Preclinical in vivo long-term evaluation of the novel Mitra-Spacer technology: experimental validation in the ovine model.
EuroIntervention
; 13(3): 272-279, 2017 Jun 20.
Article
en En
| MEDLINE
| ID: mdl-28262622
ABSTRACT
AIMS:
The Mitra-Spacer (Cardiosolutions, Bridgewater, MA, USA) is designed to treat mitral regurgitation by introducing a dynamic spacer that constantly adapts to the changing haemodynamic conditions during the cardiac cycle. We aimed to evaluate the performance and safety of this device in the chronic ovine model. METHODS ANDRESULTS:
Eight sheep were enrolled in this study. Through a left thoracotomy, the Mitra-Spacer was inserted via the transapical approach and advanced into the left atrium (LA) under imaging guidance. Device performance and safety were evaluated up to 90 days using fluoroscopy, echocardiography and histopathology. The volume within the balloon spacer shifted during the cardiac cycle in all cases. Seven animals survived up to 90 days for terminal imaging and tissue harvest. Echocardiography showed no change in left ventricle (LV) ejection fraction from baseline to 90 days. There were no observations of changes in LV diastolic function, pulmonary vein inflow, or tricuspid valve function. Histological analysis demonstrated no significant injury to the mitral apparatus.CONCLUSIONS:
In the healthy ovine model, Mitra-Spacer implantation was feasible and safe. At 90 days, no evidence of structural damage to the mitral apparatus or deterioration of cardiac performance was demonstrated.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Función Ventricular Izquierda
/
Implantación de Prótesis de Válvulas Cardíacas
/
Insuficiencia de la Válvula Mitral
Tipo de estudio:
Evaluation_studies
Límite:
Animals
Idioma:
En
Revista:
EuroIntervention
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
/
TERAPEUTICA
Año:
2017
Tipo del documento:
Article
País de afiliación:
Estados Unidos