Print this pageCyanoacrylate Vascular Sealant Reduces Anastomotic Bleeding in ePTFE Grafts; Results of a Prospective Multi-Center Randomized Trial.
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Alan Lumsden, M.D.1, John Kern, M.D.2, Worthington Schenk, III, M.D.3, Jeff Lawson, M.D.4, Samuel Money, M.D.5, Enrique Criado, M.D.6, Schild Frederick, M.D.7, David Cassada, M.D.8, Peter H'Doubler, Jr., M.D.9, Jeffrey Carpenter, M.D.10.
1Baylor College of Medicine, Houston, TX, USA, 2University of Virginia, Charlottesville, VA, USA, 3University of Virginia, Houston, TX, USA, 4Duke University, Durham, NC, USA, 5Oschner Clinic, New Orleans, LA, USA, 6SUNY, Stony Brook, NY, USA, 7University of Miami, Miami, FL, USA, 8University of Tennessee, Knoxville, TN, USA, 9Saint Joseph's - Atlanta, Atlanta, GA, USA, 10University of Pennsylvania, Philadelphia, PA, USA.
Background: Anastomotic bleeding is common, prolongs surgery, and can cause hematoma with related healing complications. Several hemostatic agents are available, however none are used routinely due to risk of disease transmission, lack of efficacy, expense and bulk. Cyanoacrylate tissue adhesives are synthetic, currently approved for closing skin where they seal and augment tensile strength. They are cleared by biological means and may reduce infection. This is the first study of a cyanoacrylate adhesive as an adjunctive sealant for vascular anastomoses.
Design: Multi-center, prospective, randomized (2:1) trial. Surgicel® was used as the hemostatic control. Study population included patients undergoing femoral-popliteal bypass surgery or arteriovenous grafts using PTFE conduit. 150 subjects were enrolled at 15 sites in Europe and the USA. The sealant consists of two cyanoacrylate monomers, 2-Octyl Cyanoacrylate and Butyl Lactoyl Cyanoacrylate in a single crushable ampoule. Primary endpoint was time from clamp release to hemostasis. Secondary endpoints included proportion achieving hemostasis and frequency of adverse events.
Statistical Analysis: Analyses were performed as two-sided t-tests at the 5% level of significance. Hemostasis within the intervals 0 (immediate), 0-1 minute, 0-5 minutes, and 0-10 minutes were analyzed as four separate variables by the Cochran-Mantel-Haenszel procedure, and stratified by the cross-classification of procedure and study center.
Results: A statistically significant difference in time to hemostasis between the sealant( mean (119.3 secs) versus Surgicel (mean 403.8 secs) p<0.001 was noted. 54.5% of patients in the sealant group versus only 10% in the surgical group had immediate hemostasis(p<0.001). No difference in incidence of adverse events occurred between the two groups( p=0.60). Over 50% of the glue patients had immediate hemostasis
Conclusion: Cyanoacrylate vascular sealant is highly effective in reducing time to hemostasis and providing immediate hemostasis without increasing adverse events. Future studies will examine the role of this cyanoacrylate as the primary modality for joining blood vessels.
Time to Hemostasis (sec)1 Summary
All Patients
| CMC Vascular Sealant (N = 101) |
Surgicel® (N = 50) | |
| Mean2 | 119.3 | 403.8 |
| Difference (CMC Vascular Sealant minus Surgicel®) (sec) | -284.4 | |
| 95% Confidence Bound on the Difference (sec) | -342.9 to -226.0 | |
| P-Value | <0.001 | |
1 The anastomotic site with the longest time was used for femoral bypass patients with multiple sites treated. All times >10 minutes are replaced by 10 minutes.
2 Adjusted for study center and type of procedure
Time to Hemostasis1 by Minute Intervals for All Procedures
All Patients
| CMC Vascular Sealant (N = 101) n (%) |
Surgicel® (N = 50) n (%) |
P-Value2 | |
| 0 (immediate) | 55 (54.5%) | 5 (10.0%) | <0.001 |
| 0-1 minutes | 61 (60.4%) | 7 (14.0%) | <0.001 |
| 0-5 minutes | 89 (88.1%) | 16 (32.0%) | <0.001 |
| 0-10 minutes | 94 (93.1%) | 29 (58.0%) | <0.001 |
1 The anastomotic site with the longest time was used for femoral bypass patients with multiple sites treated
2 Adjusted for study center and procedure
Ethicon Omnex™ Surgical Sealant Group of Clinical Investigators:
PI: Alan Lumsden, MD - Baylor University
| CMC Vascular Sealant (N = 101) |
Surgicel® (N = 50) | |
| Mean2 | 119.3 | 403.8 |
| Difference (CMC Vascular Sealant minus Surgicel®) (sec) | -284.4 | |
| 95% Confidence Bound on the Difference (sec) | -342.9 to -226.0 | |
| P-Value | <0.001 | |
| CMC Vascular Sealant (N = 101) n (%) |
Surgicel® (N = 50) n (%) |
P-Value2 | |
| 0 (immediate) | 55 (54.5%) | 5 (10.0%) | <0.001 |
| 0-1 minutes | 61 (60.4%) | 7 (14.0%) | <0.001 |
| 0-5 minutes | 89 (88.1%) | 16 (32.0%) | <0.001 |
| 0-10 minutes | 94 (93.1%) | 29 (58.0%) | <0.001 |
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