-
JACC. Advances Nov 2023Surgery for isolated functional tricuspid regurgitation (TR) poses a high risk. Several transcatheter approaches are being evaluated for the treatment of such patients....
BACKGROUND
Surgery for isolated functional tricuspid regurgitation (TR) poses a high risk. Several transcatheter approaches are being evaluated for the treatment of such patients. The K-Clip system is a percutaneous approach designed for functional TR; however, its utility remains unknown.
OBJECTIVES
This study aimed to report the 30-day echocardiographic and clinical outcomes with the K-Clip system for severe TR, including changes in TR severity and NYHA functional class.
METHODS
Transcatheter tricuspid valve annuloplasty was performed in 39 patients with intermediate or high surgical risk who underwent the K-Clip system. The right internal jugular vein procedure was performed with annuloplasty guided by fluoroscopy and echocardiography. The primary outcomes were clinical success and all-cause mortality at the 30-day follow-up.
RESULTS
The K-Clip was successfully implanted in all cases, with 1 to 3 devices deployed. At the 30-day follow-up, none of the patients had died. TR severity was reduced by at least one grade in all patients. There were no severe procedural or 30-day adverse events, except for 1 new pacemaker implantation. The proportion of NYHA class III-IV patients decreased from 79.5% to 5.1%, and the ascites disappeared. The 6-minute walk distance increased by 78 m ( < 0.05), and the Kansas City Cardiomyopathy Questionnaire score improved by 11 points ( < 0.05).
CONCLUSIONS
The K-Clip device is practical, safe, and effective for patients with severe TR. A 30-day reduction in TR and enhanced cardiac function and quality of life were associated with transcatheter tricuspid annuloplasty using the K-Clip device, according to short-term follow-up studies. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System [TriStar]; NCT05173233).
PubMed: 38938712
DOI: 10.1016/j.jacadv.2023.100671 -
Frontiers in Nutrition 2024Phospholipids (PLs) and long-chain polyunsaturated fatty acids (LCPUFAs) are naturally present in breast milk and play important roles in promoting the growth of the...
A combination of phospholipids and long chain polyunsaturated fatty acids supports neurodevelopmental outcomes in infants: a randomized, double-blind, controlled clinical trial.
Phospholipids (PLs) and long-chain polyunsaturated fatty acids (LCPUFAs) are naturally present in breast milk and play important roles in promoting the growth of the infant. Several studies have investigated the effects of the combination of PLs and LCPUFAs on neurodevelopment. However, data on the effectiveness of infant formula containing both PLs and LCPUFAs on the neurodevelopment of infants is still scarce. This randomized, double-blind, controlled clinical study was designed to evaluate the effect of an infant formula enriched with PLs and LCPUFAs on growth parameters and neurodevelopmental outcomes in term infants up to 365 days of age. Infants were enrolled within 30 days of birth who were then randomly assigned to either a control group ( = 150) or an investigational group ( = 150). Both groups consist of cow's milk-based formula which were generally identical in terms of composition, except that the investigational formula was additionally supplemented with PLs and LCPUFAs. The infants were followed for the first year of life. Breastfed infants were the reference ( = 150). Bayley Scales of Infant Development [3rd edition (Bayley-III)], Carey Toddler Temperament Scales (TTS), MacArthur-Bates Communicative Development Inventories (CDI), Single Object Attention and Free Play Tasks were used to evaluate neurodevelopmental outcomes of infant at 365 days of age. In addition, Ages and Stages Questionnaires (ASQ) were also conducted at 120, 180, and 275 days of age. Compared to breastfeeding, both infant formulas were well-tolerated and provided adequate growth, with no adverse events being reported throughout the study. Infants of the investigational group showed higher mean scores in Bayley-III cognitive performance (104.3 vs. 99.0, < 0.05), language (106.9 vs. 104.5, < 0.05), and motor skills (109.2 vs. 103.9, < 0.05) compared the control group. Similar results were being reported for other developmental scales including TTS and ASQ. Notably, the test scores of infants fed the investigational formula were similar to those who were breastfed. Our results indicate that PL and LCPUFA supplementation may be beneficial for neurodevelopment of infants throughout the first year of life. Further studies are needed to investigation long-term effects PL and LCPUFA on neurodevelopment in early life.
PubMed: 38938667
DOI: 10.3389/fnut.2024.1358651 -
PeerJ 2024Whether the relationship of intracerebral bleeding risk with lipid profile may vary by sex remains unclear. This study aims to investigate potential sex differences in... (Observational Study)
Observational Study
Sex difference in the association between triglyceride and intracerebral bleeding risk after intravenous thrombolysis for acute ischemic stroke, a multi-center retrospective study.
BACKGROUND
Whether the relationship of intracerebral bleeding risk with lipid profile may vary by sex remains unclear. This study aims to investigate potential sex differences in the association between lipid profile and the risk of symptomatic intracerebral hemorrhage (sICH) in patients with acute ischemic stroke (AIS) who received intravenous thrombolysis using recombinant tissue plasminogen activator (r-tPA).
METHODS
This multicenter retrospective observational study analyzed patients with AIS treated with intravenous r-tPA. sICH was defined as a worsening of 4 or higher points in the National Institutes of Health Stroke Scale (NIHSS) score within 36 hours after intravenous thrombolysis in any hemorrhage subtype. We assessed the odds ratio (OR) with 95% confidence interval (CI) of lipid profile for sICH for each sex using logistic regression models adjusted for potential confounding factors.
RESULTS
Of 957 participants (median age 68 (interquartile range, 59-75), men 628 (65.6%)), 56 sICH events (36 (5.7%) in men and 20 (6.1%) in women) were observed. The risk of sICH in men decreased with increasing serum levels of triglyceride after adjustment for confounding factors ( lowest tertile, medium tertile OR 0.39, 95% CI [0.17-0.91], top tertile OR 0.33, 95% CI [0.13-0.84], overall = 0.021; per point increase, adjusted OR 0.29, 95% CI [0.13-0.63], = 0.002). Neither serum levels of total cholesterol nor low-density lipoprotein (LDL) was associated with sICH in men. In women, there was no association between any of the lipid levels and the risk of sICH.
CONCLUSIONS
This study indicated that the association between serum levels of triglyceride and sICH may vary by sex. In men, increased triglyceride levels decrease the risk of sICH; in women, this association was lost. Further studies on the biological mechanisms for sex differences in stroke risk associated with triglyceride are needed.
Topics: Humans; Male; Female; Retrospective Studies; Aged; Triglycerides; Middle Aged; Ischemic Stroke; Cerebral Hemorrhage; Tissue Plasminogen Activator; Sex Factors; Risk Factors; Thrombolytic Therapy; Fibrinolytic Agents
PubMed: 38938613
DOI: 10.7717/peerj.17558 -
JACC. Advances Dec 2023Statins can improve outcomes in high-risk primary prevention populations. However, application in clinical practice has lagged.
BACKGROUND
Statins can improve outcomes in high-risk primary prevention populations. However, application in clinical practice has lagged.
OBJECTIVES
The objective of this study was to compare an active vs a passive strategy (ie, usual care) to statin prescription for primary prevention of atherosclerotic cardiovascular disease (ASCVD).
METHODS
A total of 3,770 patients ≥50 years of age without a history of ASCVD or statin use were invited to enroll in CorCal, with 601 consenting to participate. These patients were randomized 1:1 to statin initiation guided by the pooled cohort equation or by coronary artery calcium scoring (CACS). Outcomes (2.8-year follow-up) compared patients managed actively vs passively (randomly invited but declined or did not respond).
RESULTS
Patient demographics were well matched. Statin recommendation was common among enrolled patients (41.7%). During follow-up, 25.3% of active patients were taking a statin vs 9.8% managed passively ( < 0.0001). Active patients had more lipid panels (median 2.0 vs 1.0), lower low-density lipoprotein cholesterol (109 vs 117 mg/dL) (both < 0.0001), and a low rate of major adverse cardiovascular events during follow-up (0.6% vs 1.0%, = 0.47). Statistical comparisons included -tests, chi-squared tests, nonparametric tests, and time-to-event tests as appropriate.
CONCLUSIONS
An active approach to statin selection for primary ASCVD prevention identified a large treatment opportunity and led to over twice as many patients on statins compared to passive (usual care) management. A large CorCal Outcomes Trial is underway to more definitively assess the impact on outcomes of active management of statins for primary prevention.
PubMed: 38938499
DOI: 10.1016/j.jacadv.2023.100676 -
JACC. Advances Dec 2023Clinical significance of an integrated evaluation of epicardial adipose tissue (EAT) and the right ventricle (RV) in heart failure with preserved ejection fraction...
BACKGROUND
Clinical significance of an integrated evaluation of epicardial adipose tissue (EAT) and the right ventricle (RV) in heart failure with preserved ejection fraction (HFpEF) is unknown.
OBJECTIVES
The authors investigated the potential of EAT and RV quantification for obesity-related pathophysiology and risk stratification in obese HFpEF patients using cardiovascular magnetic resonance (CMR).
METHODS
A total of 150 patients (obese, body mass index ≥30 kg/m; n = 73, nonobese, body mass index <30 kg/m; n = 77) with a clinical diagnosis of HFpEF undergoing CMR were retrospectively identified. EAT volume surrounding both ventricles were quantified with manual delineation on cine images. Total RV volume (TRVV) was calculated as the sum of RV cavity and mass at end-diastole. The endpoint was the composite of all-cause mortality and first HF hospitalization.
RESULTS
During a median follow-up of 46 months, 39 nonobese patients (51%) and 32 obese patients (44%) experienced the endpoint. EAT was a prognostic biomarker regardless of obesity and was independently correlated with TRVV. In obese HFpEF, EAT correlated with RV longitudinal strain (r = 0.32, = 0.006), and increased amount of EAT and TRVV was associated with greater left ventricular end-diastolic eccentric index (r = 0.36, = 0.002). The integration of RV quantification into EAT provided improved risk stratification with a C-statistic increase from 0.70 to 0.79 in obese HFpEF. Obese patients with EAT<130 ml and TRVV<180 ml had low risk (annual event rate 3.2%), while those with increased EAT ≥130 ml and TRVV ≥180 ml had significantly higher risk (annual event rate 11.8%; < 0.001).
CONCLUSIONS
CMR quantification of EAT and RV structure provides additive risk stratification for adverse outcomes in obese HFpEF.
PubMed: 38938495
DOI: 10.1016/j.jacadv.2023.100730 -
JACC. Advances Dec 2023Lipid-lowering therapy (LLT) is a central aspect of the treatment of patients with coronary artery disease (CAD), and the benefits of LLT accrue over time. However,...
BACKGROUND
Lipid-lowering therapy (LLT) is a central aspect of the treatment of patients with coronary artery disease (CAD), and the benefits of LLT accrue over time. However, there are limited real-world data on longitudinal lipid control in patients with premature CAD.
OBJECTIVES
The purpose of this study was to assess longitudinal attainment of guideline-recommended lipid goals and outcomes in a contemporary cohort of patients with premature CAD.
METHODS
We enrolled males younger than 50 years and females younger than 55 years with coronary stenosis of >50% and examined achievement of lipid goals, LLT characteristics, and cardiovascular outcomes (major adverse cardiovascular event [MACE]).
RESULTS
Of 476 patients who presented with acute coronary syndrome (ST-elevation myocardial infarction, non-ST-segment elevation myocardial infarction, unstable angina) (68%), stable angina (28%), or other symptoms, 73.2% achieved low-density lipoprotein cholesterol (LDL-C) <1.8 mmol/L on at least 1 occasion, but only 27.3% consistently stayed in the target range for 3 years after diagnosis. Although 73.9% of patients received high-intensity LLT at the time of diagnosis, only 43.5% had good adherence over the following 3 years. In multivariable analysis, 1 mmol/L increase in time-weighted average exposure to LDL-C, but not the lowest achieved LDL-C, was associated with a higher risk of MACE, hazard ratio 2.02 (95% CI: 1.48-2.76), when adjusted for sex, age, hypertension, diabetes, and smoking.
CONCLUSIONS
We found low rates of longitudinal lipid target achievement in patients with premature CAD. Cumulative LDL-C exposure, but not lowest achieved LDL-C, was associated with risk of MACE. This highlights the critical importance of longitudinal control of lipids levels and identifies opportunities to improve LLT and maximize the time-dependent benefits of lipid-lowering.
PubMed: 38938482
DOI: 10.1016/j.jacadv.2023.100696 -
JACC. Advances Oct 2023Substance use and cardiovascular (CV) events are increasing among pregnant women in the United States, but association between substance use in pregnancy and CV events...
BACKGROUND
Substance use and cardiovascular (CV) events are increasing among pregnant women in the United States, but association between substance use in pregnancy and CV events remains unknown.
OBJECTIVES
The purpose of this study was to examine the association between substance use and acute CV events in pregnancy.
METHODS
We identified all women with a delivery hospitalization between 2004 and 2018 in the Nationwide Inpatient Sample, stratified on the presence or absence of substance use. The primary outcome was any acute CV event, defined as the presence of: acute myocardial infarction, stroke, arrhythmia, endocarditis, acute cardiomyopathy or heart failure, or cardiac arrest. Secondary outcomes were individual acute CV events, major adverse cardiac events, and maternal mortality. The association between substance use and outcomes were examined using multivariable logistical regression.
RESULTS
A total of 60,014,368 delivery hospitalizations occurred from 2004 to 2018, with substance use complicating 955,531 (1.6%) deliveries. Substance use was independently associated with CV events (adjusted odds ratio [aOR]: 1.61; 95% CI: 1.53-1.70; < 0.001), major adverse cardiac events (aOR: 1.53; 95% CI: 1.46-1.61; < 0.001), and maternal mortality (aOR: 2.65; 95% CI: 2.15-3.25; < 0.001) during delivery hospitalization. All individual substances had an increased association with CV events; however, amphetamine/methamphetamine had the strongest association (aOR: 2.71; 95% CI: 2.35-3.12; < 0.001). All substances other than cocaine and cannabis had a significant association with maternal death.
CONCLUSIONS
Substance use has a strong association with acute CV events and maternal mortality during hospitalization for delivery and women with substance use warrant increased surveillance for CV events during this time.
PubMed: 38938361
DOI: 10.1016/j.jacadv.2023.100619 -
JACC. Advances Oct 2023Little evidence is available on the disease expression in relatives of index patients with hypertrophic cardiomyopathy (HCM). This information has important implications...
BACKGROUND
Little evidence is available on the disease expression in relatives of index patients with hypertrophic cardiomyopathy (HCM). This information has important implications for family screening programs, genetic counseling, and management of affected families.
OBJECTIVES
The purpose of this study was to investigate the disease expression and penetrance in relatives of index patients carrying pathogenic/likely pathogenic (P/LP) variants in recognized HCM genes.
METHODS
A total of 453 consecutive and unrelated HCM index patients underwent clinical and genetic investigations. A total of 903 relatives of genotype-positive index patients were invited for clinical investigations and genetic testing. Penetrance, disease expression, and incidence rates of major adverse cardiac events (MACEs) were investigated in individuals carrying P/LP variants.
RESULTS
Forty percent (183/453) of index patients carried a P/LP variant. Eighty-four percent (757/903) of all relatives of index patients with P/LP variants were available for the investigation, of whom 54% (407/757) carried a P/LP variant. The penetrance of HCM among relatives was 39% (160/407). Relatives with HCM and index patients were diagnosed at a similar age (43 ± 18 years vs 46 ± 15 years; = 0.11). There were no differences in clinical characteristics or incidence rates of MACE during 8 years of follow-up.
CONCLUSIONS
The disease expression of HCM among index patients and affected relatives carrying P/LP variants in recognized disease genes was similar, with an equal risk of experiencing MACE. These findings provide evidence to support family screening and follow-up of genotype-positive HCM families to improve management and diminish the number of adverse disease complications among relatives.
PubMed: 38938358
DOI: 10.1016/j.jacadv.2023.100604 -
JACC. Advances Oct 2023The use of mobile health (mHealth, wireless communication devices, and/or software technologies) in health care delivery has increased rapidly in recent years. Their...
BACKGROUND
The use of mobile health (mHealth, wireless communication devices, and/or software technologies) in health care delivery has increased rapidly in recent years. Their integration into disease management programs (DMPs) has tremendous potential to improve outcomes for patients with coronary artery disease (CAD), yet a more robust evaluation of the evidence is required.
OBJECTIVES
The purpose of this study was to undertake a systematic review and meta-analysis of mHealth-enabled DMPs to determine their effectiveness in reducing readmissions and mortality in patients with CAD.
METHODS
We systematically searched English language studies from January 1, 2007, to August 3, 2021, in multiple databases. Studies comparing mHealth-enabled DMPs with standard DMPs without mHealth were included if they had a minimum 30-day follow-up for at least one of all-cause or cardiovascular-related mortality, readmissions, or major adverse cardiovascular events.
RESULTS
Of the 3,411 references from our search, 155 full-text studies were assessed for eligibility, and data were extracted from 18 publications. Pooled findings for all-cause readmissions (10 studies, n = 1,514) and cardiac-related readmissions (9 studies, n = 1,009) indicated that mHealth-enabled DMPs reduced all-cause (RR: 0.68; 95% CI: 0.50-0.91) and cardiac-related hospitalizations (RR: 0.55; 95% CI: 0.44-0.68) and emergency department visits (RR: 0.37; 95% CI: 0.26-0.54) compared to DMPs without mHealth. There was no significant reduction for mortality outcomes (RR: 1.72; 95% CI: 0.64-4.64) or major adverse cardiovascular events (RR: 0.68; 95% CI: 0.40-1.15).
CONCLUSIONS
DMPs integrated with mHealth should be considered an effective intervention for better outcomes in patients with CAD.
PubMed: 38938339
DOI: 10.1016/j.jacadv.2023.100591 -
JACC. Advances Oct 2023Little is known regarding the formation of coronary and carotid plaques and their impact on cardiovascular disease in patients with familial hypercholesterolemia (FH).
BACKGROUND
Little is known regarding the formation of coronary and carotid plaques and their impact on cardiovascular disease in patients with familial hypercholesterolemia (FH).
OBJECTIVES
This study aimed to determine: 1) if the development of coronary and carotid plaques is correlated; and 2) if these plaques are associated with major adverse cardiac events (MACEs) defined as cardiovascular-related death, unstable angina, myocardial infarction, or staged revascularization.
METHODS
This was a retrospective review of 622 patients with heterozygous FH (HeFH) at Kanazawa University Hospital, assessed coronary and carotid plaque scores using coronary computed tomography and carotid ultrasound within 1 year. Spearman correlation coefficients were assessed among variables. Risk factors for MACEs were determined using the Cox proportional hazard model.
RESULTS
Coronary and carotid plaque scores were significantly correlated in patients with HeFH in both sexes (Spearman's r = 0.82; < 0.001 in males and Spearman's r = 0.87; < 0.001 in females). We observed 132 MACEs during the median follow-up of 13.2 years. These scores were significantly associated with the occurrence of MACE (HR: 3.33; 95% CI: 1.88-4.78; < 0.001, HR: 2.24; 95% CI: 1.28-3.20; < 0.001, respectively).
CONCLUSIONS
Coronary and carotid plaque scores were significantly correlated, and both were independently associated with MACEs. The assessments for coronary and/or carotid plaque are useful for further risk stratifications in patients with HeFH.
PubMed: 38938338
DOI: 10.1016/j.jacadv.2023.100594