BACKGROUND: Interventional bleeding and post-interventional hematoma are the most common complications following vacuum-assisted breast biopsy (VABB). The aim of the current study was to evaluate the effectiveness of Foley catheter-induced hemostasis in VABB. METHODS: A randomized prospective controlled trial was conducted using a total of 437 consecutive 8-gauge ultrasound-guided VABB procedures that were performed in 282 patients from June 2012 to October 2013. In each procedure, hemostasis was induced with either a Foley catheter or with external compression. Bleeding during intervention, hematoma post-intervention and the time of procedure were recorded. Statistical analysis included a Chi-Square test and an independent-samples t-test, and P value <0.05 was considered to be significant. RESULTS: Significantly less bleeding and post-interventional hematoma resulted when hemostasis was induced using a Foley catheter vs. compression (7.6% vs. 17.4%, P=0.002; 8.9% vs. 27.9%, P<0.001). The mean time of breast biopsy was significantly less when using a Foley catheter vs. compression (33.6 vs. 45.5 min, P<0.001). No post-procedural infectious was encountered. In stratification analysis, there were no significantly different bleeding rates between the Foley catheter and compression methods in cases of single lesions (6.7% vs. 14.1%, P=0.346). In cases of multiple lesions, the Foley catheter method produced less bleeding/hematoma than compression (10.4% vs. 47.4%, P=0.018; 16.7% vs. 52.6%, P=0.020). Whether using a Foley catheter or compression to induce hemostasis, no significant difference was found in the rate of bleeding or hematoma when lesions <15 mm were removed (3.8% vs. 6.1%, P=0.531; 6.1% vs. 11.4%, P=0.340). When lesions ≥15 mm were excised, the rates of interventional bleeding and post-interventional hematoma were significantly lower in the Foley catheter study group than the compression control group (12.5% vs. 32.2%, P=0.034; 12.5% vs. 49.4%, P<0.001). There was significantly less bleeding (P=0.004) and hematoma (P<0.001) in the upper external quadrant when using a Foley catheter compared with compression (4.5% vs. 15.7%, P=0.004; 9.8% vs. 40.2%, P<0.001), but no significant differences for other quadrants. CONCLUSIONS: Inducing hemostasis with a Foley catheter after VABB is a very effective and safe alternative to hemostasis with compression.
RCT Entities:
BACKGROUND: Interventional bleeding and post-interventional hematoma are the most common complications following vacuum-assisted breast biopsy (VABB). The aim of the current study was to evaluate the effectiveness of Foley catheter-induced hemostasis in VABB. METHODS: A randomized prospective controlled trial was conducted using a total of 437 consecutive 8-gauge ultrasound-guided VABB procedures that were performed in 282 patients from June 2012 to October 2013. In each procedure, hemostasis was induced with either a Foley catheter or with external compression. Bleeding during intervention, hematoma post-intervention and the time of procedure were recorded. Statistical analysis included a Chi-Square test and an independent-samples t-test, and P value <0.05 was considered to be significant. RESULTS: Significantly less bleeding and post-interventional hematoma resulted when hemostasis was induced using a Foley catheter vs. compression (7.6% vs. 17.4%, P=0.002; 8.9% vs. 27.9%, P<0.001). The mean time of breast biopsy was significantly less when using a Foley catheter vs. compression (33.6 vs. 45.5 min, P<0.001). No post-procedural infectious was encountered. In stratification analysis, there were no significantly different bleeding rates between the Foley catheter and compression methods in cases of single lesions (6.7% vs. 14.1%, P=0.346). In cases of multiple lesions, the Foley catheter method produced less bleeding/hematoma than compression (10.4% vs. 47.4%, P=0.018; 16.7% vs. 52.6%, P=0.020). Whether using a Foley catheter or compression to induce hemostasis, no significant difference was found in the rate of bleeding or hematoma when lesions <15 mm were removed (3.8% vs. 6.1%, P=0.531; 6.1% vs. 11.4%, P=0.340). When lesions ≥15 mm were excised, the rates of interventional bleeding and post-interventional hematoma were significantly lower in the Foley catheter study group than the compression control group (12.5% vs. 32.2%, P=0.034; 12.5% vs. 49.4%, P<0.001). There was significantly less bleeding (P=0.004) and hematoma (P<0.001) in the upper external quadrant when using a Foley catheter compared with compression (4.5% vs. 15.7%, P=0.004; 9.8% vs. 40.2%, P<0.001), but no significant differences for other quadrants. CONCLUSIONS: Inducing hemostasis with a Foley catheter after VABB is a very effective and safe alternative to hemostasis with compression.
Entities:
Keywords:
Breast biopsy; Foley catheter; hemostasis
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