Prospective randomized study of a protein-based tissue adhesive used as a hemostatic and structural adjunct in cardiac and vascular anastomotic repair procedures.
BACKGROUND
The purpose of this study was to determine whether adjunctive use of the bovine serum albumin and glutaraldehyde tissue adhesive BioGlue (BioGlue Surgical Adhesive; CryoLife, Inc) could reduce the rate of anastomotic bleeding in patients undergoing cardiac and vascular repair procedures when compared with a standard repair control. This was a prospective multicenter, randomized, controlled clinical trial conducted in accordance with the IRB at each participating institution.


METHODS
A total of 151 patients consented to participation and were randomly assigned to standard repair plus BioGlue (n = 76) or standard repair alone (n = 75). These two groups were statistically homogeneous for age, gender, race, procedure, and number of anastomoses. Patients underwent cardiac procedures (n = 49), aortic procedures (n = 105), or peripheral vascular procedures (n = 48).


RESULTS
Anastomotic bleeding was significantly reduced in the BioGlue group (18.8% of anastomoses) compared with the control group (42.9% of anastomoses, p < 0.001). Pledget use was reduced in the BioGlue group (26.2%) compared with the control group (35.9%, p = 0.047). Days in the ICU and total days in the hospital were slightly higher in the control group. Adverse event profiles were equivalent between the two groups except for occurrence of neurological defects, which were threefold less in the BioGlue group (p = 0.009).


CONCLUSIONS
This study demonstrates that using BioGlue as an adjunct to standard repair methods is safe and significantly reduces the occurrence of intraoperative anastomotic site bleeding in cardiac and vascular repair patients. Using BioGlue along suture lines reinforces anastomoses, thus minimizing pledget use.
Coselli
Joseph S
JS
Department of Surgery, Baylor College of Medicine, Houston, TX 77030, USA.
Bavaria
Joseph E
JE
Fehrenbacher
John
J
Stowe
Cary L
CL
Macheers
Steven K
SK
Gundry
Steven R
SR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D013504:Cardiovascular Surgical Procedures / Q000379:methods*; D017277:Drug Approval; D005260:Female; D005976:Glutaral / Q000627:therapeutic use*; D006488:Hemostasis, Surgical / Q000379:methods*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012709:Serum Albumin / Q000627:therapeutic use*; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
D006490:Hemostatics; D012709:Serum Albumin; D014014:Tissue Adhesives; D005976:Glutaral