The Food and Drug Administration (FDA)-cleared TandemHeart® Percutaneous Ventricular Assist Device (CardiacAssist, Inc.) provides short-term, temporary circulatory support for patients seeking emergency cardiac assistance. A recent study has demonstrated the efficacy of the prompt use of TandemHeart in quick unloading of the left ventricle, stabilizing end-organ function and ensuring a safe aortic valve replacement (AVR) in patients experiencing critical aortic valve stenosis-associated cardiac arrest or severe refractory cardiogenic shock (SRCS), before or after AVR. The results of the research have been published in The Annals of Thoracic Surgery.
Igor D Gregoric, Associate Chief of Transplant Service, Texas Heart Institute, Houston, and colleagues, evaluated the TandemHeart device as a rescue therapy for critical aortic valve stenosis in 10 patients (mean age 62±12 years) with cardiac arrest or SRCS. Eight patients (five undergoing cardiopulmonary resuscitation and three for SRCS), inserted with the device in the cardiac catheterization laboratory, underwent AVR following hemodynamic stability. The remaining subjects were surgically fitted with the device in the operating room for postcardiotomy cardiogenic shock after urgent AVR. While all the study subjects were intubated and put on vasopressor support, seven patients were given intraaortic balloon pump. The Society of Thoracic Surgeons mortality risk preoperatively was 74.9±24.5%.
Based on the study findings, the eight patients on hemodynamic support for 6.4±3.8 days in the catheterization laboratory, demonstrated marked improvements in kidney function prior to AVR. Out of these, seven patients stayed alive 2 to 43 months following hospital discharge, while one patient succumbed to sepsis 34 days post AVR. Among the remaining patients who had the device implanted in the operating room after AVR, one died on the 8th and the other on the 21st day, indicating the efficacy of TandemHeart.
TandemHeart, a left atrial-to-femoral artery bypass system intended for extracorporeal support, consists of a centrifugal pump, a system controller and a cannula set. The device acts by bringing about a reduction in left atrial pressure, increase in mean arterial pressure, and improvement in cardiac output, resulting in an improved hemodynamic condition through a superior technology.
The system has been adopted by almost 90% of the best heart surgery hospitals in the US, with approximately 1,800 procedures conducted at about 150 hospitals across the country. Cardiogenic shock remains the leading cause of mortality among heart attack patients. The adoption of TandemHeart system in cardiac care centers contribute to 50% reduction of such mortality in comparison to national average. Worldwide adoption of TandemHeart devices as a standard circulatory support may aid in treating critically ill cardiac patients promptly and aggressively.
About CardiacAssist, Inc.: The Pittsburgh-based medical technology company focuses on developing and marketing less-invasive circulatory support products for cardiologists and cardiac surgeons.
References
1. Gregoric ID, Loyalka P, Radovancevic R, Jovic Z, Frazier OH, Kar B. TandemHeart as a rescue therapy for patients with critical aortic valve stenosis. Ann Thorac Surg. 2009 Dec;88(6):1822-6.
2. Khalife WI, Kar B. The TandemHeart pVAD in the treatment of acute fulminant myocarditis. Tex Heart Inst J. 2007;34(2):209-13.
