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Pulmonary vein (PV) isolation using radiofrequency ablation (RFA) to treat atrial fibrillation (AF) requires delivery of contiguous transmural lesions at the PV antra while avoiding injury to the esophagus. Continuous 2-dimensional phased-array intracardiac echocardiography (ICE) from within the left atrium (LA) can provide consistent high-resolution images of catheter tip contact and location during ablation.The purpose of this study was to compare near-term safety outcomes of therapeutic AF ablation with and without ICE imaging from within the LA.The study cohort included 590 consecutive patients undergoing RFA for AF including continuous ICE imaging during ablation from within either the right atrium (RA) or the LA. Subjects were followed prospectively, and periprocedural complications within 30 days were identified and recorded.All subjects had RA ICE imaging to guide transseptal catheterization. Ultrasound imaging from both RA and LA was used in 243 (41.2%). Respectively, the LA vs RA only imaging cohorts were comparable with respect to age (median 64 [interquartile range 57.4-71.2] years vs 64 [56.2-70.6] years;Routine continuous LA ICE imaging seems to be safe and holds potential to facilitate lesion delivery during RFA for AF.

Background Atrioventricular (AV)-synchronous single-chamber leadless pacing using a mechanical atrial sensing algorithm produced high AV synchrony in clinical trials, but clinical practice experience with these devices has not yet been described. Objective To describe pacing outcomes and programming changes with AV-synchronous leadless pacemakers in clinical practice. Methods Consecutive patients without persistent atrial fibrillation who received an AV-synchronous leadless pacemaker and completed follow-up between February 2020 and April 2021 were included. We evaluated tracking index (atrial mechanical sense followed by ventricular pace [AM-VP] divided by total VP), total AV synchrony (sum of AM-ventricular sense [AM-VS], AM-VP, and AV conduction mode switch), use of programming optimization, and improvement in AV synchrony after optimization. Results Fifty patients met the inclusion criteria. Mean age was 69 ± 16.8 years, 24 (48%) were women, 24 (48%) had complete heart block, and 17 (34%) required ≥50% pacing. Mean tracking index was 41% ± 34%. Thirty-five patients (70%) received ≥1 programming change. In 36 patients with 2 follow-up visits, tracking improved by +9% ± 28% (P value for improvement = .09) and +18% ± 19% (P = .02) among 15 patients with complete heart block. Average total AV synchrony increased from 89% [67%, 99%] to 93% [78%, 100%] in all patients (P = .22), from 86% [52%, 98%] to 97% [82%, 99%] in those with complete heart block (P = .04), and from 73% [52%, 80%] to 78% [70%, 85%] in those with ≥50% pacing (P = .09). Conclusion In patients with AV-synchronous leadless pacemakers, programming changes are frequent and are associated with increased atrial tracking and increased AV synchrony in patients with complete heart block., Graphical abstract

BACKGROUND: Rhythm control strategies for atrial fibrillation (AF), including catheter ablation, are substantially underused in racial/ethnic minorities in North America. OBJECTIVE: To describe outcomes in the CABANA trial as a function of race/ethnicity. METHODS: CABANA randomized 2204 symptomatic participants with AF to ablation or drug therapy including rate and/or rhythm control drugs. Only participants in North America were included in this analysis, and participants were subgrouped as racial/ethnic minority or non-minority using National Institutes of Health definitions. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. RESULTS: Of 1280 participants enrolled in CABANA in North America, 127 (9.9%) were racial and ethnic minorities. Compared with non-minorities, racial and ethnic minorities were younger with median age 65.6 versus 68.5 years, had more symptomatic heart failure (37.0% versus 22.0%, respectively), hypertension (92.1% versus 76.8%, respectively), and an ejection fraction

Background: In patients with heart failure and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life, and survival, with catheter ablation. This article describes the treatment-related outcomes of the AF patients with heart failure enrolled in the CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). Methods: The CABANA trial randomized 2204 patients with AF who were ≥65 years old or II at baseline and form the subject of this article. The CABANA trial’s primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Results: Of the 778 patients with heart failure enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction at baseline was available for 571 patients (73.0%), and 9.3% of these had an ejection fraction Conclusions: In patients with AF enrolled in the CABANA trial who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Registration: URL: https://www.clinicaltrials.gov/ct2/show/NCT00911508 ; Unique identifier: NCT0091150.

The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest.The purpose of this study was to assess recurrence of AF in the CABANA trial.The authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post-90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach.Median age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p 0.001). These findings were not sensitive to the baseline pattern of AF.Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).

Background Catheter ablation is an important rhythm control therapy in patients with atrial fibrillation (AF) with concomitant heart failure (HF). The objective of this study was to assess the comparative efficacy of AF ablation patients with ischemic vs nonischemic heart failure. Methods We conducted a retrospective, observational cohort study of patients with HF who underwent AF ablation. Outcomes were compared based on HF etiology and included in‐hospital events, symptoms (Mayo AF Symptom Inventory [MAFSI]), and functional status (New York Heart Association class) and freedom from atrial arrhythmias at 12 months. Results Among 242 patients (n = 70 [29%] ischemic, n = 172 [71%] nonischemic), patients with nonischemic cardiomyopathy were younger (mean age 64 ± 11.5 vs 69 ± 9.1, P = .002), more often female (36% vs 17%, P = .004), and had higher mean left‐ventricular ejection fraction (47% vs 42%, P = .0007). There were no significant differences in periprocedural characteristics, including mean procedure time (243 ± 74.2 vs 259 ± 81.8 minutes, P = .1) and nonleft atrial ablation (17% vs 20%, P = .6). All‐cause adverse events were similar in each group (15% vs 17%, P = .7). NYHA and MAFSI scores improved significantly at follow‐up and did not differ according to HF etiology (P = .5; P = .10‐1.00 after Bonferroni correction). There were no significant differences in freedom from recurrent atrial arrhythmia at 12‐months between ischemic (74%) and nonischemic patients (78%): adjusted RR 0.63, 95% confidence interval 0.33‐1.19. Conclusions Catheter ablation in patients with AF and concomitant heart failure leads to significant improvements in functional and symptom status without significant differences between patients with ischemic vs nonischemic HF etiology., Catheter ablation is an important rhythm control therapy in patients with atrial fibrillation (AF) with concomitant heart failure (HF). The objective of this study was to assess the comparative efficacy of AF ablation patients with ischemic versus nonischemic heart failure. We found that catheter ablation in patients with AF and concomitant heart failure leads to significant improvements in functional and symptom status without significant differences between patients with ischemic versus nonischemic HF etiology.

Cardiac implanted electronic device (CIED) pocket and systemic infection remain common complications with traditional CIEDs and are associated with high morbidity and mortality. Leadless pacemakers may be an attractive pacing alternative for many patients following complete hardware removal for a CIED infection by eliminating surgical pocket-related complications as well as lower risk of recurrent complications.To describe use and outcomes associated with leadless pacemaker implantation following extraction of a CIED system due to infection.Patient characteristics and postprocedural outcomes were described in patients who underwent leadless pacemaker implantation at Duke University Hospital between November 11, 2014 and November 18, 2019, following CIED infection and device extraction. Outcomes of interest included procedural complications, pacemaker syndrome, need for system revision, and recurrent infection.Among 39 patients, the mean age was 71 ± 17 years, 31% were women, and the most frequent primary pacing indication was complete heart block (64.1%) with 9 (23.1%) patients being pacemaker dependent at the time of Micra implantation. The primary organism implicated in the CIED infection was Staphylococcus aureus (43.6%). Nine of the 39 patients had a leadless pacemaker implanted before or on the same day as their extraction procedure, and the remaining 30 patients had a leadless pacemaker implanted after their extraction procedure. During follow-up (mean 24.8 ± 14.7 months) after leadless pacemaker implantation, there were a total of 3 major complications: 1 groin hematoma, 1 femoral arteriovenous fistula, and 1 case of pacemaker syndrome. No patients had evidence of recurrent CIED infection after leadless pacemaker implantation.Despite a prior CIED infection and an elevated risk of recurrent infection, there was no evidence of CIED infection with a mean follow up of over 2 years following leadless pacemaker implantation at or after CIED system removal. Larger studies with longer follow-up are required to determine if there is a long-term advantage to implanting a leadless pacemaker versus a traditional pacemaker following temporary pacing when needed during the periextraction period in patients with a prior CIED infection.

Background: The CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) was a randomized, prospective trial of left atrial catheter ablation versus drug therapy for treatment of atrial fibrillation (AF). As part of CABANA, a prospective imaging substudy was conducted. The main objectives were to describe the patterns of changes in the dimensions of the left atrium and pulmonary veins (PVs), and the relationship between these changes with treatment assignment and clinical outcomes. Methods: Computed tomography or magnetic resonance imaging was acquired at baseline and follow-up in 121 ablation (median follow-up 101 days) and 85 drug patients (median follow-up 97 days). Left atrial volume index, mean PV ostial diameter, and ostial diameters of each PV separately were computed. We examined the relationship between the change from baseline to follow-up with subsequent clinical outcomes (composite of death, disabling stroke, serious bleeding, or cardiac arrest [CABANA primary end point], total mortality or cardiovascular hospitalization, first AF recurrence after the 90-day blanking period, first AF/atrial flutter/atrial tachycardia after the 90-day blanking period) using Cox proportional-hazards models. Results: The median (25th to 75th) change from baseline for left atrial volume index was −7.8 mL/m 2 (−16.4 to 0.2), ablation arm and −3.5 mL/m 2 (−11.4 to 2.6), drug therapy arm. The left atrial volume index decreased in 52.9% of ablation patients versus 40.0% of drug therapy patients. Change for mean PV was −2.7 mm (−4.2 to −1.3) in the ablation arm versus −0.1 mm (−1.5 to 0.8) in the drug therapy arm. Changes in left atrium and PV dimensions had no consistent relationship with the risk of developing the study primary end point. Reductions in left atrial volume index, and in mean PV diameter were associated with decreased risk of AF recurrence. Conclusions: Ablation patients demonstrated more frequent and larger atrial structural changes compared with drug patients. These changes suggest a critical relationship between structural features and AF generation.

Background: Among patients with atrial fibrillation (AF), women are less likely to receive catheter ablation and may have more complications and less durable results. Most information about sex-specific differences after ablation comes from observational data. We prespecified an examination of outcomes by sex in the 2204-patient CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). Methods: CABANA randomized patients with AF age ≥65 years or Results: CABANA randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690). Compared with men, women were older (median age, 69 years versus 67 years for men), were more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 versus 39% for men), had more symptomatic heart failure (42% with New York Heart Association Class ≥II versus 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% versus 39% for men) ( P P =0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio for those who underwent ablation versus drug therapy was 1.01 (95% CI, 0.62–1.65) in women and 0.73 (95% CI, 0.51–1.05) in men (interaction P value=0.299). The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (hazard ratio, 0.64 [95% CI, 0.51–0.82] for women versus hazard ratio, 0.48 [95% CI, 0.40–0.58] for men; interaction P value=0.060). Conclusions: Clinically relevant treatment-related strategy differences in the primary and secondary clinical outcomes of CABANA were not seen between men and women, and there were no sex differences in adverse events. The CABANA trial results support catheter ablation as an effective treatment strategy for both women and men. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00911508.

Background Unexpected variations in treatment benefits by geographic region raise questions about the generalizability of findings from international clinical trials. Purpose Investigate the outcome of catheter ablation vs drug therapy in CABANA patients with AF treated at North American (NA) compared with non-NA sites, a pre-specified comparison. Methods CABANA randomized 2204 symptomatic patients with atrial fibrillation (AF) to ablation vs drug therapy at 126 centers in 10 countries. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Results There were 1285 patients enrolled at 85 NA sites, and 919 at 45 non-NA sites. At baseline, NA and non-NA patients differed significantly with regard to age, sex, BMI, CCS, CHA2DS2-VASc score, family history of AF, prior AF hospitalization, history of A Flutter, diabetes, NYHA class, and proportion with sleep apnea, heart disease, CAD, CHF, or EF >35%. Four-year Kaplan-Meier event rates showed considerable differences in treatment effects between NA and non-NA patients (see Table). Ablation was associated with a 50% reduction in the primary endpoint in non-NA (HR 0.50, 95% CI 0.24 to 1.03) vs a 5% reduction in NA (HR 0.95, 95% CI 0.69 to 1.30) enrollees despite higher event rates in NA patients. The trend of favorable outcome with ablation at non-NA sites was maintained after adjustment for baseline covariates that differed between the non-NA (HR 0.51, 95% CI 0.24 to 1.04) and NA populations (HR 0.93, 95% CI 0.68 to 1.20). Conclusion We observed substantial geographic variation in clinical outcomes and treatment effects in the CABANA trial that suggests an important disconnection between overall event rates and treatment benefit from ablation in AF. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): NIH

Background The CABANA trial compared drug vs ablation therapy yet did not identify a difference in the primary endpoint of death, stroke, severe bleeding, or cardiac arrest or the secondary endpoint of all-cause mortality by intention to treat (ITT) analysis. Nevertheless, there was evidence of improved outcomes and survival in the as-treated and per-protocol analyses. Objectives To determine how the treatment strategies of drug therapy vs ablation impact the atrial fibrillation progression and regression. Methods CABANA randomized 2204 pts with AF ≥65 yrs old or Results Following treatment with ablation, 64% maintained sinus rhythm with elimination of AF, 11% experienced AF regression, and only 7% had progression of AF. In contrast, in those randomized to drug therapy, only 48% experienced maintenance of sinus rhythm, 10% experienced AF regression, and 13% had progression of AF. Moreover, in the drug arm there was a 32% increase in long-standing persistent compared with a 49% reduction in the ablation arm. Conclusion Catheter ablation significantly alters the natural history of atrial fibrillation. Intention to treat analysis reveals that catheter ablation provides superior elimination of AF, protection against AF progression, and dramatically lower risks of long-standing persistent AF. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health

Background: Cardiac amyloidosis is a progressive infiltrative disease involving deposition of amyloid fibrils in the myocardium and cardiac conduction system that frequently manifests with heart failure (HF) and arrhythmias, most frequently atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT). Methods: We performed an observational retrospective study of patients with a diagnosis of cardiac amyloid who underwent catheter ablation at our institution between January 1, 2011 and December 1, 2018. Patient demographics, procedural characteristics and outcomes were determined by manual chart review. Results: A total of 13 catheter ablations were performed over the study period in patients with cardiac amyloidosis, including 10 AT/AF/AFL ablations and 3 atrioventricular nodal ablations. Left ventricular ejection fraction was lower at the time of AV node ablation than catheter ablation of AT/AF/AFL (23% vs. 40%, p = 0.003). Cardiac amyloid was diagnosed based on the results of pre-ablation cardiac MRI results in the majority of patients (n = 7, 70%). The HV interval was prolonged at 60±15 ms and did not differ significantly between AV nodal ablation patients and AT/AF/AFL ablation patients (69±18 ms vs. 57±14 ms, p = 0.36). The majority of patients undergoing AT/AF/AFL ablation had persistent AF (n = 7, 70%) and NYHA class II (n = 5, 50%) or III (n = 5, 50%) HF symptoms, while patients undergoing AV node ablation were more likely to have class IV HF (n = 2, 66%, p = 0.014). Arrhythmia-free survival in CA patients after catheter ablation of AT/AF/AFL was 40% at one year and 20% at two years. Conclusions: Catheter ablation of AT/AF/AFL may be a feasible strategy for appropriately selected patients with early to mid-stage CA, whereas AV node ablation may be more appropriate in patients with advanced stage CA. This article is protected by copyright. All rights reserved.

Background The amplitude of bipolar electrograms (EGMs) is directionally sensitive, decreasing when measured from electrode pairs oriented oblique to a propagating wavefront. Objective The purpose of this study was to use a computational model and clinical data to establish the mechanism and magnitude of directional sensitivity. Methods Simulated EGMs were created using a computational model with electrode pairs rotated relative to a passing wavefront. A clinical database of 18,740 EGMs with varying electrode separation and orientations was recorded from the left atrium of 10 patients with atrial fibrillation during pacing. For each EGM, the angle of incidence between the electrodes and the wavefront was measured using local conduction velocity (CV) mapping. Results A theoretical model was derived describing the effect of the changing angle of incidence, electrode spacing, and CV on the local activation time difference between a pair of electrodes. Model predictions were validated using simulated and clinical EGMs. Bipolar amplitude measured by an electrode pair is decreased (directionally sensitive) at angles of incidence resulting in local activation time differences shorter than unipolar downstroke duration. Directional sensitivity increases with closer electrode spacing, faster CV, and longer unipolar EGM duration. For narrowly spaced electrode pairs ( Conclusion Directional sensitivity occurs because bipolar amplitude is reduced when the component unipolar EGMs overlap, such that neither electrode is "indifferent." At the electrode spacing of clinical catheters, this is predicted to occur regardless of catheter orientation. This suggests that bipolar directional sensitivity can be lessened but not overcome by recently introduced catheters with additional rotated electrode pairs.

The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA,NCT00911508)(1) trial is testing the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art pharmacologic therapy. This international 140-center clinical trial was designed to randomize 2200 patients to a strategy of catheter ablation versus state-of-the-art rate or rhythm control drug therapy. Inclusion criteria include: 1) age> 65, or ≤65 with≥ 1 risk factor for stroke, 2) documented AF warranting treatment, and 3) eligibility for both catheter ablation and≥ 2 anti-arrhythmic or≥ 2 rate control drugs. Patients were followed every 3 to 6 months (median 4 years) and underwent repeat trans-telephonic monitoring, Holter monitoring, and CT/MR in a subgroup of patient studies to assess the impact of treatment on AF recurrence and atrial structure. With 1100 patients in each treatment arm, CABANA is projected to have 90% power for detecting a 30% relative reduction in the primary composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest. Secondary endpoints include total mortality; mortality or cardiovascular hospitalization; a combination of mortality, stroke, hospitalization for heart failure or acute coronary artery events; cardiovascular death alone; and heart failure death, as well as AF recurrence, quality of life, and cost effectiveness. At a time when AF incidence is rising rapidly, CABANA will provide critical evidence with which to guide therapy and shape health care policy related to AF for years to come.

Background Atrioesophageal fistula formation is a rare but life-threatening complication of atrial fibrillation ablation. Contact force (CF)–sensing catheters improve procedural effectiveness. However, the impact of the implementation of CF-sensing technology on the risk of atrioesophageal fistula formation has not been explored. Objective The purpose of this study was to determine the association between the use of CF-sensing catheters and atrioesophageal fistula development. Methods We searched the Manufacturer and User Facility Device Experience database for adverse event reports involving Food and Drug Administration–approved ablation catheters. Results Among 2689 device reports, we identified 78 atrioesophageal fistula cases, 65 of which involved CF-sensing catheters and 13 non–CF-sensing catheters. The percentage of total reports involving atrioeosphageal fistula was 5.4% for CF-sensing catheters (65 of 1202) and 0.9% for non–CF-sensing catheters (13 of 1487) (P Conclusion Atrioesophageal fistula formation accounted for a much higher proportion of reported adverse events with CF-sensing catheters compared with non–CF-sensing catheters. Improved understanding of the relationship between power/force delivery and esophageal damage is needed to minimize the risk of atrioesophageal fistula formation.

The utility of routine transesophageal echocardiography (TEE) to exclude left atrial appendage (LAA) thrombus before atrial fibrillation (AF) ablation in patients treated with nonvitamin K oral anticoagulant (NOAC) therapy is unclear. This single-center retrospective study sought to investigate the incidence of LAA thrombus in patients undergoing routine TEE before AF ablation treated with warfarin or NOAC therapy. We included 937 routine pre-AF ablation TEE procedures performed in patients treated with warfarin (n = 517) or NOAC (n = 420). Patients were anticoagulated without interruption for at least 4 consecutive weeks before the TEE. Patients treated with warfarin had lower LAA velocity and underwent TEE earlier in the study period than those treated with NOAC (p 0.05). The incidence of LAA thrombus was higher in patients treated with warfarin (1.55%, 8 of 517) compared with patients treated with NOAC (0.24%, 1 of 420, p = 0.0473 for difference). No LAA thrombus was identified in NOAC-treated patients with a CHA

This article reviews methods for lesion set assessment during radiofrequency catheter ablation for atrial fibrillation (AF). Pulmonary vein isolation (PVI) is the foundation for AF ablation, but PV reconnection can lead to treatment failure. Testing for entrance block can help confirm PVI, although complex electrograms that consist of both near- and far-field potentials may make assessment of entrance block challenging. Differential pacing maneuvers can help appropriately identify PV potentials. After entrance block has been achieved, pacing within the PVs to demonstrate capture of PV musculature with exit block may also help to confirm completeness of lesion sets for PVI. Employing a waiting period of at least 30 min or administering adenosine or isoproterenol can reveal dormant conduction, warranting adjunctive ablation. Additional techniques to confirm durable PVI include testing the ablation lines for excitability with high amplitude pacing, and automated waveform analysis of local electrogram morphology. Newer techniques like real-time magnetic resonance imaging and acoustic radiation force impulse elastography may have a role in testing the completeness of lesion sets in the future.

Background: Symptomatic sinus node dysfunction (SND) consists of a variety of manifestations, including tachycardia-bradycardia syndrome. Atrial fibrillation (AF) is commonly associated with SND, which complicates the management of both conditions. This paper reviews the epidemiology, pathophysiology, and clinical trial data investigating therapeutic approaches for treatment of patients with both SND and AF. Methods: The authors reviewed articles published in English describing the epidemiology, pathophysiology, and therapeutic approaches for patients with SND and AF. The search was conducted using PubMed. Keywords included: sick sinus syndrome, sinus node dysfunction, atrial fibrillation, pacing, and pulmonary vein isolation. Results: SND affects up to one in five patients with AF. AF can lead to anatomical and electrophysiological remodeling in both atria, including the region of sinoatrial node. Changes including atrial fibrosis, altered calcium channel metabolism, and transformed gene expression have been demonstrated in patients with AF and SND. Nonrandomized clinical trial data have failed to demonstrate whether any pacing strategy can reduce the risk of AF. Pulmonary vein isolation appears to decrease episodes of tachybrady syndrome and sinus pauses. Conclusions: SND affects up to one in five patients with AF. The pathophysiological derangements in gene expression, ion channel metabolism, and alterations in myocardial architecture associated with AF may lead to anatomic and electrical changes in the region of the sinoatrial node. Ablation may improve symptoms associated with SND in patients with AF. Future randomized trials are needed to clarify the epidemiology and optimal management of patients with SND and AF.

Background Prior studies suggest that catheter ablation (ABL) for atrial fibrillation (AF) is a treatment option for patients (pts) with paroxysmal AF (PAF). Pts with persistent (Per) or long-standing persistent (LSP) were routinely excluded from most ABL based clinical trials. The effectiveness of ABL compared to drug therapy (MED) in relation to underlying AF type has not been evaluated in a large randomized clinical trial. Objective To assess the impact of AF type on clinical outcomes of ABL vs. MED in pts with AF. Methods The CABANA trial randomized 2204 pts with AF at 126 sites worldwide to ABL vs. MED with rate or rhythm control drugs. The primary endpoint was a composite of death, disabling stroke, severe bleeding, or cardiac arrest. Key secondary endpoints included mortality and recurrence of AF. Outcomes of ABL vs. MED were compared within subgroups defined by AF type using Intention-to-Treat (ITT) analyses. Results Of the 2204 pts, 946 had PAF, 1042 had Per and 215 presented with LSP. There were baseline differences among AF types in age, gender, HTN, LVH, CHF and NYHA Class. For the primary endpoint, there were no significant differences between ABL and MED in pts with PAF (hazard ratio (HR) 0.82; 95% confidence interval (CI) 0.51, 1.31), Per (HR 0.87; 95% CI 0.59, 1.28), or LSP (HR 1.01, 95% CI 0.39, 2.61). Likewise, there were no significant treatment differences in mortality; PAF (HR 0.84; 95% CI 0.46, 1.52), Per (HR 0.90; 95% CI 0.56, 1.46) and LSP (HR 0.67, 95% CI 0.23, 1.94). Post-blanking AF (time to first recurrence) was significantly reduced by ABL compared to MED across all AF types (PAF by 51%), (Per by 47%) and (LSP by 36%). Clinical Characteristics and Outcomes Clinical Outcomes Comparing ABL vs. MED (HR and 95% CI) Interaction p-value Primary Endpoint 0.82 (0.51, 1.31) 0.87 (0.59, 1.28) 1.01 (0.39, 2.61) 0.925 Mortality 0.84 (0.46, 1.52) 0.90 (0.56, 1.46) 0.67 (0.23, 1.94) 0.881 Recurrent AF 0.49 (0.38, 0.62) 0.53 (0.43, 0.65) 0.64 (0.41, 1.01) 0.564 Conclusion Pts with LSP have a lower proportion of women, and a higher proportion with manifestations of heart failure despite lower CHA2DS2VASc scores. By ITT analysis, there is no significant effect of ABL compared to MED in the primary endpoint or mortality in any AF group. However, ABL is more effective than MED for reducing recurrences of AF regardless of AF type, but with a greater effect in PAF vs Per vs LSP. Acknowledgement/Funding NIH, St Jude Medical Foundation and Corporation, Biosense Webster Inc., Medtronic Corporation, and Boston Scientific Corporation

Background Sex-specific outcomes may differ amongst patients receiving catheter ablation for atrial fibrillation (AF). Purpose Assess sex-specific outcomes in the patients randomized to catheter ablation or drug therapy in CABANA. Methods CABANA randomized 2204 pts with AF to catheter ablation or drug therapy (rate/rhythm-control). The outcomes of combined death, disabling stroke, severe bleeding, or cardiac arrest (intention to treat-ITT) or all-cause death were not different. But, ablation significantly improved combined death or CV hospitalization. This analysis compares clinical characteristics by sex and determines sex-specific hazard ratios based on a comparison of ablation vs drug therapy. Results Females were 37.3% of ablation and 37.0% of drug therapy patients. Females were older, more often white race, had less CAD, or sleep apnea, but had higher NYHA Class, higher CHA2DS2VASc, and more often had paroxysmal (v. persistent) AF, and prior AF hospitalization. (Table) HTN, CVA and diabetes were the same (Table). For the CABANA primary endpoint, an ITT comparison of ablation vs. drug therapy, showed a female hazard ratio (HR) of 1.14 (95% confidence interval (CI) 0.70–1.86), and a male HR of 0.74, (95% CI 0.52–1.06). For all-cause mortality, the female HR was 0.75 (95% CI 0.41–1.40) and male HR was 0.91 (95% CI 0.59–1.40) and for all-cause mortality or CV hospitalization, the female HR was 0.90 (95% CI 0.75–1.09) and male HR was 0.79 (95% CI 0.69–0.92). All interaction p values were non-significant. Recurrent AF (post 90-day blanking) was significantly reduced for both females and males: female HR 0.64 (95% CI 0.51–0.82), male HR 0.46 95% CI 0.39–0.56), p=0.035 Clinical Characteristics and Outcomes Baseline Characteristics Female (N=818) Male (N=1385) p-value Age: Median (Q1, Q3) 69 (65, 74) 66 (60, 71) Conclusion Significant sex-specific outcomes differences were not observed. Sex should not be used as a determining factor in selecting patients for AF therapy. Acknowledgement/Funding NIH, St Jude Medical Foundation and Corporation, Biosense Webster Inc., Medtronic Corporation, and Boston Scientific Corporation

Background Pulmonary wall isolation (PWI) is increasingly used as an adjunctive lesion set to compliment pulmonary vein isolation (PVI), especially in patients with persistent atrial fibrillation (AF). The objective was to compare outcomes of catheter ablation in patients with persistent AF undergoing PVI with and without adjunctive PWI. Methods We performed a retrospective study of 558 patients who underwent de novo and repeat ablation for persistent AF. Subjects were matched using propensity score adjustments. Outcomes were freedom from recurrent atrial arrhythmia and adverse events. Results Among 558 patients who underwent ablation for persistent AF, 78 (14%) underwent PVI + PWI, 255 (46%) underwent PVI, and 225 (40%) underwent PVI + linear ablation. Stratified logistic regression analysis with propensity matching revealed higher odds of recurrent arrhythmia with PVI + PWI when compared to PVI (odds ratio [OR] 2.25, 95% CI 1.08-4.69, P = .030) and when compared to PVI + linear (OR 2.31, 95% CI 1.01-5.28, P = .048). Within the PVI + PWI group, 57.7% of subjects were in normal sinus rhythm at 6 months compared to 73.9% and 72.2% in PVI and PVI + linear groups, respectively. Adverse events were rare, with 19 events total identified across all groups. Conclusions PVI + PWI does not appear to be as effective as PVI or PVI + linear ablation in reducing the recurrence of arrhythmia within 6 months of the index procedure in patients with persistent AF. A prospective, randomized controlled trial comparing these ablation techniques is needed to clarify the role of extensive substrate modification for treatment of persistent AF. Condensed Abstract PWI is increasingly used as an adjunctive lesion set to compliment PVI in patients with persistent AF. We performed a retrospective study of 558 patients who underwent de novo and repeat ablation for persistent AF to compare the outcomes between PVI with and without adjunctive PWI. We found an increased incidence in recurrence of AF and other atrial arrhythmias at 6 months in the PVI + PWI cohort compared to PVI with or without additional linear ablation. A prospective, randomized controlled trial comparing these ablation techniques is needed to clarify the role of extensive substrate modification for treatment of persistent AF.

Cardiac perforation is a rare but potentially fatal complication of atrial fibrillation (AF) ablation that can require surgical repair for definitive management. As such, there is controversy regarding the safety of performing AF ablation at centers without on-site cardiothoracic surgery (CTS). The

Background Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance. Objectives This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF. Methods Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority. Results A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference −0.6%; lower limit of 95% confidence interval [CI]: −9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference −2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB. Conclusions Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System–Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000 )

Restoration of sinus rhythm (SR) in patients with atrial fibrillation/atrial flutter (AF/AFL) is limited principally to direct current cardioversion. The multi-ion channel blocker vanoxerine may prove an effective alternative.The purpose of this study was to assess vanoxerine, a 1,4-dialkylpiperazine derivative, for acute conversion of recent-onset, symptomatic AF and AFL.One hundred four subjects with symptomatic AF/AFL for7 days were randomized sequentially to single oral doses of vanoxerine 200, 300, and 400 mg or placebo. Holter monitors were examined for conversion to SR and proarrhythmia through ≥24 hours.Conversion to SR was dose related: 18.2%, 44.0%, and 52.0% within 4 hours, and 59.1%, 64.0%, and 84.0% within 24 hours, for the 200-, 300-, and 400-mg groups, respectively. This was significantly higher than placebo for the 300- and 400-mg groups within 4 hours (12.5% for placebo; P = .0138 and P = .0028, respectively) and for all doses within 24 hours (31.3% for placebo; P = .0421, P = .0138, P = .0001 for 200-, 300-, and 400-mg vanoxerine groups, respectively). Although vanoxerine caused significant dose-dependent QTcF (QT correction by Fridericia) prolongation, monomorphic or polymorphic ventricular tachycardia did not occur. Adverse events were mild and self-limited, with only the highest dose having a greater frequency than placebo.Oral vanoxerine converted AF/AFL to SR at a high rate, was well tolerated, and caused no ventricular proarrhythmia.

The cryothermy ablation balloon catheter was developed to facilitate pulmonary vein (PV) isolation to treat atrial fibrillation (AF). The STOP-AF (Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [[NCT00523978][1]]) trial reported that ablation with

AIMS: To assess whether obstructive sleep apnea (OSA) was associated with increased rotor burden among atrial fibrillation (AF) patients. METHODS AND RESULTS: We studied 33 consecutive patients who were scheduled for focal impulse and rotor modulation (FIRM) ablation at our institution to describe the mapping, ablation, and outcomes, among patients with and without OSA. Patients underwent biatrial FIRM mapping in AF with ablation of stable rotors in addition to conventional ablation lesion sets. Differences between groups were tested with student’s t-tests and Fisher’s exact tests, as appropriate. Survival analyses were performed using the Kaplan–Meier method. Twelve of the 33 (36%) patients had OSA and 8 (66%) used continuous positive airway pressure ventilation (CPAP). Obstructive sleep apnea patients had a higher body mass index (BMI) (33.6 vs. 28.8 kg/m(2), P = 0.01) and were more commonly on beta blockers (67% vs. 29%, P = 0.03) but were otherwise similar regarding baseline characteristics, medication use, and prior AF treatments, including antiarrhythmic drugs and prior ablation. Focal impulse and rotor modulation mapping demonstrated increased rotor burden in the OSA patients (2.6 ± 0.9 vs. 2.0 ± 1.0, P =0.03). The increased rotor burden was more evident in the right atrium (RA) (1.0 ± 0.7 vs. 0.5 ± 0.7, P =0.04 compared with left atrium (1.7 ± 0.8 vs. 1.4 ± 0.7, P = 0.15). There was no correlation between BMI and total number of rotors (r = 0.0961, P = 0.59). Among the population of patients with OSA, CPAP therapy was associated with a lower number of RA rotors (0.8 ± 0.7 vs. 1.5 ± 0.6, P = 0.05) but no significant difference in overall rotors (P = 0.33). CONCLUSION: Obstructive sleep apnea patients demonstrate increased rotor prevalence, driven predominantly by an increase in RA rotors. CPAP therapy was associated with fewer RA rotors.

In this study, the authors sought to perform a meta-analysis of controlled studies assessing the relationship between left atrial appendage (LAA) electrical isolation (EI) and recurrent atrial fibrillation (AF).LAA triggers could play an important role in AF and can be treated with complete EI of the LAA via surgical or percutaneous approaches.We conducted a meta-analysis of all controlled studies published as of November 21, 2016, assessing the relationship between left atrial appendage electrical isolation (LAAEI) and recurrent AF. The primary endpoint was atrial tachycardia (AT) or AF recurrence after the post-procedure blanking period. The association between LAAEI and AT/AF was estimated using random-effects modeling. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using the DerSimonian and Laird method.We identified 7 studies including 1,037 patients; LAAEI was performed in 566 patients (55%). LAAEI was associated with a significantly lower rate of AT/AF recurrence in the primary analysis (OR: 0.38; 95% CI: 0.16 to 0.90; p = 0.02). The association between LAAEI and recurrent AT/AF was strongest in a sensitivity analysis restricted to studies of percutaneous LAAEI (OR: 0.22; 95% CI: 0.11 to 0.46; p 0.001; 5 studies, n = 623). LAAEI was not associated with thromboembolism (OR: 0.50; 95% CI: 0.18 to 1.39; p = 0.18; 5 studies, n = 767), although these studies either incorporated LAA occlusion (3 studies, n = 552 patients) or follow-up echocardiography to assess LAA function (2 studies, n = 215 patients) to inform antithrombotic strategies.LAAEI is associated with a significant reduction in recurrent AT/AF. Randomized trials are required to confirm the efficacy and long-term safety of LAAEI and to determine the optimal concomitant antithrombotic strategy.

Background: Visual confirmation of radiofrequency ablation (RFA) lesions during clinical cardiac ablation procedures could improve procedure efficacy, safety, and efficiency. It was previously shown that acoustic radiation force impulse (ARFI) imaging can identify RFA lesions in vitro and in vivo in an animal model. This is the “first-in-human” feasibility demonstration of intracardiac ARFI imaging of RFA lesions in patients undergoing catheter ablation for atrial flutter (AFL) or atrial fibrillation (AF). Methods and Results:Patients scheduled for right atrial (RA) ablation for AFL or left atrial (LA) ablation for drug refractory AF were eligible for imaging. Diastole-gated intracardiac ARFI images were acquired usingoneoftwoequipmentconfigurations:(1)aSiemensACUSONS2000 TM ultrasoundscannerand8/10Fr AcuNav TM ultrasound catheter, or (2) a CARTO 3 TM integrated Siemens SC2000 TM and 10Fr SoundStar TM ultrasound catheter. A total of 11 patients (AFL = 3; AF = 8) were imaged. ARFI images were acquired of ablation target regions, including the RA cavotricuspid isthmus (CTI), and the LA roof, pulmonary vein ostia, posterior wall, posterior mitral valve annulus, and the ridge between the pulmonary vein and LA appendage. ARFI images revealed increased relative myocardial stiffness at ablation catheter contact sites after RFA and at anatomical mapping-tagged RFA treatment sites. Conclusions: ARFI images from a pilot group of patients undergoing catheter ablation for AFL and AF demonstrate the ability of this technique to identify intra-procedure RFA lesion formation. The results encourage further refinement of ARFI imaging clinical tools and continued investigation in larger clinical trials. (J Cardiovasc Electrophysiol, Vol. pp. 1-9)

Importance Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. Objective To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF. Design, Setting, and Participants The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017. Interventions The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. Main Outcomes and Measures The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence. Results Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2% (n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15];P = .30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21];P = .38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93];P = .001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60];P Conclusions and Relevance Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. Trial Registration ClinicalTrials.gov Identifier:NCT00911508

Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain.To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF.An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017.Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096).Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.3 points).Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P .001).Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation.ClinicalTrials.gov Identifier: NCT00911508.

Dabigatran is approved for prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (AF). The safety and effectiveness of periprocedural dabigatran in ablation for AF are unknown. We performed a meta-analysis of all studies comparing periprocedural dabigatran with warfarin for anticoagulation in AF ablation. Studies of >100 patients with post-procedure follow-up were included. Outcomes were compared by calculating maximum likelihood estimates with confidence intervals. The co-primary endpoints were neurological events and major bleeding. Ten cohort studies were included, including a total of 1,501 patients receiving dabigatran and 2,356 receiving warfarin. The mean age was 59–64 years and inclusion of women varied (10–33 %). Intra-procedural unfractionated heparin and irrigated ablation catheters were used routinely. Adverse events were low overall; however, the dabigatran group demonstrated a numerical excess of neurological events (10/1,501 [0.7 %] versus 4/2,356 [0.2 %]), but equivalent major bleeding outcomes (24/1,501 [1.6 %] versus 40/2,356 [1.7 %]). In the meta-analysis, there was a nonsignificant trend towards higher rates of the composite primary endpoints (any neurological event or major bleeding) in the dabigatran group. Dabigatran demonstrated a significantly higher rate of neurological events (estimated absolute risk difference 0.0047, 95 % confidence interval 0.0007 to 0.0099). Compared with warfarin, dabigatran may be associated with a higher frequency of periprocedural neurological events following radiofrequency ablation of AF. Randomized clinical trials are needed to definitively assess the safety and efficacy of novel oral anticoagulant use for periprocedural anticoagulation for ablation of AF.

Despite advances in ablation technology, many patients experience recurrent atrial fibrillation (AF) after radiofrequency ablation. Although estimates vary, the overall 1-year drug-free success for AF ablation is estimated at 40% to 60% for a single procedure and 70% for multiple procedures.1 The cornerstone of conventional AF ablation is pulmonary vein isolation (PVI), and in clinical practice, the most common PVI technique involves creating circular radiofrequency lesions in a point-by-point fashion around the PV ostia/antra.2 However, conventional radiofrequency ablation can be difficult and time-consuming, has less than outstanding efficacy, and can be associated with potentially serious complications, such as steam pops, perforation, tamponade, and thrombus formation, which can lead to thromboembolic events. Given the limitations of conventional radiofrequency ablation, there has been ongoing development of new technologies to facilitate the safety and efficacy of lesion formation and durability. This review will summarize several recent advancements in catheter technology for AF ablation aimed at improving lesion formation (Figure 1). Figure 1. Summary of recent innovations in lesion formation. In radiofrequency ablation, the contact force (CF) between the ablation electrode and the atrial wall is a major determinant of lesion size and durability.3,4 Insufficient CF can result in inadequate lesion formation and higher rates of PV reconnection.5 However, excessive CF can result in complications, such as perforation.6 Therefore, monitoring CF would be expected to maximize ablation efficacy and improve safety. Until recent years, CF has been monitored indirectly using a combination of visual observation of catheter tip motion, tactile feedback, local electrogram attenuation, impedance monitoring, and in some laboratories, intracardiac echocardiogaphy. Although widely used, these methods are a poor surrogate for CF.4,7,8 Recently, ablation catheters that can directly measure CF have become available in the United States. A spring-coupled catheter (SmartTouch) was …

Surgical or modified Maze procedures have been promoted to treat atrial fibrillation (AF); however, few randomized controlled clinical trials (RCTs) examine their outcomes. The purpose of this meta-analysis is to compare the efficacy of surgical Maze procedures performed concomitantly with referral cardiac surgery versus pharmacologic therapy for the treatment of AF. We searched MEDLINE, Cochrane database, FDA web-portal, and clinicaltrials.gov for all RCTs comparing surgical Maze procedures with medical therapy for sinus rhythm maintenance. Primary outcomes were either freedom from AF within 12 months postprocedure off antiarrhythmic drug (AAD), or freedom from AF while taking an AAD. Secondary outcomes included operative mortality, all-cause mortality, hospital length of stay, and postoperative complications. Both fixed- and random-effects models were used for a meta-analysis of 9 randomized controlled trials (n = 472, of which 249 underwent a Maze procedure and 213 underwent referral surgery alone). The surgical Maze procedure significantly increased the odds of freedom from AF within 12 months compared with cardiac surgery alone (OR 5.22, 95% CI 1.71-15.88). There was significant heterogeneity among the trials for freedom from AF (chi-square = 15.98 for 4 degrees of freedom, P= 0.003). Among the two studies that fully reported AAD use, there was no evidence of improved survival free from AF and AAD therapy (OR 1.78, 95% CI 0.73-4.34). Among patients with valvular AF, surgical Maze procedures are associated with a decrease in AF one year postprocedure without significant increase in mean length of hospital stay, perioperative complications, operative, or all-cause mortality. Large RCTs defining rates of freedom from AF without AADs postprocedure, are still needed to evaluate outcomes and determine the appropriate role for surgical Maze procedures in the management of AF.

Esophageal injury is a rare but serious complication of catheter ablation for atrial fibrillation using radiofrequency energy. Recent studies have begun to identify variables that may determine heat transfer to and thermal injury of the esophagus. There is significant variability in the relationship between the esophagus and left atrium among individuals. New imaging techniques can facilitate assessment of esophagus position relative to intended ablation targets. Strategies to minimize the risk of esophageal injury include avoidance of ablation near the esophagus, titration of RF energy delivery at the posterior left atrial endocardium, and the use of alternative ablation methods.

Introduction: Left atrial radiofrequency catheter ablation (RFA) is gaining acceptance as treatment for drug-refractory atrial fibrillation (AF). This therapy has been associated with esophageal injury and atrioesophageal fistula formation causing death. Methods: We describe 3 patients undergoing catheter ablation for AF during real-time monitoring of luminal esophageal temperature. Results: We observed heating of the esophagus during short duration low power RFA, at either the left or right pulmonary vein ostia. Cryoablation at the pulmonary vein ostium in one patient resulted in esophageal cooling. Furthermore, we observed that fluoroscopic localization of the ablation catheter at a site apparently distant from the esophagus is not adequate to assure avoidance of ablation-induced esophageal heating. Conclusions: Real-time monitoring of luminal esophageal position and temperature is feasible, enhances recognition of esophageal heating, and may add useful information beyond that provided by fluoroscopic assessment of esophageal position. There is a potential role for esophageal monitoring to help avoid thermal injury to the esophagus during catheter ablation for atrial fibrillation.

Warfarin is underused for stroke prevention in atrial fibrillation (AF). Previous studies addressing this have lacked longitudinal assessment. This study sought to characterize contemporary warfarin use in new-onset AF and evaluate its change over time. It was hypothesized that AF recurrence has an important influence on warfarin use patterns. One thousand five adults from 17 centers in the United States and Canada were enrolled into a prospective observational registry after their first documented episodes of AF. Detailed demographic, clinical history, and management data were collected on all subjects at enrollment, including medication use. Patients were followed at regular intervals for interim events and changes in AF management. Warfarin use at baseline and last follow-up (mean 25 +/- 8 months) after enrollment was modeled using multivariate analysis. Initially, 65% of subjects were prescribed warfarin, but only 44% were taking it at 30 months. Even in "ideal" candidates for warfarin, the rate of warfarin prescription decreased from 70% at baseline to 50% at 30 months. Stroke risk factors, including hypertension, congestive heart failure, valvular heart disease, and previous stroke or transient ischemic attack were significant predictors of warfarin prescription at baseline. At last follow-up, the relation between AF recurrence and warfarin use (odds ratio 2.3, 95% confidence interval 1.6 to 3.1) was stronger than that for any individual stroke risk factor. In conclusion, predictors of warfarin use in patients with AF include AF recurrence and selected stroke risk factors. The discontinuation of warfarin in a large number of patients with AF over time is a cause for concern in light of data from recent clinical trials.

Rationale and objectivesGeometric analysis of the left atrium and pulmonary veins is important for assessing reverse structural remodeling following cardiac ablation therapy. Most volumetric analysis techniques, however, require laborious manual tracing of image cross-sections. Pulmonary vein diameters are typically measured at the junction between the left atrium and pulmonary veins, called the pulmonary vein ostia, with manually drawn lines on volume renderings or in image slices. In this work, we describe a technique for making semi-automatic measurements of left atrial volume and pulmonary vein diameters from high resolution CT scans and demonstrate its use for analyzing reverse structural remodeling following cardiac ablation therapy. MethodsThe left atrium and pulmonary veins are segmented from high-resolution computed tomography (CT) volumes using a 3D volumetric approach and cut planes are interactively positioned to separate the pulmonary veins from the body of the left atrium. Left atrial volume and pulmonary vein ostial diameters are then automatically computed from the segmented structures. Validation experiments are conducted to evaluate accuracy and repeatability of the measurements. Accuracy is assessed by comparing left atrial volumes computed with the proposed methodology to a manual slice-by-slice tracing approach. Repeatability is assessed by making repeated volume and diameter measurements on duplicated and randomized datasets. The proposed techniques were then utilized in a study of 21 patients from the Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA) pilot study who were scanned both before and approximately 3 months following ablation therapy. ResultsIn the high resolution CT scans the left atrial volume measurements show high accuracy with a mean absolute difference of 2.3?1.9cm3 between volumes computed with the proposed methodology and a manual slice-by-slice tracing approach. In the intra-rater repeatability study, the mean absolute difference in left atrial volume was 4.7?2.5cm3 and 4.4?3.4cm3 for the two raters. Intra-rater repeatability for pulmonary vein diameters ranged from 0.9 to 2.3mm. The inter-rater repeatability for left atrial volume was 5.8?5.1cm3 and inter-rater repeatability for pulmonary vein diameter measurements ranged from 1.4 to 2.3mm. In the patient study, significant (p

Objectives The purpose of this study was to correlate patient-reported symptoms of atrial fibrillation with the underlying rhythm. Background The reliability of patient-reported symptoms as a marker of atrial fibrillation recurrence has not been well studied. Methods This prospective multicenter trial correlated the recurrence of atrial tachyarrhythmias with symptoms in patients with a history of atrial fibrillation and a standard indication for permanent pacing. Pacemaker-detected atrial tachyarrhythmia events were correlated with symptoms. Patients logged symptomatic events into the device's memory via an external manual activator. Patients were followed for 12 months and were contacted weekly to ensure compliance with activator usage. Episodes were classified as symptomatic atrial tachyarrhythmia, asymptomatic atrial tachyarrhythmia, or symptomatic nonatrial tachyarrhythmia depending on concordance between patient symptoms and the rhythm. Results Forty-eight patients underwent implantation of a DDDRP pacemaker and were followed for 12 ± 2 months. A median of 25.0 (4.0–55.8) symptomatic events attributed to atrial fibrillation. A median of 1.0 (0.0–10.0) symptomatic atrial tachyarrhythmia episodes were documented during follow-up. Symptoms related to atrial fibrillation were reported in 6% of atrial tachyarrhythmia episodes identified by the pacemaker. The probability that symptoms were associated with an atrial tachyarrhythmia (positive predictive value) was 17%. The ventricular rate between symptomatic and asymptomatic atrial tachyarrhythmia events was not significantly different. Conclusions Among patients with symptomatic bradycardia and a history of atrial fibrillation, symptoms of atrial fibrillation often were not associated with documented atrial tachyarrhythmias, and more than 90% of atrial tachyarrhythmias were clinically silent.

ObjectivesThe aim of this study was to evaluate tecadenoson safety and efficacy during conversion of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm.BackgroundTecadenoson (CVT-510), a novel adenosine receptor (Ado R) agonist, selectively activates the A1Ado R and prolongs atrioventricular (AV) nodal conduction at doses lower than those required to cause A2Ado R-mediated coronary and peripheral vasodilation. Unlike adenosine, which non-selectively activates all four Ado R subtypes and produces unwanted effects, tecadenoson appears to terminate AV node-dependent supraventricular tachycardias without hypotension and bronchoconstriction.MethodsIn this open-label, multicenter, dose escalation study, tecadenoson was administered to 37 patients (AV node re-entrant tachycardia, n = 29; AV re-entrant tachycardia, n = 8) with inducible PSVT sustained for ≥1 min during an electrophysiology study. Seven regimens (0.3 to 15 μg/kg) of up to two identical tecadenoson intravenous bolus doses were administered.ResultsAfter the first or second bolus, PSVT converted to sustained sinus rhythm for ≥5 min in 86.5% (32/37) of the patients, with 91% (29/32) of the conversions occurring after the first bolus (most within 30 s), coincident with anterograde conduction block in the AV node. No effects on sinus cycle length (SCL) or systolic blood pressure were observed. The atrial-His (AH), but not the His-ventricular (HV) interval was prolonged up to 5 min after the final tecadenoson bolus, returning to baseline by 10 min. Tecadenoson was generally well tolerated.ConclusionsIn this study, tecadenoson rapidly terminated sustained PSVT by depressing AV nodal conduction without causing hypotension. After sinus rhythm restoration, there was minimal AH interval prolongation without HV interval or SCL prolongation.