A randomized multicenter clinical study to evaluate the safety and efficacy of the TandemHeart percutaneous ventricular assist device versus conventional therapy with intraaortic balloon pumping for treatment of cardiogenic shock - 17/08/11
for the TandemHeart Investigators Groupe
Résumé |
Background and Aim |
Despite major advances in the treatment of heart failure, cardiogenic shock (CGS) remains associated with substantial mortality. Recent data suggest that the TandemHeart percutaneous ventricular assist device (pVAD) may be useful in the management of CGS. The aim of this prospective randomized study was to test the hypothesis that the TandemHeart (pVAD) provides superior hemodynamic support compared with intraaortic balloon pumping (IABP).
Methods |
Forty-two patients from 12 centers presenting within 24 hours of developing CGS were included in the study and treated in an initial roll-in phase (n = 9) or randomized to treatment with IABP (n = 14) or TandemHeart pVAD (n = 19). Thirty patients (71%) had persistent CGS despite having an IABP in place at the time of study enrollment.
Results |
Cardiogenic shock was due to myocardial infarction in 70% of the patients and decompensated heart failure in most of the remaining patients. The mean duration of support was 2.5 days. Compared with IABP, the TandemHeart pVAD achieved significantly greater increases in cardiac index and mean arterial blood pressure and significantly greater decreases in pulmonary capillary wedge pressure. Overall 30-day survival and severe adverse events were not significantly different between the 2 groups.
Conclusion |
In patients presenting within 24 hours of the development of CGS, TandemHeart significantly improves hemodynamic parameters, even in patients failing IABP. Larger-scale studies are required to assess the influence of improved hemodynamics on survival.
Le texte complet de cet article est disponible en PDF.Plan
| This study was supported by CardiacAssist, Inc, Pittsburgh, PA |
Vol 152 - N° 3
P. 469.e1-469.e8 - septembre 2006 Retour au numéro
Article précédent
- Sex and classic risk factors after myocardial infarction: a community study
- Yariv Gerber, Susan A. Weston, Jill M. Killian, Steven J. Jacobsen, Véronique L. Roger
- Myocardial perfusion in apical ballooning syndrome: Correlate of myocardial injury
- Ahmad Elesber, Amir Lerman, Kevin A. Bybee, Joseph G. Murphy, Gregory Barsness, Mandeep Singh, Charanjit S. Rihal, Abhiram Prasad
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?