Closure Device Overview
Vascular closure devices continue to emerge and evolve, offering potential benefits to both patients and practitioners.
The introduction of vascular closure devices in the past decade was only the second major innovation in vascular access management in the last half-century. The landmark work of Sven Seldinger, MD, in 1951 changed the invasive landscape by allowing access to blood vessels without a cutdown and open surgical closure. Vascular sheaths appeared in the early 1980s and allowed for repeated access and less traumatic fenestration of the vessel. The introduction of closure devices in the 1990s anticipated two important benefits: first, increased patient comfort and convenience along with early ambulation and discharge, and second, decreased complication rates. Although the first benefit has largely been achieved, the second goal has been elusive.
Why? First, there has been a shifting landscape, with progressively more aggressive anticoagulation regimens and larger sheath sizes accompanying the growth of interventional cardiology and radiology through the mid-1990s. The ability to intervene on progressively older, sicker, and more obese patients led to more diagnostic and interventional procedures on populations at higher risk for vascular complications. The early vascular closure literature, particularly in the setting of intervention, had particularly high complication rates. This was due to both the cumulative learning curve with vascular closure devices that all interventionalists had to experience, as well as the sheath sizes and multidrug anticoagulation regimens in use at the time. During the past decade, the use of glycoprotein IIb/IIIa agents has been associated with lowering heparin doses and activated clotting times (ACTs), while miniaturization of devices has allowed for progressively smaller sheath sizes. Although these advancements have led to progressive lowering of complication rates, much of the vascular closure literature is hard to interpret because it depends on historical comparisons rather than randomization.
It should be axiomatic that the primary determinant of vascular closure success is the quality of vascular access. Yet, somehow, this concept has been lost on many practitioners. In my observation, the majority of cardiologists do not use fluoroscopy before or during vascular access, and misplaced or mishandled arterial puncture remains, in my opinion, the primary cause of vascular complications. When the puncture site is not the common femoral artery over the femoral head, the risk of postprocedural complications is substantially higher; this can only be anticipated by injecting dye at the end of the procedure to assess the puncture site. This measure is rarely employed when vascular closure devices are not used and, amazingly, is frequently not done when devices are used. The latter is particularly remarkable, given the explicit instructions to do so by the device manufacturers.
One of the reasons vascular complications remain so prevalent is that the greatest benefit of device closure lies with immediate sheath pulling after intervention. In this setting, sheaths are pulled from fully anticoagulated patients. The potential hazards of having patients with indwelling arterial sheaths on a hospital floor and of sheath pulling, sometimes late at night, sometimes in an isolated setting, and sometimes by less experienced individuals, are therefore avoided. Thus, out of necessity, many studies directly compare device closure in patients with ACTs of 300 seconds versus manual compression in patients with ACTs of <150 seconds. This comparison is a tough but necessary hurdle for demonstrating complication equivalence or superiority.
The vascular closure device literature in general is not exemplary. Poor study design, lack of randomized prospective trials, inclusion of physician learning curves, imbalance between patient groups in anticoagulation, sheath sizes, and comorbidities, constantly changing device platforms, lack of preclosure femoral angiography, and sponsorship of studies primarily by industry have muddled much of the literature. Although complication rates have become relatively low, and there are now some studies that actually show a lower complication rate with device closure than manual compression, a tour of the US FDA MAUDE database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm) provides a sobering look at serious complications associated with closure devices, including 38 deaths. Because the database does not show the complications that occur when patients have manual compression, there is no way to use this information as a direct comparison.
This issue of Endovascular Today is a tribute to the ingenuity of device designers. As you read the articles that follow, you will have a chance to do an apples-to-oranges comparison of compression, collagen plugs, suture and staple closure devices, and reagents applied into the tissue track or on the skin. There are some other concepts in the works, several of which appear to have considerable merit. I categorize closure devices by whether or not they provide anchoring, an important issue with regard to closure in fully anticoagulated patients, and what, if any, foreign bodies are left behind. For example, Angio-Seal (St. Jude Medical, St. Paul, MN) provides anchoring with a collagen plug left in the tissue track, and Perclose (Abbott Laboratories, Abbott Park, IL) provides anchoring with suture material left in the arterial wall. Duett (Vascular Solutions, Inc., Minneapolis, MN) provides no anchor, but the thrombin collagen mixture leaves little residue, whereas VasoSeal (Datascope Corporation, Mahwah, NJ) also does not leave an anchor but does leave a collagen plug behind. In all of these considerations, the primary factors should be the ?four Cs?: closure effectiveness, complexity of device delivery, complication rates, and cost.
I believe the most compelling reasons for use of these devices is patient comfort and convenience, although I am hopeful that we will eventually demonstrate decreased complications compared to manual compression. Most patients are not aware of the finesse with which we perform endovascular reconstruction; what they remember is the misery of hours of indwelling sheath time after an intervention, followed by the pain from manual pressure on the arteriotomy. The debate over vascular closure is reminiscent of the debate about ionic versus nonionic contrast: although the less expensive approach may be clinically acceptable, physicians are rarely content depriving patients of an available tool that provides comfort (in Osler’s maxim, our mission is ?to comfort always?). Several attempts have been made to justify the cost of these devices by factoring in more efficient use of bed space and hospital facilities/personnel, but the cost issues will be the bane of many interventionalists in dealing with their hospital administrators.
Most importantly, I hope we will have a solid evidence base to guide practitioners in choosing among the available tools. In the next few years, smaller catheter sizes, improvements in noninvasive diagnostic testing, lack of reimbursement, and the radial approach may all limit the growth in use of these devices. For those of us who are enthusiastic about vascular closure, this remains an exciting period, during which I hope we will have not only new devices but also new indications, with an expanding database on closure of veins, vascular grafts, brachial arteries, and the like.
Zoltan G. Turi, MD, is Director of Invasive Cardiovascular Medicine at Drexel University College of Medicine in Philadelphia, Pennsylvania. He holds no financial interest in any of the products mentioned herein. Dr. Turi may be reached at (215) 762-1709; Z.Turi@drexel.edu.