One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F25%3A00010209" target="_blank" >RIV/00023884:_____/25:00010209 - isvavai.cz</a>
Result on the web
<a href="https://www.ahajournals.org/doi/10.1161/CIRCEP.124.013619" target="_blank" >https://www.ahajournals.org/doi/10.1161/CIRCEP.124.013619</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1161/CIRCEP.124.013619" target="_blank" >10.1161/CIRCEP.124.013619</a>
Alternative languages
Result language
angličtina
Original language name
One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker
Original language description
BACKGROUND:A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals. METHODS:Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing. Enrolled patients were implanted with an Aveir DR dual-chamber leadless pacemaker system, which comprised 2 communicating leadless pacemakers (1 in the right atrium and 1 in the right ventricle). The primary safety outcome evaluated whether freedom from serious device- or procedure-related events through 365 days exceeded the predetermined performance goal of 76.5%. The primary performance outcome determined whether the composite of atrial capture threshold (<= 3.0 V at 0.4 ms) and sensing amplitude (P-wave >= 1.0 mV) at the 12-month visit exceeded the predetermined performance goal of 80.0%. RESULTS:Sites attempted implantation in 300 subjects, where 63.3% had sinus-node dysfunction and 33.3% had atrioventricular block as their primary pacing indication. The primary safety end point was achieved, with a Kaplan-Meier 12-month complication-free rate of 88.6% (95% CI, 84.5-91.8; P<0.001). The primary performance end point was achieved in 92.8% of patients (95% CI, 89.7-95.8; P<0.001). CONCLUSIONS:Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual-chamber leadless pacemaker.
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
Circulation-Arrhythmia and Electrophysiology
ISSN
1941-3149
e-ISSN
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Volume of the periodical
18
Issue of the periodical within the volume
4
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
299-308
UT code for WoS article
001468720300008
EID of the result in the Scopus database
2-s2.0-105002406187