AF ablation using a novel "single-shot" map-and-ablate spherical array pulsed field ablation catheter: 1-Year outcomes of the first-in-human PULSE-EU trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F24%3A00009857" target="_blank" >RIV/00023884:_____/24:00009857 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S1547527124025360?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S1547527124025360?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.hrthm.2024.04.102" target="_blank" >10.1016/j.hrthm.2024.04.102</a>

Jazyk výsledku

angličtina

Název v původním jazyce

AF ablation using a novel "single-shot" map-and-ablate spherical array pulsed field ablation catheter: 1-Year outcomes of the first-in-human PULSE-EU trial

Popis výsledku v původním jazyce

BACKGROUND: During pulsed field ablation (PFA), electrode-tissue proximity optimizes lesion quality. A novel "single-shot" map-and-ablate spherical multielectrode PFA array catheter that is able to verify electrode-tissue contact was recently studied in a first-in-human trial of atrial fibrillation (AF). OBJECTIVE The aim of this study was to report lesion durability data, safety, and 12-month effectiveness outcomes. METHODS The spherical PFA catheter, an all-in-one mapping and ablation system, was used to render anatomy and to deliver biphasic pulses (ungated 1.7 kV pulses; w40 seconds/application). Ablation sites included pulmonary veins (PVs) and, in selected patients, posterior wall and mitral isthmus. Follow-up was invasive remapping at w3 months, electrocardiograms, Holter monitoring at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy end points were acute PV isolation (PVI), PVI durability, and atrial arrhythmia recurrence. RESULTS In the 48-patient AF cohort (paroxysmal, 48%; persistent, 52%), lesion sets included PVI (n = 48; 1.2 applications/PV), posterior wall (n = 20; 3.6 applications/posterior wall), and mitral isthmus (n = 11; 2.9 applications/mitral isthmus). Lesions were acutely successful for all 187 of 187 PVs (100%), 20 of 20 posterior walls (100%), and 10 of 11 mitral isthmuses (91%). Pulse delivery time, left atrial catheter dwell time, and procedure time were 61.5 +/- 32.8 seconds, 53.9 +/- 26.5 minutes, and 87.8 +/- 29.8 minutes, respectively. Remapping (43/48 patients [89.5%]) revealed that 158 of 169 PVs (93.5%) were durably isolated. The only complication was a drug-responsive pericarditis. The 1-year Kaplan-Meier estimates of freedom from atrial arrhythmia were CONCLUSION The single-shot spherical array PFA catheter can safely achieve durable lesions, translating into good clinical efficacy.

Název v anglickém jazyce

AF ablation using a novel "single-shot" map-and-ablate spherical array pulsed field ablation catheter: 1-Year outcomes of the first-in-human PULSE-EU trial

Popis výsledku anglicky

BACKGROUND: During pulsed field ablation (PFA), electrode-tissue proximity optimizes lesion quality. A novel "single-shot" map-and-ablate spherical multielectrode PFA array catheter that is able to verify electrode-tissue contact was recently studied in a first-in-human trial of atrial fibrillation (AF). OBJECTIVE The aim of this study was to report lesion durability data, safety, and 12-month effectiveness outcomes. METHODS The spherical PFA catheter, an all-in-one mapping and ablation system, was used to render anatomy and to deliver biphasic pulses (ungated 1.7 kV pulses; w40 seconds/application). Ablation sites included pulmonary veins (PVs) and, in selected patients, posterior wall and mitral isthmus. Follow-up was invasive remapping at w3 months, electrocardiograms, Holter monitoring at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy end points were acute PV isolation (PVI), PVI durability, and atrial arrhythmia recurrence. RESULTS In the 48-patient AF cohort (paroxysmal, 48%; persistent, 52%), lesion sets included PVI (n = 48; 1.2 applications/PV), posterior wall (n = 20; 3.6 applications/posterior wall), and mitral isthmus (n = 11; 2.9 applications/mitral isthmus). Lesions were acutely successful for all 187 of 187 PVs (100%), 20 of 20 posterior walls (100%), and 10 of 11 mitral isthmuses (91%). Pulse delivery time, left atrial catheter dwell time, and procedure time were 61.5 +/- 32.8 seconds, 53.9 +/- 26.5 minutes, and 87.8 +/- 29.8 minutes, respectively. Remapping (43/48 patients [89.5%]) revealed that 158 of 169 PVs (93.5%) were durably isolated. The only complication was a drug-responsive pericarditis. The 1-year Kaplan-Meier estimates of freedom from atrial arrhythmia were CONCLUSION The single-shot spherical array PFA catheter can safely achieve durable lesions, translating into good clinical efficacy.

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

Heart Rhythm

ISSN

1547-5271

e-ISSN

—

Svazek periodika

21

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

1218-1226

Kód UT WoS článku

001286449300001

EID výsledku v databázi Scopus

2-s2.0-85194921295