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Very interesting!!

MONDAY JANUARY 26, 2009

90 The Society of Thoracic Surgeons 45th Annual Meeting 91

New | Special Interest

Ticketed Event1:45 pm

17. Non-Blood Contacting Support Device Effectively Augments Myocardial Function of the Neonatal-Sized Failing Heart
S. Budharaju1, A. J. Pothoulakis1, L. J. Prochaska1, S. A. Kerns1, R. J. Darner1, B. A. Schmitt1, P. M. Portner2, M. P. Anstadt1
1Wright State University School of Medicine, Dayton, OH; 2Stanford University School of Medicine, Stanford, CA

FINANCIAL DISCLOSURE P.M. Portner, consultant to company and board member, Myotech, LLC; M.P. Anstadt, consultant and board member, Myotech, LLC, ownership of shares, Myotech, LLC

REGULATORY DISCLOSURE This presentation describes the use of Sapien Edwards whose FDA status is investigational, Cove Valve whose FDA status is investigational, and Ventor whose FDA Status is investigational.

Background: Direct Mechanical Ventricular Actuation (DMVA) is a non-blood contacting method that uniquely augments both systolic and diastolic ventricular function. DMVA technology (the MyoVAD) is currently under development for the small pediatric or neonatal heart. The purpose of this study was to assess DMVA feasibility for biventricular support of the neonatal-sized failing heart.

Methods: New Zealand white rabbits (n=6) were anesthetized, underwent sternotomy and instrumented for hemodynamic monitoring. A 10mHz ultrasound probe was positioned for transesophageal cardiac imaging. Heart failure (HF, cardiac output < 50% baseline) was induced with esmolol while phenylephrine was titrated for maintaining mean arterial pressure (60-70mm Hg). Steady state ECHO images were acquired during baseline, HF and subsequently DMVA during 2 hours of support. Images were analyzed for ejection fraction, stroke volume and cardiac output using Simpson’s method of discs as measures of LV function. Velocity Vector Imaging (VVI) was used to assess peak systolic and diastolic strain rates in the basal, mid, and apical regions of the LV septum and LV free wall. Peak global systolic and diastolic strain rates were used as load independent measures of myocardial systolic and diastolic function

Conclusions: In this study, DMVA provided effective non-blood contacting biventricular support of the neonatal-sized heart. Importantly, both systolic and diastolic myocardial function were significantly augmented which represents a distinct advantage to the limited systolic assist offered by direct cardiac compression devices. These findings demonstrate feasibility for supporting the pediatric and neonatal-sized failing heart using the MyoVAD technology. Future studies will assess support of congenital conditions such as the univentricular heart.

The Society of Thoracic Surgeons Page 90

http://www.sts.org/documents/pdf/annmtg/2009AM/45thprogram_monday.pdf