News | April 18, 2014

Heart Failure Cardiac Function Improved With Extracellular Matrix With LVAD

April 18, 2014 — New research presented at the 34th annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) demonstrated the CorMatrix particulate extracellular matrix (P-ECM) alone and as an adjunct to HeartWare International Inc.’s left ventricular assist device (LVAD) improved cardiac function in a bovine ischemic heart failure model, as compared to LVAD alone.

Mark S. Slaughter, M.D., department of cardiovascular and thoracic surgery, University of Louisville, and his research team presented data during the ISHLT Mechanical Circulatory Support: Bench to Bedside session in his presentation entitled “Myocardial Regeneration and Recovery with Extracellular Matrix and LVAD Support.”

This first-of-its-kind preclinical study was designed to evaluate if combining a LVAD with an extracellular matrix bioscaffold therapy would be more effective at improving cardiac function in ischemic heart failure than either therapy alone. LVADs serve as a bridge to heart transplantation or to assist mechanical function for patients with advanced-stage heart failure, whereas the P-ECM facilitates native cardiac progenitor cell engraftment and proliferation resulting in positive remodeling of the damaged heart muscle. The combined effects could encourage endogenous repair mechanisms to take hold, reversing the typical downward spiral patients experience following ischemic events.

According to Slaughter, “combining P-ECM and LVAD therapies may synergistically provide a favorable environment to enhance myocardial regeneration and promote sustained myocardial recovery and lead to LVAD removal which may improve patient outcomes and reduce healthcare costs.”

Ejection fraction (EF) increased 42 percent with LVAD+ECM (33±9% to 75±2%), 40 percent with P-ECM (27±3% to 67±12%) and 27% percent with LVAD (38±7% to 65±7%). LVAD+ECM demonstrated the largest increase in cell proliferation. Additionally, LVAD+ECM resulted in the highest end-organ RBF.

The decellularized matrix material serves as a bioscaffold to allow vascular in-growth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM material is gradually replaced as the patient’s own cells reinforces and rebuilds the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. The safety of extracellular matrices has been well established in a number of different clinical applications and more than 500 published papers. Since 1999, an estimated two million patients worldwide have received an extracellular matrix implant.

“CorMatrix is very encouraged with the results of this animal study, which confirm our belief that P-ECM will play a vital role in treating patients with ischemic heart failure. The results demonstrated the safety of the P-ECM and the potential for it to improve cardiac function, cardiac and end organ perfusion, and repopulate the damaged myocardium with new, functioning tissue," said Robert Matheny, chief medical officer, CorMatrix Cardiovascular.

Based on this study and other preclinical studies, CorMatrix plans to initiate treatments in a first-in-human study at the Central Clinical Hospital, Warsaw, Poland in the second quarter of 2014 with principle investigator Piotr Suwalskl, M.D., chief of the department of cardiac surgery and professor of cardiac surgery.

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