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Ann Thorac Surg 2001;71:270-277
© 2001 The Society of Thoracic Surgeons

Original article: cardiovascular

Safety and efficacy of a heparin removal device: a prospective randomized preclinical outcomes study

Joseph B. Zwischenberger, MDa,c, Weike Tao, MDb, Donald J. Deyo, DVMb, Roger A. Vertrees, PhDc, Scott K. Alpard, MDa, Gerald Shulman, MDc

a Department of Surgery, University of Texas Medical Branch, Galveston, Texas, USA
b Department of Anesthesiology, University of Texas Medical Branch, Galveston, Texas, USA
c Department of Medicine, University of Texas Medical Branch, Galveston, Texas, USA

Address reprint requests to Dr Zwischenberger, Division of Cardiothoracic Surgery, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555-0528
e-mail: jzwische{at}utmb.edu

Presented at the Forty-Sixth Annual Meeting of the Southern Thoracic Surgical Association, San Juan, Puerto Rico, Nov 4–6, 1999.

Background. Systemic protamine sulfate for heparin reversal after cardiopulmonary bypass (CPB) is associated with uncommon, but life-threatening adverse reactions.

Methods. In a prospective randomized 3-day outcomes study, a heparin removal device (HRD) group (n = 12; 60-, 80-, 100-kg subgroups) was compared with a matched systemic Protamine group (Protamine; n = 6) for safety and efficacy using an adult swine model of CPB (60 minutes, 28°C).

Results. HRD run time was 25 to 38 minutes depending on weight without complications. After HRD, heparin concentration decreased from 4.77 ± 0.17 to 0.45 ± 0.06 U/mL (activated clotting time [ACT] 776 ± 83 to 180 ± 12 seconds), and in Protamine, 3.94 ± 0.63 to 0.13 ± 0.02 U/mL (ACT 694 ± 132 to 101 ± 5 seconds) (p = 0.01 between groups, but no significant differences 60 minutes later). No significant difference between HRD and Protamine to 72 hours was seen in plasma-free hemoglobin C3a, heparin concentration, thromboelastogram index, platelet count, activated partial thromboplastin time, anti-thrombin III, fibrinogen, ACT, and tissue histology.

Conclusions. In a prospective randomized outcomes study, HRD achieved predictable reversal of systemic heparinization after CPB with no difference in safety or outcomes compared with protamine.






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