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).

WITHDRAWN: Hybrid Procedure (Endo/Epicardial) Versus Standard Manual Ablation in Patients Undergoing Ablation of Longstanding Persistent Atrial Fibrillation: Results from a Single Center.

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Intraprocedural and long-term incomplete occlusion of the left atrial appendage following placement of the WATCHMAN device: a single center experience.

INTRODUCTION: Transcatheter left atrial appendage (LAA) closure with the WATCHMAN device has become one of the therapeutic options in atrial fibrillation (AF) patients who are at high risk for ischemic stroke. However, the incidence and evolution of incomplete occlusion of the LAA during and after placement of the WATCHMAN device has not been reported. METHODS AND RESULTS: Fifty-eight consecutive patients who had undergone WATCHMAN device implant were included in the study. Intraprocedural, 45-day and 12-month transesophageal echocardiogram images were reviewed and analyzed. Peridevice gap was noted in 16 (27.6%), 17 (29.3%), and 20 (34.5%) patients across the 3 time points. Intraprocedural gaps are more likely to be persistent until 12 months and become larger in size over time. New gap also occurs during follow-up even if the LAA was completely sealed at implantation. One patient had an ischemic stroke 4.7 months after implant; another patient developed a left atrial thrombus over the device 21.6 months after implant. Both patients had intraprocedural gap and discontinued warfarin therapy after the 45-day evaluation. CONCLUSION: Incomplete LAA occlusion with a gap between the WATCHMAN device surface and the LAA wall is relatively common. Intraprocedural gaps are more likely to become bigger over time and persist, while new gaps also occur during follow-up. Further studies are warranted to verify whether the presence and persistence of a peridevice gap is associated with increased risk of thromboembolic event in AF patients implanted with a WATCHMAN device.

Transseptal access and atrial fibrillation ablation guided by intracardiac echocardiography in patients with atrial septal closure devices.

BACKGROUND: Percutaneous positioning of closure devices is a well-established treatment of atrial septal defects (ASDs). However, patients who have undergone the procedure are at increased risk for developing atrial fibrillation (AF), and treatment by catheter ablation is underutilized due to the perceived difficulty of obtaining transseptal access in the presence of the closure device. OBJECTIVE: The purpose of this study was to report the acute and long-term results of radiofrequency catheter ablation of AF in patients with ASD closure devices. METHODS: Thirty-nine patients (age 54 ± 6 years, 72% males) with drug-refractory AF (33% paroxysmal, 51% persistent, 16% long-standing persistent) and ASD closure devices (82% Amplatzer, 18% CardioSEAL) underwent radiofrequency catheter ablation. A double transseptal access guided by intracardiac echocardiography was obtained in all patients. RESULTS: In 35 of 39 patients (90%), the transseptal access was obtained in a portion of the native septum, whereas in 4 of 39 patients (10%), a direct access through the device was required. The latter group had a significantly longer time for achieving the double transseptal access (73.6 ± 1.1 minutes vs. 4.3 ± 0.4 minutes, P < .001), longer fluoroscopy time (122 ± 5 minutes vs. 80 ± 8 minutes, P < .001), and total procedural time (4.1 ± 0.2 hours vs. 3.1 ± 0.3 hours, P < .001). At follow-up of 14 ± 4, months the overall success rate was 77% (85% in paroxysmal AF, 73% in nonparoxysmal AF). Transthoracic contrast-enhanced echocardiography with the Valsalva maneuver, performed between 3 and 6 months after the procedure, failed to detect shunt in all patients. CONCLUSION: Radiofrequency catheter ablation of AF is feasible, safe, and effective in patients with ASD closure devices. Transseptal access can be obtained in portions of the native septum in the majority of cases. Direct transseptal puncture of the device is feasible and safe but requires longer time for each transseptal access.

Positioning of left ventricular pacing lead guided by intracardiac echocardiography with vector velocity imaging during cardiac resynchronization therapy procedure.

INTRODUCTION: Intraoperative modality for "real-time" left ventricular (LV) dyssynchrony quantification and optimal resynchronization is not established. This study determined the feasibility, safety, and efficacy of intracardiac echocardiography (ICE), coupled with vector velocity imaging (VVI), to evaluate LV dyssynchrony and to guide LV lead placement at the time of cardiac resynchronization therapy (CRT) implant. METHODS: One hundred and four consecutive heart failure patients undergoing ICE-guided (Group 1, N = 50) or conventional (Group 2, N = 54) CRT implant were included in the study. For Group 1 patients, LV dyssynchrony and resynchronization were evaluated by VVI including visual algorithms and the maximum differences in time-to-peak (MD-TTP) radial strain. Based on the findings, the final LV lead site was determined and optimal resynchronization was achieved. CRT responders were defined using standard criteria 6 months after implantation. RESULTS: Both groups underwent CRT implant with no complications. In Group 1, intraprocedural optimal resynchronization by VVI including visual algorithms and MD-TTP was a predictor discriminating CRT response with a sensitivity of 95% and specificity of 89%. Use of ICE/VVI increased number of and predicted CRT responders (82% in Group 1 vs 63% in Group 2; OR = 2.68, 95% CI 1.08-6.65, P = 0.03). CONCLUSION: ICE can be safely performed during CRT implantation. "Real-time" VVI appears to be helpful in determining the final LV lead position and pacing mode that allow better intraprocedural resynchronization. VVI-optimized acute resynchronization predicts CRT response and this approach is associated with higher number of CRT responders.

Left atrial appendage: an underrecognized trigger site of atrial fibrillation.

BACKGROUND: Together with pulmonary veins, many extrapulmonary vein areas may be the source of initiation and maintenance of atrial fibrillation. The left atrial appendage (LAA) is an underestimated site of initiation of atrial fibrillation. Here, we report the prevalence of triggers from the LAA and the best strategy for successful ablation. METHODS AND RESULTS: Nine hundred eighty-seven consecutive patients (29% paroxysmal, 71% nonparoxysmal) undergoing redo catheter ablation for atrial fibrillation were enrolled. Two hundred sixty-six patients (27%) showed firing from the LAA and became the study population. In 86 of 987 patients (8.7%; 5 paroxysmal, 81 nonparoxysmal), the LAA was found to be the only source of arrhythmia with no pulmonary veins or other extrapulmonary vein site reconnection. Ablation was performed either with focal lesion (n=56; group 2) or to achieve LAA isolation by placement of the circular catheter at the ostium of the LAA guided by intracardiac echocardiography (167 patients; group 3). In the remaining patients, LAA firing was not ablated (n=43; group 1). At the 12+/-3-month follow-up, 32 patients (74%) in group 1 had recurrence compared with 38 (68%) in group 2 and 25 (15%) in group 3 (P<0.001). CONCLUSIONS: The LAA appears to be responsible for arrhythmias in 27% of patients presenting for repeat procedures. Isolation of the LAA could achieve freedom from atrial fibrillation in patients presenting for a repeat procedure when arrhythmias initiating from this structure are demonstrated.

Locating the right phrenic nerve by imaging the right pericardiophrenic artery with computerized tomographic angiography: implications for balloon-based procedures.

BACKGROUND: Phrenic nerve (PN) injury, a known complication of radiofrequency (RF) catheter ablation of atrial fibrillation (AF), has been more commonly reported with balloon-based pulmonary vein isolation. OBJECTIVE: We present a novel approach to locating the PN and predicting patients at higher risk of this complication. METHODS: The study included 2 groups of patients. In the first group of 71 patients, computerized tomographic angiography (CTA) with 3-dimensional reconstruction of the left atrium (LA) was obtained prior to an RF ablation procedure. The location of the right pericardiophrenic artery (RPA) was identified on the axial CTA images, and the artery distance to the right superior pulmonary vein (RSPV) ostium was measured in the 3-dimensional image. During ablation, the location of the right PN was identified by pacing maneuvers. The distance to the ostium of the RSPV was measured by venography and compared with the CTA artery measurement. In the second group, CTA imaging from 37 subjects who were enrolled in 3 investigational balloon ablation trials were analyzed using the same PN location technique and compared against the clinical outcomes. In this analysis, the CTA segmentation and PN location was performed in a blinded fashion as to any clinical evidence of PN injury. RESULTS: The mean measurement difference between PN capture and imaged RPA was 0.8 mm (P = .539). In all cases, the imaged RPA could reliably identify the approximate location of the right PN (R-square 0.984, P < .001). Moreover, this analysis suggests that a PN location within 10 mm of the RSPV poses a higher risk of PN injury using these balloon ablation devices. CONCLUSION: Imaging the right pericardiophrenic artery can reliably locate the right phrenic nerve. This technique might identify anatomy more vulnerable to phrenic nerve injury using balloon-based ablation systems.

The impact of statins and renin-angiotensin-aldosterone system blockers on pulmonary vein antrum isolation outcomes in post-menopausal females.

AIMS: To assess whether treatment with statins or renin-angiotensin-aldosterone system (RAAS) inhibitors as potential procedural 'augmenting agents' improved atrial fibrillation (AF) catheter ablation recurrence rates in post-menopausal females (PMFS). METHODS AND RESULTS: Five hundred and eighteen consecutive female patients had undergone AF catheter ablation from January 2005 to May 2008. Post-menopausal females were selected and procedure outcomes were compared between cohorts of PMFS treated with statins or RAAS inhibitors to untreated PMFS. Out of 408 PMFS, 36 (8.8%) were treated with a combination of RAAS inhibitors and statins, thus were excluded leaving a total of 372 (91.2%) patients in the study. Out of 372 patients, 111 (29.8%) were on statins (Group 1), 59 (15.9%) on RAAS inhibitors (Group 2), and 202 (54.3%) without RAAS inhibitors or statins [(Group 3) control population]. Over a mean follow-up time of 24 +/- 8.3 (median 25) months, 78 (70.6%) in Group 1, 38 (65.4%) in Group 2, and 139 (68.8%) in Group 3 had procedural success. Statin or RAAS inhibitor use did not predict lower recurrence rates [hazard ratio (HR): 1.26, P = 0.282 and HR: 1.14, P = 0.728, respectively]. When compared with controls, no difference in the cumulative incidence of recurrence was found with statin or RAAS inhibitors use (P = 0.385 and P = 0.761, respectively). CONCLUSION: Treatment with statins or RAAS inhibitors did not improve catheter ablation success rates among PMFS. Thereby, from a clinical standpoint, PMFS should not be started on these treatments as a procedural 'augmenting agent' at this time.

Outcomes and complications of catheter ablation for atrial fibrillation in females.

BACKGROUND: Most atrial fibrillation (AF) ablation studies have consisted predominantly of males; accordingly, there is a paucity of information on the safety and efficacy of catheter ablation in a large cohort of female AF patients. OBJECTIVE: The purpose of this study was to evaluate catheter ablation for AF in female patients. METHODS: From January 2005 to May 2008, 3265 females underwent pulmonary vein antrum isolation. Success rates, patient profiles, and complications were collected. RESULTS: Approximately 16% of our population was female (P <.001). Females were older (59 +/- 13 vs. 56 +/- 19 years; P <.01) and had a lower prevalence of paroxysmal atrial fibrillation (PAF; 46% vs. 55%; P <.001). Females failed more antiarrhythmics (4 +/- 1 vs. 2 +/- 3; P = .04) and were referred later for catheter ablation (6.51 +/- 7 vs. 4.85 +/- 6.5 years; P = .02) than males. More females failed ablation (31.5% vs. 22.5%; P = .001) and had nonantral sites of firing than males (P <.001). Female patients had 11 (2.1%) hematomas versus 27 (0.9%) in males. CONCLUSIONS: Five times as many males underwent catheter ablation than females. Females failed more ablations possibly because of a higher prevalence of nonantral firing, non-PAF, and longer history of AF. Females had more bleeding complications than males.

Long-term functional and neurocognitive recovery in patients who had an acute cerebrovascular event secondary to catheter ablation for atrial fibrillation.

INTRODUCTION: Cerebral thromboembolic event (CTE) is a possible complication of pulmonary vein antrum isolation (PVAI). The objective of this study was to report long-term functional and neurocognitive recovery in patients who had a CTE during or within 48 hours of catheter ablation. METHODS AND RESULTS: We screened 3,060 patients who underwent PVAI between January 2000 and June 2007. Out the 3,060 patients, 26 patients (0.8%) (61 +/- 8 years, 88% males) had a CTE during or within 48 hours of the procedure. We followed these 26 patients (study group) over time and assessed their functional and neurocognitive recovery status. No preferential vascular territory for the site of obstruction was found; right anterior circulation-5 patients (26%), left anterior circulation-5 patients (26%), posterior circulation-3 patients (16%), and 2 or more territories-6 patients (32%), (P-value = 0.8). The average international normalized ratio at the time of CTE was 1.33 +/- 0.4. Two patients died during the study period. At the end of 38.4 +/- 24 months follow-up, most surviving patients had complete neurocognitive and functional recovery irrespective of the severity of periprocedural stroke. CONCLUSIONS: Periprocedural stroke in the setting of catheter ablation for atrial fibrillation is relatively rare. When it occurs, complete functional and neurocognitive recovery over time is the likely outcome for most patients.

Omega-3 polyunsaturated Fatty Acid supplementation reduced atrial fibrillation recurrence after pulmonary vein antrum isolation.

OBJECTIVE: To assess if patients treated with omega-3(n-3) polyunsaturated fatty acids (PUFAS) had lower procedural failure rates compared to an untreated population. METHODS AND RESULTS: From January 2004 to 2007, 1500 PVAI patients underwent catheter ablation. Two hundred and eighty five (19%) patients were treated with PUFAs. These patients were matched in a nested case controlled analysis. After matching, there were 129 patients in the PUFA group and 129 in the control group. Thirty-five (27.1%) patients in the study group had early recurrence vs. 57 (44.1%) in the control group p-value< 0.0001. Twenty-nine (23.2%) patients in the PUFA group vs. 41 (31.7%) in the non-PUFA group had procedural failure (p-value < 0.003). There were no significant differences in complications in the PUFA and non-PUFA groups. CONCLUSION: Patients treated with PUFAs had lower incidences of early recurrence and procedural failure compared to an untreated population.

Ablation of atrial fibrillation utilizing robotic catheter navigation in comparison to manual navigation and ablation: single-center experience.

BACKGROUND: Robotic catheter navigation and ablation either with magnetic catheter driving or with electromechanical guidance have emerged in the recent years for the treatment of atrial fibrillation. OBJECTIVE: The aim of this study was to compare our center's experience of atrial fibrillation ablation using the Hansen Robotic Medical System with our current manual ablation technique in terms of acute and chronic success, as well as procedure time and radiation exposure to both the patient and the operator. METHODS: A total of 390 consecutive patients with symptomatic and drug-resistant atrial fibrillation (289 males, 62 +/- 11 years) were prospectively enrolled in the study. All patients underwent the procedure either with conventional manual ablation (group 1, n = 197) or with the robotic navigation system (RNS) (group 2, n = 193). RESULTS: The success rate for RNS was 85% (164 patients), while for manual ablation it was 81% (159 patients) (p = 0.264) at 14.1 +/- 1.3 months with AADs previously ineffective. Fluoroscopy time was significantly lower for RNS (48.9 +/- 24.6 minutes for RNS vs. 58.4 +/- 20.1 minutes for manual ablation, P < 0.001). Mean fluoroscopy time was statistically reduced after 50 procedures (61.8 +/- 23.2 minutes for first 50 cases vs. 44.5 +/- 23.6 minutes for subsequent procedures, P < 0.0001). CONCLUSION: Robotic navigation and ablation of atrial fibrillation is safe and effective. Fluoroscopy time decreases with experience.

Bidirectional tachycardia eliminated with radiofrequency ablation.

This report describes an unusual case of bidirectional tachycardia eliminated with radiofrequency ablation. The tachycardia had alternating right and left bundle branch block morphology on a beat-to-beat basis and was successfully eliminated by ablating the right and left bundle branch block ventricular ectopic beats present during sinus rhythm.