Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F25%3A00010203" target="_blank" >RIV/00023884:_____/25:00010203 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S1547527125021769?pes=vor&utm_source=clarivate&getft_integrator=clarivate" target="_blank" >https://www.sciencedirect.com/science/article/pii/S1547527125021769?pes=vor&utm_source=clarivate&getft_integrator=clarivate</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.hrthm.2025.03.1941" target="_blank" >10.1016/j.hrthm.2025.03.1941</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study

Popis výsledku v původním jazyce

Background: Initial results were recently reported for the AVEIR DR i2i study, which involved the percutaneous implantation of a novel dual-chamber leadless pacemaker (LP) system, with right atrial and right ventricular LPs delivering atrioventricular synchronous pacing. Objective: The purpose of this study was to evaluate procedural outcomes and learning curve for de novo implantation of the dual-chamber LP (AVEIR DR, Abbott, Abbott Park, IL). Methods: Implant procedure metrics collected during the study were analyzed, including procedural complications within 30 days of implantation. Procedural outcomes were evaluated according to implanter experience: 1-4 vs 9+ dual-chamber LP implant procedures (ie, initial vs advanced implant experience). Results: De novo dual-chamber LPs were successfully implanted in 446 of 452 patients (99%) by 126 physicians. Mean procedural duration metrics included 90 +/- 37 minutes of introducer sheath insertion-to-removal time, 74 +/- 32 minutes of dual-chamber procedure duration, 26 +/- 17 minutes of right ventricular LP procedure duration, 42 +/- 24 minutes of right atrial LP procedure duration, and 20 +/- 13 minutes of fluoroscopy duration; between initial and advanced implant experience, there were reductions of 19%-36% (P<.05) in these duration metrics. There were 62 procedural complications in 50 of 452 patients (11.1%) (ie, 88.9% complication free), predominantly involving cardiac arrhythmias (ie, atrial fibrillation/flutter or complete atrioventricular block; 16 of 452 [3.5%]). Freedom from complications significantly improved from 89% to 98% of patients (P<.05) when comparing initial and advanced implant experience. Conclusion: In a pivotal investigational study, implantation of a dual-chamber LP system was successful in 99% of patients. Advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion to removal, dual-chamber procedure, ventricular LP and atrial LP procedures, and fluoroscopy) and improved freedom from complications.

Název v anglickém jazyce

Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study

Popis výsledku anglicky

Background: Initial results were recently reported for the AVEIR DR i2i study, which involved the percutaneous implantation of a novel dual-chamber leadless pacemaker (LP) system, with right atrial and right ventricular LPs delivering atrioventricular synchronous pacing. Objective: The purpose of this study was to evaluate procedural outcomes and learning curve for de novo implantation of the dual-chamber LP (AVEIR DR, Abbott, Abbott Park, IL). Methods: Implant procedure metrics collected during the study were analyzed, including procedural complications within 30 days of implantation. Procedural outcomes were evaluated according to implanter experience: 1-4 vs 9+ dual-chamber LP implant procedures (ie, initial vs advanced implant experience). Results: De novo dual-chamber LPs were successfully implanted in 446 of 452 patients (99%) by 126 physicians. Mean procedural duration metrics included 90 +/- 37 minutes of introducer sheath insertion-to-removal time, 74 +/- 32 minutes of dual-chamber procedure duration, 26 +/- 17 minutes of right ventricular LP procedure duration, 42 +/- 24 minutes of right atrial LP procedure duration, and 20 +/- 13 minutes of fluoroscopy duration; between initial and advanced implant experience, there were reductions of 19%-36% (P<.05) in these duration metrics. There were 62 procedural complications in 50 of 452 patients (11.1%) (ie, 88.9% complication free), predominantly involving cardiac arrhythmias (ie, atrial fibrillation/flutter or complete atrioventricular block; 16 of 452 [3.5%]). Freedom from complications significantly improved from 89% to 98% of patients (P<.05) when comparing initial and advanced implant experience. Conclusion: In a pivotal investigational study, implantation of a dual-chamber LP system was successful in 99% of patients. Advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion to removal, dual-chamber procedure, ventricular LP and atrial LP procedures, and fluoroscopy) and improved freedom from complications.

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

Heart Rhythm

ISSN

1547-5271

e-ISSN

—

Svazek periodika

22

Číslo periodika v rámci svazku

9

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

2391-2400

Kód UT WoS článku

001584488700012

EID výsledku v databázi Scopus

2-s2.0-105002338064