One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F25%3A00010202" target="_blank" >RIV/00023884:_____/25:00010202 - isvavai.cz</a>
Alternative codes found
RIV/00023001:_____/25:00085890
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S1547527125023793?pes=vor&utm_source=clarivate&getft_integrator=clarivate" target="_blank" >https://www.sciencedirect.com/science/article/pii/S1547527125023793?pes=vor&utm_source=clarivate&getft_integrator=clarivate</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.hrthm.2025.04.031" target="_blank" >10.1016/j.hrthm.2025.04.031</a>
Alternative languages
Result language
angličtina
Original language name
One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation
Original language description
BACKGROUND Most single-shot pulsed-field ablation (PFA) catheters require extensive repositioning for pulmonary vein isolation (PVI), posing a challenge for obtaining contiguous, durable lesions. OBJECTIVE To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating parox METHODS After PVI with the large-lattice catheter with expandable tip (Sphere-360), follow-up included Holter monitoring at 180 and 365 days and scheduled/symptomatic trans-telephonic monitoring (TTM) or modeled insertable loop recorder (ILR) data. Efficacy outcomes were acute PVI and 12-month freedom from atrial arrhythmias (AA), after 90-day blanking. Optional invasive remapping at 75 days facilitated waveform refinement from PULSE1, PULSE2, to the optimized PULSE3. RESULTS At 3 centers, 100 PAF patients underwent PFA with PULSE1 (n = 30), PULSE2 (n = 20), or PULSE3 (n = 50). Procedure, left atrial dwell, and fluoroscopy times were 57.9 +/- 20.6, 22.2 +/- 11.8 and 6.8 +/- 5.7 minutes, respectively. All 395 targeted PVs were acutely isolated, with a transpired PVI time of 11.5 +/- 6.0 minutes, using 4.0 +/- 1.3 lesions/PV. There were no primary safety events (serious device-related events within 7 days post-PFA). PVI durability with PULSE3 (n = 40) was 98% (per-vein) and 93% (per-patient). One-year freedom from AA recurrence was 82.0% (95% CI:73.0%-88.3%) overall, and 88.0% (95%CI, 75.2%- 94.4%) for PULSE3 patients. Of the ILR sub-cohort (n = 15 PULSE3 patients), 3 patients (20%) had recurrences, with an AA burden CONCLUSION The large lattice PFA catheter was efficient, safe, and effective in treating PAF. The observed high PVI durability translated to clinical effectiveness, even in continuously monitored patients.
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
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Heart Rhythm
ISSN
1547-5271
e-ISSN
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Volume of the periodical
22
Issue of the periodical within the volume
10
Country of publishing house
US - UNITED STATES
Number of pages
11
Pages from-to
2551-2561
UT code for WoS article
001589535900005
EID of the result in the Scopus database
2-s2.0-105009318772