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BACKGROUND: Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known. METHODS: We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding. RESULTS: The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year). CONCLUSIONS: Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).
Subject(s)
Anticoagulants , Arrhythmias, Cardiac , Embolism , Factor Xa Inhibitors , Aged , Female , Humans , Male , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Embolism/drug therapy , Embolism/etiology , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/therapeutic use , Hemorrhage/chemically induced , Stroke/etiology , Stroke/prevention & control , Electrodes, Implanted , Double-Blind Method , Arrhythmias, Cardiac/complications , Arrhythmias, Cardiac/diagnosis , Risk FactorsABSTRACT
BACKGROUND AND AIMS: Patients with long atrial high-rate episodes (AHREs) ≥24â h and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared with no anticoagulation in these patients. METHODS: This secondary pre-specified analysis of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes (NOAH-AFNET 6) trial examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared with placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and electrocardiogram (ECG)-diagnosed atrial fibrillation. RESULTS: Median follow-up of 2389 patients with core lab-verified AHRE was 1.8 years. AHRE ≥24 h were present at baseline in 259/2389 patients (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc 4). Clinical characteristics were not different from patients with shorter AHRE. The primary outcome occurred in 9/132 patients with AHRE ≥24â h (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). Atrial high-rate episode duration did not interact with the efficacy (P-interaction = .65) or safety (P-interaction = .98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24â h developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; P < .001). CONCLUSIONS: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.
Subject(s)
Atrial Fibrillation , Pyridines , Stroke , Thiazoles , Humans , Female , Aged , Aged, 80 and over , Male , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Atrial Fibrillation/diagnosis , Heart Atria , Risk Factors , Stroke/etiology , Stroke/prevention & control , Stroke/diagnosis , Anticoagulants/therapeutic useABSTRACT
OBJECTIVES: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions. METHODS: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed. RESULTS: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not influence the primary patency. CONCLUSIONS: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions. CLINICAL IMPACT: Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.
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PURPOSE: To report the performance of surgical treatment (ST), hybrid treatment (HT), and endovascular treatment (ET) for patients with acute limb ischemia (ALI). METHODS: This is a retrospective, comparative study of all consecutive patients with ALI treated in 2 tertiary centers between April 2010 and April 2020. Amputation and/or death (amputation-free survival; AFS) was the primary composite endpoint. Mortality, major amputation, and reintervention during follow-up were additionally analyzed. Proportional hazards modeling was used to identify confounders, results are presented as hazard ratio (HR) and 95% confidence intervals (CIs). RESULTS: In total, 395 patients (mean age=71.1±13.6 years; 51.1% female) were treated during the study period. Surgical treatment was preferred in 150 patients (38%), while 98 were treated by HT (24.8%) and 147 by ET (37.2%). Rutherford class IIa was the most common clinical presentation in the ET group (50.3%), whereas Rutherford IIb was most common in the ST (54%) and HT (48%) groups (p<0.001). Significantly, more patients presented with a de novo lesion in the ST and HT groups (79.3% and 64.3%, respectively) compared with ET (53.7%; p<0.001). Median follow-up was 20 months (range=0-111 months). In the multivariate analysis, ET showed significantly better AFS during follow-up compared with ST (HR=1.89, 95% CI=1.2-2.9, p<0.001) and HT (HR=1.73, 95% CI=1.1-3.1, p<0.001). Mortality during follow-up was also significantly lower after ET compared with ST (HR=2.21, 95% CI=1.31-3.74, p=0.003) and HT (HR=2.04, 95% CI=1.17-3.56, p=0.012). Endovascular treatment was associated with lower amputation rate compared with ST (HR=2.27, 95% CI=1.19-4.35, p=0.013) but was comparable with HT (HR=2.00, 95% CI=0.98-4.06, p=0.055). Reintervention rates did not differ significantly between the groups (ET vs ST: HR=1.52, 95% CI=0.99-2.31, p=0.053; ET vs HT: HR=1.3, 95% CI=0.81-2.07, p=0.27). CONCLUSION: Endovascular treatment for ALI was associated with improved AFS and comparable reintervention rates compared with open surgical and hybrid therapy. CLINICAL IMPACT: Treatment of acute lower limb ischemia remains a challenge for clinicians with high morbidity and mortality rates. Endovascular revascularization is considered first line treatment for many and hybrid treatments are becoming more common, however data is limited to either old trials, small series or with short follow-up. We present herein our 10-year experience with all available devices and techniques for open surgical, endovascular and hybrid acute limb ischemia treatments and compare their outcomes.
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PURPOSE: Τo evaluate the evolution of macular atrophy (MA) in patients with neovascular AMD (nAMD), compared with their fellow eyes exhibiting dry AMD (dAMD). METHODS: This retrospective study included 124 patients from three centers treated with anti-VEGF in their nAMD eye and having dAMD in the fellow eye. Patients without MA at baseline were analyzed to study the time to first MA development. Synchronous and unsynchronous time course of MA was also studied. MA was evaluated using near-infrared images, while all available optical coherence tomography (OCT) images were used to confirm the criteria proposed by the Classification of Atrophy Meetings group for complete MA. RESULTS: MA first detection in nAMD eyes increased significantly from year 2 to 6 compared to dAMD eyes. Over the study's follow-up, 45.1% of nAMD-E developed MA, compared to 16.5% of fellow eyes (p < 0.001). When MA in the two eyes was compared in a synchronous paired manner over 4 years, nAMD eyes had an average MA progression rate of 0.275 mm/year versus 0.110 mm/year in their fellow dAMD eyes. Multivariate ANOVA revealed significant time (p < 0.001), eye (p = 0.003), and time-eye interaction (p < 0.001) effects. However, when MA did develop in dAMD eyes and was compared in an asynchronous manner to MA of nAMD eyes, it was found to progress faster in dAMD eyes (dAMD: 0.295 mm/year vs. nAMD: 0.176 mm/year) with a significant time-eye interaction (p = 0.015). CONCLUSIONS: In this study, a significant difference in MA incidence and progression was documented in eyes with nAMD under treatment, compared to fellow eye exhibiting dAMD. Eyes with nAMD tended to develop more MA compared to fellow dAMD eyes. However, when atrophy did develop in the fellow dAMD eyes, it progressed faster over time compared to MA in nAMD eyes.
Subject(s)
Angiogenesis Inhibitors , Wet Macular Degeneration , Humans , Angiogenesis Inhibitors/therapeutic use , Retrospective Studies , Vascular Endothelial Growth Factor A , Visual Acuity , Wet Macular Degeneration/diagnosis , Wet Macular Degeneration/drug therapy , Tomography, Optical Coherence/methods , Atrophy/drug therapy , Ranibizumab , Intravitreal InjectionsABSTRACT
PURPOSE: This study aimed to evaluate the progression of macular atrophy (MA) based on near-infrared reflectance (NIR) and optical coherence tomography (OCT) images, in patients with age-related macular degeneration (AMD), receiving anti-vascular endothelial growth factor (anti-VEGF) treatment for at least a 6-year period. MATERIALS AND METHODS: This retrospective study included 53 naïve patients (53 eyes) with neovascular AMD from 2 centers, who were treated with anti-VEGF intravitreal injections and had no MA at baseline. MA was evaluated in an annual basis using NIR images, while all available OCT images were used to confirm that the atrophic area fulfilled the criteria proposed by the Classification of Atrophy Meetings (CAM) group for complete retinal pigment epithelium and outer retinal atrophy. Incidence and progression of MA were evaluated. Associations with best-corrected visual acuity (BCVA) and total number of injections were also studied. RESULTS: Treatment duration of our patients was 7.34 ± 1.54 years. The mean number of anti-VEGF injections was 24.4 ± 13.6. BCVA at baseline was 0.38 ± 0.27 logMAR, while at the final visit, it was 0.60 ± 0.35 logMAR (p = 0.731). The cumulative incidence of new MA at years 1, 2, 3, 4, 5, and 6 was 1.89%, 18.87%, 32.08%, 39.62%, 49.06%, and 50.94%, respectively. In patients who developed MA, mean MA area increased from zero at baseline to 5.66 ± 7.18 mm2 at the final visit. The estimated annual enlargement of MA was 0.45 mm/year based on square root transformation (1.12 mm2/year, untransformed data). MA progression does not appear to be significantly associated with age (R = 0.055; p = 0.784), gender (R = 0.113; p = 0.576), BCVA (R = 0.168; p = 0.404), and total number of injections (R = 0.133; p = 0.255). CONCLUSION: In this real-life setting, half of the neovascular AMD patients under anti-VEGF treatment, without MA at therapy initiation, developed MA over a period of at least 6 years. In this work, the number of injections did not seem to have a significant association with MA progression.
Subject(s)
Angiogenesis Inhibitors , Wet Macular Degeneration , Atrophy , Child , Child, Preschool , Fluorescein Angiography/methods , Humans , Intravitreal Injections , Ranibizumab , Retrospective Studies , Tomography, Optical Coherence/methods , Vascular Endothelial Growth Factor A , Visual Acuity , Wet Macular Degeneration/diagnosis , Wet Macular Degeneration/drug therapyABSTRACT
PURPOSE: To associate the impact of aortic reconstruction using currently available grafts and endografts on pulse wave velocity in patients with abdominal aortic aneurysm (AAA) and to evaluate its effect on early cardiac systolic function indices. MATERIALS AND METHODS: Seventy-three consecutive patients with AAA (mean age 70±8 years; all men) who underwent open (n=12) or endovascular repair (EVAR; n=61) were prospectively enrolled in an observational cohort study. Left ventricular global longitudinal strain (GLS; an important diagnostic and prognostic index of early systolic dysfunction) and carotid-femoral pulse wave velocity (cf-PWV) were estimated 1 week preoperatively, as well as at 1 and 6 months postoperatively. RESULTS: A significant time effect was found for cf-PWV, which showed an increase at 1 month that remained through 6 months (p=0.007). Additionally, a deterioration in GLS values was revealed, with a significant change at 1 month that persisted 6 months later (p<0.001). No significant group effect was observed between EVAR and open repair (p=0.98), and there was no significant interaction (p=0.96). Notably, the difference in GLS between baseline and 6 months significantly correlated with the corresponding changes in cf-PWV (r=0.494, p<0.001). CONCLUSION: AAA repair leads not only to an increase in aortic stiffness, as measured by the increase in pulse wave velocity, but also to reduced cardiac systolic function. Our findings highlight the need for a more intense cardiac surveillance program after aortic reconstruction. Further studies are needed to investigate how this may translate into long-term manifestations of cardiovascular complications and symptomatology.
Subject(s)
Aortic Aneurysm, Abdominal , Endovascular Procedures , Vascular Stiffness , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures/adverse effects , Humans , Male , Middle Aged , Pulse Wave Analysis , Treatment OutcomeABSTRACT
BACKGROUND: Studies conducted in coronary intensive care units (CICUs) have demonstrated that tachyarrhythmias are associated with increased mortality after acute coronary syndromes (ACSs). However, the data for tachyarrhythmias occurred in CICUs due to a variety of cardiovascular disorders are limited. METHODS: We conducted a single-center prospective observational study, which included consecutive CICU patients (January 1, 2014 to May 31, 2018). We recorded the ventricular arrhythmias (VAs), supraventricular tachycardias (SVTs), and days of CICU hospitalization. The patients were followed up for 6 months after CICU discharge. RESULTS: A total of 943 patients (age: 66.37 ±15.4 years; 673 males [71.4%]) were included. Patients with tachyarrhythmias had higher in-CICU mortality (8.0% vs 4.1%, P = .029, odds ratio [OR]: 2.04, 95% confidence interval [CI]: 1.08-3.86) and higher 6-month all-cause mortality (12.8% vs 6.1%, P = .002, OR: 2.27, 95% CI: 1.35-3.83) than those who did not develop tachyarrhythmias. Ventricular arrhythmias was significantly associated with higher all-cause mortality than no tachyarrhythmia (15.4% vs 6.1%; P = .001) or SVTs (15.4% vs 7.0%; P = .001). The mean duration of hospitalization for the patients with tachyarrhythmias was 3.89 ± 4.90 days, while for the patients without was 2.79 ± 3.31 days (P < .001). Patients without ACS had higher short- and long-term mortality compared to patients with ACS (9.2% vs 2.9%, P < .001 and 12.9% vs 4.9%, P < .001). CONCLUSIONS: Tachyarrhythmias were associated with prolonged CICU hospitalization, while non-ACS cardiovascular disorders and the occurrence of VAs were associated with increased short- and long-term mortality.
Subject(s)
Acute Coronary Syndrome , Intensive Care Units , Acute Coronary Syndrome/complications , Acute Coronary Syndrome/therapy , Aged , Hospitalization , Humans , Male , Prognosis , Retrospective Studies , TachycardiaABSTRACT
INTRODUCTION: Hyperthermic Ιsolated Limb Perfusion using melphalan and TNFα (TM-HILP) is a regional chemotherapy method for advanced melanoma. PURPOSE: To explore the feasibility of the study of Circulating Melanoma Cells (CMCs) in the context of acute physiological changes induced by TM-HILP and their association with oncological outcomes. METHODS: The study included 20 patients undergoing TM-HILP for unresectable in-transit melanoma of the limbs, stage III(B/C/D). CMCs in the peripheral blood were analyzed at 5-time points from the preoperative day until day 7 from surgery using the following biomarkers: MITF, Tyrosinase mRNA, Melan-A and S100b, through quantitative RT-PCR. RESULTS: No CMCs according to Tyrosinase and Melan-A biomarkers were found in any sample. Friedman test showed significant alterations perioperatively for MITF (p < .001) and S100b (p = .001). Pairwise tests showed a significant increase of MITF levels on postoperative day 7 compared with postoperative day 1, intraoperative and preoperative levels (p < .05). Pairwise tests for S100b showed a significant difference between intraoperative sample and postoperative day 7 (p < .0001). Patients who experienced a complete response to TM-HILP (n = 12) had higher mean levels of MITF and the difference was significant at the time point immediately after the operation (0.29 ± 0.27 vs. 0.06 ± 0.06, p = .014) and on postoperative day 1 (1.48 ± 2.24 vs. 0.41 ± 0.65, p = .046). There was no association of MITF or S100b levels with 4-year disease specific survival. CONCLUSION: TM-HILP is associated with increased levels of CMCs, but there was no association of this increase with survival. Patients with complete response to HILP demonstrate higher values of MITF shortly after the operation.
Subject(s)
Hyperthermia, Induced , Melanoma , Chemotherapy, Cancer, Regional Perfusion , Extremities , Feasibility Studies , Humans , Melanoma/therapy , Melphalan/therapeutic use , Perfusion , Tumor Necrosis Factor-alpha/therapeutic useABSTRACT
The mortality of patients with non-ischemic dilated cardiomyopathy (NIDCM) remains substantial. We evaluated gene expression levels of myocardin, an early cardiac gene, in the peripheral blood cells of NIDCM patients as a prognostic biomarker in their long-term outcome and mortality from congestive HF (CHF). We retrospectively analyzed 101 consecutives optimally treated NIDCM patients of Cretan origin who were enrolled from the HF clinic of our hospital from November 2005 to December 2008. Our patient data were either taken from their medical files or recorded during visits to the HF unit or hospitalizations. Follow-up was carried out by telephone interview and by accessing information from general practitioners and cardiologists in private practice. The median follow-up period was 8 years (mean follow-up 7 ± 3.4 years). The overall mortality during follow-up was 61.4%, while mortality due to congestive heart failure (CHF) was 49.5%. Higher CHF and all-cause mortality were observed in patients with myocardin levels < 14.26 (p < 0.001 for both CHF and all-cause mortality). A multivariate Cox regression analysis showed that myocardin level of expression had independent significant prognostic value for the risk of death from CHF (HR 14.5, 95% confidence interval (CI) 5.3-39) in those patients. Peripheral blood cells gene expression of myocardin, an early myocardial marker, may serve as prognostic biomarkers of the long-term outcome of patients with NIDCM. Our findings open new prospects in the risk stratification of these patients.
Subject(s)
Cardiomyopathies , Cardiomyopathy, Dilated , Cardiomyopathy, Dilated/diagnosis , Cardiomyopathy, Dilated/genetics , Heart Failure/diagnosis , Humans , Nuclear Proteins , Prognosis , Retrospective Studies , Trans-ActivatorsSubject(s)
Anticoagulants , Atrial Fibrillation , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Female , Male , Administration, Oral , Age Factors , Aged , Sex Factors , Stroke/prevention & control , Stroke/epidemiology , Comorbidity , Treatment Outcome , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/epidemiologyABSTRACT
Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation (AF). Early detection of AF and subsequent initiation of oral anticoagulation help to prevent strokes in AF patients. Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes (AHRE), but the best antithrombotic therapy in patients with AHRE is not known. RATIONALE: Stroke risk is higher in pacemaker patients with AHRE than in those without, but the available data also show that stroke risk in patients with AHRE is lower than in patients with AF. Furthermore, only a minority of patients with AHRE will develop AF, many strokes occur without a temporal relation to AHRE, and AHRE can reflect other arrhythmias than AF or artifacts. An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed. DESIGN: The Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6 ) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared with aspirin or no antithrombotic therapy based on evidence-based indications. The primary safety outcome will be major bleeding. NOAH-AFNET 6 will randomize 3,400 patients with AHRE, but without documented AF, aged ≥65 years with at least 1 other stroke risk factor, to oral anticoagulation therapy (edoxaban) or no anticoagulation. All patients will be followed until the end of this investigator-driven, prospective, parallel-group, randomized, event-driven, double-blind, multicenter phase IIIb trial. Patients will be censored when they develop AF and offered open-label anticoagulation. The sponsor is the Atrial Fibrillation NETwork (AFNET). The trial is supported by the DZHK (German Centre for Cardiovascular Research), the BMBF (German Ministry of Education and Research), and Daiichi Sankyo Europe. CONCLUSION: NOAH-AFNET 6 will provide robust information on the effect of oral anticoagulation in patients with atrial high rate episodes detected by implanted devices.
Subject(s)
Aspirin/administration & dosage , Atrial Fibrillation/epidemiology , Heart Rate , Pyridines/administration & dosage , Stroke/prevention & control , Thiazoles/administration & dosage , Administration, Oral , Aged , Atrial Fibrillation/drug therapy , Atrial Fibrillation/physiopathology , Disease-Free Survival , Double-Blind Method , Europe/epidemiology , Factor Xa Inhibitors/administration & dosage , Female , Fibrinolytic Agents/administration & dosage , Follow-Up Studies , Humans , Incidence , Male , Prospective Studies , Risk Factors , Stroke/epidemiology , Stroke/etiology , Survival Rate/trends , Time Factors , Treatment Outcome , Vitamin KABSTRACT
While the benefit of oral anticoagulants (OACs) for stroke prevention in patients with atrial fibrillation (AF) is well established, it is not known whether oral anticoagulation is indicated in patients with atrial high-rate episodes (AHRE) recorded on a cardiac implantable electronic device, sometimes also called subclinical AF, and lasting for at least 6 min in the absence of clinically diagnosed AF. Clinical evidence has shown that short episodes of rapid atrial tachycarrhythmias are often detected in patients presenting with stroke and transient ischaemic attack. Patients with AHRE have a higher likelihood of suffering from subsequent strokes, but their stroke rate seems lower than in patients with diagnosed AF, and not all AHRE episodes correspond to AF. The prognostic and pathological significance of AHRE is not yet fully understood. Clinical trials of OAC therapy are being conducted to determine whether therapeutic intervention would be beneficial to patients experiencing AHRE in terms of reducing the risk of stroke.
Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Stroke/prevention & control , Atrial Fibrillation/complications , Cardiac Resynchronization Therapy Devices , Defibrillators, Implantable , Humans , Stroke/etiologyABSTRACT
AIM: Long-term right ventricular apical (RVA) pacing may lead to left ventricular (LV) remodelling and heart failure. This study assessed changes in the expression of genes regulating LV contractile function and hypertrophy, after permanent RVA pacing and investigated whether such changes proceed or even predict LV remodelling. METHODS AND RESULTS: We enrolled 52 consecutive patients (age 79.1 ± 7.7 years, 34 males) who underwent pacemaker implantation for bradycardic indications: Group A, 24 individuals with atrioventricular conduction disturbances and group B, 28 patients with sinus node disease. In group A, peripheral blood mRNA levels of gene sarcoplasmic reticulum calcium ATPase decreased at 3, 6, and 12 months' follow-up, while α-myosin heavy chain (MHC) decreased and ß-MHC increased until 6 months follow-up. In this group, 25% of patients demonstrated significant LV remodelling. At 4 years, LV end-systolic diameter increased from 29.67 ± 3.39 mm at baseline to 35.38 ± 4.22 mm, LV end-diastolic diameter increased from 50 ± 4.95 to 56.71 ± 5.52 mm, and ejection fraction declined from 63.04 ± 10.22 to 52.83 ± 10.81%. Early alterations in gene expression were associated with a deterioration in LV function and geometry that became apparent months later. In group B, echocardiographic indexes and mRNA levels of the evaluated genes demonstrated no statistically significant changes. CONCLUSIONS: Permanent RVA pacing in patients with preserved ejection fraction is associated with alterations in the expression of genes regulating LV contractile function and hypertrophy, measured in the peripheral blood. These alterations are traceable at an early stage, before echocardiographic changes are apparent and are associated with LV remodelling that becomes evident in the long term.
Subject(s)
Cardiac Myosins/blood , Heart Ventricles/physiopathology , Myosin Heavy Chains/blood , Sarcoplasmic Reticulum Calcium-Transporting ATPases/blood , Sick Sinus Syndrome/complications , Ventricular Function, Left/genetics , Ventricular Remodeling/genetics , Aged , Aged, 80 and over , Biomarkers/blood , Bradycardia/therapy , Cardiac Pacing, Artificial/methods , Echocardiography , Female , Heart Failure/therapy , Humans , Male , Pacemaker, Artificial , Prospective Studies , Stroke VolumeABSTRACT
BACKGROUND: Our knowledge regarding the epidemiology of pediatric cardiomyopathy is based on large national population studies reporting an annual incidence of 1 case per 100,000 children, with a higher incidence observed in infancy and among selected populations. The aim here is to document the epidemiology of pediatric cardiomyopathy in a Mediterranean population. METHODS: Children younger than 18 years of age living on the Mediterranean island of Crete, Greece, who have been evaluated since the establishment of tertiary pediatric cardiology services (2002-2022) were included in this retrospective study. RESULTS: A total of 40 children were included, corresponding to an average annual incidence of pediatric cardiomyopathy of 1.59 cases (95% CI: 1.4-2.3) and a prevalence of 26 cases per 100,000 children. In decreasing order of frequency, most cases corresponded to dilated (50%), followed by hypertrophic (42.5%), arrhythmogenic (5%), and restrictive (2.5%) cardiomyopathy. An etiology was identified in 40%, including a genetic diagnosis in 22.5%. CONCLUSIONS: The incidence of pediatric cardiomyopathy in the Mediterranean island of Crete is higher compared with that reported previously for other Caucasian populations. Further study is needed to investigate the exact prevalence and specific genetic factors associated with the epidemiology of pediatric cardiomyopathy in Mediterranean populations.
ABSTRACT
BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is a major health issue with high morbidity and mortality. The epidemiology and the factors that cause HFpEF have not been fully clarified, while accurate predictive biomarkers are lacking. Our aim was to determine whether levels of microRNA-21 (miR-21) in peripheral blood monocytes, which play a critical role in many pathophysiological pathways of hypertensive heart disease, can predict the occurrence of HFpEF in older hypertensives, as well as the associated mortality and morbidity. METHODS: We enrolled 151 elderly patients >60 years old with essential hypertension but without HF at baseline. miRs expression levels in peripheral blood mononuclear cells had been quantified by real-time reverse transcription polymerase chain reaction. RESULTS: During a median follow-up of 8.2 years, 56 patients (37%) had an event. Levels of miR-21 in peripheral mononuclear blood cells proved to be significantly associated with the occurrence of HFpEF. More specifically, the median HFpEF-free period was 110 months for those with miR-21 >2.1 and 114 months for those with miR-21 <2.1. In addition, multivariate analysis showed that miR-21 (hazard ratio 11.14), followed by hemoglobin (Hg) (hazard ratio 0.56 for Hg >13.6 g/dl, a 45% risk reduction), were independent and the most significant predictors of HFpEF events. CONCLUSIONS: miR-21 levels in peripheral blood monocytes are associated with the development of future HFpEF. Our findings may alter the risk models of HFpEF and support the rationale for further research into the modulation of miRs as biomarkers and treatment targets for HFpEF.
Subject(s)
Heart Failure , Hypertension , Mercury , MicroRNAs , Humans , Aged , Middle Aged , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/genetics , Stroke Volume/physiology , Leukocytes, Mononuclear , Prognosis , Biomarkers , Hypertension/diagnosis , Hypertension/epidemiology , Hypertension/genetics , Hemoglobins , MicroRNAs/geneticsABSTRACT
PURPOSE: The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems. MATERIAL AND METHODS: A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0-4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions. RESULTS: In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5 mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12 months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24 months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12 months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24 months (LogRank = 0.36). CONCLUSIONS: In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12 months.
Subject(s)
Drug-Eluting Stents , Endovascular Procedures , Femoral Artery , Peripheral Arterial Disease , Popliteal Artery , Vascular Calcification , Humans , Male , Female , Aged , Popliteal Artery/diagnostic imaging , Femoral Artery/diagnostic imaging , Retrospective Studies , Vascular Calcification/diagnostic imaging , Vascular Calcification/therapy , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/diagnostic imaging , Endovascular Procedures/methods , Treatment Outcome , Vascular Patency , Polymers , Middle Aged , Aged, 80 and overABSTRACT
INTRODUCTION: High resolution ultrasound (US) of the cervical vagus nerve (CVN) is clinically relevant in the diagnostic workup and during neurostimulation therapy of several neurologic diseases. This prospective study aims to provide reference data of the cross-sectional area (CSA) and fascicle count of the normal CVN and to investigate their possible association with anthropometric data in a large cohort of patients. METHODS: A total of 657 CVNs in 330 individuals without history of neurological disease were examined using US (7-15Mhz). The CVN fascicle count and CSA inside the hyperechoic epineurium at the level of the thyroid lobes were measured. Three CSA measurements were performed to calculate the mean value. Anthropometric data were recorded. RESULTS: The mean fascicle count was 2.4 ± 1.1 (right) and 2 ± 1 (left) (paired t- test, p < 0.001). Two CVN patterns were identified: A single hypoechoic fascicular structure (26.2 % right, 36.3 % left) and a honeycomb structure of 2-6 discrete fascicles (72.3 % right, 63.7 % left). Right CVN mean CSA was larger compared to left (2.3 ± 1 mm2 and 1.8 ± 0.8 mm2 respectively, t-test, p-0.000). There was no difference in the CSA values between sex and no correlation to age or height. A positive correlation between the CSA and weight and BMI was found (Pearson's correlation, p = 0.01 right and p = 0.05 left). CONCLUSION: The right CVN has larger CSA and contains more fascicles than the left. CVN is usually mono- or oligo-fascicular with a honeycomb appearance. The CSA increased with increasing BMI but no age and sex specific differences were noted.
Subject(s)
Median Nerve , Vagus Nerve , Male , Female , Humans , Prospective Studies , Reference Values , Ultrasonography , Vagus Nerve/diagnostic imaging , Vagus Nerve/physiologyABSTRACT
Eye injuries are a major cause of visual disability worldwide and may present a burden to both quality of life of the sufferers and healthcare services. The aim of this study was to extract and triangulate information on the demographic, clinical, and social features of eye-injured adult patients admitted to a tertiary hospital in Greece. The design was a five-year retrospective study of eye-injured adult patients, admitted to the General University Hospital of Heraklion, Crete (GUHH), the single tertiary referral hospital on the island. Drawing the profile of eye-injured patients may add to future health planning. Data collected from 1 January 2015 to 31 December 2019, such as sociodemographic features and clinical information, were extracted. One hundred twenty-eight patients were included. Of those, there was no available information on activity during injury for 6 patients, 78 (60.9%) had work-related ocular injuries, and 44 (34.4%) had non-work-related ocular injuries. Patients with no current formal employment, those who were retired, and formally unemployed and manual force workers had the higher rates of work-related injuries. The most common work-related injuries were closed globe injuries, specifically contusions, while ruptures and penetrating wounds were the most frequent of the open globe injuries. Within the univariate analyses, work-related eye injuries were significantly associated with male gender, middle age, and the place related to daily work activity. Determinants of poor final visual acuity (VA) were the initial VA, the type of injury (p < 0.0001), the distance of the place of residence from the hospital, and the time to hospital admission (p < 0.013). In a multivariate analysis, referred patients and those with open globe injuries arrived at hospital after a two-hour interval compared with those who were not referred and those with closed globe injuries (p ≤ 0.05). A reduction in the time to hospital admission deserves further attention. The interconnection of community and health system services through a capacity increase and networking needs further research in order to obtain targeted and viable access for eye-injured patients.
ABSTRACT
Pericoronary adipose tissue (PCAT) is a source of microRNAs (miRs) that act as messengers for intercellular communication. We investigated whether the PCAT surrounding significant coronary atherosclerotic lesions shows specific miR expression patterns compared with PCAT surrounding plaque-free segments. We included 49 patients with 3-vessel coronary artery disease (CAD) and 19 patients with severe valvular disease but no CAD, who underwent elective cardiac surgery. The PCAT was harvested from two sites: adjacent to a significant atherosclerotic coronary lesion and from plaque-free segments. miR-133a, miR-21, miR-26b, miR-9, and miR-143 levels in PCAT cells were quantified by real-time reverse transcription polymerase chain reaction (data expressed as arbitrary units). Expression of miR-133, miR-21, and miR-26b in adipose tissue at a site without atherosclerotic lesion was much lower in patients with CAD than in those without CAD (0.82 ± 1.37 vs 1.86 ± 0.52, P < .001, 0.45 ± 1.3 vs 1.51 ± 1.11, P < .001, 0.3 ± 1.25 vs 1.2 ± 0.73, P = .02, respectively). In addition, miR-133, miR-21, and miR-143 in CAD patients showed significantly greater expression in PCAT from atherosclerotic lesion compared with plaque-free segments (1.32 ± 0.96 vs 0.82 ± 0.37 (P = .011), 0.91 ± 1.7 vs 0.3 ± 1.25 (P = .012), 1.2 ± 1.59 vs 0.43 ± 0.54 (P < .001), respectively). Our findings open new perspectives for the role of PCAT in the pathophysiology of atherosclerosis and should be further investigated.