Access Site Management—Review of Options
Peter Lochow
Sigmund Silber
After the first cardiac catheterization via the femoral artery (1,2), the femoral approach is now the most commonly used access for diagnostic cardiac catheterization and coronary interventions.
The brachial approach is showing a continuously declining usage, now below 5% (3, 4, 5, 6), and is mainly chosen in situations in which femoral access is not possible. The radial access remarkably increases patients’ comfort and decreases bleeding complications (7, 8, 9), even with the use of glycoprotein (GP) IIb/IIIa inhibitors (10,11), and it has been used safely in fully anticoagulated patients with international normalization ratios (INR) above 2 (12). Nevertheless, the transradial approach has a considerably longer learning curve, longer procedure time, and several more specific disadvantages (13).
Patients undergoing catheterization using the femoral approach, however, are usually immobilized for several hours, which may result in significant discomfort, with increased back pain and need for analgetics (14). Patient noncompliance regarding strict bedrest after the procedure has been reported to be a substantial factor in femoral complications, increasing the risk of hematoma formation and of (re)bleeding (15). In addition to patient discomfort, the femoral approach is limited by its risk of local vascular complications.
With the current standard stent regimen using ASA and clopidogrel, major local bleeding complications regarding femoral access still may occur in 2.5% of patients (16,17). Other adverse events include arterial-venous (AV) fistulas (18), pseudoaneurysms, and retroperitoneal bleeding (19,20). By performing a thorough physical examination and duplex ultrasound, the actual complication rate when using manual compression may be as high as 64% (10).
During the last decades, many closure devices have been invented and clinically tested to enhance femoral hemostasis (21)—although not all of them reached the market (22, 23, 24, 25). The American College of Cardiology/Society for Cardiac Angiography and Interventions (ACC/SCAI) expert consensus document from 2001 specified the recommendations regarding postprocedural hemostasis following the use of hemostatic closure devices (26).
Closure devices are divided into passive mechanical devices, which maintain groin pressure in the absence of human personnel, and active femoral closure devices, which promote with fast and active sealing or suturing of the femoral puncture site (Table 43.1). This chapter compares the basic concepts and clinical results of the four prevailing vascular closure devices and presents both some newly approved and still investigational devices.
BACKGROUND
Impact of Anticoagulation Level and Sheath Size on Local Complications
Lowering the amount of heparin in coronary interventions can reduce bleeding complications (27). On the other hand, achieving high activated clotting times (ACT) paradoxically reduced long-term ischemic coronary complications (28).
The use of low-molecular-weight heparin (LMWH) may be associated with a higher bleeding risk (29).
The use of low-molecular-weight heparin (LMWH) may be associated with a higher bleeding risk (29).
TABLE 43.1. SYSTEMATIC CLASSIFICATION OF THE 24 FEMORAL ACCESS CLOSURE DEVICES | |
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A reduction of sheath size resulted in fewer local vascular complications (30, 31, 32): Diagnostic coronary angiography can be performed using 4 Fr catheters, thus reducing in complications (33) and allowing safe outpatient catheterization in selected patients (34) with acceptable image quality (35). For percutaneous coronary interventions (PCI), newer 6 Fr guiding catheters allow safe stenting even in 3.5 mm vessels, but no reduction in bleeding complications is correlated to this reduction in sheath size (3,36,37). Outpatient PCI was reported using 6 Fr sheaths and manual compression (38). The feasibility of using 5 Fr guiding catheters for PCI, with a success rate of 80% to 95% and a very low local event rate, also has been demonstrated (39,40).
Impact of Glycoprotein IIb/IIIa Inhibitors on Local Complications
Initial large randomized clinical trials as well as retrospective registry data showed increased vascular access site bleeding with the use of glycoprotein (GP) IIb/IIIa inhibitors (41, 42, 43, 44, 45). Although in more recent trials, bleeding complications with the use of GP IIb/IIIa receptor inhibitors could be reduced by (a) using smaller sheaths, (b) pulling the sheath earlier after the intervention, and (c) using lower (weight-adjusted) doses of heparin (46, 47, 48), IIb/IIIa inhibitors still are associated with an increased risk of vascular complications (49). The femoral vascular access site is the most frequent area of bleeding in these studies (50). Pooled clinical data also report differences in bleeding complications between abciximab, eptifibatide, and tirofiban, with the latter two having less major bleeding complications (51). The latest meta-analysis in 22,501 patients receiving GP IIb/IIIa inhibitors in 18 studies resulted in a major bleeding rate of 3.6% (52). Bleeding risk with GP IIb/IIIa inhibitors especially increases in conjunction with thrombolytic therapy (49).
THE DEVICES
Devices to Facilitate Mechanical Compression
Mechanical compression devices have been developed to facilitate and/or replace manual compression, which is commonly used after diagnostic cardiac catheterization using smaller sheaths (4 to 6 Fr) (35,53,54). The mechanical C-clamp (Compressor, Instromedix, Inc., Hillsborough, Oregon) is a device with a base placed under the patient’s hip and a clamp arm with a disposable plastic pad positioned proximal to the sheath insertion site. After sheath removal, the arm is lowered to achieve compression. This device has been used with a success rate similar to that of manual compression (55). When ultrasound was used to detect vascular complications, the C-clamp significantly reduced the complication rate, compared with manual compression, in 778 patients (56). CAOW, the “Compression Apparatus on Wheels” (Anlam Corporation, Edmonton, Canada) (57) is like a C-clamp on a cart; it also is approved for use in the United States.
FemoStop (RADI Medical Systems AB, Uppsala, Sweden) is a pneumatic compression device with an inflatable pressure dome, held in place by a plastic arch and a polyester belt superior and medial to the femoral artery sheath insertion site. FemoStop II consists of a disposable set, a reusable arch, and a reusable pump. After inflation above systolic blood pressure, the sheath is removed; over the next 3 to 4 hours, the device slowly is deflated and removed. A shortening of bedrest time has been reported (58), but longer compression times and no improvement in patient comfort also have been observed (59). FemoStop also has been shown to be useful for compressing iatrogenic femoral pseudoaneurysm, with or without requiring ultrasonic guidance for positioning (60, 61, 62, 63).
Femoral Puncture Site Closure Devices
The clinical use of vascular closure devices for rapid hemostasis after femoral access was first published in 1991, in Europe (64). The first closure device was approved in the United States, in 1995, as an alternative to manual compression. Ever since, closure devices have been undoubtedly proven to increase patient comfort and decrease the burden for and increase the efficiency of the medical staff. At the same time, they may reduce hospital costs by shortening the length of stay. In contrast to mechanical compression devices, vascular closure devices allow patients to be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than
is currently possible in most centers that utilize a supine restriction period of up to 6 hours after diagnostic catheterization (65). After PCI, patient comfort is additionally increased by immediate sheath removal (66, 67, 68). Studies that include patient evaluation surveys revealed a higher level of satisfaction with femoral sealing devices after PCI (69,70). Outpatient coronary interventions may become feasible in selected patient groups (26,71, 72, 73); however, the use of infusion of GP IIb/IIIa inhibitors postintervention limits the outpatient approach (74).
is currently possible in most centers that utilize a supine restriction period of up to 6 hours after diagnostic catheterization (65). After PCI, patient comfort is additionally increased by immediate sheath removal (66, 67, 68). Studies that include patient evaluation surveys revealed a higher level of satisfaction with femoral sealing devices after PCI (69,70). Outpatient coronary interventions may become feasible in selected patient groups (26,71, 72, 73); however, the use of infusion of GP IIb/IIIa inhibitors postintervention limits the outpatient approach (74).
Thrombin injections, partially with the use of closure devices, also may be useful for the treatment of false aneurysms after failed compression therapy in patients on full-dose antiplatelet and heparin therapy (75, 76, 77, 78).
The four devices most commonly used are Angio-Seal, with its actual market share of 46%, followed by Perclose with 32%, VasoSeal with 14%, and Duett with 3% (79). The remaining 5% is shared by several other newer closure devices (79).
Angio-Seal
The Angio-Seal Concept
Angio-Seal (St. Jude Medical Devices, Daig Division, St. Paul, Minnesota) (80) works predominantly with mechanical forces (“sandwich technique”) and probably also by some collagen-induced thrombus formation (Table 43.2). Angio-Seal provides a mechanical block of the arterial puncture site with an anchor from inside the artery guiding and holding the collagen in the tissue tract (81). The device is available in two sizes: 6 Fr and 8 Fr. All three components deployed into the patient (anchor, collagen plug, and the connecting suture) are completely absorbable.
The technique of its deployment has been described in detail elsewhere (82,83). The new design of the Angio-Seal STS (Self-Tightening Suture with the Roeder knot), with an enhanced suture delivery, new release mechanism, and a redesigned anchor, results in an easier application procedure taking less than 1 minute. The STS-plus is the latest development and provides a smoother transition from insertion sheath tip to dilator.
Clinical Results of Angio-Seal
The Angio-Seal pivotal randomized, controlled, multicenter trial was published in 1995 and proved safety and efficacy in 435 patients (83) (Table 43.3). The wider experience showed deployment success rates in the range of 91% to 100% (66,67,84,85). For diagnostic procedures, a time to ambulation of 1 hour (86) and even as little as 20 minutes (87) was considered to be safe. The 6 Fr device proved its safety and efficacy in a prospective, multicenter registry, providing immediate hemostasis in 91% of the patients (88). The new STS device was tested in 106 PCI patients in nine U.S. centers and revealed superior immediate hemostasis, compared with the classic Angio-Seal PPS (post-placement spring) device (89), confirming another smaller singlecenter study using the STS device (90).
Major complication rates were 1.3% (91); the formation of a hematoma occurred in the range of 4% (86) to 7.4% (92). In a large cohort of 1,317 consecutive patients, the rate of major complications in the 644 PCI patients was the same as in the 673 diagnostic patients (0.45% versus 0.62%) (85). A trend toward more complications with Angio-Seal was evident with the use of ticlopidine, abciximab, patients receiving two or more anticoagulants or antiplatelets, 8 Fr sheath size, and female gender (93). Recently, the safety of performing repeat interventions through the same artery within less than 90 days following the deployment of the device has been shown (94). Angio-Seal also has been deployed after femoropopliteal angioplasty (95).
Perclose
The Perclose Concept
The Perclose series (Abbott Park, Illinois) is based solely on sutures (96) (Table 43.2). The main advantage compared with other closure devices is that no material is left at the puncture site, except the nonabsorbable sutures. Needles are used to guide the sutures through the vessel wall. Perclose consists of several components, including a 0.035-inch guidewire, a knot-pushing tool, and the suturecontaining device itself. Recently, the Closer device has been developed for use in 6 to 8 Fr sheaths (97,98). The 6 Fr Perclose A-T (Auto Tie), launched in November 2002, is a newer development in the Perclose series. Based on the added feature of a pre-tied knot, this device reduces deployment time to less than 4 minutes on average due to its easier deployment procedure (98). The latest development is the 6 Fr Pro-Glide device.
Clinical Results of Perclose
The main databases for Perclose were the two STAND trials (99): STAND-I (a registry, not randomized) showed successful hemostasis in 99% of the patients, in a median of 13 minutes, with a major complication rate of 1%. Time to ambulation has been reported for these diagnostic cases to be 1.8 hours, with a time to discharge of 3.9 hours (99).
STAND-II was the pivotal randomized, controlled multicenter trial (99) (Table 43.3). In the diagnostic cases, time to discharge was significantly reduced from 8.3 hours in the compression arm to 4.4 hours in the suture arm (99). In the interventional cases, time to discharge remained unaltered (25.4 hours in the compression arm versus 24.4 hours in the suture arm) (99). STAND-II proved the safety and efficacy of the suture concept. The slight trend toward increased complications with the device was not statistically different (Table 43.3).
In recent trials, the incidence of minor complications was 5.3%, and major complications ranged between 0.2% and 4.5%, with a higher complication rate observed when using larger devices (69,100, 101, 102). In a large series of over 10,000 patients, a significantly higher complication rate was noted for both major and minor complications in the diagnostic
catheterization patients treated with the Prostar-Plus device compared with manual compression (103). The newer “Closer” modification resulted in a 96% success rate, with immediate ambulation in 89% of the diagnostic catheterizations (104,105). The newest-generation Perclose system (A-T) was used in 72 procedures, with a successful deployment in 98.6% without any complications (98). Immediate ambulation (≤7 minutes after successful hemostasis) recently has been shown to be feasible and safe (106).
catheterization patients treated with the Prostar-Plus device compared with manual compression (103). The newer “Closer” modification resulted in a 96% success rate, with immediate ambulation in 89% of the diagnostic catheterizations (104,105). The newest-generation Perclose system (A-T) was used in 72 procedures, with a successful deployment in 98.6% without any complications (98). Immediate ambulation (≤7 minutes after successful hemostasis) recently has been shown to be feasible and safe (106).
TABLE 43.2. COMPARISON OF THE FOUR PREVAILING VASCULAR CLOSURE DEVICES; THE IDEAL DEVICE WOULD HAVE A “+” IN ALL CATEGORIES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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A specific feature of the Perclose system is the possibility of “pre-closure” (107): deploying the sutures at the beginning of the procedure using a smaller sheath (e.g., 6 Fr) exchanged for the Perclose device, then placing the larger sheath and tying the sutures after completion of the procedure. This method has been used with success with 7 and 8 Fr sheaths (108) as well as for the large sheaths (10 to 16 Fr) used for percutaneous valvuloplasty (109,110) and endoluminal repair of abdominal aortic aneurysms (111,112). Using a peel-away sheath for stabilization may help to salvage closure procedures that would otherwise have to be aborted due to insufficient stiffness of the device shaft (113). The Perclose device also can be used for even larger sheaths: The successful closure of up to 22 Fr femoral artery entry sites (used for stenting aortic aneurysms) has been described (114). Closing brachial access sites has been reported (115, 116, 117), as has Perclose usage in thoracic surgery procedures (118). Repeat closure several times within days and with a low complication rate is feasible. The Perclose system also can be used for closing antegrade puncture sites after infrainguinal intervention for PTA (102,119,120) even in the presence of calcified plaques (121). The multiple use of the Perclose device in the same femoral artery is safe (122).
VasoSeal
The VasoSeal Concept
VasoSeal (Datascope Corporation, Mahwah, New Jersey) was the first widely applied femoral sealing device and was therefore initially called the vascular hemostatic device (VHD). It works predominantly by collagen-induced thrombus generation and consists of purified bovine collagen plugs that induce the formation of a hemostatic cap directly over the arterial puncture site (123) (Table 43.2). Biodegradable collagen induces platelet activation and aggregation, releasing coagulation factors and resulting in the formation of fibrin and the subsequent generation of a thrombus (124). The classic VasoSeal comprised four parts: a blunt-tipped 8 Fr dilator, one of seven differently sized 11.5 Fr sheaths selected by length using a preprocedure needle depth measurement technique, and two 90 mg collagen cartridges. Details regarding these four parts are described elsewhere (125,126). The new VasoSeal ES (Extravascular Security) uses a removable J-segment wire to enhance guidance and exact localization of the arterial puncture site. The preprocedural needle depth measurement can, therefore, be omitted. The latest development is the VasoSeal ES Elite with an enhanced dilator and collagen cartridge delivery design.
TABLE 43.3. COMPARISON OF THE PIVOTAL, MULTICENTER, RANDOMIZED, CONTROLLED STUDIES OF THE FOUR PREVAILING FEMORAL SEALING DEVICES; ALL STUDIES HAVE BEEN CONDUCTED WITH THE FIRST-GENERATION DEVICES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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