Clinical Research in Cardiology最新文献

Background: Cardiac surgery with cardiopulmonary bypass (CPB) is associated with microcirculatory changes. Little is known about the effect of CPB on the structural and vascular parameters of the retina. We aimed to investigate changes in these parameters in patients after CPB surgery.

Methods: In this prospective observational clinical trial, 44 patients who underwent elective CPB surgery were enrolled. All subjects underwent a complete ophthalmological examination, optical coherence tomography (OCT), and OCT angiography (OCTA) preoperatively and 1 week after surgery. Changes in macular retinal thickness (RT), ganglion cell complex (GCC), vascular density (VD) of the superficial (SCP) and deep (DCP) capillary plexuses, and peripapillary retinal nerve fiber layer (RNFL) were assessed in relation to CPB duration and aortic cross-clamp (ACC) time.

Results: A statistically significant decrease in RT (p = 0.008) and VD of the SCP (p = 0.023) was observed in the central macula postoperatively. There was a statistically significant increase in peripapillary RNFL thickness in all quadrants and in macular GCC thickness in all regions except the superior region of the ganglion cell and inner plexiform layer (GCL +). A positive correlation was found between ACC time and RT, as well as the VD of SCP changes and the VD of DCP in the central macula.

Conclusions: CPB surgery induces significant retinal changes, including reduced RT and VD of the SCP in the central macula, along with increased thickness of the peripapillary RNFL and most regions of the macular GCC. Since retinal alterations are associated with ACC time, it is crucial to minimize ACC time to reduce the risk of ophthalmological complications.

Background: Sex-specific differences in outcomes after transcatheter aortic valve replacement (TAVR) are well established, with females more often presenting with advanced disease and experiencing higher peri-procedural risk, yet consistently exhibiting superior long-term survival. However, data on the sex-related impact on bioprosthetic valve durability and very long-term clinical outcomes remain scarce. This study aimed to assess 10-year survival, prognosis, and valve performance in males and females undergoing TAVR with self-expanding bio-prostheses (CoreValve/Evolut R).

Methods: Consecutive patients with severe symptomatic aortic stenosis treated with TAVR between 2007 and 2014 at ten Italian centers were prospectively included in the Medtronic One Hospital Clinical Service (OHCS) database and included in the present analysis. The overall population was classified according to sex. The primary endpoint was a composite of all-cause mortality, heart failure rehospitalization, or stroke at 10 years. Secondary endpoints included the single components of the primary endpoint, cardiovascular death, and valve performance.

Results: Among 1944 patients included in the analysis, 54.9% (n = 1068) were female. Compared to males, females were older and exhibited a higher baseline risk profile, characterized by more advanced renal disease and higher transvalvular gradients, yet they more frequently had preserved left ventricular ejection fraction and a lower prevalence of prior cardiovascular events. At 10 years, the primary endpoint occurred significantly more often in male patients, a finding that persisted after adjustment for relevant confounders (adjusted HR 1.15; p = 0.028) and was primarily driven by all-cause mortality. Structural valve deterioration, bioprosthetic valve failure, and valve performance were comparable between sexes at the 10-year follow-up.

Conclusions: Despite older age and increased procedural risk, female patients demonstrated more favorable long-term survival and similar valve durability compared to males over 10 years following TAVR with first-generation CoreValve/Evolut R prostheses. These findings underscore the long-term reliability of self-expanding valves and highlight the need for individualized, sex-specific strategies in TAVR patient selection and management.

Background: Cardiogenic shock complicates takotsubo syndrome (TTS) in approximately 10% of cases. The effectiveness of mechanical circulatory support (MCS) for managing cardiogenic shock in TTS remains unknown.

Methods: We assessed outcomes in TTS patients with cardiogenic shock who received MCS compared to medical therapy only by using data from the International Takotsubo Registry. Two independent propensity scores were computed to investigate outcomes of patients with an intra-aortic balloon pump (IABP) vs. medical therapy only (1:2 propensity score matched cohort) and patients with an Impella vs. medical therapy only (1:1 propensity score matched cohort). The primary endpoint was in-hospital mortality and the secondary outcomes included MCS-related complications.

Results: Among 3740 eligible patients, 309 (8.3%) patients had cardiogenic shock, of whom 112 (36.2%) had MCS and 197 (63.8%) had medical therapy only. After propensity-score matching, the use of an IABP was found to be associated with a lower in-hospital mortality rate than medical therapy only (14.5% vs. 35.5%, P = 0.002), while mortality rates in the Impella group and medical therapy only group were comparable (25.0% vs. 29.2%, P = 0.75). MCS-related complications occurred in 6.0% of the IABP cohort and in 31.3% of Impella cohort.

Conclusion: Active MCS has been increasingly used for the management of cardiogenic shock in patients with TTS. This observational study could not demonstrate an association with improved mortality with an Impella device, but possibly with an IABP when compared to patients with medical management only. MCS-related complications occurred more frequently in the Impella cohort than in the IABP cohort. Further data are required to confirm results of the present study.

Background: Heart failure (HF), including heart failure with reduced ejection fraction (HFrEF), remains a major public health issue with increasing disease burden. Recent advances, particularly data on sodium-glucose cotransporter-2 inhibitors (SGLT2i), have shifted HFrEF treatment paradigms based on strong evidence from randomised-controlled trials (RCTs). There is a lack of data reflecting HFrEF patient outcomes in relation to SGLT2i treatment in a real-world environment.

Methods: The ongoing H²-registry, initiated in 2021, collects real-world data on hospitalised HF patients in Germany. We analysed HFrEF patients (left ventricular ejection fraction, LVEF ≤ 40%) enrolled until 30-11-2024, stratified by SGLT2i treatment status at index hospital discharge and during follow-up (FU). We assessed baseline characteristics, predictors of SGLT2i use, and 12-month outcomes.

Results: Of 810 HFrEF patients (513 SGLT2i, 297 no-SGLT2i), the median age was 70 years, and 23% were female. Baseline characteristics were comparable between groups. Median LVEF was 30%, and 39% had type 2 diabetes. Use of renin-angiotensin-aldosterone system inhibitors, beta-blockers, and mineralocorticoid receptor antagonists (MRA) was more common in the SGLT2i group. Patients treated with SGLT2i at baseline had significantly lower all-cause mortality during FU in unadjusted time-to-event analyses (HR [95% CI] 0.53 [0.33-0.88]; p = 0.012). However, in multivariate analyses, only MRA treatment was independently associated with reduced mortality risk during FU (HR [95% CI] 0.41 [0.23-0.74]; p = 0.003). In a sub-cohort of patients being continuously treated with an SGLT2i during FU, the observed effect of SGLT2i was more pronounced (unadjusted HR [95% CI] 0.46 [0.28-0.77], p = 0.0023), and continuous SGLT2i treatment was significantly associated with lower all-cause mortality in multivariate analyses (adjusted HR [95% CI] 0.54 [0.30-0.99], p = 0.046).

Conclusion: In this prospective German HF registry, SGLT2i treatment was significantly associated with reduced all-cause mortality in HFrEF patients only with continuous use during FU. Treatment with MRA was independently associated with lower all-cause mortality in all performed analyses. These findings add to the available body of evidence regarding the real-world effectiveness of SGLT2i in HFrEF.

Trial registration: NCT04844944.

Background: The European Society of Cardiology regularly updates its clinical practice guidelines. However, it is not well established whether guideline changes have significant effects on actual clinical practice. Therefore, we retrospectively analyzed lipid-lowering therapy at discharge after acute coronary syndrome (ACS) in a 1-year period before and a 1-year period after publication of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias, respectively.

Methods and results: In total, we included 691 patients who were discharged alive after AMI. A total of 354 patients were treated in the period before, and 337 after the guideline change. After the guideline change, the proportion of patients discharged on high-dose statin was higher (89.3% vs 80.5%; p = 0.001) and ezetimibe was prescribed more often (31.2% vs 5.9%; p < 0.00001) resulting in more patients being discharged on high-intensity treatment (92.9% vs. 81.6%; p < 0.0001). Median on-treatment LDL-cholesterol was significantly higher in the period before (65 [IQR 47 to 90] mg/dL) than after the publication of the 2019 guidelines (48 [IQR 35 to 69] mg/dL; p < 0.0001). The LDL-C goal of < 55 mg/dL would have been reached by 37.5% patients in the earlier period and was reached by 62.9% in the later period (p < 0.0001).

Conclusions: The update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias was associated with a significant improvement in the prescription of high-dose statin and ezetimibe in patients after ACS. The change of the guidelines rapidly translated into clinical practice resulting in improved risk factor control in patients at very high risk.

Background: Heart failure (HF) is a heterogeneous clinical syndrome affecting a growing global population. Due to the high incidence of cardiovascular risk factors, a large proportion of the Western population is at risk for heart failure. Oxidative stress and inflammation play a crucial role in the pathophysiology of heart failure with preserved ejection fraction (HFpEF). While previous studies have demonstrated an association between dysfunctional HDL and heart failure, the specific link between oxidized HDL and HF remains unexplored.

Methods: In this cross-sectional observational study, the antioxidant function of HDL was assessed in 366 patients with suspected heart failure. HFpEF assessment was conducted according to current guidelines. A validated cell-free biochemical assay was used to determine reduced HDL antioxidant function as assessed by increased HDL-lipid peroxide content (HDL_ox), normalized by HDL-C levels and the mean value of a pooled serum control from healthy participants (nHDL_ox; no units). Results were expressed as median with interquartile range (IQR).

Results: Participants with HFpEF (n = 88) had 15% higher mean relative levels of nHDL_ox than those without heart failure (n = 180). Using a basic multivariate model adjusted for age, sex, eGFR and a full multivariate model (adjusted for diabetes, hypertension, atrial fibrillation, LDL cholesterol, hsCRP, and coronary artery disease), nHDL_ox was an independent predictor for HFpEF (p < 0.05). An increase in 1-SD in nHDL_ox was associated with a 67% increased risk for HFpEF if compared with participants without heart failure (p = 0.02).

Conclusion: HDL antioxidant function is reduced in patients with HFpEF. Improving HDL function is a promising target for early heart failure treatment.

Background and aims: Sympathetic overactivation plays a critical role in the pathophysiology of various conditions, such as arterial hypertension, chronic kidney disease, coronary artery disease (CAD), diabetes, metabolic syndrome, and dyslipidemia. Initially developed for hypertension management, renal denervation (RDN) has also been associated with metabolic improvements. Preclinical studies in rodent models suggest that RDN may improve lipid profiles by reducing sympathetic activity. This study analyses the effect of RDN on lipid profiles in hypertensive patients with or without CAD.

Methods: This analysis includes 122 hypertensive patients with (n = 30) or without CAD (n = 92). All patients underwent radiofrequency, ultrasound, or alcohol-injection-based RDN. Fasting lipid profile, including total cholesterol, triglyceride, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL levels was measured at baseline and 6 months after RDN in parallel to office and 24-h ambulatory blood pressure (BP).

Results: Six months after RDN, the total cohort showed significant lipid profile improvements. The total cholesterol levels decreased by 10.3 ± 26.3 mg/dL (p < 0.001), LDL by 7.0 ± 20.4 mg/dL (p < 0.001), and triglycerides by 30.7 ± 69.4 mg/dL (p < 0.001), while non-HDL cholesterol levels declined by 7.6 ± 26.3 mg/dL (p = 0.002). These changes were independent of BP reduction. In patients with CAD, total cholesterol levels declined by 21.7 ± 29.1 mg/dL (p < 0.001), triglycerides by 40.7 ± 80.0 mg/dL (p = 0.009), LDL by 15.2 ± 22.0 mg/dL (p < 0.001), HDL by 2.8 ± 4.7 mg/dL (p = 0.003), and non-HDL by 15.0 ± 34 .8 mg/dL (p = 0.021). Reductions in total cholesterol and LDL were greater in CAD than in non-CAD (p = 0.011 and p = 0.006).

Conclusion: We observed a significant improvement in lipid profiles in hypertensive patients with CAD after RDN. This improvement may represent an additive benefit of RDN in hypertensive patients with CAD.

Objectives: We investigated changes in lipid-lowering drug prescriptions in Germany as a whole and in the 16 federal states over the last 13 years and their association with hospitalization rates for acute myocardial infarction.

Design: Ecological study.

Setting: Nationwide German hospitalization, Diagnosis-Related Groups Statistic.

Patients/participants: German population in the years 2010 through 2022.

Intervention: All prescriptions of lipid-lowering drugs in the years 2010 to 2022 by federal state in Germany.

Main outcome measures: Hospitalization rates for the treatment of transmural infarction per calendar year and federal state (STEMI = ST-elevation myocardial infarction).

Results: The age-standardized prescription rates of lipid-lowering drugs per 1000 person-years increased from 77.4 in 2010 to 145.2 in 2022 (reference population: Germany 2011). Within the same period, the STEMI hospitalization rate per 100,000 person-years decreased from 143.7 to 100.1. Based on the prescription and hospitalization rates of the 16 federal states, it is shown that the STEMI hospitalization rate decreased the more the prescription rate of lipid-lowering drugs in a federal state increased over time (beta = 0.38, 95% confidence interval - 0.64; - 0.12; adjusted explained variance 0.362).

Conclusion: Increasing prescription rates of lipid-lowering drugs have correlated with decreasing rates of hospitalized cases for STEMI in Germany in the last decade.

In a cohort of patients with dyslipidemia at very high cardiovascular risk, we investigated differences in LDL-C lipid target achievement, clinical outcomes, and persistence rates between users and non-users of PCSK9 monoclonal antibodies (PCSK9-mAb) over a 3-year observation period. The prospective, multi-center observational study included 1695 patients with dyslipidemia. Eligible patients were adults with familial or non-familial hypercholesterolemia, mixed dyslipidemia, or other therapy-refractory lipid disorders in line with the G-BA reimbursement regulations. Treatment decisions, including PCSK9-mAb administration, were made at the discretion of the treating physician. At baseline, 804 (47.4%) patients received PCSK9-mAb therapy, and 891 (52.5%) did not. There were 42 (4.7%) new PCSK9-mAb receivers during the follow-up. Median propensity-score adjusted LDL-C levels in PCSK9-mAb non-receivers decreased over time from 106.0 to 68.4 mg/dL. LDL-C in PCSK9-mAb receivers dropped from 112.5 mg/dL at baseline to 58.0 mg/dL at 3 years, consistently outperforming non-receivers. Target LDL-C goal attainment (< 55mg/dL) after 3 years was higher in the PCSK9-mAb group (43.2% vs. 34.5%). Persistence with PCSK9-mAb therapy over 3 years since treatment initiation was high (91.5%). Higher discontinuation rates of PCSK9-mAb were associated with baseline statin intolerance (HR = 2.3, p = 0.012). The use of PCSK9-mAb was associated with numerically fewer cardiovascular events (9.3 versus 15.7 per 100 patient-years, p not significant) and lower hospitalization rates due to cardiovascular events compared to non-users (6.3 versus 12.4 per 100 patient years, p = 0.001). This study underscores the real-world efficacy and safety of PCSK9-mAb therapy in achieving sustained LDL-C reduction. Identifier: Clinicaltrials.gov NCT03110432.

Background: "Jena auf Ziel" ("JaZ") is a prospective cohort study in patients with ST-elevation myocardial infarction (STEMI). Early combination of a statin and ezetimibe was initiated on the day of admission and lipid-lowering therapy (LLT) was escalated during follow-up with bempedoic acid (BA) and PCSK9 inhibitors (PCSK9-I) to reach guideline-recommended LDL-cholesterol (LDL-C) levels. During the initial follow-up period of 12 months, all patients reached the recommended ESC/EAS LDL-C target for very high-risk patients of < 55 mg/dL.

Methods: Twelve months after the index event, patients enrolled in "JaZ" had the option of either continuing with regular follow-ups in the outpatient lipid clinic of the university hospital Jena or transitioning to standard care by their general practitioners (GPs). Fifty-three patients (62%) stayed with the outpatient lipid clinic and 32 (38%) preferred treatment by their local GP. After 24 months, we analyzed differences in prescribed lipid-lowering drugs, LDL-C target attainment, LDL-C time on target, and major adverse cardiac events (MACEs = nonfatal ischemic cardiovascular events, admission for heart failure, nonfatal stroke) between groups.

Results: All 85 patients enrolled in the initial study were followed up for 24 months. The average LDL-C after 24 months was 1.47 ± 0.71 mmol/L in the total study population. Fifty-one patients (60%) of the entire cohort were still on LDL-C target of 1.4 mmol/L or below (outpatient lipid clinic group: 72.5% vs. GP group: 27.5%; p = 0.037). The average LDL-C in patients followed up in the outpatient lipid clinic was significantly lower compared to patients who were treated by GPs (1.2 ± 0.7 mmol/L vs. 2.1 ± 1.04 mmol/L; p < 0.01). Moreover, patients in the outpatient lipid clinic had a longer time on LDL-C targets compared to patients treated by GPs (82.4 ± 29.5% vs. 62.4 ± 36.6%; p < 0.01). The main cause of missed LDL-C targets was deprescribing of LLT by local GPs, surpassing non-adherence (2.1 ± 1.04 mmol/L vs. LDL-C: 1.52 ± 0.53 mmol/L; p < 0.01). Patients with MACE during follow-up were characterized by a shorter time on LDL-C targets compared to patients without MACE (58.1 ± 29.9% vs. 79.1 ± 28.1%; p = 0.048) and higher LDL-C levels at 24 months (2.04 ± 1.26 mmol/L vs. 1.27 ± 0.72 mmol/L; p < 0.01).

Conclusion: In this cohort of STEMI patients, a less intensive lipid-lowering strategy during a 2-year follow-up was associated with higher LDL-C levels and a higher incidence of MACE. Therefore, a regular follow-up in a specialized lipid outpatient clinic was superior to standard care treatment by general practitioners.