Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures.
ABSTRACT Femoral arterial puncture is the most common access method for coronary angiography and percutaneous coronary interventions (PCIs). Access complications, although infrequent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no consensus on whether VCDs are superior to manual compression (MC). A retrospective review and nested case-control study of consecutive patients undergoing elective transfemoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy was performed according to the operators' discretion. Vascular complications were defined as groin bleeding (hematoma, hemoglobin decrease ≥3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, obstruction, or infection. Patients with postprocedure femoral vascular access complications were compared to randomly selected patients without complication. Data were available for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in 2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%). Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications with MC and 42 (0.64%) with VCD (p = 0.004). VCD deployment failed in 80 procedures (1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case-control analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent predictors of complications. In conclusion, the retrospective analysis of contemporary hemostasis strategies and outcomes in elective coronary procedures identified a low rate of complications (0.81%), with superior results after VCD deployment. Careful selection of hemostasis strategy and closure device may further decrease complication rates.
- Journal of vascular and interventional radiology: JVIR 01/2014; 25(1):73–84. · 1.81 Impact Factor
- JAAPA: official journal of the American Academy of Physician Assistants 09/2014; 27(9):51-3.
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ABSTRACT: Objective This study was performed to evaluate the safety and efficacy of a locally designed assiut femoral compression device (AFCD) versus manual compression (MC). Background Femoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety. Patients and methods This was a prospective study. We enrolled 206 consecutive patients undergoing diagnostic coronary angiography From July, 2012 to April, 2013. They were divided into two groups: 100 patients used AFCD and 106 patients used MC for arterial hemostasis. Results Both groups were comparable regarding baseline characteristics. Concerning the primary effectiveness end point, there was no difference in the mean time-to-hemostasis with AFCD (12.5 ± 3 min) vs. MC (13 ± 2 min, p = 0.4). As regards safety, none of our research population experienced major adverse events. No complication was new or unanticipated, and the type of complication did not differ between the two groups. The incidence of vagal episodes were comparable between both groups (3 patients (3%) in AFCD vs. 2 patients in MC (1.8%); p = 0.2). The use of AFCD was associated with similar occurrence of minor complications, mainly ecchymosis and oozing, compared with MC (27% vs. 27.4%, p = 0.8). Large hematoma >5 cm was noted only in 1 patients (1%) in the AFCD arm vs. 2 patients (1.8%) in the MC arm (p = 0.8). Conclusion Our results indicate that AFCD is a simple, safe and effective alternative to MC for hemostasis following diagnostic coronary angiography.The Egyptian Heart Journal. 01/2013;