First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F24%3A00084816" target="_blank" >RIV/00023001:_____/24:00084816 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00023884:_____/24:00009882

Výsledek na webu

<a href="https://academic.oup.com/europace/article/26/4/euae090/7641959" target="_blank" >https://academic.oup.com/europace/article/26/4/euae090/7641959</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/europace/euae090" target="_blank" >10.1093/europace/euae090</a>

Jazyk výsledku

angličtina

Název v původním jazyce

First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation

Popis výsledku v původním jazyce

Aims Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system.Methods and results After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; similar to 4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted similar to 75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 +/- 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 +/- 21.6, 10.0 +/- 6.0, 19.1 +/- 9.3, and 5.7 +/- 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort.Conclusion Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping. Graphical Abstract

Název v anglickém jazyce

First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation

Popis výsledku anglicky

Aims Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system.Methods and results After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; similar to 4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted similar to 75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 +/- 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 +/- 21.6, 10.0 +/- 6.0, 19.1 +/- 9.3, and 5.7 +/- 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort.Conclusion Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping. Graphical Abstract

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Europace

ISSN

1099-5129

e-ISSN

1532-2092

Svazek periodika

26

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

13

Strana od-do

"art. no. euae090"

Kód UT WoS článku

001223944900003

EID výsledku v databázi Scopus

2-s2.0-85191900242