Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F20%3A00008696" target="_blank" >RIV/00023884:_____/20:00008696 - isvavai.cz</a>
Result on the web
<a href="https://www.ahajournals.org/doi/full/10.1161/CIRCEP.119.007917" target="_blank" >https://www.ahajournals.org/doi/full/10.1161/CIRCEP.119.007917</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1161/CIRCEP.119.007917" target="_blank" >10.1161/CIRCEP.119.007917</a>
Alternative languages
Result language
angličtina
Original language name
Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial
Original language description
BACKGROUND: Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias. METHODS: In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software. RESULTS: Acute PV isolation was achieved in 98% of PVs-using LICU-only in 77.3% (153/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12 months or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae. CONCLUSIONS: In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2020
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Circulation-Arrhythmia and Electrophysiology
ISSN
1941-3149
e-ISSN
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Volume of the periodical
13
Issue of the periodical within the volume
3
Country of publishing house
US - UNITED STATES
Number of pages
12
Pages from-to
224-235
UT code for WoS article
000528039000005
EID of the result in the Scopus database
2-s2.0-85082097092