Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation.

BACKGROUND: Active esophageal cooling reduces the incidence of endoscopically identified severe esophageal lesions during radiofrequency (RF) catheter ablation of the left atrium for the treatment of atrial fibrillation. A formal analysis of the atrioesophageal fistula (AEF) rate with active esophageal cooling has not previously been performed. OBJECTIVES: The authors aimed to compare AEF rates before and after the adoption of active esophageal cooling. METHODS: This institutional review board (IRB)-approved study was a prospective analysis of retrospective data, designed before collecting and analyzing the real-world data. The number of AEFs occurring in equivalent time frames before and after adoption of cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were quantified across 25 prespecified hospital systems. AEF rates were then compared using generalized estimating equations robust to cluster correlation. RESULTS: A total of 14,224 patients received active esophageal cooling during RF ablation across the 25 hospital systems, which included a total of 30 separate hospitals. In the time frames before adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In the preadoption cohort, a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates for procedures using LET monitoring. In the postadoption cohort, no AEFs were found in the prespecified sites, yielding an AEF rate of 0% (P < 0.0001). CONCLUSIONS: Adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate.

Improved 1-year outcomes after active cooling during left atrial radiofrequency ablation.

BACKGROUND: Active esophageal cooling during pulmonary vein isolation (PVI) with radiofrequency (RF) ablation for the treatment of atrial fibrillation (AF) is increasingly being utilized to reduce esophageal injury and atrioesophageal fistula formation. Randomized controlled data also show trends towards increased freedom from AF when using active cooling. This study aimed to compare 1-year arrhythmia recurrence rates between patients treated with luminal esophageal temperature (LET) monitoring versus active esophageal cooling during left atrial ablation. METHOD: Data from two healthcare systems (including 3 hospitals and 4 electrophysiologists) were reviewed for patient rhythm status at 1-year follow-up after receiving PVI for the treatment of AF. Results were compared between patients receiving active esophageal cooling (ensoETM, Attune Medical, Chicago, IL) and those treated with traditional LET monitoring using Kaplan-Meier estimates. RESULTS: A total of 513 patients were reviewed; 253 received LET monitoring using either single or multi-sensor temperature probes; and 260 received active cooling. The mean age was 66.8 (SD ± 10) years, and 36.8% were female. Arrhythmias were 60.1% paroxysmal AF, 34.3% persistent AF, and 5.6% long-standing persistent AF, with no significant difference between groups. At 1-year follow-up, KM estimates for freedom from AF were 58.2% for LET-monitored patients and 72.2% for actively cooled patients, for an absolute increase in freedom from AF of 14% with active esophageal cooling (p = .03). Adjustment for the confounders of patient age, gender, type of AF, and operator with an inverse probability of treatment weighted Cox proportional hazards model yielded a hazard ratio of 0.6 for the effect of cooling on AF recurrence (p = 0.045). CONCLUSIONS: In this first study to date of the association between esophageal protection strategy and long-term efficacy of left atrial RF ablation, a clinically and statistically significant improvement in freedom from atrial arrhythmia at 1 year was found in patients treated with active esophageal cooling when compared to patients who received LET monitoring. More rigorous prospective studies or randomized studies are required to validate the findings of the current study.

Improved hospital discharge and cost savings with esophageal cooling during left atrial ablation.

BACKGROUND: Left atrial ablation to obtain pulmonary vein isolation (PVI) for the treatment of atrial fibrillation (AF) is a technologically intensive procedure utilizing innovative and continually improving technology. Changes in the technology utilized for PVI can in turn lead to changes in procedure costs. Because of the proximity of the esophagus to the posterior wall of the left atrium, various technologies have been utilized to protect against thermal injury during ablation. The impact on hospital costs during PVI ablation from utilization of different technologies for esophageal protection during ablation has not previously been evaluated. OBJECTIVE: To compare the costs of active esophageal cooling to luminal esophageal temperature (LET) monitoring during left atrial ablation. METHODS: We performed a time-driven activity-based costing (TDABC) analysis to determine costs for PVI procedures. Published data and literature review were utilized to determine differences in procedure time and same-day discharge rates using different esophageal protection technologies and to determine the cost impacts of same-day discharge versus overnight hospitalization after PVI procedures. The total costs were then compared between cases using active esophageal cooling to those using LET monitoring. RESULTS: The effect of implementing active esophageal cooling was associated with up to a 24.7% reduction in mean total procedure time, and an 18% increase in same-day discharge rate. TDABC analysis identified a $681 reduction in procedure costs associated with the use of active esophageal cooling after including the cost of the esophageal cooling device. Factoring in the 18% increase in same-day discharge resulted in an increased cost savings of $2,135 per procedure. CONCLUSIONS: The use of active esophageal cooling is associated with significant cost-savings when compared to traditional LET monitoring, even after accounting for the additional cost of the cooling device. These savings originate from a per-patient procedural time savings and a per-population improvement in same-day discharge rate.

Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update.

INTRODUCTION: Radiofrequency (RF) ablation of the left atrium of the heart is increasingly used to treat atrial fibrillation (AF). Unfortunately, inadvertent thermal injury to the esophagus can occur during this procedure, potentially creating an atrioesophageal fistula (AEF) which is 80% fatal. The ensoETM (Attune Medical, Chicago, IL), is an esophageal cooling device that has been shown to reduce thermal injury to the esophagus during RF ablation. AREAS COVERED: This review summarizes growing evidence related to active esophageal cooling during RF ablation for the treatment of AF. The review presents data demonstrating improved outcomes related to patient safety and procedural efficiency and suggests directions for future research. EXPERT OPINION: The use of active esophageal cooling during RF ablation reduces esophageal injury, reduces or eliminates fluoroscopy requirements, reduces procedure duration and post-operative pain, and increases long-term freedom from arrhythmia. These effects in turn increase patient same-day discharge rates, decrease operator cognitive load, and reduce cost. These findings are likely to further accelerate the adoption of active esophageal cooling.

Atrial fibrillation is a condition in which the heart beats irregularly, causing symptoms such as palpitations, dizziness, shortness of breath, and chest pain. Atrial fibrillation increases the risk of stroke, heart failure, dementia, and death. One treatment for atrial fibrillation is a procedure called a catheter ablation. This procedure is minimally invasive and is performed by a specialized cardiologist, called an electrophysiologist. The electrophysiologist, or operator, uses an energy source, such as radiofrequency energy (radio waves), to stop erratic electrical signals from traveling through the heart. One complication of the catheter ablation is an inadvertent injury to the esophagus, the organ that passes food from the mouth to the stomach. If the injury is severe, it may develop into an atrioesophageal fistula, which often results in death. In this review, a new technology is described that helps prevent this type of injury and can provide additional benefits for the patient, operator, and hospital.

Impact of Active Esophageal Cooling on Fluoroscopy Usage During Left Atrial Ablation.

Risks to collateral structures exist with radiofrequency (RF) ablation of the left atrium to obtain pulmonary vein isolation (PVI) for the treatment of atrial fibrillation. Passive luminal esophageal temperature (LET) monitoring is commonly utilized, but increasing data suggest limited benefits with LET monitoring. In contrast, active cooling of the esophagus has been shown to significantly reduce esophageal injury. Active cooling of the esophagus also avoids the need for stopping and repositioning an LET probe during use, which may reduce the need for fluoroscopy use. This study aimed to measure the impact on fluoroscopy use during RF ablation with esophageal cooling using a dedicated cooling device in a low-fluoroscopy practice. All patients who underwent PVI over a one-year timeframe by a single provider were analyzed. Patients undergoing PVI prior to the incorporation of an esophageal cooling protocol into standard ablation practice were treated with traditional LET monitoring. Patients treated after this point received active esophageal cooling, in which no LET monitoring is utilized. A total of 280 patients were treated; 91 patients were treated using LET monitoring, and 189 patients were treated with esophageal cooling. The mean total fluoroscopy time before the implementation of the esophageal cooling protocol in 91 patients was 194 seconds [standard deviation (SD): 182 seconds] per case, with a median of 144 seconds. The mean total fluoroscopy time after implementation in 189 patients was 126 seconds (SD: 120 seconds) per case with a median of 96 seconds, representing a reduction of 35% per case (p < 0.0001, Mann-Whitney U test). In this largest study to date of active esophageal cooling during PVI, a 35% reduction in fluoroscopy time compared with patients who received LET monitoring was found. This reduction was seen despite an already low fluoroscopy usage rate in place.

Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study.

BACKGROUND: Intracardiac electrogram data remain one of the primary diagnostic inputs guiding complex ablation procedures. However, the technology to collect, process, and display intracardiac signals has known shortcomings and has not advanced in several decades. OBJECTIVE: The purpose of this study was to evaluate a new signal processing platform, the PURE EP™ system (PURE), in a multi-center, prospective study. METHODS: Intracardiac signal data of clinical interest were collected from 51 patients undergoing ablation procedures with PURE, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, controlled evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE signals when compared to conventional sources. Each reviewer assessed the same (92) signal sample sets and responded to (235) questions using a 10-point rating scale. If two or more reviewers rated the PURE signal higher than the control, it was deemed superior. RESULTS: A total of 93% of question responses showed consensus amongst the blinded reviewers. Based on the ratings for each pair of signals, a cumulative total of 164 PURE signals out of 218 (75.2%) were statistically rated as Superior for this data set (p < .001). Only 14 PURE signals out of 218 were rated as Inferior (6.4%). CONCLUSION: The PURE intracardiac signals were statistically rated as superior when compared to conventional systems.

Cooling or Warming the Esophagus to Reduce Esophageal Injury During Left Atrial Ablation in the Treatment of Atrial Fibrillation.

Ablation of the left atrium using either radiofrequency (RF) or cryothermal energy is an effective treatment for atrial fibrillation (AF) and is the most frequent type of cardiac ablation procedure performed. Although generally safe, collateral injury to surrounding structures, particularly the esophagus, remains a concern. Cooling or warming the esophagus to counteract the heat from RF ablation, or the cold from cryoablation, is a method that is used to reduce thermal esophageal injury, and there are increasing data to support this approach. This protocol describes the use of a commercially available esophageal temperature management device to cool or warm the esophagus to reduce esophageal injury during left atrial ablation. The temperature management device is powered by standard water-blanket heat exchangers, and is shaped like a standard orogastric tube placed for gastric suctioning and decompression. Water circulates through the device in a closed-loop circuit, transferring heat across the silicone walls of the device, through the esophageal wall. Placement of the device is analogous to the placement of a typical orogastric tube, and temperature is adjusted via the external heat-exchanger console.

Prevalence of right atrial non-pulmonary vein triggers in atrial fibrillation patients treated with thyroid hormone replacement therapy.

BACKGROUND: Thyroid hormone (TH) is known to enhance arrhythmogenicity, and high-normal thyroid function is related with an increased recurrence of atrial fibrillation (AF) after catheter ablation. However, the impact of thyroid hormone replacement (THR) on AF ablation is not well known. METHODS: This study evaluated 1163 consecutive paroxysmal AF patients [160 (14%) on THR and 1003 (86%) without THR] undergoing their first catheter ablation. A total of 146 patients on THR and 146 controls were generated by propensity matching, based on calculated risk factor scores, using a logistic model (age, sex, body mass index, and left atrium size). The presence of non-pulmonary vein (PV) triggers was disclosed by a high-dose isoproterenol challenge (up to 30 µg/min) after PV isolation. RESULTS: Clinical characteristics were not different between the groups. When compared to the control, non-PV triggers were significantly greater in the THR patients [112 (77%) vs. 47 (32%), P < 0.001], and most frequently originated from the right atrium (95 vs. 56%, P < 0.001). Other sources of non-PV triggers were the interatrial septum (25 vs. 11%, P = 0.002), coronary sinus (70 vs. 52%, P = 0.01), left atrial appendage (47 vs. 34%, P = 0.03), crista terminalis/superior vena cava (11 vs. 8%, P = 0.43), and mitral valve annulus (7 vs. 5%, P = 0.45) (THR vs. control), respectively. After mean follow-up of 14.7 ± 5.2 months, success rate was lower in patients on THR therapy [94 (64.4%)] compared to patients not receiving THR therapy [110 (75.3%), log-rank test value = 0.04]. CONCLUSIONS: Right atrial non-PV triggers were more prevalent in AF patients treated with THR. Elimination of non-PV triggers provided better arrhythmia-free survival in the non-THR group.

Left Atrial Appendage Isolation in Patients With Longstanding Persistent AF Undergoing Catheter Ablation: BELIEF Trial.

BACKGROUND: Longstanding persistent (LSP) atrial fibrillation (AF) is the most challenging type of AF. In addition to pulmonary vein isolation, substrate modification and triggers ablation have been reported to improve freedom from AF in patients with LSPAF. OBJECTIVES: This study sought to assess whether the empirical electrical isolation of the left atrial appendage (LAA) could improve success at follow-up. METHODS: This was an open-label, randomized study assessing the effectiveness of empirical electrical left atrial appendage isolation for the treatment of LSPAF. Patients were randomly assigned to undergo empirical electrical left atrial appendage isolation along with extensive ablation (group 1; n = 85) or extensive ablation alone (group 2; n = 88). Recurrence of atrial arrhythmias was the primary endpoint. Secondary endpoints included cardiac-related hospitalization, all-cause mortality, and stroke at follow-up. RESULTS: Major clinical characteristics were not different between the 2 groups. At 12-month follow-up, 48 (56%) patients in group 1 and 25 (28%) in group 2 were recurrence free after a single procedure (unadjusted hazard ratio [HR] for recurrence with standard ablation: 1.92; 95% confidence interval [CI]: 1.3 to 2.9; log-rank p = 0.001). After adjusting for age, sex, and left atrial size, standard ablation was predictive of recurrence (HR: 2.22; 95% CI: 1.29 to 3.81; p = 0.004). During repeat procedures, empirical electrical left atrial appendage isolation was performed in all patients. After an average of 1.3 procedures, cumulative success at 24-month follow-up was reported in 65 (76%) in group 1 and in 49 (56%) in group 2 (unadjusted HR: 2.24; 95% CI: 1.3 to 3.8; log-rank p = 0.003). CONCLUSIONS: This randomized study showed that both after a single procedure and after redo procedures in patients with LSPAF, empirical electrical isolation of the LAA improved long-term freedom from atrial arrhythmias without increasing complications. (Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Catheter Ablation [BELIEF]; NCT01362738).

Is transesophageal echocardiogram mandatory in patients undergoing ablation of atrial fibrillation with uninterrupted novel oral anticoagulants? Results from a prospective multicenter registry.

BACKGROUND: Transesophageal echocardiography (TEE) is recommended in patients undergoing atrial fibrillation (AF) ablation, but use of this strategy is variable. OBJECTIVE: To evaluate whether TEE is necessary before AF ablation in patients treated with novel oral anticoagulants (NOACs). METHODS: We performed a prospective multicenter registry of AF patients undergoing radiofrequency catheter ablation on uninterrupted NOACs (apixaban and rivaroxaban). All patients were on NOACs for at least 4 weeks before ablation. Heparin bolus was administered to all patients before transseptal catheterization to maintain a target activated clotting time above 300 seconds. A subset of 86 patients underwent brain diffuse magnetic resonance imaging (dMRI) to detect silent cerebral ischemia (SCI). RESULTS: A total of 970 patients (514 [53%] apixaban patients and 456 [47%] rivaroxaban patients) were enrolled for this study. The mean age was 69.5 ± 9.0 years, with 824 patients (85%) having nonparoxysmal AF, and 636 patients (65.6%) were male. The average CHA2DS2-VASc score was 3.01 ± 1.3 and CHADS2 score was ≥2 in 609 patients (62.8%). Intracardiac echocardiogram ruled out left atrial appendage thrombus in all patients whose left atrial appendage was visualized (692, 71%), and detected "smoke" in 407 patients (42%). SCI at postprocedure dMRI was detected in 2.3% (2/86). One thromboembolic event (transient ischemic attack) (0.10%) with positive dMRI occurred in a patient on uninterrupted rivaroxaban with longstanding persistent AF. CONCLUSION: Our study illustrates that performing AF ablation while on uninterrupted apixaban and rivaroxaban without TEE is feasible and safe. This finding has important clinical and economic relevance.

Importance of non-pulmonary vein triggers ablation to achieve long-term freedom from paroxysmal atrial fibrillation in patients with low ejection fraction.

BACKGROUND: Whether ablation of non-pulmonary vein (PV) triggers after pulmonary vein antrum isolation (PVAI) improves the long-term procedure outcome in patients with paroxysmal atrial fibrillation (PAF) and left ventricular systolic dysfunction is unknown. OBJECTIVE: We sought to evaluate whether a more extensive ablation procedure improves outcomes at follow-up. METHODS: Consecutive patients with PAF refractory to antiarrhythmic drugs presenting for PVAI were prospectively studied. Patients were categorized into 2 groups: patients with left ventricular ejection fraction (LVEF) ≤35% (group I; n = 175) and patients with LVEF ≥50% (group II; n = 545). Patients in group I were further divided according to whether additional ablation of non-PV triggers was performed (group IA; n = 88) or not (group IB; n = 87). Long-term ablation success off antiarrhythmic drugs after a single procedure was analyzed. RESULTS: Patients in group I had more non-PV triggers than did patients in group II (69.1% vs 26.6%; P < .001). During a follow-up of 15.8 ± 4.7 months, fewer patients in group I remained free from recurrences than those in group II (53.7% vs 81.7%; P < .001). Long-term ablation success was higher in group IA than in group IB (75.0% vs 32.2%; P < .001) and similar to that in group II (75.0% vs 81.7%; P = .44). In multivariate analysis, LVEF ≤35% (hazard ratio 1.68; P = .003) and non-PV triggers (hazard ratio 3.12; P < .001) were independent predictors of recurrences. CONCLUSION: In patients with PAF and left ventricular systolic dysfunction, ablation of non-PV triggers in addition to PVAI significantly improves their long-term procedure outcome.

Effect of catheter ablation and periprocedural anticoagulation regimen on the clinical course of migraine in atrial fibrillation patients with or without pre-existent migraine: results from a prospective study.

BACKGROUND: We examined the influence of catheter ablation and periprocedural anticoagulation regimen on trajectory of migraine in atrial fibrillation patients with or without migraine history. METHODS AND RESULTS: Forty patients with (group 1: 64 ± 8 years; men 78%) and 85 (group 2: 61 ± 10 years; men 73%) without migraine history undergoing atrial fibrillation-ablation were enrolled. Migraine status and quality of life were evaluated using standardized questionnaires. Diffusion magnetic resonance imaging of brain was performed for all at pre and 24 hours post procedure. Catheter ablation was performed with (88, 70%) or without (37, 30%) continuous warfarin treatment. Fifty-four patients (11 and 43 from groups 1 and 2, respectively) had subtherapeutic international normalized ratio on procedure day. At 17 ± 5 months follow-up, from group 1, 25 (63%) reported no migraine, 10 (25%) had < 1, and 3 (8%) had 2 to 3 monthly symptoms. Intensity of pain decreased from baseline 7 (Q1-Q3, 4-8) to 2 (0-4) scale points at follow-up (P < 0.001) and duration of headache from median 8 (Q1-Q3, 4-15) to 0.5 (Q1-Q3, 0-2) hours (P < 0.001). Two patients from group 1 reported increased migraine severity and 2 from group 2 had new-onset migraine. Follow-up diffusion magnetic resonance imaging revealed new infarcts in 9.6% (12/125) patients; of which 11 had subtherapeutic preprocedural international normalized ratio on or off continuous warfarin. Quality of life improved significantly in patients with successful ablation, being more pronounced in group 1. CONCLUSIONS: In most patients, migraine symptoms improved substantially after catheter ablation. Interestingly, the only cases of new migraine and aggravation of pre-existent headache had subtherapeutic international normalized ratio during the procedure and new cerebral infarcts.

Effect of periprocedural amiodarone on procedure outcome in patients with longstanding persistent atrial fibrillation undergoing extended pulmonary vein antrum isolation: results from a randomized study (SPECULATE).

BACKGROUND: The impact of amiodarone on ablation outcome in longstanding persistent atrial fibrillation (LSPAF) patients is not known yet. OBJECTIVE: The purpose of this study was to assess the effect of amiodarone on procedural-outcomes in LSPAF patients undergoing catheter ablation. METHODS: We enrolled 112 LSPAF patients on amiodarone and scheduled to undergo atrial fibrillation (AF) ablation. Patients were randomized to amiodarone discontinuation 4 months before ablation (group 1, n = 56) and a control group (group 2, n = 56) in which ablation was performed without amiodarone discontinuation. All patients underwent pulmonary vein (PV) antrum and posterior wall isolation, defragmentation and extra PV triggers ablation. Patients were followed up for recurrence for 32 ± 8 months post-ablation. Repeat procedures in all recurrent patients were performed off amiodarone. RESULTS: During ablation, AF termination was more frequent in group 2 compared to group 1 [44 (79%) vs 32 (57%), P = .015]. After high-dosage isoproterenol, more non-PV triggers were disclosed in group 1 compared to group 2 (42 [75%] vs 24 [43%] respectively, P <.001). Group 2 had lower procedure, radiofrequency and fluoroscopy times compared to group 1 (2.7 ± 1 vs 3.1 ± 1 h, 69 ± 13 min vs 87 ± 11 min and 64 ± 14 min vs 85 ± 18 min respectively, p < .05). At 32 ± 8 month follow-up, on or off antiarrhythmic drug success rate was 37 (66%) in group 1 and 27 (48%) in group 2 (P = .04). During redo, new non-PV trigger sites were identified in group 2 patients. CONCLUSION: Periprocedural continuous amiodarone was associated with higher organization rate and lower radiofrequency ablation rate. However, masking non-PV triggers increased the late recurrence rate.

Outcomes of atrioesophageal fistula following catheter ablation of atrial fibrillation treated with surgical repair versus esophageal stenting.

INTRODUCTION: Atrioesophageal fistula (AEF) is a rare but devastating complication of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). Surgical repair and esophageal stents are available treatment options for AEF. We report outcomes of these 2 management strategies. METHODS: Nine patients with AEF post-RFCA for AF were included in this study. AEF was diagnosed based on symptoms and chest CT imaging. Of the 9 patients, 5 received stents and 4 underwent surgical repair of fistula. RESULTS: AF ablation was performed under general anesthesia (n = 4) or conscious sedation (n = 5). During ablation, RF power was maintained between 25 and 35 Watts in areas close to the esophagus and energy delivery discontinued when esophageal temperature reached 38 °C. Seven patients underwent ablation with 3.5-mm open-irrigated catheter, 1 with 8-mm nonirrigated catheter, and 1 had surgical epicardial ablation. Seven patients received proton pump inhibitor and sucralfate before and after procedure. AEF symptoms developed within 2­6 weeks from ablation. Esophageal stenting was performed in 5 patients (median age 58 years, median time from RFCA 4 weeks) and 4 underwent surgical repair (median age 54 years, median time from RFCA 4 weeks) within 2­4 hours from diagnosis. All 5 patients receiving stents died within 1 week of the procedure due to cerebral embolism, septic shock, or respiratory failure. On the other hand, the 4 patients that received surgical repair were alive at median follow-up of 2.1 years (P = 0.005). CONCLUSIONS: Esophageal stenting should be discouraged and prompt surgical repair is crucial for survival in patients with atrioesophageal fistula.

Catheter ablation of asymptomatic longstanding persistent atrial fibrillation: impact on quality of life, exercise performance, arrhythmia perception, and arrhythmia-free survival.

BACKGROUND: Impact of catheter ablation on exercise performance, quality of life (QoL) and symptom perception in asymptomatic longstanding persistent AF (LSP-AF) patients has not been reported yet. METHODS AND RESULTS: Sixty-one consecutive patients (mean age 62 ±13 years, 71% males) with asymptomatic LSP-AF undergoing first catheter ablation were enrolled. Extended pulmonary vein antrum isolation plus ablation of complex fractionated atrial electrograms and nonpulmonary vein triggers was performed in all. QoL survey was taken at baseline and 12-months postablation, using Short Form-36 (SF-36). Information on arrhythmia perception was obtained using a standard questionnaire and corroborating symptoms with documented evidence of arrhythmia. Exercise tests were performed on 38 patients at baseline and 5 months after procedure. Recurrence was assessed using event recorder, cardiology evaluation, electrocardiogram, and 7-day holter monitoring. After 20 ± 5 months follow-up, 36 (57%) patients remained recurrence-free off-AAD. Of the 25 patients experiencing recurrence, 21 (84%) were symptomatic. Compared to baseline, follow-up SF-36 scores improved significantly in many measures. For patients with successful ablation, physical component summary (PCS) and mental component summary (MCS) demonstrated substantial improvement ( MCS: 64.2 ± 22.3 to 70.1 ± 18.6 [P = 0.041]; PCS: 62.6 ± 18.4 to 70.0 ± 14.4 [P = 0.032]). Postablation exercise study in recurrence-free patients showed significant reduction in resting and peak heart rate (75 ± 11 vs. 90 ± 17 and 132 ± 20 vs. 154.5 ± 36, respectively, P < 0.001), increase in peak oxygen pulse (13.4 ± 3 vs. 18.9 ± 16 mL/beat, Δ5.5 ± 15, P = 0.001), peak VO2 /kg (19.7 ± 5 to 23.4 ± 13 mL/kg/min [Δ 3.7 ± 10, P = 0.043]), and corresponding MET (5.6 ± 1 to 6.7 ± 4 [Δ1.1 ± 3, P = 0.03]). No improvement was observed in patients with failed procedures. CONCLUSION: Successful ablation improves exercise performance and QoL in asymptomatic LSP-AF patients.

Long-term outcome of catheter ablation in atrial fibrillation patients with coexistent metabolic syndrome and obstructive sleep apnea: impact of repeat procedures versus lifestyle changes.

INTRODUCTION: Metabolic syndrome (MS) and obstructive sleep apnea (OSA) are well-known independent risk factors for atrial fibrillation (AF) recurrence. This study evaluated ablation outcome in AF patients with coexistent MS and OSA and influence of lifestyle modifications (LSM) on arrhythmia recurrence. METHODS AND RESULTS: We included 1,257 AF patients undergoing first catheter ablation (30% paroxysmal AF). Patients having MS + OSA were classified into Group 1 (n = 126; 64 ± 8 years; 76% male). Group 2 (n = 1,131; 62 ± 11 years; 72% male) included those with either MS (n = 431) or OSA (n = 112; no CPAP users) or neither of these comorbidities (n = 588). Patients experiencing recurrence after first procedure were divided into 2 subgroups; those having sporadic events (frequency < 2 months) remained on previously ineffective antiarrhythmic drugs (AAD) and aggressive LSM, while those with persistent arrhythmia (incessant or ≥2 months) underwent repeat ablation. After 34 ± 8 months of first procedure, 66 (52%) in Group 1 and 386 (34%) in Group 2 had recurrence (P < 0.001). Recurrence rate in only-MS, only-OSA, and without MS/OSA groups were 40%, 38%, and 29%, respectively. Patients with MS + OSA experienced substantially higher recurrence compared to those with lone MS or OSA (52% vs. 40% vs. 38%; P = 0.036). Of the 452 patients having recurrence, 250 underwent redo-ablation and 194 remained on AAD and LSM. At 20 ± 6 months, 76% of the redo group remained arrhythmia-free off AAD whereas 74% of the LSM group were free from recurrence (P = 0.71), 33% of which were off AAD. CONCLUSIONS: MS and OSA have additive negative effect on arrhythmia recurrence following single procedure. Repeat ablation or compliant LSM increase freedom from recurrent AF.

Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial.

BACKGROUND: Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. METHODS AND RESULTS: This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). CONCLUSION: This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01006876.