Interventional Cardiology. Группа авторов

wings against the inner vessel wall. The sliding element with the attached clip is then depressed splitting the sheath and applies the clip to the arterial wall at the end of the assembly. At this stage, it is very important to ensure that the skin does not block the “splitter.” It is reasonable therefore to nick the skin after the proprietary sheath is placed. The procedure is completed by release of the clip using a button “trigger.” In the CLIP trial, which compared the StarClose with manual compression, device success was 87%, with no difference in complications between the groups [29].

Figure 2.6 The StarClose device is delivered through a special sheath provided with the device. After the device is loaded into the artery, nitinol wings are opened within the artery and pulled back to capture the inner arterial wall. The clip device, shown on the left part of the figure, is then advanced to the outside surface of the artery. When a clip is fired, it inverts and the tines of the clip capture the arteriotomy and force it closed. This device is unique in that what is left behind is entirely extra‐arterial.

Figure 2.7 Femoral angiogram 1 year after closure with the StarClose device. The arrowhead on the left shows the device, and on the right contrast injection demonstrates the insertion site of the re‐puncture. The device is entirely extravascular.

      Exoseal, Femoseal

      Exoseal (Cordis, Bridgewater, NJ) is a passive closure device that consists of deployment of a polyglycolic acid plug (absorbed within 90 days) over the arteriotomy site for hemostasis. The system is delivered through 5–7 Fr sheaths. The minimum diameter of the femoral artery is 5 mm for closure. Time to achieve hemostasis and ambulation appears to be lower than with manual compression. Access through the same site requires a delay of at least 30 days.

      Femoseal (St. Jude Medical Systems, Uppsala, Sweden) comprises a bioabsorbable polymer anchor plate that remains inside the artery and an outer disk. After procedural sheath removal, the anchor seal is deployed within the artery while the outer locking disk is placed on the outer wall of the artery. The arteriotomy is sandwiched between the two disks and held together by a bioabsorbable multifilament.

      Manta

The MANTA™ vascular closure device (Essential Medical, Exton, PA) is a collagen‐based closure device (Figure 2.8). It is intended to directly close large bore accesses at the end of the procedure, without pre‐closure, and is compatible with an 0.035‐inch guidewire. The system consists of a poly‐lactic‐co‐glycolic component (toggle) attached to a collagen plug and a delivery system used to place the toggle‐collagen plug implant. The toggle is deployed within the artery while the bovine collagen plug remains outside the vessel wall. A stainless‐steel lock is tampered down pushing the collagen and toggle together in order to sandwich the arterial puncture site between the toggle and the collagen. The proper amount of tension that the operator has to apply is indicated by the appearance of a green marker on the device handle. The radiopaque lock is visible under angiography and is a helpful landmark for future interventions. The toggle and collagen plug resolve completely in 6 months. Recommended re‐access point is 2.5 cm above or below the existing MANTA Device. The device comes in two sizes: 14 Fr and 18 Fr for arteriotomy closure between 10 and 14 Fr and 14 and 22 Fr, respectively. MANTA has also been applied for completely percutaneous closure of axillary arteriotomies after TAVI.

Figure 2.8 MANTA device. A bovine collage pad in grey seals the arteriotomy from the outside of the vessel and is connected with the endoluminal bioresorbable toggle through a suture that is closed by a stainless‐steel suture lock.

      The available preliminary results report a successful implant in 100% of patients, with a mean time to haemostasis of 2 min and 23 sec and a good safety profile [30].

      Hemostatic patches

      Hemostatic patches were originally designed for military purposes to achieve temporary arterial hemostasis in the battlefield. The mechanisms of action include causing vasoconstriction, creation of a positively charged environment, which attracts negatively charged red blood cells and platelets, or direct promotion of rapid coagulation [31–33]. Available patches include: Syvek Patch using poly‐N‐glucosamine (Marine Polymer Technologies, Danvers, MA); Neptune pad using calcium alginate (Biotronik, Bulach, Switzerland); Closure PAD (Medtronic, Santa Rosa, CA); Chito‐Seal using chitosan gel (Abbott Vascular, Redwood, CA); SafeSeal using a microporous polysaccharide (Possis Medical, Minneapolis MN, formerly Stasys Patch, St. Jude Medical, St. Paul, MN); and D‐ Stat Dry using thrombin (Vascular Solutions, Minneapolis, MN) (Table 2.1) [31].

Hemostatic patches allow sheath removal in anticoagulated patients, with ACT as high as 300 seconds. Studies on hemostatic patches have generally demonstrated shorter time to hemostasis and ambulation. However, a period of manual compression is generally required and may be longer than the recommended compression times from manufacturers [33–35]. It is likely a combination of both hemostatic properties of the patch and manual compression that leads to hemostasis. There are no consistent data demonstrating reduction in vascular complications with the use of hemostatic patches over manual compression. Neither the Syvek patch nor Chito‐Seal has been shown to reduce vascular complications over manual compression in a review of cases registered with the American College of Cardiology‐National Cardiovascular Data Registry (ACC‐ NCDR) [36]. D‐Stat Dry used after diagnostic procedures reduced vascular complications compared to manual compression in a series utilizing a historical control [33], but no direct comparisons have been performed. As the complication rate from vascular puncture in general appears to be declining with time, direct comparisons are necessary to clearly demonstrate decreased complication rates using these patches [4]. There are now several other patches available.

      Evidence‐based issues for vascular closure devices

      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