Safety and Performance of the Micra VR Leadless Pacemaker in a Japanese Cohortã- Comparison With Global Studies.
Circ J
; 87(12): 1809-1816, 2023 11 24.
Article
en En
| MEDLINE
| ID: mdl-37532552
ABSTRACT
BACKGROUND:
The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.MethodsâandâResults:
Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval 1.61-6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria.CONCLUSIONS:
In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Marcapaso Artificial
/
Arritmias Cardíacas
Tipo de estudio:
Risk_factors_studies
Límite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
Circ J
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2023
Tipo del documento:
Article