Читать книгу Interventional Cardiology - Группа авторов - Страница 62

The design goals of active vascular closure devices (as replacement of manual compression for management of femoral arterial sheath removal) would include reduction in hemostasis and ambulation times with associated improved patient comfort and reduction in hemorrhagic vascular complications. As experience with this family of devices has grown it is clear that hemostasis and ambulation times can be decreased, but the reduction of vascular complications has not been as well shown. Nevertheless the use of vascular closure devices is widespread and growing over time; a recent large report of Veterans Affairs Clinical Assessment, Reporting, and Tracking Program showed device use in 75.3% of PCI procedures in 2018 [37].

There are concerns for the potential to increase rare but serious complications such as infection, arterial occlusion, distal embolization, and arterial wall injury with pseudoaneurysm. In addition, bleeding complications, should they occur, could potentially be more severe than seen with manual compression because manual compression requires normalization of ACT prior to sheath removal while vascular closure devices can be deployed at elevated ACT [4]. In a review of case series of AngioSeal and Perclose, the reported incidence of such complications includes: infection 0.6%; pseudoaneurysm or arteriovenous fistula 0.6–1%; and occlusion or embolism 0.2–0.4% [26]. In a review of 4 years of cardiac catheterizations and interventions at the Mayo Clinic between 2000 and 2003, during which vascular closure devices were used in 1662 patients, the incidence of device‐related infection was 0.24% [38].

There are numerous randomized and non‐randomized comparisons of vascular closure devices and manual compression. There is significant heterogeneity between the trials in inclusion criteria and definitions of outcomes. Three meta‐analyses have reviewed the studies involving collagen plug devices (AngioSeal and VasoSeal) and suture devices (Perclose) [36,39]. Use of vascular closure devices is associated with significant reductions in time to hemostasis (by 17 minutes), time to ambulation (by up to 11 hours) and time to discharge (by 0.6 days) [40]. However, in these analyses in both diagnostic and interventional settings, there is no substantial difference (benefits or harms) in vascular complications by the vascular closure devices, except for the VasoSeal device, which has been associated with increased vascular complications in two of the meta‐analyses [39,41]. There are a number of limitations to assessing the relative rates of complications with manual compression and vascular closure devices. First, some trials have required femoral angiography, and higher risk patients may be eliminated from the trials, because of small caliber femoral vessels, atherosclerosis of the puncture site, or calcification. In addition, many of the trials have rigorous protocol specifications for the manner in which the closure devices are used, but generally give no guidance regarding manual compression methods, which can be highly variable. In some institutions, there are sheath removal teams who become quite expert at sheath removal, manual compression, and puncture site management used to exist, obtaining excellent results [42]. It is difficult to make comparisons between these programs and lower volume programs, or programs where new trainees are relegated to the task of sheath removal and manual compression.

The largest registry study of femoral hemostasis comes from the ACC‐NCDR [36]. From this registry, the outcomes of 166 680 patients who underwent diagnostic and interventional cardiac catheterizations in 2001 were evaluated, with suture devices used in 25 495 cases, collagen‐plug devices used in 28 160 cases, while the rest underwent manual compression. In the overall multivariate analysis, use of collagen plug devices was associated with reduced bleeding in diagnostic catheterization (odds ratio 0.68) and both types of closure devices were associated with reduced risk of pseudoaneurysm formation in diagnostic and interventional procedures (odds ratio 0.46–0.52). It is possible that among individual operators who develop special expertise with a particular closure device, there is potential to achieve improved success rates with lower complication rate [43]. A propensity analysis from the British Cardiovascular Intervention Society and the National Institute for Cardiovascular Outcomes Research showed a minor reduction in 30‐day mortality in patients treated with vascular closure devices, slightly more evident in women and in patients presenting with acute coronary syndrome or recent lysis [44]. A recent Cochrane review comparing collagen‐based, metallic‐clip, and suture‐based vascular closure devices with extrinsic compression confirmed reduced time to hemostasis using a closure device, no difference in infection rate between the different modalities and reduced incidence of groin hematomas and pseudoaneurysms with collagen‐based devices, no differences were found for other complications between the different types of hemostasis [45].

What then are the advantages of vascular closure devices? Unquestionably, the complete avoidance of compression with immediate hemostasis and early ambulation improves patient satisfaction [46]. This alone can justify the use of these devices in many cases. However, with no clear difference in complication rates, possibly the strongest benefit may be an early (same‐day) discharge of patients after percutaneous coronary intervention that could result from early ambulation [4,47]. Over the past years, major vascular complications have decreased among patients undergoing percutaneous coronary intervention in the Northern New England Cardiovascular Disease Study Group. In their database, with 36 631 patients undergoing percutaneous coronary intervention, arterial complications decreased from 3.37% in 2002 to 1.98% in 2006 [39]. Whether this reflects more careful attention to needle puncture and sheath insertion, improved management of anticoagulation, better manual compression, or optimized use of closure devices cannot be ascertained without a randomized trial. Such a trial would require such a large population that is unlikely ever to be performed.

Vascular closure devices shorten the time to hemostasis and ambulation, compared with manual compression, but the aggregate of reports is mixed regarding the potential for closure devices to increase or decrease the risk of vascular complications. In a recent study of patients undergoing diagnostic coronary angiogram with a 6 Fr system, the vascular closure devices were not inferior to manual pressure. There were no increased risks of vascular complications; however, it is important to note that in this study the patients did not undergo any coronary interventions so the results should be considered in the context of diagnostic angiography. This study compared FemoSeal (Terumo) with ExoSeal (Cordis). ExoSeal is not frequently used in the USA, and FemoSeal is only currently available in Europe [48].

Vascular closure devices for small arteriotomies have no clear benefit over external compression and their widespread use is mainly driven by the reduction of time to ambulation and discharge. Conversely, for large bore arteriotomies the use of percutaneous closure devices is perceived as mandatory. Observational data demonstrated that percutaneous approach to TAVR using suture‐mediated vascular closure devices with preclosure is associated with similar vascular outcomes to surgical cut‐down for arterial access, but with shorter length of stay and less wound complications [49,50]. Recently the new MANTA system, specifically designed for large bore arterial access closure, showed preliminary outcomes comparable to Proglide [51].

Routine use of vascular closure devices might reduce bleeding and vascular complications, facilitate patient ambulation and decrease hospital length of stay even though the inherent complications of vascular closure device use such as infection, embolization, and device failure leading to ischemia or access‐site bleeding will probably never be completely abolished.