Abstract 11760: The Outcomes of Children Implanted With Ventricular Assist Devices in the US: First Analysis of the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS)
BACKGROUND: Use of pediatric mechanical circulatory support to decrease mortality has expanded dramatically. A national account of the use of FDA-approved devices in children is essential to understanding outcomes, refining patient selection, and improving quality of care.
METHODS: PediMACs is an NIH-supported national registry for FDA-approved temporary and durable VAD usage in patients < 18 years of age. Between the launch in Sept 2012 and March 2014, 32 US hospitals enrolled patients. This first report of data from this registry analyzed pre-implant patient characteristics, survival using competing outcomes, and adverse events.
RESULTS: One hundred and thirty pediatric pts underwent 153 VAD implantations. Etiology of heart disease included 87 (67%) pts with cardiomyopathy, 26 (20%) with congenital heart disease. Twenty pts transitioned from ECMO and 37 had prior cardiac surgery. Most pts were Intermacs level 1 (28%) and level 2 (55%) at implant, with 12% Intermacs level 3. There were 26 temporary devices. Of the durable devices, 65 (51%) were pulsatile and 62 (49%) continuous flow (CF) (compared to adult Intermacs implants: 4% pulsatile, 96% CF). Age at first implant included 22 pts (17%) < 1 yr of age, 23 (18%) 1-5 yrs, 26 (20%) 6-10 yrs and 59 (45%) 10-18 yrs. Patients were supported with LVAD alone in 99 (76%), BiVAD in 24 (18%) and total artificial heart in 2 (2%) and represented 484 months of follow-up. The 104 patients receiving primary durable devices had an actuarial survival of 90% at 6 mos. Competing risk analysis at 6 mos revealed 54% of pts transplanted, 37% alive on support, 8 % died and 1 % recovery. In the overall cohort, there were 8 early (<1mo) and 5 late deaths. Reported serious adverse events included infection (42), bleeding (40), device malfunction (37) and neurologic dysfunction (33).
CONCLUSIONS: Pedimacs constitutes the largest single data repository with detailed information of pediatric pts implanted with all types of VADs. Initial data show a higher rate of use of pulsatile devices as compared to contemporaneous adult data. Survival rates are excellent despite varying patient characteristics and pump types. With further data collection, analysis of patient risk factors critical to improving outcomes will be possible.
Author Disclosures: E.D. Blume: None. D.N. Rosenthal: None. J.W. Rossano: None. J.T. Baldwin: None. P. Eghtesady: None. D.L. Morales: Expert Witness; Significant; Otjen, Gendelman, Zitzer, Johnson & Weir, S.C.. Consultant/Advisory Board; Modest; Cormatrlx Medical Advisory Board, Syncardia TAH Proctor, Bertin Heart CEC Committee. R.S. Cantor: None. J. Conway: None. C.S. Almond: None. D.C. Naftel: None. J.K. Kirklin: None.
- © 2014 by American Heart Association, Inc.