A Summary of the 5-Year Experience

The Pediatric Circulatory Support Program (PCSP) of the National Heart, Lung, and Blood Institute (NHLBI) was established to fund the development of novel circulatory support devices for children with medically refractory heart failure.1 Before this, developers of circulatory support devices found little incentive to enter the pediatric market because of the small patient numbers that are generally insufficient to justify the significant costs required to develop these devices. As a result of the lack of availability of new devices for circulatory support of pediatric patients, extracorporeal membrane oxygenation (ECMO), which first had been used clinically in the 1960s, remained the most commonly used modality to support these critically ill children during the next 40 years.2 The most attractive feature of ECMO for pediatric circulatory support is its ability to be used in even the smallest infants and neonates. However, ECMO support is characterized by thromboembolic complications and sepsis in a significant percentage of patients.3 Perhaps most importantly, ECMO has generally only been suitable for short-term support, limiting its usefulness as a bridge to transplantation, and the size and extracorporeal configuration of the system components usually limit its use to the intensive care unit setting and preclude ambulation and rehabilitation during support. In recognition of the limitations of the existing devices for pediatric mechanical circulatory support and the limitations for the entry of device companies into the pediatric market, the NHLBI established the PCSP to “perform basic and applied research to develop novel circulatory assist devices or other bioengineered systems for infants and children with congenital and acquired cardiovascular disease who experience cardiopulmonary failure and circulatory collapse.”4 Because the PCSP was a development program for new devices to address a broad goal (circulatory support for pediatric heart failure) rather than for a specific design, and because funding various promising approaches would improve the chances of successfully achieving the objectives of the program, proposals were solicited under a Broad Agency Announcement. Broad Agency Announcements are used, as in this case, when proposals with varying scientific or technical approaches are anticipated. After receipt, review, and assessment of the proposals submitted in response to the Broad Agency Announcement, contracts totaling $20 million were awarded by the NHLBI in the spring of 2004 to 5 contractors to develop a family of pediatric circulatory support devices (Table 1). Funding support for the PCSP concluded in 2009. In 2006, a summary report was published that described these devices and the development goals of their respective programs as the PCSP was initiated.1 Because the PCSP was a development program involving different devices, the design processes, the in vitro and in vivo tests and analyses, and the goals for those tests varied between contractors. However, to make the most of the program, contractors participated in monthly conference calls, attended and presented their progress at annual meetings, and shared quarterly progress reports. These activities provided a means for each of the contractor teams to learn from and leverage the progress made by the other contractors and, as appropriate, to modify their approach and improve their device. The present report provides a summary of progress for each of the contractors at the conclusion of this program, including a sampling of some of the test results and analyses. The report concludes with the plans for achieving clinical application of these and other promising pediatric circulatory support devices.