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2.
J Cardiovasc Electrophysiol ; 31(6): 1462-1469, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32356380

RESUMO

INTRODUCTION: Implantable cardioverter defibrillators (ICDs) are proven to prevent sudden death in patients at elevated risk for sustained ventricular tachycardia or fibrillation. Complications related to ICD failure can stem from lead dysfunction, manufacturing defects, patient characteristics, or implantation technique. We conducted a review of all ICD leads implanted at our center from 2011 to 2017 to determine risk factors for premature lead failure. METHODS: We conducted a retrospective review of patients of all ICD leads implanted from December 2011 to June 2017 at our institution. A total of 660 patients (Biotronik Linox S/SD, n = 281; Sprint Quatro, n = 207; Durata, n = 121; Endotak, n = 51) underwent ICD implantations. Patient and lead characteristics, procedural outcomes and complications were recorded. Lead failure was defined per Heart Rhythm Society lead-management consensus as a lack of procedural or clinical success, thus requiring an extraction of the lead. Patient and lead outcomes were recorded and variables associated with lead failure were assessed by the Kaplan-Meier method. RESULTS: Overall failure rate was similar for all leads: Linox S/SD-0.29%/year; Sprint Quattro-0.21%/year, Durata-0.39%/year and Endotak Reliance-0.0% (P = .769). No difference was found in overall survival when comparing all ICD manufacturers during the study period. Subgroup analysis revealed the risk of premature lead failure was particularly pronounced in multi-lead ICD systems implanted via cephalic access (P < .001). The estimated failure rate of Linox leads implanted via cephalic access in multi-lead systems was 19%/year. The estimated failure rate of non-Linox leads implanted via cephalic access in multi-lead systems was 11%/year. Neither age, nor gender were risk factors for lead failure in the Linox, or non-Linox cohorts. CONCLUSION: All analyzed ICD leads were found to have a similar overall risk of premature failure. ICD lead implantation via cephalic access in multilead ICD systems may be a previously unidentified risk factor for premature ICD lead failure, although these findings require further validation.

3.
Heart Rhythm ; 2020 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-32438018

RESUMO

Chloroquine and hydroxychloroquine are now being widely used for treatment of COVID-19. Both medications prolong the QT interval and accordingly may put patients at increased risk for torsades de pointes and sudden death. Published guidance documents vary in their recommendations for monitoring and managing these potential adverse effects. Accordingly, we set out to conduct a systematic review of the arrhythmogenic effect of short courses of chloroquine or hydroxychloroquine. We searched on MEDLINE and Embase, as well as in the gray literature up to April 17, 2020, for the risk of QT prolongation, torsades, ventricular arrhythmia, and sudden death with short-term chloroquine and hydroxychloroquine usage. This search resulted in 390 unique records, of which 41 were ultimately selected for qualitative synthesis and which included data on 1515 COVID-19 patients. Approximately 10% of COVID-19 patients treated with these drugs developed QT prolongation. We found evidence of ventricular arrhythmia in 2 COVID-19 patients from a group of 28 treated with high-dose chloroquine. Limitations of these results are unclear follow-up and possible publication/reporting bias, but there is compelling evidence that chloroquine and hydroxychloroquine induce significant QT-interval prolongation and potentially increase the risk of arrhythmia. Daily electrocardiographic monitoring and other risk mitigation strategies should be considered in order to prevent possible harms from what is currently an unproven therapy.

4.
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.

5.
Heart Rhythm ; 2020 May 12.
Artigo em Inglês | MEDLINE | ID: mdl-32407884

RESUMO

BACKGROUND: There is no known effective therapy for patients with coronavirus disease 2019 (COVID-19). Initial reports suggesting the potential benefit of hydroxychloroquine/azithromycin (HY/AZ) have resulted in massive adoption of this combination worldwide. However, while the true efficacy of this regimen is unknown, initial reports have raised concerns about the potential risk of QT interval prolongation and induction of torsade de pointes (TdP). OBJECTIVE: The purpose of this study was to assess the change in corrected QT (QTc) interval and arrhythmic events in patients with COVID-19 treated with HY/AZ. METHODS: This is a retrospective study of 251 patients from 2 centers who were diagnosed with COVID-19 and treated with HY/AZ. We reviewed electrocardiographic tracings from baseline and until 3 days after the completion of therapy to determine the progression of QTc interval and the incidence of arrhythmia and mortality. RESULTS: The QTc interval prolonged in parallel with increasing drug exposure and incompletely shortened after its completion. Extreme new QTc interval prolongation to >500 ms, a known marker of high risk of TdP, had developed in 23% of patients. One patient developed polymorphic ventricular tachycardia suspected as TdP, requiring emergent cardioversion. Seven patients required premature termination of therapy. The baseline QTc interval of patients exhibiting extreme QTc interval prolongation was normal. CONCLUSION: The combination of HY/AZ significantly prolongs the QTc interval in patients with COVID-19. This prolongation may be responsible for life-threatening arrhythmia in the form of TdP. This risk mandates careful consideration of HY/AZ therapy in light of its unproven efficacy. Strict QTc interval monitoring should be performed if the regimen is given.

6.
Artigo em Inglês | MEDLINE | ID: mdl-32314841

RESUMO

INTRODUCTION: Catheter stability during atrial fibrillation ablation is associated with higher ablation success rates. Rapid cardiac pacing and high-frequency jet ventilation (HFJV) independently improve catheter stability. Simultaneous modulation of cardiac and respiratory motion has not been previously studied. The objective of this study was to determine the effect of simultaneous heart rate and respiratory rate modulation on catheter stability. METHODS: Forty patients undergoing paroxysmal atrial fibrillation ablation received ablation lesions at 15 prespecified locations (12 left atria, 3 right atria). Patients were randomly assigned to undergo rapid atrial pacing for either the first or the second half of each lesion. Within each group, half of the patients received HFJV and the other half standard ventilation. Contact force and ablation data for all lesions were compared among the study groups. Standard deviation of contact force was the primary endpoint defined to examine contact force variability. RESULTS: Lesions with no pacing and standard ventilation had the greatest contact force standard deviation (5.86 ± 3.08 g), compared to lesions with pacing and standard ventilation (5.45 ± 3.28 g; P < .01) or to lesions with no pacing and HFJV (4.92 ± 3.00 g; P < .01). Lesions with both pacing and HFJV had the greatest reduction in contact force standard deviation (4.35 ± 2.81 g; P < .01), confirming an additive benefit of each maneuver. Pacing and HFJV together was also associated with a reduction in the proportion of lesions with excessive maximum contact force (P < .001). DISCUSSION: Rapid pacing and HFJV additively improve catheter stability. Simultaneous pacing with HFJV further improves catheter stability over pacing or HFJV alone to optimize ablation lesions.

7.
Heart Rhythm ; 17(5 Pt A): 721-727, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31978595

RESUMO

BACKGROUND: Increased peak luminal esophageal temperature (LET) is associated with increased risk of esophageal injury after left atrial posterior wall (LAPW) ablation. The magnitude, distribution, and risk factors of LET increase with high-power short-duration (HPSD) LAPW ablation are not well understood. OBJECTIVE: The purpose of this study was to describe the spatial and temporal characteristics of LET changes associated with HPSD LAPW radiofrequency (RF) ablation. METHODS: LET was sampled at 20 Hz using a 12-point esophageal temperature monitor (CIRCA S-CATH; Circa Scientific, Inc) in 16 patients undergoing LAPW ablation. Esophageal temperature sensor position and lesion locations were recorded using an electroanatomic mapping system with fluoroscopic integration (CARTO 3, CARTOUNIVU; Biosense Webster, Inc). Point-by-point LAPW ablation was performed at 50 W for 6 seconds. The first 20 LAPW lesions were individually analyzed in each patient. RESULTS: LET increase ≥4°C (8 lesions: max LET 5.8°C), 2°-4°C (34 lesions), and 1°-2°C (58 lesions) occurred at 9 ± 2 mm, 8 ± 2 mm, and 13 ± 2 mm from sensors, respectively. Lesions placed >20 mm from a temperature sensor did not result in an LET increase ≥2°C. Temperature resolution to within 1°C of baseline occurred ∼60 seconds after cessation of RF application. Consecutive lesions resulting in additive heating of at least 1°C occurred in 17 lesion pairs with an interlesion distance of 9 ± 4 mm and interlesion time of 21 ± 4 seconds. CONCLUSION: HPSD LAPW ablation can result in severe esophageal temperature increases. Significant LET increase will be undetected when lesions are >20 mm away from a temperature sensor. Additive LET increase was observed with consecutive lesions placed <20 mm apart within 60 seconds.

9.
Artigo em Inglês | MEDLINE | ID: mdl-31707533

RESUMO

INTRODUCTION: Clinical trials have failed to reliably show improved outcomes with utilization of contact-force sensing (CFS) radiofrequency (RF) ablation catheters. It is unknown whether the unfavorable outcomes observed in these trials are attributable to inexperience with CFS technology. OBJECTIVES: To compare catheter ablation outcomes of stepwise linear ablation with versus without CFS technology and to assess the impact of operator experience with CFS technology on procedural outcomes. METHODS: Clinical outcomes were evaluated in 228 consecutive NPAF patients undergoing first-time left atrial ablation using a stepwise linear approach. Arrhythmia recurrence was assessed using 2-week event monitors at 3-month intervals following index ablation. RESULTS: A total of 228 patients were included in our study. There was no statistically significant difference in risk of recurrent atrial arrhythmias at 12 and 24 months between CFS and non-CFS patients (p = 0.5 and p = 0.169). The time to recurrence of atrial arrhythmias at 24 months in the second half of CFS patients was significantly lower when compared to both the first half of CFS patients (p = 0.002) and non-CFS patients (p = 0.005). CONCLUSION: While there was no difference in overall outcomes between CFS and non-CFS ablation using a stepwise linear approach in patients with NPAF, procedural efficacy of the second half of CFS patients was significantly improved compared to both the first half of CFS patients and all non-CFS patients. Lack of benefit seen in clinical trials using CFS technology may be related to operator inexperience with CFS ablation catheters at the time of the trials.

10.
Echocardiography ; 36(8): 1601-1604, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31385344

RESUMO

Recent improvements in 3D TEE post processing rendering techniques referred to as TrueVue (Philips Medical Systems, Andover, MA, USA). It allows for novel photorealistic imaging of cardiac structures including left atrial appendage (LAA) and its closure devices. Here we present TrueVue images of the LAA prior to and after LAA exclusion/occlusion using various percutaneous and surgical techniques. TrueVue may improve delineation of LAA anatomy prior to occlusion as well as visualization of occluder device position within the LAA.

11.
Pacing Clin Electrophysiol ; 42(10): 1347-1354, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31429947

RESUMO

INTRODUCTION: A common complication of transcatheter aortic valve repair (TAVR) is development of conduction defects requiring pacemaker (PPM) implantation. These defects are not universally permanent. OBJECTIVE: To determine the incidence and predictors of persistent device dependency in patients with PPM implantation following TAVR with a self-expanding prosthesis. METHODS: Records of patients who underwent post-TAVR PPM implantation were reviewed. Patients with persistent complete AV block (AVBIII) one month post-TAVR were compared to those regaining conduction. RESULTS: Between September 2014 and March 2017, 485 patients underwent TAVR with a self-expanding prosthesis; 77 (15.9%) underwent PPM implantation for AVBIII. Device interrogation at one month was available for 61 patients (79%): 22 (36.1%) had resolution of AVBIII while 39 (63.9%) remained pacemaker-dependent. Pre-TAVR right bundle branch block was more frequent in device-dependent patients (19 of 38, 50% vs 4 of 22, 18%; RR 2.75; P = .01). Device-dependence was associated with AVBIII as the first postprocedural rhythm (37 of 39, 95% vs 12 of 22, 55%; RR 1.74; P < .0001), earlier implantation (median 1d, IQR: 0-1.5d vs 2d, IQR: 1.0-4.0d, P = .0004), and a shorter duration of hospitalization (median 3d, IQR: 2-3.5d vs 4d, IQR: 2-5.75d, P = .03). Pacemaker dependence was also associated with a higher prosthesis-to left ventricular outflow tract (LVOT) diameter (1.45 ± 0.11 vs 1.39 ± 0.07; P = .02) and the lack of prior aortic valvuloplasty (5 of 39, 13% vs 8 of 22, 36%; RR 0.35; P = .03). CONCLUSIONS: In patients receiving a PPM following self-expanding TAVR, a long-term pacing requirement can be predicted from the timing of AV block, existing conduction-system disease, larger prosthesis-to-LVOT diameter, and the lack of aortic valvuloplasty.

12.
Curr Cardiol Rep ; 21(7): 66, 2019 06 10.
Artigo em Inglês | MEDLINE | ID: mdl-31183616

RESUMO

PURPOSE OF REVIEW: Atrial fibrillation is the most common arrhythmia worldwide and is a major risk factor for embolic stroke. For patients with atrial fibrillation who are unable to tolerate systemic anticoagulation, left atrial appendage (LAA) occlusion has been shown to mitigate stroke risk. In this article, we describe the vital role of the echocardiographer in intraprocedural guidance of percutaneous LAA occlusion procedures as well as in the pre- and post-procedure assessment of these patients. RECENT FINDINGS: A few percutaneously delivered devices for LAA exclusion from the systemic circulation are available in contemporary practice. These devices employ an either exclusive endocardial LAA occlusion approach, such as the Watchman (Boston Scientific, Maple Grove, MN) and Amulet (St. Jude Medical, Minneapolis, MN), or both an endocardial and pericardial (epicardial) approach such as the Lariat procedure (SentreHEART, Palo Alto, CA). Two- and three-dimension transesophageal echocardiography is critical for patient selection, procedure planning, procedural guidance, and ensuring satisfactory immediate as well as long-term LAA occlusion/exclusion efficacy. This review will provide an overview of the role of the echocardiographer in all aspects of LAA occlusion/exclusion procedures for the most commonly used commercially available devices in current practice.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/métodos , Ecocardiografia Transesofagiana/métodos , Cirurgia Assistida por Computador/métodos , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/diagnóstico , Átrios do Coração , Humanos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
13.
JACC Clin Electrophysiol ; 5(5): 626-634, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31122386

RESUMO

OBJECTIVES: This study sought to determine whether a radiation safety time-out reduces radiation exposure in electrophysiology procedures. BACKGROUND: Time-outs are integral to improving quality and safety. The authors hypothesized that a radiation safety time-out would reduce radiation exposure levels for patients and the health care team members. METHODS: The study was performed at the New York University Langone Health Electrophysiology Lab. Baseline data were collected for 6 months prior to the time-out. On implementation of the time-out, data were collected prospectively with analyses to be performed every 3 months. The primary endpoint was dose area product. The secondary endpoints included reference point dose, fluoroscopy time, use of additional shielding, and use of alternative imaging such as intracardiac and intravascular ultrasound. RESULTS: A total of 1,040 patient cases were included. The median dose area product prior to time-out was 18.7 Gy∙cm2, and the median during the time-out was 14.7 Gy∙cm2, representing a 21% reduction (p = 0.007). The median reference point dose prior to time-out was 163 mGy, and during the time-out was 122 mGy (p = 0.011). The use of sterile disposable protective shields and ultrasound imaging for access increased significantly during the time-out. CONCLUSIONS: A radiation safety time-out significantly reduces radiation exposure in electrophysiology procedures. Electrophysiology laboratories, as well as other areas of cardiovascular medicine using fluoroscopy, should strongly consider the use of radiation safety time-outs to reduce radiation exposure and improve safety.

14.
J Interv Card Electrophysiol ; 54(2): 119-124, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30264289

RESUMO

PURPOSE: Elimination of pace-capture along pulmonary vein isolation (PVI) lesion sets reduces atrial fibrillation (AF) recurrence in catheter ablation of paroxysmal AF. Pacing from the RF ablation electrode during RF application is prevented within the CARTO electroanatomic mapping system (Biosense Webster, Inc.) due to theoretical safety considerations. We evaluated a method of pacing the distal ablation electrode during RF application in the CARTO system, thus avoiding repeated activation and inactivation of the pacing channel and facilitating immediate recognition of pace-capture loss. We investigated the safety, feasibility, and utility of simultaneous pace-ablate (SPA) during AF ablation with the CARTO-3 system and a contact-force sensing RF ablation catheter. METHODS: Safety of feasibility of SPA was evaluated in 250 patients undergoing first-time AF ablation. Frequency and regional distribution of pace-capture following PVI was evaluated in a cohort of 50 consecutive patients undergoing catheter ablation of paroxysmal AF. RESULTS: SPA was successfully performed in all 250 patients without adverse event. At least one pace-capture site was noted in 22 of 50 PAF patients (44%), and pace-capture following PVI was most common at anterior and superior left atrial sites. There were 2.0 ± 3.3 RF applications during pacing via the distal ablation electrode per patient, and all lesions sets were successfully rendered unexcitable. CONCLUSIONS: Pace-capture along the completed PVI lesion set remains common despite utilization of contact-force sensing RF ablation catheters and automated lesion annotation. Simultaneous pace-ablate in AF ablation using the CARTO system may be safely used to render atrial lesion sets unexcitable.


Assuntos
Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Segurança do Paciente/estatística & dados numéricos , Veias Pulmonares/cirurgia , Ablação por Radiofrequência/métodos , Idoso , Fibrilação Atrial/diagnóstico , Estimulação Cardíaca Artificial/métodos , Estudos de Coortes , Terapia Combinada , Eletrocardiografia/métodos , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Medição de Risco , Cirurgia Assistida por Computador/instrumentação , Resultado do Tratamento
17.
JACC Clin Electrophysiol ; 4(4): 483-490, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-30067488

RESUMO

OBJECTIVES: This study sought to investigate the effect of pacing mediated heart rate modulation on catheter-tissue contact and impedance reduction during radiofrequency ablation in human atria during atrial fibrillation (AF) ablation. BACKGROUND: In AF ablation, improved catheter-tissue contact enhances lesion quality and acute pulmonary vein isolation rates. Previous studies demonstrate that catheter-tissue contact varies with ventricular contraction. The authors investigated the impact of modulating heart rate on the consistency of catheter-tissue contact and its effect on lesion quality. METHODS: Twenty patients undergoing paroxysmal AF ablation received ablation lesions at 15 pre-specified locations (12 left atria, 3 right atria). Patients were assigned randomly to undergo rapid atrial pacing for either the first half or the second half of each lesion. Contact force and ablation data with and without pacing were compared for each of the 300 ablation lesions. RESULTS: Compared with lesion delivery without pacing, pacing resulted in reduced contact force variability, as measured by contact force SD, range, maximum, minimum, and time within the pre-specified goal contact force range (p < 0.05). There was no difference in the mean contact force or force-time integral. Reduced contact force variability was associated with a 30% greater decrease in tissue impedance during ablation (p < 0.001). CONCLUSIONS: Pacing induced heart rate acceleration reduces catheter-tissue contact variability, increases the probability of achieving pre-specified catheter-tissue contact endpoints, and enhances impedance reduction during ablation. Modulating heart rate to improve catheter-tissue contact offers a new approach to optimize lesion quality in AF ablation. (The Physiological Effects of Pacing on Catheter Ablation Procedures to Treat Atrial Fibrillation [PEP AF]; NCT02766712).


Assuntos
Fibrilação Atrial/cirurgia , Estimulação Cardíaca Artificial/métodos , Ablação por Cateter/métodos , Átrios do Coração/cirurgia , Frequência Cardíaca/fisiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
19.
J Am Soc Echocardiogr ; 31(4): 454-474, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29158017

RESUMO

Atrial fibrillation is the most common arrhythmia worldwide and is a major risk factor for embolic stroke. In this article, the authors describe the crucial role of two- and three-dimensional transesophageal echocardiography in the pre- and postprocedural assessment and intraprocedural guidance of percutaneous left atrial appendage (LAA) occlusion procedures. Although recent advances have been made in the field of systemic anticoagulation with the novel oral anticoagulants, these medications come with a significant risk for bleeding and are contraindicated in many patients. Because thromboembolism in atrial fibrillation typically arises from thrombi originating in the LAA, surgical and percutaneous LAA exclusion/occlusion techniques have been devised as alternatives to systemic anticoagulation. Currently, surgical LAA exclusion is typically performed as an adjunct to other cardiac surgical procedures, which limits the number of eligible patients. Recently, several percutaneously delivered devices for LAA exclusion from the systemic circulation have been developed, some of which have been shown in clinical trials to reduce the risk for thromboembolism. These devices use an either purely endocardial LAA occlusion approach, such as the Watchman and Amulet procedures, or both an endocardial and a pericardial (epicardial) approach, such as the Lariat procedure. In the Watchman and Amulet procedures, a transseptally delivered structure composed of nitinol is placed in the LAA orifice, thereby excluding the LAA from the systemic circulation. In the Lariat procedure, a magnet link is created between a transseptally delivered endocardial wire and epicardially delivered pericardial wire, followed by epicardial suture ligation of the LAA.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , Ecocardiografia Transesofagiana/métodos , Cirurgia Assistida por Computador/métodos , Tromboembolia/prevenção & controle , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/diagnóstico , Humanos , Tromboembolia/etiologia
20.
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
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