Location, Location, Location: Is the Star Really Close?

Vascular closure devices (VCDs) debuted in the 1990s as an alternative to the gold standard of manual compression (MC) for femoral access hemostasis. The current guidelines for closure devices dictate the importance of the puncture site, meticulous technique, operator experience and verification of the puncture site by femoral angiogram to achieve success.^1,2 These devices have success rates of >90%, improve patient comfort, and decrease the time required for hemostasis, ambulation, and discharge.³ However, results from large registries and meta-analyses of randomized trials comparing VCDs to MC are inconsistent with regard to their effect on reducing vascular complication rates and cost effectiveness.^1-6 Additionally, the use of VCDs was seen to be associated with a mild increased risk of groin infection, lower limb ischemia, arterial stenosis, device entrapment in the artery, and need of vascular surgery for arterial complications.⁴ Data presented tends to be outdated as newer generations of a product are released with improvements.² Generalization and direct comparison is limited by the differences in study populations, operator experience, procedural variables, anticoagulation therapies, and definitions of vascular complications.³ Therefore, caution should be exercised when interpreting study results comparing VCDs and one should be mindful that not all VCDs have the same mechanism of action.

Presently, there are several VCDs available and are categorized as an intravascular or extravascular closure device. Regardless of the systematic approach an operator employs to identify the optimal location for femoral artery access, whether it be anatomic, fluoroscopic, and/or manual, no approach is foolproof. Key trials evaluating closure devices exclude cases where the femoral puncture is at or below the bifurcation as device deployment is contraindicated in this unfavorable anatomic location. While closure devices are generally avoided at the bifurcation, those primarily with intravascular components (such as Angioseal^®) are especially not recommended as they theoretically carry a higher risk of luminal obstruction compared to those with extravascular closures (such as Starclose^® and Mynx^®).

In this issue of the Journal of Invasive Cardiology, Dr. Bangalore et al have described their prospective single-center experience with an extravascular closure device (Starclose^®) at the common femoral artery bifurcation in patients undergoing cardiac catheterization (both diagnostic and percutaneous coronary interventions).⁷ This study was conducted at a high-volume center in which VCD use was routine and the Starclose^® device was the device of choice when cannulation occurred near the bifurcation. The learning curve for this particular device was minimized in this setting. Oozing at the arteriotomy site has been reported in 38% of patients treated with Starclose, compared to 21% of patients with Angioseal, and persisted for more than 24 hours in some cases.⁸ The authors also comment on the use of local lidocaine with epinephrine injection as needed to stop oozing, though do not present the data regarding the frequency of its use in their study. This is important because a high incidence of oozing can lead to an increased nursing burden and potentially prolong hospital stays.

The current guidelines are clear about the importance of femoral puncture site and the deployment of VCDs.^1,2,11 Additionally, the instructions for use (IFU) available on the Abbott Vascular website clearly states under the title, “WARNING: Do not use the Star Close SE Vascular Closure System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, since such puncture sites may result in a pseudo-aneurysm, intimal dissection or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify location of the puncture site.”⁹

Bangalore et al should be congratulated for achieving their objective and addressing a clinically relevant issue. We believe that it is prudent to await more data on the use of extravascular closure devices at the bifurcation, including a longer follow-up period for late complications and evidence from randomized clinical trials before the Interventional Cardiology community uses this strategy widely. In the same vein, a direct comparison of the Starclose device to other vascular closure devices when used at the bifurcation has yet to be performed. While there appears to be no difference based on whether or not the deployment of the Starclose^® device is at the bifurcation, the authors did report an increased risk of vascular complication as the arteriotomy site moved farther away from the bifurcation. Indeed, VCDs used in high arterial punctures have been associated with an odds ratio as high as 17:1 for retroperitoneal hemorrhage.¹⁰

We would like to reemphasize that the success of vascular closure is often dependent on the quality of vascular access itself and there must be close attention paid to improvement in techniques.¹¹ While manufacturers of femoral access closure devices continue to evolve and improve their products with new technology, the U.S. Government is increasingly pressured to contain healthcare costs. Time will tell whether the uptake of transradial access, which has the potential to significantly impact upon costly vascular complication rates and post-procedure care, will increase, as it continues to be the technique of choice in the rest of the world.

Acknowledgements. We would like to thank Dr. V. S. Srinivas for his help with preparation of the manuscript.

References

1. Patel MR, Jneid H, Liu CP et al. Arteriotomy Closure Devices for Cardiovascular Procedures: A Scientific Statement from the American Heart Association. Circulation 2010;122:1882–1893.
2. Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: The second decade. J Am Coll Cardiol 2007;50:1617–1626.
3. Schwartz BG, Burstein S, Economides C, et al. Review of vascular closure devices. J Invasive Cardiol 2010;22: 599–607.
4. Biancari F, D'Andrea V, Di Marco C, et al. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J 2010;159(4):518–531.
5. Vaitkus PT. A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. J Invasive Cardiol 2004;16:243–246.
6. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and meta-analysis. JAMA 2004;291:350–357.
7. Bangalore S, Vidi VD, Liu CB et al. Efficacy and safety of the nitinol clip-based vascular closure device (Starclose®) for closure of common femoral arterial cannulation at or near the bifurcation: A propensity score adjusted analysis. J Invasive Cardiol 2011;23:194–199.
8. Deuling JH, Vermeulen RP, Anthonio RA, et al. Closure of the femoral artery after cardiac catheterization: A comparison of Angio-Seal, StarClose, and manual compression. Catheter Cardiovasc Interv 2008;71:518–523.
9. https://www.abbottvascular.com/static/cms_workspace/pdf/ifu/vessel_closure/eIFU_StarClose_SE_0211.pdf
10. Ellis SG, Bhatt D, Kapadia S, et al. Correlates and outcomes of retroperitoneal hemorrhage complicating percutaneous coronary intervention. Cathet Cardiovasc Interv 2006;67:541–545.
11. Turi ZG. Overview of Vascular Closure. Cardiac Interventions Today 2008:July/August, 24–32

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From the ¹Albert Einstein College of Medicine and the ²Division of Cardiology, Montefiore-Einstein Heart Center, Bronx, New York.
Address for correspondence: Seshasayee Narasimhan, MD, MRCP (UK), FRACP, Department of Medicine, Cardiovascular Division, Montefiore-Einstein Heart Center, Jack D. Weiler Hospital of the Albert Einstein College of Medicine, 1825 Eastchester Road, Bronx, New York: 10461-2373. Email: docsesh@gmail.com