Vascular Closure Device Complications: The Case is Not Closed Yet

Vascular site complications are a major cause of morbidity after arteriotomy for cardiac catheterization. Prolonged bedrest after cardiac catheterization procedures is one of the major concerns for patients who come for such procedures. Management of arteriotomy site is especially important after percutaneous intervention in this era of aggressive anticoagulant and anti thrombotic therapy. Vascular closure devices are being increasingly used since their introduction in the early 1990s. A variety of devices are currently available for use. Two major categories are sealant devices and suture devices. Several other methods are also being employed for vascular closure including staple devices, surface patches and a novel technique of ultrasound mediated closure. Angioseal (a sealant device) and Perclose (a suture device) enjoy about 75% of global market share. Various modifications of existing devices and development of new devices are underway. The use of these devices has had a major impact on improving patient comfort, decreasing time to hemostasis, early ambulation, and early hospital discharge. The overall frequency of access site complications ranges from 1.5–9%.^1,2 This seemingly wide variability in the literature is due to inconsistent reporting standards for minor complications, variations in patient risk profiles, and mixed populations of diagnostic and interventional procedures. Predictors of vascular site complications include advanced age, female gender, renal failure, lower extremity vascular disease, shock, longer time to sheath removal, PCI within 24 hours of thrombolytic therapy, stent implantation, higher heparin doses, concomitant placement of venous sheath, use of thienopyridines and glycoprotein IIb/IIIa inhibitor therapy.^3,4 The impact of vascular closure devices on vascular complications is less clear. The published complication rates with vascular closure devices have been 1.1–12% after diagnostic cardiac catheterization and 2.2–20% after PCI.^5,7–9 Results of clinical trials have been mixed with some studies showing superiority^5,6 while other studies suggesting no difference when vascular closure devices were compared to manual compression.^8,9 One large observational showed inferiority⁷ of these devices compared to manual compression as did a recently published meta-analysis.¹⁰ Recent studies have shown a decrease or no difference in vascular complications with the use of vascular closure devices while studies done earlier suggested an increase when compared to manual compression suggesting a trend towards improved safety. While interpreting the results of these trials, one has to keep in mind that most of them are observational studies and retrospective analyses of registry data. Moreover, the majority of the studies published in the last few years have used first generation devices and therefore, are not truly representative of currently used versions. Anticoagulant and antithrombotic therapies in conjunction with percutaneous coronary interventions have changed significantly over time and may have an impact on vascular complications rates. Randomized, controlled trials comparing these devices to manual compression in a head-to-head fashion are lacking. Therefore, a conclusion regarding the comparative safety of these devices is difficult to draw from the data currently available. The study by Eggebrecht, et al. in this issue (see pages 247–250) reports on the usage of 8 French Angioseal devices and the most common serious complication reported was that of compromised flow in the femoral artery and lower limb. Clinical practice has already shifted to using predominantly 6 French sheaths for diagnostic and interventional procedures, thereby obviating the need for use of 8 French vascular closure devices in the vast majority of patients. These smaller devices are at least theoretically less likely to obstruct flow in the vessel. As the authors point out, the increased risk of this complication in women may be due to the smaller vessel size in females, in which case downsizing the closure device may result in a lower incidence of this complication. Increasing familiarity and experience with the use of vascular closure devices and continued refinements in technology will lead to increased safety and convenience. It is, therefore, reasonable to expect a further decline in the rate of complications associated with the use of closure devices. Closure devices are here to stay!