Abstract
Background
Left atrial appendage closure (LAAC) procedures prevent cardioembolic stroke in patients with atrial fibrillation who have contraindications to oral anticoagulant medications. ...However, these procedures carry certain risks of peri-procedural complications. One such complication is silent brain infarcts (SBI), which can lead to cognitive impairment and mood disturbances. The implementation of mechanical neuroprotection systems during LAAC procedures may reduce the risk of SBI and associated cognitive and mood disorders.
Methods
The LAAC-SBI trial is a prospective, multicenter, randomized, and double-blind interventional study. The study aims to enroll a total of 240 patients, with 120 patients allocated to each group. The study group will evaluate the use of the Sentinel CPS during LAAC, while the control group will undergo LAAC procedures without the Sentinel CPS. The primary endpoint of the study is the number of new SBIs or stroke foci detected by diffusion-weighted magnetic resonance imaging (DW MRI). Secondary endpoints include deterioration of cognitive function, development of dementia syndrome, and occurrence of depressive disorders. These endpoints will be assessed using questionnaire tools such as the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Controlled Oral Word Association Test (COWAT), and Hospital Anxiety and Depression Scale (HADS). The observational period for patients in the study is 2 years.
Discussion
If the study demonstrates a favorable outcome with reduced incidence of SBI and improved cognitive and mood outcomes in patients receiving cerebral protection devices during LAAC, it will have significant implications for clinical management standards. This would support the use of neuroprotection devices not only for LAAC but also in procedures such as atrial fibrillation ablation or transcatheter mitral valve interventions, where the risk of embolic events and subsequent brain injury may also be present.
Trial registration
ClinicalTrials.gov NCT05369195. Registration on 11.05.2022.
Left atrial appendage closure (LAAC) is an alternative approach to anticoagulants. Nonetheless, data regarding the outcomes of LAAC procedures in patients with thrombocytopenia remain lacking. The ...primary objective was to determine the incidence of the composite endpoint comprising ischemic stroke, intracranial hemorrhage, major bleeding, and cardiac cause of death among patients with atrial fibrillation (AF) and thrombocytopenia who were either undergoing LAAC or receiving oral anticoagulants. The secondary endpoint was the determination of total mortality. Data from a prospective, single-center registry of patients undergoing LAAC procedures were analyzed. A subset of 50 consecutive patients with thrombocytopenia were selected. Thrombocytopenia was defined as a thrombocyte count below 150,000. Subsequently, from patients hospitalized with AF receiving oral anticoagulants, 50 patients were further chosen based on propensity score matching, ensuring comparability with the study group. The primary endpoint occurred in 2% of patients in the LAAC group and 10% of patients in the non-LAAC group (
= 0.097). Additionally, a significant difference was noted in the occurrence of the secondary endpoint, which was observed in 0% of patients in the LAAC group and 10% of patients in the non-LAAC group (
= 0.025). In patients with thrombocytopenia the LAAC procedure improves prognosis compared with continued anticoagulant treatment.
Introduction The coexistence of atrial fibrillation (AF) and chronic kidney disease (CKD) increases the risk of thromboembolic complications, as well as hemorrhagic incidents – percutaneous left ...atrial appendage occlusion (LAAO) is an alternative. Aim To evaluate the long-term outcomes of LAAO performed in patients with CKD and non-valvular AF. Material and methods Two hundred and seventy-two patients with AF who underwent LAAO between 2009 and 2019 were prospectively analyzed. Patients were divided into two groups: CKD (105 patients) and non-CKD (167 patients) (cut-off point: eGFR 60 ml/min/1.73 m2). The mean follow-up period was 25.56 months. Results The LAAO was successful in 269 (98.9%) patients. Seven (2.6%) patients suffered an ischemic stroke, including 2 (1.9%) with CKD and 5 (3.0%) in the non-CKD (p = 0.581) group. The risk of ischemic stroke was 0.25/100 patient-years (PY) for CKD and 0.39/100 PY for the non-CKD (p =0.028) group. The LAAO was associated with a relative risk reduction (RRR) of 96.4% (CKD group) and 91.8% (non-CKD group) on average compared to expected stroke rates. Hemorrhagic stroke occurred in 1 (0.6%) patient of the non-CKD group, whereas major bleeding occurred in 1 (0.6%) non-CKD patient and 1 (1.0%) CKD patient (p = 0.427). The risk of major bleeding was 0.13/100 PY for CKD and 0.15/100 PY for non-CKD (p = 0.768), corresponding to an RRR of 97.9% (CKD) and 97.4% (non-CKD) on average compared to oral anticoagulant therapy. Conclusions Considering the significant reduction in thromboembolic events, with a simultaneous reduction of major bleeding complications, LAAO is a safe and effective alternative for AF patients with CKD.
IntroductionOne indication for the implantation of a cardioverter-defibrillator is a reduction in the left ventricular ejection fraction (LVEF) ≤ 35%. However, in certain patients following an acute ...myocardial infarction (AMI) a gradual improvement in LVEF has been observed. The factors determining this increase in LVEF have not been conclusively determined. AimTo ascertain the independent predictors associated with the improvement of LVEF in patients following AMI who underwent invasive treatment, while observing their progress over a 6-month follow-up period. Material and methodsAmong 665 patients with AMI, a population with LVEF ≤ 35% was selected. After 6 months, a follow-up echocardiogram was performed. Further analysis compared patients with at least 5% improvement in LVEF (Group I) with those without an increase (Group II). ResultsGroup I consisted of 34 individuals out of 80 patients (43%) with LVEF ≤ 35%. The factors linked to a reduced probability of LVEF improvement were: higher levels of cardiac troponin T (cTnT) (OR 0.841 for 1 ng/ml increase in cTnT, CI 0.715-0.989; p = 0.037), presence of diabetes mellitus (OR = 0.217, 95% CI: 0.058-0.813, p = 0.023) and moderate or severe mitral regurgitation (OR = 0.178, 95% CI: 0.053-0.597; p = 0.005). ConclusionsThe study findings indicate that the presence of severe or moderate mitral regurgitation is the most significant factor contributing to the lack of LVEF improvement following AMI. Moreover, the extent of myocardial damage, as indicated by elevated cTnT values, along with compromised adaptation to hypoxia in patients with diabetes, are identified as independent factors associated with reduced chances of an increase in LVEF.
Abstract To assess the clinical impact of atrial fibrillation (AF) in patients with ST-segment elevation myocardial infarction (STEMI) complicated by new-onset AF depending on STEMI location and ...timing of arrhythmia. We analyzed 4, 363 consecutive STEMI-patients treated invasively. Finally, 4,099 subjects were included into further analysis, as 264 patients were excluded because of previous AF history. 1800 (43.9%) subjects with anterior infarction were included into Group 1, whereas Group 2 encompassed 2299 (56.1%) patients with non-anterior infarction. Subsequently, both groups were divided into patients with new-onset AF (AF-Group 1 and 2, respectively) and without AF (Control Group 1 and 2). New-onset AF was recognized in 225 patients (5.5%) – 96 (5.3%) with an anterior wall infarction (AF-Group 1) and 129 (5.6%) with a non-anterior wall infarction (AF-Group 2). The incidence of early-onset arrhythmia (within 24 hours after admission) was significantly higher in AF-Group 2 than in AF-Group 1: 71.3% vs. 35.4% (p<0.001). In Group 1, both early- and late-onset AF were associated with significantly increaseased in-hospital mortality compared to AF-free population (17.7% and 27.4%, respectively vs. 6.3%; p<0.05). Whereas, in Group 2 in-hospital mortality was increased only in subjects with late-onset AF compared to AF-free population (13.5% vs. 4.2%; p<0.05). New-onset AF was the independent predictor of death only in Group 1 (HR 2.16) and this effect was stronger for late-onset AF (HR 2.86). In conclusion, one in 20 patients with STEMI treated invasively was affected by new-onset AF. The predictive value of new-onset AF was strongly related with STEMI location and timing of arrhythmia.
To assess the incidence of atrial fibrillation (AF) and the clinical impact of AF types on outcomes in patients with acute myocardial infarction (AMI) treated invasively, we analyzed 2,980 ...consecutive patients with AMI admitted to our department from 2003 through 2008. Data collected by the insurer were screened to identify patients who died during the median follow-up of 41 months. AF was recognized in 282 patients (9.46%, AF group); the remaining 2,698 patients (90.54%) were free of this arrhythmia (control group). The AF group was divided into 3 subgroups: prehospital paroxysmal AF (n = 92, 3.09%), new-onset AF (n = 109, 3.66%), and permanent AF (n = 81, 2.72%). In-hospital and long-term mortalities were significantly higher (p <0.001 for the 2 comparisons) in the AF than in the control group (14.9% vs 5.3%, 37.2% vs 17.0%, respectively). Long-term mortality was significantly higher (p <0.001 for the 2 comparisons) in the new-onset AF (35.8%) and permanent AF (54.3%) groups than in the control group but did not differ significantly between the prehospital AF and control groups (21.7% vs 17.0%, p = NS). Considering types of arrhythmia separately, only permanent AF (hazard ratio 2.59) was an independent risk factor for death in the studied population. In conclusion, AF occurs in 1 of 10 patients with AMI treated invasively, with nearly equal distributions among prehospital, new-onset, and permanent forms. Although arrhythmia is a marker of worse short- and long-term outcomes, only permanent AF is an independent predictor for death in this population.
Aim To assess incidence, predisposing factors and outcomes of cardiac device-related infective endocarditis (CDRIE) in patients undergoing cardiac resynchronization therapy (CRT). Methods and Results ...High-volume, single-center cardiology database was screened to identify all CDRIE cases, based on modified Duke criteria, amongst 765 consecutive CRT implantations between 2002 and 2015 (70.8% de novo implantations, 13.7% and 15.5% up-grades from pacemaker and implantable cardioverter-defibrillator ICD, respectively). During the median follow-up (FU) of 1207 days (range:256–2664) overall 38 CDRIE (4.97%) cases were identified (incidence: 15/1000 person-years). Multivariate Cox regression model, incorporating significant baseline differences as covariates (model 1), demonstrated that both up-grade from ICD to CRT and higher baseline NYHA class were independently associated with increased risk of CDRIE (adjusted HR 4.29, 95%CI 1.93–9.57; and HR 2.43, 95%CI 1.32–4.49, respectively). In the second model (including all differences with P < 0.2) up-grade from ICD (HR 4.36, 95%CI 1.96–9.69), higher NYHA class (HR 2.04, 95%CI 1.11–3.75), hypertrophic cardiomyopathy (HR 5.85, 95% CI 1.46–23.52), lower baseline hemoglobin level (HR 0.68, 95%CI 0.50–0.94) and chronic obstructive pulmonary disease (HR 2.46, 95%CI 1.05–5.77) were all independently associated with higher risk of CDRIE. All-cause mortality in patients with CDRIE was significantly higher than in subjects without infective complications (68.4% vs. 33.7%, P < 0.001), and 50% of patients with CDRIE died during index hospitalization. Conclusions The prevalence of CDRIE in CRT recipients is almost 5% within 3.5 years post implantation. Up-grade from ICD and high baseline NYHA class flag up patients at high-risk of CDRIE. CRT-related infective complications are associated with very poor prognosis.
OBJECTIVESThe primary aim of the study was to evaluate risk factors for ventricular fibrillation/sustained ventricular tachycardia (VF/VT) and to develop the risk score for prediction of VF/VT in ...patients with ST-segment elevation myocardial infarction (STEMI) treated invasively. The secondary aim was to assess the effect of VF/VT on mortality depending on timing of arrhythmia.
PATIENTS AND METHODSWe analyzed 4363 consecutive patients with STEMI treated invasively. Among them, 163 patients with pre-reperfusion arrhythmia were excluded from the study. Group ventricular arrhythmias (VA) encompassed patients with VF/VT – those with reperfusion-induced arrhythmia were included into group VA1, whereas group VA2 consisted of patients with postreperfusion arrhythmia. The control group comprised patients free of VF/VT.
RESULTSVF or VT occurred in 313 (7.45%) patients – group VA1 encompassed 103 (32.9%) and group AV2 210 (67.1%) patients. Cardiogenic shock on admission hazard ratio (HR) 3.5, new-onset atrial fibrillation (HR 2.1), incomplete revascularization (HR 1.7), prior myocardial infarction (HR 1.6) and symptom-to-balloon time more than 3 h (HR 1.3) were the independent predictors of VF/VT occurrence. In group VA2, the in-hospital and long-term mortality were 4- and 1.5-fold higher than in the arrhythmia-free population (20.5 vs. 4.5% and 36.2 vs. 22.6%, respectively; P<0.001). On the contrary, in group VA1, the long-term mortality was not significantly higher compared with the control group (26.2 vs. 22.6%; P=NS), whereas in-hospital mortality was almost three-fold increased (12.5 vs. 4.5%, respectively; P<0.001).
CONCLUSIONThe risk score based on simple clinical parameters might be useful for risk stratification for VF/VT in patients with STEMI. The predictive value of VF/VT was strongly dependent on timing of arrhythmia.
Paravalvular leak (PVL) has significant impact on long-term outcomes in patients after transcatheter aortic valve implantation (TAVI). This study sought to determine whether multi-slice computed ...tomography (MSCT)-guided valve selection reduces PVL after CoreValve implantation.
The analysis encompassed 69 patients implanted with CoreValve and were divided into two groups. In Group I (30 patients), valve selection was based on standard procedures, in Group II (39 patients), on MSCT measurements. Paravalvular leak was assessed with angiography and echocardiography.
Multi-slice computed tomography results influenced a change of decision as to the size of the implanted valve in 12 (30.9%) patients in Group II and would have caused the decision to change in 9 (37.5%) patients in Group I. The degree of oversizing in Group I and II was 12.8% ± ± 7.6% vs. 18.6% ± 5.1% (p = 0.0006), respectively. The oversizing among the patients with leak degree of 0-1 and ≥ 2 was 18.1% ± 6.0% and 12.8% ± 7.4% (p = 0.0036). Angiographic assessment indicated post-procedural PVL ≥ 2 in 50% of patients in Group I and 20.5% in Group II (p = 0.01), while echocardiographic assessment indicated the same in 73.3% of patients in Group I and 45.6% in Group II (p = 0.0136). The composite endpoint occurred in 26.6% (8/30) patients in Group I vs. 5.1% (2/39) patients in Group II (p = 0.0118).
Selecting the CoreValve device based on MSCT resulted in smaller rates of PVL and less frequent composite endpoint. In 1/3 of patients MSCT led to a change of the valve size. The degree of oversizing had a significant impact on PVL.
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