Bleeding and Vascular Complications at the Femoral Access Site Following Percutaneous Coronary Intervention (PCI): An Evaluation of Hemostasis Strategies
- Volume 24 - Issue 7 - July 2012
- Posted on: 6/29/12
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Abstract: Background. Previous research found at least one vascular closure device (VCD) to be associated with excess vascular complications, compared to manual compression (MC) controls, following cardiac catheterization. Since that time, several more VCDs have been approved by the Food and Drug Administration (FDA). This research evaluates the safety profiles of current frequently used VCDs and other hemostasis strategies. Methods. Of 1089 sites that submitted data to the CathPCI Registry from 2005 through the second quarter of 2009, a total of 1,819,611 percutaneous coronary intervention (PCI) procedures performed via femoral access site were analyzed. Assessed outcomes included bleeding, femoral artery occlusion, embolization, artery dissection, pseudoaneurysm, and arteriovenous fistula. Seven types of hemostasis strategy were evaluated for rate of “any bleeding or vascular complication” compared to MC controls, using hierarchical multiple logistic regression analysis, controlling for demographic factors, type of hemostasis, several indices of co-morbidity, and other potential confounding variables. Rates for different types of hemostasis strategy were plotted over time, using linear regression analysis. Results. Four of the VCDs and hemostasis patches demonstrated significantly lower bleeding or vascular complication rates than MC controls: Angio-Seal (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.65-0.70); Perclose (OR, 0.54; CI, 0.51-0.57); StarClose (OR, 0.77; CI, 0.72-0.82); Boomerang Closure Wire (OR, 0.63; CI, 0.53-0.75); and hemostasis patches (OR, 0.70; CI, 0.67-0.74). All types of hemostasis strategy, including MC, exhibited reduced complication rates over time. All trends were statistically significant except one. Conclusions. This large, nationally representative observational study demonstrated better safety profiles for most of the frequently used VCDs, compared to MC controls.
J INVASIVE CARDIOL 2012;24(7):328-334
Key words: hemostasis patch, mechanical compression, vascular closure device
Bleeding and vascular complications were the most common non-cardiac, procedure-related adverse outcomes of the estimated 1,178,000 percutaneous coronary interventions (PCIs) performed in 2007.1,2 While it is not surprising that adverse vascular events are associated with a procedure that begins via puncture of an artery, the number and type of local vascular complications, and the clinical outcomes associated with them (increased morbidity, mortality, and length of stay in the hospital), underscore the importance of continuing surveillance by the Food and Drug Administration (FDA).
Clinicians who performed PCIs in the early years of the procedure achieved hemostasis after femoral sheath removal via manual and/or mechanical compression approaches. These hemostasis strategies required that patients remain immobilized for extended periods of time (up to 8 hours after a procedure). This approach created substantial discomfort and extended hospital stays. Alternative methods of achieving hemostasis were introduced into cardiac catheterization laboratories approximately 20 years ago. Loosely termed vascular closure devices (VCDs), these alternatives typically included sutures, sealants, clips, and arterial compression mechanisms, and offered clinicians an alternative to manual and mechanical compression. Since the inception of these devices, the federal government has required that they receive premarketing approval from the FDA, as well as undergo postmarketing surveillance and safety assessments. The FDA has approved these devices for the purpose of decreasing the amount of time to achieve hemostasis, which thereby allows patients to ambulate earlier.3
Between 1996 and 2000, nearly 2000 reports of serious adverse events and 36 deaths associated with the use of VCDs were received by the FDA through its routine surveillance system, with a large proportion of these events occurring in women.4 Because of its concern about these reports, the FDA collaborated with the American College of Cardiology (ACC) and its National Cardiovascular Data Registry (NCDR) to analyze closure-device related adverse events. Analysis indicated that a higher rate of vascular complications was associated with one particular device,5 which was subsequently, and voluntarily, removed from the market by its manufacturer. This experience underscored the value of investigating real-world methods of hemostasis via analysis of data collected in observational registries such as those within the NCDR. Since that study, the FDA has approved more closure devices, and is again collaborating with the NCDR to evaluate safety profiles of the most frequently used closure devices, and compare their safety profiles to manual and mechanical compression.
Data source. The data used in this study were obtained from the NCDR CathPCI Registry. This registry is co-sponsored by the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI). Data analyzed in this study utilized cath lab module v3, which included more than 200 core data elements needed for measuring the clinical management and outcomes of patients undergoing diagnostic cardiac catheterizations and PCIs.6 Although it is voluntary, several states and health plans require participation in the NCDR CathPCI Registry to fulfill state or performance recognition reporting requirements. As of June 2009, over 1200 institutions had joined the CathPCI Registry. This study included data from 1089 sites, and from 1,861,566 patients who received PCI and were discharged between January 1, 2005 and June 30, 2009.
Outcomes and definitions. Only outcomes that occurred during the hospital stay were included in this analysis. Data were analyzed according to 3 outcome categories:
Bleeding complication: Blood loss at the site of arterial or venous access, or due to perforation of a traversed artery or vein requiring transfusion and/or prolonging the hospital stay, and/or causing a drop in hemoglobin of >3.0 g/dL. Bleeding attributable to the vascular site could be retroperitoneal (retroperitoneal bleeding), a local hematoma >10 cm with femoral access, >2 cm with radial access, or >5 cm with brachial access (hematoma bleeding), or external (entry site bleeding).
Vascular complication: This category included the presence of any one of the following vascular complications pertaining to the percutaneous access site: occlusion, defined as total obstruction of the artery by thrombus, usually at the site of access requiring surgical repair; embolization, defined as loss of distal pulse, pain and/or discoloration (especially the toes); dissection, defined as a disruption of an arterial wall resulting in splitting and separation of the intimal (subintimal) layers; pseudoaneurysm, defined as the occurrence of a disruption and dilation of the arterial wall without identification of the arterial wall layers at the site of the catheter entry demonstrated by arteriography or ultrasound; or AV fistula, defined as a connection between the access artery and the accompanying vein demonstrated by arteriography or ultrasound and most often characterized by a continuous bruit.
Bleeding or vascular complication: Either one or the other, or both.
Inclusion/exclusion criteria. Catheterization laboratory discharges involving PCI for the first quarter of 2005 through the second quarter of 2009 were included in this analysis. Excluded from the analysis were: (1) any subject for whom information was not complete with regard to type of hemostasis strategy or for whom the strategy used was characterized by less than 5000 uses during the period of the study; (2) any subject who was discharged on the same day of admission who didn’t die prior to discharge; and (3) data submissions were excluded if they failed to pass data quality standards.
Statistical analysis. Hierarchical multiple logistic regression analyses were performed separately using “bleeding complications,” “vascular complications,” and “bleeding or vascular complications” as the dependent variables. In this model, two-level data of patients within hospitals were considered and random effect of patient-level intercept was used for the clustering of patients among hospitals.
Independent variables were selected based on clinical meaning and medical publications based on our previous experience, which included age, gender, race (white vs non-white vs other), type of hemostasis strategy, body mass index (BMI), several indices of co-morbidity (New York Heart Association [NYHA] classification, presence of diabetes, hypertension, peripheral vascular disease, left main coronary artery stenosis, shock, acute renal failure, history of congestive heart failure, and previous recent PCI), status of procedure (routine, urgent, emergency, or salvage), use of IABP, use of anticoagulants or anti-platelet agents during procedure (aspirin, IIb/IIIa inhibitors, thrombin inhibitors, thrombolytics, low molecular weight heparin, and unfractionated heparin, each assessed individually), and number of annual admissions for PCI. In the hierarchial logistic models, two-level data of patients within hospitals were considered. Missing values were rare, and imputed as the median values for continuous variables and as the most common category for categorical variables. Odds ratios and P-values were calculated for all independent variables with respect to the clinical endpoints.
The “type of hemostasis strategy” was characterized in 2 different ways. The first was by 1 of the following 8 “strategy groups:” manual compression (MC); mechanical compression devices (MCD); hemostasis patches; and 1 of 5 VCDs, including Perclose (Abbott Vascular); Angio-Seal (St Jude Medical, Inc); Boomerang Closure Wire (Cardiva Medical, Inc); Mynx (AccessClosure, Inc); and StarClose (Abbott Vascular). The other was by more specific identification of VCDs within some of the larger groupings, as follows: Perclose (A-T and ProGlide); Angio-Seal (plain, VIP, STS, and STS PLUS); StarClose (vascular closure system and SE); and patches (Clo-Sur pad, Chito-Seal, Syvek Patch, D-stat, and Neptune Patch). Type of hemostasis strategy was defined according to the first strategy used in each subject in each visit. For that purpose, strategies were categorized into 3 hierarchical levels (Level 1 = manual or mechanical compression; Level 2 = any patch; and Level 3 =any VCD), whereby “first strategy used” was defined as the first strategy used in the highest categorical level for a particular procedure. The independent effect of the type of hemostasis strategy on clinical outcome was evaluated using the hierarchical logistic regression models. Adjusted ORs and P-values for each combination of clinical outcome and type of hemostasis strategy were reported, using MC as the reference group.
In addition, the trend in “bleeding or vascular complications” was plotted by quarter for each device group, beginning with the quarter in which the device was used in at least 10 cath lab visits. Linear regression, using the rate for each quarter as the unit of analysis, was then used to assess for statistically significant trends.