To Hold or to Fold — What’s Your Best Bet?

Achieving hemostasis at the arteriotomy site after percutaneous coronary intervention has been discussed in The Journal of Invasive Cardiology previously.1–3 In this month’s Journal, Lasic et al.4 (see pages 356–358) compare the safety and efficacy of the first and new-generation Angio-Seal device in patients undergoing PCI. The first generation Angio-Seal device, while effective, was limited with respect to ease-of-deployment as well as patient comfort (patient immobile while the post-placement spring was intact). Conversely, the new-generation device allows for complete deployment while the patient is still on the catheterization table, reducing the procedure to one step while minimizing patient discomfort. The authors attempted to design and complete a study to demonstrate non-inferiority of the new-generation device compared to its first-generation. They concluded that the “new generation of the Angio-Seal STS closure device, which permits faster deployment, does not decrease the arterial closure rate or increase vascular complications compared with the first generation of Angio-Seal.” Several questions are generated from this study. Are we playing with a full deck? In spite of design questions (underpowered to show non-inferiority, selection bias due to non-randomized patient recruitment and enrollment, use of historical matched controls, reported device failure rates and event rates for minor and major complications that are more than reported in the literature, and discrepancies between procedural success and device failure as reported in Tables 3 and 4) the paper reaffirms the value of vascular closure devices in selected patient populations. To “complete the deck,” a randomized design that also included a control group managed with manual compression may have been more useful for the overall assessment. Which cards are missing? Assuming that safety and efficacy are not at issue, the only additional value of the second generation devices relates to satisfaction and economics. Information regarding time to hemostasis, time to ambulation and discharge, patient satisfaction, and the incidence of late complications (femoral artery occlusion, infection) beyond the initial hospitalization period would have been valuable to study. What is the wild card? Does deployment of the Angio-Seal collagen plug prohibit repeat arteriotomy at the same site for a period of 90 days? Theoretically, resticking could disrupt or dislodge the collagen plug. If so, this limits the utility of such a device after performing an intervention limiting vascular access options should the need for repeat angiography arise during this period. Even in this new era of drug-eluting stents with reduced in-stent restenosis, patients continue to present with recurrent chest pain that requires repeat coronary angiography during the first three months after a procedure. Furthermore, many cardiologists stage multivessel percutaneous procedures beyond a single catheterization. Recently, Applegate et al. reported the safety of “resticking” in three time periods after the initial procedure.5 Another major question is the risk of concomitant use of glycoprotein IIb/IIIa inhibitors for post device complications. In another publication, Applegate et al. compared the bleeding complications of arterial closure devices with standard anticoagulation versus glycoprotein IIb/IIIa inhibition and showed that these devices can be utilized with vascular complications that are equal to or less than those historically reported in the literature.6 Does one hand take the entire pot? In 2004, there is clearly a place for percutaneous vascular closure devices following PCI. They are equivalent to manual compression in achieving hemostasis with the potential to improve time to ambulation and patient comfort. However, newer versions of these closure devices will probably not be the factor that makes PCI an outpatient procedure for all patients. More than demonstrating that the newer generation Angio-Seal device is safe and effective, this study reinforces the value of sound clinical judgment and appropriate case selection with the knowledge that “one size does not fit all.” In the end, operator discretion and experience are still the most important factors when considering the most effective method of achieving hemostasis following PCI.

1. Fry SM. Review of the Angio-Seal hemostatic puncture closure device. J Invas Cardiol 1998;10:111–120. 2. Sesana M, Vaghetti M, Albiero R, et al. Effectiveness and complications of vascular closure devices after interventional procedures. J Invas Cardiol 2000:12:395–399. 3. Duffin D, Muhlstein JB, Allison SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invas Cardiol 2001;13:354–362. 4. Lasic Z, Mehran R, Dangas G, et al. Comparison of safety and efficacy between first and second generation Angio-Seal closure devices in interventional patients. J Invas Cardiol 2004;16:xxx–xxx. 5. Applegate RJ, Rankin KM, Little WC, et al. Restick following initial Angioseal use. Cathet Cardiovasc Intervent 2003;58:181–184. 6. Applegate RJ, Graarczyk MA, Little WC. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 2002;40:78–83.