Technologies

Minimally Invasive VAD (MIVAD)

PediaFlow VAD

Need for the PediaFlow

Pediatric Heart Failure in America

  • Greater than 35,000 babies are born each year with congenital heart defects
  • During the 1st critical year of life, 25% (~9,000) require invasive treatment
    • Phased corrective surgery and/or heart transplant: ~6 months
  • 5,000-6,000 die from complications or from waiting for a suitable donor (> 50% of those on HTx list)

Need and Impact of the PediaFlow VAD

  • At least 20% (~1800) of these deaths can be prevented
  • Another 20% (~1800) may have better outcomes and a better life going forward with reduced complications using this therapy/li>
  • While numbers are small (~3600 potential patients/yr in US), the impact on the intended patient population is significant

Existing mechanical circulatory support technology is inadequate

  • '60s technology, ECMO (Extra-Corporeal Membrane Oxygenation) is being used beyond its designed-for capabilities (see figure)
    • Presently the mainstay of mechanical circulatory support for infants and children
    • Not suitable for longer-term support (A few days use at most)
    • Extra-corporeal pneumatic blood pump available to keep babies alive
  • Mortality and complications on ECMO and existing blood pumps remainhigh (as tabulated below that summarizes the experience of one of the leading pediatric heart centers in the United States: the Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center)


The photo below shows a child (upper left) being
supported by the ECMO (foreground)

Table: Outcomes and complications in pediatric cardiac failure patients treated with existing VAD or ECMO technology at CHP of UPMC, (Maul et al., ICMMB, 2008).

 

VAD

ECMO

Number of pts

24

59

Age (yrs)

12.25 +/- 5.7
(0.5-18)

2.34 +/- 4.71
(0-17.83)

Gender

13(M),9(F)

25(M),34(F)

BSA (m2)

1.4 +/- 0.56
(0.25-2.3)

0.43 +/- 0.4
(0.12-1.79)

Duration of Support (days)

46.4 +/- 51.4
(0.1-175)

4.47 +/- 3.72
(0.13-21.54)

CAUSE OF HEART FAILURE

CHD

3

36

Cardiomyopathy

21

9

Cardiogenic Shock

0

8

Cardiac Arrest

0

3

Post-transplant

0

2

Myocarditis

0

1

SURVIVAL STATISTICS

MCS survival

19 (86%)

39 (66%)

Survival to discharge

18 (82%)

29 (43%)

COMPLICATIONS

Bleeding

5 (23%)

13 (21%)

Device Malfunction

0 (0%)

7 (11.5%)

Neurologic Event

5 (23%)

7 (11.5%)

Infection

7 (32%)

2 (3.3%)

Renal

N/A

29 (47.5%)

Cardiovascular

1 (5%)

22 (36.1%)

Clearly, there exists a clinical need for a longer-term pediatric VAD such as the PediaFlow VAD designed to provide significantly improved biocompatibility to support bridge to transplant and bridge to recovery in a broader range of pediatric heart failure.