Review of Vascular Closure Devices

Pages: 1, 10-20

Note: This article is corrected from the print version to note that the Exoseal device's plug is not collagen, but polyglycolic acid, which is synthetic and not biologic like collagen. CLD regrets the error.

Abstract

Background. Vascular access-site complications are an important cause of morbidity following catheterization procedures. Manual compression is the “gold standard” in achieving hemostasis of an arteriotomy site; however, manual compression is limited by the need to interrupt anticoagulation, prolonged bed rest, patient discomfort and time demands for healthcare providers. Vascular closure devices (VCDs) improve patient comfort, free medical staff resources and shorten the time needed for hemostasis, ambulation and discharge. However, the safety of VCDs remains in question and they may increase the risks of infection and leg ischemia. Compared with manual compression, the rate of major complications appears to be increased with VasoSeal, decreased with Angio-Seal and decreased in diagnostic cases with Perclose. The safety of VCDs cannot be assumed due to “class effect,” and nearly all individual trials are underpowered to detect differences in complication rates, so the safety of other individual VCDs is unclear. In the absence of puncture site-related risk factors, VCDs as a whole appear to have little influence on complication rates, and patients at high baseline risk for bleeding due to clinical factors may benefit from these devices. Screening with femoral angiography prior to VCD placement and avoidance of VCDs in the presence of puncture site-related risk factors might reduce the risk of vascular complications. This review describes the mechanism, efficacy and safety of VCDs including hemostasis pads, the FemoStop, Clamp Ease, Mynx, Duett, FISH, Boomerang, ExoSeal, Starclose, VasoSeal, Angio-Seal and Perclose devices.

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In the early 1990s, ~6% of patients undergoing percutaneous coronary intervention (PCI) developed peripheral vascular complications, of which 22–25% received a blood transfusion and 21–38% required vascular surgical repair.^1,2 Recently, the rate of vascular complications has declined to approximately 2%.^3–6 However, the 1-year mortality rate for patients with peripheral vascular complications was 7.5% compared with 1.1% for patients without such complications.² Peripheral vascular complications prolong hospitalization and nearly double mean hospital costs (from $9,583 to $18,350).²

Arterial access sites were managed exclusively with manual compression (MC) and bed rest for 30 years after Seldinger introduced his technique of percutaneous arterial access in 1959. However, MC necessitates interruption of anticoagulation and requires considerable time and resources (i.e., wait for activated clotting time to decrease and maintain MC for 15–30 minutes with a 6 French [Fr] sheath). Also, MC requires prolonged bed rest, which is associated with patient discomfort, back pain and urinary retention.

Vascular closure devices (VCDs) were introduced in the early 1990’s with the goal of limiting the time, labor, bed rest and patient discomfort associated with MC. There are two types of VCDs: active and passive. Passive VCDs enhance hemostasis with prothrombotic material or mechanical compression, but do not achieve prompt hemostasis or shorten the time to ambulation. Active VCDs can be categorized as suture devices, collagen plug devices or clips. Active VCDs were used in 42% of over 1.5 million PCIs between 2004 and 2008 in a registry including 955 institutions.⁶ After 20 years of experience, the safety of VCDs remains controversial and some may increase the risk of limb ischemia and groin infection.^7,8 Do the benefits of VCDs outweigh the risks? Do VCDs benefit certain patients more than others? Are all VCDs created equal?

This review describes each VCD’s mechanism, efficacy and safety profile. It is important to note that few reports can be directly compared due to differences in patient population, procedural characteristics, operator experience, anticoagulation profile and definition of vascular complications, all of which influence the rate of peripheral vascular complications. Variations in study protocol greatly impact the time to hemostasis, ambulation and discharge. Several devices have evolved since their conception to improve their safety and ease of use. In addition, VCD complication rates decrease over time as operators gain experience with a particular device (the so-called “learning curve”). Despite these limitations, the risk-benefit profile of various VCDs will be described.

Manual Compression

MC remains the “gold standard” in achieving hemostasis of an arteriotomy site. With MC, the sheath can be removed immediately after a diagnostic procedure, but is delayed (often 2–4 hours) after an interventional procedure to allow the activated clotting time to decrease to < 170 seconds. As the sheath is removed, firm manual pressure is placed over the femoral artery, typically 2 cm proximal to the skin entry site. Firm pressure is held for 10 minutes, then slightly less firm pressure for 2–5 minutes, then light pressure while applying a pressure dressing. Pressure should be maintained longer for larger sheath sizes and in the setting of anticoagulation. If bleeding persists, MC is maintained for an additional 15 minutes. Once hemostasis is achieved, bed rest is recommended for 6–8 hours. When VCDs fail, MC is used to achieve hemostasis.

Passive Vascular Closure Devices

Hemostasis pads. Several hemostasis pads, including Chito-Seal (Abbott Vascular, Redwood City, Calif.), Clo-Sur PAD (Scion Cardiovascular, Miami, Fl.), SyvekPatch (Marine Polymer Technologies, Inc., Danvers, Mass.), Neptune Pad (Biotronik, Berlin, Germany) and D-Stat Dry (Vascular Solutions, Minneapolis, Minn.) can be used in conjunction with MC. The pads are coated with procoagulant material to enhance coagulation and hemostasis.^9,10 Hemostasis pads have been analyzed in small randomized trials with patients undergoing diagnostic or interventional coronary procedures^10–12 or peripheral percutaneous interventions.⁹ Technical failure was reported in 5–19% of Clo-Sur PAD cases,^11,12 and in 8% of D-Stat Dry cases.¹³ Compared with MC, no difference in complication rates was observed with the Chito-Seal, Clo-Sur PAD or SyvekPatch,^10–12,14 whereas the D-Stat Dry reduced vascular complication rates¹⁵ and the Neptune Pad increased the risk of minor bleeding (15% vs. 3%).⁹ Compared with MC, the Neptune Pad⁹ and Clo-Sur PAD^11,12 improved patient and physician comfort. Hemostasis pads did not shorten the time to ambulation compared with MC.^9,10 The clinical utility of hemostasis pads is questionable since their influence on hemostasis is small and they do not reduce the time to ambulation.¹⁰

Compression devices: FemoStop and ClampEase. The FemoStop plus Compression System (St. Jude Medical, Minnetonka, Minn.) consists of a belt that wraps around the patient and a transparent, inflatable pneumatic bubble (Figure 1).¹⁶ A hemostatic dressing is placed on the arteriotomy site, then the bubble is positioned 1 cm above the arteriotomy. The bubble is inflated to ~70 mmHg while the sheath is removed, then to suprasystolic pressure for ~2 minutes, and it is deflated to the mean arterial pressure for 15 minutes (pedal pulse is palpable), then slowly deflated to 30 mmHg for 1–2 hours, and is finally carefully removed. The ClampEase device (Pressure Products Inc., Rancho Palos Verdes, Calif.) consists of a flat metal pad that is placed under the patient for stability, and a C-arm clamp with a translucent pressure pad.¹⁷ As the sheath is removed, the C-arm clamp is lowered so that the pressure pad compresses the access site. These compression devices have high technical success rates approaching 100%,^17–19 but do not shorten the time to hemostasis, ambulation or discharge compared with MC; they simply replace human compression with mechanical compression.^19,20 Major complication rates associated with the compression devices are low.^17,21 While compression devices relieve healthcare workers from performing MC, allowing them to care for more patients and relieving hand fatigue, they are less comfortable for patients.

Active Vascular Closure Devices

Cardiva Catalyst (Boomerang)

The Cardiva Catalyst (Cardiva Medical, Inc., Sunnyvale, Calif.) uniquely facilitates hemostasis through the existing arterial sheath, although MC is still required. The Cardiva Catalyst is indicated for diagnostic or interventional procedures with sheath sizes up to 7 Fr. The device is inserted through the existing sheath. Once the tip is within the arterial lumen, a conformable 6.5 mm disk is deployed, similar to an umbrella. The sheath is removed and the disk is gently pulled against the arterial wall, where it is held in place by a tension clip. The disk, which is coated with protamine sulfate, provides temporary intravascular tamponade, facilitating physiologic vessel contraction and thrombosis. After 15 minutes of “dwell time” (120 minutes for interventional cases) the device is withdrawn and light MC is held for 5 minutes. The Cardiva Catalyst successfully facilitated hemostasis in 99% of 96 patients undergoing diagnostic catheterization with a 5 Fr sheath without any major vascular complications and with minor complications in 5% (rebleeding during bed rest).²² Most patients can ambulate 90 minutes after a diagnostic procedure with this device. The Cardiva Catalyst device does not leave any material behind in the body, which minimizes the risk of ischemic and infectious complications and allows for repeat vascular access. The Cardiva Catalyst is compatible with most patients and has been used successfully in limited numbers of patients with peripheral vascular disease (6 patients), profunda artery or femoral bifurcation arteriotomies (19 patients), internal jugular arteriotomies (18 patients), and in pediatric patients.^22,23

Collagen plug device: Angio-Seal

The Angio-Seal device (St. Jude Medical, Minnetonka, Minn.) contains a small, flat, absorbable rectangular anchor (2 x 10 mm), an absorbable collagen plug and an absorbable suture (Figure 2).²⁴ First, the existing arterial sheath is exchanged for a specially designed 6 Fr or 8 Fr sheath with an arteriotomy locator. Once blood return confirms proper positioning within the arterial lumen, the sheath is held firmly in place while the guidewire and arteriotomy locator are removed. The Angio-Seal device is inserted into the sheath until it snaps in place. Next, the anchor is deployed and pulled back against the arterial wall. As the device is withdrawn further, the collagen plug is exposed just outside the arterial wall and the remainder of the device is removed from the tissue track. Finally, the suture which connects the anchor, the collagen plug, and the device is cut below skin level, leaving behind only the anchor, collagen plug and suture, all of which are absorbable.

Although Angio-Seal labeling indicates compatibility with 8 Fr or smaller procedural sheaths, the Angio-Seal has been used successfully to close 10 Fr arteriotomies utilizing a “double wire” technique.²⁵ With this technique, at the conclusion of the procedure, the Angio-Seal wire and a second, additional wire are placed through the sheath. The Angio-Seal is deployed in standard fashion using the Angio-Seal wire, leaving the second wire in place. If hemostasis is achieved, the second wire is carefully removed while maintaining pressure on the collagen plug. If hemostasis is not achieved, the second wire serves as a “back-up/safety” to allow deployment of a second Angio-Seal device. Using this “double wire” technique, 21 of 21 arteriotomies > 8 Fr (17 were 10 Fr) were successfully closed (18 with a single device, 3 required a second device).²⁵

In 4,525 patients undergoing interventional procedures (89% with 8–9 Fr sheaths) the Angio-Seal had a device success of 97%.²⁶ The Angio-Seal device significantly improved patient comfort at the time of discharge compared with MC.²⁷ Compared with the FemoStop device, patients treated with the Angio-Seal device had significantly less discomfort at 4 and at 8 hours after the procedure.²⁰ Angio-Seal safety data are described in detail below, but it reduced the risk of major vascular complications compared with MC in meta-analyses.^28,29

Collagen plug device: Mynx

The Mynx Vascular Closure Device (AccessClosure, Mountain View, Calif.) features a polyethylene glycol sealant (“hydrogel”) that deploys outside the artery while a balloon occludes the arteriotomy site within the artery (Figure 3).³⁰ The Mynx device is inserted through the existing procedural sheath and a small, semicompliant balloon is inflated within the artery and pulled back to the arterial wall, serving as an anchor to ensure proper placement. The sealant is then delivered just outside the arterial wall where it expands to achieve hemostasis. Finally, the balloon is deflated and removed through the tract, leaving behind only the expanded, conformable sealant.

The Mynx device was investigated prospectively in 190 patients (50% interventional, 94% 6 Fr)³⁰ and retrospectively in 238 patients (100% diagnostic and 6 Fr).³¹ Device success was achieved in 91–93%.^30,31 Mean time to hemostasis was 1.3 minutes and mean time to ambulation was 2.6 hours.³⁰ Six of 190 patients (3.2%) developed a hematoma > 6 cm^2,30 and major complications occurred in 2.1%.³¹ The Mynx device leads to rapid hemostasis and ambulation, but additional studies are needed to confirm its safety. The Mynx is indicated for interventional and diagnostic procedures and, in addition to the 6/7 Fr model, a 5 Fr device was recently introduced.

Polyglycolic Acid (PGA) plug device: ExoSeal

The ExoSeal device (Cordis Corporation, Miami Lakes, Florida) delivers a synthetic, bioabsorbable plug to the extravascular space adjacent to the arteriotomy using visual guidance for 6 Fr arteriotomy closure. In a randomized trial of 401 patients (41% interventional) device success was 94%, ambulation occurred in a mean of 2.5 hours and complication rates were not significantly different from MC.³²

FISH

The FISH device (Morris Innovative, Bloomington, In.) is indicated for diagnostic procedures using 5–8 Fr procedural sheaths and uses a bioabsorbable extracellular matrix “patch” made from porcine small intestinal submucosa (SIS). The “patch,” which resembles a roll of wrapping paper, is inserted through the arteriotomy so that it straddles the arterial wall, then a wire is pulled to release the “patch” from the device. Next, a compression suture is pulled, which incorporates the patch firmly in place. In a randomized trial of 297 patients (100% diagnostic, 90% 5–6 Fr), device success was 98%, which did not include the 27 early withdrawals, and mean time to ambulation was 2.4 hours.³³ More data are needed regarding the safety of the FISH device and of concern is that the patch resides on both sides of the vessel wall, meaning a portion of the patch remains intravascular.

Clip device: Starclose

The Starclose device (Abbott Vascular, Redwood City, Calif.) achieves hemostasis with a 4 mm nitinol clip implant (Figure 4).³⁴ The device is inserted into the arterial lumen, then “wings” are deployed such that when the device is withdrawn, the wings are pulled against the arterial wall, indicating proper positioning. The clip is then deployed just outside the arterial wall. The clip grasps the edges of the arteriotomy, drawing them together for closure. The Starclose device is labeled for diagnostic and interventional procedures and for closure of 5–6 Fr arteriotomies, but has been used with 7–8 Fr arteriotomies.

The device success of Starclose is reported as 87%–97% (majority interventional)^34–38 and 91% with 7–8 Fr sheaths.³⁹ For patients treated on an outpatient basis, the median length of stay was 157 minutes.³⁸ Minor complications were observed in 4%,³⁴ 11%,³⁹ and 15%.³⁶ Major complications were reported in 1%,^34,36 2%,^37,38 and 3.5% (7–8 Fr sheaths).³⁹ Persistent oozing at the arteriotomy site was reported in 38% of patients treated with Starclose, which was significantly more than with Angio-Seal (21%; p = 0.001).³⁵ Oozing of blood contributed to a significantly lower rate of successful hemostasis (Starclose 94%, Angio-Seal 99%, MC 100%; p = 0.002).³⁵ In some patients, oozing persisted for over 24 hours.³⁵ At 1 month after the procedure, patients treated with Starclose had less pain at the puncture site than patients treated with MC.³⁵

Complications requiring surgical repair have been reported in up to 1.3% of patients treated with the Starclose device.^34,36,37,39 Case reports involving the Starclose device describe femoral artery laceration,⁴⁰ arterial occlusion due to device capture of the anterior and posterior arterial walls,⁴¹ and high-grade stenosis causing debilitating symptoms 3 weeks after closure.⁴² In conclusion, the Starclose device improves patient comfort and bed rest time, but its utility may be limited in patients receiving anticoagulation because of persistent oozing.

Suture devices: Perclose

Perclose (Abbott Vascular) offers suture-mediated VCDs that have evolved from the Prostar in 1994, to the Techstar, to the Closer, to the Perclose A-T, to the ProGlide. Originally, the Prostar and Techstar featured needles that were deployed within the arterial lumen and directed towards the skin through the arterial wall. The Closer introduced a fundamental change whereby the needles were deployed outside of the artery and directed inward. To operate the ProGlide, the device is inserted over a guidewire until blood return indicates positioning within the lumen (Figure 5). Then, a lever is pulled which deploys “feet” within the arterial lumen. The device is gently pulled back, positioning the feet against the anterior arterial wall. Needle deployment and formation of a suture loop is fully automated by depressing a plunger on the device. As the plunger is depressed, two needles are deployed within the tissue track and directed towards the feet. As the plunger is depressed further, the needles are advanced through the arterial wall and into the feet. The feet capture the needles, creating a suture loop. The device (containing the needles) is then removed, leaving behind the two suture tails. A knot is tied and pushed toward the arteriotomy to achieve hemostasis. The 6 Fr ProGlide is designed for procedures using 5–8 Fr sheaths, whereas the Prostar is used with 8.5–10 Fr sheaths.

The Prostar uses 4 needles (two sutures) directed outward from within the arterial lumen. First, the Prostar is advanced over a guidewire until blood return indicates proper placement, which is confirmed visually (Figure 6). By pulling on the device handle, the needles are deployed and pulled through the arterial wall. The needles remain contained within the device shaft and are removed by pulling them up through the device shaft, leaving behind 4 suture ends (2 sutures). The sutures are tied and pushed toward the arteriotomy and the device is removed.

Using the “pre-closure” technique, the ProGlide can be used to close larger arteriotomies. After placing a 6 Fr sheath and performing a femoral angiogram, the sheath is replaced with the ProGlide, the needles are deployed and the ProGlide is removed, leaving behind only the suture. A larger sheath can then be placed for the procedure, and at the conclusion of the procedure, the suture is tied and pushed toward the arteriotomy for closure.⁴³ Using two ProGlide devices simultaneously with the “pre-closure” technique, successful hemostasis was achieved in 94% of 292 patients undergoing percutaneous endovascular aortic repairs, 64% of which had sheaths 18–24 Fr.⁴⁴

Device success of the Perclose devices is 91–94%.^26,45,46 Of 46 patients that experienced both Techstar and MC, 76% stated they would prefer Techstar and 17% would prefer MC (p < 0.001).47 A cost analysis suggested that Techstar, compared with MC, reduced post-PCI costs by 13% by facilitating earlier discharge.⁴⁷ The meta-analyses discussed below indicate that Perclose devices improve major complication rates in diagnostic procedures compared with MC.^28,29 However, these meta-analyses included older Perclose devices and complication rates have since improved as the device has evolved.⁴⁸

Benefits of VasoSeal, Angio-Seal and Perclose

The VasoSeal, Angio-Seal and Perclose devices each decreased the time to hemostasis, ambulation and discharge compared with MC.⁴⁹ The effects of these VCDs on time parameters in individual reports are influenced by protocol and publication bias, making direct comparisons difficult.⁴⁹ In a meta-analysis of reports comparing MC to the VasoSeal, Angio-Seal and Perclose devices, the VCDs decreased the time to hemostasis by a mean of 17 minutes, decreased bed rest time by a mean of 10.8 hours, and decreased hospital stay by a mean of 0.6 days.⁴⁹

Safety of VasoSeal, Angio-Seal and Perclose

The VasoSeal, Angio-Seal and Perclose devices have been more extensively studied than the other VCDs. Still, most trials were small, underpowered and of poor quality.^29,49 Meta-analyses were performed to improve the statistical power to assess the safety of VCDs (Tables 1 and 2).^28,29,49,50 Each meta-analysis included diagnostic cases, but interventional cases predominated.^28,29,49,50 A meta-analysis of 30 studies comparing VCDs to MC including 37,066 patients found that the incidence of major vascular complications was increased with all VCDs (odds ratio [OR] 1.34; 95% confidence interval [CI] 1.01–1.79) and with VasoSeal (OR 2.27; CI 1.35–3.80).²⁸ No significant difference was observed with either the Angio-Seal or Perclose devices, although when only randomized studies were analyzed, the Angio-Seal device tended to reduce the incidence of major complications in interventional patients (OR 0.46; CI 0.20–1.04; p = 0.062).

A separate meta-analysis of 16 randomized studies with 5,048 patients reported that VCDs decreased the risk of major complications (OR 0.89; CI 0.86–0.91).²⁹ When both diagnostic and interventional cases were considered, Perclose and Angio-Seal significantly decreased the incidence of major complications, whereas VasoSeal significantly increased the risk. In interventional cases, the risk of major complications was not affected by Perclose (OR 1.0; CI 0.13–7.48), was reduced with Angio-Seal (OR 0.51; CI 0.45–0.58), and was increased with VasoSeal (OR 1.18; CI 1.16–1.20).²⁹

A registry including 214 institutions and 166,680 patients (113,025 MC; 25,495 suture device; 28,160 collagen plug device) (Tables 1 and 2) reported that the incidence of any vascular complication was decreased with VCDs compared with MC in diagnostic cases and in all cases (OR 0.83), but showed no significant effect in interventional cases.⁵ Even though the 3 articles listed in Table 1 reported inconsistent results, the evidence suggests that the rate of major complications is increased by VasoSeal, reduced by Angio-Seal, and reduced by Perclose in diagnostic cases, while Perclose has little influence on complication rates in interventional cases.

The inconsistent results reported by the registry and meta-analyses may reflect the relative proportions within each report of each VCD, of interventional procedures, of various biases, and of the degree of anticoagulation. In particular, in many nonrandomized studies, the MC group had a significantly higher incidence of risk factors for vascular complications. In the registry described above,⁵ the MC group had significantly greater risk factors, though the difference in vascular complication rates remained highly significant (p = 0.0004) after controlling for numerous variables. The authors pointed out, however, that unmeasured factors could have influenced the results.⁵ For instance, VCDs may have been avoided if vessel wall injury was apparent or if a femoral angiogram demonstrated high risk. Despite these limitations, the registry results reflect the incidences of vascular complications in the “real world” and indicate that, with appropriate patient selection, VCDs are associated with a low risk for vascular complications.

The results of the meta-analyses differ from those of the individual, underpowered studies, which almost uniformly concluded that the safety of the VCD studied was equivalent to or noninferior to MC.²⁹ For example, both the Duett and VasoSeal devices, each of which is no longer in use, were reported to be “safe and effective” in small, underpowered studies;^18,51–54 however, the Duett device increased the risk of acute leg ischemia,⁵⁵ and meta-analyses concluded that VasoSeal increased the risk of major vascular complications.^28,29 This underscores the importance of adequate statistical power when evaluating safety and suggests that the safety of the newer VCDs remains unclear without more robust evidence. Furthermore, safety cannot be inferred by assuming a “class effect.” Angio-Seal and VasoSeal are both collagen plug devices, but Angio-Seal decreases the risk of major vascular complications where VasoSeal increases the risk.^28,29

Risks of Individual Vascular Complications in Relation to VCDs

Two meta-analyses of randomized trials compared the incidence of individual complications in patients treated with MC versus VCDs (Table 2).^49,50 Bleeding is the most common vascular complication related to endovascular procedures, comprising ~70% of all complications, followed by pseudoaneurysm (~20%).⁵ In meta-analyses, VCDs tended to increase the incidence of local bleeding and did not appear to significantly influence hematoma, pseudoaneurysm or arteriovenous fistula formation.^49,50 When analyzing only trials that reported an intention-to-treat approach, the risk of hematoma was higher (relative risk [RR] 1.89) and the risk of pseudoaneurysm was higher (RR 5.40) with VCDs.⁴⁹ VCDs increased the risk of groin infection and tended to increase the risk of leg ischemia and a complication requiring surgical repair.^49,50

A registry including 1,522,935 patients who underwent percutaneous coronary intervention at 955 hospitals between 2004 and 2008 analyzed bleeding complications, which occurred in 30,654 patients (2%).⁶ With similar baseline characteristics, patients who received a VCD (363,769) were less likely to suffer from bleeding complications compared with patients treated with MC (529,247) (2.1% vs. 2.8%, p < 0.001; OR 0.77, 95% CI 0.73-0.80). Not surprisingly, with increased baseline bleeding risk, the use of MC increased and the use of VCDs decreased. Interestingly, however, the benefit of VCDs in decreasing the risk of bleeding was apparent in patients with intermediate (OR 0.76) and high bleeding risk (OR 0.79), but not with low bleeding risk (OR 1.07). This suggests that patients with high baseline bleeding risk are most likely to benefit from VCDs. But, these results should be interpreted with caution. Two meta-analyses of randomized trials^49,50 concluded that VCDs increase the risk of bleeding, yet two large registries^5,6 concluded that VCDs decrease the risk of bleeding. Bleeding risk was increased somewhat in the two meta-analyses, because of the inclusion of VasoSeal and older device models. The influence of unmeasured factors in uncontrolled registries likely favored the use of MC in patients at high risk for bleeding due to puncture site-related factors observed during femoral angiography. All things considered, in the absence of puncture site risk factors, VCDs can be deployed safely. Patients with a high risk of bleeding related to clinical factors may benefit from a VCD in the absence of puncture site risk factors.

Vascular Closure Device-Related Complications

VCDs can cause leg ischemia and groin infections which rarely occur with MC.^7,8 In a retrospective analysis (VasoSeal 937, Angio-Seal 742, Techstar 1,001, MC 1,019 patients, respectively), infections occurred in 0.3–0.4% of all VCD patients and in none of the MC patients.⁸ Complications requiring surgical repair occur slightly more frequently with VCDs compared with MC.^{8,49,50,56,57} An analysis was done of all patients requiring surgical intervention following complications from percutaneous vascular access (hemostasis originally achieved with VCDs in 18 patients and with MC in 41 patients).⁵⁶ The indications for surgery in the MC patients were primarily pseudoaneurysm (71%), hemorrhage (32%) and arterial venous fistula (15%), all of which tended to occur more often with MC compared with VCDs. Infectious complications (5%) and limb ischemia (7%) were infrequent indications for surgery following MC, but were significantly more common in the VCD patients that required surgery (infectious in 39%, ischemia in 28%). More complex surgical procedures were required for VCD patients, such as interposition of bypass grafts.⁵⁶ VCDs can cause severe complications related to device misuse or malfunction. Although the risks of severe complications are low and probably decreasing as operators gain experience, patients should be examined diligently for complications after the use of a VCD, and VCDs should be avoided in patients with puncture site-related risk factors.

Minimizing the Risk for Vascular Access-Site Complications

The benefit of VCDs is reduced if early ambulation is not desired, so MC should be considered for such patients. For infection control during cardiac catheterization, the Society for Cardiovascular Angiography and Interventions and Centers for Disease Control recommend use of aseptic technique, including a cap, mask, sterile gown, sterile gloves, and a large sterile sheet.⁵⁸ Also, antibiotic coverage is recommended for patients with diabetes receiving a VCD.⁵⁸

Although supporting evidence is not available, pre-procedure fluoroscopy and ultrasound imaging have been advocated to reduce the risk of inaccurate sheath insertion and vascular complications, with expected benefits in the small percentage of patients with unusual anatomy.⁵⁹ Nine hundred seventy-two (972) patients undergoing cardiac catheterization via a femoral approach were randomized to fluoroscopic guidance or anatomic landmark guidance for vascular access.⁶⁰ There was no difference in deemed suitability for VCD placement (79.5% vs. 80.7%; p = 0.7), the study was not powered to detect a significant difference in vascular complication rate (2.1% vs. 2.8%; p = 0.48), and results suggested a benefit with routine fluoroscopy in obese patients and females.⁶⁰ Femoral angiography should be performed before using an active VCD to confirm that the arteriotomy is in the common femoral artery, superior to the femoral artery bifurcation, inferior to the inferior epigastric artery, and to confirm the absence of peripheral arterial disease and in particular, vascular calcification at the access site.⁴ Device failure independently predicts vascular complications,²⁶ so when VCD placement is challenging or high-risk features are present, VCDs should be avoided.

Numerous predictors of vascular complications have been identified (Table 3). The clinical factors associated with the greatest risk for vascular complications include female gender, advanced age (≥ 70 years), and low body surface area (< 1.6 m2) (Figure 7).³ Patients undergoing more complex, interventional procedures are also more likely to be under full anticoagulation and are more likely to suffer bleeding complications. In most nonrandomized comparisons and registries, patients treated with VCDs had fewer risk factors than patients treated with MC, reflecting operator preference to avoid VCDs in high-risk patients. Furthermore, most randomized trials excluded high-risk patients altogether. Active VCDs carry numerous cautions and warnings for restricted use, including non-common femoral sheath location, small femoral artery size (< 4 mm), bleeding diathesis, morbid obesity, inflammatory disease, uncontrolled hypertension, and significant peripheral vascular disease.⁴ The safety and efficacy of VCDs in high-risk patients is unknown.

Use of active VCDs is cautioned against in the presence of peripheral vascular disease, because of higher complication rates.⁴ Also, VCDs can reduce the ankle brachial index. Mean ankle brachial index decreased by 0.05 in 214 patients treated with Angio-Seal and by 0.06 in 152 patients treated with Perclose.⁶¹ Moreover, 11% of patients experienced a decrease in ankle brachial index of > 0.15.⁶¹ Even the Starclose device, which achieves hemostasis with an extravascular clip, led to a decrease in ankle-brachial index of > 0.10 in 27 of 232 patients (11%) at 1 month after the procedure.³⁸

Operator Experience/Learning Curve

Operator experience with various VCDs provides insight that may not be apparent in clinical trials (Table 4). The Angio-Seal device is easy to use and has high technical success. The Starclose device is also simple to use, but since oozing occurs frequently, the Starclose device is better suited for diagnostic procedures than interventional procedures with full anticoagulation. The Boomerang device can be used in the presence of peripheral vascular disease and is preferred by many vascular surgeons, because nothing is left behind in the artery. With Perclose, access to the artery is maintained (guide wire remains in place), even with device failure, and complications generally become evident immediately, as opposed to delayed complications that may occur with other VCDs. The Perclose devices allow for repeat vascular access immediately (this has not been studied), whereas the same site cannot be accessed for several weeks or months following deployment of collagen plug devices. However, in 181 patients previously treated with an Angio-Seal device, repeat access in the same artery in < 90 days was effective without major vascular complications (3 large hematomas, 1.7%).⁶² The Prostar and ProGlide, using the “pre-close” technique, are the only active VCD commonly used to close arteriotomies larger than 8 Fr; the ProGlide is preferred by many cardiologists, whereas many surgeons favor the Prostar. Using a “double wire” technique, the Angio-Seal has been used successfully to close 10 Fr arteriotomies.²⁵

Conclusion

MC remains the gold standard for achieving hemostasis at a vascular access site. The FemoStop and ClampEase have high success rates in achieving hemostasis and can be used safely in most patients. Other than the FemoStop and ClampEase, VCDs improve patient comfort. All active VCDs shorten the time to hemostasis and ambulation to a relatively similar degree. The incidence of major complications is increased by VasoSeal, reduced by Angio-Seal, and reduced by Perclose in diagnostic cases. The safety of VCDs cannot be assumed due to “class effect” and nearly all individual trials are underpowered to detect differences in complication rates, so the safety of other individual VCDs is unclear. In the absence of puncture site-related risk factors, VCDs as a whole appear to have little influence on complication rates and patients at high baseline risk for bleeding due to clinical factors may benefit from VCDs. VCDs increase the risk of leg ischemia, groin infection, and complications requiring surgical repair, which are rare with MC. Screening with femoral angiography prior to VCD placement and avoidance of VCDs in the presence of puncture site-related risk factors might reduce the risk of vascular complications.

The authors can be contacted at bschwartz15@hotmail.com.  

References

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Reprinted with permission from J Invasive Cardiol 2010 Dec;22:599–607.
Disclosures: S. Burstein: honoraria – Abbott Vascular; D. Shavelle: Grants pending – Abbott Vascular; payment for development of educational presentations including service on speakers bureaus – Abbott Vascular; G. Mayeda: consultancy – Abbott Vascular, AccessClosure; payment for development of educational presentations including service on speakers bureaus – Abbott Vascular.