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    IntroductionThe prospective, nonrandomized, multicenter Q‐FFICIENCY study demonstrated the safety and 12‐month efficacy of paroxysmal atrial fibrillation (AF) ablation with the novel QDOT MICRO temperature‐controlled, contact... more
    IntroductionThe prospective, nonrandomized, multicenter Q‐FFICIENCY study demonstrated the safety and 12‐month efficacy of paroxysmal atrial fibrillation (AF) ablation with the novel QDOT MICRO temperature‐controlled, contact force‐sensing, radiofrequency (RF) catheter. Participants underwent pulmonary vein isolation with very high‐power short‐duration (vHPSD) mode (90 W, ≤4 s) alone or combined with conventional‐power temperature‐controlled (CPTC) mode (25–50 W). This study aimed to assess quality‐of‐life (QOL) and healthcare utilization (HCU) benefits experienced by Q‐FFICIENCY study participants.MethodsBesides evaluating procedural efficiency, QOL and HCU were assessed through 12 months postablation via Atrial Fibrillation Effect on Quality‐of‐Life Tool (AFEQT) score, antiarrhythmic drug (AAD) use, and incidence of cardioversion and cardiovascular hospitalization.ResultsOf 191 participants enrolled, 166 were ablated with the new catheter. Compared to baseline, statistically signi...
    BACkgRoUnd For years, physicians have been treating atrial fibrillation (AF) with radiofrequency (RF) catheter ablation. RF energy is used to create long, continuous lesions in the left atrium, but long term success rates leave room for... more
    BACkgRoUnd For years, physicians have been treating atrial fibrillation (AF) with radiofrequency (RF) catheter ablation. RF energy is used to create long, continuous lesions in the left atrium, but long term success rates leave room for improvement. Follow up procedures are often required when the initial procedure fails to eliminate the arrhythmia. ii Better understanding of the physical processes that take place during ablation may help improve the procedure outcome.
    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... more
    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.
    Sinoatrial block (SAB) is often difficult to identify in the presence of bradycardic rhythms. This study demonstrates several manifestations of so-called escape capture bigeminy in 14 patients. Although periods of 1: 1 sinoatrial... more
    Sinoatrial block (SAB) is often difficult to identify in the presence of bradycardic rhythms. This study demonstrates several manifestations of so-called escape capture bigeminy in 14 patients. Although periods of 1: 1 sinoatrial conduction can aid in the analysis of SAB, the electrocardiographic pattern of bigeminal rhythm may be the only electrocardiographic clue of SAB. In one case, both sinoatrial
    Ventricular tachycardia (VT) and ventricular fibrillation (VF) remain a challenging problem in patients with implantable cardioverter-defibrillators (ICDs). This study aimed to determine whether ranolazine administration decreases the... more
    Ventricular tachycardia (VT) and ventricular fibrillation (VF) remain a challenging problem in patients with implantable cardioverter-defibrillators (ICDs). This study aimed to determine whether ranolazine administration decreases the likelihood of VT, VF, or death in patients with an ICD. This was double-blind, placebo-controlled clinical trial in which high-risk ICD patients with ischemic or nonischemic cardiomyopathy were randomized to 1,000 mg ranolazine twice a day or placebo. The primary endpoint was VT or VF requiring appropriate ICD therapy or death, whichever occurred first. Pre-specified secondary endpoints included ICD shock for VT, VF, or death and recurrent VT or VF requiring ICD therapy. Among 1,012 ICD patients (510 randomized to ranolazine and 502 to placebo) the mean age was 64 ± 10 years and 18% were women. During 28 ± 16 months of follow-up there were 372 (37%) patients with primary endpoint, 270 (27%) patients with VT or VF, and 148 (15%) deaths. The blinded stud...
    BACkgRoUnd For years, physicians have been treating atrial fibrillation (AF) with radiofrequency (RF) catheter ablation. RF energy is used to create long, continuous lesions in the left atrium, but long term success rates leave room for... more
    BACkgRoUnd For years, physicians have been treating atrial fibrillation (AF) with radiofrequency (RF) catheter ablation. RF energy is used to create long, continuous lesions in the left atrium, but long term success rates leave room for improvement. Follow up procedures are often required when the initial procedure fails to eliminate the arrhythmia. ii Better understanding of the physical processes that take place during ablation may help improve the procedure outcome.
    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... more
    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 ...
    ObjectivesThe 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... more
    ObjectivesThe 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.DesignSystematic literature review and meta-analysis.BackgroundEmerging evidence suggests improved clinical outcomes of AF ablation using CF-sensing catheters; however, reviews to date have included data from multiple, distinct CF technologies.MethodsWe 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 als...
    Experience with frequency domain analysis over the past two decades strongly suggests that it represents a unique, noninvasive tool for achieving a more precise assessment of autonomic function in both the experimental and clinical... more
    Experience with frequency domain analysis over the past two decades strongly suggests that it represents a unique, noninvasive tool for achieving a more precise assessment of autonomic function in both the experimental and clinical settings. Available studies indicate that the significance of the HF component is far better understood than that of the lower frequency components. In general, it is considered to reflect vagal activity, and because it is readily manipulated pharmacologically, is used as a an index of that activity. However, some caution is required because this parameter also is strongly influenced by the degree of coupling between respiration and heart rate, which, in turn, reflects the intensity of the respiratory effort as well as of parasympathetic activity. Respiratory pattern also can significantly influence HF power. The use of controlled breathing minimizes these problems, improves reproducibility of test findings, and also facilitates quantitative comparisons. ...
    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... more
    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. 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 a...
    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. The study sought to assess... more
    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. 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. 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. 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 ...
    The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation. AF ablation requires optimal periprocedural anticoagulation for minimizing bleeding and... more
    The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation. 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. 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. 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. In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.
    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... more
    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. 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). 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.
    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... more
    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.