Six-month electrical performance of the first dual-chamber leadless pacemaker

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Six-month electrical performance of the first dual-chamber leadless pacemaker

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

Six-month electrical performance of the first dual-chamber leadless pacemaker

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Heart Rhythm

ISSN

1547-5271

e-ISSN

—

Svazek periodika

21

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

1929-1938

Kód UT WoS článku

001329092600001

EID výsledku v databázi Scopus

2-s2.0-85195086788