Pulsed Field Ablation of Paroxysmal Atrial Fibrillation

Reddy, Vivek Y.; Dukkipati, Srinivas R.; Neužil, Petr; Anić, Ante; Petrů, Jan; Funasako, Moritoshi; Cochet, Hubert; Minami, Kentaro; Brešković, Toni; Sikirić, Ivan; Šedivá, Lucie; Chovanec, Milan; Koruth, Jacob S.; Jaı̈s, Pierre

doi:10.1016/j.jacep.2021.02.014

Cited by 271 publications

(332 citation statements)

References 34 publications

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“…A late update of the Farapulse studies revealed an 84.8% durability rate at repeat. Moreover, one should keep in mind that repeat procedures in volunteers (protocol-mandated) are more likely to provide higher durability rates compared to the durability rates observed in patients suffering from arrhythmia recurrence [24]. If the promise that electroporation results in tissue-selectivity and durability of isolation holds true, it seems obvious that that PFA will replace point-by-point RF ablation.…”

Section: Upcoming Technologies For Pulmonary Vein Isolation: the End Of The Close Protocol?mentioning

confidence: 99%

How Close Are We toward an Optimal Balance in Safety and Efficacy in Catheter Ablation of Atrial Fibrillation? Lessons from the CLOSE Protocol

Lycke

O’Neill

Gillis

et al. 2021

JCM

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Catheter ablation for atrial fibrillation (AF) is a common treatment strategy in patients with drug-resistant, symptomatic AF. In patients with paroxysmal and short-standing persistent AF, pulmonary vein isolation (PVI) is often enough to prevent recurrence of atrial tachyarrhythmia (ATA). Point-by-point encircling of the PVs with radiofrequency (RF) applications, together with cryoballoon ablation, have been the mainstay strategies for the last 10 to 20 years. Each of these strategies, however, suffers from the delicate balance between preventing PV reconnection, on the one hand (toward more energy), and preventing (mainly esophageal) complications (toward less energy), on the other. The CLOSE protocol was developed as an RF ablation strategy that would result in the safe creation of durable isolation leading to improved outcomes. Basically, the aim of the protocol is to enclose the pulmonary veins with stable, contiguous (intertag distance, ITD ≤ 6 mm) and optimized lesions (35 Watts, W, RF applications up to ablation index targets of ≥400 and ≥550 at the posterior and anterior wall). In this review, we describe the background of the CLOSE protocol and the studies from the St Jan Bruges research group on procedural performance, efficacy, and safety of the CLOSE protocol in (a) single-center prospective PILOT study (CLOSE-PILOT), (b) a single-center prospective study with continuous rhythm monitoring (CLOSE to CURE), (c) a database of systematic esophageal endoscopic studies, (d) a multicenter prospective study (VISTAX), and (e) the CLOSE database (comprising > 400 patients). We also discuss the results of the randomized POWER-AF study comparing conventional CLOSE to high power CLOSE (up to 50 W). Finally, we discuss the performance, safety, and efficacy of the CLOSE protocol in light of the emerging changes in the field of catheter ablation being ultra-short high-power ablation and electroporation.

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Section: Upcoming Technologies For Pulmonary Vein Isolation: the End Of The Close Protocol?mentioning

confidence: 99%

How Close Are We toward an Optimal Balance in Safety and Efficacy in Catheter Ablation of Atrial Fibrillation? Lessons from the CLOSE Protocol

Lycke

O’Neill

Gillis

et al. 2021

JCM

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“…In this study, we assessed acute PFA lesion formation (by the Farwave catheter, Farapulse Inc.) and level of PV isolation using ultrahigh‐density mapping (UHDx; with the multi‐electrode Orion™ mapping catheter and the Rhythmia™ 3D mapping system, Boston Scientific) combined with PFA catheter visualization in symptomatic AF patients undergoing PVI by PFA, including persistent AF patients receiving additional PFA lesions. This is the first description of a series of patients performed outside of the initial first‐in‐human work that has been published 4 …”

Section: Introductionmentioning

confidence: 99%

Pulsed‐field ablation combined with ultrahigh‐density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations

Gunawardene

Schaeffer

Jularic

et al. 2022

Cardiovasc electrophysiol

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Background: Pulsed-field ablation (PFA) yields a novel ablation technology for atrial fibrillation (AF). PFA lesions promise to be highly durable, however clinical data on lesion characteristics are still limited.Objective: This study sought to investigate PFA lesion creation with ultrahighdensity (UHDx) mapping.Methods: Consecutive AF patients underwent PFA-based pulmonary vein isolation (PVI) using a multispline catheter (Farwave, Farapulse Inc.). Additional ablation, including left atrial posterior wall isolation (LAPWI) and mitral isthmus ablation (MI) were performed in a subset of persistent AF patients. The extent of PFA-lesions and decrease of LA-voltage were assessed with pre-and post PFA UHDx-mapping (Orion™ catheter and Rhythmia™ 3D-mapping system, Boston Scientific).Results: In 20 patients, acute PVI was achieved in 80/80 PVs, LAPW isolation in 9/9 patients, MI ablation in 2/2 (procedure time: 123 ± 21.6 min, fluoroscopy time: 19.2 ± 5.5 min). UHDx-mapping subsequent to PVI revealed early PV-reconnection in five case (5/80, 6.25%). Gaps were located at the anterior-superior PV ostia and were successfully targeted with additional PFA. Repeat UHDx mapping after PFA revealed a significant decrease of voltage along the PV ostia (1.67 ± 1.36 mV vs. 0.053 ± 0.038 mV, p < .0001) with almost no complex electrogram-fractionation at the lesion border zones. PFA-catheter visualization within the mapping system was feasible in 17/19 (84.9%) patients and adequate in 92.9% of ablation sites. Conclusion:For the first time illustrated by UHDx mapping, PFA creates wide antral circumferential lesions and homogenous LAPW isolation with depression of tissue voltage to a minimum. Although with a low incidence, early PV reconnection can still occur also in the setting of PFA.

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“…The lack of published data in this regard makes it necessary to make assumptions in terms of the applied waveforms or the irreversible electroporation electric field thresholds for cardiac tissue. Clinical trials are currently under development comparing RFA and PFA in terms of safety and effectiveness 30 .…”

Section: Introductionmentioning

confidence: 99%

A computational comparison of radiofrequency and pulsed field ablation in terms of lesion morphology in the cardiac chamber

Gómez-Barea

García-Sánchez

Ivorra

2022

Sci Rep

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Pulsed Field Ablation (PFA) has been developed over the last years as a novel electrical ablation technique for treating cardiac arrhythmias. It is based on irreversible electroporation which is a non-thermal phenomenon innocuous to the extracellular matrix and, because of that, PFA is considered to be safer than the reference technique, Radiofrequency Ablation (RFA). However, possible differences in lesion morphology between both techniques have been poorly studied. Simulations including electric, thermal and fluid physics were performed in a simplified model of the cardiac chamber which, in essence, consisted of a slab of myocardium with blood in motion on the top. Monopolar and bipolar catheter configurations were studied. Different blood velocities and catheter orientations were assayed. RFA was simulated assuming a conventional temperature-controlled approach. The PFA treatment was assumed to consist in a sequence of 20 biphasic bursts (100 µs duration). Simulations indicate that, for equivalent lesion depths, PFA lesions are wider, larger and more symmetrical than RFA lesions for both catheter configurations. RFA lesions display a great dependence on blood velocity while PFA lesions dependence is negligible on it. For the monopolar configuration, catheter angle with respect to the cardiac surface impacted both ablation techniques but in opposite sense. The orientation of the catheter with respect to blood flow direction only affected RFA lesions. In this study, substantial morphological differences between RFA and PFA lesions were predicted numerically. Negligible dependence of PFA on blood flow velocity and direction is a potential important advantage of this technique over RFA.

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Pulsed Field Ablation of Paroxysmal Atrial Fibrillation

Cited by 271 publications

References 34 publications

How Close Are We toward an Optimal Balance in Safety and Efficacy in Catheter Ablation of Atrial Fibrillation? Lessons from the CLOSE Protocol

How Close Are We toward an Optimal Balance in Safety and Efficacy in Catheter Ablation of Atrial Fibrillation? Lessons from the CLOSE Protocol

Pulsed‐field ablation combined with ultrahigh‐density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations

A computational comparison of radiofrequency and pulsed field ablation in terms of lesion morphology in the cardiac chamber

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