HYPOTHESIS: Bovine pericardium (BP) demonstrates improved intraoperative hemostasis and equivalent perioperative morbidity compared with Dacron when used as patch material for angioplasty following carotid endarterectomy. OBJECTIVE: To prospectively compare BP and Dacron patch angioplasty after carotid endarterectomy in a randomized fashion. METHODS:Ninety-five consecutive primary carotid endarterectomies were performed in a prospective randomized fashion in 92 patients. Fifty-one procedures were performed using BP and 44 using Dacron. Intraoperative suture line bleeding was subjectively evaluated by observing bleeding at 3 and 4 minutes following carotid cross-clamp removal and then objectively weighing the sponge used to tamponade bleeding during these time intervals. Perioperative morbidity, including cervical wound hematoma, transient ischemic attack, and stroke, and perioperative mortality were recorded. Statistical analysis was performed using paired t tests, chi(2) analysis, Fisher exact test, or multiple linear regression as appropriate. RESULTS:Suture line bleeding at 3 minutes was present in 7 (14%) of 51 patients in the BP group and 24 (55%) of 44 patients in the Dacron group (P<.001). Suture line bleeding evaluated at 4 minutes was present in 2 (4%) of 51 patients in the BP group and 13 (30%) of 44 patients in the Dacron group (P =.001). Net +/- SEM sponge weight (total intraoperative suture line bleeding) was 6.25 +/- 0.55 g in the BP group and 16.34 +/- 1.85 g in the Dacron group (P<.001). Total suture line bleeding was significantly affected by activated clotting time; however, multivariate analysis demonstrated that bleeding was significantly less with BP (P<.001) even after adjusting for differences in activated clotting time. CONCLUSIONS:Bovine pericardium demonstrated a statistically significant decrease in intraoperative suture line bleeding compared with Dacron. Handling characteristics were judged by the surgeons to be superior for BP. Therefore, we believe BP may be an alternative to Dacron when performing patch angioplasty of the carotid artery after endarterectomy.
RCT Entities:
HYPOTHESIS: Bovine pericardium (BP) demonstrates improved intraoperative hemostasis and equivalent perioperative morbidity compared with Dacron when used as patch material for angioplasty following carotid endarterectomy. OBJECTIVE: To prospectively compare BP and Dacron patch angioplasty after carotid endarterectomy in a randomized fashion. METHODS: Ninety-five consecutive primary carotid endarterectomies were performed in a prospective randomized fashion in 92 patients. Fifty-one procedures were performed using BP and 44 using Dacron. Intraoperative suture line bleeding was subjectively evaluated by observing bleeding at 3 and 4 minutes following carotid cross-clamp removal and then objectively weighing the sponge used to tamponade bleeding during these time intervals. Perioperative morbidity, including cervical wound hematoma, transient ischemic attack, and stroke, and perioperative mortality were recorded. Statistical analysis was performed using paired t tests, chi(2) analysis, Fisher exact test, or multiple linear regression as appropriate. RESULTS: Suture line bleeding at 3 minutes was present in 7 (14%) of 51 patients in the BP group and 24 (55%) of 44 patients in the Dacron group (P<.001). Suture line bleeding evaluated at 4 minutes was present in 2 (4%) of 51 patients in the BP group and 13 (30%) of 44 patients in the Dacron group (P =.001). Net +/- SEM sponge weight (total intraoperative suture line bleeding) was 6.25 +/- 0.55 g in the BP group and 16.34 +/- 1.85 g in the Dacron group (P<.001). Total suture line bleeding was significantly affected by activated clotting time; however, multivariate analysis demonstrated that bleeding was significantly less with BP (P<.001) even after adjusting for differences in activated clotting time. CONCLUSIONS:Bovine pericardium demonstrated a statistically significant decrease in intraoperative suture line bleeding compared with Dacron. Handling characteristics were judged by the surgeons to be superior for BP. Therefore, we believe BP may be an alternative to Dacron when performing patch angioplasty of the carotid artery after endarterectomy.
Authors: Xin Li; Yuanyuan Guo; Kenneth R Ziegler; Lynn S Model; Sammy D D Eghbalieh; Robert A Brenes; Susun T Kim; Chang Shu; Alan Dardik Journal: Ann Vasc Surg Date: 2011-01-28 Impact factor: 1.466
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