Vascular Access Closure Devices: In Search of “Perfect” Closure

The demand for vascular access closure devices (VCD) has grown in conjunction with the rapid expansion of percutaneous coronary intervention (PCI). As the vast majority of invasive cardiovascular procedures are performed using femoral arterial access,¹ closure of this arteriotomy site is an integral component of every case. Closure devices were initially introduced into clinical use in the mid 1990s for the purposes of reducing vascular complications and to improve patient comfort following cardiac catheterization. The utilization of vascular closure devices has grown to keep pace with procedural volume over the past 15 years, but their utility has been in question for almost as long.² The optimal VCD is one that achieves reliable closure of the arteriotomy in a painless, cost-effective manner with minimal injury to the artery. Other metrics that are important in defining an optimal device include decreasing time to ambulation and ease of use. In this issue of the Journal, Lupi et al report their large, single-center experience with the Angio-Seal Evolution (ASE; St. Jude Medical, Minneapolis, Minnesota). Their case series included 451 patients who underwent arteriotomy closure with an ASE after having a PCI or diagnostic catheterization using a 6 Fr sheath.³ Femoral angiography was performed on all of these patients to insure suitability for closure. They compared their outcomes with a propensity score-matched group of patients who underwent manual compression in 2007 at their center. The overall complication rate with either strategy was very low. They observed an increased rate of groin hematomas (> 5 cm) in the ASE group (5.5% vs. 2.7%). In addition, 1.8% of patients had early failure of the VCD. They found that early failure of the VCD was associated with an increased risk for subsequent major and minor vascular complications. Prior research studies have been inconsistent in showing the benefits of these devices on prevention of vascular complications. This study continues in that tradition. A recent meta-analysis of randomized trials of VCDs reported no difference in the rate of adverse vascular events or bleeding among patients who received a VCD or manual compression.⁴ Biancari et al noted that among patients who received a VCD there was a small increase in the rate of groin infections, but they had a decrease in time to hemostasis. In three separate meta-analyses from 2004, two studies concluded that VCDs were, at best, equivalent to manual compression in terms of preventing vascular complications,^5,6 while one suggested there may be some benefit with particular VCDs and harm with others.⁷ Vascular complications occur after catheter-based procedures at a rate of 2–6%, but are clearly related to patient and procedural complexity.⁸ Diagnostic catheterization with a 4/5 Fr sheath has a vascular complication rate of 0.4–0.7%,⁹ while patients undergoing emergent PCI with a large sheath have access-site complication rates of > 3%.¹⁰ Well-established predictors of vascular complications following PCI include advanced age, female gender, level of anticoagulation and patients with acute coronary syndromes.¹⁰ Directed studies in high-risk cohorts may identify an opportunity for VCDs to provide benefit. For instance, Chevalier et al demonstrated a decrease in need for prolonged compression in the VCD group, but no difference in other vascular complications in a high-risk, post-PCI study population.¹¹ The AHA recently published a Scientific Statement regarding this topic¹² and recommended a balanced approach for the use of VCDs with the intention to achieve hemostasis faster, shorter duration of bed rest and possibly improve patient comfort (Class IIa). They recommended against using a VCD strictly to decrease vascular access-site complications (Class III). These devices improve time to hemostasis and decrease time to ambulation, but according to the current literature, their impact on vascular complications are, at best, no different than manual compression, and in some cases, possibly worse. Incorporating risk stratification for vascular complications may identify which patient will benefit most from a VCD. Use of smaller sheaths and anticoagulation choices can alter access-site complications. Finally, alternative access strategies such as transradial access will dramatically impact vascular complication rates. But for now, the search for the perfect VCD continues.

References

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———————————————————— The author reports no conflicts of interest regarding the content herein. Address for correspondence: Adhir Shroff, MD, MPH, FACC, FSCAI, Assistant Professor of Medicine, University of Illinois – Chicago, 1853 West Polk Street, Room 130 CMW, Mail Code 784, Chicago, IL 60612. Email: arshroff@uic.edu