Anticoagulants versus Left Atrial Appendage Occlusion in Patients with Atrial Fibrillation and Co-Morbid Thrombocytopenia.

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 (p = 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 (p = 0.025). In patients with thrombocytopenia the LAAC procedure improves prognosis compared with continued anticoagulant treatment.

Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial.

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.

Predictive factors of left ventricular ejection fraction improvement after myocardial infarction treated invasively.

Introduction: One 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. Aim: To 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 methods: Among 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). Results: Group 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). Conclusions: The 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.

Long-term results of percutaneous left atrial appendage occlusion in patients with atrial fibrillation and chronic kidney disease.

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.

Long-term outcomes in patients after left atrial appendage occlusion: The results from the LAAO SILESIA registry.

BACKGROUND: The benefits of oral anticoagulation (OAC) therapy are undeniable. However, such treatment is contraindicated in 2%-10% of patients. According to the latest guidelines, percutaneous left atrial appendage occlusion (LAAO) may be considered in stroke prevention. AIMS: We analyzed the data of patients from the Polish population, who had undergone LAAO procedures in the Silesian Province based on limited reports. METHODS: The data from the SILCARD database of all patients who underwent LAAO between 2006 and 2019, and the data from the databases of the centers performing the procedures in the Silesian Province were included in the LAAO SILESIA registry. We analyzed the efficacy and safety of the procedure and its relationship with the occurrence of stroke and bleeding in the post-hospital follow-up. RESULTS: We analyzed 649 patients with the mean values of CHA2DS2-VASc and HAS-BLED scores of 4.1 and 3.2, respectively. The predominant indication for LAAO was a history of bleeding during OAC. The most frequent in-hospital major adverse cardiac events were anemia, which required blood transfusion (5.5%), and pericardial effusion, which was treated either conservatively (0.9%) or interventionally (1.2%). During hospitalization, stroke was detected in 4 patients and three patients died of any cause. LAAO reduced the annual risk of stroke by 84% and the annual risk of bleeding by 27%. CONCLUSIONS: Based on a "real-life" cohort of patients from the Silesian Province, we concluded that LAAO is related to low in-hospital major cardiovascular adverse events. In the long-term follow-up, LAAO reduced the rates of stroke and bleeding.

Clinical manifestations of device-related infective endocarditis in cardiac resynchronization therapy recipients.

INTRODUCTION: The aim of the study was to analyse microbiological characteristics and clinical manifestations of cardiac device-related infective endocarditis (CDRIE) in cardiac resynchronization therapy (CRT) recipients, and to compare the diagnostic value of modified Duke (MDC) versus modified Duke lead criteria (MDLC; including to MDC local infection and pulmonary infection or embolism as major criteria). MATERIAL AND METHODS: The study population comprised 765 consecutive CRT patients from a high-volume, tertiary care centre from 2002 to 2015. All patients were screened for CDRIE. RESULTS: During a median follow-up of 1692 days (range: 457-3067) 5.36% of patients (n = 41) developed CDRIE, which was accompanied by CRT pocket infection in 17.1% (n = 7) and recurrent pulmonary infection or pulmonary embolism in 29.3% (n = 12). Fever was present in 95.1% of patients (n = 39), whereas blood cultures were positive in 65.9% (n = 27). Staphylococcus was the most prevalent pathogen in 59.3% (n = 16), Gram-negative bacteria in 25.9% (n = 7). Transoesophageal echocardiography showed intracardiac vegetations in 73.2% of patients (n = 30). Non-different pathogen types with the most common methicillin-sensitive Staphylococcus aureus were observed for early versus late CDRIE (endocarditis ≤ 6 vs. > 6 months from CRT or other device-related procedure). All 3 inflammatory markers (C-reactive protein, white blood cells, procalcitonin) were normal in 4.9% of patients (n = 2). MDC versus MDLC indicated definite CDRIE in 48.8% versus 80.5%, respectively (p = 0.003). CONCLUSIONS: Fever is the most common symptom of CRT-related CDRIE, and transoesophageal echocardiography allows vegetations to be visualised in nearly 3/4 of patients with CDRIE. Although the most common pathogens were Staphylococci, Gram-negative bacteria accounted for a quarter of CDRIE. Modified Duke lead criteria proved superior to MDC.

Upgrade from implantable cardioverter-defibrillator vs. de novo implantation of cardiac resynchronization therapy: long-term outcomes.

AIMS: To assess and compare long-term mortality and predictors thereof in de novo cardiac resynchronization therapy defibrillators (CRT-D) vs. upgrade from an implantable cardioverter-defibrillator (ICD) to CRT-D. METHODS AND RESULTS: Study population consisted of 595 consecutive patients with CRT-D implanted between 2002 and 2015 in a tertiary care, university hospital, in a densely inhabited, urban region of Poland [480 subjects (84.3%) with CRT-D de novo implantation; 115 patients (15.7%) upgraded from ICD to CRT-D]. In a median observation of 1692 days (range 457-3067), all-cause mortality for de novo CRT-D vs. CRT-D upgrade was 35.5% vs. 43.5%, respectively (P = 0.045). On multivariable regression analysis including all CRT recipients, the previously implanted ICD was an independent predictor for death [hazard ratio (HR) 1.58, 95% confidence interval (CI) 1.10-2.29, P = 0.02]. For those, who were upgraded from ICD to CRT-D, the independent predictors for all-cause death were as follows: creatinine level (HR 1.01, 95% CI 1.00-1.02, P = 0.01), left ventricular end-systolic diameter (HR 1.07, 95% CI 1.02-1.11, P = 0.002), New York Heart Association (NYHA) IV class at baseline (HR 2.36, 95% CI 1.00-5.53, P = 0.049) and cardiac device-related infective endocarditis during follow-up (HR 2.42, 95% CI 1.02-5.75, P = 0.046). A new CRT scale (Creatinine ≥150 µmol/L; Remodelling, left ventricular end-systolic ≥59 mm; Threshold for NYHA, NYHA = IV) showed high prediction for mortality in CRT-D upgrades (AUC 0.70, 95% CI 0.59-0.80, P = 0.0007). CONCLUSION: All-cause mortality in patients upgraded from ICD is significantly higher compared with de novo CRT-D implantations and reaches almost 45% within 4.5 years. A new CRT scale (Creatinine; Remodelling; Threshold for NYHA) has been proposed to help survival prediction following CRT upgrade.

Cardiac arrhythmias in the emergency settings of acute coronary syndrome and revascularization: an European Heart Rhythm Association (EHRA) consensus document, endorsed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Acute Cardiovascular Care Association (ACCA).

Despite major therapeutic advances over the last decades, complex supraventricular and ventricular arrhythmias (VAs), particularly in the emergency setting or during revascularization for acute myocardial infarction (AMI), remain an important clinical problem. Although the incidence of VAs has declined in the hospital phase of acute coronary syndromes (ACS), mainly due to prompt revascularization and optimal medical therapy, still up to 6% patients with ACS develop ventricular tachycardia and/or ventricular fibrillation within the first hours of ACS symptoms. Despite sustained VAs being perceived predictors of worse in-hospital outcomes, specific associations between the type of VAs, arrhythmia timing, applied treatment strategies and long-term prognosis in AMI are vague. Atrial fibrillation (AF) is the most common supraventricular tachyarrhythmia that may be asymptomatic and/or may be associated with rapid haemodynamic deterioration requiring immediate treatment. It is estimated that over 20% AMI patients may have a history of AF, whereas the new-onset arrhythmia may occur in 5% patients with ST elevation myocardial infarction. Importantly, patients who were treated with primary percutaneous coronary intervention for AMI and developed AF have higher rates of adverse events and mortality compared with subjects free of arrhythmia. The scope of this position document is to cover the clinical implications and pharmacological/non-pharmacological management of arrhythmias in emergency presentations and during revascularization. Current evidence for clinical relevance of specific types of VAs complicating AMI in relation to arrhythmia timing has been discussed.

Two-dimensional versus three-dimensional transesophageal echocardiography in percutaneous left atrial appendage occlusion.

BACKGROUND: Real-time three-dimensional transesophageal echocardiography (RT3D TEE) enables better visualization of the left atrial appendage (LAA) and may be superior to real-time two-dimensional transesophageal echocardiography (RT2D TEE) for LAA occlusion (LAAO). The aim of this study was to assess inter- and intra-observer variability of RT2D TEE and RT3D TEE measurements of LAA, and to assess the accordance of RT2D TEE and RT3D TEE with appropriate occluder selection. METHODS: Transesophageal echocardiography was performed in 40 patients during LAAO. RT2D TEE and RT3D TEE measurements of the ostium and landing zone were performed independently by two echocardiographers. The appropriate choice of occluder was confirmed with fluoroscopic criteria. After the procedures, RT2D TEE and RT3D TEE evaluation were repeated separately by the same echocardiographers. RESULTS: The mean ostium diameters by RT2D TEE obtained by the two observers were 23.6 ± 4.2 vs. 24.8 ± 5.2 (p = 0.04), and the mean landing zone diameters were 17.7 ± 4.4 vs. 19.4 ± 3.9 (p < 0.01). In the case of RT3D TEE, the ostium diameters were 29.6 ± 5.3 vs. 29.4 ± 6.4 (p = not significant [NS]) and the landing zone diameters were 21.4 ± 3.8 vs. 21.6 ± 3.9 (p = NS). Intra-observer differences were absent in the case of RT3D TEE. The comparison of RT2D TEE vs. RT3D TEE analyses performed by the same echocardiographer revealed significant differences in the ostium and landing zone measurements (both p < 0.01). Agreement between the suggested device size was better for RT3D TEE (weighted kappa was 0.62 vs. 0.28, respectively). CONCLUSIONS: The results obtained with RT3D TEE showed significantly larger dimensions of the ostium and the landing zone. RT3D TEE showed lesser inter- and intra-observer variability and better agreement with the implanted device.

Comparison of transesophageal and intracardiac echocardiography in guiding percutaneous left atrial appendage closure with an Amplatzer Amulet device.

INTRODUCTION: Percutaneous occlusion of the left atrial appendage (LAAO) is becoming an extensively used method of stroke prevention in individuals with contraindications to oral anticoagulants. Transesophageal echocardiography (TOE) is the gold standard for LAAO guiding, but intracardiac echocardiography (ICE) appears to be a potential alternative. AIM: To compare the LAAO procedure guided by TOE or ICE with respect to procedural success and safety. MATERIAL AND METHODS: TOE-guided LAAO was performed in 12 patients and ICE-guided LAAO in 11 patients. ICE was performed using an 8F AcuNav probe and the ACUSON SC2000 system. For LAAO the Amplatzer Amulet was used. After 1 month TOE was performed. RESULTS: Procedural success was achieved in all patients in TOE and ICE groups. There was 1 complication (groin hematoma). The procedure time was significantly longer in the TOE group (43 to 80 min; median: 54 min) compared to the ICE group (28 to 67 min; median: 45 min), (p = 0.02) The time needed to puncture the interatrial septum and time needed to remove the sheath did not differ between groups. Fluoroscopic time was insignificantly longer in the ICE group (9.91 ±4.01s) compared to the TOE group (7.69 ±3.21s), and a significantly larger contrast media volume was used in the ICE group (30.00 ±6.67 ml vs. 40.45 ±23.18 ml, p = 0.03). There were no statistically significant differences in the results between TOE and ICE groups in follow-up assessments. CONCLUSIONS: LAAO using the Amplatzer Amulet may be successfully and safely guided by ICE. ICE offered shorter procedure time and similar results irrespectively of left atrial appendage anatomy compared to TOE guidance.

Risk stratification for complex ventricular arrhythmia complicating ST-segment elevation myocardial infarction.

OBJECTIVES: The 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 METHODS: We 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. RESULTS: VF 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). CONCLUSION: The 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.

Outcomes in patients undergoing cardiac resynchronisation therapy complicated by device-related infective endocarditis.

BACKGROUND: Cardiac device-related infective endocarditis (CDRIE) is one of the most serious complications of cardiac resynchronisation therapy (CRT). AIM: We sought to assess clinical outcomes and their determinants in CRT patients with CDRIE. METHODS: A tertiary cardiology centre database was screened to identify all CDRIE cases, diagnosed based on the modified Duke criteria, amongst 765 consecutive CRT implantations performed between 2002 and 2015 (70.8% de novo implantations, 29.2% upgrades). RESULTS: During the median follow-up of 1692 days (range: 457-3067 days) CDRIE was diagnosed in 41 (5.4%) patients. Overall, in-hospital and long-term mortality rates of CDRIE patients were 51.2% and 75.6%, respectively. Among patients with CDRIE, in whom the device was vs. was not explanted, in-hospital death rates were 39.3% (11/28 patients) vs. 76.9% (10/13 patients; p = 0.025). In multivariate regression analysis, device removal was independently associated with significantly lower in-hospital mortality (hazard ratio [HR] 0.09, 95% confidence interval [CI] 0.03-0.35, p = 0.0004). The need for temporary pacing after device removal (HR 5.92, 95% CI 1.13-30.96, p = 0.035), a time period of less than seven days between CDRIE diagnosis and CRT removal (HR 6.69, 95% CI 1.48-30.27, p = 0.01), and the highest serum creatinine level during infection (HR 1.02, 95% CI 1.004-1.03, p = 0.01) were identified as independent predictors of higher in-hospital mortality. CONCLUSIONS: Device removal is independently associated with lower mortality in patients with CRT and CDRIE. Early device removal (less than seven days since the diagnosis), the need for temporary pacing after removal and acute renal failure are independent mortality predictors in CRT patients who developed CDRIE.