Vascular closure devices (VCDs) became available to the interventional cardiology community in the mid-1990s. VCDs were initially created to treat the high rates of access-site bleeding associated with percutaneous coronary intervention (PCI) procedures and improve other potential vascular complications with sheath access and removal. Previous studies have assessed this theory and have produced mixed results with regard to the relative risks of serious adverse events such as hemorrhage with the use of VCDs compared with manual compression. Almost all studies to date have used time to ambulation as the primary metric for any VCD, however, all surrogate secondary endpoints such as hematoma and hemorrhage requiring transfusion invariably favor manual compression, which remains the gold standard.
1,2
The recently published subgroup analysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial evaluated the outcomes of 11,621 patients who underwent angiography with or without PCI by the femoral route; in this study, 37.1% of the patients received a VCD. At 30 days, major vascular complications were significantly reduced among the patients who received a VCD. Indeed, the lowest rate of access-site bleeding (3
While VCDs are not routinely used, this technology is an important part of interventional cardiology at many institutions and new devices are being developed with an estimated market growth of up to 11% per year since 2006.
4 It was estimated that in 2007, VCDs were used to achieve hemostasis at the access site in approximately 30% of the nearly 10 million percutaneous vascular procedures performed in the United States.
5 There are a wide variety of VCDs available today. Many utilize suture-, metallic- or collagen-based technologies to stitch, clip or compress the arteriotomy at the time of sheath removal to achieve hemostasis.
VCDs reliably shorten the time to hemostasis compared to manual compression and allow earlier patient ambulation.
6,7 In addition, VCDs allow immediate removal of the femoral sheath despite the anticoagulation status of the patient, which can lead to greater patient satisfaction and comfort compared with simple manual compression.
One of the newest designs available for groin access management is the FDA-approved Mynx Vascular Closure Device (AccessClosure, Inc., Mountain View, California), which utilizes a water-soluble, freeze-dried polyethylene glycol (PEG) material that rapidly expands inside the tissue tract by absorbing blood and subcutaneous fluids above the arteriotomy site, providing an immediate mechanical seal over the access site and within the tissue tract.
8 The Mynx sealant appears to facilitate tissue healing with less potential for intravascular complications than with other commonly used devices.
In this issue of the Journal of Invasive Cardiology, Azmoon et al report the results from their retrospective study comparing the incidence of vascular complications after PCI following hemostasis with the Angio-Seal (St. Jude Medical, Inc., St. Paul Minnesota) and the Mynx VCDs.
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This is the first study that makes a head-to-head comparison of these two VCDs. They describe the outcomes of the two groups from January 2008 to September 2008, including patients who presented for left-heart catheterization (LHC) and underwent subsequent immediate PCI, all performed by a single operator. All patients received antiplatelet therapy according to the standard guidelines and were fully anticoagulated with intravenous unfractionated heparin with a target activated clotting time (ACT) of 200–300 seconds. The average heparin dose in the Mynx VCD group was 6,531 USP units versus 3,833 USP units in the Angio-Seal group.
Although the decision of which VCD to use was at the operator’s discretion, which introduces an inherent bias as to the results, there was a clear preference for the Mynx VCD. In this patient cohort, a total of 428 patients were included; 190 (44.4%) were treated with the Angio-Seal VCD and 238 (55.6%) were treated with the Mynx VCD. The primary endpoints were post-VCD major vascular complication rates defined as retroperitoneal bleeding, hemorrhage with loss of greater than 3 grams of hemoglobin requiring blood transfusion, hemorrhage requiring surgical intervention, pseudoaneurysm formation necessitating surgical repair and the need for surgical removal of a malfunctioning VCD. The results presented are intriguing in that the primary endpoint in both groups was similar, with major vascular complications observed in 2.1% in both groups (4 and 6 patients, respectively; Angio-Seal and Mynx). Two patients required surgical removal of malfunctioning device in the Angio-Seal group. Further, 1 patient had a drop in hemoblogin requiring blood transfusion and 1 had a hemorrhage requiring surgical intervention in the Angio-Seal group. In the Mynx VCD group, 2 patients required pseudoaneurysm repair, 2 developed retroperitoneal bleed and 1 had a drop in hematocrit requiring blood transfusion.
Interestingly, procedure failure, defined as deployment of the device needing additional manual compression for more than 30 minutes to obtain hemostasis, was significantly higher in the Mynx VCD group compared with the Angio-Seal VCD group (9.2% versus 3.7%), and according to the authors, this finding may be due to a higher body mass index and higher doses of intravenous heparin in the Mynx VCD group combined with an initial learning curve with the device.
Beyond the retrospective nature of this report, it also represents the experience of a single (high-volume) operator who performed at least 428 interventions in 9 months, and these results may not represent the experience of many contemporary interventionists. Another major limitation in this review is the lack of separation between elective and emergent PCI and different approaches to anticoagulation.
However, we believe this report continues in a long line of reports to suggest that although vascular closure at the time of any vascular access procedure seems attractive for patient comfort or ambulation, the data continue to suggest that their routine use still has risks involved that many who perform vascular interventions do not routinely appreciate; although their consequences can be significant. A perfect vascular closure device remains elusive. Until one is found, we agree with the authors that a larger randomized trial may be useful to determine the actual benefit of time spent post procedure with patient groin management and patient comfort compared with the surrogate secondary endpoints of bleeding and hemorrhage.
References
1. 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.
2. Ansel G, Yakubov S, Neilsen C, et al. Safety and efficacy of staple-mediated femoral arteriotomy closure: Results from a randomized multicenter study. Catheter Cardiovasc Interv 2006;67:546–553.
3. Sanborn TA, Ebrahimi R, Manoukian SV, et al. Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circ Cardiovasc Interv 2010;3:57–62.
4. Bradley JT, Schmoker JD, Dauerman HL. Complete Cypher stent fracture and migration in the ostium of the right coronary artery. J Invasive Cardiol 2007;19:E99 –E101.
5. Turi ZG. An evidence-based approach to femoral arterial access and closure. Rev Cardiovasc Med 2008;9:6–18.
6. 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.
7. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and metaanalysis. JAMA 2004;291:350–357.
8. Ansel M, Garasic J. The MYNX™ Vascular Closure Device: Initial clinical experience using a novel approach to vascular closure. Endovascular Today 2008, January.
9. Azmoon S, Pucillo AL, Aronow WS, et al. Vascular complications after percutaneous coronary intervention following hemostasis with the Mynx vascular closure device versus the AngioSeal vascular closure device. J Invasive Cardiol 2010:22:175–178.
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From the Section of Interventional Cardiology and the Vascular Medicine Program, St. Elizabeth’s Medical Center, Boston, Massachusetts.
The authors report no conflicts of interest regarding the content herein.
Address for correspondence: Lawrence A. Garcia, MD, FACC, FAHA, Chief, Section Interventional Cardiology, Associate Director, Vascular Medicine Program, St. Elizabeth’s Medical Center, 736 Cambridge Street, Boston, MA 02135. E-mail: Lawrence.Garcia@caritaschristi.org
