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CLINICAL DATA

Becoming the New Standard of Care
for End-Stage Biventricular Heart Failure

For patients suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), there are two options for medium-to long-term mechanical circulatory support: biventricular assist devices (BiVADs), which are composed of two pumps that each support one ventricle, and the SynCardia temporary Total Artificial Heart.

BiVADs provide biventricular support for the failing native heart, which is left intact, while the Total Artificial Heart provides biventricular replacement, which allows the failing heart to be removed. Similar to a heart transplant, the SynCardia 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 end-stage biventricular failure.

By replacing the failing heart, the Total Artificial Heart also eliminates the following native heart complications:

  • Ventricle dysfunction/failure
  • Malfunctioning/diseased heart valves
  • Arrhythmias and other electrical problems requiring pacemaker/defibrillator

 

Professional Papers:

Recently, several professional papers have documented improved patient survival with the Total Artificial Heart over BiVADs.

 

"Survival to transplant (TAH, 89%; BiVAD, 50%; LVAD, 79%) was significantly better for the TAH group vs the BiVAD group (p=.004)…"

"Patients receiving a TAH showed improved survival to transplant compared to those receiving a BiVAD and did as well as the LVAD alone group despite the TAH patients being sicker, as measured by the iProfile."

Source: "Survival to Transplant in Patients Undergoing Mechanical Circulatory Support as Bridge: Retrospective Analysis of LVAD, BiVAD and TAH Strategy." O.E. Pajaro, A.V. Kalya, R.S. Gopalan, L.L. Staley, K.L. Diane, J.M. Spadafore, C.N. Pierce, B.N. Noble, C. Krishnaswamy, R.L. Scott, F.A. Arabia. Presented as an abstract at the International Society for Heart & Lung Transplantation (ISHLT) 32nd Annual Meeting, Concurrent Session 43: VAD Bad, April 21, 2012.

 

The Total Artificial Heart had a survival rate of 80% (80/99) versus 65% (239/368) for BiVADs (Figure 7). Use of a BiVAD was a risk factor for death with an early hazard ratio of 3.27 (Table 3, p. 125).

Source: "The Fourth INTERMACS Annual Report: 4,000 Implants and Counting." James K. Kirklin, MD, David C. Naftel, PhD, Robert L. Kormos, MD, Lynne W. Stevenson, MD, Francis D. Pagani, MD, PhD, Marissa A. Miller, DVM, MPH, J. Timothy Baldwin, PhD, and James B. Young, MD. J Heart Lung Transplan. Vol. 31 No. 2 February, 2012 p.117-126
doi:10.1016/j.healun.2011.12.001

 

"Survival while on support and after heart transplantation did not differ significantly in patients supported with paracorporeal BiVADs, implantable BiVADs, or the TAH. Patients undergoing prolonged support (>90 days) tended to have improved survival when supported with TAH compared with BiVADs, which may be related to a lower incidence of neurologic events."

Source: "Survival after biventricular mechanical circulatory support: Does the type of device matter?" Matthias Kirsch, MD, PhD, Jean-Philippe Mazzucotelli, MD, PhD, Jean-Christian Roussel, MD, Olivier Bouchot, MD, PhD, Joseph N'Loga, MD, Pascal Leprince, MD, PhD, Pierre-Yves Litzler, MD, PhD, and André Vincentelli, MD, PhD, for the Groupe de Réflexion sur l'Assistance Mécanique (GRAM). J Heart Lung Transplan. Vol. 31 No. 5 May, 2012 p.501-508
doi:10.1016/j.healun.2011.11.024

 

"Compared to the BIVAD group, patients receiving the TAH had a longer length of mechanical support, and significantly lower incidence of stroke and re-operation. Despite a higher incidence of infection, the TAH was a more successful device in bridging patients to transplantation. Consequently, patients receiving a TAH were more likely to be discharged from the hospital after transplantation."

Source: "Is the Total Artificial Heart Superior to BIVAD Therapy as a Method of Bridging Patients to Heart Transplantation?" Bradley G. Leshnower MD1, Richard G. Smith MSEE2, Mary Lou O'Hara RN, Y. Joseph Woo MD, Alberto Pochettino MD, Rohinton J. Morris MD, Timothy J. Gardner MD3, Marvin J. Slepian MD2, Jack G. Copeland, MD2, Michael A. Acker MD, 1Division of Cardiovascular Surgery Hospital of the University of Pennsylvania , 2The University of Arizona Sarver Heart Center , 3Center for Heart and Vascular Health, Christiana Care Health System. Presented as an poster at the Society of Thoracic Surgeons (STS) 43rd Annual Meeting, January 2007.

 

 

torso-tah-2012

SynCardia Total Artificial Heart

 

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Biventricular Assist Device

 

NEXT ›› LVADs & RV Dysfunction

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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