ReliantHeart, Inc., an innovative supplier of advanced mechanical circulatory assist technologies has released information that indicates that from the first implant of the HeartAssist5® LVAD (HA5) to the 68th consecutive implant, there has been no evidence of de novo thrombus patterns in the HA5.
Thrombus that originates in an LVAD is referred to as de novo thrombus. De novo thrombus can hide under the impeller of a HeartWare HVAD or aggregate on the bearings of the Thoratec HeartMateII.
Measured TrueFlow and the leading indicators of Power, TrueFlow and Speed in combination with the TrueFlow waveform can be an early alert to certain types of flow obstruction in an LVAD. TrueFlow and the amplitude of TrueFlow are measured at the outbound end of the HA5 by a TrueFlow Transonic flow sensor. There are distinct patterns of early alert.
The remote monitoring experience of the HeartAssist5® supports the finding in the Stony Brook(1) shear study published February 2014 comparing the Thoratec HeartMate II to the ReliantHeart HeartAssist5®. According to Stony Brook: “de novo thrombus is absent in the HA5”.
The Texas Heart Institute (2) published a study indicating that the HeartAssist5® is 28 times more pulsatile than the Thoratec HeartMate II and 6 times more pulsatile than the earlier NASA designed impeller.
Some other LVADs include a “pulse generator” that occasionally slows and speeds up the pump for the purpose of washing the pump of thrombus or exercising the aortic valve.
Pulse generating is not necessary in the HeartAssist5® as the natural pressure of the human ventricle accelerates blood through the HeartAssist5® with each beat of the heart. Each beat washes the HA5 and in turn the HA5 assists the natural human heart; a truly symbiotic relationship.
The HeartWare Endurance One Trial of 445 as-treated patients revealed that thrombus events of all kind were 13.4% for HeartMate II and 10% for the HeartWare HVAD(3).
ReliantHeart, Inc. is an innovative supplier of advanced mechanical circulatory assist technologies that are changing the approach to the treatment of advanced heart failure. It develops and manufactures the HeartAssist5® Ventricular Assist Device. ReliantHeart’s roots are in Houston, Texas, where it has been generously influenced by the transplant centers of Texas Heart, Methodist DeBakey and Memorial Hermann, and its technology originally inspired by NASA, the Johnson Space Center and Baylor School of Medicine.
- Thromboresistance Comparison of the HeartMate II Ventricular Assist Device with the Thrombogenicity Emulation Optimized HeartAssist5® VAD. Danny Bluestein, et al, Department of Biomedical Engineering,, Stony Brook University, Stony Brook, NY 11794-8151, email: firstname.lastname@example.org, Journal of Biomechanical Engineering Copyright VC 2014 by ASME FEBRUARY 2014, Vol. 136 / 021014-1
- Optimization of axial-pump pressure sensitivity for a continuous-flow total artificial heart. O. H. Frazier, MD,Hassan A. Khalil, BS, Robert J. Benkowski, BS, and William E. Cohn, MD, 2010 International Society for Heart and Lung Transplantation. All rights reserved. doi:10.1016/j.healun.2009.12.017
- Results of the ENDURANCE Destination Therapy Trial. FD Pagani, et al. ISHLT April 15-18, 2015. Data from the first cohort in the Endurance study, referred to as Endurance 1. In this group 446 patients with end-stage heart failure were randomized 2:1 to HVAD or HeartMate II