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1.
Europace ; 2020 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-32464648

RESUMO

AIMS: Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. METHODS AND RESULTS: A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy. CONCLUSIONS: Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.

2.
Ann Thorac Surg ; 2020 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-32035914

RESUMO

Surgical suture or exclusion of the left atrial appendage (LAA) is a commonly performed technique in patients undergoing cardiothoracic revascularization and/or valve repair. However, incomplete surgical sealing of the LAA is not a rare phenomenon and has been shown to strongly increase the risk for future cerebrovascular embolic events. We report the first in man implantation of a Watchman LAA occluder during redo minimally invasive open-heart surgery. This approach offers a new alternative for LAA occlusion in patients for whom surgery is scheduled.

3.
Europace ; 22(4): 607-612, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-31998940

RESUMO

AIMS: Using a modified CARTO 3D mapping system, we studied if premature ventricular contractions (PVCs) cause position shifts within the 3D co-ordinate system. We quantified magnitude of the phenomenon and corrected for it, by creating both an activation map that represents the conventional local activation time (LAT) and one corrected for this position shift (hybrid LAT map). METHODS AND RESULTS: We prospectively enrolled patients planned for PVC ablation. Distances between the earliest LAT, the earliest hybrid-LAT, and the best pacemap positions were calculated in a 3D model. Ablation was performed at the best hybrid-LAT location. Efficacy was evaluated by acute response to ablation as well as clinical outcome on 24-h Holter at 1 year. One hundred and twenty-seven LAT-hybrid pairs were studied in 18 patients (age 48.3 ± 18.0 years, 12 female). Baseline PVC burden was 16 ± 12%. The mean position shift between LAT-hybrid and its associated LAT position was 8.9 ± 5.5 mm. The mean position shift between best LAT-hybrid and best pacemap was 6.2 ± 5.0 mm and the mean shift between best conventional LAT and best pacemap was 13.5 ± 7.0 mm (P < 0.0001 for all pairwise comparisons). Exclusive targeting of best LAT-hybrid position resulted in acute abolition of PVC activity in all patients. After 1-year follow-up, mean PVC burden reduction was 16% (baseline) to <1%. CONCLUSION: Premature ventricular contractions cause a position shift in 3D mapping systems compared with the same endocardial position in sinus rhythm. An approach to account for this phenomenon, correct it and target exclusively the adjusted 3D position is feasible and highly efficient in terms of acute and 1-year clinical outcome after radiofrequency ablation.

4.
Rev Esp Cardiol (Engl Ed) ; 73(1): 21-27, 2020 Jan.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30956034

RESUMO

INTRODUCTION AND OBJECTIVES: Elderly patients with atrial fibrillation are at greater risk of both cardioembolic events and major bleeding than younger patients. Left atrial appendage occlusion (LAAO) could be an attractive alternative for these patients, but there are limited data on outcomes with LAAO in patients ≥ 85 years old. The aim of the present study was to assess the safety and efficacy of LAAO in patients ≥ 85 years old. METHODS: A total of 1025 patients included in the EWOLUTION registry who underwent LAAO were analyzed and 84 patients ≥ 85 years old were identified and compared with the younger cohort. RESULTS: Patients ≥ 85 years old had higher estimated stroke and hemorrhagic risks than younger patients (CHA2DS2-VASc: 5.2±1.2 vs 4.4±1.6, P <.0001; HAS-BLED: 2.7±1.1 vs 2.3±1.2; P=.003; ≥ 85 years vs <85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; P=.99). There were no differences in 7-day device- or procedure-related adverse event rates (2.6% in ≥ 85 years vs 3.1% in <85 years; P=.80). Despite the higher baseline stroke risk, there was no difference at follow-up between the groups in the annualized stroke rate (0.8/100 patient-years in ≥ 85 years vs 1.3/100 patient-years in <85 years; P=.649). CONCLUSIONS: LAAO in patients ≥ 85 years is safe and effective even though these patients are at high risk for embolic and hemorrhagic events. LAAO may be a reasonable alternative to oral anticoagulation in these patients.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/métodos , Sistema de Registros , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Estudos Prospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
6.
Adv Ther ; 37(2): 785-799, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31865547

RESUMO

INTRODUCTION: Ablation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF). METHODS: Individual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted. RESULTS: Primary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions. CONCLUSIONS: Radiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.

7.
Artigo em Inglês | MEDLINE | ID: mdl-31625008

RESUMO

BACKGROUND OR PURPOSE: The purpose of this analysis was to report on efficacy of a standardized workflow for atrial fibrillation (AF) ablation using technology advances such as 3D imaging and contact force sensing in a real-world setting. METHODS: Consecutive AF ablations from 2014 to 2015 at a high-volume site in Belgium were included. The workflow consisted of a pre-specified procedure sequence including 3D modeling followed by radiofrequency encircling of the pulmonary veins (25 W posterior wall, 35 W anterior wall) with a THERMOCOOL SMARTTOUCH® Catheter guided by CARTO VISITAG™ Module (2.5 mm/5 s stability, 50% > 7 g) and ablation index (targets: 550 anterior wall, 400 posterior wall). Efficiency endpoints were procedure time, fluoroscopy time, and radiation dose. The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence. RESULTS: A total of 605 paroxysmal AF (PAF) and 182 persistent AF (PsAF) patients were followed for 436 ± 199 days. Mean procedure times were short (PAF: 96.1 ± 26.2 min; PsAF: 109.2 ± 35.6 min) with most procedures (90.6% PAF; 81.3% PsAF) completed in ≤ 120 min. Minimal fluoroscopy was utilized (PAF: 6.1 ± 3.8 min, 5.9 ± 3.4 Gy*cm2; PsAF: 6.9 ± 4.7 min, 7.4 ± 4.9 Gy*cm2). Freedom from atrial arrhythmia recurrence was higher for PAF than PsAF patients (OR: 2.0, 95% CI: 1.4-2.9, p = 0.0003), but adjusted mean rates were high in both groups (81.0% vs. 67.9%). Rates were adjusted for prior ablation and age (at 65 years). CONCLUSION: AF ablation using a standardized workflow resulted in low procedure times and variability, with minimal fluoroscopy exposure. Long-term freedom from atrial arrhythmia recurrence was high in both PAF and PsAF populations.

8.
Europace ; 21(11): 1670-1677, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31504477

RESUMO

AIMS : To define the clinical characteristics and long-term clinical outcomes of a large cohort of patients with idiopathic ventricular fibrillation (IVF) and normal 12-lead electrocardiograms (ECGs). METHODS AND RESULTS: Patients with ventricular fibrillation as the presenting rhythm, normal baseline, and follow-up ECGs with no signs of cardiac channelopathy including early repolarization or atrioventricular conduction abnormalities, and without structural heart disease were included in a registry. A total of 245 patients (median age: 38 years; males 59%) were recruited from 25 centres. An implantable cardioverter-defibrillator (ICD) was implanted in 226 patients (92%), while 18 patients (8%) were treated with drug therapy only. Over a median follow-up of 63 months (interquartile range: 25-110 months), 12 patients died (5%); in four of them (1.6%) the lethal event was of cardiac origin. Patients treated with antiarrhythmic drugs only had a higher rate of cardiovascular death compared to patients who received an ICD (16% vs. 0.4%, P = 0.001). Fifty-two patients (21%) experienced an arrhythmic recurrence. Age ≤16 years at the time of the first ventricular arrhythmia was the only predictor of arrhythmic recurrence on multivariable analysis [hazard ratio (HR) 0.41, 95% confidence interval (CI) 0.18-0.92; P = 0.03]. CONCLUSION : Patients with IVF and persistently normal ECGs frequently have arrhythmic recurrences, but a good prognosis when treated with an ICD. Children are a category of IVF patients at higher risk of arrhythmic recurrences.

9.
JACC Clin Electrophysiol ; 5(7): 778-786, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31320006

RESUMO

OBJECTIVES: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. BACKGROUND: The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. METHODS: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. RESULTS: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits. CONCLUSIONS: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).

10.
J Am Coll Cardiol ; 74(7): 829-839, 2019 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-31085320

RESUMO

BACKGROUND: Patients with high stroke risk and atrial fibrillation who are unsuitable to oral anticoagulants (OACs) require other stroke prevention strategies. A novel permanent coil filter directly placed into both common carotid arteries (CCAs) was designed to capture emboli >1.4 mm in diameter. OBJECTIVES: The multicenter, nonrandomized, first-in-human clinical CAPTURE (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients) trial sought to determine the feasibility and safety of bilateral CCA filter placement. METHODS: Eligible patients had atrial fibrillation, CHA2DS2-VASc (Congestive heart failure, Hypertension, Age 75 years, Diabetes, Stroke/transient ischemic attack, Vascular disease, Age 65 to 74 years, Sex category) ≥2, OAC unsuitability, CCA size 4.8 to 9.8 mm, and no carotid stenosis >30%. Under ultrasound guidance, after direct transcutaneous carotid puncture with a 24-gauge needle, a motorized unit expels the filter to unfurl in the artery. Patients received aspirin/clopidogrel for 3 months, and aspirin thereafter. Primary endpoints were: 1) procedural success-bilateral, properly positioned CCA filters; and 2) 30-day incidence of major adverse events-death, stroke, major bleeding, filter migration, CCA thrombus, or stenosis. Carotid ultrasounds were conducted post-procedure, pre-discharge, at 1 week, and at 1, 3, 6, and 12 months. RESULTS: At 3 centers, 25 patients were enrolled: age 71 ± 9 years, CHA2DS2-VASc = 4.4 ± 1.0, prior embolism in 48%. Procedure success was 92% (23 of 25 patients); 1 patient had unilateral deployment. There were no device/procedure-related major adverse events; minor puncture site hematomas/edema occurred in 5 of 25 (20%). After 6-month mean follow-up, asymptomatic thrombi were detected in 4 patients (1 bilateral, 4 unilateral), adjudicated as captured (n = 3), unclassified (n = 2), or in situ (n = 0). In all patients, the thrombi dissolved with subcutaneous heparin. In 1 patient, 2 device/procedure-unrelated minor strokes occurred. CONCLUSIONS: Permanent carotid filter placement for stroke prophylaxis is technically feasible and safe. (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients [CAPTURE]; NCT03571789).

11.
Front Physiol ; 10: 237, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30967786

RESUMO

According to clinical studies, around one third of patients with atrial fibrillation (AF) will suffer a stroke during their lifetime. Between 70 and 90% of these strokes are caused by thrombus formed in the left atrial appendage. In patients with contraindications to oral anticoagulants, a left atrial appendage occluder (LAAO) is often implanted to prevent blood flow entering in the LAA. A limited range of LAAO devices is available, with different designs and sizes. Together with the heterogeneity of LAA morphology, these factors make LAAO success dependent on clinician's experience. A sub-optimal LAAO implantation can generate thrombi outside the device, eventually leading to stroke if not treated. The aim of this study was to develop clinician-friendly tools based on biophysical models to optimize LAAO device therapies. A web-based 3D interactive virtual implantation platform, so-called VIDAA, was created to select the most appropriate LAAO configurations (type of device, size, landing zone) for a given patient-specific LAA morphology. An initial LAAO configuration is proposed in VIDAA, automatically computed from LAA shape features (centreline, diameters). The most promising LAAO settings and LAA geometries were exported from VIDAA to build volumetric meshes and run Computational Fluid Dynamics (CFD) simulations to assess blood flow patterns after implantation. Risk of thrombus formation was estimated from the simulated hemodynamics with an index combining information from blood flow velocity and complexity. The combination of the VIDAA platform with in silico indices allowed to identify the LAAO configurations associated to a lower risk of thrombus formation; device positioning was key to the creation of regions with turbulent flows after implantation. Our results demonstrate the potential for optimizing LAAO therapy settings during pre-implant planning based on modeling tools and contribute to reduce the risk of thrombus formation after treatment.

12.
Circ Arrhythm Electrophysiol ; 12(4): e006841, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30939908

RESUMO

BACKGROUND: Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice. METHODS: One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years. RESULTS: Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHA2DS2-VASc score ≥5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ≥3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (-76% and -41%) or hemorrhagic (-81% and 67%) stroke and prior bleeding (-85% and -30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up ( P=0.28). CONCLUSIONS: During the complete 2-year follow-up of Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov . Unique identifier: NCT01972282.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Dispositivos de Proteção Embólica , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/fisiopatologia , Feminino , Hemorragia/epidemiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Tromboembolia/epidemiologia , Tromboembolia/prevenção & controle , Resultado do Tratamento
13.
Trends Cardiovasc Med ; 29(4): 228-236, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30205924

RESUMO

Atrial fibrillation (AF) is common and is a prominent risk factor for ischemic stroke. Oral anticoagulant (OAC) therapy has been the main strategy for stroke prevention in AF patients; however, OAC therapy carries a bleeding risk and is not tolerated by all patients. Left atrial appendage (LAA) closure offers a non-pharmacological alternative for stroke prevention in patients with non-valvular AF. In this update, an overview of current and emerging LAA occluders is given - with special attention to the key design features of every single device and, if available, preclinical or clinical data.


Assuntos
Apêndice Atrial , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Acidente Vascular Cerebral/prevenção & controle , Animais , Apêndice Atrial/fisiopatologia , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Desenho de Equipamento , Humanos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento
14.
Eur Heart J ; 40(21): 1728-1738, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-30226525

RESUMO

AIMS: The provision of high-quality education allows the European Society of Cardiology (ESC) to achieve its mission of better cardiovascular practice and provides an essential component of translating new evidence to improve outcomes. METHODS AND RESULTS: The 4th ESC Education Conference, held in Sophia Antipolis (December 2016), brought together ESC education leaders, National Directors of Training of 43 ESC countries, and representatives of the ESC Young Community. Integrating national descriptions of education and cardiology training, we discussed innovative pathways to further improve knowledge and skills across different training programmes and health care systems. We developed an ESC roadmap supporting better cardiology training and continued medical education (CME), noting: (i) The ESC provides an excellent framework for unbiased and up-to-date cardiovascular education in close cooperation with its National Societies. (ii) The ESC should support the harmonization of cardiology training, curriculum development, and professional dialogue and mentorship. (iii) ESC congresses are an essential forum to learn and discuss the latest developments in cardiovascular medicine. (iv) The ESC should create a unified, interactive educational platform for cardiology training and continued cardiovascular education combining Webinars, eLearning Courses, Clinical Cases, and other educational programmes, along with ESC Congress content, Practice Guidelines and the next ESC Textbook of Cardiovascular Medicine. (v) ESC-delivered online education should be integrated into National and regional cardiology training and CME programmes. CONCLUSION: These recommendations support the ESC to deliver excellent and comprehensive cardiovascular education for the next generation of specialists. Teamwork between international, national and local partners is essential to achieve this objective.

15.
J Cardiovasc Electrophysiol ; 30(3): 326-331, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30575165

RESUMO

INTRODUCTION: Ablation without shaft repositioning may make the endoscopic laser ablation system (EAS) more like a single shot approach. We tested the feasibility of wide circumferential ablation (WCA; no carina ablation and no shaft repositioning) in an "open 8" pattern for pulmonary vein isolation (PVI). METHODS AND RESULTS: Forty-eight patients (n = 48, age 64.6 ± 12 years) with paroxysmal and persistent atrial fibrillation (AF) were referred to our center for PVI with the EAS. WCA for the lateral and septal pulmonary veins was attempted in all patients. If not feasible, individual full circular isolation of each pulmonary vein (iPVI) was performed. Additional lesions were applied if acute complete electrical isolation was not achieved on the first encirclement. Any documented episode of AF after a 1-month blanking period was registered as a recurrence. Bilateral WCA was feasible in 21 out of 48 patients (43.8%). Additional lesions for complete electrical isolation after the first-pass ablation were less in WCA compared with iPVI (P = 0.02). WCA was accomplished faster, with less applied energy at both lateral (P < 0.01) and septal side (P < 0.01). The mean follow-up of the patient population was 232 ± 150 days. AF recurrence occurred later in patients treated with WCA (315 ± 124 vs 110 ± 88 days, P = 0.008). CONCLUSIONS: WCA with the EAS is safe, at least moderately feasible and highly effective, if achieved. Compared with iPVI it may be less time consuming, results in less energy application, and suppresses AF more effectively.

16.
J Adv Nurs ; 74(11): 2577-2587, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29944735

RESUMO

AIMS: This study aimed to: (a) determine adherence rates to oral anticoagulants in atrial fibrillation patients with a high risk for thromboembolic events postradiofrequency ablation; (b) evaluate patients' knowledge and perceptions towards oral anticoagulants; and (c) explore the impact of patients' knowledge and perceptions on treatment adherence. BACKGROUND: Atrial fibrillation is a common arrhythmia associated with an increased risk of developing thromboembolic events such as stroke. Although adherence to oral anticoagulants is crucial to prevent such complications, the relationship between adherence, knowledge and patient perceptions is poorly understood in patients with atrial fibrillation at high risk for thromboembolic events after radiofrequency ablation. DESIGN: A cross-sectional observational survey study was performed in a single centre. METHODS: The levels of adherence, knowledge, and perception towards oral anticoagulants were assessed using the 8-item Morisky Medication Adherence Scale, Knowledge of Oral Anticoagulation Tool, Perception of Anticoagulant Treatment Questionnaire and Benefit-Risk Perception Tool, respectively. Results from these self-reported tools were analysed descriptively. A multivariable binary logistic regression model was used to identify factors associated with levels of adequate adherence. RESULTS: Adequate treatment adherence was found in three-quarters of patients. The total mean knowledge score was low. Participants expressed high ease of use and low burden of treatment. Higher total knowledge and satisfaction scores were significant factors associated with higher levels of adherence. CONCLUSION: There remains a huge unmet need to follow-up and educate patients with atrial fibrillation, focusing on good knowledge and correct perception of the advantages and disadvantages of oral anticoagulants. Our results suggest that increased knowledge and satisfaction rates might have a positive impact on adherence to oral anticoagulants.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Ablação por Radiofrequência/efeitos adversos , Ablação por Radiofrequência/métodos , Trombose/tratamento farmacológico , Trombose/etiologia , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Adesão à Medicação/psicologia , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Pacientes/psicologia , Medição de Risco , Fatores de Risco , Inquéritos e Questionários , Resultado do Tratamento
17.
Int J Numer Method Biomed Eng ; : e3100, 2018 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-29737037

RESUMO

The left atrial appendage (LAA) is a complex and heterogeneous protruding structure of the left atrium (LA). In atrial fibrillation patients, it is the location where 90% of the thrombi are formed. However, the role of the LAA in thrombus formation is not fully known yet. The main goal of this work is to perform a sensitivity analysis to identify the most relevant LA and LAA morphological parameters in atrial blood flow dynamics. Simulations were run on synthetic ellipsoidal left atria models where different parameters were individually studied: pulmonary veins and mitral valve dimensions; LAA shape; and LA volume. Our computational analysis confirmed the relation between large LAA ostia, low blood flow velocities and thrombus formation. Additionally, we found that pulmonary vein configuration exerted a critical influence on LAA blood flow patterns. These findings contribute to a better understanding of the LAA and to support clinical decisions for atrial fibrillation patients.

19.
Eur Heart J ; 39(32): 2942-2955, 2018 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-29579168

RESUMO

Aims: It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested. Methods and results: We compared continuous apixaban (5 mg b.i.d.) to vitamin K antagonists (VKA, international normalized ratio 2-3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-centre study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (Bleeding Academic Research Consortium 2-5). A high-resolution brain magnetic resonance imaging (MRI) sub-study quantified acute brain lesions. Cognitive function was assessed by Montreal Cognitive Assessment (MoCA) at baseline and at end of follow-up. Overall, 674 patients (median age 64 years, 33% female, 42% non-paroxysmal atrial fibrillation, 49 sites) were randomized; 633 received study drug and underwent ablation; 335 undertook MRI (25 sites, 323 analysable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA {difference -0.38% [90% confidence interval (CI) -4.0%, 3.3%], non-inferiority P = 0.0002 at the pre-specified absolute margin of 0.075}, including 2 (0.3%) deaths, 2 (0.3%) strokes, and 24 (3.8%) ISTH major bleeds. Acute small brain lesions were found in a similar number of patients in each arm [apixaban 44/162 (27.2%); VKA 40/161 (24.8%); P = 0.64]. Cognitive function increased at the end of follow-up (median 1 MoCA unit; P = 0.005) without differences between study groups. Conclusions: Continuous apixaban is safe and effective in patients undergoing atrial fibrillation ablation at risk of stroke with respect to bleeding, stroke, and cognitive function. Further research is needed to reduce ablation-related acute brain lesions.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/psicologia , Encéfalo/diagnóstico por imagem , Cognição , Feminino , Humanos , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico por imagem , Resultado do Tratamento , Vitamina K/antagonistas & inibidores
20.
Europace ; 20(FI_3): f410-f418, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-29315382

RESUMO

Aims: Real-time contact force (CF)-sensing radiofrequency ablation catheter for treatment of paroxysmal atrial fibrillation (PAF) allows optimization of electrode-tissue contact, which correlates with long-term success. This prospective, multicentre observational registry assessed the real-world clinical effectiveness of a CF-sensing catheter for ablation of drug-refractory PAF. Methods and results: Patients were followed-up at 3, 6, and 12 months after ablation. Outcome measures included isolation of targeted pulmonary veins (PVs) confirmed by entrance block (acute success), patient-reported freedom from symptomatic atrial fibrillation (AF) at 12 months (long-term effectiveness), Atrial Fibrillation Effect on Quality-of-life scores at 6 and 12 months, and incidence of predefined procedural complications. The registry enrolled 261 PAF patients (mean age 58.8 ± 11.3 years; 70.7% men; 91.7% Caucasian). Acute PV isolation was reported in 98.8% of patients [95% confidence interval (CI): 96.4-99.7%], and 12-month success for freedom from symptomatic AF was 75.7% (95% CI: 69.7-80.7%). Average CF for the evaluable cohort was 16.4 ± 3.9 g. There was a significant correlation between long-term effectiveness and stability of CF use [percentage of time CF was within investigator-selected working range; odds ratio (95% Wald CI), 1.0 (1.00-1.1); P = 0.030]. Average CF did not correlate with 12-month success. Clinically meaningful quality of life (QoL) improvements were observed at 6 and 12 months. Primary adverse events occurred in 2.7% patients. Conclusion: This observational registry showed that PAF ablation with a CF-sensing catheter had high acute success rates, favourable 12-month outcomes, and a good safety profile. Patients' QoL improved significantly. Long-term effectiveness significantly correlated with stable CF with adequate catheter-tissue contact (NCT01677052).


Assuntos
Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Ablação por Cateter/instrumentação , Veias Pulmonares/cirurgia , Transdutores de Pressão , Potenciais de Ação , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Austrália , Canadá , Ablação por Cateter/efeitos adversos , Desenho de Equipamento , Europa (Continente) , Feminino , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Intervalo Livre de Progressão , Estudos Prospectivos , Veias Pulmonares/fisiopatologia , Qualidade de Vida , Recidiva , Sistema de Registros , Fatores de Risco , Fatores de Tempo
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