One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker

Popis výsledku anglicky

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.

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

2025

Kód důvěrnosti údajů

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

Název periodika

Circulation-Arrhythmia and Electrophysiology

ISSN

1941-3149

e-ISSN

—

Svazek periodika

18

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

299-308

Kód UT WoS článku

001468720300008

EID výsledku v databázi Scopus

2-s2.0-105002406187