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In a randomized trial involving patients with aortic stenosis, the use of a cerebral protection device during TAVR did not decrease the risk of periprocedural stroke, but there were fewer disabling strokes.

A previous analysis in this trial showed that among patients with severe, symptomatic aortic stenosis who were at low surgical risk, the rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR) than with surgical aortic-valve replacement. Longer-term outcomes are unknown. We randomly assigned patients with severe, symptomatic aortic stenosis and low surgical risk to undergo either TAVR or surgery. The first primary end point was a composite of death, stroke, or rehospitalization related to the valve, the procedure, or heart failure. The second primary end point was a hierarchical composite that included death, disabling stroke, nondisabling stroke, and the number of rehospitalization days, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, and health-status outcomes were assessed through 5 years. A total of 1000 patients underwent randomization: 503 patients were assigned to undergo TAVR, and 497 to undergo surgery. A component of the first primary end point occurred in 111 of 496 patients in the TAVR group and in 117 of 454 patients in the surgery group (Kaplan-Meier estimates, 22.8% in the TAVR group and 27.2% in the surgery group; difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P = 0.07). The win ratio for the second primary end point was 1.17 (95% CI, 0.90 to 1.51; P = 0.25). The Kaplan-Meier estimates for the components of the first primary end point were as follows: death, 10.0% in the TAVR group and 8.2% in the surgery group; stroke, 5.8% and 6.4%, respectively; and rehospitalization, 13.7% and 17.4%. The hemodynamic performance of the valve, assessed according to the mean (±SD) valve gradient, was 12.8±6.5 mm Hg in the TAVR group and 11.7±5.6 mm Hg in the surgery group. Bioprosthetic-valve failure occurred in 3.3% of the patients in the TAVR group and in 3.8% of those in the surgery group. Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

Transcatheter repair of secondary mitral regurgitation was associated with a lower rate of hospitalization for heart failure and lower all-cause mortality than medical therapy at 5 years of follow-up.

An updated 2016 echocardiographic algorithm for diagnosing left ventricular (LV) diastolic dysfunction (DD) was recently proposed. We aimed to assess the reliability of the 2016 echocardiographic LVDD grading algorithm in predicting elevated LV filling pressure and clinical outcomes compared to the 2009 version. We retrospectively identified 460 consecutive patients without atrial fibrillation or significant mitral valve disease who underwent transthoracic echocardiography within 24 hours of elective heart catheterization. LV end-diastolic pressure (LVEDP) and the time constant of isovolumic pressure decay (Tau) were determined. The association between DD grading by 2009 LVDD Recommendations and 2016 Recommendations with hemodynamic parameters and all-cause mortality were compared. The 2009 LVDD Recommendations classified 55 patients (12%) as having normal, 132 (29%) as grade 1, 156 (34%) as grade 2, and 117 (25%) as grade 3 DD. Based on 2016 Recommendations, 177 patients (38%) were normal, 50 (11%) were indeterminate, 124 (27%) patients were grade 1, 75 (16%) were grade 2, 26 (6%) were grade 3 DD, and 8 (2%) were cannot determine. The 2016 Recommendations had superior discriminatory accuracy in predicting LVEDP (P<.001) but were not superior in predicting Tau. During median follow-up of 416 days (interquartile range: 5 to 2004 days), 54 patients (12%) died. Significant DD by 2016 Recommendations was associated with higher risk of mortality (P=.039, subdistribution HR1.85 [95% CI, 1.03-3.33]) in multivariable competing risk regression. The grading algorithm proposed by the 2016 LV diastolic dysfunction Recommendations detects elevated LVEDP and poor prognosis better than the 2009 Recommendations.

The coronavirus disease 2019 (COVID-19) pandemic has resulted in severe psychological, social, and economic stress in people's lives. It is not known whether the stress of the pandemic is associated with an increase in the incidence of stress cardiomyopathy. To determine the incidence and outcomes of stress cardiomyopathy during the COVID-19 pandemic compared with before the pandemic. This retrospective cohort study at cardiac catheterization laboratories with primary percutaneous coronary intervention capability at 2 hospitals in the Cleveland Clinic health system in Northeast Ohio examined the incidence of stress cardiomyopathy (also known as Takotsubo syndrome) in patients presenting with acute coronary syndrome who underwent coronary arteriography. Patients presenting during the COVID-19 pandemic, between March 1 and April 30, 2020, were compared with 4 control groups of patients with acute coronary syndrome presenting prior to the pandemic across 4 distinct timelines: March to April 2018, January to February 2019, March to April 2019, and January to February 2020. Data were analyzed in May 2020. Patients were divided into 5 groups based on the date of their clinical presentation in relation to the COVID-19 pandemic. Incidence of stress cardiomyopathy. Among 1914 patient presenting with acute coronary syndrome, 1656 patients (median [interquartile range] age, 67 [59-74]; 1094 [66.1%] men) presented during the pre-COVID-19 period (390 patients in March-April 2018, 309 patients in January-February 2019, 679 patients in March-April 2019, and 278 patients in January-February 2020), and 258 patients (median [interquartile range] age, 67 [57-75]; 175 [67.8%] men) presented during the COVID-19 pandemic period (ie, March-April 2020). There was a significant increase in the incidence of stress cardiomyopathy during the COVID-19 period, with a total of 20 patients with stress cardiomyopathy (incidence proportion, 7.8%), compared with prepandemic timelines, which ranged from 5 to 12 patients with stress cardiomyopathy (incidence proportion range, 1.5%-1.8%). The rate ratio comparing the COVID-19 pandemic period to the combined prepandemic period was 4.58 (95% CI, 4.11-5.11; P < .001). All patients during the COVID-19 pandemic had negative reverse transcription-polymerase chain reaction test results for COVID-19. Patients with stress cardiomyopathy during the COVID-19 pandemic had a longer median (interquartile range) hospital length of stay compared with those hospitalized in the prepandemic period (COVID-19 period: 8 [6-9] days; March-April 2018: 4 [3-4] days; January-February 2019: 5 [3-6] days; March-April 2019: 4 [4-8] days; January-February: 5 [4-5] days; P = .006). There were no significant differences between the COVID-19 period and the overall pre-COVID-19 period in mortality (1 patient [5.0%] vs 1 patient [3.6%], respectively; P = .81) or 30-day rehospitalization (4 patients [22.2%] vs 6 patients [21.4%], respectively; P = .90). This study found that there was a significant increase in the incidence of stress cardiomyopathy during the COVID-19 pandemic when compared with prepandemic periods.

ObjectiveCalcium metabolism has long been implicated in aortic stenosis (AS). Studies assessing the long-term safety of oral calcium and/or vitamin D in AS are scarce yet imperative given the rising use among an elderly population prone to deficiency. We sought to identify the associations between supplemental calcium and vitamin D with mortality and progression of AS.MethodsIn this retrospective longitudinal study, patients aged ≥60 years with mild-moderate native AS were selected from the Cleveland Clinic Echocardiography Database from 2008 to 2016 and followed until 2018. Groups were stratified into no supplementation, supplementation with vitamin D alone and supplementation with calcium±vitamin D. The primary outcomes were mortality (all-cause, cardiovascular (CV) and non-CV) and aortic valve replacement (AVR), and the secondary outcome was AS progression by aortic valve area and peak/mean gradients.ResultsOf 2657 patients (mean age 74 years, 42% women) followed over a median duration of 69 months, 1292 (49%) did not supplement, 332 (12%) took vitamin D alone and 1033 (39%) supplemented with calcium±vitamin D. Calcium±vitamin D supplementation was associated with a significantly higher risk of all-cause mortality (absolute rate (AR)=43.0/1000 person-years; HR=1.31, 95% CI (1.07 to 1.62); p=0.009), CV mortality (AR=13.7/1000 person-years; HR=2.0, 95% CI (1.31 to 3.07); p=0.001) and AVR (AR=88.2/1000 person-years; HR=1.48, 95% CI (1.24 to 1.78); p<0.001). Any supplementation was not associated with longitudinal change in AS parameters in a linear mixed-effects model.ConclusionsSupplemental calcium with or without vitamin D is associated with lower survival and greater AVR in elderly patients with mild-moderate AS.

We aimed to evaluate the secular trends in demographics, risk factors, and clinical characteristics of patients presenting with acute myocardial infarction (AMI) or acute ischemic stroke (AIS), using a large nationally representative data set of in-hospital admissions. We used the 2003 to 2013 Nationwide Inpatient Sample. All admissions with primary diagnosis of AMI or AIS were included. Across 2003 to 2013, a total of 1,360,660 patients with AMI and 937,425 patients with AIS were included in the study. We noted a progressive reduction in the mean age of patients presenting with AMI and AIS (p trend <0.001 for all groups), implying that the burden of young patients with these acute syndromes is progressively increasing. In addition, there was a progressive increase in the proportion of patients who are uninsured among patients presenting with AMI and AIS. Furthermore, despite a progressively younger age at presentation, there was an observed increase in the prevalence of atherosclerotic risk factors including hypertension, hyperlipidemia, diabetes, smoking, and obesity among patients presenting with AMI or AIS during 2003 to 2013. Significant disparities were noted in the prevalence of risk factors among various demographic and geographical cohorts. Low socioeconomic status as well as uninsured patients had a significantly higher prevalence of preventable risk factors like smoking and obesity as compared to the high socioeconomic status and insured patients, respectively. In conclusion, there have been significant changes in the risk factor profile of patients presenting with AMI and AIS over the last decade.

Potent statin therapy has been demonstrated to reduce cardiovascular events. Although statins have been considered to stabilize atherosclerotic plaque, this effect has not been well characterized in vivo. We investigated the relation between potent statin therapy and plaque microstructures imaged by frequency-domain optical coherence tomography. Two hundred ninety nonculprit lipid plaques in 275 patients with stable coronary artery disease receiving atorvastatin or rosuvastatin were analyzed. Patients were stratified into no statin, low-, and high-dose statin groups. Plaques in the high-dose statin group demonstrated a smaller lipid arc (p = 0.02) and a greater fibrous cap thickness (p = 0.01). In patients receiving statin therapy, high-dose statin therapy was associated with a greater fibrous cap thickness in patients with smaller (148.2 ± 30.5 vs 105.3 ± 41.1 μm, p = 0.004) but not larger lipid index (91.1 ± 32.6 vs 78.1 ± 43.3 μm, p = 0.21). In conclusion, potent statin therapy is associated with less vulnerable plaque features on frequency-domain optical coherence tomography imaging. This finding varies according to the size of plaque lipid content, being less effective in lipid-loaded plaques.

Ischemic mitral regurgitation (IMR) has been associated with worse outcome myocardial infarction. However, severity of mitral regurgitation (MR) and its impact on patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) remains unknown. We sought to determine impact of increasing severity of IMR on outcomes in patients with STEMI undergoing primary PCI. All patients presenting with STEMI who underwent primary PCI within 12 hours of symptoms from 1994 to 2014 were included. IMR was graded from 0 to 4+ within 3 days of index myocardial infarction by echocardiography. Overall, 4,005 patients with STEMI were included. None, 1+, 2+, 3+, and 4+ MR were present in 3,200 (79.9%), 427 (10.7%), 260 (6.5%), 91 (2.3%), and 27 (0.7%) patients, respectively. On multivariate logistic regression analysis, more severe MR was associated with older age, female gender, lower body mass index, anemia, inferior STEMI, and longer door-to-balloon time. The 30-day mortality rates were 6.8%, 7.3%, 8.8%, 19.8%, and 26.1%, respectively, with increasing grade of MR. The 1-year mortality rates were 10.8%, 12.4%, 20.8%, 37.4%, and 37.1%, whereas 5-year mortality rates were 16.2%, 23.1%, 36.5%, 53.8%, and 63%, respectively (p <0.001 all), for none to 4+ MR. After adjusting for age, gender, co-morbidities, ejection fraction, and shock by multivariate analysis, severity of IMR was associated with incremental effect on long-term mortality (hazard ratios of 1.42, 1.83, 2.41, and 2.95 for 1+ to 4+ MR respectively, p <0.01 for all). In conclusion, higher grades of MR in patients with STEMI undergoing primary PCI are associated with worse short- and long-term outcomes.