Stroke; A Journal Of Cerebral Circulation[JOURNAL]
Sun
200 papers
Clinical Usefulness of PRECISE-DAPT Score for Predicting Bleeding Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: An Analysis From the SMART-DATE Randomized Trial.
Choi KH, Song YB, Lee JM … +21 more , Park TK, Yang JH, Choi JH, Choi SH, Oh JH, Cho DK, Lee JB, Doh JH, Kim SH, Jeong JO, Bae JH, Kim BO, Cho JH, Suh IW, Kim DI, Park HK, Park JS, Choi WG, Lee WS, Gwon HC, Hahn JY
Circ Cardiovasc Interv · 2020 May · PMID 32354228 · Publisher ↗
BACKGROUND: Although the current guidelines endorse the PRECISE-DAPT score (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) to inform clinical decisio...
BACKGROUND: Although the current guidelines endorse the PRECISE-DAPT score (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy) to inform clinical decisions regarding duration of DAPT in patients undergoing percutaneous coronary intervention, use of the PRECISE-DAPT score to guide duration of DAPT has not been properly validated by randomized trials focused on the population with acute coronary syndrome. This study aimed to evaluate the usefulness of the PRECISE-DAPT score for predicting future bleeding and ischemic events and to compare clinical outcomes of short-term and long-term DAPT duration according to the PRECISE-DAPT score in patients with acute coronary syndrome. METHODS: This was a substudy of the SMART-DATE trial (6- Versus 12-Month or Longer Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome), in which patients with acute coronary syndrome undergoing percutaneous coronary intervention were randomly assigned to either 6- (n=1357) or 12-month or longer DAPT (n=1355). Major bleeding (Bleeding Academic Research Consortium type 3-5) and ischemic (myocardial infarction, stent thrombosis, or ischemic stroke) events at 18 months after the index procedure were compared between the 6- and 12-month or longer DAPT groups, according to PRECISE-DAPT score. RESULTS: The PRECISE-DAPT score was moderately effective at predicting bleeding events (area under the curve, 0.754 [95% CI, 0.655-0.854]; <0.001). In patients with nonhigh PRECISE-DAPT score (<25, n=1967 [72.5%]), 6-month DAPT was associated with higher ischemic risk (2.7% versus 1.3%; HR, 2.01 [95% CI, 1.03-3.91]; =0.040; absolute risk difference, +1.3%; =0.035) with similar bleeding risk (0.4% versus 0.3%; HR, 2.00 [95% CI, 0.37-10.94]; =0.422; absolute risk difference, +0.2%; =0.498), compared with 12-month or longer DAPT. Among patients with high PRECISE-DAPT score (≥25, n=745 [27.5%]), 6-month DAPT presented a similar ischemic risk (4.8% versus 3.4%; HR, 1.43 [95% CI, 0.68-2.98], =0.348; absolute risk difference, +1.5%; =0.327) but significantly reduced major bleeding risk (0.6% versus 2.3%; HR, 0.25 [95% CI, 0.05-1.17]; =0.079; absolute risk difference, -1.7%; =0.045). CONCLUSIONS: Consistent with current guidelines, determination of the duration of DAPT according to PRECISE-DAPT score could improve the clinical outcomes in patients with acute coronary syndrome after percutaneous coronary intervention with current-generation drug-eluting stents. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01701453.
Representativeness of the PIONEER-HF Clinical Trial Population in Patients Hospitalized With Heart Failure and Reduced Ejection Fraction.
Fudim M, Sayeed S, Xu H … +7 more , Matsouaka RA, Heidenreich PA, Velazquez EJ, Yancy CW, Fonarow GC, Hernandez AF, DeVore AD
Circ Heart Fail · 2020 Apr · PMID 32248695 · Full text
BACKGROUND: In PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-pro BNP in Patients Stabilized From an Acute Heart Failure Episode), the in-hospital initiation of sacubitril/valsartan in pa...
BACKGROUND: In PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-pro BNP in Patients Stabilized From an Acute Heart Failure Episode), the in-hospital initiation of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure (ADHF) was well-tolerated and led to improved outcomes. We aim to determine the representativeness of the PIONEER-HF trial among patients hospitalized for ADHF using real-world data. METHODS: The study population was derived from all patients discharged alive for ADHF in the Get With The Guidelines-HF registry from 2006 to 2018 with HF with reduced ejection fraction (HFrEF; all HFrEF with ADHF). We then determined the proportion of patients meeting PIONEER-HF eligibility criteria (PIONEER-HF eligible) and those meeting a set of limited eligibility criteria (actionable cohort). Rates of HF readmissions and all-cause mortality were then compared between the all HFrEF with ADHF, PIONEER-HF eligible, and actionable cohorts using linked Medicare claims data. RESULTS: A total of 99 767 patients with HFrEF in Get With The Guidelines-HF were hospitalized for ADHF. PIONEER-HF inclusion criteria were met by 71 633 (71.8%) patients, and both inclusion and exclusion criteria were met by 20 704 (20.8%) patients. Further, 68 739 (68.9%) patients met the criteria for the actionable cohort. Among the Centers for Medicare and Medicaid-linked patients, the HF rehospitalization rate at 1 year was 35.1% (95% CI, 34.5-35.8) for all HFrEF with ADHF patients, 32.6% (95% CI, 31.3-33.9) for the PIONEER-HF eligible cohort, and 33.1% (95% CI, 32.3-33.9) for the actionable cohort. The 1-year all-cause mortality was 36.7% (95% CI, 36.1-7.4) for all HFrEF with ADHF patients, 31.6% (95% CI, 30.3-32.9) for the PIONEER-HF eligible cohort, and 32.2% (95% CI, 31.4-33.0) for the actionable cohort. CONCLUSIONS: Patient characteristics and clinical outcomes for patients eligible for PIONEER-HF only modestly differ when compared with those encountered in routine practice, suggesting that the in-hospital initiation of sacubitril/valsartan should be routinely considered for patients with HFrEF hospitalized for ADHF.
Novel Risk Modeling Approach of Atrial Fibrillation With Restricted Mean Survival Times: Application in the Framingham Heart Study Community-Based Cohort.
Staerk L, Preis SR, Lin H … +8 more , Casas JP, Lunetta K, Weng LC, Anderson CD, Ellinor PT, Lubitz SA, Benjamin EJ, Trinquart L
Circ Cardiovasc Qual Outcomes · 2020 Apr · PMID 32228064 · Full text
BACKGROUND: Risk prediction models for atrial fibrillation (AF) do not give information about when AF might develop. Restricted mean survival time (RMST) quantifies risk into the time domain. Our objective was to use RMS...
BACKGROUND: Risk prediction models for atrial fibrillation (AF) do not give information about when AF might develop. Restricted mean survival time (RMST) quantifies risk into the time domain. Our objective was to use RMST to re-express individualized AF risk predictions. METHODS AND RESULTS: We included AF-free participants from the Framingham Heart Study community-based cohorts. We predicted new-onset AF over 10-year follow-up according to baseline covariates: age, height, weight, systolic blood pressure, diastolic blood pressure, current smoking, antihypertensive treatment, diabetes mellitus, prevalent heart failure, and prevalent myocardial infarction. First, we fitted a Cox regression model and estimated the 10-year predicted risk of AF. Second, we fitted an RMST model and estimated the predicted mean time free of AF and alive over a time horizon of 10 years. We included 7586 AF-free participants contributing to 11 088 examinations (mean age 61±11 years, 44% were men). During 10-year follow-up, 822 participants developed AF. The Cox and RMST models were in agreement regarding the direction, strength, and statistical significance of associations for all covariates. Low (<5%), intermediate (5%-15%), and high (>15%) 10-year predicted risk of AF corresponded to predicted mean time alive and free of AF of 9.9, 9.6, and 8.8 years, respectively. A 60-year-old woman with a body mass index of 25 kg/m, no use of hypertension treatment and no history of heart failure had a predicted mean time alive and free of AF of 9.9 years, whereas a 70-year-old man with a body mass index of 30 kg/m, use of hypertension treatment, and with prevalent heart failure had a predicted mean time alive and free of AF of 7.9 years. CONCLUSIONS: The RMST can be used to develop risk prediction models to express results in a time scale. RMST may offer a complementary risk communication tool for AF in clinical practice.
Reducing Hypermuscularization of the Transitional Segment Between Arterioles and Capillaries Protects Against Spontaneous Intracerebral Hemorrhage.
Ratelade J, Klug NR, Lombardi D … +8 more , Angelim MKSC, Dabertrand F, Domenga-Denier V, Al-Shahi Salman R, Smith C, Gerbeau JF, Nelson MT, Joutel A
Circulation · 2020 Jun · PMID 32183562 · Full text
BACKGROUND: Spontaneous deep intracerebral hemorrhage (ICH) is a devastating subtype of stroke without specific treatments. It has been thought that smooth muscle cell (SMC) degeneration at the site of arteriolar wall ru...
BACKGROUND: Spontaneous deep intracerebral hemorrhage (ICH) is a devastating subtype of stroke without specific treatments. It has been thought that smooth muscle cell (SMC) degeneration at the site of arteriolar wall rupture may be sufficient to cause hemorrhage. However, deep ICHs are rare in some aggressive small vessel diseases that are characterized by significant arteriolar SMC degeneration. Here we hypothesized that a second cellular defect may be required for the occurrence of ICH. METHODS: We studied a genetic model of spontaneous deep ICH using and mouse lines that are mutated for the α1 chain of collagen type IV. We analyzed cerebroretinal microvessels, performed genetic rescue experiments, vascular reactivity analysis, and computational modeling. We examined postmortem brain tissues from patients with sporadic deep ICH. RESULTS: We identified in the normal cerebroretinal vasculature a novel segment between arterioles and capillaries, herein called the transitional segment (TS), which is covered by mural cells distinct from SMCs and pericytes. In mutant mice, this TS was hypermuscularized, with a hyperplasia of mural cells expressing more contractile proteins, whereas the upstream arteriole exhibited a loss of SMCs. TSs mechanistically showed a transient increase in proliferation of mural cells during postnatal maturation. Mutant brain microvessels, unlike mutant arteries, displayed a significant upregulation of SM genes and target genes, and genetic reduction of in mice protected against ICH. Retina analysis showed that hypermuscularization of the TS was attenuated, but arteriolar SMC loss was unchanged in , mice. Moreover, hypermuscularization of the retinal TS increased its contractility and tone and raised the intravascular pressure in the upstream feeding arteriole. We similarly found hypermuscularization of the TS and focal arteriolar SMC loss in brain tissues from patients with sporadic deep ICH. CONCLUSIONS: Our results suggest that hypermuscularization of the TS, through increased Notch3 activity, is involved in the occurrence of ICH in mutant mice, by raising the intravascular pressure in the upstream feeding arteriole and promoting its rupture at the site of SMC loss. Our human data indicate that these 2 mutually reinforcing vascular defects may represent a general mechanism of deep ICH.
Dual-Tracer Positron-Emission Tomography for Identification of Culprit Carotid Plaques and Pathophysiology In Vivo.
Evans NR, Tarkin JM, Chowdhury MM … +4 more , Le EPV, Coughlin PA, Rudd JHF, Warburton EA
Circ Cardiovasc Imaging · 2020 Mar · PMID 32164454 · Publisher ↗
BACKGROUND: Inflammation and microcalcification are interrelated processes contributing to atherosclerotic plaque vulnerability. Positron-emission tomography can quantify these processes in vivo. This study investigates...
BACKGROUND: Inflammation and microcalcification are interrelated processes contributing to atherosclerotic plaque vulnerability. Positron-emission tomography can quantify these processes in vivo. This study investigates (1) F-fluorodeoxyglucose (FDG) and F-sodium fluoride (NaF) uptake in culprit versus nonculprit carotid atheroma, (2) spatial distributions of uptake, and (3) how macrocalcification affects this relationship. METHODS: Individuals with acute ischemic stroke with ipsilateral carotid stenosis of ≥50% underwent FDG-positron-emission tomography and NaF-positron-emission tomography. Tracer uptake was quantified using maximum tissue-to-background ratios (TBR) and macrocalcification quantified using Agatston scoring. RESULTS: In 26 individuals, median most diseased segment TBR (interquartile range) was higher in culprit than in nonculprit atheroma for both FDG (2.08 [0.52] versus 1.89 [0.40]; <0.001) and NaF (2.68 [0.63] versus 2.39 [1.02]; <0.001). However, whole vessel TBR was higher in culprit arteries for FDG (1.92 [0.41] versus 1.71 [0.31]; <0.001) but not NaF (1.85 [0.28] versus 1.79 [0.60]; =0.10). NaF uptake was concentrated at carotid bifurcations, while FDG was distributed evenly throughout arteries. Correlations between FDG and NaF TBR differed between bifurcations with low macrocalcification (=0.38; <0.001) versus high macrocalcification (=0.59; <0.001). CONCLUSIONS: This is the first study to demonstrate increased uptake of both FDG and NaF in culprit carotid plaques, with discrete distributions of pathophysiology influencing vulnerability in vivo. These findings have implications for our understanding of the natural history of the disease and for the clinical assessment and management of carotid atherosclerosis.
Dystrophic Cardiac Calcinosis.
Moudgil R, Tan C, Hammer DF
Circ Cardiovasc Imaging · 2020 Mar · PMID 32098497 · Publisher ↗
Abstract loading — click title to view on PubMed.
Deriving a Passive Surveillance Stroke Severity Indicator From Routinely Collected Administrative Data: The PaSSV Indicator.
Yu AYX, Austin PC, Rashid M … +4 more , Fang J, Porter J, Hill MD, Kapral MK
Circ Cardiovasc Qual Outcomes · 2020 Feb · PMID 32069092 · Publisher ↗
BACKGROUND: Adjusting for stroke severity is crucial for stroke outcomes research. However, this information is not available in administrative healthcare data. We aimed to derive an indicator of baseline stroke severity...
BACKGROUND: Adjusting for stroke severity is crucial for stroke outcomes research. However, this information is not available in administrative healthcare data. We aimed to derive an indicator of baseline stroke severity using these data. METHODS AND RESULTS: We identified patients with stroke enrolled in a population-based registry in Ontario, Canada, and used the Canadian Neurological Scale (CNS), documented in the registry, as a measure of stroke severity. We derived an estimated CNS from a linear regression model in which we regressed the observed CNS on predictor variables: age, sex, arrival by ambulance, interhospital transfer, mechanical ventilation, and an emergency department triage score. The effect of stroke severity on the estimated hazard ratios for 30-day mortality was determined in 3 Cox-proportional hazards models with (1) no CNS, (2) observed CNS, and (3) estimated CNS, all adjusted for age, sex, Charlson index, and stroke type. We assessed model discrimination using C statistics. To assess for construct validity, we repeated these analyses in a subset of patients with documented National Institute of Health Stroke Scale and in a cohort of patients with stroke external to the registry. We derived the estimated stroke severity in 41 481 patients (48.7% female, median age of 75 years [interquartile range, 64- 83]). The magnitude of the association between stroke severity and mortality was similar for the observed and estimated CNS. The discriminative ability of the Cox-proportional hazards models to predict mortality was highest when the observed CNS was included (C statistic, 0.82 [95% CI, 0.81-0.82]), moderate with estimated CNS (0.76 [0.75-0.76]), and lowest without CNS (0.69 [0.69-0.70]. Our findings were replicated with the National Institute of Health Stroke Scale and in the external cohort. CONCLUSIONS: We derived an estimated measure of stroke severity using administrative data. This can be applied for risk adjustment in population-based stroke outcomes research and in assessments of health system performance.
Aromatase Inhibitors and the Risk of Cardiovascular Outcomes in Women With Breast Cancer: A Population-Based Cohort Study.
Khosrow-Khavar F, Filion KB, Bouganim N … +2 more , Suissa S, Azoulay L
Circulation · 2020 Feb · PMID 32065766 · Publisher ↗
BACKGROUND: The association between aromatase inhibitors and cardiovascular outcomes among women with breast cancer is controversial. Given the discrepant findings from randomized controlled trials and observational stud...
BACKGROUND: The association between aromatase inhibitors and cardiovascular outcomes among women with breast cancer is controversial. Given the discrepant findings from randomized controlled trials and observational studies, additional studies are needed to address this safety concern. METHODS: We conducted a population-based cohort study using the UK Clinical Practice Research Datalink linked to the Hospital Episode Statistics and Office for National Statistics databases. The study population consisted of women newly diagnosed with breast cancer initiating hormonal therapy with aromatase inhibitors or tamoxifen between April 1, 1998, and February 29, 2016. We usedCox proportional hazards models with inverse probability of treatment and censoring weighting to estimate hazard ratios (HRs) with 95% CIs comparing new users of aromatase inhibitors with new users of tamoxifen for each of the study outcomes (myocardial infarction, ischemic stroke, heart failure, and cardiovascular mortality). RESULTS: The study population consisted of 23 525 patients newly diagnosed with breast cancer, of whom 17 922 initiated treatment with either an aromatase inhibitor or tamoxifen (8139 and 9783, respectively). The use of aromatase inhibitors was associated with a significantly increased risk of heart failure (incidence rate, 5.4 versus 1.8 per 1000 person-years; HR, 1.86 [95% CI, 1.14-3.03]) and cardiovascular mortality (incidence rate, 9.5 versus 4.7 per 1000 person-years; HR, 1.50 [95% CI, 1.11-2.04]) compared with the use of tamoxifen. Aromatase inhibitors were associated with elevated HRs, but with CIs including the null value, for myocardial infarction (incidence rate, 3.9 versus 1.8 per 1000 person-years; HR, 1.37 [95% CI, 0.88-2.13]) and ischemic stroke (incidence rate, 5.6 versus 3.2 per 1000 person-years; HR, 1.19 [95% CI, 0.82-1.72]). CONCLUSIONS: In this population-based study, aromatase inhibitors were associated with increased risks of heart failure and cardiovascular mortality compared with tamoxifen. There were also trends toward increased risks, although nonsignificant, of myocardial infarction and ischemic stroke. The increased risk of cardiovascular events associated with aromatase inhibitors should be balanced with their favorable clinical benefits compared with tamoxifen.
Comparison of BNP and NT-proBNP in Patients With Heart Failure and Reduced Ejection Fraction.
Rørth R, Jhund PS, Yilmaz MB … +11 more , Kristensen SL, Welsh P, Desai AS, Køber L, Prescott MF, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Packer M, McMurray JJV
Circ Heart Fail · 2020 Feb · PMID 32065760 · Publisher ↗
BACKGROUND: Both BNP (B-type natriuretic peptide) and NT-proBNP (N-terminal pro B-type natriuretic peptide) are widely used to aid diagnosis, assess the effect of therapy, and predict outcomes in heart failure and reduce...
BACKGROUND: Both BNP (B-type natriuretic peptide) and NT-proBNP (N-terminal pro B-type natriuretic peptide) are widely used to aid diagnosis, assess the effect of therapy, and predict outcomes in heart failure and reduced ejection fraction. However, little is known about how these 2 peptides compare in heart failure and reduced ejection fraction, especially with contemporary assays. Both peptides were measured at screening in the PARADIGM-HF trial (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure). METHODS: Eligibility criteria in PARADIGM-HF included New York Heart Association functional class II to IV, left ventricular ejection fraction ≤40%, and elevated natriuretic peptides: BNP ≥150 pg/mL or NT-proBNP ≥600 pg/mL (for patients with HF hospitalization within 12 months, BNP ≥100 pg/mL or NT-proBNP ≥400 pg/mL). BNP and NT-proBNP were measured simultaneously at screening and only patients who fulfilled entry criteria for both natriuretic peptides were included in the present analysis. The BNP/NT-proBNP criteria were not different for patients in atrial fibrillation. Estimated glomerular filtration rate <30 mL/min per 1.73 m was a key exclusion criterion. RESULTS: The median baseline concentration of NT-proBNP was 2067 (Q1, Q3: 1217-4003) and BNP 318 (Q1, Q3: 207-559), and the ratio, calculated from the raw data, was ≈6.25:1. This ratio varied considerably according to rhythm (atrial fibrillation 8.03:1; no atrial fibrillation 5.75:1) and with age, renal function, and body mass index but not with left ventricular ejection fraction. Each peptide was similarly predictive of death (all-cause, cardiovascular, sudden and pump failure) and heart failure hospitalization, for example, cardiovascular death: BNP hazard ratio, 1.41 (95% CI, 1.33-1.49) per 1 SD increase, <0.0001; NT-proBNP, 1.45 (1.36-1.54); <0.0001. CONCLUSIONS: The ratio of NT-proBNP to BNP in heart failure and reduced ejection fraction appears to be greater than generally appreciated, differs between patients with and without atrial fibrillation, and increases substantially with increasing age and decreasing renal function. These findings are important for comparison of natriuretic peptide concentrations in heart failure and reduced ejection fraction.
Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study.
Kalogeropoulos A, Papadimitriou L, Georgiopoulou VV … +3 more , Dunbar SB, Skopicki H, Butler J
Circ Heart Fail · 2020 Jan · PMID 31959014 · Full text
BACKGROUND: We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals...
BACKGROUND: We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure. METHODS: Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of these, 27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15) sodium meals. RESULTS: On-study retention at 12 weeks was 77% (82% versus 73%; =0.53); 6 patients (2 in 1500-mg, 4 in 3000-mg arm) withdrew before study completion. Food satisfaction questionnaires indicated that both diets were well tolerated. Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm. Average compliance with meals was 52% (based on urinary sodium) and was not significantly different between arms (42% versus 60%; =0.25). Study meals reduced 24-hour urinary sodium by 137±21 mmol (1500-mg arm) and 82±16 mmol (3000-mg arm), both <0.001; between-arms difference was 55 mmol (95% CI, 3-107; =0.037). NT-proBNP (N-terminal pro-B-type natriuretic peptide) was not affected. Hospitalizations and low blood pressure events did not differ significantly between arms. Serum creatinine decreased more (by 0.17 mg/dL [95% CI, 0.06-0.28]; =0.003) in the 1500-mg arm. Creatinine increases >0.5 mg/dL over baseline only occurred in 1 patient in the 3000-mg arm. CONCLUSIONS: Even with prepared meals, investigating optimal dietary sodium in heart failure comes with challenges, including need for extensive screening, reluctance to participate, and compliance issues. Because both diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with modifications to improve participation and compliance, would be ethical and feasible. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02467296.
Mechanistic Effects of Spironolactone on Cardiovascular and Renal Biomarkers in Heart Failure With Preserved Ejection Fraction: A TOPCAT Biorepository Study.
Myhre PL, Vaduganathan M, O'Meara E … +9 more , Claggett BL, de Denus S, Jarolim P, Anand IS, Pitt B, Rouleau JL, Solomon SD, Pfeffer MA, Desai AS
Circ Heart Fail · 2020 Jan · PMID 31957468 · Publisher ↗
BACKGROUND: Spironolactone has been demonstrated to reduce heart failure (HF) hospitalization in patients with HF with preserved ejection fraction in the Americas region of the TOPCAT trial (Treatment of Preserved Cardia...
BACKGROUND: Spironolactone has been demonstrated to reduce heart failure (HF) hospitalization in patients with HF with preserved ejection fraction in the Americas region of the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial). We assessed effects of 12 months of treatment with spironolactone on biomarkers reflecting myocardial stress, myocardial injury, renal function, and systemic inflammation. METHODS: This TOPCAT biorepository substudy evaluated 247 patients (14% of the total 1767 patients in the Americas region) with symptomatic HF, ejection fraction ≥45%, and elevated natriuretic peptides or a prior HF hospitalization. Paired blood samples at baseline and after 12 months of treatment with spironolactone or placebo were available in 204 patients. RESULTS: At baseline, the median (interquartile range) concentration of BNP (B-type natriuretic peptide) was 124 (69-197) ng/L, NT-proBNP (N-terminal-pro-B-type natriuretic peptide) 624 (307-1312) ng/L, hs-cTnI (high sensitivity cardiac troponin I) 6.3 (3.4-13.0) ng/L, hs-CRP (high sensitivity C-reactive protein) 2.8 (1.3-6.1) mg/L, uric acid 7.2 (5.8-8.7) mg/dL, and urine protein-creatinine ratio 0.11 (0.08-0.20) mg/mg. Compared with placebo-assigned participants at 12 months, those randomized to spironolactone experienced greater reductions from baseline in levels of NT-proBNP (=0.017) and BNP (=0.002); these differences persisted after adjustment for demographics, comorbidities, estimated glomerular filtration rate, and enrollment strata. No between-group differences in changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio were observed. CONCLUSIONS: This TOPCAT biorepository substudy suggests potential effects on markers of cardiac wall stress or filling pressures during 12 months of treatment with spironolactone in patients with chronic HF with preserved ejection fraction. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00094302.
Cardiac Calcified Amorphous Tumor as a Rare Cause of Ischemic Stroke: Clinical Case.
Formelli B, Farina A, Pescini F … +5 more , Palumbo V, Grazia D'Alfonso M, Oddo A, Mori F, Poggesi A
Circ Cardiovasc Imaging · 2020 Jan · PMID 31906700 · Publisher ↗
Abstract loading — click title to view on PubMed.
Safety and Outcomes of Intravenous tPA in Acute Ischemic Stroke Patients With Prior Stroke Within 3 Months: Findings From Get With The Guidelines-Stroke.
Shah S, Liang L, Kosinski A … +8 more , Hernandez AF, Schwamm LH, Smith EE, Fonarow GC, Bhatt DL, Feng W, Peterson ED, Xian Y
Circ Cardiovasc Qual Outcomes · 2020 Jan · PMID 31903770 · Publisher ↗
Background Guidelines recommend against the use of intravenous tPA (tissue-type plasminogen activator; IV tPA) in acute ischemic stroke patients with prior ischemic stroke within 3 months. However, there are limited data...
Background Guidelines recommend against the use of intravenous tPA (tissue-type plasminogen activator; IV tPA) in acute ischemic stroke patients with prior ischemic stroke within 3 months. However, there are limited data on the safety of IV tPA in this population. Methods and Results A retrospective observational study of patients ≥66 years of age linked to Medicare claims and treated with IV tPA at Get With The Guidelines-Stroke hospitals (February 2009 to December 2015). We identified 293 patients treated with IV tPA who had a prior ischemic stroke within 3 months and 30 655 with no history of stroke. Patients with prior stroke had a higher stroke severity (median National Institutes of Health Stroke Scale, 11 [6-19] versus 11 [6-18]; absolute standardized difference, 11.2%) and a higher prevalence of cardiovascular comorbidities. Patients with prior stroke had a higher unadjusted risk for symptomatic intracranial hemorrhage (7.7% versus 4.8%) and in-hospital mortality (12.6% versus 8.9%), but these differences were not statistically significant after adjustment. When stratified by prespecified time epochs, the elevated risk for symptomatic intracranial hemorrhage was seen only within the first 14 days (16.3% versus 4.8%; adjusted odds ratio [aOR], 3.7 [95% CI, 1.62-8.43]) but not in other epochs (2.1% versus 4.8%; aOR, 0.38 [95% CI, 0.05-2.79] for 15-30 days and 7.4% versus 4.8%; aOR, 1.36 [95% CI, 0.77-2.40] for 31-90 days). In addition, patients with prior stroke were significantly more likely to have a combined outcome of in-hospital mortality or discharge to hospice (25.9% versus 17.0%; aOR, 1.70 [95% CI, 1.21-2.38]), less likely to be discharged to home (28.3% versus 32.3%; aOR, 0.72 [95% CI, 0.54-0.98]), or to have good functional outcomes at discharge (modified Rankin Scale, 0-1; 11.3% versus 20.0%; aOR, 0.46 [95% CI, 0.24-0.89]). Conclusions Stroke providers need to continue to be vigilant about the safety of IV tPA in patients with prior stroke, particularly those with an event in the previous 14 days.
Increased Myocardial Stiffness in Patients With High-Risk Left Ventricular Hypertrophy: The Hallmark of Stage-B Heart Failure With Preserved Ejection Fraction.
Hieda M, Sarma S, Hearon CM … +9 more , Dias KA, Martinez J, Samels M, Everding B, Palmer D, Livingston S, Morris M, Howden E, Levine BD
Circulation · 2020 Jan · PMID 31865771 · Full text
BACKGROUND: Individuals with left ventricular hypertrophy (LVH) and elevated cardiac biomarkers in middle age are at high risk for the development of heart failure with preserved ejection fraction (HFpEF). However, it is...
BACKGROUND: Individuals with left ventricular hypertrophy (LVH) and elevated cardiac biomarkers in middle age are at high risk for the development of heart failure with preserved ejection fraction (HFpEF). However, it is unknown what the pathophysiological underpinnings of this high-risk state may be. We tested the hypothesis that patients with LVH and elevated cardiac biomarkers would demonstrate elevated left ventricular (LV) myocardial stiffness in comparison with healthy controls as a key marker for future HFpEF. METHODS: Forty-six patients with LVH (LV septum >11 mm) and elevated cardiac biomarkers (N-terminal pro-B-type natriuretic peptide [>40 pg/mL] or troponin T [>0.6 pg/mL]) were recruited, along with 61 age- and sex-matched (by cohort) healthy controls. To define LV pressure-volume relationships, right heart catheterization and 3-dimensional echocardiography were performed while preload was manipulated using lower body negative pressure and rapid saline infusion. RESULTS: There were significant differences in body size, blood pressure, and baseline pulmonary capillary wedge pressure between groups (eg, pulmonary capillary wedge pressure: LVH, 13.4±2.7 versus control, 11.7±1.7 mm Hg, <0.0001). The LV was less distensible in LVH than in controls (smaller volume for the same filling pressure). When preload was expressed as transmural filling pressure (pulmonary capillary wedge pressure - right atrial pressure), LV myocardial stiffness was nearly 30% greater in LVH than in controls (LVH stiffness constant, 0.053±0.027 versus controls, 0.042±0.020, =0.028). CONCLUSIONS: LV myocardial stiffness in patients with LVH and elevated biomarkers (stage-B HFpEF) is greater than in age- and sex-matched controls and thus appears to represent a transitional state from a normal healthy heart to HFpEF. Although the LV myocardial stiffness of patients with LVH is greater than that of healthy controls at this early stage, further studies are required to clarify whether interventions such as exercise training to improve LV compliance may prevent the full manifestation of the HFpEF syndrome in these high-risk individuals. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT03476785 and NCT02039154.
Trends in Outcomes of Patients With Ischemic Stroke Treated Between 2002 and 2016: Insights From a Chinese Cohort.
Liu J, Zheng L, Cheng Y … +7 more , Zhang S, Wu B, Wang D, Zhang S, Tao W, Wu S, Liu M
Circ Cardiovasc Qual Outcomes · 2019 Dec · PMID 31830825 · Publisher ↗
BACKGROUND: Little is known about long-term trends in outcomes of patients with ischemic stroke in China. We aimed to assess longitudinal trends in these outcomes over the past 15 years in China and explore possible fact...
BACKGROUND: Little is known about long-term trends in outcomes of patients with ischemic stroke in China. We aimed to assess longitudinal trends in these outcomes over the past 15 years in China and explore possible factors behind the trends. METHODS AND RESULTS: Patients with ischemic stroke admitted to the Department of Neurology at West China Hospital were prospectively and consecutively enrolled in a central registry since 2002, and the present study analyzed data from those admitted to hospital within 7 days of stroke during the period 2002 to 2016. Patients were binned into three 5-year intervals for temporal analysis. Death, disability, and death/disability at 3 and 12 months after stroke were compared among the time intervals across the entire sample and in subsets stratified by age (<65 or ≥65 years). To explore the possible factors related to the trends in outcomes, interaction between the factors and time on outcomes was entered separately into the multivariable logistic regression model. Of 6462 patients with ischemic stroke in the final analysis, 3837 (59.4%) were men, and mean age was 64.2 years (SD, 13.7). Mean age at stroke onset and National Institutes of Health Stroke Scale score at admission decreased significantly during the 15-year period (<0.001). Between 2002 to 2006 and 2012 to 2016, cumulative incidences declined significantly for death at 3 months (from 9.6% to 6.4%), disability at 3 months (from 36.8% to 28.7%), and death/disability at 3 months (from 42.9% to 33.3%), as well as for death at 12 months (from 15.9% to 10.7%), disability at 12 months (from 23.2% to 17.6%), and death/disability at 12 months (from 35.4% to 26.4%; all <0.001). The decreases in disability and death/disability at 3 and 12 months between 2002 to 2006 and 2012 to 2016 remained significant after adjusting for confounders, and the results were similar for the entire cohort and for subgroups of patients <65 or ≥65 years. Only interactions of National Institutes of Health Stroke Scale score on admission and time period (2012-2016) were found to significantly correlate with disability and death/disability at 3 and 12 months (all ≤0.03). CONCLUSIONS: Our study from a large medical center in southwest China suggests that since 2002, risks of disability and death/disability at 3 and 12 months after ischemic stroke have declined. This appears to be due, at least in part, to a significant decline in National Institutes of Health Stroke Scale score on admission, which may reflect greater public awareness of stroke detection, willingness to seek medical attention, and ease of access to healthcare infrastructure. The factors behind this apparent improvement require further study.
Searching for Atrial Fibrillation Poststroke: A White Paper of the AF-SCREEN International Collaboration.
Schnabel RB, Haeusler KG, Healey JS … +42 more , Freedman B, Boriani G, Brachmann J, Brandes A, Bustamante A, Casadei B, Crijns HJGM, Doehner W, Engström G, Fauchier L, Friberg L, Gladstone DJ, Glotzer TV, Goto S, Hankey GJ, Harbison JA, Hobbs FDR, Johnson LSB, Kamel H, Kirchhof P, Korompoki E, Krieger DW, Lip GYH, Løchen ML, Mairesse GH, Montaner J, Neubeck L, Ntaios G, Piccini JP, Potpara TS, Quinn TJ, Reiffel JA, Ribeiro ALP, Rienstra M, Rosenqvist M, Themistoclakis S, Sinner MF, Svendsen JH, Van Gelder IC, Wachter R, Wijeratne T, Yan B
Circulation · 2019 Nov · PMID 31765261 · Publisher ↗
Cardiac thromboembolism attributed to atrial fibrillation (AF) is responsible for up to one-third of ischemic strokes. Stroke may be the first manifestation of previously undetected AF. Given the efficacy of oral anticoa...
Cardiac thromboembolism attributed to atrial fibrillation (AF) is responsible for up to one-third of ischemic strokes. Stroke may be the first manifestation of previously undetected AF. Given the efficacy of oral anticoagulants in preventing AF-related ischemic strokes, strategies of searching for AF after a stroke using ECG monitoring followed by oral anticoagulation (OAC) treatment have been proposed to prevent recurrent cardioembolic strokes. This white paper by experts from the AF-SCREEN International Collaboration summarizes existing evidence and knowledge gaps on searching for AF after a stroke by using ECG monitoring. New AF can be detected by routine plus intensive ECG monitoring in approximately one-quarter of patients with ischemic stroke. It may be causal, a bystander, or neurogenically induced by the stroke. AF after a stroke is a risk factor for thromboembolism and a strong marker for atrial myopathy. After acute ischemic stroke, patients should undergo 72 hours of electrocardiographic monitoring to detect AF. The diagnosis requires an ECG of sufficient quality for confirmation by a health professional with ECG rhythm expertise. AF detection rate is a function of monitoring duration and quality of analysis, AF episode definition, interval from stroke to monitoring commencement, and patient characteristics including old age, certain ECG alterations, and stroke type. Markers of atrial myopathy (eg, imaging, atrial ectopy, natriuretic peptides) may increase AF yield from monitoring and could be used to guide patient selection for more intensive/prolonged poststroke ECG monitoring. Atrial myopathy without detected AF is not currently sufficient to initiate OAC. The concept of embolic stroke of unknown source is not proven to identify patients who have had a stroke benefitting from empiric OAC treatment. However, some embolic stroke of unknown source subgroups (eg, advanced age, atrial enlargement) might benefit more from non-vitamin K-dependent OAC therapy than aspirin. Fulfilling embolic stroke of unknown source criteria is an indication neither for empiric non-vitamin K-dependent OAC treatment nor for withholding prolonged ECG monitoring for AF. Clinically diagnosed AF after a stroke or a transient ischemic attack is associated with significantly increased risk of recurrent stroke or systemic embolism, in particular, with additional stroke risk factors, and requires OAC rather than antiplatelet therapy. The minimum subclinical AF duration required on ECG monitoring poststroke/transient ischemic attack to recommend OAC therapy is debated.
Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial.
Kuck KH, Merkely B, Zahn R … +8 more , Arentz T, Seidl K, Schlüter M, Tilz RR, Piorkowski C, Gellér L, Kleemann T, Hindricks G
Circ Arrhythm Electrophysiol · 2019 Dec · PMID 31760819 · Publisher ↗
BACKGROUND: Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is con...
BACKGROUND: Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is controversial. METHODS: Patients with persistent/longstanding persistent AF and LVEF ≤35% were randomly allocated to catheter ablation of AF or best medical therapy (BMT). The primary study end point was the absolute increase in LVEF from baseline at 1 year. Secondary end points included 6-minute walk test, quality-of-life, and NT-proBNP (N-terminal pro-brain natriuretic peptide). Pulmonary vein isolation was the primary ablation approach; BMT comprised rate or rhythm control. All patients were discharged after index hospitalization with a cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted. The study was terminated early for futility. RESULTS: Of 140 patients (65±8 years, 126 [90%] men) available for the end point analysis, 68 and 72 patients were assigned to ablation and BMT, respectively. At 1 year, LVEF had increased in ablation patients by 8.8% (95% CI, 5.8%-11.9%) and in BMT patients by 7.3% (4.3%-10.3%; =0.36). Sinus rhythm was recorded on 12-lead electrocardiograms at 1 year in 61/83 ablation patients (73.5%) and 42/84 BMT patients (50%). Device-recorded AF burden at 1 year was 0% or maximally 5% of the time in 28/39 ablation patients (72%) and 16/36 BMT patients (44%). There was no difference in secondary end point outcome between ablation patients and BMT patients. CONCLUSIONS: The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF. This was mainly because of the fact that at 1 year, LVEF increased in ablation patients to a similar extent as in BMT patients. The effect of catheter ablation of AF in patients with HF may be affected by the extent of HF at baseline, with a rather limited ablation benefit in patients with seriously advanced HF. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00652522.
Application of the Academic Research Consortium High Bleeding Risk Criteria in an All-Comers Registry of Percutaneous Coronary Intervention.
Natsuaki M, Morimoto T, Shiomi H … +12 more , Yamaji K, Watanabe H, Shizuta S, Kato T, Ando K, Nakagawa Y, Furukawa Y, Tada T, Nagao K, Kadota K, Toyofuku M, Kimura T
Circ Cardiovasc Interv · 2019 Nov · PMID 31707804 · Publisher ↗
BACKGROUND: Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 o...
BACKGROUND: Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) has been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥4% at 1-year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world percutaneous coronary intervention practice. METHODS: We applied the ARC-HBR criteria in the CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) registry cohort-2, a multicenter registry that enrolled 13 058 consecutive patients who underwent their first percutaneous coronary intervention. The primary bleeding end point was defined as the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries moderate/severe bleeding. There were 5570 patients (43%) in the HBR group and 7488 patients in the no-HBR group. RESULTS: Cumulative incidence of the primary bleeding end point was much higher in the HBR group than in the no-HBR group (10.4% versus 3.4% at 1-year, and 18.9% versus 6.6% at 5-year, <0.0001). Presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and prior ischemic stroke, was also associated with major bleeding risk higher than 4% at 1-year. Cumulative 5-year incidence of the primary bleeding end point got incrementally higher as the number of the ARC-HBR major criteria increased (≥3 majors: 49.9%, 2 majors: 30.6%, 1 major: 18.5%, ≥2 minors: 14.7%, and no-HBR: 6.6%, <0.0001). CONCLUSIONS: ARC-HBR criteria successfully identified those patients with very HBR after percutaneous coronary intervention, who represented 43% of patients in this all-comers registry.
Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement: Findings From the EXTEND Study.
Strom JB, Zhao Y, Faridi KF … +9 more , Tamez H, Butala NM, Valsdottir LR, Curtis J, Brennan JM, Shen C, Boulware M, Popma JJ, Yeh RW
Circ Cardiovasc Interv · 2019 Nov · PMID 31694411 · Full text
BACKGROUND: Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural he...
BACKGROUND: Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials. METHODS: Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016. Claims consistent with CVEs within 14 days of a similar trial-adjudicated CVE were considered a match. The sensitivity, specificity, and positive and negative predictive values of billing codes for cerebrovascular disease were determined against trial-defined CVEs as the criterion standard. Kaplan-Meier estimates of claims-defined versus trial-defined CVEs were compared. RESULTS: Among 4230 linked trial participants (linkage rate 79.8%), 550 (13.0%) sustained 630 adjudicated CVEs over a 5-year follow-up period. Linked and nonlinked individuals were similar. An algorithm using 4 codes (434.91, 434.11, 433.11, and 997.02) had a sensitivity of 60.9%, specificity of 99.0%, positive predictive value of 86.5%, and negative predictive value of 95.8% for identifying a trial-adjudicated ischemic stroke. An algorithm using 3 codes (I63.9, I63.40, I63.49) had a sensitivity of 66.7%, specificity of 99.4%, positive predictive value of 88.9%, and negative predictive value of 97.6%. CONCLUSIONS: In linked clinical trial and Medicare claims data, 4 and 3 billing codes identified half of trial-adjudicated CVEs during follow-up with high specificity and predictive value, but imperfect sensitivity. Although low sensitivity may limit the use of claims to substitute for traditional trial outcomes to identify CVEs, high specificity suggests claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.
Association of Total Reproductive Years With Incident Atrial Fibrillation, and Subsequent Ischemic Stroke in Women With Natural Menopause.
Yang S, Kwak S, Kwon S … +8 more , Lee HJ, Lee H, Park JB, Lee SP, Kim H, Han K, Kim YJ, Kim HK
Circ Arrhythm Electrophysiol · 2019 Nov · PMID 31661971 · Publisher ↗
BACKGROUND: The association of lifetime exposure to endogenous sex hormone with incident atrial fibrillation (AF) and subsequent ischemic stroke has never been studied. METHODS: This study involved 4 638 299 natural post...
BACKGROUND: The association of lifetime exposure to endogenous sex hormone with incident atrial fibrillation (AF) and subsequent ischemic stroke has never been studied. METHODS: This study involved 4 638 299 natural postmenopausal waomen aged ≥40 years without prior history of AF and with national breast cancer check-up between January 1, 2009 and December 31, 2014. The primary end point was incident AF, and the secondary end point was subsequent ischemic stroke once AF has developed. Cox proportional hazard regression analysis was used to estimate the risk of end points. RESULTS: During the mean follow-up of 6.3 years, shorter total reproductive years (<30 years) were associated with 7% increased risk of AF after adjusting for confounding variables (adjusted hazard ratio [aHR], 1.07 [95% CI, 1.05-1.09]). Risk of AF declined progressively with every 5-yearly increment in total reproductive years (-for-trend <0.001). However, the prolonged (≥2 years) use of hormone replacement therapy after menopause was paradoxically associated with a 3% increase in AF risk (aHR, 1.03 [95% CI, 1.01-1.05]). For the secondary end point analysis, the risk of ischemic stroke after AF development significantly decreased with each 5-yearly increment in total reproductive years (with <30 years as reference; aHR, 0.93 [95% CI, 0.88-0.99] for 30-34 years; aHR, 0.84 [95% CI, 0.79-0.89] for 35-39 years; and aHR, 0.88 [95% CI, 0.80-0.97] for ≥40 years, -for-trend <0.001). CONCLUSIONS: In women with natural menopause, shorter lifetime exposure to endogenous sex hormone, that is, shorter total reproductive years, was significantly associated with a higher risk of AF and subsequent ischemic stroke. Paradoxically, prolonged exogenous hormone replacement therapy increased the risk of incident AF.
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