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1.
Artigo em Inglês | MEDLINE | ID: mdl-32462550

RESUMO

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.

2.
BMJ Open ; 9(6): e023775, 2019 06 11.
Artigo em Inglês | MEDLINE | ID: mdl-31189669

RESUMO

OBJECTIVES: The objective of our review was to systematically assess available evidence on the effectiveness, safety and efficiency of a spring sensor-irrigated contact force (CF) catheter (THERMOCOOL SMARTTOUCH Catheter (ST)) for percutaneous ablation of paroxysmal or persistent atrial fibrillation (AF), compared with other ablation catheters, or with the ST with the operator blinded to CF data. DESIGN: Systematic literature review and meta-analysis. BACKGROUND: Emerging evidence suggests improved clinical outcomes of AF ablation using CF-sensing catheters; however, reviews to date have included data from multiple, distinct CF technologies. METHODS: We conducted a systematic review and meta-analysis of published studies comparing the use of ST versus other ablation catheters for the treatment of AF. A comprehensive search of electronic and manual sources was conducted. The primary endpoint was freedom from recurrent atrial tachyarrhythmia (AT) at 12 months. Procedural and safety data were also analysed. RESULTS: Thirty-four studies enrolling 5004 patients were eligible. The use of ST was associated with increased odds of freedom from AT at 12 months (71.0%vs60.8%; OR 1.454, 95% CI 1.12 to 1.88, p=0.004) over the comparator group, and the effect size was most evident in paroxysmal AF patients (75.6%vs64.7%; OR 1.560, 95% CI 1.09 to 2.24, p=0.015). Procedure and fluoroscopy times were shorter with ST (p=0.05 and p<0.01, respectively, vs comparator groups). The reduction in procedure time is estimated at 15.5 min (9.0%), and fluoroscopy time 4.8 min (18.7%). Complication rates, including cardiac tamponade, did not differ between groups. CONCLUSIONS: Compared with the use of other catheters, AF ablation using the CF-sensing ST catheter for AF is associated with improved success rates, shorter procedure and fluoroscopy times and similar safety profile.

3.
Europace ; 20(FI_3): f392-f400, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-29016769

RESUMO

Aims: THERMOCOOL SMARTTOUCH® SF Catheter is a new contact-force (CF)-sensing catheter with 56-hole porous tip designed for improved cooling and reduced fluid delivery compared with a standard 6-hole open-irrigated catheter. The SMART SF study examined the periprocedural safety, acute effectiveness, and procedural efficiency of the catheter for drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) ablation. Methods and results: The prospective, open-label, non-randomized SMART-SF was conducted at 17 US sites. Circumferential pulmonary vein (PV) isolation was performed with confirmation of entrance block in all PVs. Stable ablation sites were identified using CARTO VISITAG™ Module. Primary adverse events (AEs; ≤1 week of index procedure), periprocedural AEs within 30 days of ablation procedure, acute effectiveness (confirmation of entrance block for targeted PVs), CF, and procedural parameters were assessed. Overall, 165 patients were enrolled (mean age, 62.7 years; male, 57.9%; white, 97%; left ventricular ejection fraction, 60.1 ± 7%; left atrium diameter, 38.8 ± 6 mm); 159 underwent radiofrequency ablation and comprised the safety cohort. Primary safety performance criteria were met: primary AE rate was 2.5% (4/159; cardiac tamponade [n = 2], thrombo-embolism [n = 1], transient ischaemic attack [n = 1]). All primary AEs resolved/improved within the 1-month follow-up period. Acute procedural effectiveness was attained in 96.2% (95% confidence interval: 92.0-98.6%) of patients. Procedure time, fluoroscopy time, and fluid delivered were observed in comparison to predecessor catheters. Conclusion: In the SMART-SF trial, the predetermined safety performance goal was met, demonstrating the safety and acute effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter for PAF ablation.


Assuntos
Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Ablação por Cateter/instrumentação , Frequência Cardíaca , Veias Pulmonares/cirurgia , Irrigação Terapêutica/instrumentação , Potenciais de Ação/efeitos dos fármacos , Idoso , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Resistência a Medicamentos , Desenho de Equipamento , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Porosidade , Estudos Prospectivos , Veias Pulmonares/fisiopatologia , Fatores de Risco , Irrigação Terapêutica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
4.
J Am Coll Cardiol ; 64(7): 647-56, 2014 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-25125294

RESUMO

BACKGROUND: Catheter ablation is important for treatment of paroxysmal atrial fibrillation (PAF). Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation. OBJECTIVES: The study sought to assess the safety and effectiveness of an irrigated, contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF. METHODS: A prospective, multicenter, nonrandomized study was conducted. Enrollment criteria included: ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug (Class I to IV). Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint. RESULTS: A total of 172 patients were enrolled at 21 sites, where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application. Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade (n = 4), pericarditis (n = 3), heart block (n = 1, prior to radiofrequency application), and vascular access complications (n = 4). By Kaplan-Meier analyses, 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5%. The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80% of the time during therapy, outcomes were 4.25 times more likely to be successful (p = 0.0054; 95% confidence interval: 1.53 to 11.79). CONCLUSIONS: The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF, with no unanticipated device-related adverse events. The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence. Stable CF during radiofrequency application increases the likelihood of 12-month success. (THERMOCOOL® SMARTTOUCH® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation; NCT01385202).


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Cateteres , Sistema de Condução Cardíaco/cirurgia , Taquicardia Paroxística/cirurgia , Fibrilação Atrial/fisiopatologia , Eletrocardiografia , Desenho de Equipamento , Feminino , Seguimentos , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Veias Pulmonares/cirurgia , Recidiva , Taquicardia Paroxística/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
5.
Heart Rhythm ; 11(11): 1919-24, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25068575

RESUMO

BACKGROUND: Atrial fibrillation (AF) recurrence after pulmonary vein isolation (PVI) is associated with PV to left atrium reconduction. Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium. OBJECTIVE: The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes. METHODS: Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter. In 25 patients, ablation was guided by real-time contact force measurements (CF group; SmartTouch, Biosense Webster). A control group of 50 patients underwent PVI using a standard nonforce sensing catheter (standard group; ThermoCool, Biosense Webster). After PVI, all patients underwent adenosine testing to unmask dormant conduction. Patients were followed up at 3, 6, and 12 months and by transtelephonic monitoring as well. RESULTS: Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs (8%; 16% of patients) in the CF group and 35 PV pairs (35%; 52% of patients) in the standard group (P = .0004 per PV pair; P = .0029 per patient). The single-procedure, off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88% in the CF group vs 66% in the standard group (P = .047). Procedure duration and fluoroscopy time were significantly longer in the CF group (P = .0038 and P = .0001, respectively). CONCLUSION: The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias. The utility of a contact force-guided approach requires evaluation in a long-term prospective randomized study.


Assuntos
Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Sistema de Condução Cardíaco/fisiopatologia , Veias Pulmonares/cirurgia , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Resultado do Tratamento
6.
Circ Arrhythm Electrophysiol ; 6(6): 1103-8, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24097372

RESUMO

BACKGROUND: Atrial fibrillation recurrence after pulmonary vein (PV) isolation is associated with PV to left atrium reconduction. We prospectively studied the use of 2 procedural techniques designed to facilitate identification of residual gaps within the index ablation line. METHODS AND RESULTS: After wide circumferential PV isolation, 40 patients received additional ablation targeted at locations of left atrial capture during high-output pacing (pace-capture group), while 40 patients underwent adenosine testing with targeted ablation at sites of dormant conduction (adenosine group). Patients were followed up at 3, 6, and 12 months. After PV isolation, high-output pace-capture was documented in 39 PVs (25%; 50% of patients) in the pace-capture group. Dormant conduction was unmasked in 34 PVs (22%; 53% of patients) in the adenosine group. A subset of 25 patients in the pace-capture group underwent adenosine testing without targeted ablation of dormant conduction. In these patients, only 10 out of 86 PVs (11.6%; 24% of patients) demonstrated dormant conduction after the elimination of local pace-capture. At a follow-up of 329±124 days, the single procedure off antiarrhythmic drug freedom from recurrent atrial fibrillation was 67.5% in the adenosine group and 65.0% in the pace-capture group (P=0.814). Procedure duration and fluoroscopy time were significantly longer in the pace-capture group (P=0.002 and P<0.001), whereas radiofrequency ablation time was comparable (P=0.192). CONCLUSIONS: The use of high-output pacing post-PV isolation results in a significant reduction in the incidence of dormant conduction with a comparable long-term freedom from recurrent atrial fibrillation (versus adenosine-guided ablation). The use of these approaches requires evaluation in a long-term prospective randomized study. [corrected].


Assuntos
Estimulação Cardíaca Artificial , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , Adenosina/farmacologia , Idoso , Antiarrítmicos/farmacologia , Eletrocardiografia , Feminino , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
7.
Circ Arrhythm Electrophysiol ; 5(6): 1073-80, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23051838

RESUMO

BACKGROUND: Implantable cardioverter-defibrillator system efficacy is tested at implant by induction of ventricular fibrillation (VF). Defibrillation safety margin can be assessed without VF induction using upper limit of vulnerability methods, but these methods have required manual determination of T-wave timing. METHODS AND RESULTS: To test the feasibility of an inductionless system of implant testing, a multicenter prospective study of an automated vulnerability safety margin system was conducted, which measured T-wave timing using an intracardiac electrogram during a ventricular pacing train. The system delivered up to 4 T-wave shocks of 18 J. Lack of VF induction by all 4 shocks was considered evidence of defibrillation adequacy. Patients subsequently underwent conventional defibrillation testing to meet a standard implant criterion. The 95% lower CI for defibrillation success at 25 J for noninduced patients was found using Bayesian statistics. Sixty patients were enrolled at 6 centers. Vulnerability testing and defibrillation success results were obtained from 54 patients. Vulnerability testing induced VF in 10 (19%) patients, of whom 2 required system revision. All patients not induced by vulnerability testing were successfully defibrillated twice at ≤25 J. The Bayesian credible interval was 97% to 100% for the population success rate of defibrillation at 25 J for automated vulnerability safety margin noninduced patients. CONCLUSIONS: An automated system identified all patients who failed conventional safety margin testing, while inducing only 19% of patients. Although limited by sample size, this study suggests the feasibility of automated implant testing that substantially reduces the need for VF induction in patients receiving implantable cardioverter-defibrillators.


Assuntos
Desfibriladores Implantáveis , Cardioversão Elétrica/efeitos adversos , Segurança de Equipamentos/métodos , Fibrilação Ventricular/etiologia , Fibrilação Ventricular/terapia , Idoso , Teorema de Bayes , Eletrocardiografia , Técnicas Eletrofisiológicas Cardíacas , Estudos de Viabilidade , Feminino , Humanos , Masculino , Teste de Materiais/métodos , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Fibrilação Ventricular/fisiopatologia
8.
J Interv Card Electrophysiol ; 34(3): 311-5, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22434335

RESUMO

OBJECTIVE: The objective of this study was to evaluate the use of continuous catheter impedance monitoring prior to ablation to facilitate differentiation of the coronary sinus ostium (CSO) and the middle cardiac vein (MCV) from the right atrial posteroseptal region (RPS). BACKGROUND: Empiric observations have suggested that continuous catheter impedance monitoring could differentiate the CSO and MCV from the RPS region. Radiofrequency ablation in the MCV or coronary sinus has been associated with coronary artery injury. Differentiation of these areas may be difficult with either fluoroscopy or electrogram characteristics. METHODS AND RESULTS: Continuous impedance measurements using a 4-mm Navistar (Biosense Webster) ablation catheter were conducted in 17 consecutive patients undergoing ablation for supraventricular tachycardia. The average impedance value was recorded at the right atrial septum (RS) posterior to the bundle of His, the RPS region, within 1 cm inside the CSO and in the MCV. These areas were confirmed and demarcated with 3-D mapping and biplane fluoroscopy. A significant increase in impedance was observed between the CSO (X = 146.6 ± 24.8) and RPS [Formula: see text] regions (p < 0.001). Furthermore, a significant rise in impedance was seen between the MCV [Formula: see text] and RPS and CSO, respectively (p < 0.001). No significant change in impedance was found between the RS [Formula: see text] and RPS regions. CONCLUSIONS: Continuous impedance measurements during mapping can facilitate differentiation of catheter locations inside the CSO and MCV from extracoronary sinus regions. This may reduce the risk of inadvertent coronary artery damage during the ablation procedure.


Assuntos
Ablação por Cateter/efeitos adversos , Ablação por Cateter/instrumentação , Seio Coronário/lesões , Vasos Coronários/lesões , Migração de Corpo Estranho/diagnóstico , Taquicardia por Reentrada no Nó Atrioventricular/cirurgia , Adulto , Idoso , Cateterismo Cardíaco , Impedância Elétrica , Eletrocardiografia , Técnicas Eletrofisiológicas Cardíacas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Taquicardia por Reentrada no Nó Atrioventricular/fisiopatologia , Resultado do Tratamento
9.
J Am Coll Cardiol ; 59(13): 1168-74, 2012 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-22305113

RESUMO

OBJECTIVES: The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation. BACKGROUND: AF ablation requires optimal periprocedural anticoagulation for minimizing bleeding and thromboembolic complications. The safety and efficacy of dabigatran as a periprocedural anticoagulant for AF ablation are unknown. METHODS: We performed a multicenter, observational study from a prospective registry including all consecutive patients undergoing AF ablation in 8 high-volume centers in the United States. All patients receiving dabigatran therapy who underwent AF ablation on periprocedural dabigatran, with the dose held on the morning of the procedure, were matched by age, sex, and type of AF with an equal number of patients undergoing AF ablation with uninterrupted warfarin therapy over the same period. RESULTS: A total of 290 patients, including 145 taking periprocedural dabigatran and an equal number of matched patients taking uninterrupted periprocedural warfarin, were included in the study. The mean age was 60 years with 79% being male and 57% having paroxysmal AF. Both groups had a similar CHADS(2) score, left atrial size, and left ventricular ejection fraction. Three thromboembolic complications (2.1%) occurred in the dabigatran group compared with none in the warfarin group (p = 0.25). The dabigatran group had a significantly higher major bleeding rate (6% vs. 1%; p = 0.019), total bleeding rate (14% vs. 6%; p = 0.031), and composite of bleeding and thromboembolic complications (16% vs. 6%; p = 0.009) compared with the warfarin group. Dabigatran use was confirmed as an independent predictor of bleeding or thromboembolic complications (odds ratio: 2.76, 95% confidence interval: 1.22 to 6.25; p = 0.01) on multivariate regression analysis. CONCLUSIONS: In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/terapia , Benzimidazóis/uso terapêutico , Sistema de Registros , Varfarina/uso terapêutico , beta-Alanina/análogos & derivados , Idoso , Anticoagulantes/efeitos adversos , Benzimidazóis/efeitos adversos , Ablação por Cateter , Dabigatrana , Estudos de Viabilidade , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória , Estudos Prospectivos , Tromboembolia/induzido quimicamente , Resultado do Tratamento , beta-Alanina/efeitos adversos , beta-Alanina/uso terapêutico
10.
J Cardiovasc Electrophysiol ; 19(9): 915-9, 2008 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-18393956

RESUMO

INTRODUCTION: Complex fractionated atrial electrograms (CFAEs) have been described as a potential target for ablation of atrial fibrillation (AF). The purpose of this study is to assess the consistency of the CFAE phenomena using custom software for automated detection of CFAEs in the left atrium during AF. METHODS AND RESULTS: This prospective study included 10 patients referred for catheter ablation of symptomatic drug-refractory AF. Ten consecutive points at a single location (cluster) were acquired as electroanatomical points every 3 seconds. Atrial signals were automatically classified as CFAEs by the software algorithm. The number of intervals between 50 ms and 110 ms and in the voltage range 0.05-0.15 mV during the 2.5-second recordings was determined and referred to as the interval confidence level (ICL). A total of 2,226 points were acquired during mapping of AF. A dominant group of ICL using one of two different configurations of ICL fractionation was identified. A dominant group was defined as the ICL categorization occurring with greatest frequency in a given cluster of points. The results show the consistency ranged from 73%+/- 21 for the three-group configuration (ICL < or = 4; 4 < ICL < or = 7; ICL > 7) to 84%+/- 16 for the two-group configuration (ICL < or = 5; ICL > 5). CONCLUSION: This novel software offers an objective method for CFAE analysis during atrial fibrillation. CFAE consistency ranged from 73% to 84% with wide standard deviation. Automated detection of CFAEs may remove the pitfalls associated with subjective visual detection, thus removing one variable in comparative studies of using CFAEs as AF ablation targets.


Assuntos
Inteligência Artificial , Fibrilação Atrial/diagnóstico , Mapeamento Potencial de Superfície Corporal/métodos , Diagnóstico por Computador/métodos , Átrios do Coração , Reconhecimento Automatizado de Padrão/métodos , Software , Algoritmos , Fibrilação Atrial/cirurgia , Ablação por Cateter , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
11.
J Cardiovasc Electrophysiol ; 16(3): 244-8, 2005 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-15817079

RESUMO

This report describes different imaging techniques of the esophagus in four patients during radiofrequency catheter ablation of atrial fibrillation in the left atrium. A novel use of a mixture of barium cream and gadolinium diglutamate allowed esophageal imaging during magnetic resonance angiography of the left atrium and pulmonary veins. Barium cream used during computer tomography angiographic imaging of the left atrium and pulmonary veins allowed esophageal imaging. The esophagus was also imaged with an electroanatomic mapping system. Esophageal and left atrial imaging helped to avoid catheter ablation in left atrial tissue overlapping the esophagus.


Assuntos
Fibrilação Atrial/diagnóstico , Esôfago , Átrios do Coração/fisiopatologia , Angiografia por Ressonância Magnética/métodos , Adulto , Idoso , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Feminino , Humanos , Imageamento Tridimensional , Masculino , Pessoa de Meia-Idade , Segurança
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