Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry.
Eur Heart J
; 45(14): 1241-1251, 2024 Apr 07.
Article
em En
| MEDLINE
| ID: mdl-38426911
ABSTRACT
BACKGROUND AND AIMS:
Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed.METHODS:
All Micra PAR patients undergoing implant attempts were included. Endpoints included system- or procedure-related major complications and system revision rate for any cause through 60 months post-implant. Rates were compared through 36 months post-implant to a reference dataset of 2667 transvenous pacemaker patients using Fine-Gray competing risk models.RESULTS:
1809 patients were enrolled between July 2015 and March 2018 and underwent implant attempts from 179 centres in 23 countries with a median follow-up period of 51.1 months (IQR 21.6-64.2). The major complication rate at 60 months was 4.5% [95% confidence interval (CI) 3.6%-5.5%] and was 4.1% at 36 months, which was significantly lower than the 8.5% rate observed for transvenous systems (HR .47, 95% CI .36-.61; P < .001). The all-cause system revision rate at 60 months was 4.9% (95% CI 3.9%-6.1%). System revisions among Micra patients were mostly for device upgrades (41.2%) or elevated thresholds (30.6%). There were no Micra removals due to infection noted over the duration of follow-up. At 36 months, the system revision rate was significantly lower with Micra vs. transvenous systems (3.2% vs. 6.6%, P < .001).CONCLUSIONS:
Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Marca-Passo Artificial
/
Arritmias Cardíacas
Limite:
Humans
Idioma:
En
Revista:
Eur Heart J
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Geórgia