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Artigo em Inglês | MEDLINE | ID: mdl-32462550


PURPOSE: The prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-term effectiveness and safety results that have not yet been reported. METHODS: Ablations were performed using the 56-hole porous tip irrigated CF catheter guided by the 3D mapping system stability module. The primary effectiveness endpoint was freedom from atrial tachyarrhythmia (including atrial fibrillation, atrial tachycardia, and/or atrial flutter), based on electrocardiographic data at 12 months. Atrial tachyarrhythmia recurrence occurring 3 months post procedure, acute procedural failures such as lack of entrance block confirmation of all PVs, and undergoing repeat procedure for atrial fibrillation in the evaluation period (91 to 365 days post the initial ablation procedure) were considered to be effectiveness failures. RESULTS: Seventy-eight patients (age 64.8 ± 9.7 years; male 52.6%; Caucasian 96.2%) participated in the 12-month effectiveness evaluation. Mean follow-up time was 373.5 ± 45.4 days. The Kaplan-Meier estimate of freedom from 12-month atrial tachyarrhythmia was 74.9%. Two procedure-related pericardial effusion events were reported at 92 and 180 days post procedure. There were no pulmonary vein stenosis complications or deaths reported through the 12-month follow-up period. CONCLUSIONS: The SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.

J Atr Fibrillation ; 11(4): 2059, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31139281


Introduction: Significant improvements in catheter technology, electro-anatomic (EA) mapping and techniques to reduce fluoroscopy during radiofrequency ablation (RFA) of atrial fibrillation (AF) are on-going.However, few educational opportunities are available post fellowship for Electrophysiologists (EPs) to understand and integrate them into their practice, preventing wide spread adoption. The impact of observational learning for adoption of new technologies and techniques in the field of cardiac electrophysiology has not been studied. We sought to report the impact of a visit to a high-volume center with experience in new technologies and fluoroscopy reductionto the clinical practice of EPs. Methods: Between 8/2014 and 10/2017 a total of 150 EPs visited 3 hospitals that perform a high volume of AF RFAs. EPs observed a minimum of 4 RFAs, primarily AF. AF RFAs were performed without fluoroscopy, using Carto 3 Version 4 (Biosense Webster) and intracardiac Echocardiography. There was ample interaction and discussion between hosting and visiting EP. Results: 73 EPs (48.6% of visitors) completed an electronic survey after the visit. The majority reported a significant reduction in fluoroscopy (>50%) and procedure (>20%).68% adopted a rigorous workflow and reported an increase in their confidence level with intracardiac echo (79%), continuous mapping (52%) and the Visitag module (61%). Conclusions: Observational experience can have an immense impact on the clinical practice of EPs. Further effort should be devoted to such programs and to study in a more systematic way their ultimate impact on patient care.

Pacing Clin Electrophysiol ; 40(4): 391-400, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28151545


BACKGROUND: Atrial fibrillation (AF) prevalence increases significantly with age. Little is known about the effect of AF ablation on quality of life and healthcare utilization in the elderly. The objective of this study was to quantify the healthcare utilization and quality of life benefits of catheter ablation for AF, for patients ≥65 years compared to patients <65 years. METHODS: Two multicenter U.S. registry studies enrolled patients with paroxysmal AF. Baseline characteristics and acute outcomes were collected for 736 patients receiving catheter ablation with the Navistar® ThermoCool® SF Catheter (Biosense Webster, Inc., Diamond Bar, CA, USA). Healthcare utilization and quality of life outcomes were collected through 1 year postablation for 508 patients. RESULTS: The rates of acute pulmonary vein isolation were high and similar between patients ≥65 years and <65 years (97.5% vs 95.8%, P = 0.2130). Length of stay for the index procedure was similar between age groups with 82.2% of the older group and 83.2% of the younger group having one-day hospitalization. Disease-specific quality of life instrument scores improved significantly and similarly for older and younger patients at 1 year postablation, compared to baseline. AF-related hospitalizations and emergency department visits were similar or lower in older patients compared to younger patients, as reported at 1 year postablation. CONCLUSION: For older patients undergoing catheter ablation for paroxysmal AF, healthcare utilization parameters were lower or not significantly different than for younger patients, and quality of life outcomes were similarly improved. These findings support the use of catheter ablation as a treatment option in older patients with paroxysmal AF.

Fibrilação Atrial/psicologia , Fibrilação Atrial/cirurgia , Ablação por Cateter/psicologia , Ablação por Cateter/estatística & dados numéricos , Acesso aos Serviços de Saúde/estatística & dados numéricos , Qualidade de Vida/psicologia , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Distribuição por Sexo , Resultado do Tratamento , Estados Unidos/epidemiologia , Revisão da Utilização de Recursos de Saúde , Adulto Jovem
Heart Rhythm ; 13(5): 1030-1036, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-26872554


BACKGROUND: Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results. OBJECTIVE: The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device. METHODS: This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point. RESULTS: LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (<2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of >5 mm. CONCLUSION: LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.

Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardiovasculares , Traumatismos Cardíacos , Complicações Intraoperatórias , Efeitos Adversos de Longa Duração/epidemiologia , Pericardite , Complicações Pós-Operatórias/epidemiologia , Idoso , Fibrilação Atrial/mortalidade , Procedimentos Cirúrgicos Cardiovasculares/efeitos adversos , Procedimentos Cirúrgicos Cardiovasculares/instrumentação , Procedimentos Cirúrgicos Cardiovasculares/métodos , Feminino , Traumatismos Cardíacos/epidemiologia , Traumatismos Cardíacos/etiologia , Traumatismos Cardíacos/prevenção & controle , Humanos , Complicações Intraoperatórias/epidemiologia , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/prevenção & controle , Ligadura/efeitos adversos , Ligadura/métodos , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Pericardite/epidemiologia , Pericardite/etiologia , Punções/instrumentação , Punções/métodos , Sistema de Registros/estatística & dados numéricos , Estados Unidos/epidemiologia
J Am Coll Cardiol ; 64(6): 565-72, 2014 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-25104525


BACKGROUND: Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. OBJECTIVES: This study sought to assess the early safety and efficacy of transcatheter ligation of the LAA for stroke prevention in atrial fibrillation. METHODS: This was a retrospective, multicenter study of consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S. sites. The primary endpoint was procedural success, defined as device success (suture deployment and <5 mm leak by post-procedure transesophageal echocardiography), and no major complication at discharge (death, myocardial infarction, stroke, Bleeding Academic Research Consortium bleeding type 3 or greater, or cardiac surgery). Post-discharge management was per operator discretion. RESULTS: A total of 154 patients were enrolled. Median CHADS2 score (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism [doubled]) was 3 (interquartile range: 2 to 4). Device success was 94%, and procedural success was 86%. A major complication occurred in 15 patients (9.7%). There were 14 major bleeds (9.1%), driven by the need for transfusion (4.5%). Significant pericardial effusion occurred in 16 patients (10.4%). Follow-up was available in 134 patients at a median of 112 days (interquartile range: 50 to 270 days): Death, myocardial infarction, or stroke occurred in 4 patients (2.9%). Among 63 patients with acute closure and transesophageal echocardiography follow-up, there were 3 thrombi (4.8%) and 13 (20%) with residual leak. CONCLUSIONS: In this initial multicenter experience of LAA ligation with the Lariat device, the rate of acute closure was high, but procedural success was limited by bleeding. A prospective randomized trial is required to adequately define clinical efficacy, optimal post-procedure medical therapy, and the effect of operator experience on procedural safety.

Apêndice Atrial/cirurgia , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Feminino , Seguimentos , Humanos , Ligadura , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
J Cardiol ; 55(1): 1-12, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20122543


Cardiologists and physicians have witnessed a significant change in the management of atrial fibrillation (AF): antiarrhythmic agents are no longer considered more effective than just merely using compounds that control ventricular response of the arrhythmia with anticoagulation in high-risk patients. Catheter ablation has grown into wider acceptance as an important therapeutic modality in treating tachyarrhythmias. And over the past decade, several studies have clearly established that catheter ablation of atrial fibrillation is safe and effective and is an important alternative therapeutic option to the pharmacological approach. In general, there are two approaches to AF ablation: The anatomical approach, the most popular one, relies on isolation of electrical connections of all four pulmonary veins to the left atrium with or without adjuvant ablations, i.e. additional linear ablations. The second approach is the electrogram-guided approach by mapping and targeting areas of complex fractionated atrial electrograms (CFAE) which is the main topic of this review. The myriad pathologies leading to and resulting from AF have led to many theories regarding how substrate should be defined and how to reconcile substrate ablation with trigger ablation. The identification of spatiotemporally stable areas of very low amplitude short cycle length CFAE in a sea of otherwise discrete normal amplitude and relatively longer cycle length electrograms led to ablate the CFAE as a marker of abnormal substrate. This pure substrate-based ablation strategy has resulted in remarkable success, including mortality benefit, even in high-risk patients with very long standing persistent AF. In this review, we discuss in detail the prevailing mechanisms underlying CFAE, how to map and ablate CFAE sites, correlation of CFAE areas to those of ganglionic plexi, clinical outcomes of the approach, and the role of CFAE in the hybrid approach of AF ablation using a combination of pulmonary vein isolation and targeting CFAE areas.

Fibrilação Atrial/cirurgia , Mapeamento Potencial de Superfície Corporal/métodos , Ablação por Cateter/métodos , Fibrilação Atrial/fisiopatologia , Eletrocardiografia , Humanos