OBJECTIVES: Several devices have been proposed as an alternative to manual compression (MC) for femoral access management (FAME) following catheterization. Although these devices allow earlier ambulation, they have not always been shown to reduce vascular complications. As a consequence, their cost efficacy is not obvious. METHODS: During MC a special catheter deployed temporarily within the artery to achieve haemostasis (Bio-DISC) (BD) was compared with an anchor-collagen based system Angio-Seal (AS) among 463 consecutive patients undergoing PCI. We examined vascular or systemic complications, nursing time spent to puncture site management and patient's satisfaction. RESULTS: Relative contra-indications to the use of vascular closure devices were encountered in 158 patients. There were no significant differences in baseline characteristics between the patients assigned to each of the 3 treatment groups. The deployment success rate was 98% for AS and 90% for BD (p = 0.037). Vascular complications occurred in 10.8%, 4.0% and 5.8% (p: NS) of MC, AS and BD patients, respectively. The longer sheath dwell time contributed to most of the complications in MC and BD. Nursing time spent for access management was 48.9 min in MC; 28.1 min in BD and 9.9 min in AS (p < 0.0001 ). Satisfaction score above 70 was noted in 46%, 86% and 92% of patients managed by MC, BD and AS, respectively. CONCLUSION: AS use is associated with fewer complications, improved patient well being and saves 39 minutes of nursing time. The additional cost of AS is justified when used in selected patients undergoing PCI.
RCT Entities:
OBJECTIVES: Several devices have been proposed as an alternative to manual compression (MC) for femoral access management (FAME) following catheterization. Although these devices allow earlier ambulation, they have not always been shown to reduce vascular complications. As a consequence, their cost efficacy is not obvious. METHODS: During MC a special catheter deployed temporarily within the artery to achieve haemostasis (Bio-DISC) (BD) was compared with an anchor-collagen based system Angio-Seal (AS) among 463 consecutive patients undergoing PCI. We examined vascular or systemic complications, nursing time spent to puncture site management and patient's satisfaction. RESULTS: Relative contra-indications to the use of vascular closure devices were encountered in 158 patients. There were no significant differences in baseline characteristics between the patients assigned to each of the 3 treatment groups. The deployment success rate was 98% for AS and 90% for BD (p = 0.037). Vascular complications occurred in 10.8%, 4.0% and 5.8% (p: NS) of MC, AS and BD patients, respectively. The longer sheath dwell time contributed to most of the complications in MC and BD. Nursing time spent for access management was 48.9 min in MC; 28.1 min in BD and 9.9 min in AS (p < 0.0001 ). Satisfaction score above 70 was noted in 46%, 86% and 92% of patients managed by MC, BD and AS, respectively. CONCLUSION:AS use is associated with fewer complications, improved patient well being and saves 39 minutes of nursing time. The additional cost of AS is justified when used in selected patients undergoing PCI.