Association of device surface and biomaterials with immunologic sensitization after mechanical support.
OBJECTIVE
Biomaterials and textured surfaces in early pulsatile left ventricular assist devices (HeartMate I; Thoratec Corporation, Pleasanton, Calif) may increase immunologic risk through allosensitization. We hypothesized that axial-flow devices without biologic membranes or textured surfaces (HeartMate II; Thoratec; and DeBakey; MicroMed Cardiovascular, Inc, Houston, Tex) would cause less allosensitization than devices with such membranes and surfaces.


METHODS
HeartMate II and DeBakey (n = 24) and HeartMate I (n = 36) devices were implanted from 1999 to 2006 in patients with severe heart failure cohort-matched for age, etiology, and support duration. Serum samples reacting with more than 10% of the HLA reference panel were considered positive for anti-HLA antibodies. Endomyocardial biopsy samples were collected after transplant.


RESULTS
There were no significant cohort differences in age, etiology, sex, blood transfusion, or support duration. Anti-HLA antibodies were not detected at implantation of either HeartMate II and DeBakey or HeartMate I devices; however, significant increases in anti-HLA antibodies were present within 1 and 3 months of support with HeartMate I but not HeartMate II and DeBakey devices. Overall, fewer patients with HeartMate II and DeBakey devices demonstrated positive anti-HLA antibodies during support (8% vs 28%, P = .02), and fewer episodes of acute rejection per patient were seen within the first 9 posttransplant months(0.31 vs 0.69, P = .052). Long-term posttransplant survival was not different between groups.


CONCLUSIONS
Hemodynamic support with HeartMate II and DeBakey devices produced less allosensitization than did HeartMate I devices. Device selection may improve clinical outcomes for high-risk patients.
Department of Surgery, Division of Cardiothoracic Surgery, College of Physicians and Surgeons of Columbia University, New York, NY, USA. isaacgeorge@hotmail.com
Isaac
I
George
Patrick
P
Colley
Mark J
MJ
Russo
Timothy P
TP
Martens
Elizabeth
E
Burke
Mehmet C
MC
Oz
Mario C
MC
Deng
Donna M
DM
Mancini
Yoshifumi
Y
Naka
D000328:Adult; D020099:Coated Materials, Biocompatible; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006680:HLA Antigens / Q000276:immunology*; D006333:Heart Failure / Q000276:immunology* / Q000401:mortality / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D007114:Immunization / Q000379:methods*; D053208:Kaplan-Meier Estimate; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D016019:Survival Analysis
D020099:Coated Materials, Biocompatible; D006680:HLA Antigens