Practices and Complications of Vascular Closure Devices and Manual Compression in Patients Undergoing Elective Transfemoral Coronary Procedures
Center for Interventional Vascular Therapy, New York-Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA.The American journal of cardiology (Impact Factor: 3.28). 04/2012; 110(2):177-82. DOI: 10.1016/j.amjcard.2012.02.065
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.
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ABSTRACT: Since its advent over two decades ago, transradial access for cardiac catheterization and percutaneous intervention has evolved into a versatile and evidence-based approach for containing the risks of access-site bleeding and vascular complications without compromising the technical range or success associated with contemporary percutaneous coronary intervention (PCI). Early studies demonstrated reduced rates of vascular complications and access-site bleeding with radial-access catheterization but at the cost of increased access-site crossover and reduced procedural success. Contemporary data demonstrate that while the rates of major bleeding with femoral-access PCI in standard-risk cohorts have declined significantly over time, the transradial approach still retains significant advantages by way of reductions in vascular complications, length of stay, and enhanced patient comfort and patient preference over the femoral approach, while maintaining procedural success. Major adverse cardiovascular events and bleeding are lowest with the transradial approach when procedures are performed at high-volume radial centers, by experienced radial operators, or in the context of ST-segment elevation myocardial infarction. Choice of procedural anticoagulation appears to differentially impact access-site bleeding in transradial versus transfemoral PCI; however, non-access site bleeding remains a significant contributor to major bleeding in both groups. Despite abundant supporting data, adoption of transradial technique as the default strategy in cardiac catheterization in the United States has lagged behind many other countries. However, recent trends suggest that interest and adoption of the technique in the United States is growing at a brisker pace than previously observed.
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ABSTRACT: Radial artery access for coronary angiography and interventions has been promoted for reducing hemostasis time and vascular complications compared with femoral access, yet it can take longer to perform and is not always successful, leading to concerns about its cost. We report a cost-benefit analysis of radial catheterization based on results from a systematic review of published randomized controlled trials. The systematic review added 5 additional randomized controlled trials to a prior review, for a total of 14 studies. Meta-analyses, following Cochrane procedures, suggested that radial catheterization significantly increased catheterization failure (OR, 4.92; 95% CI, 2.69-8.98), but reduced major complications (OR, 0.32; 95% CI, 0.24-0.42), major bleeding (OR, 0.39; 95% CI, 0.27-0.57), and hematoma (OR, 0.36; 95% CI, 0.27-0.48) compared with femoral catheterization. It added approximately 1.4 minutes to procedure time (95% CI, -0.22 to 2.97) and reduced hemostasis time by approximately 13 minutes (95% CI, -2.30 to -23.90). There were no differences in procedure success rates or major adverse cardiovascular events. A stochastic simulation model of per-case costs took into account procedure and hemostasis time, costs of repeating the catheterization at the alternate site if the first catheterization failed, and the inpatient hospital costs associated with complications from the procedure. Using base-case estimates based on our meta-analysis results, we found the radial approach cost $275 (95% CI, -$374 to -$183) less per patient from the hospital perspective. Radial catheterization was favored over femoral catheterization under all conditions tested. Radial catheterization was favored over femoral catheterization in our cost-benefit analysis.
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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.
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