Six-month electrical performance of the first 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_____%2F24%3A00009900" target="_blank" >RIV/00023884:_____/24:00009900 - isvavai.cz</a>
Result on the web
<a href="https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/pii/S1547527124025256?via%3Dihub" target="_blank" >https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/pii/S1547527124025256?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.hrthm.2024.04.091" target="_blank" >10.1016/j.hrthm.2024.04.091</a>
Alternative languages
Result language
angličtina
Original language name
Six-month electrical performance of the first dual-chamber leadless pacemaker
Original language description
BACKGROUND The first dual-chamber leadless pacemaker (DC-LP) system consists of 2 separate atrial and ventricular devices that communicate to maintain synchronous atrioventricular pacing and sensing. The initial safety and efficacy were previously reported. OBJECTIVE The purpose of this study was to evaluate the chronic electrical performance of the DC-LP system. METHODS Patients meeting standard dual-chamber pacing indications were enrolled and implanted with the DC-LP system (Aveir DR, Abbott), including right atrial and ventricular helix-fixation fixation LPs (atrial leadless pacemaker [ALP], ventricular leadless pacemaker [VLP]). Pacing capture threshold, sensed amplitude, and pacing impedance were collected using the device programmer at prespecified fi ed timepoints from 0-6 months postimplant. RESULTS De novo devices were successfully implanted in 381 patients with complete 6-month data (62% male; age 69 +/- 14 years; weight 82 +/- 20 kg; 65% sinus nodal dysfunction, 30% atrioventricular block). ALPs were implanted predominantly in the right atrial appendage anterior base and VLPs primarily at the mid-to-apical right ventricular septum. From implant to 1 month, pacing capture thresholds (0.4-ms pulse width) improved in both ALPs (2.4 +/- 1.5 V to 0.8 +/- 0.8 V; P <.001) and VLPs (0.8 +/- 0.6 V to 0.6 +/- 0.4 V; P <.001). Sensed amplitudes improved in both ALPs (1.8 +/- 1.3 mV to 3.4 +/- 1.9 mV; P <.001) and VLPs (8.8 +/- 4.0 mV to 11.7 +/- 4.2 mV; P <.001). Impedances were stable in ALPs (334 +/- 68 S2 to 329 +/- 52 S2; P = . 17) and reduced in VLPs (789 +/- 351 S2 to 646 +/- 190 S2; P <.001). Electrical measurements remained relatively stable from 1-6 months postimplant. No differences in electrical metrics were observed among ALP or VLP implant locations. CONCLUSION This first in-human evaluation of the new dual-chamber leadless pacemaker system demonstrated reliable electrical performance throughout the initial 6-month evaluation period.
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
2024
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
21
Issue of the periodical within the volume
10
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
1929-1938
UT code for WoS article
001329092600001
EID of the result in the Scopus database
2-s2.0-85195086788