The Berlin Heart Excor Ventricular Assist Device (Berlin VAD) was designed for use in children with heart failure. The Berlin VAD has allowed for successful bridging of these patients to heart transplantation (HTx). The exposure to blood products and VAD components during VAD implant, may result in the production of anti-HLA antibodies (Abs) which are a risk factor for rejection in HTx patients.

We immunologically profiled 35 pediatric Berlin VAD patients (19 males, 16 females with a mean age of 6 ± 6 years of age) between 1999-2012 pre/post VAD implant and pre/post HTx. Immune profiling consisted of determining Flow panel reactive antibodies (PRAs), presence of donor specific antibody (DSA) and antibody fixation to complement (C1q assay). Assays were perfomed using One Lambda, Inc. reagents according to manufacturer's instructions. Patients were excluded when immune data was unavailable.

Sixty percent (21/35) of the Berlin VAD patients had a 0% PRA for both class I/class II HLA Abs pre/post VAD and pre/post Tx. In contrast 40% (14/35) of the Berlin VAD patients had HLA class I PRAs pre/post VAD of 17 ± 18% and 25 ± 15% respectively and HLA class II PRAs pre/post VAD of 17 ± 33% and 23 ± 32% respectively. The HLA class I PRAs pre/post Tx were 25 ± 28% and 22 ± 26% respectively and HLA class II PRAs pre/post Tx were 22 ± 34% and 29 ± 31% respectively. Only two patients (2/35, 6 %) presented with donor specific antibodies (anti-HLA DQ) and only one of the two was C1q reactive. All but one (34/35) of the Berlin VAD patients were successfully bridged to Tx. The one, two and three year graft survivals for these Berlin VAD patients were 94%, 91% and 88%, respectively.

Although Berlin VAD patients were exposed to sensitizing risk factors, only 40% of the patients presented with HLA Abs post-VAD and/or post-Tx. Moreover, only 2/35 (6%) of the patients presented with DSA post HTX and only one of the two was C1q reactive. These data, from our single pediatric heart transplant center, suggest that Berlin VAD use in pediatric heart failure patients does not result in an immunological sensitization risk and that these patients can be successfully bridged to transplant with excellent clinical outcomes post HTx.

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