Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60076658%3A12110%2F19%3A43899611" target="_blank" >RIV/60076658:12110/19:43899611 - isvavai.cz</a>
Výsledek na webu
<a href="https://www.sciencedirect.com/science/article/pii/S2405500X19303032?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2405500X19303032?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.jacep.2019.04.009" target="_blank" >10.1016/j.jacep.2019.04.009</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial
Popis výsledku v původním jazyce
Objectives: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power–short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. Background: The vHPSD catheter is a novel contact force–sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. Methods: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. Results: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions—all classified as asymptomatic without clinical or neurologic deficits. Conclusions: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters.
Název v anglickém jazyce
Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial
Popis výsledku anglicky
Objectives: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power–short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. Background: The vHPSD catheter is a novel contact force–sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. Methods: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. Results: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions—all classified as asymptomatic without clinical or neurologic deficits. Conclusions: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters.
Klasifikace
Druh
J<sub>SC</sub> - Článek v periodiku v databázi SCOPUS
CEP obor
—
OECD FORD obor
30201 - Cardiac and Cardiovascular systems
Návaznosti výsledku
Projekt
—
Návaznosti
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Ostatní
Rok uplatnění
2019
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
JACC: Clinical Electrophysiology
ISSN
2405-5018
e-ISSN
—
Svazek periodika
5
Číslo periodika v rámci svazku
7
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
9
Strana od-do
778-786
Kód UT WoS článku
—
EID výsledku v databázi Scopus
2-s2.0-85068253918