Early ablation of newly diagnosed paroxysmal atrial fibrillation (NEWPaAF) versus newly diagnosed persistent atrial fibrillation (NEWPeAF): Comparison of patient populations and ablation outcomes.

INTRODUCTION: Little is known about very early atrial fibrillation (AF) ablation after first AF detection. METHODS: We evaluated patients with AF ablation <4 months from newly diagnosed paroxysmal AF (NEWPaAF) and newly diagnosed persistent AF (NEWPeAF). We compared the two patient populations and compared ablation outcomes to those undergoing later ablation. RESULTS: Ablation was done <4 months from AF diagnosis in 353 patients (135 = paroxysmal, 218 = persistent). Early ablation outcome was best for NEWPaAF versus NEWPeAF for initial (p = 0.030) but not final (p = 0.102) ablation. Despite recent AF diagnosis in both groups, they were clinically quite different. NEWPaAF patients were younger (64.3 ± 13.0 vs. 67.3 ± 10.9, p = 0.0020), failed fewer drugs (0.39 vs. 0.60, p = 0.007), had smaller LA size (4.12 ± 0.58 vs. 4.48 ± 0.59 cm, p < 0.0001), lower BMI (28.8 ± 5.0 vs. 30.3 ± 6.0, p = 0.016), and less CAD (3.7% vs. 11.5%, p = 0.007), cardiomyopathies (2.2% vs. 22.9%, p = 0.0001), hypertension (46.7% vs. 67.4%, p < 0.0001), diabetes (8.1% vs. 17.4%, p = 0.011) and sleep apnea (20.0% vs. 30.3%, p = 0.031). For NEWPaAF, early ablation AF-free outcome was no better than later ablation (p = 0.314). For NEWPeAF, AF-free outcomes were better for early ablation than later ablation (p < 0.0001). Delaying ablation allowed more strokes/TIAs in both AF types (paroxysmal p = 0.014, persistent p < 0.0001). CONCLUSIONS: Patients presenting for early ablation after newly diagnosed persistent AF have more pre-existing comorbidities and worse initial ablation outcomes than patients with NEWPaAF. For NEWPaAF, there was no advantage to early ablation, as long as the AF remained paroxysmal. For NEWPeAF, early ablation gave better outcomes than later ablation and they should undergo early ablation. For both AF types, waiting was associated with more neurologic events, suggesting all patients should consider earlier ablation.

Electrographic flow mapping of persistent atrial fibrillation: intra- and inter-procedure reproducibility in the absence of 'ground truth'.

AIMS: Validating mapping systems that identify atrial fibrillation (AF) sources (focal/rotational activity) is confounded by the absence of ground truth. A key concern of prior mapping technologies is spatiotemporal instability, manifesting as poor map reproducibility. Electrographic flow (EGF) employs a novel algorithm that visualizes atrial electrical wavefront propagation to identify putative AF sources. We analysed both intra- (3 min) and inter- (>3 months) procedure EGF map reproducibility. METHODS AND RESULTS: In 23 persistent AF patients, after pulmonary vein isolation (PVI), EGF maps were generated from 3 serial 1 min recordings using a 64-electrode basket mapping catheter (triplets) at right and left atrial locations. Source prevalence from map triplets was compared between recordings. Per protocol, 12 patients returned for 3-month remapping (1 non-inducible): index procedure post-PVI EGF maps were compared with initial EGF remapping at 3-month redo. Intra-procedure reproducibility: analysing 224 map triplets (111 right atrium, 113 left atrium) revealed a high degree of map consistency with minimal min-to-min shifts: 97 triplets (43%), exact match of leading sources on all 3 maps; 95 triplets (42%), leading source within 1 electrode space on 2 of 3 maps; and 32 triplets (14%), chaotic leading source pattern. Average deviation in source prevalence over 60 s was low (6.4%). Inter-procedure reproducibility: spatiotemporal stability of EGF mapping >3 months was seen in 16 of 18 (89%) sources mapped in 12 patients with (re)inducible AF. CONCLUSION: Electrographic flow mapping generates reproducible intra- and inter-procedural maps, providing rationale for randomized clinical trials targeting these putative AF sources.

Functional electrographic flow patterns in patients with persistent atrial fibrillation predict outcome of catheter ablation.

AIMS: Electrographic flow (EGF) mapping is a method to detect action potential sources within the atria. In a double-blinded retrospective study we evaluated whether sources detected by EGF are related to procedural outcome. METHODS: EGF maps were retrospectively generated using the Ablamap® software from unipolar data recorded with a 64-pole basket catheter from patients who previously underwent focal impulse and rotor modulation-guided ablation. We analyzed patient outcomes based on source activity (SAC) and variability. Freedom from atrial fibrillation (AF) was defined as no recurrence of AF, atypical flutter or atrial tachycardia at the follow-up visits. RESULTS: EGF maps were from 123 atria in 64 patients with persistent or long-standing persistent AF. Procedural outcome correlation with SAC peaked at >26%. S-type EGF signature (source-dependent AF) is characterized by stable sources with SAC > 26% and C-type (source-independent AF) is characterized by sources with SAC ≤ 26%. Cases with AF recurrence at 3-, 6-, or 12-month follow-up showed a median final SAC 34%; while AF-free patients had sources with significantly lower median final SAC 21% (p = .0006). Patients with final SAC and Variability above both thresholds had 94% recurrence, while recurrence was only 36% for patients with leading source SAC and variability below threshold (p = .0001). S-type EGF signature post-ablation was associated with an AF recurrence rate 88.5% versus 38.1% with C-type EGF signature. CONCLUSIONS: EGF mapping enables the visualization of active AF sources. Sources with SAC > 26% appear relevant and their presence post-ablation correlates with high rates of AF recurrence.

Performance of a novel active fixation quadripolar left ventricular lead for cardiac resynchronization therapy: Attain Stability Quad Clinical Study results.

INTRODUCTION: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. METHODS: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. RESULTS: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. CONCLUSIONS: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.

Comparison of CHADS2 and CHA2DS2-VASC anticoagulation recommendations: evaluation in a cohort of atrial fibrillation ablation patients.

AIMS: Atrial fibrillation (AF) is associated with a high incidence of strokes/thromboembolism. The CHADS2 score assigns points for several clinical variables to identify stroke risk. The CHA2DS2-VASC score uses the same variables but also incorporates age 65 to 74, female gender, and vascular disease in an effort to provide a more refined risk of stroke/thromboembolism. We aimed to examine oral anticoagulation (OAC) recommendations for a cohort of patients undergoing AF ablation depending upon whether thrombo-embolic risk was determined by the CHADS2 or CHA2DS2-VASC score. METHODS AND RESULTS: For 1411 patients we compared OAC recommendations for each of these risk stratification schemes to one of the three OAC strategies: (i) NO-OAC, (ii) CONSIDER-OAC, and (iii) DEFINITE-OAC. Compared with the CHADS2 score, the CHA2DS2-VASC score reduced NO-OAC from 40.3 to 21.8% and CONSIDER-OAC from 36.6 to 27.9% while increasing DEFINITE-OAC from 23.0 to 50.2% of patients. Age 65 to 74 and female gender accounted for 95.2% and vascular disease for only 4.8% of recommendations for more aggressive OAC using CHA2DS2-VASC. Most vascular disease occurred in patients with higher CHADS2 scores already recommended for DEFINITE-OAC (P < 0.0001). Reclassifying 30 females of age <65 with a CHA2DS2-VASC score of 1 to the NO-OAC group had minimal effect on the overall recommendations. CONCLUSION: Compared with the CHADS2 score, in our AF ablation population, the CHA2DS2-VASC score markedly increases the number of AF patients for whom OAC is recommended. It will be important to determine by randomized trials if this major paradigm shift to greater use of OAC using the CHA2DS2-VASC scoring improves patient outcomes.

Peri-procedural interrupted oral anticoagulation for atrial fibrillation ablation: comparison of aspirin, warfarin, dabigatran, and rivaroxaban.

AIMS: Atrial fibrillation ablation requires peri-procedural oral anticoagulation (OAC) to prevent thromboembolic events. There are several options for OAC. We evaluate peri-procedural AF ablation complications using a variety of peri-procedural OACs. METHODS AND RESULTS: We examined peri-procedural OAC and groin, bleeding, and thromboembolic complications for 2334 consecutive AF ablations using open irrigated-tip radiofrequency (RF) catheters. Pre-ablation OAC was warfarin in 1113 (47.7%), dabigatran 426 (18.3%), rivaroxaban 187 (8.0%), aspirin 472 (20.2%), and none 136 (5.8%). Oral anticoagulation was always interrupted and intraprocedural anticoagulation was unfractionated heparin (activated clotting time, ACT = 237 ± 26 s). Pre- and post-OAC drugs were the same for 1591 (68.2%) and were different for 743 (31.8%). Following ablation, 693 (29.7%) were treated with dabigatran and 291 (12.5%) were treated with rivaroxaban. There were no problems changing from one OAC pre-ablation to another post-ablation. Complications included 12 (0.51%) pericardial tamponades [no differences for dabigatran (P = 0.457) or rivaroxaban (P = 0.163) compared with warfarin], 12 (0.51%) groin complications [no differences for rivaroxaban (P = 0.709) and fewer for dabigatran (P = 0.041) compared with warfarin]. Only 5 of 2334 (0.21%) required blood transfusions. There were two strokes (0.086%) and no transient ischaemic attacks (TIAs) in the first 48 h post-ablation. Three additional strokes (0.13%), and two TIAs (0.086%) occurred from 48 h to 30 days. Only one stroke had a residual deficit. Compared with warfarin, the neurologic event rate was not different for dabigatran (P = 0.684) or rivaroxaban (P = 0.612). CONCLUSION: Using interrupted OAC, low target intraprocedural ACT, and irrigated-tip RF, the rate of peri-procedural groin, haemorrhagic, and thromboembolic complications was extremely low. There were only minimal differences between OACs. Low-risk patients may remain on aspirin/no OAC pre-ablation. There are no problems changing from one OAC pre-ablation to another post-ablation.

A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF).

BACKGROUND: Electrographic flow (EGF) mapping enables full spatiotemporal reconstruction of organized wavefront propagation to identify extrapulmonary vein sources of atrial fibrillation (AF). OBJECTIVES: FLOW-AF (A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW [EGF] Algorithm Technology [Ablamap Software] to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation) was multicenter, randomized controlled study of EGF mapping to: 1) stratify a nonparoxysmal AF population undergoing redo ablation; 2) guide ablation of these extrapulmonary vein AF sources; and 3) improve AF recurrence outcomes. METHODS: FLOW-AF enrolled persistent atrial fibrillation (PerAF)/long-standing PerAF patients undergoing redo ablation at 4 centers. One-minute EGF maps were recorded from standardized biatrial basket positions. Patients with source activity ≥26.5% were randomized 1:1 to PVI + EGF-guided ablation vs PVI only; patients without sources ≥26.5% threshold were not randomized. Follow-up and electrocardiographic monitoring occurred at 3, 6, and 12 months. RESULTS: We enrolled 85 patients (age 65.6 ± 9.3 years, 37% female, 24% long-standing PerAF). Thirty-four (40%) patients had no sources greater than threshold; at least 1 source greater than threshold was present in 46 (60%) (EGF-guided ablation, n = 22; control group, n = 26). Patients with sources were older (68.2 vs 62.6 years; P = 0.005) with higher CHA2DS2-VASc scores (2.8 vs 1.9; P = 0.001). The freedom from safety events was 97.2%, and 95% of EGF-identified sources were successfully ablated. In randomized patients, AF-free survival at 12 months was 68% for EGF-guided ablation vs 17% for the control group (P = 0.042); freedom from AF/atrial tachycardia/atrial flutter at 12 months was 51% vs 14% (P = 0.103), respectively. CONCLUSIONS: In nonparoxysmal AF patients undergoing redo ablation, EGF mapping identified AF sources in 60% of patients, and could be successfully ablated in 95%. Compared with PVI alone, PVI + source ablation improved AF-free survival by 51% on an absolute basis. (FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology [A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation]; NCT04473963).

Laser lead extraction in congenital heart disease: a case-controlled study.

INTRODUCTION: Patients with congenital heart disease (CHD) and implanted cardiac rhythm management devices have a high rate of endocardial lead issues requiring lead extraction. Laser lead extraction (LLE) is a promising modality for lead management though few studies have evaluated this technique in CHD. METHODS: This is a retrospective, case-controlled (gender- and age-matched, without CHD) analysis of all CHD patients from 2002-2010 at a single institution who underwent LLE as a primary extraction modality. The aim is to evaluate the utility of LLE in patients with CHD compared with controls without CHD. The primary outcome is LLE clinical success. Secondary outcomes include procedural success, complications, and factors related to LLE failure. RESULTS: Twenty-two patients with CHD underwent 24 LLE procedures to extract 35 leads. These were compared with 22 patients without CHD who underwent 24 LLE procedures to extract 37 leads. LLE clinical success was achieved for 26 of 35 leads (74%) in patients with CHD versus 35 of 37 leads (92%) in patients without CHD [P = 0.02]. No factors within the CHD group predicted LLE failure. Six of the nine leads for which LLE was unsuccessful were extracted using other methods. No complications were observed in the CHD group. CONCLUSIONS: Patients with CHD are less likely to have successful LLE than gender- and age-matched controls without CHD. LLE failures in CHD may be related to calcified adhesions. Mechanical-rotational devices and the femoral snare technique are useful for LLE failures. LLE provides an effective first-line approach for patients with CHD.

Visualization of electrographic flow fields of increasing complexity and detection of simulated sources during spontaneously persistent AF in an animal model.

Background: Mapping algorithms have thus far been unable to localize triggers that serve as drivers of AF, but electrographic flow (EGF) mapping provides an innovative method of estimating and visualizing in vivo, near real-time cardiac wavefront propagation. Materials and Methods: One-minute unipolar EGMs were recorded in the right atrium (RA) from a 64-electrode basket catheter to generate EGF maps during atrial rhythms of increasing complexity. They were obtained from 3 normal, animals in sinus rhythm (SR) and from 6 animals in which persistent AF which was induced by rapid atrial pacing. Concurrent EGF maps and high-resolution bipolar EGMs at the location of all EGF-identified sources were acquired. Pacing was subsequently conducted to create focal drivers of AF, and the accuracy of source detection at the pacing site was assessed during subthreshold, threshold and high-output pacing in the ipsilateral or contralateral atria (n = 78). Results: EGF recordings showed strong coherent flow emanating from the sinus node in SR that changed direction during pacing and were blocked by ablation lesions. Additional passive rotational phenomena and lower activity sources were visualized in atrial flutter (AFL) and AF. During the AF recordings, source activity was not found to be correlated to dominant frequency or f wave amplitude observed in concurrently recorded EGMs. While pacing in AF, subthreshold pacing did not affect map properties but pacing at or above threshold created active sources that could be accurately localized without any spurious detection in 95% of cases of ipsilateral mapping when the basket covered the pacing source. Discussion: EGF mapping can be used to visualize flow patterns and accurately identify sources of AF in an animal model. Source activity was not correlated to spectral properties of f-waves in concurrently obtained EGMs. The locations of sources could be pinpointed with high precision, suggesting that they may serve as prime targets for focal ablations.

Electrographic flow mapping for atrial fibrillation: theoretical basis and preliminary observations.

Ablation strategies remain poorly defined for persistent atrial fibrillation (AF) patients with recurrence despite intact pulmonary vein isolation (PVI). As the ability to perform durable PVI improves, the need for advanced mapping to identify extra-PV sources of AF becomes increasingly evident. Multiple mapping technologies attempt to localize these self-sustained triggers and/or drivers responsible for initiating and/or maintaining AF; however, current approaches suffer from technical limitations. Electrographic flow (EGF) mapping is a novel mapping method based on well-established principles of optical flow and fluid dynamics. It enables the full spatiotemporal reconstruction of organized wavefront propagation within the otherwise chaotic and disorganized electrical conduction of AF. Given the novelty of EGF mapping and relative unfamiliarity of most clinical electrophysiologists with the mathematical principles powering the EGF algorithm, this paper provides an in-depth explanation of the technical/mathematical foundations of EGF mapping and demonstrates clinical applications of EGF mapping data and analyses. Starting with a 64-electrode basket catheter, unipolar EGMs are recorded and processed using an algorithm to visualize the electrographic flow and highlight the location of high prevalence AF "source" activity. The AF sources are agnostic to the specific mechanisms of source signal generation.

Very long term outcomes of atrial fibrillation ablation.

BACKGROUND: Little is known about the very long term durability of atrial fibrillation (AF) ablation. OBJECTIVE: The purpose of this study was to evaluate very long term AF ablation outcomes. METHODS: We followed 5200 patients undergoing 7145 ablation procedures. We evaluated outcomes after single and multiple ablation procedures for paroxysmal (PAF; 33.6%), persistent (PeAF; 56.4%), and long-standing (LsAF; 9.9%) AF. We compared 3 ablation eras by initial ablation catheter: early (101 patients) using solid big tip (SBT) catheters (October 2003 to December 2005), intermediate (2143 patients) using open irrigated tip (OIT) catheters (December 2005 to August 2016), and contemporary (2956 patients) using contact force (CF) catheters (March 2014 to December 2021). RESULTS: AF freedom at 5, 10, and 15 years was as follows: initial ablation: PAF 67.8%, 56.3%, 47.6%; PeAF 46.6%, 35.6%, 26.5%; and LsAF 30.4%, 18.0%, 3.4%; final ablation: PAF 80.3%, 72.6%, 62.5%; PeAF 60.1%, 50.2%, 42.5%; and LsAF 43.4%, 32.0%, 20.6%. For PAF and PeAF, CF ablation procedures were better than OIT ablation procedures (P < .0001) and both were better than SBT ablation procedures (P < .001). LsAF had no outcome improvement over the eras. The 8-year success rate after final ablation for CF, OIT, and SBT catheter eras was as follows: PAF 79.1%, 71.8%, 60.0%; PeAF 55.9%, 50.7%, 38.0%; and LsAF 42.7%, 36.2%, 31.8%. Highest AF recurrence was in the first 2 years, with a 2- to 15-year recurrence of 2%/yr. Success predictors after initial and final ablation procedures were younger age, smaller left atrium, shorter AF duration, male sex, less persistent AF, lower CHA2DS2-VASc score, fewer drugs failed, and more recent catheter era. CONCLUSION: After year 2, there is 2%/yr recurrence rate for all AF types. Ablation success is best in the CF catheter era, intermediate in the OIT era, and worst in the SBT era. Over the ablation eras, outcomes improved for PAF and PeAF but not for LsAF. We should follow patients indefinitely after ablation. We need an understanding of how to better ablate more persistent AF.

Electrographic flow-guided ablation in redo patients with persistent atrial fibrillation (FLOW-AF): design and rationale.

Background: Electrographic flow (EGF) mapping enables the dynamic detection of functional or active atrial fibrillation (AF) sources outside the pulmonary veins (PVs), and the presence or absence of these sources offers a novel framework for classifying and treating persistent AF patients based on the underlying pathophysiology of their AF disease. Objective: The primary objective of the FLOW-AF trial is to evaluate the reliability of the EGF algorithm technology (Ablamap software) to identify AF sources and guide ablation therapy in patients with persistent AF. Methods: The FLOW-AF trial (NCT04473963) is a prospective, multicenter, randomized clinical study in which patients with persistent or long-standing persistent AF who have failed prior PV isolation (PVI) undergo EGF mapping after confirmation of intact PVI. In total, 85 patients will be enrolled and stratified based on the presence or absence of EGF-identified sources. Patients with an EGF-identified source above the predetermined activity threshold of ≥26.5% will be randomized in a 1:1 fashion to PVI only vs PVI + ablation of EGF-identified extra-PV sources of AF. Results: The primary safety endpoint is freedom from serious adverse events related to the procedure through 7 days following the randomization procedure; and the primary effectiveness endpoint is the successful elimination of significant sources of excitation with the target parameter the activity of the leading source. Conclusions: The FLOW-AF trial is a randomized study designed to evaluate the ability of the EGF mapping algorithm to identify patients with active extra-PV AF sources.

The use of dabigatran immediately after atrial fibrillation ablation.

INTRODUCTION: Atrial fibrillation (AF) ablation requires postprocedural anticoagulation to prevent thromboembolic events because of the ablation procedure itself or due to recurrent AF postprocedure. Dabigatran is a new anticoagulant and may be useful after AF ablation to prevent thromboembolic events. METHODS AND RESULTS: We evaluated 123 consecutive patients who were started on dabigatran after AF ablation. Patients were given enoxaparin 0.5 mg/kg at the end of the procedure, which was repeated 12 hours later and then discontinued. Dabigatran was started 22 hours postablation with drug dose based on renal function. Primary outcomes were thromboembolic events, bleeding complications, and side effects over a 30-day follow-up period. The preablation anticoagulant was warfarin in 56 (45.5%) patients, dabigatran in 34 (27.6%), and aspirin in 26 (21.1%). Seven (5.7%) patients were on no anticoagulant before ablation. The patients on dabigatran before ablation with normal renal function had the drug stopped 36 hours preablation. There were no preprocedural or intraprocedural thromboembolic episodes or bleeding. Three patients received dabigatran 75 mg bid and the rest 150 mg bid. There were no postablation strokes, transient ischemic attacks, or systemic thromboemboli in any patient. Three patients discontinued dabigatran and were changed to warfarin, 2 because of gastrointestinal side effects and 1 because of a diffuse rash. CONCLUSIONS: Dabigatran is safe and well tolerated after AF ablation. It did not cause bleeding complications and there were no thromboembolic events. Dabigatran appears to be an alternative to warfarin after AF ablation.

Prior antiarrhythmic drug use and the outcome of atrial fibrillation ablation.

AIMS: Atrial fibrillation (AF) ablation is generally performed after patients fail antiarrhythmic drug (AAD) therapy. Some patients have drug contraindications or choose to avoid a lifetime of drug therapy. Little is known about the impact of previous drug therapy on ablation outcomes. We evaluated AAD use before AF ablation and its impact on ablation outcomes. METHODS AND RESULTS: We evaluated freedom from AF after ablation and patients' clinical characteristics by number of AADs failed in 1125 patients undergoing 1504 ablations. We also evaluated reasons why some patients did not receive prior drug therapy. Cox multivariate analysis examined factors predicting ablation failure. Patients failing more drugs before ablation were older (P = 0.001), had a longer duration of AF (P = 0.0001), were more likely female (P = 0.037), had more repeat ablations (P = 0.045), and less paroxysmal AF (P = 0.003). For patients with either paroxysmal or persistent AF, the number of drugs failed predicted AF recurrence (P = 0.0001). Other factors predicting AF recurrence following final ablation included age (P = 0.004), left atrial size (P = 0.002), female gender (P = 0.0001), and persistent AF (P = 0.0001). The reason for not receiving prior drug therapy was medical in 21.5% and patient choice in 78.5%. Number of drugs failed did not influence ablation outcome for patients with long-standing persistent AF (P = 0.352). CONCLUSIONS: For paroxysmal and persistent AF patients undergoing ablation, those failing fewer AADs have different clinical characteristics than those who fail more drugs. Our study also suggests that the more drugs failed pre-ablation, the lower the freedom from AF post-procedure, possibly due to AF progression during drug trials.

Left atrial anatomical variations correlate with atrial fibrillation sources near the left atrial ridge.

Introduction: Anatomical variations and characteristics of the left atrium (LA) may have a previously undescribed effect on source locations in atrial fibrillation (AF). This is the first study aiming to investigate the relationship between anatomical characteristics of the LA and non-PV sources detected by electrographic flow (EGF) mapping in patients with persistent AF. Materials and methods: We analyzed cardiac computed tomography (CT) and EGF mapping data in patients who underwent radiofrequency catheter ablation (CA). EGF mapping is a novel method based on Horn-Schunk flow estimation algorithm, used to estimate cardiac action potential flow in the atria that can detect AF sources in patients with persistent AF. By analyzing EGF maps obtained during CA procedures, we localized non-PV sources in the LA. Results: Thirty patients were included in this study (mean age 62.4 ± 6.8 years). Ten patients had AF sources near the LA ridge, while twenty patients had no leading source (source activity > 26%) near the LA ridge. LA anatomical characteristics, left atrial appendage (LAA) length, and ostial diameter showed no correlation with the presence of a leading source. We documented 19 patients with abutting LAA and left superior pulmonary vein (LSPV) (distance < 2 mm), and 11 patients with non-abutting LAA-LSPV (distance > 2 mm). Three out of 19 patients presented with a leading source near ridge in the abutting LAA-LSPV group, while 7 out of 11 patients presented with a leading source near the ridge in the non-abutting LAA-LSPV group (p = 0.01). Conclusion: Our data suggests that non-abutting LAA-LSPV is associated with the presence of AF sources near the LA ridge.

Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with an increased risk of stroke, heart failure, and death. Data on contemporary treatment patterns and outcomes associated with AF in clinical practice are limited. METHODS/DESIGN: The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation is a multicenter, prospective, ambulatory-based registry of incident and prevalent AF. The registry will be a nationwide collaboration of health care providers, including internists, primary care physicians, cardiologists, and electrophysiologists. Initial target enrollment is approximately 10,000 patients to be recruited from approximately 200 US outpatient practices. Enrolled patients will be observed for ≥2 years. A patient-reported outcomes substudy in ≥1,500 patients will provide serial quality-of-life assessments. The goal is to characterize treatment and outcomes of patients with AF, thereby promoting better quality of AF care and improved patient outcomes. CONCLUSION: The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation will provide insights into "real-world" treatment including rate and rhythm control, stroke prevention, transitions to new therapies, and clinical and patient-centered outcomes among patients with AF in community practice settings (ClinicalTrials.gov NCT01165710).

Efficacy of adjunctive ablation of complex fractionated atrial electrograms and pulmonary vein isolation for the treatment of atrial fibrillation: a meta-analysis of randomized controlled trials.

AIMS: Although useful, percutaneous left atrial ablation for pulmonary vein isolation (PVI) does not eliminate atrial fibrillation (AF) in all patients. The ablation of complex fractionated atrial electrograms (CFAEs) has been proposed as an adjunctive strategy to improve the maintenance of sinus rhythm after PVI. Our objective was to analyse the efficacy of adjunctive CFAE ablation. METHODS AND RESULTS: We meta-analysed six randomized controlled trials (total, n=538) using random-effects modelling to compare PVI (n=291) with PVI plus CFAE ablation (PVI+CFAE) (n=237). The primary outcome was freedom from AF or other atrial tachyarrhythmias (ATs) after a single ablation with or without antiarrhythmic drugs. Following a single ablation, PVI+CFAE improved the odds of freedom from any AF/AT compared with PVI alone (odds ratio 2.0, 95% confidence interval 1.04-3.8, P=0.04) at ≥3-month follow-up. There was moderate heterogeneity among trials (I2=63.0%). Complex fractionated atrial electrogram ablation significantly increased mean procedural (178.5±66.9 vs. 331.5±92.6 min, P<0.001), mean fluoroscopy (59.5±22.2 vs. 115.5±35.3 min, P<0.001), and mean radiofrequency (RF) energy application times (46.9±36.6 vs. 74.4±43.0 min, P<0.001). CONCLUSIONS: Pulmonary vein isolation followed by adjunctive CFAE ablation is associated with increased freedom from AF after a single procedure. Adjunctive CFAE ablation increased procedural, fluoroscopy, and RF application times, and the risk/benefit profile of adjunctive CFAE ablation deserves further evaluation with additional studies and longer-term follow-up.

Internationally validated score to predict the outcome of non-paroxysmal atrial fibrillation ablation: the 'FLAME score'.

BACKGROUND: The clinical effectiveness of ablating non-paroxysmal atrial fibrillation (non-PAF) relies on proper patient selection. We developed and validated a scoring system to predict non-PAF ablation outcomes. METHODS: Data on 416 non-PAF ablations were analysed using binary logistic regression at a London centre. Identified preprocedural variables, which independently predicted freedom from atrial tachyarrhythmia. Twenty-one possible predictive variables and a model with c-statistic 0.751-explained outcome variation in London at mean follow-up 12±3 months. An additive point score (range 0-9) was developed-the FLAME score: female=1; long-lasting persistent atrial fibrillation=1; left atrial diameter in mm: 40 to <45 = 1, 45 to <50 = 2, 50 to <55=3, ≥55 =4; mitral regurgitation (MR) mild to moderate=1; extreme comorbidity=2. Extreme comorbidities include severe MR, moderate mitral stenosis, mitral replacement, hypertrophic cardiomyopathy or congenital heart disease. RESULTS: The FLAME score was applied to data (882 non-PAF ablations) at a Californian centre, and predicted the outcome of both single (p<0.0001) and multiple (p<0.0001) procedures. For first ablation (follow-up 2.1 years (median, IQR 1.0-4.1)), FLAME score: 0-1 predicts 62% success, 2-4 44% and ≥5 29% (Ptrend <0.0001). After the final ablation (mean procedures: 1.4±0.6, follow-up 1.8 years (median, IQR 0.8-3.6)), FLAME score: 0-1 predicts 81% success, 2-4 65% and ≥5 44% (Ptrend <0.0001). CONCLUSIONS: FLAME score is easily calculated, derived in London, and predicted single and multiple procedural outcomes for non-PAF ablations in California. In patients with a high score, even multiple procedures are usually ineffective.

Cost-effectiveness of implantable cardioverter defibrillators in patients >or=65 years of age.

BACKGROUND: More than 80% of sudden cardiac deaths (SCDs) occur in patients >or=65 years old; the cost-effectiveness of implantable cardioverter defibrillator (ICD) therapy in older patients remains unclear. We sought to examine the cost-effectiveness of ICD therapy in at-risk patients >or=65 years old. METHODS: We developed a Markov model to evaluate lifetime costs and benefits of ICD therapy compared with optimal medical therapy in patients >or=65 years of age with left ventricular dysfunction. Data were derived from the literature and existing clinical trials of primary prevention of SCD. Outcome measures included life years, quality-adjusted life years, costs, and incremental cost-effectiveness. RESULTS: Benefits and costs of ICD therapy in older individuals varied widely by clinical-trial population. In the 5 trials considered, for patients >or=65 years of age, ICDs demonstrated a life expectancy benefit compared with control therapy (incremental cost-effectiveness ratios ranging from $37,031-$138,458 per quality-adjusted life year). For 75-year-old patients, the findings were qualitatively similar, although cost-effectiveness was reduced in all trial populations. In sensitivity analyses, cost-effectiveness of ICD therapy in older individuals depended upon the trial population, quality of life, device cost, and frequency of generator replacement. Sensitivity analyses on other variables did not change the results substantially. CONCLUSIONS: The cost-effectiveness of ICD therapy for primary prevention in older patients varies widely among trials. Given an aging US population and the high risk of SCD in these individuals, further studies of ICD therapy and their cost-effectiveness-specifically in older patients-are needed.

Addressing disparities in sudden cardiac arrest care and the underutilization of effective therapies.

Sudden cardiac arrest (SCA) is the most common cause of death in the Unites States. Despite its major impact on public health, significant challenges exist at the patient, provider, public, and policy levels with respect to raising more widespread awareness and understanding of SCA risks, identifying patients at risk for SCA, addressing barriers to SCA care, and eliminating disparities in SCA care and outcomes. To address many of these challenges, the Duke Center for the Prevention of Sudden Cardiac Death at the Duke Clinical Research Institute (Durham, NC) held a think tank meeting on December 7, 2009, convening experts on this issue from clinical cardiology, cardiac electrophysiology, health policy and economics, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality, and device and pharmaceutical manufacturers. The specific goals of the meeting were to examine existing educational tools on SCA for patients, health care providers, and the public and explore ways to enhance and disseminate these tools; to propose a framework for improved identification of patients at risk of SCA; and to review the latest data on disparities in SCA care and explore ways to reduce these disparities. This article summarizes the discussions that occurred at the meeting.