Cardiology and Therapy最新文献

Introduction: In dyslipidemia associated with type 2 diabetes (T2DM), elevated triglycerides (TG), increased low-density lipoprotein cholesterol (LDL-C), and decreased high-density lipoprotein cholesterol (HDL-C) levels are commonly found, resulting in a high prevalence of mixed dyslipidemia among patients with T2DM. Therefore, the combination therapy of atorvastatin/fenofibrate may be useful for simplifying pharmacological regimens, enhancing adherence, and requiring fewer doses of each drug to achieve the target, which decreases the number of adverse events.

Methods: We conducted a randomized multicenter, double-blind clinical trial of patients with T2DM and mixed dyslipidemia to evaluate the magnitude of change in lipid profile with a fixed-dose combination (FDC) therapy group of atorvastatin 20 mg/fenofibrate 160 mg (G_FDC) versus atorvastatin 20 mg monotherapy group (G_M), both oral route, one tablet every 24 h. The magnitude of change in the lipid profile at 2 and 4 months was compared within each group and between groups using the analysis of variance (ANOVA) test. A p value ≤ 0.05 was considered statistically significant.

Results: A total of 76 patients were included (38 per group), with an age of 56.7 ± 10.2 years, and 56.6% were women. The values at 4 months for G_FDC vs. G_M were as follow: TG mg/dL (-144.3 vs. -64.0, p = 0.004), TG percentage change (%C) (-47.9 vs. -33.1, p = 0.007); LDL-C mg/dL (-50.5 vs. -51.7, p = 0.784), LDL-C %C (-42.5 vs. -45.6, p = 0.899). The percentage of patients who achieved the targets for triglycerides (TG) was 56.7% compared to 43.8% (p = 0.309), while for LDL-C, it was 73.3% compared to 78.1% (p = 0.660). Finally, the predictive cardiovascular risk indices (∆ of change) showed a TG/HDL index of -3.9 ± 4.6 vs. -1.5 ± 2.9 (p = 0.015) and a Tg/glucose index of -0.7 ± 0.5 vs. -0.3 ± 0.4 (p = 0.003).

Conclusion: The FDC therapy of atorvastatin 20 mg/fenofibrate 160 mg achieved a greater percentage reduction in lipid profile than atorvastatin alone. No differences in adverse events were observed between the groups.

Clinical trials registration: ClinicalTrials.gov No. NCT04882293, registration date: February 28, 2022.

Introduction: Mavacamten, a cardiac myosin inhibitor, has demonstrated positive outcomes in left ventricular outflow tract (LVOT) gradient reduction and improvements of symptoms and function in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in EXPLORER-CN. This exploratory analysis aimed to evaluate the effect of mavacamten on echocardiographic measures of cardiac structure and function and its relationship with other clinical biomarkers.

Methods: Key echocardiographic parameters acquired over 30 weeks from 81 patients (n = 54 on mavacamten and n = 27 on placebo) were assessed in a central laboratory.

Results: At 30 weeks, greater improvements in measures of diastolic function were observed with mavacamten versus placebo, including lateral E/e' (least-squares mean [LSM] change from baseline [CFB] - 5.1 vs. 0.6; between-group LSM difference - 5.7; 95% confidence interval [CI] - 7.6 to - 3.7), septal E/e' (LSM CFB - 6.0 vs. - 0.3; between-group LSM difference - 5.7; 95% CI - 7.8 to - 3.7), and left atrial volume index (LAVI) (LSM CFB - 11.7 vs. - 3.5 ml/m²; between-group LSM difference - 8.2; 95% CI - 12.0 to - 4.4) (nominal p < 0.001 for all). Twelve patients (23.1%) treated with mavacamten had complete resolution of mitral valve systolic anterior motion (SAM) versus two patients (7.4%) receiving placebo. Among mavacamten-treated patients, reductions in resting and Valsalva LVOT gradients, left ventricular (LV) mass index, LAVI, and lateral and septal E/e' were associated with reduced N-terminal pro-B-type natriuretic peptide levels (nominal p < 0.0001 for all). In the mavacamten group, reductions in LVOT gradients and LV end-diastolic interventricular septal thickness were associated with improved patient-reported Kansas City Cardiomyopathy Questionnaire Overall Summary Score (nominal p < 0.05 for all).

Conclusions: Clinically meaningful improvements were evident in Chinese patients treated with mavacamten compared with placebo in several hallmarks of obstructive HCM, including measures of LV diastolic function, SAM, and LVOT gradient. These results add further evidence to support the positive effects of mavacamten in cardiac remodeling.

Registration: ClinicalTrials.gov identifier: NCT05174416.

Introduction: The challenge in heart failure medical practice is to address the clinical and laboratory method integrations for the shared decision-making process in caring for patients and families. Furthermore, stressful life events may worsen outcomes in patients with heart failure. This study aimed to explore patient perceptions regarding cardiac care analyzing the individual needs and features of adverse life event experiences.

Methods: A mixed-methods design was used in this study. This quantitative research focuses on clinical (medical and psychological) data. Giorgi's phenomenological method was applied to the interview analysis.

Results: Qualitative analyses highlighted the role of patient-engagement strategies powered by cardiologists in a personalized approach that favors adherence to complex medical therapies. Active patient involvement and associated engagement based on cardiologists' confidence are focal points for facilitating management-therapy strategies to improve outcomes and reduce the perception of the frailty burden. The quality of therapeutic relationships with cardiologists is a key protective factor for accurate risk stratification and therapeutic decision-making in patients, addressing the potential benefits of therapeutic interventions.

Conclusions: In conclusion, the engaged patient contributes to more efficient cardiological care and the personalized patient-centered approach leads to the more efficient 'cure and care' clinical model. In adverse life events, acute psychological and physiological stress responses intensify detrimental outcomes for patients with cardiovascular disorders. Integrative management of physical risks and mental resilience factors in the development of cardiac disease appears to be strategic for patients with a positive quality of life (QoL) and clinical management of heart failure (HF).

Introduction: Cardiogenic shock (CS) is a life-threatening failure of the heart to supply adequate blood, requiring immediate treatment. Although nowadays Impella^® heart pumps and veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) are both widely employed in routine clinical practice for the management of patients with CS, extensive comparative information on their cost-effectiveness is lacking. The aim of the present study was to conduct a cost-effectiveness analysis comparing Impella to VA-ECMO in patients with CS from the National Healthcare Service (NHS) perspective in Italy. A secondary objective was to compare costs from both NHS and hospital perspectives.

Methods: A Markov model projected, on a lifetime horizon, life years (LYs), quality-adjusted life years (QALYs), and costs associated with Impella and VA-ECMO. Costs from the NHS perspective were estimated mainly through Italian reimbursement rates, while hospital costs were derived from a clinical center in Italy.

Results: From an NHS perspective, Impella showed lower costs and better life expectancy and patients' quality of life (€50,303, 1.544 LYs, 0.905 QALYs) compared to VA-ECMO (€76,795, 1.391 LYs, 0.784 QALYs). DRG overall reimbursements for Impella (€49,998) do not completely cover the hospital costs and the cost for the technology (€57,770). Conversely, the hospital cost for the strategy VA-ECMO (€52,190) is lower than the NHS overall reimbursements (€76,790).

Conclusions: Our analysis suggests that Impella may be cost-saving over VA-ECMO, while also providing better health outcomes for patients with CS; however, discrepancies in costs and reimbursement rates were observed, likely due to variability in patient care and hospital resource utilization. Future real-world studies are needed to confirm these findings, but decision-makers can use this data as an initial reference for health technology assessments in Italy.

Introduction: Anthracyclines treat a myriad of malignancies; however, they are known to lead to cancer therapy-related cardiomyopathy (CTRC). Randomized controlled trials (RCTs) evaluating the role of angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARBs) in primary prevention of CTRC have yielded mixed results.

Methods: A systematic search of MEDLINE, Cochrane, and Scopus databases was performed to identify RCTs that evaluated outcomes in patients receiving anthracyclines and ACEi or ARBs versus control. The primary outcome was occurrence of CTRC. All data were pooled using a random-effects model.

Results: The final analysis included 10 RCTs, with 1049 patients assessed. The weighted follow-up period was 16.8 months. The average age was 43.2 years and 90% were female. Breast cancer (80%) and lymphomas (13%) were the most common malignancies. There was no statistically significant difference between the groups with regards to occurrence of CTRC (16% vs 24%; risk ratio (RR) 0.67, 95% confidence interval (CI) [0.31, 1.45]). Compared with control, ACEi/ARBs were associated with favorable absolute changes in left ventricular ejection fraction (LVEF) (standardized mean difference (SMD) + 1.20%, 95% CI [0.40, 2.00]), left ventricular end-diastolic volume (SMD - 0.36 mL, 95% CI [- 0.66, - 0.06]), and left ventricular end-systolic volume (SMD - 1.04 mL, 95% CI [- 1.79, - 0.29]). There was also a lower risk of arrhythmias in the ACEi/ARBs group compared to control (1.6% vs 8.0%; RR 0.30, 95% CI [0.10, 0.94]), but no difference in all-cause mortality (2.8% vs 3.2%; RR 0.82, 95% CI [0.26, 2.61]), or heart failure (1.2% vs 7.1%; RR 0.40, 95% CI [0.03, 4.54]).

Conclusions: ACEi/ARBs therapy was not associated with a reduction in CTRC among patients with cancer receiving anthracyclines. However, there were favorable changes in LVEF and left ventricular remodeling with ACEi/ARBs therapy. Further large-scale studies are needed to better understand the potential role of ACEi/ARBs in preventing long-term cardiotoxicity.

Introduction: May Measurement Month (MMM) is a global campaign with the aim to improve awareness of arterial hypertension (AH). Kazakhstan participated in the campaign in 2021, 2022 and 2023.

Methods: During the cross-sectional 2021-2023 MMM surveys, volunteer adults (≥ 18 years) from cities in Kazakhstan had their blood pressure (BP) measured three times in a seated position, and received a questionnaire on their demographics, lifestyle and medical history. In those not receiving antihypertensive treatment, AH was defined as a mean systolic and/or diastolic BP ≥ 140/90 mmHg.

Results: A total of 8231 individuals took part in the survey, with 1805 participants in 2021, 2410 participants in 2022 and 4016 participants in 2023. The prevalence of AH was estimated to be 37% in 2021 and 45% in 2022 and 2023. Of those identified as having AH, 51-70% were aware that they had the condition. Among those who were aware that they had AH, 68-91% were receiving antihypertensive therapy. However, 70-82% of treated participants were only receiving one to two drugs. BP was controlled to < 140/90 mmHg in 43-50% of treated participants and to < 130/80 mmHg in 15-16%.

Conclusion: The 2021, 2022 and 2023 MMM campaigns showed that high proportion of AH, a low level of AH awareness and inadequate BP control in Kazakhstan. Programs are needed to increase awareness of the risks of high BP and to improve the diagnosis and effective treatment of AH.

Introduction: Routine defibrillation threshold (DFT) testing at the time of implantable cardioverter-defibrillator (ICD) implantation is no longer recommended because testing did not improve shock efficacy or reduce arrhythmic death. However, patients with severe chronic kidney disease (CKD) were not included in these trials and might benefit from DFT testing. International guidelines shed no light on the subject of the effect of kidney function on DFT testing in patients with CKD.

Methods: In this retrospective study, we aimed to identify the success and safety of DFT in patients with CKD stages 1-5 (ages 55-80 years) undergoing primary transvenous ICD implantation.

Results: A total of 451 patients were stratified into three groups based on kidney function: group 1 with CKD stage 1-2 (n = 294), group 2 with CKD stage 3-4 (n = 90), and group 3 with CKD stage 5 (n = 67). Ventricular fibrillation was induced 827 times. The median number of threshold testing per patient was two (interquartile range 1-2; range 1-7). No evidence of between CKD-group differences in ICD defibrillation success rates could be found when using all patient attempts, regardless of correction for energy levels (p = 0.262). DFT-related complications occurred in 16 patients (3.5%), predominantly hypoxemia due to hypoventilation (1.6%) and atrial arrhythmias. Five patients (1.1%) underwent ICD or lead revision following abnormal DFT test results.

Conclusions: We did not demonstrate a correlation between CKD and increased DFT or an increased rate of inadequate defibrillation safety margin. DFT testing is feasible with a low risk of serious complications in patients with moderate and advanced CKD when clinically deemed necessary. DFT testing is not routinely required in patients with (advanced) CKD.

Introduction: The ROsulord® sAfety for patients with Dyslipidemia study (ROAD study) in the Republic of Korea investigated the safety and efficacy of rosuvastatin in routine clinical practice.

Methods: This non-interventional, multicenter, prospective, observational study was conducted over a period of approximately 4.6 years and involved 14,243 participants. During this study, we assessed the adverse events, changes in laboratory test results, and efficacy endpoints associated with rosuvastatin use.

Results: The findings revealed a notably low adverse event rate of 1.63%, indicating a favorable safety profile for rosuvastatin in the management of dyslipidemia. Importantly, no clinically significant incidences of statin-associated myopathy, hepatotoxicity, or diabetes were observed during the study period. Moreover, this study demonstrated significant improvements in lipid profiles among patients receiving rosuvastatin treatment, with a reduction in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels. These improvements contributed to a lower cardiovascular risk in the study population.

Conclusion: Overall, these findings suggest that rosuvastatin is safe and effective in managing dyslipidemia in real-world clinical settings, providing clinicians with valuable insights into the benefits and risks associated with statin therapy in this patient population.

In addition to traditional risk factors, patients with breast cancer are at an increased risk of atrial fibrillation due to cancer itself and certain cancer therapies. Atrial fibrillation in these patients adds to their morbidity and mortality. The precise mechanisms leading to the increased atrial fibrillation in patients with breast cancer are not well understood. The main goal of atrial fibrillation management in this population is to facilitate uninterrupted cancer treatment while addressing the arrhythmia and other cardiovascular sequelae of cancer treatment. Rhythm control is often challenging to implement in patients with breast cancer during active antineoplastic therapy because of the need for uninterrupted anticoagulation, potential drug-drug interactions between cancer treatments and antiarrhythmic medications, and the increased likelihood of atrial fibrillation recurrence. Prevention of thromboembolism and anticoagulation can also be challenging in patients with breast cancer as a result of the increased risk of cancer-related procoagulant state and coagulopathies. The integration of a cardio-oncology team and a multidisciplinary approach are crucial for better outcomes. The therapeutic interventions should be tailored toward individual patients' profiles through a shared decision-making approach. The precise mechanisms leading to the increased atrial fibrillation in patients with breast cancer are not well understood, highlighting the gaps in our knowledge. More research is required to reduce these gaps, refine risk stratification, and optimize treatment strategies in these patients.