Article

Management of Haemostasis with Combined Use of Vascular Closure Devices and Bivalirudin - A Review

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Abstract

Bleeding and vascular complications related to invasive cardiovascular procedures are associated with significant morbidity and mortality. The aim of this article is to evaluate the literature to determine haemostasis strategies in percutaneous coronary intervention when using bivalirudin with or without a vascular closure device. The literature data seem to underline that the combination of vascular closure devices and bivalirudin was associated with significantly lower bleeding rates. However, these strategies were less often used among high-risk patients. We recommend that prospective clinical studies are undertaken to determine the potential disadvantages of using vascular closure devices and bivalirudin in combination in high-risk patients.

Disclosure:The authors have no conflicts of interest to declare.

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Correspondence Details:Emanuela de Cillis, Dipartimento Emergenza e Trapianti d'Organo Sezione di Cardiochirurgia, Piazza Giulio Cesare 11, 70124 Bari, Italy. E: e.decillis@cardiochir.uniba.it

Copyright Statement:

The copyright in this work belongs to Radcliffe Medical Media. Only articles clearly marked with the CC BY-NC logo are published with the Creative Commons by Attribution Licence. The CC BY-NC option was not available for Radcliffe journals before 1 January 2019. Articles marked ‘Open Access’ but not marked ‘CC BY-NC’ are made freely accessible at the time of publication but are subject to standard copyright law regarding reproduction and distribution. Permission is required for reuse of this content.

Bleeding and vascular complications related to invasive cardiovascular procedures are associated with significant morbidity and mortality. Indeed, the most common complications resulting from cardiac catheterisation are vascular-related, including external bleeding at the arterial puncture site, ecchymosis, retroperitoneal haematoma and pseudoaneurysms. As guidelines recommend that the patient should be given anticoagulant medications to lower the risk of developing an arterial blood clot (thrombosis) or of blood clots forming and travelling through the body (embolisation), such therapy increases the risk of post-percutaneous coronary intervention (PCI) bleeding. The association between the use of bleeding avoidance strategies and post-PCI bleeding as a function of a patient’s pre-procedural risk of bleeding is unknown. If use of a vascular closure device is to be considered as a part of the bleeding avoidance strategy, it should be noted that, while the use of an intraprocedural VCD has been shown to significantly reduce haemostasis and ambulation times after diagnostic coronary, angiography and percutaneous coronary intervention, there are conflicting data on whether use of a VCD increases or decreases the risk of access-site bleeding (ASB).1

Bivalirudin Versus Heparin

Among the current agents in the class of direct thrombin inhibitors, bivalirudin (Angiomax®, The Medicines Company, NJ, USA) has seen increased use in cardiovascular medicine over the past decade through its primary indication as an anticoagulant used during PCI. Bivalirudin has been further investigated and used as the anticoagulation strategy in the setting of cardiac and endovascular surgical procedures and is frequently used in the management of patients with heparin-induced thrombocytopenia. In comparison with heparin, bivalirudin exhibits a low immunogenic profile and provides similar or reduced major bleeding rates as well as a predictable degree of anticoagulation that is dose-related. Bivalirudin primarily undergoes dual elimination via proteolytic cleavage and renal elimination, and thus requires dose adjustment in the setting of severe renal dysfunction. Given the body of supportive data, bivalirudin is likely to continue to figure prominently as a reliable and efficient anticoagulation strategy.2

Four randomised controlled trials3 were identified that compared bivalirudin with heparin (with or without glycoprotein GP IIb/IIIa inhibitors [GPI]) in PCI. The incidence of death, myocardial infarction (MI), revascularisation and major bleeding at 48 hours was compared between these two agents overall and in patients with and without diabetes, hypertension, renal insufficiency and advanced age. The trials consisted of 11,638 patients (bivalirudin 5,861; heparin 5,777). There were no significant differences in patient characteristics between the two groups. At 48 hours, the incidence of death, MI, revascularisation and major bleeding was significantly reduced in the bivalirudin group (7.8 versus 1.08 %; p<0.001); individual ischaemic endpoints were significantly reduced for death (0.01 versus 0.02 %; p=0.049) and revascularisation (2.0 versus 2.7 %; p=0.02), with a similar reduction for major bleeding (2.7 versus 5.8 %; p<0.001). In a recent prospective PCI cohort study,4 bivalirudin was associated with reduced major and minor bleeding without a significant increase in hospital costs compared with other anticoagulation regimens. This analysis further supports the superiority of bivalirudin compared with heparin. Bivalirudin therefore provides excellent ischaemic protection with a significant reduction of bleeding complications, even in high-risk subgroups.

Overview of Vascular Closure Devices

VCDs are medical devices used to achieve haemostasis of the small hole in the artery resulting from a cardiovascular procedure or after an endovascular surgery requiring a catheterisation. During such procedures, a small incision is made in the groin area and a hole is created in the femoral artery to gain access to the artery. This hole is referred to as the access site or puncture site. On completion of the procedure, this hole needs to be closed. If appropriate care is taken with the initial arterial puncture, the chances of achieving an excellent arterial closure will be increased. Before the development of VCDs, the main method for closing the femoral artery was the application of manual compression; this involved up to 30 minutes of manual pressure or mechanical clamps applied directly to the patient’s groin, which was very painful. This was followed by up to eight hours of bed rest in the hospital recovery room. VCDs were introduced in the early 1990s in an effort to reduce the time to haemostasis, enable early ambulation and improve patient comfort. Initially, devices focused on technologies involving a suture or a collagen plug. While these technologies are effective at closing the hole, they often leave an intravascular component in the artery, which can cause complications. In addition, these technologies failed to completely address patient pain.

More recent methods to close the hole involve the use of novel materials that dissolve over a short period of time, such as polyethylene glycol.4 These technologies incorporate a more gentle deployment of the material to the outside of the artery and avoid the use of intravascular components, leaving nothing behind in the artery and consequently improving patient comfort.5

In general, VCDs can be categorised as either active closure devices (ACDs) (including immediate closure with suture devices, clips and collagen plug devices; see Table 1), passive closure devices (including devices that help with compression, such as clamps/tamping devices, assisted or enhanced coagulation and sealants; see Table 2) or hybrid devices (see Table 3). These VCDs may have a gradient of risk for vascular complications based on their respective mechanisms of action. Although small studies have identified differing rates of vascular complications for specific devices, there are no definitive data across a wide spectrum of patients.

Randomised Clinical Studies in Active Closure Devices Collagen-mediated Devices

The Vasoseal® device (Datascope Corp, Montvale, NJ, US) was one of the first ACDs developed. It was originally studied in a cohort of 100 patients undergoing diagnostic or interventional catheterisation procedures and randomised to the device or to conventional pressure dressing.6 Use of the Vasoseal resulted in a shorter compression time (4 versus 42 minutes; p<0.001) and faster ambulation (6 versus 22 hours; p<0.001) and demonstrated a trend towards a reduction in bleeding rates.6–8 The efficacy of the Vasoseal was subsequently confirmed in other randomised studies,9,10 although other trials showed small increases in access-site complications or failed to demonstrate superiority over mechanical compression during PCI.11,12 This device is no longer marketed because of findings from subsequent observational studies and inconsistency in haemostasis performance.

Angio-Seal™ (St Jude Medical, St Paul, MN, US) is among the most widely used ACDs. One of its earliest and largest randomised studies was a multicentre trial of 435 patients undergoing cardiac catheterisation and angioplasty procedures who were randomised (1:1) to the device or to manual compression.13 Angio-Seal achieved faster haemostasis (2.5 versus 15.3 minutes; p<0.0001) and lower rates of bleeding, haematoma or any complication.

A more contemporary randomised study was conducted by Chevalier and colleagues,14 who enrolled 612 moderate- to high-risk patients undergoing PCI and demonstrated faster haemostasis (5 versus 52 minutes p<0.001), reduced bed-rest time (438 versus 952 minutes; p<0.001) and reduced complication rates (6 versus 18 %; p<0.001) with Angio-Seal compared with manual compression. Although these effects of Angio-Seal were confirmed by others,15 one study still favoured mechanical compression with the FemoStop® device (St Jude Medical, St Paul, MN, US) over Angio-Seal.16

Suture-mediated Devices

Perclose® (Abbott Vascular, Redwood City, CA, US) was the first suture-mediated ACD. One of its early studies, conducted by Gerckens et al.,17 randomised 600 patients to the device or to manual compression and demonstrated faster haemostasis (8 versus 13 minutes; p<0.0001) and faster ambulation (5 versus 18 hours; p<0.0001) with Perclose use. In this particular study, Perclose was associated with comparable rates of vascular complications to those observed with manual compression in all patient populations but with lower rates in patients undergoing diagnostic procedures. The safety and efficacy of Perclose were subsequently supported by the results of other randomised studies.18,19

Clip-/Staple-mediated Devices

The StarClose™ Vascular Closure System (Abbott Vascular, Redwood City, CA, US) was the first clip-mediated ACD and uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy closing. Its pivotal study was the Clip closure in percutaneous procedures (CLIP) study, a prospective, randomised (2:1) multicentre trial that compared the safety and efficacy of StarClose with that of manual compression. A total of 596 subjects were enrolled, of whom 208 underwent diagnostic angiography only. In the latter population subset, no differences in the rates of major and minor vascular complications were observed between the two strategies.20 StarClose also reduced the mean time to haemostasis (15.5 versus 1.5 minutes; p<0.001) and time to ambulation (269 versus 163 minutes; p<0.001) and was deployed successfully in 94 % of patients. The remaining CLIP study findings were subsequently demonstrated in the interventional population subset (n=275), in which no differences in the rates of major vascular complications or infections and a trend towards a lower rate of minor complications were observed with StarClose.21

An ultrasound substudy from CLIP also confirmed these findings with StarClose.22 In a recent randomised trial of patients undergoing diagnostic and interventional procedures, StarClose and Angio-Seal were found to have similar rates of haemostasis (69 %), with some increased bruising with Angio-Seal.23

Evidence for Passive Closure Devices

Passive closure devices include devices such as clamps for assisted compression and newer technologies, such as coagulant patches and sealants. Clinical studies examining these devices are limited.

The FemoStop femoral compression system has been studied primarily as part of the control arm for clinical studies on haemostasis after endovascular procedures.24 Single-centre observational studies25,26 and a small randomised study27 found similar or reduced rates of vascular complications with FemoStop compared with manual pressure in patients undergoing interventional procedures. By contrast, a randomised study of 212 patients found FemoStop use to have a higher rate of vascular complications than manual compression.28

The Boomerang™ assisted compression system (Cardiva Medical, Inc., Mountain View, CA, US) has been studied in 96 consecutive patients undergoing diagnostic cardiac catheterisation, with successful deployment in 99 % of patients without any major complications in the study cohort.29 The D-Stat dry patch™ (Vascular Solutions, Minneapolis, MN, US) was compared with manual compression in a multicentre randomised trial of 376 patients undergoing diagnostic or peripheral angiography.30 Although time to ambulation was slightly shorter (392 versus 415 minutes; p=0.02), there were no differences in time to discharge or vascular complications. In a large, single-centr observational study, a retrospective analysis found the D-Stat patch with facilitated manual compression to be associated with earlier time to ambulation and similar vascular complication rates as standard manual compression.31 However, in a randomised trial (n=852) comparing D-Stat with Angio-Seal and Perclose in patients undergoing diagnostic or interventional procedures, the D-Stat was associated with a statistically higher rate of vascular complications than the ACDs (7.1 versus 1.9 %; p<0.0001).32

Other patch and sealant systems have even less available data. The Mynx™ water-soluble sealant system (AccessClosure Inc., Mountain View, CA, US) was studied in a multicentre single-arm study of 190 consecutive patients undergoing diagnostic and interventional procedures (5F to 7F).33 The device was found to have a major complication rate of 0.5 % in this low- to intermediate-risk population. A randomised study using the procoagulant pads Chito-Seal (Abbott Vascular, Redwood City, CA, US) and the Clo-Sur P.A.D.™ (Medtronic Vascular, Santa Rosa, CA, US) compared with manual compression for patients undergoing PCI found only a slightly reduced time to haemostasis with procoagulant pad use without an effect on overall bed-rest time or vascular complications. The Syvek Patch® (Marine Polymer Technologies, Inc., Danvers, MA, US) has been examined in a single-centre study of 1,000 consecutive patients undergoing diagnostic and interventional catheterisation and electrophysiological procedures, with minimal clinical complications.34

Overall, the evidence for passive closure devices varies significantly across device types, with the majority of studies characterised as observational studies or small randomised controlled trials in limited-risk populations.

The literature search yielded 31 prospective, randomised studies including 7,528 patients who were randomised to VCDs or manual/mechanical compression after diagnostic angiography and/or endovascular procedures. Most of these studies have excluded patients at high risk of puncture-site complication.35 Meta-analysis showed similar results in the study groups in terms of groin haematoma, bleeding, pseudoaneurysm and blood transfusion. Lower-limb ischaemia and other arterial ischaemic complications (arterial stenosis/device entrapment in the artery: 0.3 versus 0 %; p=0.07) as well as need for surgery for vascular complications (0.7 versus 0.4 %; p=0.10) were more frequent with VCDs. The incidence of groin infection was significantly more frequent with VCDs (0.6 versus 0.2 %; p=0.02).36 The use of VCDs was uniformly associated with a significantly shorter time to haemostasis. Such differences in complication rates were more evident in patients undergoing PCI, whereas use of VCD was associated with similar rates of adverse events among patients undergoing diagnostic coronary angiography.37 A large number of studies have been performed to evaluate the safety and efficacy of several types of VCDs, the results of which have encouraged their widespread use. However, a few years ago, meta-analyses on this topic failed to show a real advantage with the use of these devices.38

Of particular concern is the perceived increased risk of developing severe complications at the puncture site. Despite this, a significant number of studies have been carried out and, more recently, several prospective, randomised studies have been performed to evaluate the superiority of one device over another without any control group.39–41 Further studies are needed to obtain more conclusive results, particularly in patients at high risk of femoral-puncture-related complications (patients at the highest risk of vascular complications include but are not limited to those with known peripheral arterial disease, advanced age, female sex, liver disease, coagulopathy, immunosuppression, following valve replacement and renal dysfunction). High-risk clinical indications include emergent procedures such as primary percutaneous intervention for acute MI, prolonged multivessel intervention or procedures that require larger sheath sizes (>8F). In fact, the real challenge is in endovascular procedures currently addressed by the Preclose technique.

Bivalirudin Use – Are Closure Devices Necessary?

Marso et al.42 analysed bleeding rates after PCI procedures associated with the use of manual compression, VCDs, bivalirudin or both strategies (VCD plus bivalirudin) in patients across a spectrum of pre-procedural bleeding risk. The analysis included data from 1,522,935 patients undergoing PCI procedures performed at 955 US hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry from January 2004 to September 2008.

Overall, bleeding occurred in 30,429 patients (2 %). Manual compression was used in 35 % of patients, VCDs in 24 %, bivalirudin in 23 % and VCD plus bivalirudin in 18 %. Bleeding events were reported in 2.8 % of patients who received manual compression compared with 2.1 % of those receiving VCDs, 1.6 % of those receiving bivalirudin only and 0.9 % of those receiving both strategies. According to the NCDR CathPCI bleeding risk model, bleeding risk was classified as low (less than 1 %) in 31 % of patients, intermediate (1–3 %) in 49 % and high (greater than 3 %) in 20 % of patients. Observed rates of bleeding in these categories were 0.72, 1.73 and 4.69 %, respectively.

In high-risk patients, use of both strategies was associated with lower bleeding rates (manual compression 6.1 %; VCDs 4.6 %; bivalirudin 3.8 %; VCD plus bivalirudin 2.3 %). Use of both strategies was selected least often in high-risk patients (14.4 % compared with 21.0 % in low-risk patients). The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies but also to determine the need to test interventions to overcome the risk-treatment paradox, such as enabling physicians to purposefully direct bleeding avoidance strategies to patients by providing pre-procedural estimates of post-PCI bleeding.

The Acute catheterization and urgent intervention triage strategy (ACUITY)43 demonstrated that bivalirudin monotherapy significantly reduces major bleeding compared with heparin (unfractionated or enoxaparin) or bivalirudin plus a GPI in acute coronary syndromes (ACS). This study sought to determine whether VCD use impacts major ASB in patients with ACS undergoing early invasive management by the femoral approach. Between 23 August 2003 and 5 December 2005, 13,819 patients with ACS were enrolled at 450 academic and community-based centres in 17 countries and randomised to heparin (unfractionated or enoxaparin) plus GPI, bivalirudin plus GPI or bivalirudin monotherapy. Access site information was collected only for the first coronary angiography procedure. Patients undergoing deferred PCI, in whom a different access site was potentially used, were therefore excluded from the analysis (n=28), as were patients with brachial access (n=90), radial access (n=798) or those whose records lacked access-site (n=914) or VCD use (n=368) information. After excluding these patients, the study population consisted of 11,621 patients who underwent coronary angiography with or without PCI by the femoral approach. Of the 11,621 patients in the study population, 4,307 (37.1 %) received a VCD (2,971 AngioSeal, 1,113 Perclose, 109 VasoSeal, 33 Duett and 81 other or unknown) and 7,314 (62.9 %) did not. Patients who received a VCD were generally a lowerrisk population compared with those who did not; they were younger in age and had lower rates of diabetes, hypertension, anaemia, baseline renal insufficiency prior MI and prior coronary artery bypass graft. Furthermore, patients who received a VCD were less likely to have elevated biomarkers at baseline. The ACUITY trial demonstrated that, compared with antithrombin regimens containing a GPI, bivalirudin monotherapy significantly reduces major and minor bleeding complications, including ASB, without increasing ischaemic complications in patients with moderate- and high-risk ACS managed with an early invasive strategy. Furthermore, the rates of major femoral ASB were significantly lower with VCD use compared with manual compression and with bivalirudin monotherapy compared with GPI-containing antithrombin regimens, regardless of VCD usage. Major ASB rates were lowest (<1 %) in patients who received both a VCD and bivalirudin monotherapy. These results suggest that the combined use of bivalirudin and a VCD may reduce major ASB in patients with ACS managed with an early invasive strategy from the femoral approach. As this trial examined only major ASB and did not consider other vascular complications such as pseudoaneurysm, arteriovenous fistula and limb ischaemia, it is important to consider the relative occurrence of these with and without the use of VCD when determining whether to use a VCD.

Conclusion and Outlook

Use of a VCD plus bivalirudin is associated with significantly lower bleeding rates. However, this strategy has been less often used among higher-risk patients. We recommend that prospective clinical studies are undertaken to determine the potential disadvantages of using VCDs and bivalirudin in combination in high-risk patients.

References

  1. Stone GW, Bertrand M, Colombo A, et al., Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial: study design and rationale, Am Heart J, 2004;148:764–75.
    Crossref | PubMed
  2. Stone GW, McLaurin BT, Cox DA, et al.; for the ACUITY Investigators, Bivalirudin for patients with acute coronary syndromes, N Engl J Med, 2006;355:2203–16.
    Crossref | PubMed
  3. Ebrahimi R, Lincoff AM, Bittl JA, et al., Bivalirudin vs heparin in percutaneous coronary intervention: a pooled analysis, J Cardiovasc Pharmacol Ther, 2005;10:209–16.
    Crossref | PubMed
  4. Hona LQ, Ganeshanb A, Thomasc SM, et al., An overview of vascular closure devices: what every radiologist should know, Eur J Radiology, 2010;73:181–90.
    Crossref | PubMed
  5. Lindsey JB, Cohen DJ, Stolker JM, et al., The impact of bivalirudin on percutaneous coronary intervention-related bleeding, EuroIntervention, 2010;6:206–13.
    Crossref | PubMed
  6. Schräder R, Steinbacher S, Burger W, et al., Collagen application for sealing of arterial puncture sites in comparison to pressure dressing: a randomized trial, Cathet Cardiovasc Diagn, 1992;27:298–302.
    Crossref | PubMed
  7. Ansel G, Yakubov S, Neilsen C, et al., Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study, Catheter Cardiovasc Interv, 2006;67:546–53.
    Crossref | PubMed
  8. Slaughter PM, Chetty R, Flintoft VF, et al., A single center randomized trial assessing use of a vascular hemostasis device vs. conventional manual compression following PTCA: what are the potential resource savings?, Cathet Cardiovasc Diagn, 1995;34:210–4.
    Crossref | PubMed
  9. Sanborn TA, Gibbs HH, Brinker JA, et al., A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty, J Am Coll Cardiol, 1993;22:1273–9.
    Crossref | PubMed
  10. Silber S, Björvik A, Mühling H, Rösch A, Usefulness of collagen plugging with VasoSeal after PTCA as compared to manual compression with identical sheath dwell times, Cathet Cardiovasc Diagn, 1998;43:421–7.
    Crossref | PubMed
  11. Camenzind E, Grossholz M, Urban P, et al., Collagen application versus manual compression: a prospective randomized trial for arterial puncture site closure after coronary angioplasty, J Am Coll Cardiol, 1994;24:655–62.
    Crossref | PubMed
  12. Von Hoch F, Neumann FJ, Theiss W, et al., Efficacy and safety of collagen implants for haemostasis of the vascular access site after coronary balloon angioplasty and coronary stent implantation: a randomized study, Eur Heart J, 1995;16:640–6.
    PubMed
  13. Kussmaul WG 3rd, Buchbinder M, Whitlow PL, et al., Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device, J Am Coll Cardiol, 1995;25:1685–92.
    Crossref | PubMed
  14. Chevalier B, Lancelin B, Koning R, et al.; HEMOSTASE Trial Investigators, Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial, Catheter Cardiovasc Interv, 2003;58:285–91.
    Crossref | PubMed
  15. Ward SR, Casale P, Raymond R, et al.; Angio-Seal Investigators, Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography, Am J Cardiol, 1998;81:569–72.
    Crossref | PubMed
  16. Amin FR, Yousufuddin M, Stables R, et al., Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the Angio-Seal device vs. the FemoStop device, Int J Cardiol, 2000;76:235–40.
    Crossref | PubMed
  17. Gerckens U, Cattelaens N, Lampe EG, Grube E, Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device, Am J Cardiol, 1999;83:1658–63.
    Crossref | PubMed
  18. Nasu K, Tsuchikane E, Sumitsuji S; PARADISE Investigators, Clinical effectiveness of the Prostar XL suture-mediated percutaneous vascular closure device following PCI: results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) Trial, J Invasive Cardiol, 2003;15:251–6.
    PubMed
  19. Noguchi T, Miyazaki S, Yasuda S, et al., A randomised controlled trial of Prostar Plus for haemostasis in patients after coronary angioplasty, Eur J Vasc Endovasc Surg, 2000;19:451–5.
    Crossref | PubMed
  20. Hermiller J, Simonton C, Hinohara T, et al., Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization, J Invasive Cardiol, 2005;17:504–10.
    PubMed
  21. Hermiller JB, Simonton C, Hinohara T, et al., The StarClose Vascular Closure System: interventional results from the CLIP study, Catheter Cardiovasc Interv, 2006;68:677–83.
    Crossref | PubMed
  22. Jaff MR, Hadley G, Hermiller JB, et al., The safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study, Catheter Cardiovasc Interv, 2006;68:684–9.
    Crossref | PubMed
  23. Veasey RA, Large JK, Silberbauer J, et al., A randomised controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital: the SCOAST study, Int J Clin Pract, 2008;62:912–8.
    Crossref | PubMed
  24. Korngold EC, Inglessis I, Garasic JM, A novel technique for 14 French arteriotomy closure after percutaneous aortic valvuloplasty using two Mynx closure devices, J Interv Cardiol, 2009;22:179–83.
    Crossref | PubMed
  25. Sridhar K, Fischman D, Goldberg S, et al., Peripheral vascular complications after intracoronary stent placement: prevention by use of a pneumatic vascular compression device, Cathet Cardiovasc Diagn, 1996;39:224–9.
    Crossref | PubMed
  26. Jaspers L, Benit E, Immediate sheath removal after PCI using a Femostop is feasible and safe: results of a registry, Acta Cardiol, 2003;58:535–7.
    Crossref | PubMed
  27. Rudisill PT, Williams LB, Craig S, Schopp P, Study of mechanical versus manual/mechanical compression following various interventional cardiology procedures, J Cardiovasc Nurs, 1997;11:15–21.
    Crossref | PubMed
  28. Walker SB, Cleary S, Higgins M, Comparison of the FemoStop device and manual pressure in reducing groin puncture site complications following coronary angioplasty and coronary stent placement, Int J Nurs Pract, 2001;7:366–75.
    Crossref | PubMed
  29. Doyle BJ, Godfrey MJ, Lennon RJ, et al., Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization, Catheter Cardiovasc Interv, 2007;69:203–8.
    Crossref | PubMed
  30. Hallak OK, Cubeddu RJ, Griffith RA, Reyes BJ, The use of the D-STAT dry bandage for the control of vascular access site bleeding: a multicenter experience in 376 patients, Cardiovasc Intervent Radiol, 2007;30:593–600.
    Crossref | PubMed
  31. Applegate RJ, Sacrinty MT, Kutcher MA, et al., Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention using thrombin hemostatic patch-facilitated manual compression, J Invasive Cardiol, 2007;19:164–70.
    PubMed
  32. Nguyen N, Hasan S, Caufield L, et al., Randomized controlled trial of topical hemostasis pad use for achieving vascular hemostasis following percutaneous coronary intervention, Catheter Cardiovasc Interv, 2007;69:801–7.
    Crossref | PubMed
  33. Scheinert D, Sievert H, Turco MA, et al., The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx, Catheter Cardiovasc Interv 2007;70:627–33. Erratum: Catheter Cardiovasc Interv, 2008;71:129.
    Crossref | PubMed
  34. Nader RG, Garcia JC, Drushal K, Pesek T, Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures, J Invasive Cardiol, 2002;14:305–7.
    PubMed
  35. Vaitkus P, A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention, J Invasive Cardiol, 2004;16:243–6.
    PubMed
  36. Biancari F, D’Andrea V, Di Marco C, et al., Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty, Am Heart J, 2010;159:518–31.
    Crossref | PubMed
  37. Vaiktus PT, A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention, J Invasive Cardiol, 2004;16:243–6.
    PubMed
  38. Koreny M, Riedmuller E, Nikfardjam M, et al., Arterial puncture closing devices compared with standard manual catheterization. Systematic review and meta-analysis, JAMA, 2004;291:350–7.
    Crossref | PubMed
  39. Biancari F, Ylönen K, Mosorin M, et al., Lower limb complications after the use of arterial puncture closure devices, Eur J Vasc Endovasc Surg, 2006;32:504–5.
    Crossref | PubMed
  40. Shammas NW, Rajendran VR, Alldredge SG, et al., Randomized comparison of VasoSeal and AngioSeal closure devices in patients undergoing coronary angiography and angioplasty, Cathet Cardiovasc Interv, 2002;55:421–5.
    Crossref | PubMed
  41. Veasey RA, Large JK, Silberbauer J, et al., A randomised controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital: the SCOAT study, Int J Clin Pract, 2008;62:912–8.
    Crossref | PubMed
  42. Marso SP, Amin AP, House JA, et al. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention, JAMA, 2010;303:2156–64.
    Crossref | PubMed
  43. Sanborn TA, Ebrahimi R, Manoukian SV, et al., Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes. The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) Trial, Circ Cardiovasc Interv, 2010;3;57–62
    Crossref | PubMed