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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

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30201 - Cardiac and Cardiovascular systems

Result continuities

  • Project

  • 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

  • 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