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Journal of Arrhythmia Jun 2024Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often...
Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN-ICD/WCD study): Rationale and design of a...
BACKGROUND
Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients.
METHODS
We are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all-cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints.
RESULTS
Not applicable.
CONCLUSION
This study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.
PubMed: 38939793
DOI: 10.1002/joa3.13028 -
Journal of Arrhythmia Jun 2024Warfarin is considered the primary oral anticoagulant for patients with atrial fibrillation and end-stage renal disease (ESRD) requiring dialysis. Although warfarin can...
BACKGROUND
Warfarin is considered the primary oral anticoagulant for patients with atrial fibrillation and end-stage renal disease (ESRD) requiring dialysis. Although warfarin can offer significant stroke prevention in this population, the accompanying major bleeding risks make warfarin nearly prohibitive. Apixaban was shown to be superior to warfarin in preventing stroke or systemic embolism, with a lower risk of bleeding and mortality in a large, randomized trial of individuals with mostly normal renal function but none with ESRD.
METHODS
We systematically reviewed evidence comparing apixaban versus warfarin for atrial fibrillation in this population, and evaluated outcomes of stroke or systemic embolism, and major bleeding using random-effects models. The main safety outcome was major bleeding, and the main effectiveness outcome was stroke or systemic embolism.
RESULTS
We found five observational studies of 10 036 patients (2638 receiving apixaban, and 7398 receiving warfarin) meeting inclusion criteria. Pooled analysis demonstrated a significant reduction in major bleeding with apixaban as compared to warfarin (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.42-0.61; < .0001). Apixaban was also associated with a reduction in intracranial bleeding (OR 0.58, 95% CI 0.37-0.92; = .02) and in gastrointestinal bleeding (OR 0.61, 95% CI 0.51-0.73; < .0001). Furthermore, apixaban was associated with a reduction in stroke/systemic embolism (OR 0.64, 95% CI 0.50-0.82; < .0001).
CONCLUSION
Apixaban was associated with superior outcomes and reduced adverse events compared to warfarin in observational studies of patients with atrial fibrillation on dialysis. Randomized controlled studies are needed to confirm these findings.
PubMed: 38939758
DOI: 10.1002/joa3.13051 -
American Journal of Preventive... Jun 2024The American Heart Association's (AHA) Life's Essential 8 (LE8) score is a helpful tool to quantify cardiovascular health (CVH) metrics. We sought to assess sex...
BACKGROUND
The American Heart Association's (AHA) Life's Essential 8 (LE8) score is a helpful tool to quantify cardiovascular health (CVH) metrics. We sought to assess sex differences in relation to LE8 and its components along with association with mortality.
METHODS
The National Health and Nutrition Examination Survey (NHANES) between 2009 and 2018 was utilized to evaluate the prevalence of health metrics included in LE8 among adult participants > age 18, stratified by sex. We categorized overall CVH, health factors, and health behaviors into 3 levels (low: <50, moderate: 50 -79, high: ≥80) following the AHA's algorithm. Health metrics were further subdivided into health behaviors (diet, physical activity, nicotine exposure, and sleep) and health factors (body mass index, non-high density lipoprotein cholesterol, blood glucose, and blood pressure). LE8 scores were also evaluated based on age, race/ethnicity, and socioeconomic status. Cox proportional hazard models were used to evaluate the association between the levels of CVH and risk of all-cause and cardiovascular mortality, with adjustment for age group and race.
RESULTS
Among 22,761 participants, 52 % were female. Overall CVH score was similar in both females and males (65.8 vs. 65.9). Females had higher health factors score (64.3 vs. 63.1, < 0.001) and lower health behaviors score (67.2 vs 68.6, < 0.001). Amongst individual metrics, blood pressure score was higher in females (73.2 vs. 67.7, < 0.001) while males had higher physical activity score (70.6 vs. 54.9, < 0.001). For individuals under 65 years of age, overall CVH and health factors scores were higher in females while in those age 65 or older, males had higher scores. The most prominent sex differences were noted in non-Hispanic Black females who had significantly lower CVH scores than Black males (62.6 vs. 74.7, respectively, < 0.001. High LE8 scores vs. low LE8 scores demonstrated lower all-cause (HR 0.37 vs 0.35) and CV mortality (HR 0.35 vs. 0.36) in both males and females, respectively (p-interaction 0.21 and 0.28). High health behaviors scores also demonstrated a significant association with lower all-cause (0.34 vs. 0.24) and CV mortality (HR 0.47 vs. 0.26) in both males and females, respectively (p-interaction 0.20 and 0.11).
CONCLUSIONS
We demonstrate important sex differences in CVH metrics along with notable variations based on age and race/ethnicity. Furthermore, we highlight that CVH metrics including health factors and health behaviors are associated with mortality in both females and males. These findings underscore the importance of designing and implementing effective strategies for both sexes, aimed at targeting these specific factors.
PubMed: 38939696
DOI: 10.1016/j.ajpc.2024.100685 -
JACC. Advances Apr 2024Statins are highly effective for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and mortality. Data on the benefit of statins in adults with heart...
BACKGROUND
Statins are highly effective for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and mortality. Data on the benefit of statins in adults with heart failure with preserved ejection fraction (HFpEF) and without ASCVD are limited.
OBJECTIVES
The purpose of this study was to determine whether statins are associated with a lower risk of mortality and major adverse cardiovascular events (MACE) in HFpEF.
METHODS
Veterans Health Administration data from 2002 to 2016, linked to Medicare and Medicaid claims and pharmaceutical data, were collected. Patients had a new HFpEF diagnosis and no known ASCVD or prior statin use at baseline. Cox proportional hazards models were fit to evaluate the association of new statin use with outcomes (all-cause mortality and MACE). Propensity score overlap weighting (PSW) was used to balance baseline characteristics.
RESULTS
Among 7,970 Veterans, 47% initiated a statin over a mean 6.0-year follow-up. At HFpEF diagnosis, mean age was 69 ± 12 years, 96% were male, 67% were White, 14% were Black, and mean EF was 60% ± 6%. Before PSW, statin users were younger with more prevalent metabolic syndrome, arthritis, and other chronic conditions. All characteristics were balanced after PSW. There were 5,314 deaths and 4,859 MACE events. After PSW, the hazard for all-cause mortality for statin users vs nonusers was 22% lower (HR: 0.78; 95% CI: 0.73-0.83). The HR for MACE was 0.79 (95% CI: 0.74-0.84), 0.69 (95% CI: 0.60-0.80) for all-cause hospitalization, and 0.72 (95% CI: 0.59-0.88) for HF hospitalization.
CONCLUSIONS
New statin use was associated with reduced all-cause mortality, MACE, and hospitalization in Veterans with HFpEF without prevalent ASCVD.
PubMed: 38939680
DOI: 10.1016/j.jacadv.2024.100869 -
JACC. Advances Apr 2024There is a paucity of data on long-term outcomes after Fontan palliation in patients with a dominant morphological univentricular right (uRV) vs left (uLV) ventricle.
BACKGROUND
There is a paucity of data on long-term outcomes after Fontan palliation in patients with a dominant morphological univentricular right (uRV) vs left (uLV) ventricle.
OBJECTIVES
The purpose of this study was to compare the incidence of atrial arrhythmias, thromboembolic events, cardiac transplantation, and death following Fontan palliation in patients with uRV vs uLV.
METHODS
The Alliance for Adult Research in Congenital Cardiology conducted a multicenter retrospective cohort study on patients with total cavopulmonary connection Fontan palliation across 12 centers in North America. All components of the composite outcome, that is, atrial arrhythmias, thromboembolic events, cardiac transplantation, and death, were reviewed and classified by a blinded adjudicating committee. Time-to-event analyses were performed that accounted for competing risks.
RESULTS
A total of 384 patients were followed for 10.5 ± 5.9 years. The composite outcome occurred in 3.7 vs 1.7 cases per 100 person-years for uRV (N = 171) vs uLV (N = 213), respectively ( < 0.001). In multivariable analyses, uRV conferred a >2-fold higher risk of the composite outcome (HR: 2.17, 95% CI: 1.45-3.45, < 0.001). In secondary analyses of components of the primary outcome, uRV was significantly associated with a greater risk of cardiac transplantation or death (HR: 9.09, 95% CI: 2.17-38.46, < 0.001) and atrial arrhythmias (HR: 2.17, 95% CI: 1.20-4.00, = 0.010) but not thromboembolic events (HR: 1.64, 95% CI: 0.86-3.16, = 0.131).
CONCLUSIONS
Fontan patients with uRV vs uLV morphology have a higher incidence of adverse cardiovascular events, including atrial arrhythmia, cardiac transplantation, and all-cause mortality.
PubMed: 38939676
DOI: 10.1016/j.jacadv.2024.100871 -
JACC. Advances Apr 2024Pediatric pulmonary embolism (PE) is rare and potentially life-threatening. Though thrombolysis and thrombectomy are increasingly used in adult PE, trends in pediatric...
BACKGROUND
Pediatric pulmonary embolism (PE) is rare and potentially life-threatening. Though thrombolysis and thrombectomy are increasingly used in adult PE, trends in pediatric treatment and outcomes remain incompletely described.
OBJECTIVES
The purpose of this study was to describe the incidence of PE, proportion of cases treated with anticoagulation alone, systemic thrombolysis, and directed therapy (local thrombolysis and thrombectomy), clinical outcomes, and total costs.
METHODS
A multicenter observational study was performed using administrative data from the Pediatric Health Information System database to study PE treated at U.S. pediatric hospitals from 2015 to 2021. Outcomes by treatment were evaluated using multivariable generalized linear mixed effects models.
RESULTS
Of 3,136 subjects, 70% were at least 12 years of age, and 46% were male. Sixty-two percent had at least 1 comorbidity, and congenital heart disease of any kind was the most prevalent (20%). Eighty-eight percent of subjects received anticoagulation alone, 7% received systemic thrombolysis, and 5% received directed therapy. Overall in-hospital mortality was 7.5%. Treatment approach did not change over time ( = 0.98). After adjusting for patient characteristics, directed therapy was associated with a lower risk of mortality (adjusted percentage -3%, [95% CI: -5% to 0%]) than anticoagulation alone. Systemic thrombolysis was associated with a greater total cost of hospitalization ($113,043 greater [95% CI: $62,866, $163,219]). Length of hospital stay did not differ by treatment.
CONCLUSIONS
Pediatric patients with PE have a high incidence of underlying chronic disease. Anticoagulation alone remains the mainstay of treatment, with thrombolysis and thrombectomy rarely being used. Given the relative rarity of pediatric PE, additional research requiring innovative study designs is paramount.
PubMed: 38939674
DOI: 10.1016/j.jacadv.2024.100895 -
JACC. Advances Apr 2024Maternal mortality is a major public health crisis in the United States. Cardiovascular disease (CVD) is a leading cause of maternal mortality and morbidity. Labor and... (Review)
Review
Maternal mortality is a major public health crisis in the United States. Cardiovascular disease (CVD) is a leading cause of maternal mortality and morbidity. Labor and delivery is a vulnerable time for pregnant individuals with CVD but there is significant heterogeneity in the management of labor and delivery in high-risk patients due in part to paucity of high-quality randomized data. The authors have convened a multidisciplinary panel of cardio-obstetrics experts including cardiologists, obstetricians and maternal fetal medicine physicians, critical care physicians, and anesthesiologists to provide a practical approach to the management of labor and delivery in high-risk individuals with CVD. This expert panel will review key elements of management from mode, timing, and location of delivery to use of invasive monitoring, cardiac devices, and mechanical circulatory support.
PubMed: 38939671
DOI: 10.1016/j.jacadv.2024.100901 -
JACC. Advances Apr 2024Adult congenital heart disease (ACHD) patients have significant morbidity and rise in cardiac admissions. Their outcome with high-dose influenza vaccination is unknown...
BACKGROUND
Adult congenital heart disease (ACHD) patients have significant morbidity and rise in cardiac admissions. Their outcome with high-dose influenza vaccination is unknown in comparison to those without ACHD.
OBJECTIVES
The purpose of this study was to compare all-cause mortality or cardiopulmonary hospitalizations in self-identified ACHD versus non-ACHD patients receiving high- or low-dose influenza vaccination within the INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure trial.
METHODS
We prospectively included ACHD patients in the INVESTED (INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure) trial. The primary endpoint was all-cause death or hospitalization for cardiovascular or pulmonary causes.
RESULTS
Of the 272 ACHD patients, 132 were randomly assigned to receive high-dose trivalent and 140 to standard-dose quadrivalent influenza vaccine. Compared to the non-ACHD cohort (n = 4,988), ACHD patients were more likely to be younger, women, smokers, have atrial fibrillation, and have a qualifying event of heart failure. The primary outcome was 49.8 events versus 42.8 events per 100 person-years (adjusted HR: 1.17; 95% CI: 0.95-1.45; = 0.144) in the ACHD group and non-ACHD group, respectively. The interaction between ACHD status and randomized treatment effect was not significant for the primary outcome ( = 0.858). Vaccine-related adverse events were similar in both groups.
CONCLUSIONS
Patients who self-identify as being ACHD had similar primary outcome of all-cause death or hospitalization for cardiovascular or pulmonary causes compared to non-ACHD cohort. High-dose influenza vaccination was similar to standard-dose influenza vaccination on the primary outcome in patients who self-identify as ACHD.
PubMed: 38939662
DOI: 10.1016/j.jacadv.2024.100897 -
JACC. Advances Apr 2024Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models...
BACKGROUND
Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models have important limitations, including reliance on data that may not be routinely available, narrow focus on primary prevention, limited patient populations, and longtime horizons for risk prediction.
OBJECTIVES
The purpose of this study was to derive and internally validate a claims-based prediction model for 1-year risk of MACE in type 2 diabetes.
METHODS
Using medical and pharmacy claims for adults with type 2 diabetes enrolled in commercial, Medicare Advantage, and Medicare fee-for-service plans between 2014 and 2021, we derived and internally validated the annualized claims-based MACE estimator (ACME) model to predict the risk of MACE (nonfatal acute myocardial infarction, nonfatal stroke, and all-cause mortality). The Cox proportional hazards model was composed of 30 covariates, including patient age, sex, comorbidities, and medications.
RESULTS
The study cohort comprised 6,623,526 adults with type 2 diabetes, mean age 68.1 ± 10.6 years, 49.8% women, and 73.0% Non-Hispanic White. ACME had a concordance index of 0.74 (validation index range: 0.739-0.741). The predicted 1-year risk of the study cohort ranged from 0.4% to 99.9%, with a median risk of 3.4% (IQR: 2.3%-6.5%).
CONCLUSIONS
ACME was derived in a large usual care population, relies on routinely available data, and estimates short-term MACE risk. It can support population risk stratification at the health system and payer levels, participant identification for decentralized clinical trials of cardiovascular disease, and risk-stratified observational studies using real-world data.
PubMed: 38939660
DOI: 10.1016/j.jacadv.2024.100852 -
JACC. Advances Apr 2024The progression rate of aortic stenosis differs between patients, complicating clinical follow-up and management.
BACKGROUND
The progression rate of aortic stenosis differs between patients, complicating clinical follow-up and management.
OBJECTIVES
This study aimed to identify predictors associated with the progression rate of aortic stenosis.
METHODS
In this retrospective longitudinal single-center cohort study, all patients with moderate aortic stenosis who presented between December 2011 and December 2022 and had echocardiograms available were included. The individual aortic stenosis progression rate was calculated based on aortic valve area (AVA) from at least 2 echocardiograms performed at least 6 months apart. Baseline factors associated with the progression rate of AVA were determined using linear mixed-effects models, and the association of progression rate with clinical outcomes was evaluated using Cox regression.
RESULTS
The study included 540 patients (median age 69 years and 38% female) with 2,937 echocardiograms (median 5 per patient). Patients had a linear progression with a median AVA decrease of 0.09 cm/y and a median peak jet velocity increase of 0.17 m/s/y. Rapid progression was independently associated with all-cause mortality (HR: 1.77, 95% CI: 1.26-2.48) and aortic valve replacement (HR: 3.44, 95% CI: 2.55-4.64). Older age, greater left ventricular mass index, atrial fibrillation, and chronic kidney disease were associated with a faster decline of AVA.
CONCLUSIONS
AVA decreases linearly in individual patients, and faster progression is independently associated with higher mortality. Routine clinical and echocardiographic variables accurately predict the individual progression rate and may aid clinicians in determining the optimal follow-up interval for patients with aortic stenosis.
PubMed: 38939659
DOI: 10.1016/j.jacadv.2024.100879