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Aims: Influence of atrial fibrillation (AF) type on outcomes seen with catheter ablation vs. drug therapy is incompletely understood. This study assesses the impact of AF type on treatment outcomes in the Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)., Methods and Results: CABANA randomized 2204 patients ≥65 years old or <65 with at least one risk factor for stroke to catheter ablation or drug therapy. Of these, 946 (42.9%) had paroxysmal AF (PAF), 1042 (47.3%) had persistent AF (PersAF), and 215 (9.8%) had long-standing persistent AF (LSPAF) at baseline. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Symptoms were measured with the Mayo AF-Specific Symptom Inventory (MAFSI), and quality of life was measured with the Atrial Fibrillation Effect on Quality of Life (AFEQT). Comparisons are reported by intention to treat. Compared with drug therapy alone, catheter ablation produced a 19% relative risk reduction in the primary endpoint for PAF {adjusted hazard ratio [aHR]: 0.81 [95% confidence interval (CI): 0.50, 1.30]}, and a 17% relative reduction for PersAF (aHR: 0.83, 95% CI: 0.56, 1.22). For LSPAF, the ablation relative effect was a 7% reduction (aHR: 0.93, 95% CI: 0.36, 2.44). Ablation was more effective than drug therapy at reducing first AF recurrence in all AF types: by 51% for PAF (aHR: 0.49, 95% CI: 0.39, 0.62), by 47% for PersAF (aHR: 0.53, 95% CI: 0.43,0.65), and by 36% for LSPAF (aHR 0.64, 95% CI 0.41,1.00). Ablation was associated with greater improvement in symptoms, with the mean difference between groups in the MAFSI frequency score favouring ablation over 5 years of follow-up in all subgroups: PAF had a clinically significant -1.9-point difference (95% CI: -1.2 to -2.6); PersAF a -0.9 difference (95% CI: -0.2 to -1.6); LSPAF a clinically significant difference of -1.6 points (95% CI: -0.1 to -3.1). Ablation was also associated with greater improvement in quality of life in all subgroups, with the AFEQT overall score in PAF patients showing a clinically significant 5.3-point improvement (95% CI: 3.3 to 7.3) over drug therapy alone over 5 years of follow-up, PersAF a 1.7-point difference (95% CI: 0.0 to 3.7), and LSPAF a 3.1-point difference (95% CI: -1.6 to 7.8)., Conclusion: Prognostic treatment effects of catheter ablation compared with drug therapy on the primary and major secondary clinical endpoints did not differ consequentially by AF subtype. With regard to decreases in AF recurrence and improving quality of life, ablation was more effective than drug therapy in all three AF type subgroups., Clinicaltrials.gov Identifier: NCT00911508., Competing Interests: Conflict of interest: K.H.M. reports grants from the NIH/NHLBI, St. Jude Foundation and Corporation, Biosense Webster, Inc., Medtronic, Inc., and Boston Scientific Corp., during the conduct of the study; consulting without compensation from Biosense Webster, Inc.; and personal fees from Thermedical outside the submitted work. T.J.B. reports research grants from Boston Scientific, Altathera, Boehringer Ingelheim, no personal compensation received. D.B.M. reports grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study; grants from Merck and HeartFlow; and personal fees from Novartis outside the submitted work. J.E.P. reports research grants paid directly to the University of Washington from Biotonik, Kestra Medical and AtriCure. T.D.B. reports grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study; grants from St. Jude Medical, Inc, Abbott Medical, Biosense Webster Inc, Johnson & Johnson, and Boston Scientific Corp and consulting from Cardiofocus, Inc, outside of the submitted work. H.R.A.-K. reports grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study. A.P.S. and M.R.D. report no disclosures during the conduct of the study. K.L.L. reports grants from the NIH/NHLBI and Mayo Clinic, as well as Data and Safety Monitoring Board service on studies funded by Astra-Zeneca, Medtronic, Merck, Amgen, and the Cardiovascular Research Foundation during the conduct of the study. D.L P. in the past 12 months has provided consulting services for Abbott, AtriFix, Biosense Webster, Inc., Cardio Syntax, EBAmed, Johnson & Johnson, MediaSphere Medical, LLC, MedLumics, Medtronic, NeuCures, St. Jude Medical, Siemens, Spectrum Dynamics, Centrix, Thermedical, and Xenter, Inc. D.L.P. received no personal compensation for these consulting activities, unless noted. D.L.P. receives research funding from Abbott, Biosense Webster, Boston Scientific/EPT, CardioInsight, EBAmed, Medtronic, Inc., NeuCures, Siemens, St. Jude Medical, Inc, Thermedical, Inc., NIH, Robertson Foundation, Vital Project Funds, Inc., Xenter, Inc., Mr. and Mrs. J. Michael Cook/Fund. Mayo Clinic and D.L.P. have a financial interest in Analyze-AVW technology that may have been used to analyze some of the heart images in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to commercial entities, and both Mayo Clinic and D.L.P. have received royalties greater than $10 000, the federal threshold for significant financial interest. In addition, Mayo Clinic holds an equity position in the company to which the AVW technology has been licensed. D.L.P. and Mayo Clinic jointly have equity in a privately held company, EBAmed. Royalties from Wiley & Sons, Oxford, and St. Jude Medical. D.L.P. has a licensing agreement with the American Heart Association for the Mayo AF Symptom Inventory (MAFSI) Survey and has contractual rights to receive future royalties under this license., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Purpose: Both warfarin and non-vitamin K antagonist oral anticoagulants (NOACs) have pleiotropic effects including anti-inflammatory and anti-fibrotic properties. This study aims to explore whether arrhythmia recurrence after AF ablation is influenced by the choice of oral anticoagulant., Methods: We retrospectively studied all patients who underwent primary AF ablation between 2011 and 2017 and divided them into two groups according to the anticoagulant used: Warfarin vs. NOACs. The primary endpoint was atrial tachyarrhythmia recurrence after ablation., Results: Of the 1106 patients who underwent AF ablation in the study period (median age 62.5 years; 71.5% males, 48.2% persistent AF), 697 (63%) received warfarin and 409 (37%) received NOACs. After a median of 26.4 months follow-up, arrhythmia recurrence was noted in 368 patients in warfarin group and 173 patients in NOACs group, with a 1-year recurrence probability of 35% vs. 36% (log rank P = 0.81) and 5-year recurrence probability of 62% vs. 63% (Log rank P = 0.32). However, NOACs use was associated with a higher probability of recurrence (46% for 1 year, 68% for 5 years) in patients with persistent AF compared with those taking warfarin (34% for 1 year, 63% for 5 years; log rank P = 0.01 and P = 0.02 respectively). Multivariate analysis indicated that in patients with persistent AF, use of NOACs was an independent risk factor of atrial tachyarrhythmia recurrence after ablation (HR 1.39, 95% CI 1.07-1.81, P = 0.013)., Conclusion: In this large contemporary cohort, overall AF recurrence after ablation was similar with NOACs or warfarin use. However, in patients with persistent AF, NOACs use was associated with a higher probability of arrhythmia recurrence and was an independent risk factor of recurrence at long-term follow-up., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

Background: In the CABANA trial (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation), catheter ablation did not significantly reduce the primary end point of death, disabling stroke, serious bleeding, or cardiac arrest compared with drug therapy by intention-to-treat, but did improve the quality of life and freedom from atrial fibrillation recurrence. In the heart failure subgroup, ablation improved both survival and quality of life. Cost-effectiveness was a prespecified CABANA secondary end point., Methods: Medical resource use data were collected for all CABANA patients (N=2204). Costs for hospital-based care were assigned using prospectively collected bills from US patients (n=1171); physician and medication costs were assigned using the Medicare Fee Schedule and National Average Drug Acquisition Costs, respectively. Extrapolated life expectancies were estimated using age-based survival models. Quality-of-life adjustments were based on EQ-5D-based utilities measured during the trial. The primary outcome was the incremental cost-effectiveness ratio, comparing ablation with drug therapy on the basis of intention-to-treat, and assessed from the US health care sector perspective., Results: Costs in the first 3 months averaged $20 794±SD 1069 higher with ablation compared with drug therapy. The cumulative within-trial 5-year cost difference was $19 245 (95% CI, $11 360-$27 170) and the lifetime mean cost difference was $15 516 (95% CI, -$2963 to $35,512) higher with ablation than with drug therapy. The drug therapy arm accrued an average of 12.5 life-years (LYs) and 10.7 quality-adjusted life-years (QALYs). For the ablation arm, the corresponding estimates were 12.6 LYs and 11.0 QALYs. The incremental cost-effectiveness ratio was $57 893 per QALY gained, with 75% of bootstrap replications yielding an incremental cost-effectiveness ratio < $100 000 per QALY gained. With no quality-of-life/utility adjustments, the incremental cost-effectiveness ratio was $183 318 per LY gained., Conclusions: Catheter ablation of atrial fibrillation was economically attractive compared with drug therapy in the CABANA Trial overall at present benchmarks for health care value in the United States on the basis of projected incremental QALYs but not LYs alone.

Background: Observational data suggest that catheter ablation may be safe and effective to treat younger and older patients with atrial fibrillation. No large, randomized trial has examined this issue. This report describes outcomes according to age at entry in the CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation)., Methods: Patients with atrial fibrillation ≥65 years of age, or <65 with ≥1 risk factor for stroke, were randomly assigned to catheter ablation versus drug therapy. The primary outcome was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Secondary outcomes included all-cause mortality, the composite of mortality or cardiovascular hospitalization, and recurrence of atrial fibrillation. Treatment effect estimates were adjusted for baseline covariables using proportional hazards regression models., Results: Of 2204 patients randomly assigned in CABANA, 766 (34.8%) were <65 years of age, 1130 (51.3%) were 65 to 74 years of age, and 308 (14.0%) were ≥75 years of age. Catheter ablation was associated with a 43% reduction in the primary outcome for patients <65 years of age (adjusted hazard ratio [aHR], 0.57 [95% CI, 0.30-1.09]), a 21% reduction for 65 to 74 years of age (aHR, 0.79 [95% CI, 0.54-1.16]), and an indeterminate effect for age ≥75 years of age (aHR, 1.39 [95% CI, 0.75-2.58]). Four-year event rates for ablation versus drug therapy across age groups, respectively, were 3.2% versus 7.8%, 7.8% versus 9.6%, and 14.8% versus 9.0%. For every 10-year increase in age, the primary outcome aHR increased (ie, less favorable to ablation) an average of 27% (interaction P value=0.215). A similar pattern was seen with all-cause mortality: for every 10-year increase in age, the aHR increased an average of 46% (interaction P value=0.111). Atrial fibrillation recurrence rates were lower with ablation than with drug therapy across age subgroups (aHR 0.47, 0.58, and 0.49, respectively). Treatment-related complications were infrequent for both arms (<3%) regardless of age., Conclusions: We found age-based variations in clinical outcomes for catheter ablation compared with drug therapy, with the largest relative and absolute benefits of catheter ablation in younger patients. No prognostic benefits for ablation were seen in the oldest patients. No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT00911508.

Objectives: This study aimed to compare the efficacy and safety of ablation with high and low power settings using either a flexible tip or straight SF tip irrigated catheter in the left ventricle (LV) using a peripheral microemboli monitoring system., Background: The microemboli risk of flexible and straight SF tip irrigated catheters in creating ablative lesions in the LV at variable power settings has not been adequately assessed., Methods: Six pigs underwent catheter ablation in the LV using a flexible tip or straight SF tip catheter with 2 energy settings (30 or 50 W, 30 seconds, irrigation saline 17 mL/min)., Results: A total of 79 radiofrequency (RF) applications were assessed. High power settings via a flexible tip formed a significantly higher arterial microbubble volume in the extracorporeal circulation (P = 0.005). Notably, RF applications with a steam pop induced an exponential increase of microbubble volume with both catheters. A higher power setting induced a significantly higher number of microembolic signals on carotid artery Doppler ultrasound with a flexible tip irrigated catheter (P < 0.001). Similarly, the straight SF tip irrigated catheter tended to increase the number of microembolic signals with 50 W (P = 0.091)., Conclusions: RF ablation at high power settings in the LV carries a risk of microembolic events compared with lower power settings. When high power settings are used for creating ablative lesions for deep intramural foci in the LV, the risk of microembolic events induced by RF ablation should be carefully monitored., Competing Interests: Funding Support and Author Disclosures Abbott corporation funded this study; however, the Mayo study participants independently organized the design and conduct of the study, without industry interference. Dr Hohmann is funded by the Deutsche Forschungsgemeinschaft (German Research Foundation) (project no. 380200397). Dr Packer in the past 12 months has provided consulting services for Abbott, AtriFix, Biosense Webster, Inc., Cardio Syntax, EBAmed, Johnson & Johnson ($0), MediaSphere Medical, LLC (<$5000), MedLumics, Medtronic, NeuCures, St. Jude Medical, Siemens, Spectrum Dynamics, Centrix, and Thermedical; he receives no personal compensation for these consulting activities, unless noted; has received research funding from the Abbott, Biosense Webster, Boston Scientific/EPT, CardioInsight, EBAmed, German Heart Foundation, Medtronic, NIH, Robertson Foundation, St. Jude Medical, Siemens, Thermedical, Inc., Vital Project Funds, Inc., Mr. and Mrs. J. Michael Cook. Mayo Clinic has a financial interest in Analyze-AVW technology that may have been used to analyze some of the heart images in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to commercial entities, and Mayo Clinic has received royalties >$10,000, the federal threshold for significant financial interest. In addition, Mayo Clinic holds an equity position in the company to which the AVW technology has been licensed. Dr Packer and Mayo Clinic jointly have equity in a privately held company, External Beam Ablation Medical Devices. Royalties from John Wiley & Sons, Oxford, and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Aims: With the implementation of saline-enhanced radiofrequency (SERF) needle-tip ablation, real-time validation of lesion formation is needed for the controllable creation of transmural lesions. The aim of the study was to analyse the ability of two-dimensional intracardiac echocardiography (2D-ICE) to guide and validate SERF ablation in real-time., Methods and Results: Fifty-six SERF energy deliveries at left ventricular sites of 11 dogs guided by 2D-ICE were analysed (power: 15-50 W; time: 25-120 s; irrigation saline: 60°C with 10 mL/min flow rate). Catheter tip/tissue orientation and lesion formation could be well detected by 2D-ICE in 49 (87.5%) energy deliveries. Gross pathology analysis confirmed excellent 2D-ICE lesion localization, the ability to detect transmural lesions (70% sensitivity, 47% specificity) and positive correlation between 2D-ICE and the corresponding gross pathology measurements of 'maximal lesion depth'; (repeated measures correlation: rrm = 0.43, P = 0.012) and 'depth at maximal lesion width' (D@MW; rrm = 0.51, P = 0.003). The median angle between SERF catheter tip and endocardium was 76° [interquartile range (IQR) 58-83°]. The more perpendicular the catheter tip/tissue orientation was the deeper D@MW (rrm = 0.32, P = 0.045). Grade 3 microbubbles on 2D-ICE during ablation, indicating inadequate catheter tip/tissue contact, was associated with smaller lesion volumes than with Grade 1 microbubbles (284.8 mm3 [IQR 151.3-343.1] vs. 2114.1 mm3 [IQR 1437.0-3026.3], P < 0.001)., Conclusion: With excellent lesion localization and a 70% detection rate of transmural lesions, 2D-ICE is well suited to validate SERF ablation lesion formation in real-time. The catheter tip/tissue angle impacts the lesion formation and through perpendicular catheter positioning, deeper intramural areas of the myocardium can be reached., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: Rhythm control strategies for atrial fibrillation (AF), including catheter ablation, are substantially underused in racial/ethnic minorities in North America., Objectives: This study sought to describe outcomes in the CABANA trial as a function of race/ethnicity., Methods: CABANA randomized 2,204 symptomatic participants with AF to ablation or drug therapy including rate and/or rhythm control drugs. Only participants in North America were included in the present analysis, and participants were subgrouped as racial/ethnic minority or nonminority with the use of National Institutes of Health definitions. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest., Results: Of 1,280 participants enrolled in CABANA in North America, 127 (9.9%) were racial and ethnic minorities. Compared with nonminorities, racial and ethnic minorities were younger with median age 65.6 versus 68.5 years, respectively, and had more symptomatic heart failure (37.0% vs 22.0%), hypertension (92.1% vs 76.8%, respectively), and ejection fraction <40% (20.8% vs 7.1%). Racial/ethnic minorities treated with ablation had a 68% relative reduction in the primary endpoint (adjusted hazard ratio [aHR]: 0.32; 95% confidence interval [CI]: 0.13-0.78) and a 72% relative reduction in all-cause mortality (aHR: 0.28; 95% CI: 0.10-0.79). Primary event rates in racial/ethnic minority and nonminority participants were similar in the ablation arm (4-year Kaplan-Meier event rates 12.3% vs 9.9%); however, racial and ethnic minorities randomized to drug therapy had a much higher event rate than nonminority participants (27.4% vs. 9.4%)., Conclusion: Among racial or ethnic minorities enrolled in the North American CABANA cohort, catheter ablation significantly improved major clinical outcomes compared with drug therapy. These benefits, which were not seen in nonminority participants, appear to be due to worse outcomes with drug therapy. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508)., Competing Interests: Funding Support and Author Disclosures This work was supported by the National Institutes of Health (U01HL89709, U01HL089786, U01HL089907, and U01HL089645), St. Jude Medical Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific Corporation. The content of this paper does not necessarily represent the views of the National Heart, Lung, and Blood Institute or the Department of Health and Human Services. Dr. Thomas has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health), Patient-Centered Outcomes Research Institute, and American Heart Association; and has received consulting fees from Sanofi, Boehringer Ingelheim, Janssen, Bristol Myers Squibb, and Medtronic during the conduct of the study. Dr. Al-Khalidi has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health) and the Mayo Clinic during the conduct of the study. Dr. Monahan has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health), St. Jude Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific during the conduct of the study; has consulted without compensation from Biosense Webster; and has received personal fees from Thermedical outside the submitted work. Dr. Bahnson has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health) and the Mayo Clinic for conduct of the study; has received grants from Boston Scientific, St. Jude Medical Corporation, Biosense Webster, and Medtronic; and has received compensation for consulting from Cardiofocus and Ventrix during the conduct of the study but outside of the submitted work. Dr. Poole has received grants from ATriCure outside the submitted work. Dr. Mark has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health), the Mayo Clinic during the conduct of the study; and has received grants from Merck and HeartFlow outside the submitted work. Dr. Packer in the past 12 months has provided consulting services for Biosense Webster, Inc., Boston Scientific, CyberHeart, Medtronic, Inc., nContact, Sanofi, St. Jude Medical, and Toray Industries but has received no personal compensation for these consulting activities; has received grants from Abbott, Biosense Webster, Boston Scientific, CardioFocus, Medtronic, St. Jude Medical, CardioInsight, National Institutes of Health, Siemens, Thermedical, Endosense, Robertson Foundation, and Hansen Medical; has served on the advisory board without compensation for Abbott, Biosense Webster, Boston Scientific, CardioFocus, Medtronic, St. Jude Medical, Spectrum Dynamics, Siemens, Thermedical, Johnson & Johnson, and SigNum Preemptive Healthcare; has received speaking fees and honoraria from Biotronik and MediaSphere Medical; has received royalties from Wiley & Sons, Oxford, and St. Jude Medical; has joint equity with the Mayo Clinic in a privately held company, External Beam Ablation Medical Devices, outside the submitted work; and has received research funding from the NIH, Medtronic, Inc., Cryo Cath, Siemens AG, EP Limited, Minnesota Partnership for Biotechnology and Medical Genomics/University of Minnesota, Biosense Webster, Inc., and Boston Scientific. Mayo Clinic and Drs. Packer and Robb have a financial interest in mapping technology that may have been used at some of the 10 centers participating in this pilot research; in accordance with the Bayh-Dole Act, this technology has been licensed to St. Jude Medical, and Mayo Clinic and Drs. Packer and Robb received annual royalties >$10,000, the federal threshold for significant financial interest. Dr. Silverstein has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

[Figure: see text].

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 <65 years old with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate or rhythm control drugs. Of these, 778 (35%) had New York Heart Association class >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 <40%, whereas 11.7% had ejection fractions between 40% and 50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite end point (hazard ratio, 0.64 [95% CI, 0.41-0.99]) and a 43% relative reduction in all-cause mortality (hazard ratio, 0.57 [95% CI, 0.33-0.96]) compared with drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (hazard ratio, 0.56 [95% CI, 0.42-0.74]). The adjusted mean difference for the AFEQT (Atrial Fibrillation Effect on Quality of Life) summary score averaged over the entire 60-month follow-up was 5.0 points, favoring the ablation arm (95% CI, 2.5-7.4 points), and the MAFSI (Mayo Atrial Fibrillation-Specific Symptom Inventory) frequency score difference was -2.0 points, favoring ablation (95% CI, -2.9 to -1.2)., 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.

Background: Pulmonary vein isolation (PVI) with autonomic modulation may be more successful than PVI alone for atrial fibrillation (AF) ablation and may be signaled by changes in sinus rhythm heart rate (HR) post ablation. We sought to determine if a change in sinus rhythm HR predicted AF recurrence post PVI., Methods: Patients who underwent AF ablation from 2000 to 2011 were included if sinus rhythm was noted on ECG within 90 days pre and 7 days post ablation. Basic ECG interval and HR changes were analyzed and outcomes determined., Results: A total of 1152 patients were identified (74.3% male, mean age 57 ± 11 years). Mean AF duration was 5.2 ± 5.3 years. Paroxysmal AF was noted in 712 (61.8%) of the patients. Mean EF was 61% ± 6%. Sinus rhythm HR was 61 ± 11 pre-ablation and 76 ± 13 bpm post-ablation (27% ± 24% increase, p < .001). The ability of relative HR change post-ablation to predict AF recurrence was borderline (hazard ratio 0.65 [0.41-1.01], p = .067). With patients separated into quartiles based on the relative HR change, the upper quartile with the largest relative increase in HR had a significantly lower rate of AF recurrence compared to the lowest quartile following multi variable modeling (p = .038). There were significant changes in PR (171 ± 28 to 167 ± 30 ms) and QTc (424 ± 25 to 434 ± 29 ms) intervals (both p < .001) but these were not predictive of outcome., Conclusion: Relative changes in HR post AF ablation correlates with AF recurrence. Further prospective studies are needed to confirm this relationship., (© 2021 Wiley Periodicals LLC.)

Background: Irrigated needle catheter ablation is efficacious for creation of transmural lesions in the left ventricle (LV). However, interdependence of needle orientation and myocardial fiber orientation and the resulting influence on lesion creation remain unclear., Objective: The purpose of this study was to investigate the impact of myocardial fiber orientation on reproducibility and controllability of lesion creation in LV myocardium using a heated saline-enhanced radiofrequency (SERF) needle-tip catheter system., Methods: Eleven dogs underwent catheter ablation using this novel catheter. Ablative lesions were created using different power and ablation times (15-50 W; application 25-120 seconds; 60°C irrigation saline at 10 mL/min). Hearts were explanted, and lesions were evaluated using 3-T cardiac magnetic resonance (CMR), gross pathologic, and histologic investigations., Results: Forty-three of 57 lesions (75.4%) were transmural, and lesion depth reached approximately 90% of LV wall thickness. Lesion volume in both gross pathology and ex vivo CMR showed a positive linear correlation with power × radiofrequency (RF) time index (r = 0.637, P <.001; and r = 0.786, P <.001, respectively). Maximum width (circumferential direction of LV) and maximum length (long-axis direction) of all lesions were distributed in the middle layer of LV where myocardium runs circumferentially. Paired-sample t-test showed maximum lesion width was significantly greater than maximum lesion length by both CMR and gross pathologic evaluation (26.1 ± 9.6 mm vs 17.2 ± 6.7 mm, P <.001; and 22.5 ± 7.7 mm vs 18.6 ± 5.9 mm, P <.001, respectively)., Conclusion: This catheter showed feasibility in creating transmural LV lesions. Power × RF time index was strongly correlated with lesion volume and predicted lesion size. More importantly, SERF lesions extended along the myocardial fiber orientation., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

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 <65 years with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents. The primary composite outcome was death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence., 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 <0.0001 for all). Women were less likely to have ancillary (nonpulmonary vein) ablation procedures performed during the index procedure (55.7% versus 62.2% in men, 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: Inability to eliminate intramural arrhythmogenic substrate may lead to recurrent ventricular tachycardia after catheter ablation. The aim of the present study was to evaluate intramural and full thickness lesion formation using a heated saline-enhanced radiofrequency (SERF) needle-tip catheter, compared with a conventional ablation catheter in normal and infarcted myocardium., Methods: Twenty-two adult mongrel dogs (30-40 kg, 15 normal and 7 myocardial infarct group) were studied. Lesions were created using the SERF catheter (40 W/50 °C) or a standard contact force (CF) catheter in both groups., Results: Comparing SERF to CF ablation, the SERF catheter produced larger lesion volumes than the standard CF catheter-even with >20 g of CF-in both normal (983.1±905.8 versus 461.9±178.3 mm 3 ; P =0.023) and infarcted left ventricular myocardium (1052.3±543.0 versus 340.3±160.5 mm 3 ; P =0.001). SERF catheter lesions were more often transmural than standard CF lesions with >20 g of CF in both groups (59.1% versus 7.7%; P <0.001 and 60.0% versus 12.5%; P =0.017, respectively). Using the SERF catheter, mean depth of ablated lesions reached 90% of the left ventricular wall in both normal and infarcted myocardium., Conclusions: The SERF catheter created more transmural and larger ablative lesions in both normal and infarcted canine myocardium. SERF ablation is a promising new approach for endocardial intramural and full thickness ablation of ventricular tachycardia substrate that is not accessible with current techniques.

Background: Scar-related ventricular arrhythmias are common after myocardial infarction. Catheter ablation can improve prognosis, but the procedure is invasive and results are not always satisfactory. Noninvasive, catheter-free ablation using ionizing radiation has recently gained interest among electrophysiologists, but the tissue effects and physiological outcome have not been fully characterized., Objective: The purpose of this study was to investigate the structural effects of cardiac scanned pencil beam proton therapy on infarct scar, the time course of imaging biomarkers, arrhythmias, and cardiac function in a porcine model., Methods: Fourteen infarcted swine underwent proton beam treatment of the scar (40 or 30 Gy) and were followed for up to 30 weeks. Magnetic resonance imaging was performed every 4 weeks., Results: Treated scar areas showed a significantly lower fraction of surviving myocytes at 30 weeks compared to untreated scar (30.1% ± 18.5% and 59.9% ± 10.1% in treated and untreated infarct, respectively), indicating scar homogenization. Four animals died suddenly during follow-up, all from documented monomorphic ventricular tachycardia. Cardiac function remained stable over the course of the study. Distinct imaging morphologies corresponded to certain tissue dose ranges and time points., Conclusion: Radioablation of cardiac infarct scar leads to significant homogenization of the scar, replicating the histologic effects of radiofrequency ablation. These changes correspond to distinct imaging morphologies on delayed contrast-enhanced cardiac magnetic resonance imaging, enabling noninvasive confirmation of tissue ablation effects The present study is the first to thoroughly investigate the structural effects of cardiac proton beam therapy in infarcted myocardium., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The cryoballoon (CB) catheter is an established tool for pulmonary vein isolation (PVI), but its use is limited for that purpose., Objective: The purpose of this study was to investigate the biophysical properties of a newly developed linear cryoablation catheter for creation of linear ablation lesions in an in vivo model., Methods: Twenty-nine dogs (14 acutely ablated, 15 chronically followed) underwent cryoablation using the linear cryoablation catheter. Regions of interest included the cavotricuspid isthmus (CTI), mitral isthmus (MI), left atrial (LA) roof, and LA posterior wall in an acute study. Cryoablations for CTI and MI were performed in 14 atrial fibrillation animals after PVI and followed over 1 month in the chronic study. Tissue temperature during cryoablation was monitored using implanted thermocouples in the regions of interest. Gross and microscopic pathologic characteristics of the lesions were assessed., Results: In acute animals, lesion length (transmurality) was CTI 34 ± 4 mm (89% ± 11%); MI 29 ± 4 mm (90% ± 13%); LA roof 19 ± 3 mm (90% ± 8%); and LA posterior wall 19 ± 2 mm (81% ± 13%), with 1 or 2 freezes. Chronic bidirectional block was achieved in 13 of 14 CTI (93%) and 10 of 14 MI (71%) ablations after 1-month follow-up and was consistent with lesion continuity and transmurality upon pathology. The lowest tissue temperature correlated well with the closest distance to the linear cryocatheter (r = 0.688; P <.001)., Conclusion: This linear cryocatheter created continuous and transmural linear lesions with "single-shot" cryoenergy application and has the potential for clinical use in the setting of various arrhythmias., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Proton beam therapy offers radiophysical properties that are appealing for noninvasive arrhythmia elimination. This study was conducted to use scanned proton beams for ablation of cardiac tissue, investigate electrophysiological outcomes, and characterize the process of lesion formation in a porcine model using particle therapy., Methods: Twenty-five animals received scanned proton beam irradiation. ECG-gated computed tomography scans were acquired at end-expiration breath hold. Structures (atrioventricular junction or left ventricular myocardium) and organs at risk were contoured. Doses of 30, 40, and 55 Gy were delivered during expiration to the atrioventricular junction (n=5) and left ventricular myocardium (n=20) of intact animals., Results: In this study, procedural success was tracked by pacemaker interrogation in the atrioventricular junction group, time-course magnetic resonance imaging in the left ventricular group, and correlation of lesion outcomes displayed in gross and microscopic pathology. Protein extraction (active caspase-3) was performed to investigate tissue apoptosis. Doses of 40 and 55 Gy caused slowing and interruption of cardiac impulse propagation at the atrioventricular junction. In 40 left ventricular irradiated targets, all lesions were identified on magnetic resonance after 12 weeks, being consistent with outcomes from gross pathology. In the majority of cases, lesion size plateaued between 12 and 16 weeks. Active caspase-3 was seen in lesions 12 and 16 weeks after irradiation but not after 20 weeks., Conclusions: Scanned proton beams can be used as a tool for catheter-free ablation, and time-course of tissue apoptosis was consistent with lesion maturation.

Background: 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., Objectives: The purpose of this study was to assess recurrence of AF in the CABANA trial., Methods: 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., Results: 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., Conclusions: 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)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Noninvasive electrocardiographic imaging (ECGi) is used clinically to map arrhythmias before ablation. Despite its clinical use, validation data regarding the accuracy of the system for the identification of arrhythmia foci is limited., Methods: Nine pigs underwent closed-chest placement of endocardial fiducial markers, computed tomography, and pacing in all cardiac chambers with ECGi acquisition. Pacing location was reconstructed from biplane fluoroscopy and registered to the computed tomography using the fiducials. A blinded investigator predicted the pacing location from the ECGi data, and the distance to the true pacing catheter tip location was calculated., Results: A total of 109 endocardial and 9 epicardial locations were paced in 9 pigs. ECGi predicted the correct chamber of origin in 85% of atrial and 92% of ventricular sites. Lateral locations were predicted in the correct chamber more often than septal locations (97% versus 79%, P =0.01). Absolute distances in space between the true and predicted pacing locations were 20.7 (13.8-25.6) mm (median and [first-third] quartile). Distances were not significantly different across cardiac chambers., Conclusions: The ECGi system is able to correctly identify the chamber of origin for focal activation in the vast majority of cases. Determination of the true site of origin is possible with sufficient accuracy with consideration of these error estimates.

Background: Noninvasive cardiac ablation of ventricular tachycardia (VT) using radiotherapy has recently gained interest among electrophysiologists. The effects of left ventricular (LV) ablative radiation treatment on global LV function and volumes are unknown., Objective: The purpose of this study was to investigate the effects of noninvasive ablation on LV function over time., Methods: Twenty domestic swine underwent proton beam treatment of LV sites in a dose-finding design and were followed for up to 40 weeks by cardiac magnetic resonance imaging at 4-week intervals. Doses investigated were either 40 Gy at 1 site (n = 8) or 30 Gy at 2 sites (n = 4) in the low-dose group and 40 Gy at 3 sites (n = 8) in the high-dose group., Results: LV mean dose (13.2 ± 1.8 Gy vs 4.6 ± 1.8 Gy) and the volume receiving at least 20 Gy (V 20Gy ) (24.7% ± 4.8% vs 6.4% ± 3.0%) differed significantly between groups. Dose-dependent effects on left ventricular ejection fraction (LVEF) and LV end-diastolic volume became manifest about 3 months after treatment. LVEF decline was correlated to mean dose (correlation coefficient ρ = -0.69; P = .008) and V 20Gy (ρ = -0.66; P = .01), as was LV dilation (ρ = 0.72; P = .005; and ρ = 0.75, P = .003 respectively)., Conclusion: Possible adverse effects on LV function, seen about 3 months after treatment, are dose dependent. Therefore, precise target definition and focused energy delivery are paramount in catheter-free ablation., (Copyright © 2019 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Importance: 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., Objective: To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF., Design, Setting, and Participants: 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., Interventions: 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)., Main Outcomes and Measures: 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)., Results: 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)., Conclusions and Relevance: 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., Trial Registration: ClinicalTrials.gov Identifier: NCT00911508.

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 < .001)., 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.

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., (Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to identify clinical and procedural risk factors associated with pulmonary vein (PV) restenosis., Background: Pulmonary vein stenosis (PVS) is a rare but morbid complication of PV isolation for atrial fibrillation (AF) ablation. Interventions such as PV balloon angioplasty (BA) or stenting achieve excellent acute success; however, subsequent restenosis is common., Methods: A total of 113 patients underwent invasive treatment for severe PVS between 2000 and 2014 and were followed prospectively. Baseline patient and lesion characteristics were abstracted from chart review and analyzed. Univariate and multivariate analyses were performed using patient and procedural characteristics to determine which factors were associated with an increased risk for subsequent PV restenosis., Results: Over a median follow-up of 4.6 years there was PVS recurrence in 75 veins; 52 veins (57%) were treated with index BA and 23 veins were treated with stenting. After multivariate analysis, the only patient factor that was significantly associated with restenosis was a history of more than 1 AF ablation (hazard ratio [HR]: 1.91; 95% confidence interval [CI]: 1.07 to 3.41; p = 0.03). Multivariate analysis on a per-vein level demonstrated a significantly lower risk of restenosis in veins treated with a stent (HR: 2.84; 95% CI: 1.75 to 4.61; p < 0.0001). In veins treated with BA alone, inflation of the balloon to higher atmospheres significantly reduced the risk of recurrence (HR: 0.87; 95% CI: 0.78 to 0.98; p = 0.02)., Conclusions: Restenosis is common after a successful PV intervention and the risk of restenosis is highest in those with a history of multiple AF ablations and in those treated with BA. Proceduralists should take into account the number of AF ablations a patient has undergone and should strongly consider stent deployment when intervening on PVS to reduce risk of restenosis., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The frequency of pulmonary vein stenosis (PVS) after ablation for atrial fibrillation has decreased, but it remains a highly morbid condition. Although treatment strategies including pulmonary vein dilation and stenting have been described, the long-term impacts of these interventions are unknown. We evaluated the presentation of severe PVS, and examined the risk for restenosis after intervention using either balloon angioplasty (BA) alone or BA with stenting., Methods: This was a prospective, observational study of 124 patients with severe PVS evaluated between 2000 and 2014., Results: All 124 patients were identified as having severe PVS by computed tomography in 219 veins. One hundred two patients (82%) were symptomatic at diagnosis. The most common symptoms were dyspnea (67%), cough (45%), fatigue (45%), and decreased exercise tolerance (45%). Twenty-seven percent of patients experienced hemoptysis. Ninety-two veins were treated with BA, 86 were treated with stenting, and 41 veins were not treated. A 94% acute procedural success rate was observed and did not differ by initial management. Major procedural complications occurred in 4 of the 113 patients (3.5%) who underwent invasive assessment, and minor complications occurred in 15 patients (13.3%). Overall, 42% of veins developed restenosis including 27% of veins (n=23) treated with stenting and 57% of veins (n=52) treated with BA. The 3-year overall rate of restenosis was 37%, with 49% of BA-treated veins and 25% of stented veins developing restenosis (hazard ratio, 2.77; 95% confidence interval, 1.72-4.45; P<0.001). After adjustment for age, CHA2DS2-VASc score, hypertension, and the time period of the study, there was still a significant difference in the risk of restenosis for BA versus stenting (hazard ratio, 2.46; 95% confidence interval, 1.47-4.12; P<0.001)., Conclusions: The diagnosis of PVS is challenging because of nonspecific symptoms and the need for dedicated pulmonary vein imaging. There is no difference in acute success by type of initial intervention; however, stenting significantly reduces the risk of subsequent pulmonary vein restenosis in comparison with BA., (© 2016 American Heart Association, Inc.)

Background: The mechanisms of atrial fibrillation (AF) are highly divergent. The prevalence of AF increases significantly with age, and underling mechanisms might vary with age. Endothelial dysfunction may be associated with AF and atrial arrhythmia recurrence after catheter ablation. We tested the hypothesis that the impact of endothelial dysfunction on arrhythmia recurrence following catheter ablation is age dependent., Methods and Results: This study enrolled 92 participants with AF undergoing catheter ablation. Endothelial function was assessed by peripheral arterial tonometry before ablation, and the natural logarithmic transformation of reactive hyperemia index was calculated. Endothelial dysfunction was defined as a natural logarithmic transformation of reactive hyperemia index <0.618 (median). Participants were followed for atrial tachycardia, flutter, and fibrillation recurrence for a median of 14 months. The mean age was 57±10 years. There was significant interaction between age and endothelial dysfunction in association with recurrence of AF (P=0.029) and any atrial arrhythmia (P=0.015), and the risk associated with endothelial dysfunction for arrhythmia recurrence was higher in younger versus older participants. Participants were divided into 2 age groups at a threshold of 60 years. Among participants aged ≤60 years, multivariate Cox proportional hazards analysis revealed the independent association between endothelial dysfunction and increased risk of arrhythmia recurrence (hazard ratio for AF 4.18 [95% CI 1.33-15.82], P=0.014, and for any atrial arrhythmia 3.62 [95% CI 1.29-11.81], P=0.014). Kaplan-Meier analysis showed that participants with endothelial dysfunction had significantly higher rates of recurrence of AF (P=0.01) and any atrial arrhythmia (P=0.002)., Conclusions: The risk associated with endothelial dysfunction for arrhythmia recurrence following catheter ablation was age dependent and was higher in younger participants., (© 2016 The Authors and Mayo Foundation for Medical Education and Research. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Rationale and Objectives: Geometric 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., Methods: The 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., Results: In the high resolution CT scans the left atrial volume measurements show high accuracy with a mean absolute difference of 2.3±1.9 cm(3) 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±2.5 cm(3) and 4.4±3.4 cm(3) for the two raters. Intra-rater repeatability for pulmonary vein diameters ranged from 0.9 to 2.3 mm. The inter-rater repeatability for left atrial volume was 5.8±5.1 cm(3) and inter-rater repeatability for pulmonary vein diameter measurements ranged from 1.4 to 2.3 mm. In the patient study, significant (p<.05) decreases in left atrial volume and all four pulmonary vein diameters were observed. The absolute change in LA volume was 20.0 cm(3), 95%CI [12.6, 27.5]. The left inferior pulmonary vein diameter decreased 2.1 mm, 95%CI [0.4, 3.7], the left superior pulmonary vein diameter decreased 3.2 mm, 95%CI [1.0, 5.4], the right inferior pulmonary vein diameter decreased 1.5 mm, 95%CI [0.3, 2.7], and the right superior pulmonary vein diameter decreased 2.8 mm, 95%CI [1.4, 4.3]., Conclusions: Using the proposed techniques, we demonstrate high accuracy of left atrial volume measurements as well as high repeatability for left atrial volume and pulmonary vein diameter measurements. Following cardiac ablation therapy, a significant decrease was observed for left atrial volume as well as all four pulmonary vein diameters., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Introduction: Ablation eliminates atrial fibrillation (AF) in studies with 1 year follow-up, but very late recurrences may compromise long-term efficacy. In a large cohort, we sought to describe the determinants of delayed recurrence after AF ablation., Methods and Results: Seven hundred and seventy-four patients with AF (428 paroxysmal [PAF, 55%] and 346 persistent or longstanding persistent [PersAF, 45%]) underwent wide area circumferential ablation (WACA, 62%) or pulmonary vein isolation (38%). Over 3.0 ± 1.9 years, there were 135 recurrences in PAF patients and 142 in PersAF patients. AF elimination was achieved in 61% of patients with PersAF at 2 years after last ablation and in 71% of patients with PAF (P = 0.04). This finding was related to a higher initial rate of very late recurrence in PersAF. From 1.0 to 2.5 years, the recurrence increased by 20% (from 37% to 57%) in PersAF patients versus only 12% (from 27% to 39%) in PAF patients. Independent predictors of overall recurrence included diabetes (HR 1.9 [1.3-2.9], P = 0.002) and PersAF (HR 1.6 [1.2-2.0], P < 0.001). Independent predictors of very late recurrence included PersAF (HR 1.7 [1.1-2.7], P = 0.018) and WACA (HR 1.8 [1.1-2.7], P = 0.018), while diabetes came close to significance. In PAF patients, left atrial size >45 mm was identified as an AF-type specific predictor (HR 2.4 [1.3-4.7], P = 0.009), whereas in PersAF patients, no unique predictors were identified., Conclusion: Late recurrences reduced the long-term efficacy of AF ablation, particularly in patients with PersAF and underlying cardiovascular diseases., (© 2010 Wiley Periodicals, Inc.)

Ablation procedures for atrial fibrillation are being performed with increasing frequency. One of the most serious complications is the development of pulmonary vein stenosis, which occurs in 1% to 3% of current series. The presentation of pulmonary vein stenosis varies widely. The majority of patients are symptomatic although specific referral bias patterns can affect this. Symptoms may include dyspnea or hemoptysis or may be consistent with bronchitis. These symptoms are affected by the number of stenotic veins as well as the severity of the stenosis. The more severe the stenosis and the greater number of stenosed veins result in more symptoms. Because of the variability in symptoms, clinicians must have heightened sensitivity to the presence of the condition. Diagnostic tests of value include magnetic resonance angiography and computed tomography. Although echocardiography has been used, it does not usually provide adequate assessment. Progression of stenosis is unpredictable and may be rapid. The specific anatomy of the stenosis varies widely and affects management. Because of the presence of antral fusion of the origin of the left superior and left inferior pulmonary vein, a stenosis involving 1 or the other can impinge and affect outcome. In this setting, bifurcation techniques familiar to interventional cardiology are very helpful. Controversy currently exists about the optimal treatment approach. The use of balloons and larger stents (approximately 10 mm) results in more optimal results than just balloon angioplasty alone; however, even with stent implantation, recurrent restenosis may occur in 30% to 50% of patients. Follow-up of these patients typically involves computed tomography imaging to document restenosis. If significant restenosis is identified, it should be treated promptly because of the potential for progression to total occlusion.

Unlabelled: Flutter Ablation and Subsequent Arrhythmia., Introduction: Patients with atrial flutter (AFL) treated medically are at high risk for subsequent development of atrial fibrillation (AF). Whether curative radiofrequency ablation of AFL can modify the natural history of arrhythmia progression is not clear. We aimed to determine whether ablation of AFL decreases the subsequent development of AF in patients without previous AF., Methods and Results: Patients with AFL as the sole atrial arrhythmia were selected from patients who underwent successful AFL ablation at Mayo Clinic between 1997 and 2003 (N = 137). The cohort was divided by presence (n = 50) or absence (n = 87) of structural heart disease. A control group comprised 59 patients with AFL and no history of paroxysmal AF, who received only medical therapy. Occurrence of AF after AFL ablation was compared among study groups and controls. Symptomatic AF occurred in 49 patients during 5 years of follow-up after AFL ablation, with similar frequency in both study groups. The cumulative probability of paroxysmal and chronic AF was similar in controls and each study group. By multivariate analysis, the AFL ablation procedure carries significant risk of AF occurrence during follow-up. Fifty patients discontinued antiarrhythmic drugs after AFL ablation, and the rate of cardioversions decreased., Conclusion: Successful ablation of AFL does not improve the natural history of atrial arrhythmia progression; postablation AF is frequent. This suggests that AFL may be initiated by bursts of AF and that in the absence of AFL substrate the AF continues to progress.

Background: Hypertrophic cardiomyopathy (HCM) is often accompanied by atrial fibrillation (AF) due to diastolic dysfunction, elevated left atrial pressure, and enlargement. Although catheter ablation for drug-refractory AF is an effective treatment, the efficacy in HCM remains to be established., Methods: Thirty-three consecutive patients (25 male, age 51 +/- 11 years) with HCM underwent pulmonary vein (PV) isolation (n = 8) or wide area circumferential ablation with additional linear ablation (n = 25) for drug-refractory AF. Twelve-lead and 24-hour ambulating ECGs, echocardiograms, event monitor strips, and SF 36 quality of life (QOL) surveys were obtained before ablation and for routine follow-up., Results: Twenty-one (64%) patients had paroxysmal AF and 12 (36%) had persistent/permanent AF for 6.2 +/- 5.2 years. The average ejection fraction was 0.63 +/- 0.12. The average left atrial volume index was 70 +/- 24 mL/m(2). Over a follow-up of 1.5 +/- 1.2 years, 1-year survival with AF elimination was 62%(Confidence Interval [CI]: 66-84) and with AF control was 75%(CI: 66-84). AF control was less likely in patients with a persistent/chronic AF, larger left atrial volumes, and more advanced diastolic disease. Additional linear ablation may improve outcomes in patient with severe left atrial enlargement and more advanced diastolic dysfunction. Two patients had a periprocedureal TIA, one PV stenosis, and one died after mitral valve replacement from prosthetic valve thrombosis. QOL scores improved from baseline at 3 and 12 months., Conclusion: Outcomes after AF ablation in patients with HCM are favorable. Diastolic dysfunction, left atrial enlargement, and AF subtype influence outcomes. Future studies of rhythm management approaches in HCM patients are required to clarify the optimal clinical approach.

Patients with the Marfan syndrome may pose a difficult challenge for catheter-based interventions due to frequent coexisting valve disease, potential delay in vascular healing and repair, and intra-atrial scar from prior cardiac surgery. We report a case series of four patients with Marfan or Marfan-like syndromes who underwent ablation for drug-refractory atrial fibrillation. Ultimately three of four patients remained in sinus rhythm, however most patients required multiple ablative attempts and long-term atrial flutter was common. Nonetheless, peri-procedural complications were minimal despite the connective tissue disorder and prosthetic valves in three of four patients. In conclusion, catheter ablation of AF in patients with Marfan syndrome is a viable option in those individuals refractory to conventional therapy.

Objectives: The purpose of this study was to characterize the occurrence of phrenic nerve injury (PNI) and its outcome after radiofrequency (RF) ablation of atrial fibrillation (AF)., Background: It is recognized that extra-myocardial damage may develop owing to penetration of ablative energy., Methods: Between 1997 and 2004, 3,755 consecutive patients underwent AF ablation at five centers. Among them, 18 patients (0.48%; 9 male, 54 +/- 10 years) had PNI (16 right, 2 left). The procedure consisted of pulmonary vein (PV) isolation in 15 patients and anatomic circumferential ablation in 3 patients, with additional left atrial lesions (n = 11) and/or superior vena cava (SVC) disconnection (n = 4)., Results: Right PNI occurred during ablation of right superior PV (n = 12) or SVC disconnection (n = 3). Left PNI occurred during ablation at the left atrial appendage. Immediate features were dyspnea, cough, hiccup, and/or sudden diaphragmatic elevation in 9, and in the remaining the diagnosis was made after ablation owing to dyspnea (n = 7) or on routine radiographic evaluation (n = 2). Four patients (22%) were asymptomatic. Complete recovery occurred in 12 patients (66%). Recovery occurred within 24 h in the two patients with left PNI and in one patient with right PNI occurring with SVC disconnection. In the other nine patients, right PNI recovery occurred after 4 +/- 5 months (1 to 12 months) with respiratory rehabilitation. After a mean follow-up of 36 +/- 33 months, six patients have persistent PNI (three with partial and three with no recovery)., Conclusions: In this multicenter experience, PNI was a rare complication (0.48%) of AF ablation. Ablation of the right superior PV, SVC, and left atrial appendage were associated with PNI. Complete (66%) or partial (17%) recovery was observed in the majority.

Background: Perforation during catheter procedures in either the atrium or ventricle is relatively uncommon, but potentially fatal if tamponade ensues. This study analyzes the occurrence and outcomes of cardiac perforation during catheter-based radiofrequency ablation procedures in the left atrium., Methods: All patients with a periprocedure perforation who have undergone radiofrequency ablation for atrial fibrillation (AF) or tachycardia were included., Results: Of 632 procedures performed from January 1999 to October 2004, 15 (2.4%) were complicated by perforation requiring pericardiocentesis. The perforation site was left atrium in 9 (60.0%), right atrium in 1 (6.7%), and right ventricle in 5 (33.3%). Intracardiac echocardiography was used in 13 (86.7%) and revealed an effusion before overt instability in 11 (73.3%). Thirteen (86.7%) patients developed a blood pressure <60 mmHg. The pressure stabilized in all patients after pericardiocentesis (hypotension to intervention: 10.1 +/- 5.1 minutes). The total blood volume removed was 848 +/- 880 mL (left atrium/right atrium: 1,074 +/- 1,002 vs right ventricle: 396 +/- 266, P = 0.168). Two patients required surgery to close left atrium dome perforations. The ablation was completed in 7 (46.7%) patients. Ten (66.7%) later developed early reoccurrence of AF. All patients were neurologically intact at hospital discharge. During a 1.5 +/- 1.1 year follow-up, AF was eliminated (n = 4) or controlled (n = 1) in 5 (71.4%) patients with complete procedures, and 2 (20.0%) patients underwent successful repeat ablation., Conclusion: The incidence of perforation during ablation of the left atrium is low. Most perforations occur in the left atrium; however, few require surgical closure. Although less than with uncomplicated procedures, the majority of patients with complete ablations achieve long-term elimination of AF.

Dobutamine stress echocardiography (DSE) is widely used for the diagnosis and evaluation of coronary artery disease. Studies examining the safety of this technique typically have involved DSE supervised by physicians. At the Mayo Clinic, experienced registered nurse (RN) sonographers were trained to perform DSE under the direct supervision of a physician. To prove that the safety of DSE was not compromised with the change in supervision, we examined data from 1035 consecutive outpatient studies: 516 patients were monitored by cardiologists or cardiology fellows (group 1) and 519 were monitored by trained RN sonographers (group 2). Risk factors, history of coronary artery disease, stress parameters, and complication rates were similar in both groups. In group 1, one patient experienced sustained ventricular tachycardia requiring treatment. In group 2, one patient experienced ventricular fibrillation during recovery and was successfully resuscitated. Outpatient DSE is safe when supervised by RN sonographers.

Background: The implications of hypotension occurring during dobutamine stress echocardiography have not been elucidated. We observed in some patients that hyperdynamic left ventricular function developed during dobutamine stress echocardiography and hypothesized that intracavitary obstruction was occurring and might account for hypotension in some patients., Methods and Results: Fifty-seven consecutive patients undergoing dobutamine stress echocardiography underwent pulsed-wave and continuous-wave Doppler examination of the left ventricular cavity at rest and at peak dobutamine infusion. The development of an intraventricular gradient with dobutamine stress was defined as a late-peaking left ventricular Doppler velocity profile that exceeded basal velocity by at least 1 m/sec. During dobutamine stress testing, left ventricular outflow velocity or intracavitary velocity increased in all patients. Obstruction occurred in 12 patients (21%, group 1). Group 2 was the remaining 45 patients. Peak velocities in group 1 ranged from 2.0 to 5.0 m/sec (mean, 3.5 m/sec), and the mean increase from velocity at rest was 2.3 m/sec. The mean change in systolic blood pressure was significantly lower in patients in group 1 (-15 versus 4 mm Hg, p = 0.02). When the 18 patients with an ischemic response to stress testing (evidenced by new or worsening wall motion abnormalities) were excluded from analysis, systolic blood pressure response was still significantly different for the two groups (-19 versus 2 mm Hg, p = 0.03)., Conclusions: Dynamic left ventricular obstruction is a new observation; it may develop frequently in patients undergoing dobutamine stress echocardiography. Obstruction rather than ischemia may explain a decrease in blood pressure during dobutamine stress echocardiography.