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Abstract & Commentary
Synopsis: Vascular complication rates after PCI were higher in patients treated with ACDs than in those receiving manual compression.
Source: Dangas G, et al. J Am Coll Cardiol. 2001;38: 638-641.
For many patients undergoing cardiac catheterization or percutaneous coronary intervention (PCI), the most discomfort occurs with removal of vascular access sheaths and during the time spent supine after the completion of the procedure. The vast majority of complications and attendant patient discomfort resulting from these procedures are related to vascular access, most notably hematoma formation, but also bleeding, pseudoaneurysm, and arteriovenous fistula formation. In addition, the time devoted to manual compression, the time spent supine after sheath removal, and, most notably, the time attributed to addressing vascular complications, all contribute to cost and length of stay, both in the cardiac catheterization laboratory proper, and in the hospital prior to discharge. For these reasons, the concept of arteriotomy closure devices (ACDs) holds considerable appeal for patients, invasive cardiologists, and hospital administrators alike, and their use has been rapidly embraced at many institutions performing cardiac catheterization.
All commercially available ACDs have undergone carefully conducted clinical trials prior to FDA approval for clinical use. However, the results of these trials might not reflect the "real-world" experience with the use of these devices. Therefore, Dangas and associates performed a retrospective analysis of 6408 PCI procedures performed at Washington Hospital Center between January 1996 and June 1998, and compared the outcomes of 5892 (92%) cases receiving manual compression with 516 (8%) who were treated with ACDs, at the operator’s discretion, after sheath removal. A variety of ACDs were used in this series, but the largest numbers of patients were treated with the Angioseal (Daig, St. Paul, Minn.) n = 371, followed by the Techstar device (Perclose Inc, Redwood City, Calif.) n = 101. Clinical, procedural, and laboratory results, as well as occurrence of major adverse cardiac events (MACE, defined as death, Q-wave MI, need for urgent coronary artery bypass graft surgery, or repeat PCI of target lesion), and vascular complications were obtained from hospital chart review. Univariate and multivariate logistic regression analyses were performed to identify predictors of vascular and hemorrhagic complications.
The patients receiving ACDs were well matched to those treated with manual compression in terms of baseline clinical characteristics, with the exception of prior PCI and prior MI which were both more prevalent in the group receiving ACDs. In terms of procedural variables, the manual compression group exhibited longer total procedure time, higher final and maximal activated clotting time (ACT), and increased rates of debulking device use and balloon angioplasty alone. Rates of non-ST elevation myocradial infarction (NSTEMI) and creatine kinase-MB (CK-MB) elevation > 3 times normal were higher in patients receiving ACDs, but there was no difference in total MACE between the 2 groups. Significant bleeding, defined as a drop in hematocrit (> 15%) was more common in patients receiving ACDs (5.2% vs 2.5%; P < 0.001). Vascular complications also occurred more frequently in patients receiving ACDs than in those treated with manual compression. These included hematoma formation (9.3% vs 5.1%; P < 0.001), hematoma with significant drop in hematocrit (2.0% vs 0.6%; P < 0.001), and need for surgical vascular repair (2.5% vs 1.3%; P = 0.03). Due to small sample size, no comparisons could be drawn among the different ACDs used in terms of complication rates. Independent predictors of any vascular complication by multivariate analysis included increasing age, decreasing body surface area (BSA), and female gender. Hematoma and significant bleeding were predicted by use of ACD.
Dangas et al conclude that vascular complication rates after PCI were higher in patients treated with ACDs than in those receiving manual compression. They acknowledge several limitations of this study including its retrospective, nonrandomized design, nonstandardized criteria for ACD selection and application, and variety of ACDs used. They also point out that this represents a relatively early experience with the use of these devices, with an early "generation" of devices.
Comment by Sarah M. Vernon, MD
Pulling sheaths continues to be the bane of many a cardiology fellow’s existence. However, the fact remains that many, if not most, complications of cardiac catheterization or PCI occur during and immediately after sheath removal, when the procedure is, in many respects, completed. Thus, from a quality assurance standpoint, it is probably worth considering postprocedural management of the vascular access site to be an essential component of every diagnostic catheterization and PCI procedure. Patient comfort, complication rates, resource use, length-of-stay, and cost should all be considered when deciding whether to use an ACD, or which device to use. This has resulted in a large degree of operator and institutional variability in regards to how patients are managed after invasive cardiac procedures.
In the present study, Dangas et al report an almost two-fold higher incidence of bleeding and vascular complication rates in patients treated with ACDs for sheath removal after PCI, than in those treated with manual compression. Of even more concern is the finding of the increased need for surgical repair (2.5%) in the ACD group, which is several fold higher than generally reported for manual compression. Dangas et al acknowledge several limitations to their study to which I would add, a low rate of glycoprotein IIb-IIIa inhibitor use, lack of information regarding sheath size, and actual time to ambulation. However, despite these many limitations, these data may be more applicable to the average catheterization laboratory than results reported from industry sponsored pre-FDA approval clinical trials, or results from extremely experienced operators or centers with strictly outlined criteria for patient selection.
Interpretation of the published data regarding vascular access site management is a challenge. In a recent editorial, Dr. Zoltan Turi points out many of the pitfalls the reader faces in attempting to interpret the literature in this area. He suggests that, at a minimum, it is important to consider procedural variables such as details of the anticoagulation regimen (including ACTs and use of glycoprotein IIb/IIIa inhibitors), sheath size, and physician learning curves. In addition, he emphasizes the importance of patient related variables such as gender and presence of diabetes. He further suggests that use of preclosure femoral angiography (which is recommended by some device manufacturers, but not others) should be standardized, and assessed for caliber of the femoral artery and location of the arteriotomy, as well as presence of calcification or atherosclerotic disease.1 In addition, I would suggest that the experience of the operator performing manual compression, the duration of manual hold, time to ambulation, cost, and length of stay should be considered when evaluating the published literature regarding postprocedural vascular access site management.
The recent report by Dangas et al raises serious concerns about the safety of ACDs after PCI. However, the design of these devices continues to evolve and, in fact, has already significantly improved their ease of use. In all likelihood, this will result in improved safety and efficacy of these devices over time. We have much to learn about which patients are likely to benefit most from the use of these devices, as well as those most likely to suffer complications. For this reason, consideration should be given to performing preclosure femoral angiography in all patients who will be treated with ACDs. Despite manufacturer’s claims, the actual time spent supine, and time to ambulation and ultimately discharge, as well as cost (which, for the ACD alone can range from $150 to more than $300), will vary among institutions. More importantly, complication rates should be critically evaluated in comparison to manual compression, as well as to the published literature, at every institution electing to use these devices. Lastly, as with any technique in invasive cardiology, the importance of operator experience should not be underestimated.
1. Turi ZG. Catheterization and Cardiovascular Interventions. 2001;53:443-444.