Background: Previous reports, all concerning pulsatile devices, have indicated an increased risk of development of circulating antileukocyte antigen (HLA; human leukocyte antigen) antibodies during ventricular assist device (VAD) support. We investigated sensitization in patients implanted with the DeBakey VAD (MicroMed Technology, Inc, Houston, TX) axial flow pump as a bridge to heart transplantation.
Methods: Inclusion criteria for this prospective study were the following. Patients implanted with the DeBakey VAD axial flow pump, without HLA antibodies prior to implantation, with a duration of support of at least one month. The HLA antibody testing for IgG and IgM class I and II antibodies was performed weekly during support, using both a complement dependant cytotoxicity assay and an enzyme-linked immunosorbent assay (ELISA). Retrospective cross match was performed for all patients transplanted. The occurrence of graft rejection was determined by regular endomyocardial biopsies after heart transplantation, graded according to the International Society for Heart and Lung Transplantation (ISHLT) guidelines. Additionally, the transfusion history was reviewed for all patients.
Results: Fourteen patients were included representing 1,220 cumulative patient-days of support (mean duration time on support, 87 days). No patient developed detectable IgG antibodies to class I or II. One patient had a positive ELISA, corresponding to nonsignificant (6/30) class I IgM antibodies at 3 weeks postimplantation. Ten patients underwent successful heart transplantation, representing 156 cumulative months. No retrospective cross match was positive. The percentage of significant acute rejection episodes (ISHLT grade 3A or more) was 6% and 4.3% in the first 6 months and from 6 to 12 months, respectively. No vascular rejection was noted. The posttransplantation survival rate was 87% at 6 months and 75% at 1 year, respectively.
Conclusions: Patients implanted with the DeBakey VAD axial flow pump as a bridge to heart transplantation do not appear to be exposed to an increased risk of sensitization.