Authors' objectives: The CardioWest™ is an implantable device designed to replace the function of the two ventricles in patients with irreversible biventricular failure at risk of imminent death and candidates for heart transplantation. Three technology briefings and four observational cohort studies were recovered in the systematic search carried out to assess the effectiveness and safety of the CardioWest™ device. The cohort not exposed (conventional support treatment) was retrospective in three. The fourth study compared the CardioWestTM with two other ventricular assistance devices, ThoratecTM and NovacorTM. In this report, both cohorts were retrospective.

Authors' recommendations: In general, the systematic review included good-quality studies, which presented comparable cohorts, defined inclusion criteria and exclusion and objective variables. The main limitations referred to the ambispective design (that could have introduced biases deriving fundamentally from the differences in the treatments). Besides, the studies were carried out by the same group of experts, without detailing the handling of the technique nor the characteristics of the center (an important issue to assess the external validity), and the lack of multivariate analysis for the identification of confounding factors. The outcomes of the studies showed a significant higher survival rates in patient treated with CardioWestTM versus standard treatment (survival to transplant 79%-96% vs. 44%-46%; p < 0.001; survival rate after a year 70%-92% vs. 31%-33%; p < 0,001; survival rate after the transplant 86%-96% vs. 69%-75%). The CardioWest™ device also showed a higher survival rate after transplantation (75%) when it was compared with the implantation of Thoratec™ (38%) and Novacor™ (57%). The main causes of death were related with the evolution of the disease: multi-organ failure, right ventricular failure and right heart failure.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/corazon-artificial-total-cardiowest-tah-t/

Year Published: 2013

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_15_07_11_Cardiowest_def.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)