigilance study was designed that aims to identify any discrepancies between the reported adverse events & assess the safety profile of SGLT2 inhibitors. METHODS: We studied diabetic ketoacidosis (DKA), euglycemic DKA, amputation, urinary tract infection (UTI), mycotic genital infection & hypotension associated with empagliflozin, dapagliflozin, canagliflozin & ertugliflozin in RCTs and reporting databases. WHO's VigiBase, FAERS, EMA's EudraVigilance & DAEN were thoroughly studied to obtain spontaneously reported real-world adverse events. RESULTS: Different SGLT2 inhibitors exhibit varied side effect profiles. Additionally, the findings suggest that adverse events may be more likely to occur in a broader population in the real world than in a highly inclusive clinical trial subset CONCLUSION: Our study provides comparison of the real world reported adverse events to adverse events reported in the clinical trials studying the efficacy of SGLT 2 inhibitors.