Ablation of Atrial Fibrillation With Pulsed Electric Fields

Reddy, Vivek Y.; Koruth, Jacob S.; Jaı̈s, Pierre; Petrů, Jan; Timko, Ferdinand; Skalský, Ivo; Hebeler, Robert F.; Labrousse, Louis; Barandon, Laurent; Královec, Štěpán; Funosako, Moritoshi; Mannuva, Boochi Babu; Šedivá, Lucie; Neužil, Petr

doi:10.1016/j.jacep.2018.04.005

Cited by 185 publications

(128 citation statements)

References 19 publications

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“…Atrial lesions did not present a different T1 signal or surviving cardiomyocytes in the observed area, but animal studies on intact rabbit hearts hinted that the atria might be more susceptible to electroporation (Fedorov et al, 2008). It is also possible that AC-PFA lesions might take more time to mature, compared to RF ones, due to the non-necrotic scar formation (Reddy et al, 2018). Flexibility of PFA is demonstrated by the similar efficacy reported with the plethora of pulse features presented in the literature.…”

Section: Discussionsupporting

confidence: 54%

“…Cardiac muscle sensitivity has been demonstrated in several in vitro, in vivo (Sugrue et al, 2019), and in pilot clinical studies (Reddy et al, 2018). It represents, with tissue selectivity, the cornerstone of the potential success of PFA in clinical trials.…”

Section: Discussionmentioning

confidence: 99%

“…We have presented how PFA methods, and in particular AC-PFA, can readily benefit from the existing catheter technologies: we employed commercially available catheters, in particular nonirrigated diagnostic circular ones, with good efficacy. Other groups, or companies, have presented their own dedicated catheter design (DeSimone et al, 2014;Neven et al, 2014;Reddy et al, 2018;Stewart et al, 2019), which is usually matched with a specific or proprietary PFA generator. The acquired experience within the bioengineering and medical communities led to the overcoming of the initial issues with DC-PFA, such as arching, barotrauma and arrhythmia induction (Guandalini et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

“…AC biphasic pulses or bursts can help to prevent these issues (Wojtaszczyk et al, 2018), although they impose a lower equivalent electric field on the tissue, and they are more subjected to electrode surface heating due to skineffect. Asymmetrical AC has been introduced, proved feasible and effective in animal studies (Stewart et al, 2019) and clinical trials (Reddy et al, 2018). Both symmetrical and asymmetrical AC pulses have been proved to ablate ventricular myocardium in an epicardial porcine model with customized applicators (van Es et al, 2019b).…”

Section: Introductionmentioning

confidence: 99%

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AC Pulsed Field Ablation Is Feasible and Safe in Atrial and Ventricular Settings: A Proof-of-Concept Chronic Animal Study

Caluori

Odehnalová

Jadczyk

et al. 2020

Front. Bioeng. Biotechnol.

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IntroductionPulsed field ablation (PFA) exploits the delivery of short high-voltage shocks to induce cells death via irreversible electroporation. The therapy offers a potential paradigm shift for catheter ablation of cardiac arrhythmia. We designed an AC-burst generator and therapeutic strategy, based on the existing knowledge between efficacy and safety among different pulses. We performed a proof-of-concept chronic animal trial to test the feasibility and safety of our method and technology.MethodsWe employed 6 female swine – weight 53.75 ± 4.77 kg – in this study. With fluoroscopic and electroanatomical mapping assistance, we performed ECG-gated AC-PFA in the following settings: in the left atrium with a decapolar loop catheter with electrodes connected in bipolar fashion; across the interventricular septum applying energy between the distal electrodes of two tip catheters. After procedure and 4-week follow-up, the animals were euthanized, and the hearts were inspected for tissue changes and characterized. We perform finite element method simulation of our AC-PFA scenarios to corroborate our method and better interpret our findings.ResultsWe applied square, 50% duty cycle, AC bursts of 100 μs duration, 100 kHz internal frequency, 900 V for 60 pulses in the atrium and 1500 V for 120 pulses in the septum. The inter-burst interval was determined by the native heart rhythm – 69 ± 9 bpm. Acute changes in the atrial and ventricular electrograms were immediately visible at the sites of AC-PFA – signals were elongated and reduced in amplitude (p < 0.0001) and tissue impedance dropped (p = 0.011). No adverse event (e.g., esophageal temperature rises or gas bubble streams) was observed – while twitching was avoided by addition of electrosurgical return electrodes. The implemented numerical simulations confirmed the non-thermal nature of our AC-PFA and provided specific information on the estimated treated area and need of pulse trains. The postmortem chest inspection showed no peripheral damage, but epicardial and endocardial discolorations at sites of ablation. T1-weighted scans revealed specific tissue changes in atria and ventricles, confirmed to be fibrotic scars via trichrome staining. We found isolated, transmural and continuous scars. A surviving cardiomyocyte core was visible in basal ventricular lesions.ConclusionWe proved that our method and technology of AC-PFA is feasible and safe for atrial and ventricular myocardial ablation, supporting their systematic investigation into effectiveness evaluation for the treatment of cardiac arrhythmia. Further optimization, with energy titration or longer follow-up, is required for a robust atrial and ventricular AC-PFA.

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Section: Discussionsupporting

confidence: 54%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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AC Pulsed Field Ablation Is Feasible and Safe in Atrial and Ventricular Settings: A Proof-of-Concept Chronic Animal Study

Caluori

Odehnalová

Jadczyk

et al. 2020

Front. Bioeng. Biotechnol.

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“…In addition to these limitations, recurrence of AF may occur in as much as 50% of persons with persistent AF within the first 18 months of the initial RFA procedure [7]. As a result, techniques utilizing alternate energy sources including cryotherapy, and more recently laser and pulsed electric fields have been explored with clinical efficacy comparable to RFA with similar procedural and side effect profiles [8,9].…”

Section: Introductionmentioning

confidence: 99%

Clinical Applications of Laser Technology: Laser Balloon Ablation in the Management of Atrial Fibrillation

et al. 2021

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Catheter-based ablation techniques have a well-established role in atrial fibrillation (AF) management. The prevalence and impact of AF is increasing globally, thus mandating an emphasis on improving ablation techniques through innovation. One key area of ongoing evolution in this field is the use of laser energy to perform pulmonary vein isolation during AF catheter ablation. While laser use is not as widespread as other ablation techniques, such as radiofrequency ablation and cryoballoon ablation, advancements in product design and procedural protocols have demonstrated laser balloon ablation to be equally safe and effective compared to these other modalities. Additionally, strategies to improve procedural efficiency and decrease radiation exposure through low fluoroscopy protocols make this technology an increasingly promising and exciting option.

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Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Turagam,

Neuzil,

Schmidt

et al. 2023

JAMA Cardiol

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ImportancePrevious studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile.ObjectiveTo compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry.Design, Setting, and ParticipantsThis was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF.ExposurePFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator.Main Outcomes and MeasuresThe primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (&lt;7 days postprocedure) and chronic (&gt;7 days) major adverse events (MAEs).ResultsOf 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P &lt; .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P &lt; .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P &lt; .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19).Conclusion and RelevanceResults of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.

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Ablation of Atrial Fibrillation With Pulsed Electric Fields

Abstract: These data usher in a new era of tissue-specific, ultrarapid ablation of atrial fibrillation.

Cited by 185 publications

References 19 publications

AC Pulsed Field Ablation Is Feasible and Safe in Atrial and Ventricular Settings: A Proof-of-Concept Chronic Animal Study

AC Pulsed Field Ablation Is Feasible and Safe in Atrial and Ventricular Settings: A Proof-of-Concept Chronic Animal Study

Clinical Applications of Laser Technology: Laser Balloon Ablation in the Management of Atrial Fibrillation

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

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