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1.
J Cardiothorac Surg ; 19(1): 397, 2024 Jun 27.
Artigo em Inglês | MEDLINE | ID: mdl-38937763

RESUMO

OBJECTIVES: Current recommendations support surgical treatment of atrial fibrillation (AF) in patients indicated for cardiac surgery. These procedures are referred to as concomitant and may be carried out using radiofrequency energy or cryo-ablation. This study aimed to assess the electrophysiological findings in patients undergoing concomitant cryo-ablation. METHODS: Patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement were included in the trial if concomitant cryo-ablation was part of the treatment plan according to current guidelines. The patients reported in this study were assigned to undergo staged percutaneous radiofrequency catheter ablation (PRFCA), i.e., hybrid treatment, as a part of the SURHYB trial protocol. RESULTS: We analyzed 103 patients who underwent PRFCA 105 ± 35 days after surgery. Left and right pulmonary veins (PVs) were found isolated in 65 (63.1%) and 63 (61.2%) patients, respectively. The LA posterior wall isolation and mitral isthmus conduction block were found in 38 (36.9%) and 18 (20.0%) patients, respectively. Electrical reconnections (gaps) in the left PVs were more often localized superiorly than inferiorly (57.9% vs. 26.3%, P = 0.005) and anteriorly than posteriorly (65.8% vs. 31.6%, P = 0.003). Gaps in the right PVs were more equally distributed anteroposteriorly but dominated in superior segments (72.5% vs. 40.0%, P = 0.003). There was a higher number of gaps on the roof line compared to the inferior line (131 (67.2%) vs. 67 (42.2%), P < 0.001). Compared to epicardial cryo-ablation, endocardial was more effective in creating PVs and LA posterior wall isolation (P < 0.05). Cryo-ablation using nitrous oxide (N20) or argon (Ar) gas as cooling agents was similarly effective (P = NS). CONCLUSIONS: The effectiveness of surgical cryo-ablation in achieving transmural and durable lesions in the left atrium is surprisingly low. Gaps are located predominantly in the superior and anterior portions of the PVs and on the roof line. Endocardial cryo-ablation is more effective than epicardial ablation, irrespective of the cooling agent used.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Humanos , Fibrilação Atrial/cirurgia , Criocirurgia/métodos , Masculino , Feminino , Ablação por Cateter/métodos , Pessoa de Meia-Idade , Idoso , Veias Pulmonares/cirurgia , Resultado do Tratamento , Ponte de Artéria Coronária/métodos
2.
Healthcare (Basel) ; 12(10)2024 May 09.
Artigo em Inglês | MEDLINE | ID: mdl-38786387

RESUMO

INTRODUCTION: Education of patients prior to an invasive procedure is pivotal for good cooperation and knowledge retention. Virtual reality (VR) is a fast-developing technology that helps educate both medical professionals and patients. OBJECTIVE: To prove non-inferiority of VR education compared to conventional education in patients prior to the implantation of a permanent pacemaker (PPM). METHODS: 150 participants scheduled for an elective implantation of a PPM were enrolled in this prospective study and randomized into two groups: the VR group (n = 75) watched a 360° video about the procedure using the VR headset Oculus Meta Quest 2, while the conventional group (n = 75) was educated by a physician. Both groups filled out a questionnaire to assess the quality of education pre- and in-hospital, their knowledge of the procedure, and their subjective satisfaction. RESULTS: There was no significant difference in the quality of education. There was a non-significant trend towards higher educational scores in the VR group. The subgroup with worse scores was older than the groups with higher scores (82 vs. 76 years, p = 0.025). Anxiety was reduced in 92% of participants. CONCLUSION: VR proved to be non-inferior to conventional education. It helped to reduce anxiety and showed no adverse effects.

3.
Europace ; 26(2)2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38306687

RESUMO

AIMS: Data on the hybrid atrial fibrillation (AF) treatment are lacking in patients with structural heart disease undergoing concomitant CryoMaze procedures. The aim was to assess whether the timely pre-emptive catheter ablation would achieve higher freedom from AF or atrial tachycardia (AT) and be associated with better clinical outcomes than surgical ablation alone. METHODS AND RESULTS: The trial investigated patients with non-paroxysmal AF undergoing coronary artery bypass grafting and/or valve repair/replacement with mandatory concomitant CryoMaze procedure who were randomly assigned to undergo either radiofrequency catheter ablation [Hybrid Group (HG)] or no further treatment (Surgery Group). The primary efficacy endpoint was the first recurrence of AF/AT without class I or III antiarrhythmic drugs as assessed by implantable cardiac monitors. The primary clinical endpoint was a composite of hospitalization for arrhythmia recurrence, worsening of heart failure, cardioembolic event, or major bleeding. We analysed 113 and 116 patients in the Hybrid and Surgery Groups, respectively, with a median follow-up of 715 (IQR: 528-1072) days. The primary efficacy endpoint was significantly reduced in the HG [41.1% vs. 67.4%, hazard ratio (HR) = 0.38, 95% confidence interval (CI): 0.26-0.57, P < 0.001] as well as the primary clinical endpoint (19.9% vs. 40.1%, HR = 0.51, 95% CI: 0.29-0.86, P = 0.012). The trial groups did not differ in all-cause mortality (10.6% vs. 8.6%, HR = 1.17, 95%CI: 0.51-2.71, P = 0.71). The major complications of catheter ablation were infrequent (1.9%). CONCLUSION: Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Taquicardia Supraventricular , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/tratamento farmacológico , Resultado do Tratamento , Taquicardia Supraventricular/cirurgia , Antiarrítmicos/uso terapêutico , Hemorragia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Recidiva
4.
J Cardiovasc Electrophysiol ; 34(9): 1885-1895, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37529864

RESUMO

INTRODUCTION: Observational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). METHODS: The Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). RESULTS: The trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. CONCLUSION: During the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Apêndice Atrial/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Hemorragia/induzido quimicamente , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico
5.
J Appl Biomed ; 21(2): 67-72, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37212155

RESUMO

BACKGROUND: Atrial fibrillation is common in patients with structural heart disease who are undergoing cardiac surgery. Surgical CryoMaze has been shown to be an effective treatment in several trials, but success rates have varied considerably, between 47-95%. The sequential hybrid approach, combining surgical CryoMaze followed by radiofrequency catheter ablation, can achieve high freedom from atrial arrhythmias. However, in patients with concomitant surgical atrial fibrillation treatment, data comparing the hybrid approach to CryoMaze alone are lacking. METHODS: The SurHyb study was designed as a prospective, open-label, multicentre randomized trial. Patients with non-paroxysmal atrial fibrillation who were scheduled for coronary artery bypass grafting or valve repair/replacement were randomized to either surgical CryoMaze alone or surgical CryoMaze followed by radiofrequency catheter ablation 3 months post-surgery. The primary outcome measure was arrhythmia-free survival without class I or III antiarrhythmic drugs, which has been evaluated using implantable cardiac monitors. CONCLUSIONS: This is the first randomized study that compares concomitant surgical CryoMaze alone with the staged hybrid surgical CryoMaze followed by catheter ablation, in patients with non-paroxysmal atrial fibrillation using rigorous rhythm monitoring. The results may contribute to the optimization of the treatment in patients undergoing concomitant CryoMaze for atrial fibrillation.


Assuntos
Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Ablação por Cateter , Humanos , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/tratamento farmacológico , Procedimentos Cirúrgicos Cardíacos/métodos , Ablação por Cateter/métodos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
6.
Hellenic J Cardiol ; 73: 24-35, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37088344

RESUMO

BACKGROUND: For the treatment of patients with electrical storm (ES), we established a two-step algorithm comprising standard anti-arrhythmic measures and early ultrasound-guided stellate ganglion blockade (SGB). In this single-center study, we evaluated the short-term efficacy of the algorithm and tested the hypothesis that early SGB might prevent the need for intubations. METHODS: Overall, we analyzed data for 70 ES events in 59 patients requiring SGB (mean age 67.7 ± 12.4 years, 80% males, left ventricular ejection fraction 30.0% ± 9.1%), all with implantable cardioverter-defibrillators (ICDs). RESULTS: The mean time from ES onset to SGB was 13.2 ± 12.3 hours. Percentage and mean absolute reduction in shocks at 48 hours after SGB reached 86.8% (-6.3 shocks), and anti-tachycardiac pacing (ATP) declined by 65.9% (-51.1 ATPs; all P < 0.001). Patients with the highest sustained ventricular arrhythmia (VA) burden (shocks ≥10/48 h; ATPs 10-99/48 h and ≥100/48 h) experienced the highest percentage decrease in ICD therapy (shocks -99.1%; ATPs -92.1% and -100.0%, respectively). For clinical response by defined criteria and two outcome periods (1/no sustained VA ≤48 hours post SGB, and 2/no ICD shock or <3 ATPs/day from day 3 to discharge/catheter ablation/day 8), 75.7% and 76.1% experienced complete response, respectively. Catecholamine support, no/low-dose ß-blocker therapy, polymorphic/mixed-type VA, and baseline sinus rhythm versus atrial fibrillation were more frequent in patients with early arrhythmia recurrence. Temporary Horner's syndrome occurred in 67.1%, and no other adverse events were recorded. Intubation and general anesthesia during and after SGB were not needed. CONCLUSION: The presented two-step algorithm for treating ES proved efficacious and safe. The results support implementation of early SGB in routine ES management.


Assuntos
Fibrilação Atrial , Desfibriladores Implantáveis , Taquicardia Ventricular , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , Taquicardia Ventricular/etiologia , Volume Sistólico , Função Ventricular Esquerda , Fibrilação Atrial/etiologia , Desfibriladores Implantáveis/efeitos adversos , Intubação Intratraqueal/efeitos adversos , Resultado do Tratamento
7.
BMJ Open ; 12(6): e056522, 2022 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-35705334

RESUMO

INTRODUCTION: Atrial fibrillation (AF), with a prevalence of 2%, is the most common cardiac arrhythmia. Catheter ablation (CA) has been documented to be superior to treatment by antiarrhythmic drugs (AADs) in terms of sinus rhythm maintenance. However, in obese patients, substantial weight loss was also associated with AF reduction. So far, no study has compared the modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA) treatment. The aim of the trial is to compare the efficacy of modern invasive (CA) and non-invasive (AADs with risk factor management) treatment of AF. METHODS AND ANALYSIS: The trial will be a prospective, multicentre, randomised non-inferiority trial. Patients with symptomatic AF and a body mass index >30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio. In the CA arm, pulmonary vein isolation (in combination with additional lesion sets in non-paroxysmal patients) will be performed. For patients in the RFM+AAD arm, the aim will be a 10% weight loss over 6-12 months, increased physical fitness and a reduction in alcohol consumption. The primary endpoint will be an episode of AF or regular atrial tachycardia lasting >30 s. The secondary endpoints include AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints. An AF freedom of 65% in the RFM+AAD and of 60% in the CA is expected; therefore, 202 patients will be enrolled to achieve the non-inferiority with 80% power, 5% one-sided alpha and a non-inferiority margin of 12%. ETHICS AND DISSEMINATION: The PRAGUE-25 trial will determine if modern non-invasive AF treatment strategies are non-inferior to CA. The study was approved by the Ethics Committee of the University Hospital Kralovske Vinohrady. Results of the study will be disseminated on scientific conferences and in peer-reviewed scientific journals. After the end of follow-up, data will be available upon request to principal investigator. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04011800).


Assuntos
Fibrilação Atrial , Ablação por Cateter , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Humanos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Fatores de Risco , Resultado do Tratamento , Redução de Peso
8.
J Am Coll Cardiol ; 79(1): 1-14, 2022 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-34748929

RESUMO

BACKGROUND: The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk. OBJECTIVES: This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17. METHODS: PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and with a history of cardioembolism, clinically-relevant bleeding, or both CHA2DS2-VASc ≥3 and HASBLED ≥2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically relevant bleeding, or procedure-/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat. RESULTS: This study randomized 402 patients with AF (201 per group, age 73.3 ± 7.0 years, 65.7% male, CHA2DS2-VASc 4.7 ±1.5, HASBLED 3.1 ± 0.9). After 3.5 years median follow-up (1,354 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural clinically relevant bleeding. The primary endpoint outcomes were similar in the per-protocol (sHR: 0.80; 95% CI: 0.54-1.18; P = 0.25) and on-treatment (sHR: 0.82; 95% CI: 0.56-1.20; P = 0.30) analyses. CONCLUSIONS: In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944).


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/terapia , Inibidores do Fator Xa/uso terapêutico , Idoso , Feminino , Seguimentos , Hemorragia/epidemiologia , Humanos , Ataque Isquêmico Transitório/epidemiologia , Ataque Isquêmico Transitório/prevenção & controle , Masculino , Estudos Prospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle
9.
J Am Coll Cardiol ; 75(25): 3122-3135, 2020 06 30.
Artigo em Inglês | MEDLINE | ID: mdl-32586585

RESUMO

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES: This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS: Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS: A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS: Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos , Inibidores do Fator Xa , Hemorragia , Implantação de Prótese , Acidente Vascular Cerebral , Idoso , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/instrumentação , Procedimentos Cirúrgicos Cardíacos/métodos , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Implantação de Prótese/efeitos adversos , Implantação de Prótese/instrumentação , Implantação de Prótese/métodos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
10.
Artigo em Inglês | MEDLINE | ID: mdl-29955186

RESUMO

AIMS: Optimal ECG monitoring in detecting recurrences of atrial fibrillation (AF) or atrial tachycardia (AT) after catheter ablation has not been well established. The purpose of this prospective study was to compare the utility of daily ECG monitoring with episodic card recorder (ECR) vs. periodic monitoring with episodic loop recorder (ELR) for the detection of post-blanking AF/AT recurrences during early (Months 4-6) and late (Months 7-12) periods after catheter ablation for paroxysmal AF. METHODS: The study included 105 consecutive patients, who received ECR for 12 months and were instructed to send at least 2 random ECG recordings daily with extra-recordings during symptoms. The patients were simultaneously monitored for one week with ELR at the end of each period (Months 6 and 12). RESULTS: Thirty-one and 12 patients with AF/AT recurrence were identified by means of ECR and ELR, respectively. In patients with complete and valid data, ELR technology was inferior to ECR by detecting AF/AT in 5 (31%) of 16 and 5 (26%) of 19 patients with arrhythmia identified by ECR in the early and late period, respectively. Overall, ELR had a sensitivity of 8/23 (35%) for detecting AF/AT recurrence. There was no single patient with AF/AT recurrence on ELR that would not be known from ECR monitoring. Only 2 patients with arrhythmia recurrence were completely asymptomatic throughout the study period. CONCLUSION: Daily ECG monitoring with ECR was better than periodic monitoring with ELR in detecting AF/AT recurrences during the follow-up periods. Entirely asymptomatic patients with AF/AT recurrences were rare.


Assuntos
Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/cirurgia , Ablação por Cateter , Eletrocardiografia Ambulatorial , Complicações Pós-Operatórias/fisiopatologia , Idoso , Antiarrítmicos , Fibrilação Atrial/diagnóstico , Ablação por Cateter/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico , Estudos Prospectivos , Recidiva , Fatores de Tempo , Resultado do Tratamento
11.
Am Heart J ; 183: 108-114, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27979034

RESUMO

Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA. OBJECTIVE: To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation. STUDY DESIGN: The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA2DS2VASc ≥3 and HAS-BLED score ≥2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1:1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications. CONCLUSION: The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate- to high-risk AF patients.


Assuntos
Anticoagulantes/uso terapêutico , Apêndice Atrial/cirurgia , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/cirurgia , Doenças Cardiovasculares/mortalidade , Embolia/etiologia , Hemorragia/etiologia , Humanos , Estudos Prospectivos , Qualidade de Vida , Acidente Vascular Cerebral/etiologia , Vitamina K/antagonistas & inibidores
12.
Pacing Clin Electrophysiol ; 33(5): 541-8, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20025720

RESUMO

BACKGROUND: Left atrial (LA) endocardial voltage characteristics assessed during atrial fibrillation (AF) have not been previously compared in different AF types. This study was aimed at investigating the LA voltages and volumes in patients with paroxysmal and persistent AF. METHODS: LA electroanatomic voltage maps acquired during AF were compared between consecutive patients without major structural heart disease undergoing first catheter ablation for paroxysmal AF (n = 100) or persistent AF (n = 100). The groups were comparable in baseline clinical characteristics. RESULTS: Patients with persistent AF presented with lower median LA voltage (median 0.41, interquartile range [IQR] 0.31-0.51 mV versus median 0.99, IQR 0.47-1.56 mV; P < 0.001), and maximum LA voltage (4.07 +/- 1.76 vs 6.42 +/- 2.16 mV; P < 0.001). They also had a higher proportion of the LA points exhibiting voltage <0.2 mV (30 +/- 20 vs 12 +/- 11%; P < 0.001) and voltage 0.2-1.0 mV (55 +/- 15 vs 42 +/- 19%; P < 0.001). They further displayed higher LA volume/body surface area (75 +/- 16 vs 58 +/- 13 mL/m(2); P < 0.001). In the multivariate regression model, both LA voltage (P < 10(-9)) and LA volume (P < 10(-5)) were significant determinants of AF type. CONCLUSION: Patients with persistent AF had significantly lower LA voltage compared with patients with paroxysmal AF even after adjustment for differences in indexed LA volume. LA voltage represents an independent covariate of clinical manifestation of AF.


Assuntos
Fibrilação Atrial/fisiopatologia , Átrios do Coração/fisiopatologia , Adulto , Idoso , Fibrilação Atrial/cirurgia , Mapeamento Potencial de Superfície Corporal , Ablação por Cateter , Fenômenos Eletrofisiológicos , Feminino , Átrios do Coração/cirurgia , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
13.
J Interv Card Electrophysiol ; 23(3): 189-98, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-18839297

RESUMO

PURPOSE: The aim of the study was to identify variables associated with successful long-term maintenance of sinus rhythm (SR) after a single ablation of long-lasting persistent atrial fibrillation (AF). METHODS: Complex left atrial (LA) ablation was performed in 100 patients. Restoration of SR by ablation was the desired procedure endpoint. RESULTS: SR was restored by ablation in 38 patients during the first procedure. Following one ablation, 50 patients remained in SR for 31 +/- 14 months. SR maintenance was associated with shorter duration of the persistent AF (median 14 vs. 22 months; P = 0.05), lower proportion of the LA points exhibiting voltage <0.2 mV (median 20% vs. 33%; P = 0.006), and higher proportion of LA points showing voltage >1 mV (median 15% vs. 11%; P = 0.02). CONCLUSION: Among clinical variables, shorter duration of persistent AF and higher voltage recorded around the LA predicted long-term maintenance of SR after single ablation.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Adulto , Idoso , Fibrilação Atrial/fisiopatologia , Distribuição de Qui-Quadrado , Técnicas Eletrofisiológicas Cardíacas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estatísticas não Paramétricas , Resultado do Tratamento
14.
Pacing Clin Electrophysiol ; 31(8): 985-97, 2008 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-18684255

RESUMO

BACKGROUND: Left atrial (LA) structures for the maintenance of different atrial fibrillation (AF) forms are not uniform. The incidence, electrophysiological patterns, and LA sites of sinus rhythm (SR) restoration during ablation of different AF forms were evaluated. METHODS: One hundred patients with long-lasting persistent AF were retrospectively compared to 35 patients with short-lasting persistent AF and 59 patients with a sustained episode of paroxysmal AF. All patients underwent a first ablation using a stepwise ablation approach with the endpoint of SR restoration by ablation. RESULTS: SR was restored in 38%, 83%, and 97% of patients with long-lasting persistent, short-lasting persistent, and paroxysmal AF, respectively (P <0.001 for long-lasting persistent vs paroxysmal AF; P = 0.02 for long-lasting persistent vs short-lasting persistent AF). When modes and sites of SR restoration were evaluated among the patients with long-lasting persistent, short-lasting persistent, and paroxysmal AF, SR was restored via conversion into LA tachycardia in 79%, 52%, and 4% of patients (P <0.001 for long-lasting persistent vs paroxysmal AF); by the pulmonary vein encircling in 8%, 24%, and 93% patients (P <0.001 for long-lasting persistent vs paroxysmal AF); and by ablation at the LA anterior wall or inside the coronary sinus in 66%, 45%, and 2% patients (P <0.001 for long-lasting persistent and paroxysmal AF). During the 31 +/- 14 month follow-up since the first ablation, of the 50 patients with long-term SR maintenance (38 patients free of class I or III antiarrhythmic drugs), SR was restored by ablation in 29 (58%) patients versus nine (18%) patients out of 50 patients with unsuccessful clinical outcome (P = 0.009). CONCLUSION: Ablation of long-lasting persistent AF was characterized by more frequent failure to restore SR, and predominant conversion into LA tachycardia prior to SR restoration, and SR restoration by ablation outside the LA posterior wall. SR restoration by ablation was associated with better clinical outcome in these patients.


Assuntos
Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
15.
J Interv Card Electrophysiol ; 22(1): 13-21, 2008 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-18418704

RESUMO

PURPOSE: We tested the hypothesis that electroanatomic pulmonary vein (PV) antra encircling for the PV isolation will improve the outcome in treatment of paroxysmal atrial fibrillation (PAF), compared with segmental PV isolation. METHODS: Fifty-four patients underwent segmental PV isolation (group 1) and 56 patients circumferential PV isolation (group 2) for symptomatic PAF in a randomized study. RESULTS: Following single ablation procedure, at the 48 +/- 8 month follow-up, 30 (56%) and 32 (57%) patients in groups 1 and 2 remained free of arrhythmia (P = 0.41). After repeat ablation, 43 (80%) and 45 (80%) patients in groups 1 and 2 were free of arrhythmia without antiarrhythmic drugs (AADs); 48 (89%) and 51 (91%) patients in groups 1 and 2 did not have arrhythmia recurrences without or with AADs. CONCLUSION: This study demonstrates no advantage in long-term arrhythmia-free clinical outcome after circumferential PV isolation in patients with frequent PAF.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , Adulto , Idoso , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Técnicas Eletrofisiológicas Cardíacas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Retratamento
16.
J Cardiovasc Electrophysiol ; 18(8): 824-32, 2007 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-17537207

RESUMO

INTRODUCTION: Atrial macroreentry tachycardia (AMRT) in patients without obvious structural heart disease or previous surgical or catheter intervention has not been characterized in detail. METHODS AND RESULTS: Electroanatomical mapping and ablation of right or left AMRT were performed in 33 patients. Right atrial central conduction obstacle was formed by an electrically silent area (ESA) in 15 (68%) patients and by a line of double potentials (DPs) in seven (32%) patients. Left atrial ESAs were found in all 11 patients with the left AMRT. Reentry circuit was reconstructed in 19 (86%) patients with right AMRT and seven (64%) patients with left AMRT. Of the ESA-related right AMRT, eight (50%) were double-loop reentry circuits utilizing a narrow critical isthmus within the ESA and eight (50%) were single-loop reentry circuits with a critical isthmus bounded by ESA and either ostium of the vena cava. Single-loop DP-related AMRTs had the critical isthmus between the DP line and the ostium of the inferior vena cava (IVC). Left AMRTs included a variety of single-, double-, or triple-loop reentry circuits and their critical isthmuses. During the 37 +/- 15 month follow-up, atrial tachyarrhythmia-free clinical outcome was achieved in 21 (95%) patients (18 patients, 82%, without antiarrhythmic drugs) with the right AMRT and in nine (82%) patients (six patients, 55%, without antiarrhythmic drugs) with the left AMRT. CONCLUSION: The majority of right and left AMRTs were related to the presence of ESA. Ablation can be successful with a favorable risk of atrial tachyarrhythmia recurrence.


Assuntos
Mapeamento Potencial de Superfície Corporal , Ablação por Cateter , Sistema de Condução Cardíaco/fisiopatologia , Sistema de Condução Cardíaco/cirurgia , Taquicardia Atrial Ectópica/fisiopatologia , Taquicardia Atrial Ectópica/cirurgia , Idoso , Cateterismo Cardíaco , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Taquicardia Atrial Ectópica/complicações , Resultado do Tratamento , Disfunção Ventricular Esquerda/complicações , Disfunção Ventricular Esquerda/fisiopatologia
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