MECHANICAL CIRCULATORY SUPPORT DEVICES: CHALLENGES AND POTENTIAL

"When used as bridge-to-transplantation, usually 90 days on average, current pumps are reasonable," explains Deborah D. Ascheim, MD. "For this duration, they are very reliable, and the infection rate is low. For destination therapy, however, pumps must become more reliable and have lower risks." During each year of implantation, patients with LVADs as destination therapy may experience the following rates of serious adverse effects:

20-40% of patients suffer sepsis
56% experience a serious bleeding event requiring hospitalization
39% undergo neurologic complications such as stroke or TIA
39% experience infection of a single organ
25% suffer renal failure
14% endure a peripheral embolic event
12% develop a supraventricular arrhythmia

In addition to these events, the rate of LVAD malfunction increases over time, which is less relevant for the BTT population, but clearly important when the devices are used for destination therapy, according to Dr. Ascheim.

The SCCOR program will simultaneously investigate the most serious adverse events — infection, coagulopathy, and neurological events — and will seek to improve myocardial recovery with the goal of early removal of the device (avoiding long-term therapy). Seven other institutions, members of the network of heart failure centers of excellence that investigated the clinical values of destination LVAD therapy in the REMATCH trial, will participate as collaborating clinical sites. At the same time, additional collaboration with industry-sponsored trials will facilitate the development of the next generation of devices using continuous flow technologies. This technology will facilitate further miniaturization of the devices, expects Dr. Gelijns. According to Michael Parides, PhD, "The SCCOR program represents a critical opportunity to develop innovations that we hope will lead to significant improvements in device performance in the near future."