CLINICAL DATA
Right Ventricular Dysfunction/Failure After
Implantation of a Left Ventricular Assist Device
| SynCardia Comments: Most mechanical circulatory support (MCS) devices augment blood flow through the failing ventricle(s). While these devices may reduce the patient's symptoms and slow the progression of heart failure, they do not stop it. Many professional papers have documented the incidence of right ventricular dysfunction/failure after implantation of a Left Ventricular Assist Device (LVAD). Definitions of right ventricular dysfunction and failure vary by paper. Similar to a heart transplant, the SynCardia temporary Total Artificial Heart replaces both failing heart ventricles and the four native heart valves. It is the only device that eliminates the symptoms and source of biventricular failure. |
| Pre-Market Approval Results for the HeartMate II | |
| 19% | of patients developed right heart failure during the pre-market approval of the HeartMate II. Source: HeartMate II FDA Summary of Safety and Effectiveness. http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf |
| ADVANCE Clinical Study Results for the HeartWare HVAD | |
| 22% | of patients developed right heart failure requiring either a right ventricular assist device (RVAD) or inotropic support. Source: Evaluation of the HeartWare HVAD Left Ventricular Assist System for the Treatment of Advanced Heart Failure: Results of the ADVANCE Bridge to Transplant Trial; Keith Aaronson, Mark Slaughter, Edwin McGee, et al. for the HeartWare ADVANCE Investigators; American Heart Association Scientific Sessions November 2010 |
| Professional Papers | |
| 33% | Tricuspid annular motion as a predictor of severe right ventricular failure after left ventricular assist device implantation. Puwanant S, Hamilton KK, et al. J Heart Lung Transplant. 2008 Oct;27(10):1102-7. |
| 25% | The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates. Matthews JC, Koelling TM, et al. J Am Coll Cardiol. 2008 Jun 3;51(22):2163-72. |
| 39% | Right heart failure after left ventricular assist device implantation in patients with chronic congestive heart failure. Dang NC, Topkara VK, et al. J Heart Lung Transplant. 2006 Jan;25(1):1-6. Epub 2005 Dec 9. |
NEXT ›› Professional Papers
*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.
