COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F25%3A43928383" target="_blank" >RIV/00064173:_____/25:43928383 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11120/25:43928383
Result on the web
<a href="https://doi.org/10.1161/CIRCULATIONAHA.125.074427" target="_blank" >https://doi.org/10.1161/CIRCULATIONAHA.125.074427</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1161/CIRCULATIONAHA.125.074427" target="_blank" >10.1161/CIRCULATIONAHA.125.074427</a>
Alternative languages
Result language
angličtina
Original language name
COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial
Original language description
BACKGROUND: Deep analgosedation (DAS) or general anesthesia (GA) is mandatory for pulsed-field ablation (PFA) of atrial fibrillation (AF). In contrast to DAS, GA (conventional or total intravenous anesthesia [TIVA]) requires airway management. To find the optimal sedation regimen, this study compared ketamine-remimazolam DAS and propofol-opioid TIVA to propofol-opioid DAS, focusing on sedation-related adverse events. METHODS: Patients indicated for AF catheter ablation were randomly assigned in a 1:1:1 ratio to (1) DAS using intermittent propofol-opioid boluses (arm P), (2) continuous remimazolam-ketamine DAS (arm R), or (3) continuous propofol-opioid TIVA with secured airways (arm TIVA). Catheter ablation was performed using the FARAPULSE system (Boston Scientific, MA, USA). The major exclusion criterion was obstructive sleep apnea syndrome. The primary endpoint was defined as a composite of hypoxemia, hypotensive, or hypertensive events requiring intervention or leading to procedure discontinuation. Secondary endpoints included hemodynamic instability events, procedure time, serious adverse events, and patient satisfaction. RESULTS: One-hundred and twenty-seven patients (mean age 62.9 +- 10.3 years, 35.1% female, 47.2% with paroxysmal AF) were enrolled and randomized to the P (N = 42), R (N = 43) or TIVA (N = 42) arms. The primary endpoint occurred in 85.7% of P pts., 27.9% of R pts., and 66.7% of TIVA pts. (P < 0.001), driven by hypoxemia in the P arm (100% of pts. with the primary endpoint) and by hypotension in the TIVA arm (100%). The R arm showed a similar distribution of hypoxemia (50%) and hypotensive (66.7%) events. No differences were observed in mean procedural times, rates of serious adverse events, and assessment of patient satisfaction. CONCLUSIONS: In PFA procedures for AF, remimazolam-ketamine DAS was superior to propofol-opioid regimens (either boluses or continuous) and had the lowest risk of hypoxemia and hypotensive events. More than 80% of patients undergoing conventional propofol-opioid analgosedation experienced hypoxemia.
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
<a href="/en/project/LX22NPO5104" target="_blank" >LX22NPO5104: National Institute for Research of Metabolic and Cardiovascular Diseases</a><br>
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
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
Circulation
ISSN
0009-7322
e-ISSN
1524-4539
Volume of the periodical
152
Issue of the periodical within the volume
3
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
150-159
UT code for WoS article
001530500200004
EID of the result in the Scopus database
2-s2.0-105010918288