A Novel Visually Guided Radiofrequency Balloon Ablation Catheter for Pulmonary Vein Isolation One-Year Outcomes of the Multicenter AF-FICIENT I Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F21%3A00009104" target="_blank" >RIV/00023884:_____/21:00009104 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.ahajournals.org/doi/full/10.1161/CIRCEP.120.009308" target="_blank" >https://www.ahajournals.org/doi/full/10.1161/CIRCEP.120.009308</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1161/CIRCEP.120.009308" target="_blank" >10.1161/CIRCEP.120.009308</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A Novel Visually Guided Radiofrequency Balloon Ablation Catheter for Pulmonary Vein Isolation One-Year Outcomes of the Multicenter AF-FICIENT I Trial

Popis výsledku v původním jazyce

BACKGROUND: A multielectrode saline-irrigated radiofrequency (RF) balloon catheter with an integrated camera system was designed to perform single-shot pulmonary vein (PV) isolation. To optimize ablation, simultaneous circumferential RF energy can be delivered, albeit with power output that is tailored to individual electrodes based on direct visualization of tissue-electrode contact. In a first-in-human multicenter clinical trial, we studied the feasibility, performance, safety, and efficacy of PV isolation using this novel ablation catheter to treat atrial fibrillation. METHODS: AF-FICIENT-I was a prospective, 5-center, single-arm study. After transseptal puncture, the RF balloon was positioned over the wire at each pulmonary (PV) ostium using a 13.3F sheath. RF energy was titrated based on visual contact (6-10 W; up to 60 seconds per ablation). Electrical PV isolation was confirmed using either, (1) sensing mini-electrodes situated on the RF balloon itself or (2) a circular mapping catheter. Patients were clinically assessed for recurrent atrial arrhythmias lasting >30 s over 12 months, after a 3-month blanking period. RESULTS: Six operators performed de novo PV isolation in 99 patients (95 paroxysmal/4 persistent; age, 58 +/- 11; men, 67.7%). Median times, including procedure, fluoroscopy, ablation (time from first RF to last RF application), and balloon (time elapsing between catheter introduction to removal from the body) times, were 85 (interquartile range, 62-118), 14 (interquartile range, 9-23), 31 (interquartile range, 20-53), and 43 minutes (interquartile range, 32-70), respectively. The 12-month Kaplan-Meier estimates of freedom from any atrial arrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) or atrial fibrillation alone were 77.5% (95% CI, 67.6%-84.7%) and 84.1% (95% CI, 74.9%-90.1%), respectively. There were no device-related serious adverse events.

Název v anglickém jazyce

A Novel Visually Guided Radiofrequency Balloon Ablation Catheter for Pulmonary Vein Isolation One-Year Outcomes of the Multicenter AF-FICIENT I Trial

Popis výsledku anglicky

BACKGROUND: A multielectrode saline-irrigated radiofrequency (RF) balloon catheter with an integrated camera system was designed to perform single-shot pulmonary vein (PV) isolation. To optimize ablation, simultaneous circumferential RF energy can be delivered, albeit with power output that is tailored to individual electrodes based on direct visualization of tissue-electrode contact. In a first-in-human multicenter clinical trial, we studied the feasibility, performance, safety, and efficacy of PV isolation using this novel ablation catheter to treat atrial fibrillation. METHODS: AF-FICIENT-I was a prospective, 5-center, single-arm study. After transseptal puncture, the RF balloon was positioned over the wire at each pulmonary (PV) ostium using a 13.3F sheath. RF energy was titrated based on visual contact (6-10 W; up to 60 seconds per ablation). Electrical PV isolation was confirmed using either, (1) sensing mini-electrodes situated on the RF balloon itself or (2) a circular mapping catheter. Patients were clinically assessed for recurrent atrial arrhythmias lasting >30 s over 12 months, after a 3-month blanking period. RESULTS: Six operators performed de novo PV isolation in 99 patients (95 paroxysmal/4 persistent; age, 58 +/- 11; men, 67.7%). Median times, including procedure, fluoroscopy, ablation (time from first RF to last RF application), and balloon (time elapsing between catheter introduction to removal from the body) times, were 85 (interquartile range, 62-118), 14 (interquartile range, 9-23), 31 (interquartile range, 20-53), and 43 minutes (interquartile range, 32-70), respectively. The 12-month Kaplan-Meier estimates of freedom from any atrial arrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) or atrial fibrillation alone were 77.5% (95% CI, 67.6%-84.7%) and 84.1% (95% CI, 74.9%-90.1%), respectively. There were no device-related serious adverse events.

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

2021

Kód důvěrnosti údajů

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

Název periodika

Circulation-Arrhythmia and Electrophysiology

ISSN

1941-3149

e-ISSN

—

Svazek periodika

14

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

919-928

Kód UT WoS článku

000708617400006

EID výsledku v databázi Scopus

2-s2.0-85119458302