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JACC. Advances Feb 2024Increased particulate matter <2.5 μm (PM) air pollution is associated with adverse cardiovascular outcomes. However, its impact on patients with prior coronary artery...
BACKGROUND
Increased particulate matter <2.5 μm (PM) air pollution is associated with adverse cardiovascular outcomes. However, its impact on patients with prior coronary artery bypass grafting (CABG) is unknown.
OBJECTIVES
The purpose of this study was to evaluate the association between major adverse cardiovascular events (MACE) (defined as myocardial infarction, stroke, or cardiovascular death) and air pollution after CABG.
METHODS
We linked 26,403 U.S. veterans who underwent CABG (2010-2019) nationally with average annual ambient PM estimates using residential address. Over a 5-year median follow-up period, we identified MACE and fit a multivariable Cox proportional hazard model to determine the risk of MACE as per PM exposure. We also estimated the absolute potential reduction in PM attributable MACE simulating a hypothetical PM lowered to the revised World Health Organization standard of 5 μg/m.
RESULTS
The observed median PM exposure was 7.9 μg/m (IQR: 7.0-8.9 μg/m; 95% of patients were exposed to PM above 5 μg/m). Increased PM exposure was associated with a higher 10-year MACE rate (first tertile 38% vs third tertile 45%; < 0.001). Adjusting for demographic, racial, and clinical characteristics, a 10 μg/m increase in PM resulted in 27% relative risk for MACE (HR: 1.27, 95% CI: 1.10-1.46; < 0.001). Currently, 10% of total MACE is attributable to PM exposure. Reducing maximum PM to 5 μg/m could result in a 7% absolute reduction in 10-year MACE rates.
CONCLUSIONS
In this large nationwide CABG cohort, ambient PM air pollution was strongly associated with adverse 10-year cardiovascular outcomes. Reducing levels to World Health Organization-recommended standards would result in a substantial risk reduction at the population level.
PubMed: 38939372
DOI: 10.1016/j.jacadv.2023.100781 -
Przeglad Gastroenterologiczny 2024The eradication rate of () has decreased due to antibiotics resistance and inadequate acid suppression. Vonoprazan is a novel potassium-competitive acid blocker...
INTRODUCTION
The eradication rate of () has decreased due to antibiotics resistance and inadequate acid suppression. Vonoprazan is a novel potassium-competitive acid blocker (P-CAB), which has a rapid and sustained acid inhibitory effect and may be more effective than conventional proton pump inhibitors (PPIs) in eradication.
AIM
to study the efficacy and safety of vonoprazan as a component of first-line eradication treatment compared with conventional PPI-based therapy.
MATERIAL AND METHODS
This randomised (one to one) non-blinded study was conducted on 400 consecutive proven infected patients, of whom 200 received vonoprazan-based triple therapy, while 200 patients received PPI-based triple therapy for 14 days. The study outcomes were evaluated as eradication rate and adverse events in both patient groups.
RESULTS
The eradication rate was 86% in the vonoprazan group and 74.5% in the PPI group. The vonoprazan eradication rate was significantly higher than that of PPIs ( = 0.004). There was no significant difference regarding adverse events between both patient groups.
CONCLUSIONS
Vonoprazan-based therapy was more effective than PPI-based therapy as a first-line eradication treatment. Vonoprazan was generally safe and well tolerated.
PubMed: 38939071
DOI: 10.5114/pg.2024.139426 -
Przeglad Gastroenterologiczny 2024Because not all liver dysfunction patients are suitable for transplantations and there is a shortage of grafts, liver support therapies have gained interest. In this... (Review)
Review
Safety and efficacy of Single-Pass Albumin Dialysis (SPAD), Prometheus, and Molecular Adsorbent Recycling System (MARS) liver haemodialysis vs. Standard Medical Therapy (SMT): meta-analysis and systematic review.
INTRODUCTION
Because not all liver dysfunction patients are suitable for transplantations and there is a shortage of grafts, liver support therapies have gained interest. In this regard, extracorporeal albumin dialysis devices such as single-pass albumin dialysis (SPAD), Prometheus, and molecular adsorbent recycling system (MARS) have been valuable in supplementing standard medical therapy (SMT). However, the efficacy and safety of these devices is often questioned.Aim: We performed a systematic review to summarize the efficacy and safety of MARS, SPAD, and Prometheus as supportive treatments for liver dysfunction.
MATERIAL AND METHODS
PubMed, Medline, Cochrane Library, Web of Science, and Google Scholar electronic databases were extensively searched for all randomized trials published in English. In addition, meta-analytic analyses were performed with Review Manager software, and Cochrane's risk of bias tool embedded in this software was used for bias assessment.
RESULTS
Twelve trials including a total of 653 patients were eligible for inclusion. Subgroup analyses of data from these trials revealed that MARS and Prometheus were associated with significant removal of bilirubin (MD = -5.14 mg/dl; 95% CI: -7.26 - -3.02; < 0.00001 and MD = -8.11 mg/dl; 95% CI: -12.40 - -3.82; = 0.0002, respectively) but not bile acids and ammonia when compared to SMT. Furthermore, MARS was as effective as Prometheus and SPAD in the reduction of bilirubin (MD = 2.98 mg/dl; 95% CI: -4.26 - 10.22; = 0.42 and MD = 0.67 mg/dl; 95% CI: -2.22 - 3.56; = 0.65), bile acids (MD = -17.06 µmol/l; 95% CI: -64.33 - 30.20; = 0.48 and MD = 16.21 µmol/l; 95% CI: -17.26 - 49.68; = 0.34), and ammonia (MD = 26 µmol/l; 95% CI: -12.44 - 64.44; = 0.18). In addition, MARS had a considerable effect in improving hepatic encephalopathy (HE) (RR = 1.54; 95% CI: 1.15-2.05; = 0.004). However, neither MARS nor Prometheus had a mortality benefit compared to SMTRR (0.86; 95% CI: 0.71-1.03; = 0.11 and RR = 0.87; 95% CI: 0.66-1.14; = 0.31, respectively).
CONCLUSIONS
MARS, SPAD, and Prometheus, as liver support therapies, are equally effective in reducing albumin-bound and water-soluble substances. Moreover, MARS is associated with HE improvement. However, none of the therapies was associated with a significant reduction in mortality or adverse events.
PubMed: 38939063
DOI: 10.5114/pg.2024.139297 -
JACC. Advances Jul 2023Arterial stiffness leads to several adverse events in the older population, but there is a lack of data on its association with frailty, disability, and mortality in the...
BACKGROUND
Arterial stiffness leads to several adverse events in the older population, but there is a lack of data on its association with frailty, disability, and mortality in the same population.
OBJECTIVES
The purpose of this study was to evaluate the role of arterial stiffness in the loss of functional ability (frailty and disability) and mortality.
METHODS
Data were taken from community-dwelling aged 65 years participants without diabetes in the Toledo Study of Healthy Ageing cohort. Pulse wave velocity (PWV), assessed through SphygmoCor, was recorded at baseline. Median follow-up time were 2.99 years for frailty (frailty phenotype [FP] and Frailty Trait Scale-5 [FTS5]) and disability (Katz Index) and 6.2 for mortality. Logistic regressions models were built for disability and frailty and Cox proportional hazards model for death, adjusted by age and sex, comorbidity, cardiovascular risk factors, asymmetric dimethylarginine levels, and polypharmacy.
RESULTS
Overall, 978 (mean age 74.5 ± 5.6 years, 56.7% female) participants were included. Different cut-off points were shown for each outcome. PWV >11.5 m/s was cross-sectionally associated with frailty (FP: OR fully-adjusted model: 1.69, 95% CI: 1.45-1.97; FTS5: OR: 1.51, 95% CI: 1.22-1.87) and disability (OR: 1.51, 95% CI: 1.26-1.79); PWV >10 m/s with incident frailty by FP (OR: 1.36, 95% CI: 1.10-1.68) and FTS5 (OR: 1.40, 95% CI: 1.12-1.75), and PWV >11 m/s with death (HR: 1.28, 95% CI: 1.09-1.50). For incident (OR: 1.28, 95% CI: 1.06-1.55) and worsening disability (OR: 1.21, 95% CI: 1.02-1.45) the threshold was 12.5 m/s. Below these cut-off points, age was the best predictor of adverse outcomes.
CONCLUSIONS
Arterial stiffness predicts frailty, disability, and mortality in older people, with different cut-off points, ie,severity degrees, for each of the assessed outcomes.
PubMed: 38939008
DOI: 10.1016/j.jacadv.2023.100423 -
JACC. Advances Jun 2024Cardiogenic shock (CS) in the setting of acute myocardial infarction (AMI) is associated with high morbidity and mortality. Frailty is a common comorbidity in patients...
BACKGROUND
Cardiogenic shock (CS) in the setting of acute myocardial infarction (AMI) is associated with high morbidity and mortality. Frailty is a common comorbidity in patients with cardiovascular disease and is also associated with adverse outcomes. The impact of preexisting frailty at the time of CS diagnosis following AMI has not been studied.
OBJECTIVES
The purpose of this study was to examine the prevalence of frailty in patients admitted with AMI complicated by CS (AMI-CS) hospitalizations and its associations with in-hospital outcomes.
METHODS
We retrospectively analyzed the National Inpatient Sample from 2016 to 2020 and identified all hospitalizations for AMI-CS. We classified them into frail and nonfrail groups according to the hospital frailty risk score cut-off of 5 and compared in-hospital outcomes.
RESULTS
A total of 283,700 hospitalizations for AMI-CS were identified. Most (70.8%) occurred in the frail. Those with frailty had higher odds of in-hospital mortality (adjusted OR [aOR]: 2.17, 95% CI: 2.07 to 2.26, < 0.001), do-not-resuscitate status, and discharge to a skilled nursing facility compared with those without frailty. They also had higher odds of in-hospital adverse events, including intracranial hemorrhage, gastrointestinal hemorrhage, acute kidney injury, and delirium. Importantly, AMI-CS hospitalizations in the frail had lower odds of coronary revascularization (aOR: 0.55, 95% CI: 0.53-0.58, < 0.001) or mechanical circulatory support (aOR: 0.89, 95% CI: 0.85-0.93, < 0.001). Lastly, hospitalizations for AMI-CS showed an overall increase from 53,210 in 2016 to 57,065 in 2020 ( trend <0.001), with this trend driven by a rise in the frail.
CONCLUSIONS
A high proportion of hospitalizations for AMI-CS had concomitant frailty. Hospitalizations with AMI-CS and frailty had higher rates of in-hospital morbidity and mortality compared to those without frailty.
PubMed: 38938859
DOI: 10.1016/j.jacadv.2024.100949 -
JACC. Advances Jun 2024Heart failure with reduced ejection fraction (HFrEF) is characterized by ventricular remodeling and impaired myocardial energetics. Left ventricular pressure-volume (PV)...
BACKGROUND
Heart failure with reduced ejection fraction (HFrEF) is characterized by ventricular remodeling and impaired myocardial energetics. Left ventricular pressure-volume (PV) loop analysis can be performed noninvasively using cardiovascular magnetic resonance (CMR) imaging to assess cardiac thermodynamic efficiency.
OBJECTIVES
The aim of the study was to investigate whether noninvasive PV loop parameters, derived from CMR, could predict major adverse cardiac events (MACE) in HFrEF patients.
METHODS
PV loop parameters (stroke work, ventricular efficiency, external power, contractility, and energy per ejected volume) were computed from CMR cine images and brachial blood pressure. The primary end point was MACE (cardiovascular death, heart failure (HF) hospitalization, myocardial infarction, revascularization, ventricular tachycardia/fibrillation, heart transplantation, or left ventricular assist device implantation within 5 years). Associations between PV loop parameters and MACE were evaluated using multivariable Cox regression.
RESULTS
One hundred and sixty-four HFrEF patients (left ventricular ejection fraction ≤40%, age 63 [IQR: 55-70] years, 79% male) who underwent clinical CMR examination between 2004 and 2014 were included. Eighty-eight patients (54%) experienced at least one MACE after an average of 2.8 years. Unadjusted models demonstrated a significant association between MACE and all PV loop parameters ( < 0.05 for all), HF etiology ( < 0.001), left ventricular ejection fraction ( = 0.003), global longitudinal strain ( < 0.001), and N-terminal prohormone of brain natriuretic peptide level ( = 0.001). In the multivariable Cox regression analysis adjusted for age, sex, hypertension, diabetes, and HF etiology, ventricular efficiency was associated with MACE (HR: 1.04 (95% CI: 1.01-1.08) per-% decrease, = 0.01).
CONCLUSIONS
Ventricular efficiency, derived from noninvasive PV loop analysis from standard CMR scans, is associated with MACE in patients with HFrEF.
PubMed: 38938852
DOI: 10.1016/j.jacadv.2024.100946 -
JACC. Advances Mar 2024FAV is offered to fetuses with severe aortic valve stenosis and evolving hypoplastic left heart syndrome. An inferential analysis of TS and SAE in a large series has not...
BACKGROUND
FAV is offered to fetuses with severe aortic valve stenosis and evolving hypoplastic left heart syndrome. An inferential analysis of TS and SAE in a large series has not been reported.
OBJECTIVES
The purpose of this study was to determine factors associated with fetal aortic valvuloplasty (FAV) technical success (TS) and serious adverse events (SAEs).
METHODS
Retrospective, single-center, cohort analysis of attempted FAV from March 1, 2000, to December 31, 2020. The primary outcome was the TS of FAV, and the secondary outcome was the presence of an SAE.
RESULTS
A total of 165 FAVs were attempted in 163 patients with a median gestational age of 24.6 weeks (IQR: 22.9-27.1 weeks). FAV TS was 85% (141/165) and was higher in the 2010 to 2020 era (94% [85/90] vs 75% [56/75]; < 0.001). Pre-FAV echocardiographic left ventricle (LV) long axis dimension z-score >-0.10 ( < 0.001) and higher LV ejection fraction ( = 0.037) were independently associated with a higher odds of TS. There were 117 SAEs in 67 attempted FAVs (41%), 13 of which were fetal deaths (7.9%). By classification and regression tree analysis, gestational age <21 weeks or in older fetuses, a procedure time of ≥39.6 minutes was associated with higher SAE rate. In the multivariable logistic regression model correcting for gestational age, fetuses with an LV end-diastolic volume <4.09 mL had an age-adjusted OR of 4.71 (95% CI: 1.67-13.29; = 0.004) for experiencing an SAE.
CONCLUSIONS
TS of FAV has improved over time, and failure is associated with smaller fetal left heart sizes. SAEs are common and are associated with smaller left hearts and longer procedure times.
PubMed: 38938833
DOI: 10.1016/j.jacadv.2024.100835 -
Frontiers in Neurology 2024Real-world studies have shown the sustained therapeutic effect and favourable safety profile of OnabotulinumtoxinA (BoNTA) in the long term and up to 4 years of...
BACKGROUND
Real-world studies have shown the sustained therapeutic effect and favourable safety profile of OnabotulinumtoxinA (BoNTA) in the long term and up to 4 years of treatment in chronic migraine (CM). This study aims to assess the safety profile and efficacy of BoNTA in CM after 5 years of treatment in a real-life setting.
METHODS
We performed a retrospective chart review of patients with CM in relation to BoNTA treatment for more than 5 years in 19 Spanish headache clinics. We excluded patients who discontinued treatment due to lack of efficacy or poor tolerability.
RESULTS
489 patients were included [mean age 49, 82.8% women]. The mean age of onset of migraine was 21.8 years; patients had CM with a mean of 6.4 years (20.8% fulfilled the aura criteria). At baseline, patients reported a mean of 24.7 monthly headache days (MHDs) and 15.7 monthly migraine days (MMDs). In relation to effectiveness, the responder rate was 59.1% and the mean reduction in MMDs was 9.4 days (15.7 to 6.3 days; < 0.001). The MHDs were also reduced by 14.9 days (24.7 to 9.8 days; < 0.001). Regarding the side effects, 17.5% experienced neck pain, 17.3% headache, 8.5% eyelid ptosis, 7.5% temporal muscle atrophy and 3.2% trapezius muscle atrophy. Furthermore, after longer-term exposure exceeding 5 years, there were no serious adverse events (AE) or treatment discontinuation because of safety or tolerability issues.
CONCLUSION
Treatment with BoNTA led to sustained reductions in migraine frequency, even after long-term exposure exceeding 5 years, with no evidence of new safety concerns.
PubMed: 38938776
DOI: 10.3389/fneur.2024.1417831 -
JACC. Advances Nov 2023Guideline-recommended low-density lipoprotein cholesterol (LDL-C) thresholds are often not achieved in women. The proprotein convertase subtilisin/kexin type-9 inhibitor...
BACKGROUND
Guideline-recommended low-density lipoprotein cholesterol (LDL-C) thresholds are often not achieved in women. The proprotein convertase subtilisin/kexin type-9 inhibitor (PCSK9i) monoclonal antibodies can help further reduce LDL-C and major adverse cardiovascular events (MACE) although differences in efficacy by sex and type are less understood.
OBJECTIVES
The authors sought to determine if there are differences in the efficacy of LDL-C lowering and reduction in the risk of MACE by sex and type of PCSK9i.
METHODS
A comprehensive literature search was done through October 17, 2022, for published trials comparing PCSK9i vs control. Outcomes assessed were LDL-C reduction and incidence of MACE following the use of PCSK9i vs placebo, stratified by sex and type of PCSK9i used.
RESULTS
We identified 16 trials with 54,996 adults, and 15,143 (27.5%) of them were female. PCSK9i significantly reduced MACE compared to placebo in both women (HR: 0.86, 95% CI: 0.74-0.97, < 0.001) and men (HR: 0.85, 95% CI: 0.79-0.91, < 0.001) with no significant sex difference (MD -0.01, 95% CI: -0.14 to -0.13, = 0.930). PCSK9i also significantly reduced LDL-C levels in both sexes at 12 weeks (females: MD -62.57, 95% CI: -70.24 to -54.91, < 0.001; males: MD -66.19, 95% CI: -72.03 to -60.34, < 0.001) and 24 weeks (females: MD -47.52, 95% CI: -52.94 to -42.09, < 0.001; males: MD -54.07, 95% CI: -59.46 to -48.68, < 0.001). Significant sex difference was seen in the LDL reduction of PCSK9i for both 12 weeks (males vs females: MD -4.55, 95% CI: -7.34 to -1.75, < 0.01) and 24 weeks (males vs females: MD -7.11, 95% CI: -9.99 to -4.23, < 0.001).
CONCLUSIONS
The use of PCSK9i results in significant LDL-C and MACE reduction in both males and females. While there is no significant sex difference in MACE reduction, LDL-C reduction is greater in males than in females. Our data support the equal use of PCSK9i in all eligible patients, regardless of sex.
PubMed: 38938736
DOI: 10.1016/j.jacadv.2023.100669 -
JACC. Advances Nov 2023Homozygous familial hypercholesterolemia (HoFH) is characterized by early-onset atherosclerotic cardiovascular disease due to the high low-density lipoprotein...
BACKGROUND
Homozygous familial hypercholesterolemia (HoFH) is characterized by early-onset atherosclerotic cardiovascular disease due to the high low-density lipoprotein cholesterol (LDL-C) burden. Patients with null-null low-density lipoprotein receptor () variants respond poorly, if at all, to statins and proprotein convertase subtilisin/kexin type 9 inhibitors, which act by upregulating expression. The 24-week double-blind treatment period (DBTP) of the phase 3 ELIPSE HoFH (Evinacumab Lipid Studies in Patients with Homozygous Familial hypercholesterolemia; NCT03399786) study demonstrated significant LDL-C reductions in patients with HoFH; LDL-C reductions were also observed in those with null-null mutations.
OBJECTIVES
The purpose of this study was to evaluate longer-term efficacy and safety of evinacumab in patients with HoFH from the ELIPSE HoFH study.
METHODS
Patients with HoFH on stable lipid-lowering therapies (LLTs) ± lipoprotein apheresis and screening LDL-C ≥70 mg/dL who completed the DBTP entered the 24-week open-label treatment period (OLTP) and received intravenous evinacumab 15 mg/kg every 4 weeks. OLTP results were summarized descriptively.
RESULTS
A total of 64 patients completed the DBTP and received open-label evinacumab. Despite multiple LLTs, the mean baseline LDL-C at DBTP entry was 250.5 ± 162.3 mg/dL. From baseline to week 48 (end of OLTP), evinacumab reduced mean LDL-C by 46.3% (mean reduction, 134.3 ± 117.3 mg/dL), with similar mean LDL-C reductions for patients with null-null (47.2%) and non-null variants (45.9%). Adverse events occurred in 47 (73.4%) patients; 4 (6.3%) patients experienced adverse events considered evinacumab-related (drug hypersensitivity, infusion-related reaction and asthenia, generalized pruritis, and muscle spasms).
CONCLUSIONS
In patients with HoFH, evinacumab demonstrated substantial and sustained LDL-C reduction regardless of LDLR function, and was generally well tolerated.
PubMed: 38938723
DOI: 10.1016/j.jacadv.2023.100648