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).

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.

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure).

BACKGROUND: Various randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively. AIMS: The prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety. METHODS AND RESULTS: The total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent. CONCLUSIONS: The ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers. Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803 .

Efficacy and safety of the GOLD FORCE multicentre randomized clinical trial: multielectrode phased radiofrequency vs. irrigated radiofrequency single-tip catheter with contact force ablation for treatment of symptomatic paroxysmal atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF. METHODS AND RESULTS: The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group [absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003]. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782). CONCLUSION: In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times.

Retrospective analysis of FIRM-guided ablation in patients with recurrent atrial fibrillation: a single-center study.

BACKGROUND: Ablation of recurrent atrial fibrillation (AF) is common. Studies indicate that AF recurrence is primarily due to pulmonary vein (PV) re-conduction. This retrospective analysis characterized and evaluated recurrent AF patients using focal impulse and rotor mapping (FIRM) plus PV re-isolation, with follow up at 3, 6, 12, and 24 months after the repeat ablation. METHODS AND RESULTS: Patients (consecutive, n = 100) underwent FIRM-guided ablation followed by conventional PV re-isolation for recurrent AF treatment. All FIRM patients had failed one or more conventional ablation procedures (1.4 ± 0.08) for paroxysmal (14%), persistent (15%), and long-standing persistent (71%) AF. Stable rotors were identified in 97/100 patients: 60% in the right atrium (RA) and 82% in left atrium (LA) (mean 1.5 ± 0.8 and 2.1 ± 1.2 per patient, respectively). No correlation was noted between the previous number of ablations, AF duration, or LA diameter to the number of rotors (R2 = 0.0039, R2 = 0.0017, and R2 = 0.006, respectively). In this limited observation, only 22% of identified rotors were associated with proximity to low voltage areas. The 12- and 24-month arrhythmia free rate was 93% (13/14) and 92% (12/13) for paroxysmal AF, 60% (9/15) and 47% (7/15) for persistent AF, and 70% (48/69) and 64% (43/67) for long-standing persistent AF, respectively, after a single FIRM procedure and re-isolation of the veins. CONCLUSIONS: The data show a benefit for FIRM-guided ablation in recurrent AF at 12 months. No correlation was found between rotors and tissue characterization, AF duration, or previous number of ablations, suggesting that rotors may play an independent role in maintaining recurrent AF after prior failed ablation.

Rotor mapping: black box or very simple? The FIRM approach.

Catheter ablation has become the most common therapy in patients with atrial fibrillation (AF). However, despite significant advances in technology and operators' experience, ablation outcomes remain suboptimal, especially in patients with persistent AF. Focal impulse and rotor modulation (FIRM) represents a new technology for mapping and ablation of patient-specific AF sources. This approach is based on the concept of localized sources, which can be understood as organized rotational waves or focal impulses driving disorganized AF. Several studies, mainly single-center case series, have shown an incremental benefit in long-term outcome when adding FIRM-guided ablation to conventional pulmonary vein isolation (PVI). Therefore, the results of ongoing multicenter randomized trials are needed to support this data.

Circumferential pulmonary vein isolation with second-generation multipolar catheter in patients with paroxysmal or persistent atrial fibrillation: Procedural and one-year follow-up results.

BACKGROUND: There is a lack of procedural and follow-up data on pulmonary vein isolation (PVI) with the second-generation pulmonary vein ablation catheter® (PVAC Gold) in patients with atrial fibrillation (AF). This study provides data on PVI procedures and 1-year follow-up results with PVAC Gold in patients with AF treated in clinical practice. METHODS AND RESULTS: Three hundred and eighty four patients with documented symptomatic paroxysmal (n=198) or persistent (n=186) AF were included in a non-randomized prospectively designed database. Patients were enrolled consecutively at 2 high-volume centers. Procedural as well as 1year follow-up data were systematically analyzed. Average procedure times±standard deviations were 94±23min and 97±23min, respectively, in patients with paroxysmal and persistent AF. Average fluoroscopy times were 14.7±5.4min and 15.2±5.6min and total application times 18.1±5.0min and 18.8±5.2min, respectively, in the 2 patient cohorts. At 12months, 70.7% (70/99) and 61.9% (70/113) of patients with paroxysmal and persistent AF, respectively, were free from AF. Four early complications occurred. In the group with persistent AF, 1 posterior cerebral infarction occurred 2days after the procedure during initiation of anticoagulation. There was no phrenic nerve palsy or esophageal injury associated with the procedures. No thromboembolic events were recorded during follow-up. CONCLUSIONS: In patients with paroxysmal or persistent AF, second generation multi-electrode-phased radiofrequency ablation delivers favorable mid-term PVI success rates with few procedure-related or follow-up complications.

Treatment of Recurrent Nonparoxysmal Atrial Fibrillation Using Focal Impulse and Rotor Mapping (FIRM)-Guided Rotor Ablation: Early Recurrence and Long-Term Outcomes.

INTRODUCTION: A patient-tailored ablation approach focused on the elimination of both pulmonary vein triggers as well as substrate drivers may result in favorable outcomes in recurrent persistent AF patients. OBJECTIVE: We evaluated the long-term outcomes of rotor ablation combined with conventional pulmonary vein isolation (PVI) in patients with recurrent nonparoxysmal AF. METHODS: Fifty-eight consecutive patients underwent FIRM-guided rotor ablation followed by conventional PVI for the treatment of recurrent nonparoxysmal AF. A software algorithm was used to display rotational activity at rotor sites by creating propagation maps from unipolar electrograms recorded using a 64-electrode basket catheter. These rotor sites were targeted for ablation, followed by conventional PVI. RESULTS: All patients had nonparoxysmal AF (83% longstanding persistent) and a previously failed conventional ablation procedure. Stable rotors were identified in all patients (mean of 3.0 ± 1.6 per patient), with 55.2% having right atrial rotors and 96.6% left atrial rotors, respectively. Complications occurred in 5.2% of patients, none related to the FIRM procedure. The median follow-up was 12 months. At 6 and 12 months of follow-up, 73.2% and 76.9% of patients remained free from AF/AT, respectively. Excluding 2 patients who underwent a successful redo ablation procedure/electrical cardioversion, at 12 months of follow-up, 69.2% were free from any AF/AT and 73.1% were free from AF after a single FIRM-guided ablation procedure. CONCLUSION: A high degree of success was observed in this cohort of primarily longstanding persistent AF patients treated for recurrent AF with FIRM-guided rotor ablation. Prospective randomized controlled trials are needed.

Stand-alone mapping using different transluminal mapping catheters--an accurate and safe way to isolate all pulmonary veins with the cryoballoon?

PURPOSE: Cryoballoon isolation of the pulmonary veins (PVI) is an effective and safe method in the treatment of patients with paroxysmal atrial fibrillation (PAF). The circular mapping catheter Achieve® (Medtronic Inc., Minneapolis, USA) can be introduced into the pulmonary vein (PV) through the inner lumen of the balloon catheter, allowing online mapping of the PV electrograms during ablation. We prospectively compared the accuracy of this catheter in both available sizes to a standard circular mapping catheter (SCMC) in order to determine bidirectional PV block. METHODS: Patients with symptomatic PAF underwent cryoballoon ablation using either the Achieve® 15-mm catheter (group 1, 15 patients) or the Achieve® 20 mm (group 2, 15 patients). PV potentials were recorded using Achieve® before, during, and after ablation, and exit block was obtained by pacing from inside the PV. Accuracy of PV potential detection was controlled by a SCMC before and after ablation. RESULTS: Rate of PV which could be isolated exclusively using the Achieve® as guidewire was 98 % (59/60) in group 1 and 93 % (57/60) in group 2. Online signal recording during ablation was possible in 40 and 60 % of PV (p = 0.037), respectively. Final Achieve® diagnosis was accurate in 55/60 (92 %) of the PVs and 12/15 (80 %) of patients in group 1 and 60/60 (100 %) of PV and 15/15 (100 %) of patients in group 2. CONCLUSION: Stand-alone mapping using Achieve® 15 mm resulted in a significant lack of diagnostic accuracy. Achieve® 20 mm provided excellent diagnostic accuracy comparable to a SCMC and should be preferentially used.

Recurrence of paroxysmal atrial fibrillation after cryoisolation of the pulmonary veins. Is a "redo" procedure using the cryoballoon useful?

BACKGROUND: Pulmonary vein (PV) isolation with the cryoballoon technique is an effective and safe method to treat patients with paroxysmal atrial fibrillation (AF). However, the optimal treatment strategy for patients with recurrences after this ablation is unclear. AIMS: The aim of this single centre study was to evaluate the efficacy and safety of a "redo" procedure using the cryoballoon in this patient cohort. The secondary study objectives were to determine the rate of reconduction for individual PVs of the patients undergoing "redo" ablation and potential predictors of persistent PV isolation (PVI). METHODS: Between April 2006 and September 2009, all patients with paroxysmal AF recurrences after cryoballoon ablation a "redo" ablation with the cryoballoon was offered. PV conduction was determined and cryoapplications were performed in all reconnected PVs. Every 3 months, 7-day Holter ECG, symptom-driven transtelephonic ECG recordings, and questionnaires were collected for 12 months. RESULTS: Forty-seven patients underwent "redo" cryoballoon ablation. In all these patients, at least one PV with reconduction was found. Recurrent conduction was documented in 63 % of the left superior PV, 56 % of the left inferior PV, 43 % of the right superior PV, and 56 % of the right inferior PV. In 28 of the 47 patients (60 %), no AF recurrence was detectable during the 12-month follow-up (after 3 months blanking period). Rate of severe complications was low and not significantly different from that of the initial ablations. CONCLUSION: "Redo" ablation using cryoballoon technology may be an effective and safe method to treat patients with recurrence of paroxysmal AF after cryoballoon PVI.