Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario

Lemoine, Marc D.; Fink, Thomas; Mencke, Celine; My, Ilaria; Obergassel, Julius; Bergau, Leonard; Sciacca, Vanessa; Rottner, Laura; Moser, Julia; Kany, Shinwan; Moser, Fabian; Münkler, Paula; Dinshaw, Leon; Kirchhof, Paulus; Reißmann, Bruno; Ouyang, Feifan; Sommer, Philipp; Sohns, Christian; Rillig, Andreas; Metzner, Andreas

doi:10.1007/s00392-022-02091-2

Cited by 39 publications

(34 citation statements)

References 29 publications

(37 reference statements)

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“… 7 This is the first prospective large-scale study to show a very low-risk profile of pulsed field ablation, even within a 41-center setting with multiple operators; other pulsed field ablation studies with >100 patients have reported major complication rates, from 1.5% to 3.3%, or low rates within single-center studies. 21 – 24 In this study, the total risk of primary safety adverse events was <1%, with no indication of pulmonary vein, esophageal, or phrenic damage. Furthermore, silent cerebral risk was in keeping with other forms of ablation, which have reported rates of 4% to 10% for cryoablation and 0% to 19% for radiofrequency ablation.…”

Section: Discussionmentioning

confidence: 61%

“…Some studies suggested better efficacy with pulsed field ablation, but these were pilot studies with surrogate outcomes or limited-center studies without robust arrhythmia monitoring. 21 , 23 , 24 , 32 , 33 One large pulsed field ablation registry showed lower success compared with early pilot data. 22 , 23 , 32 , 33 Only 1 pulsed field ablation study has published results with robust arrhythmia monitoring such as weekly transtelephonic transmissions, but 20% of the published 121-patient cohort did not reach 12-month follow-up, and 32% underwent a repeat ablation at any time during the study.…”

Section: Discussionmentioning

confidence: 99%

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Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial

et al. 2023

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BACKGROUND: Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. METHODS: The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points. RESULTS: Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts. CONCLUSIONS: PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.

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Section: Discussionmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 99%

Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial

et al. 2023

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“…2 Initial clinical observations in controlled trials recently reported data on safety, efficacy, and follow-up data of PFA-based PVI. 3,4 On the other hand, the RFB is a compliant balloon catheter compatible with a 3D electroanatomical mapping system (CARTO 3; Biosense Webster) and provides an established energy source; it allows for selective titration of RF energy delivery from each surface electrode to prevent collateral damage and to apply energy in a segmental area if needed. 5 Two multicenter trials (RADIANCE 5,6 and SHINE 7 ) demonstrated the feasibility, safety, and 12-month outcome of this technology.…”

Section: Discussionmentioning

confidence: 99%

Acute lesion extension following pulmonary vein isolation with two novel single shot devices: Pulsed field ablation versus multielectrode radiofrequency balloon

My,

Lemoine,

Butt

et al. 2023

Cardiovasc electrophysiol

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IntroductionPulsed‐field ablation (PFA) and the multielectrode radiofrequency balloon (RFB) are two novel ablation technologies to perform pulmonary vein isolation (PVI). It is currently unknown whether these technologies differ in lesion formation and lesion extent. We compared the acute lesion extent after PVI induced by PFA and RFB by measuring low‐voltage area in high‐density maps and the release of biomolecules reflecting cardiac injury.MethodsPVI was performed with a pentaspline catheter (FARAPULSE) applying PFA or with the compliant multielectrode RFB (HELIOSTAR). Before and after PVI high‐density mapping with CARTO 3 was performed. In addition, blood samples were taken before transseptal puncture and after post‐PVI remapping and serum concentrations of high‐sensitive Troponin I were quantified by immunoassay.ResultsSixty patients undergoing PVI by PFA (n = 28, age 69 ± 12 year, 60% males, 39.3% persistent atrial fibrillation [AF]) or RFB (n = 32, age 65 ± 13 year, 53% males, 21.9% persistent AF) were evaluated. Acute PVI was achieved in all patients in both groups. Mean number of PFA pulses was 34.2 ± 4.5 and mean number RFB applications was 8.5 ± 3 per patient. Total posterior ablation area was significantly larger in PFA (20.7 ± 7.7 cm²) than in RFB (7.1 ± 2.09 cm²; p < .001). Accordingly, posterior ablation area for each PV resulted in larger lesions after PFA versus RFB (LSPV 5.2 ± 2.7 vs. 1.9 ± 0.8 cm², LIPV 5.5 ± 2.3 vs. 1.9 ± 0.8 cm², RSPV 4.7 ± 1.9 vs. 1.6 ± 0.5 cm², RIPV 5.3 ± 2.1 vs. 1.6 ± 0.7 cm,² respectively; p < .001). In a subset of 38 patients, increase of hsTropI was higher after PFA (625 ± 138 pg/mL, n = 28) versus RFB (148 ± 36 pg/mL, n = 10; p = .049) supporting the evidence of larger lesion extent by PFA.ConclusionPFA delivers larger acute lesion areas and higher troponin release upon successful PVI than multielectrode RFB‐based PVI in this single‐center series.

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“… 27) Other clinical studies reported similar data all highlighting the acute efficiency, short procedure time, beneficial safety profile and favorable rate of clinical outcomes up to 1 year follow-up. 88) 90) 91) …”

Section: Pulsed Field Ablation: Efficacy Safety and Fields Of Applica...mentioning

confidence: 99%

Pearls and Pitfalls of Pulsed Field Ablation

et al. 2023

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Author's summary Pulsed field ablation (PFA) is a fast advancing technology in the interventional treatment of cardiac arrhythmias that utilizes the phenomenon of irreversible electroporation as a non-thermal energy source. Pre-clinical and first clinical studies suggest that PFA could overcome the main limitations of current standard of care energy sources and improve the efficacy and safety profile of cardiac catheter ablation. This review provides an overview of the current knowledge on PFA and discusses “pearls” and potential “pitfalls” of the technology.

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Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario

Cited by 39 publications

References 29 publications

Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial

Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial

Acute lesion extension following pulmonary vein isolation with two novel single shot devices: Pulsed field ablation versus multielectrode radiofrequency balloon

Pearls and Pitfalls of Pulsed Field Ablation

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