Vascular Closure Devices — One More Truth to Immediate Closure

Amjad AlMahameed, MD, MPH, RPVI and Lawrence A. Garcia, MD Caregroup/Harvard Medical School, Boston, Massachusetts
Amjad AlMahameed, MD, MPH, RPVI and Lawrence A. Garcia, MD Caregroup/Harvard Medical School, Boston, Massachusetts
Vascular closure devices (VCDs) provide simple, painless and reliable hemostasis following endovascular procedures performed via femoral arterial access. Their use has enhanced patient comfort and satisfaction, shortened the time to ambulation and preserved valuable catheterization laboratory resources.1–3 Despite these desirable results, however, VCDs are used in only 20–25% of all catheter-based procedures performed worldwide.4–5 The reason for this gap has historically been attributed to two major issues: cost considerations and the lack of level-I data proving a clinically relevant reduction in access-site major vascular complications (MVCs) compared to the gold-standard practice of manual compression. Another important, yet relatively underrated, factor that may explain this discrepancy is that the original VCD studies had remarkably long lists of exclusions, which in turn limited the pool of potential recipients. Optimal underlying anatomy, seamless healthy average-sized vessels and perfect sheath insertion site, among others, were prerequisite before a closure device was even considered in the catheterization laboratory. This likely hindered the external generalizability of reported trials which was reflected by slower penetration in the endovascular community. In this issue, Rashid and colleagues present the results of a single-center, prospective, off-label registry utilizing the second-generation, extravascular, metallic clip-based Starclose™ (Abbott Vascular, Santa Clara, California) VCD in 98 patients undergoing diagnostic coronary angiography.6 This registry is unique in that it tested the use of this device in participants who had at least one reason to either contraindicate or recommend against the use of Starclose based on the device’s instruction manual. Approximately one-third of participants had more than one inclusion criterion, with 30% qualifying based on the presence of angiographically confirmed femoral artery stenosis, 24% had femoral arterial calcification and 46% had a non-common femoral sheath insertion. Importantly, subjects who underwent intracoronary instrumentation (intravascular ultrasound, percutaneous coronary intervention, etc.) and/or intraprocedural anticoagulation were excluded and a notable 18% of participants were markedly obese (body mass index > 35%). Despite this higher-than-usual risk for access site complications, the Starclose device performed well, allowing for 100% procedural success (final hemostasis achieved without MVCs) and 94% device success (immediate [ 6) screened-to-enrolled ratio, the requirement for experienced operators who had long graduated from their early learning curves (must each have successfully performed ≥ 25 Starclose deployments), and the use of 6 Fr arterial sheaths in all patients at a time when many laboratories are using 5 or 4 Fr sheaths for diagnostic cardiac catheterization, further limit the external generalizability. Interestingly, patients who qualified based on stenotic indications were enrolled because of the presence of mild-to-moderate (30–70%) femoral artery stenosis. On final quantitative angiographic analysis, however, the average luminal stenosis was 35.3 ± 5.1%, indicating that most patients had mild, rather than moderate or significant, peripheral arterial disease. Although the issue of immediate or future local and systemic inflammation caused by VCDs continues to be investigated, recent data suggest that closure devices that actively approximate the arteriotomy edges, leaving behind an intraluminal foreign body such as the Angio-Seal (St. Jude Medical, St. Paul, Minnesota), which leaves a permanent anchor and collagen sponge, and the Perclose (Abbott Vascular, Abbott Park, Illinois), which leaves behind a nonabsorbable suture, did not trigger a more intense systemic inflammatory response following diagnostic coronary angiography than that seen with closure technologies that employed passive mechanical compression (FemoStop®, Radi Medical Systems, Inc., Reading, Massachusetts).8 On the other hand, histologic data in a canine model demonstrated more extensive extravascular and periadventitial scarring with the use of the AngioSeal device compared with the Perclose device at 4 weeks post femoral artery closure. It is intuitive to presume that such local changes are likely most prominent in thrombin-based, suture-based and collagen-based intravascular devices compared with extravascular devices. The Starclose is an extravascular closure device with tines designed to deploy in the vessel wall media. It remains unclear whether the reaction between the external layers of the arterial wall and the surrounding soft tissue on one side and the nonabsorbable nitinol clip would provoke exaggerated inflammation or scar formation that may potentially prohibit future use of VCDs (both endo- and extravascular). Likewise, the safety and efficacy of using this device in individuals with access site scar tissue caused by accessing the site previously, even in the absence of prior use of a VCD, has been questioned.9 These are particularly important issues to consider given the frequent need for repeat endovascular procedures in these patients. The arrival of extravascular VCD designs that provide totally absorbable sealants has energized the endovascular community about this technology.10 Whether these will eliminate such concerns and bring us a step closer to the optimal VCD remains largely unknown, but certainly merits further testing. Finally, we share the authors’ initiative that there is a need for rapid and safe management of the femoral access site in subgroups deemed high-risk for serious complications. Thus, we agree that it is time for large-scale studies to evaluate the use of closure devices in these populations.
1. Sanborn TA, Gibbs HH, Brinker JA, et al. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993;22:1273–1279. 2. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: Results of the Suture To Ambulate aNd Discharge (STAND I and STAND II) trials. Am J Cardiol 2000;85:864–869. 3. Duffin DC, Muhlestein JB, Allisson 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 Invasive Cardiol 2001;13:354–362. 4. Turi ZG. It’s time to seal every artery but . . . comparing apples and oranges in the vascular sealing literature. Catheter Cardiovasc Interv 2001;53:443–444. 5. Tavris DR, Gallauresi BA, Lin B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 2004;16:459–464. 6. Rashid MN, Ahmed B, Straight F, et al. Extravascular closure for patients with high-risk femoral anatomy. J Invasive Cardiol 2008;20:328–332. 7. Hermiller J, Simonton C, Hinohara T, et al. Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization. J Invasive Cardiol 2005;17:504–510. 8. Jensen J, Saleh N, Jensen U, et al. The inflammatory response to femoral arterial closure devices: A randomized comparison among FemoStop, AngioSeal, and Perclose. Cardiovasc Intervent Radiol 2008, Apr 9. [Epub ahead of print] 9. Fowler SJ, Nguyen A, Kern M. Trapping of vascular clip closure device in previously accessed femoral puncture site. Catheter Cardiovasc Interv 2007;70:62–64. 10. Scheinert D, Sievert H, Turco MA, et al. The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: Initial clinical results for Mynx. Catheter Cardiovasc Interv 2007;70:627–633.