American heart journal最新文献

Background: Clinical trials of antithrombotic agents typically use separate time-to-event analyses for bleeding and ischemic events, but this framework has limitations. Days alive and out of hospital (DAOH) is an alternative that may provide additional insight. We assessed the utility of DAOH as a clinical trial endpoint among patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention METHODS: AUGUSTUS, a randomized clinical trial, compared apixaban with warfarin and aspirin with placebo in 4614 patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention. We used Poisson regression with a robust variance estimate to compare DAOH by treatment group.

Results: Mean (SD) DAOH was 168 (31); median (IQR) was 177 (169-180); 75% of patients neither died nor were hospitalized. Mean (SD) DAOH was 169 (28) with apixaban+placebo, 168 (29) with apixaban+aspirin, 168 (33) with warfarin+placebo, and 167 (33) with warfarin+aspirin. There were no significant differences in the rate ratio for DAOH for apixaban vs. warfarin (RR 1.00, 95% CI 0.99-1.00) or aspirin vs. placebo (RR 1.00, 95% CI 1.00-1.01). Apixaban increased the proportion of patients who neither died nor were hospitalized during follow-up (76.8 vs. 73.3%; OR 0.83, 95% CI 0.73-0.95).

Conclusion: In this analysis of AUGUSTUS, there was no difference in DAOH by treatment arm. These findings contrast with time-to-event analyses, which showed lower rates of major bleeding and hospitalization with apixaban and placebo. DAOH may not be very a useful measure of effects of antithrombotic therapies in this population.

Amyloidosis is a systemic disease affecting multiple organs, and often presents with cardiac involvement, with two primary underlying pathologies: amyloid light chain- and transthyretin cardiac amyloidosis. Chest pain can occur in both types with variable clinical presentations. This narrative review describes the relationship between CA and chest pain. A PubMed search (June 03. 2024) identified 393 articles related to chest pain in CA. Twenty-eight studies, in English and with full text, were selected. Articles included were case reports, reviews, perfusion- and autopsy studies. In CA patients 10-20% report chest pain as the initial symptom preceding the diagnosis, and the overall prevalence of chest pain is 38% of patients with CA and it is related to an increased risk of heart failure hospitalization. The mechanisms leading to chest pain in CA patients include increased left ventricular diastolic pressure, infiltration of amyloid fibrils inside and around coronary arteries, and amyloid compression of the microvasculature. The mechanisms commonly lead to elevations of plasma troponin levels, which are higher in amyloid patients with chest pain compared to amyloid patients without chest pain. Symptomatic treatment of chest pain can be challenging due to the low tolerability of medical therapy and poor outcomes of coronary interventions in alleviating the pain and with a higher rate of complications. Our review underscores the importance of recognizing chest pain as a CA symptom, particularly in the elderly. Persistent troponin elevation without coronary artery disease could indicate CA. Screening-based and longitudinal studies are crucial for understanding the relationship between chest pain and CA. Acknowledging the significance of chest pain in CA may facilitate early intervention and improve patient outcomes.

Policymakers have intensified calls to expand work requirements in Medicaid across the United States, which could have implications for low-income adults who experience a high burden of cardiometabolic risk factors and disease. In this difference-in-differences analysis, we found that the implementation of Medicaid work requirements was associated with decreased health insurance coverage, no change in employment status, and a trend towards worse access to care. Our findings suggest that the expansion of work requirements could have major implications for the cardiovascular health of working-age adults in the US.

Background: Tricuspid regurgitation (TR) and mitral regurgitation (MR) are common valvular conditions encountered in patients undergoing transcatheter aortic valve replacement (TAVR). This retrospective study investigates the impact of moderate or severe TR and MR on all-cause mortality in one-year post-TAVR patients.

Methods: Consecutive patients who underwent TAVR at the 3 academic tertiary care centers in our health system between 2012 and 2018 were identified. Patients were stratified into 2 groups based on valvular regurgitation severity: moderate/severe MR vs. no/mild MR, and moderate/severe TR vs. no/mild TR. Primary outcome was all-cause mortality at 1-year and 5-year follow up, and secondary outcome was in-hospital death. Logistic regression analysis was conducted to assess the relationship between moderate/severe MR or TR and all-cause mortality at 1-year and 5-year follow-up.

Results: We included a total of 1,071 patients who underwent TAVR with mean age 80.9 ± 8.6 years, 97% white, and 58.3% males. Moderate or severe MR group included 52 (4.88%) patients while mild or no MR group included 1,015 (95.12%) patients. There was no significant difference between both groups in TAVR procedure success rate (100% vs. 97.83%, p=0.283), in-hospital mortality (0 vs. 1.08%, p=0.450), or mortality at 1-year follow up (15.38% vs. 14.09%, p=0.794). At 5-year follow up, moderate/severe MR group had higher mortality (61.4% vs. 49.5%, p=0.046). In multivariable logistic regression analysis, moderate or severe MR did not show significant correlation with all-cause mortality at 1-year and 5-year follow up. Moderate or severe TR group included 86 (8.03%) patients while mild or no TR group included 985 (91.97%) patients. There was no difference between both groups in TAVR procedure success (98.8% vs. 97.9%, p=0.54) or in-hospital mortality (0% vs. 1.1%, p=0.33). At 1-year follow up, patients with moderate or severe TR had higher mortality (26.7% vs. 13.2%, p=0.001) compared to patients with mild or no TR. Same finding was noted with extended follow up at 5-years (68.3% vs. 48.7%, p<0.001). In multivariable cox regression analysis, moderate/severe TR was associated with higher all-cause mortality at 1-year (OR 1.94, 95% CI [01.09, 3.44], p=0.0.023) and at 5-year (OR 1.46, 95% CI [1.092, 1.952], p=0.0.011) follow up. Patients with combined moderate/severe MR and TR have even higher mortality compared to either moderate/severe valve regurgitation alone or mild/no valve regurgitation at 5-year follow up.

Conclusion: At long term follow up, moderate/severe TR, but not MR, is associated with higher mortality in patients underwent TAVR. Combined moderate/severe TR and MR had even worse mortality. Careful assessment of multi-valvular heart disease prior to the procedure is warranted.

Background: The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown.

Objectives: We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable vs. self-expanding THVs.

Methods: In a retrospective analysis from the Bern TAVI registry, patients with LVEF <50% who underwent TAVI with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups.

Results: A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; P <0.001) and a higher incidence of ≥mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; P <0.001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, HR_adjusted: 1.44; 95% CI: 1.02-2.03; P = 0.037). There were no significant differences in other clinical outcomes up to 5 years between groups.

Conclusions: In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV.

Clinical trial registration: https://www.

Clinicaltrials: gov. NCT01368250.

Background: Both high-sensitive C-reactive protein (hsCRP) and CYP2C19 genotypes are independent predictors of clinical outcomes after ischemic stroke. We aim to evaluate the association of CYP2C19 loss-of-function alleles (LoFA) carrying status with the effects of dual/single antiplatelet therapy at different hsCRP levels using the CHANCE trial.

Methods: Subjects with both of CYP2C19 major alleles information (*2, *3, and *17) and hsCRP measurements were enrolled from the prespecified subgroup. CYP2C19 LoFA carriers were defined as patients with either*2 or *3 allele. Cox proportional hazards models were used to assess the interaction of CYP2C19 LoFA carrying status with the effects of dual/single antiplatelet therapy at different hsCRP levels. The primary outcome was recurrent stroke within 90 days.

Results: Among 2801 patients, 1646 (58.8%) were LoFA carriers, and 922 (32.9%) had elevated hsCRP. In patients with non-elevated hsCRP, there was a significant interaction effect between CYP2C19 LoFA carrying status and dual/single antiplatelet regimens for prevention of recurrent stroke and combined vascular events (p =0.048, 0.048, respectively), but, not in patients with elevated hsCRP (p =0.502, 0.472, respectively). Only among patients with non-elevated hsCRP and non-carrier of CYP2C19 LoFA, dual antiplatelets significantly reduced the risk of recurrent stroke compared with aspirin alone (hazard ratio= 0.44 [0.26-0.74], p=0.003). No significant differences in bleeding were found.

Conclusions: Non-elevated hsCRP and non-carrier of CYP2C19 LoFA may predict a better response to dual antiplatelet therapy in reducing stroke recurrence and composite vascular events for patients with minor stroke and high-risk TIA.

Trial registration: clinicaltrials.gov Identifier: NCT00979589.

Background: Research to reduce maternal morbidity due to cardiovascular disease is vitally important in the United States, especially for the growing number of individuals with congenital heart disease (CHD) reaching childbearing age. Understanding patient experiences through patient engagement is critical to designing research that is aligned with the needs of adults with CHD undergoing pregnancy.

Methods: This patient engagement project, grounded in human centered design, focuses on the discovering patient and healthcare provider priorities for reducing maternal morbidity in CHD through patient centered outcomes research (PCOR). In this first stage, a capacity building consortium of over 90 key partners, including patients, advocates, healthcare providers, and researchers, was assembled. Baseline education on patient engagement, PCOR, and survey instrument design was delivered virtually. Two questionnaires were designed to elicit tacit knowledge - one for patients and one for providers - regarding gaps and needs across four key pillars: access to clinical care, patient and provider education, mental health, and research opportunities. The pillars were determined through thematic summaries from consortium discussions.

Results: The patient questionnaire received 828 responses (age range: 18-60 years) from 48 U.S. states. The provider questionnaire garnered 218 responses from professionals. Several common themes for areas of research were observed across all pillars including improved access to specialized cardio-obstetric care and improved education about the need for specialized care. Healthcare providers cited insufficient care coordination models and resources as a major barrier to providing effective clinical care. Both patients and providers expressed a need for improved access to mental health care. While only 28% of patient respondents who underwent a pregnancy reported a pre-existing mental health diagnosis, nearly 2/3 reported having significant anxiety symptoms related to their pregnancy. Of those with significant symptoms, 44% were unable to access mental health services. Additionally, only 55% of healthcare providers reported referral for assessment and treatment if mental health concerns arose during or after pregnancy.

Conclusion: The results provide valuable insights into the unique challenges faced by patients with CHD and their providers during pregnancy. By addressing the identified gaps through PCOR, we can work towards a goal to improve maternal care for women with CHD.

Background: The win ratio (WR) is an emerging alternative for reporting composite outcomes, prioritizing clinically significant events such as mortality while incorporating surrogate measures. However, its benefits should be weighed against limitations, particularly the influence of lower hierarchical outcomes. This secondary analysis of the PARAGLIDE-HF trial performed a WR sensitivity analysis using a modified hierarchical composite outcome to assess the utility of WR sensitivity analysis and the efficacy of sacubitril/valsartan versus valsartan.

Methods: PARAGLIDE-HF compared sacubitril/valsartan with valsartan in heart failure (HF) patients with ejection fraction >40% (N=466). A hierarchical outcome in the primary analysis included cardiovascular death, HF hospitalizations, urgent HF visits, and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP), with a 25% decrease considered a win. In the pre-specified subgroup with ejection fraction ≤60% (N=357), sacubitril/valsartan showed a treatment effect on the hierarchical outcome (WR, 1.46; 95% CI, 1.08-1.97). Sensitivity analyses for this subgroup included: 1) excluding NT-proBNP change, 2) substituting the 25% proportion change of NT-proBNP with 10% or 50%, and 3) including renal outcomes within the hierarchical outcome. In addition to the WR, the win odds (WO), in which 50% of the ties are allocated to both the numerator and denominator of the WR-a potentially more suitable modification of the WR that accounts for the presence of ties-were presented.

Results: Excluding NT-proBNP (WR, 1.49; 95% CI, 1.00-2.22; WO, 1.12; 95% CI, 1.00-1.26), adjusting the NT-proBNP threshold from 25% to 10% or 50% (WR, 1.41; 95% CI, 1.06-1.89; WO, 1.27; 95% CI, 1.04-1.56 for 10%; and WR, 1.54; 95% CI, 1.11-2.12; WO, 1.25; 95% CI, 1.06-1.48 for 50%), and incorporating renal outcomes (WR, 1.44; 95% CI, 1.07-1.94; WO, 1.28; 95% CI, 1.05-1.56) consistently favored sacubitril/valsartan.

Conclusions: Multiple WR sensitivity analyses support a consistent treatment benefit of sacubitril/valsartan versus valsartan in patients with ejection fraction >40% to 60%. Future studies could consider prespecifying WR sensitivity analysis for comprehensive assessment of treatment effects.

Trial registration: PARAGLIDE-HF; ClinicalTrials.gov ID, NCT03988634 (https://clinicaltrials.gov/study/NCT03988634).

Background: Survivors of breast and prostate cancer, especially those that are Black and/or Hispanic, are at high risk for cardiovascular events. Physical activity can reduce the risk of cardiovascular events in cancer survivors, but Black and Hispanic people are less likely to engage in routine physical activity. Concepts from behavioral economics have been used to design scalable, low-touch, gamification interventions that increase physical activity in individuals at high risk for cardiovascular events, but the effectiveness of these strategies in Black and Hispanic survivors of breast and prostate cancer is uncertain.

Study design and objectives: ALLSTAR (NCT05176756) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of a gamification intervention informed by behavioral economic concepts to increase daily physical activity in Black and Hispanic breast and prostate cancer survivors who received cardiotoxic therapies and have additional risk factors for cardiovascular disease. Patients were either referred by their cancer care team or identified by electronic health record searches; contacted by letter, email, text message and/or phone; and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 1500-3000 steps from baseline, and are randomized 1:1 to control or gamification. Interventions continue for 6 months, with follow-up for an additional 3 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 150 participants, with a primary endpoint of change from baseline in daily steps over the 6-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 3-month post-intervention follow-up period, change in moderate to vigorous physical activity over the intervention and follow-up periods, and change in patient-reported measures of physical function, fatigue, and overall quality of life.

Conclusions: ALLSTAR is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification is superior to control in increasing physical activity in Black and Hispanic breast and prostate cancer survivors. Its results will have important implications for strategies to promote physical activity in survivors of breast and prostate cancer, specifically among minority populations.

Clinical trial registration: clinicaltrials.gov; https://clinicaltrials.gov/study/NCT05176756.