Clinical Research in Cardiology最新文献

Background: Administering antithrombotic therapy (ATT) in patients with infective endocarditis (IE) involves a complex balance of bleeding and thromboembolic risks. Data on outcomes beyond the acute phase remain limited. This retrospective single-center cohort study had two aims: first, to describe the use of anticoagulation during the acute phase of left-sided IE; and second, to examine, without inferring causality, how anticoagulation, as used in routine care, correlated with in-hospital and long-term clinical outcomes, including mortality and neurological events.

Methods: ATT in patients with left-sided IE was assessed retrospectively and categorized into two groups: any therapy that included anticoagulation (AC) and therapy without anticoagulation (No-AC). Two observational periods were analyzed: the in-hospital phase and the period beginning 3 months after discharge, when 30% of patients had their ATT modified. Vital and neurological status were obtained by standardized telephone follow-up (mean follow-up time 4.2 ± 3.1 years). Log-rank tests, Kaplan-Meier estimates, Cox regression analyses, and matched analyses were used to explore correlations between ATT and these outcomes.

Results: A total of 504 hospitalized patients (mean age 65 ± 13 years, 25% female) with left-sided IE were included. During inpatient treatment, 83 patients (16%) died, with no relevant difference between AC and No-AC groups. During follow-up, patients in the AC group showed a more favorable value for the combined endpoint of mortality and unfavorable neurological function (P = 0.029) that was driven primarily by higher survival rates (P < 0.001). In Cox regression analyses, higher age, CHA₂DS₂-VA score, EuroSCORE II, Staphylococcus aureus bacteremia, and atrial fibrillation were each linked to a higher hazard of the combined endpoint, whereas AC showed an inverse correlation. Consecutive matched analyses yielded similar results.

Conclusion: In this retrospective cohort, anticoagulated patients did not show a higher rate of adverse events during hospitalization and had a lower long-term event rate. These findings represent correlations observed in a non-randomized, single-center setting and may partly reflect differences in underlying risk profiles and treatment selection (confounding by indication and residual confounding). Prospective studies are needed to confirm any causal effects and to define more precisely the role of ATT in patients with IE and elevated cardiovascular risk.

Background: The role of cardiovascular magnetic resonance (CMR)-imaging-based pulse wave velocity (PWV) and aortic distensibility (AD) in population-based cohorts as a risk stratification tool remains unclear. The purpose of this study was the CMR-based quantification of PWV and AD in the context of cardiovascular risk factors (CVRF) and/or diseases (CVD) in the Hamburg City Health Study (HCHS).

Methods: The HCHS is a prospective, population-based cohort study. 2D-phase-contrast-flow CMR measurements were performed to quantify PWV and AD in the ascending (AD AoAsc) and descending aorta (AD AoDesc).

Results: The CMR cohort consisted of 2270 participants (41.5% females, median age 66.5 years). PWV was 5.80 [4.91, 7.19] m/s, AD AoAsc 0.54 [0.34, 0.78] [1/(10^3*kPa)], and AD AoDesc 0.61 [0.39, 0.84] [1/(10^3*kPa)] in participants without any CVRF and/or CVD. In participants with at least one CVRF and/or CVD PWV was significantly higher, AD AoAsc and AD AoDesc significantly lower. After adjustment for age and sex, PWV was significantly associated with smoking (OR 1.05), CAD (OR 0.932), and hypertension (OR 1.118); AD AoAsc with hypertension (OR 0.448); and AD AoDesc with hypertension (OR 0.343), BMI > 30 kg/m² (OR 0.575), CAD (OR 2.17), and history of myocardial infarction (OR 2.413).

Conclusions: The presence of CVRF and/or CVD is related to significantly higher PWV and lower AD values. However, hypertension is the only CVRF/CVD consistently associated with higher PWV and lower AD after adjustment for age and sex. Our findings do not indicate a predictive value of abnormal PWV and AD values for prevalent CAD and MI.

Background: Pregnancy-associated spontaneous coronary artery dissection (P-SCAD) remains an incompletely characterized cause of acute coronary syndrome during pregnancy and postpartum period. We aimed to compare clinical presentation, comorbidities and outcomes of P-SCAD with non-pregnancy associated spontaneous coronary artery dissection (NP-SCAD).

Methods: We studied 83 women with prior SCAD and at least one pregnancy (aged 44.8 ± 9.7y at SCAD event, 36% with hypertension), including 11 P-SCAD and 72 NP-SCAD cases in SCAD-POL Registry. P-SCAD was defined as SCAD occurring during pregnancy or within 12 months postpartum.

Results: P-SCAD occurred between 2 and 32 weeks after delivery. Compared with NP-SCAD, women with P-SCAD were younger (33.1 ± 4.9 vs 46.4 ± 9.1y, p < 0.001), had higher parity (3.6 ± 1.2 vs 2.5 ± 1.1 pregnancies, p < 0.01) and more often reported ≥ 1 miscarriage (63.5% vs 27.8%, p < 0.05). Pregnancies in the P-SCAD were more frequently complicated with hypertension (45.5% vs 6.9%, p < 0.005) and pre-eclampsia (27.3% vs 1.4%, p < 0.01). All P-SCAD patients had at least one caesarean section versus 35.8% in the NP-SCAD group (p < 0.001). P-SCAD patients more often required coronary bypass grafting (18.2% vs 1.6%, p < 0.05). Frequency of fibromuscular dysplasia was non-significantly higher in P-SCAD (45.5% vs 29.2%).

Conclusions: Pregnancies in women with P-SCAD were more often complicated by hypertension, pre-eclampsia and miscarriage than in NP-SCAD. P-SCAD events occurred mainly in the early postpartum period and more often required surgical revascularization. Given the small sample, these findings are exploratory and hypothesis-generating.

Purpose: Our hypothesis was that computed tomography angiography (CTA)-derived Hounsfield units (HU) can differentiate between thrombosis and leaflet fibrosis (defined by a lack of response to oral anticoagulation) in patients with bioprosthetic heart valve dysfunction.

Materials and methods: Valvular leaflet HU were retrospectively assessed in 95 patients (derivation cohort) undergoing CTA 35 days after bioprosthetic heart valve (BHV) implantation showing signs of subclinical leaflet thrombosis (hypoattenuated leaflet thickening, HALT). A second (validation) cohort included 46 patients undergoing CTA for suspected BHV dysfunction 2 years [interquartile range IQR 1.5-5.0] after valve replacement. This study included CTA between May 2012 and December 2017.

Results: In the derivation cohort, the median HU (95 patients) was 87 (IQR 77; 96). In the validation cohort, patients with resolution of findings in a follow-up CTA after newly initiated anticoagulation ("thrombosis" subgroup, 19 patients) similarly demonstrated HU of 87 (IQR 74; 100) (p = 0.816). In contrast, patients without improvement under oral anticoagulation ("fibrosis" subgroup, 27 patients) exhibited a median of 137 HU (IQR 116, 164; p < 0.001 vs. thrombosis subgroup). In multivariable Cox regression analysis, lower HU were an independent predictor of thrombosis. C-statistics demonstrated an area under the receiver operating characteristic curve of 0.94 ± 0.02 (CI 0.897-0.983, p < 0.001) with a value of 105 HU resulting in a sensitivity of 84% and a specificity of 91% for the differentiation between thrombosis and fibrosis.

Conclusion: A value of 105 HU on CTA provides good discriminatory power to distinguish between leaflet fibrosis (as defined by a lack of response to oral anticoagulation) and thrombosis after bioprosthetic valve replacement and may help in choosing optimal treatment.

Background: Severe symptomatic aortic stenosis is associated with increased morbidity and mortality. Surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are established treatment options. Neurological complications such as subclinical cerebral ischemia, delirium, and postoperative cognitive decline can occur during either treatment; however, precise data on neurological impairment remain scarce.

Objectives: The aim of this study was to compare neurological outcomes of patients undergoing TAVI or SAVR.

Methods: COSTA (Cognitive Outcome after Surgical and Transcatheter Aortic valve replacement) is a single-center sub-study of the randomized DEDICATE trial (clinicaltrials.gov ID: NCT04535076). Neurocognitive tests (memory, attention, language, executive functions), questionnaires on neuropsychology (cognitive failures questionnaire [CFQ], hospital anxiety, and depression scale [HADS]), and health-related quality of life (SF-36) were used before intervention and 3 months thereafter. Cranial magnetic resonance imaging (MRI) was carried out post-intervention. In addition, there was a systematic assessment of delirium during the hospital stay.

Results: The study cohort (mean age 71.8 years, 32% female) consisted of SAVR (n = 13) and TAVI (n = 18) patients. In the SAVR group, subsyndromal delirium was more common (54 vs. 11%, p = 0.017; OR = 8.58), visual recognition ability was worse (mean difference (MD) =  - 0.6 vs. + 0.3, p = 0.036, η² = 0.14), and emotional impairment was numerically more declined (MD =  - 36.8 vs. - 4.7, p = 0.058, η² = 0.12) when compared to the TAVI group.

Conclusion: In this small, exploratory sample, SAVR showed a trend toward less favorable neuropsychological outcomes compared with TAVI in patients with low-to-intermediate surgical risk.

Trial registration: ClinicalTrials.gov Identifier: NCT04535076. 27 August 2020 (retrospectively registered).

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.