August 8th, 2012
Risks and Benefits of Pediatric VAD Explored
Larry Husten, PHD
Few options besides extracorporeal membrane oxygenation (ECMO) have been available for children with systolic heart failure awaiting transplantation. Now, a report by Charles Fraser, Jr., and colleagues published in the New England Journal of Medicine provides important new information about a ventricular assist device (VAD) designed for children.
Trial investigators implanted 48 patients with the Excor Pediatric VAD (Berlin Heart) and compared them with matched historical controls who had received ECMO. The VAD group comprised two 24-patient cohorts based on body-surface area. Survival was dramatically and significantly longer in both VAD cohorts:
- Cohort 1 (body surface area, <0.7 m2): the median survival time in the VAD group had not yet been reached at 174 days, while the median survival time with ECMO was 13 days (p<0.001)
- Cohort 2 (0.7 to <1.5 m2): median survival: 114 days with VAD versus 10 days with ECMO (p<0.001)
However, VAD treatment was associated with clinically significant adverse events. Major bleeding occurred in 42% of cohort 1 patients and 50% of cohort 2 patients, infection in 63% and 50%, and stroke occurred in 29% of patients in each cohort.
In an accompanying editorial, Linda Addonizio observes that the development of pediatric VADs has been markedly slower than the development of adult VADs, although “the potential number of years of life saved for each person is much greater for children.” However, because of the high rate of neurological complications, she urges caution before “extending the current practice in adults of early implementation of ventricular assist devices to children.” VADs, she writes, “should remain, at present, a last resort in small children.”
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