CLINICAL DATA
Percentage of Patients Who Experience Right Ventricular Dysfunction
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. The SynCardia temporary CardioWest™ Total Artificial Heart replaces both native ventricles. It is the only device that eliminates the symptoms and source of biventricular failure. |
| 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. |
| 30% | Right ventricular dysfunction and organ failure in left ventricular assist device recipients: a continuing problem. Kavarana MN, Pessin-Minsley MS, et al. Ann Thorac Surg. 2002 Mar;73(3):745-50. |
| 15-26% | Device and patient management in a bridge-to-transplant setting. El-Banayosy A, Körfer R, Arusoglu L, et al. Ann Thorac Surg. 2001 Mar;71(3 Suppl):S98-102; discussion S114-5. |
| 33% | Bridge experience with long-term implantable left ventricular assist devices. Are they an alternative to transplantation? Oz MC, Argenziano M, et al. Circulation. 1997 Apr 1;95(7):1844-52. |
| 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 |
Dr. Rohinton J. Morris
Surgical Director, Heart Transplantation and
Mechanical Assist Program
Hospital of the University of Pennsylvania
Philadelphia, PA, U.S.
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