Critical Care Nurse. 2009;29: 39-46 doi:10.4037/ccn2009157
Copyright © 2009 by the American Association of Critical-Care Nurses.
Clinical Article
CE Article
Femoral Artery Closure After Cardiac Catheterization
Wallace J. Hamel, RN, BSN, MSN, APRN
Wallace J. Hamel is an advanced practice registered nurse for the Connecticut Multispeciality Group’s division of cardiology at Hartford Hospital in Hartford, Connecticut.
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Financial Disclosures
None reported.
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To learn more about coronary heart disease issues, read "Uncertainty and Health-Related Quality of Life 1 Year After Coronary Angiography," by Jo-Ann Eastwood et al in the American Journal of Critical Care 2008;17:232–242. Available at www.ajcconline.org.
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This article has been designated for CE credit. A closed-book, multiple-choice examination follows this article, which tests your knowledge of the following objectives:- Identify 2 benefits resulting from percutaneous cardiac interventions quickly restoring blood flow to the heart
- Describe 3 traditional things cardiac catherization is designed to do
- List 2 risks related to the cardiac catherization method of arterial closure
Corresponding author: Wallace J. Hamel, RN, BSN, MSN, APRN, Cardiology Division, Hartford Hospital, 80 Seymour St, Hartford, CT 06106 (e-mail: chamel0804{at}charter.net).
Coronary heart disease is the leading cause of death in the United States today.1 Treatment options include medical management, coronary interventions, and cardiac revascularization. An estimated 1.3 million inpatient cardiac catheterizations are performed annually; half of those patients have percutaneous cardiac interventions and about 400 000 undergo coronary artery bypass graft operations.1 Since the late 1990s, the death rate due to coronary heart disease has decreased by more than 30%.1 Because percutaneous cardiac interventions quickly reestablish blood flow to the heart, patients have a shorter length of stay and less cost.
Cardiac catheterization is the traditional method for examining coronary anatomy, determining coronary artery disease, and providing percutaneous intervention. Access to the heart is through a catheter via the femoral or radial artery. The femoral artery is preferred because of its larger diameter. Catheters range in size from 4F to 10F. Which size to use depends on the vascular and cardiac anatomy, the need to adequately opacify the coronary arteries and cardiac chambers, how much the catheter must be manipulated, and the desire to limit vascular injury and complications.2 Catheters from 7F to 10F are considered large. They allow increased manipulation and excellent visualization, but because of their large size, they can cause complications such as injury of the coronary or peripheral vasculature and bleeding. Because of their smaller size, catheters from 4F to 6F are less traumatic and subsequently have less chance of complications. In addition, hemostasis is easier to achieve when smaller catheters are removed.3 A smaller size, however, may decrease the quality of the study because of limitations in the ability to deliver contrast material.2 A 6F catheter is used most often because it is large enough for percutaneous intervention but small enough to allow rapid hemostasis.2,4
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Complications of Cardiac Catheterization
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Cardiac catheterization (even with a 6F catheter) can cause complications, both vascular access complications and complications from closure of the arteriotomy incision. Like any invasive procedure, accessing the heart through the femoral artery has risks. In 2% to 10% of cases, complications such as bleeding, thrombotic complications, and vascular trauma occur5–8 (Table 1
). Procedural factors that influence risk include sheath size greater than 8F, excessive use of anticoagulants, and site of entry below the common femoral artery.8 Vascular complications can also be affected by any of the following patient-specific factors: history of hypertension, female sex, bleeding diathesis, peripheral vascular disease, age, obesity, and anticoagulation regimen.4,9,10 Additional complications can arise from closure of the arteriotomy incision. After removal of the catheter, hemostasis is traditionally achieved by manual compression. This technique, developed by Dr Sven Seldinger, a radiologist from Sweden, in the 1950s,11 has been the reference standard for hemostasis of the vascular access site. In order to achieve hemostasis, a significant amount of pressure over the access site is required, along with prolonged bed rest for the patient. Manual compression may cause pain for some patients and deep vein thrombosis due to femoral vein compression and stasis.12
In 1994, femoral artery closure devices (FACDs) were introduced as an alternative to compression. Their purpose was to reduce time to hemostasis and ambulation. The superiority of FACDs over manual compression remains unclear.9,13,14 Vascular access complications remain the leading source of morbidity, cost, and legal ramifications.13 In this article, I examine the safety and effectiveness of 4 methods of closing arteriotomy incisions: manual compression and FACD closure with sutures, a collagen plug, and a clip. Then I describe the complications, advantages, and disadvantages of each method. Last, I address nursing care after cardiac catheterization and discharge instructions.
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Safety and Effectiveness of Closure Methods
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The method of arterial closure is chosen by the physician. Arterial closure can be managed by manual compression. The purpose of manual compression is to stop bleeding from the femoral artery by compressing the artery and allowing clot formation. Actual compression of the artery can be done manually or with mechanical compression devices. With mechanical devices, a stand with a compression disk like a C-clamp or a compression arch with a pneumatic dome is used to compress the artery. Although compression is relatively safe and easy to perform, achieving hemostasis by compression can be painful and can take up to a mean of 20 minutes, especially if a large catheter or anticoagulants were used.4
Arterial closure can also be accomplished with an FACD. These devices mechanically close the puncture site in the femoral artery. The suture-mediated closure device ties off the femoral artery with the use of sutures, similar to conventional surgical techniques. Another device available uses an extravascular clip rather than sutures to close off the puncture site in the artery. Another device seals the arteriotomy by using a collagen plug that stimulates thrombus formation and platelet aggregation. All 3 FACDs (suture, clip, and plug) must be deployed through a specialized carrier device. The device is introduced through the sheath put in place during the catheterization. The devices can accommodate a variety of sheath sizes and can close puncture sites up to 10F. Table 2 summarizes the effectiveness and safety of all 4 methods of arterial closure. Time to achieve hemostasis specific to each method is discussed in the sections on advantages and disadvantages.
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Vascular Complications Related to Method of Arterial Closure
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In addition to the vascular complications associated with accessing the femoral artery, specific complications can occur depending on the method of arterial closure (Table 3). No large randomized trials have been done to determine vascular complications specific to any device. Typically, safety data compare major and minor vascular complications, as described earlier. One complication that all 3 FACDs have in common is failure of the device, which occurs in up to 8% of cases.12 When failure occurs, manual compression is used.
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Selection of Closure Method: Preventing Complications at the Vascular Site
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In an effort to avoid complications, a femoral angiogram is recommended to rule out marked peripheral vascular disease, extensive calcification, or plaque and to aid in proper sheath placement in the common femoral artery.10,14,19 The results of the femoral angiogram, examination of the patient for such features as size and anticoagulant use, and procedural risk factors help physicians decide which method to use to close the arteriotomy incision. Table 4 displays the indications for use of compression vs an FACD.
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The Closure Devices
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Suture-Mediated Closure System
The Perclose system, introduced in 1994, was the first suture-mediated device to be approved by the Food and Drug Administration. Abbott Vascular Devices in Redwood City, California, manufactures and distributes these suture-mediated devices: Prostar XL, Perclose A-T, and Perclose ProGlide. The Perclose ProGlide is the latest generation, introduced in 2004. It offers improvements in the ease of knot delivery and strength and the noninflammatory nature of the suture material.13
The Perclose ProGlide allows percutaneous delivery of a suture to close the access site to the common femoral artery during either diagnostic or interventional catheterization procedures with 5F to 8F sheaths.21 The system is composed of a sheath, a guide, a knot pusher accessory, and a suture trimmer. Inside the guide are needles, sutures, and the foot.19 The guide is advanced through the sheath into the femoral artery and precisely controls the placement of needles around the puncture site with the help of the foot.21 The needles are deployed to capture the sutures (Figure 1). The plunger holding the needles is retracted, and the knot is advanced by using a knot pusher. The Perclose ProGlide is completely removed from the artery, and the knot is tightened. Hemostasis is achieved when the knot is fully advanced to the arterial surface. Last, the tails of the sutures are trimmed below the surface of the skin. A dry, sterile dressing is applied at the insertion point.21
Collagen Plug Closure System
The Angio-Seal vascular closure device is manufactured and marketed by St Jude Medical, Incorporated, in St Paul, Minnesota. The models available include Angio-Seal VIP Platform, Angio-Seal STS Plus Platform, and Angio-Seal STS Platform. The main difference among them is the range in size of the anchor that holds the collagen plug in place in the arteriotomy incision.
The Angio-Seal device is made up of 3 components: a specially designed polymer anchor, an absorbable collagen sponge, and an absorbable self-tightening suture. All 3 components dissolve in 60 to 90 days. The sponge is positioned in the puncture track outside the artery wall by a pulley system created by the anchor and suture. The device seals and sandwiches the arteriotomy between the anchor and the collagen plug. The collagen not only acts as a plug at the puncture site but has coagulation-inducing properties that aid in hemostasis (Figure 2).22
Clip Closure System
The StarClose is a clip-mediated closure device developed by Abbott Vascular in Redwood City, California. It was approved by the Food and Drug Administration in 2005 but has been successfully used in Europe since 2004. In January 2007, StarClose was approved for interventional use.
The StarClose introduces a small, circumferential, flexible clip that mechanically binds the surface of the femoral artery together (Figure 3). The clip is made of nitinol, a nickel-titanium alloy whose superelastic properties allow it to return to its original shape once released from the device.23 Its use involves a 4-step or click process: (1) replacement of the procedural sheath with the Star-Close sheath, (2) deployment of the vessel locator, (3) delivery of the clip, and (4) deployment of the clip, achieving hemostasis.19 Because the clip is on the outside of the artery, nothing is left behind on the inside to cause potential blockages later.
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Figure 3 Use of the StarClose: (A) application of the clip. (B) Hemostasis of the femoral artery. (C) Hemostasis with StarClose device in place.
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Advantages and Disadvantages of Closure Methods
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The various methods of femoral artery closure have numerous advantages and disadvantages (Table 5). A reduction in time to hemostasis and ambulation is an important advantage of using any of the FACDs compared with compression. Other advantages include a reduction in work load for cardiac catheterization staff, an increase in patients’ comfort, a decrease in patients’ length of stay, and the subsequent cost savings. The cost savings is reduced somewhat by the initial cost for a closure device and supplies compared with the costs of manual compression. No one device is considered superior to another. A variety of variables must be considered for safe and effective closure of the femoral artery such as patient and procedural factors and the physician’s ability in deploying the device.
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Nursing Care After Cardiac Catheterization
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The nursing standards of care for patients undergoing an interventional cardiac catheterization are not well established.27 The main goals of management after the procedure are the maintenance of hemostasis at the puncture site and assessment for vascular complications. Meeting these goals requires effective assessment of patients before the procedure, knowledge of exactly how hemostasis of the arteriotomy incision was achieved, and diligent monitoring of vital signs, groin site, and pulses (Table 6).6,19,28,29 Oozing at the groin site may be controlled by 10 minutes of manual pressure, mechanical compression, or a pressure dressing.19,29
Duration of bed rest and time to ambulation depend on the method of arterial closure. The criteria for determining whether a patient is ready for ambulation and discharge are that the overall clinical condition of the patient (including vital signs) has returned to baseline levels, sedation has worn off, and hemostasis at the groin site has been maintained.13,19,29 The final decision for time to ambulation and discharge is up to the cardiac interventionalist.
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Discharge Instructions
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Before a patient leaves the hospital, discharge instructions (Table 7) should be reviewed with the patient and the patient’s family. The information should be presented at a level they understand.
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Conclusion
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Methods of femoral artery closure after cardiac catheterization include compression, suture, collagen plug, and clip closure. A variety of factors can influence the choice of which method to use, including the physician’s preference, ability to successfully deploy the device, cost, and patient-specific factors such as peripheral vascular disease and use of anticoagulation. No one method is better than the others. Although all 4 methods are comparable in terms of safety and effectiveness, the FACDs consistently are associated with quicker hemostasis and ambulation. Information on vascular complications from access of the femoral artery, the methods of arterial closure, and postprocedural care including discharge instructions helps critical care nurses provide safe and effective care to patients after cardiac catheterization.
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PRIME POINTS
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- After diagnostic and interventional cardiac catheterization, femoral artery closure devices offer quicker time to hemostasis, ambulation, and discharge than does manual compression.
- Nurses should understand how femoral artery closure devices work, the potential vascular complications that may occur with their use, and the recommended time to ambulation and discharge.
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References
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- American Heart Association. Heart Disease and Stroke Statistics: 2007 Update. Dallas, TX: American Heart Association; 2007.
- Reddy BK, Brewster PS, Walsh T, Burket MW, Thomas WJ, Cooper CJ. Randomized comparison of rapid ambulation using radial, 4 French femoral access, or femoral access with Angioseal closure. Catheter Cardiovasc Interv. 2004;62(2):143–149.[CrossRef][Medline]
- Turi Z. Overview of vascular closure. Endovasc Today. 2005;43:32–37.
- 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(10):504–510.[Medline]
- Turi ZG. The essentials of vascular access and closure [PowerPoint presentation]. April 8, 2005. http://www.tctmd.com/Show.aspx?id=58214. Accessed October 28, 2008.
- Weisz G. Diagnosis and management of femoral site complications III: AV-fistulae, perforations, infections [PowerPoint presentation]. Oct 16,2005. www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1354878. Accessed March 19, 2007.
- White C. Vascular access and complications [PowerPoint presentation]. November 6, 2003. www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=862328. Accessed March 19, 2007.
- Davis C, VanRiper S, Longstreet J, Moscucci M. Vascular complications of coronary interventions. Heart Lung. 1997;26(2):118–127.[CrossRef][Medline]
- Exaire JE, Tcheng JE, Kereiakes DJ, et al. Closure devices and vascular complications among percutaneous coronary intervention patients receiving enoxaprin, glycoprotein IIb/IIIa inhibitors and clopidogrel. Catheter Cardiovasc Intern. 2005;64(3):369–372.[CrossRef]
- Applegate RJ, Sacrinty M, Kutcher MA, et al. Vascular complications with newer generations of Angioseal vascular closure devices. J Interv Cardiol. 2006;19(1):67–74.[CrossRef][Medline]
- Seldinger SI. Catheter replacement of the needle in percutaneous arteriography. Acta Radiol. 1953;39(5):366–376.
- Eggebrecht H, Naber C, Woertgen U, et al. Percutaneous suture-mediated closure of femoral access sites deployed through the procedure sheath: initial clinical experience with a novel vascular closure device. Catheter Cardiovasc Intern. 2003;58(3):313–321.[CrossRef]
- Kim M. Vascular closure devices. Cardiol Clin. 2006;24(2):277–286.[CrossRef][Medline]
- Koreny M, Riedmüller E, Nikfardjam M, Siostrzonek P, Müllner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004;291(3):350–357.[Abstract/Free Full Text]
- Applegate RJ, Sacrinty MT, Kutcher MA, et al. Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention 1998–2003. Catheter Cardiovasc Interv. 2006;67(4):556–562.[CrossRef][Medline]
- Arora N, Matheny M, Sepke C, Resnic F. A propensity analysis of the risk of cardiovascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J. 2007;153(4): 606–611.[CrossRef][Medline]
- Goyen M, Manz S, Kroger K, et al. Interventional therapy of vascular complications caused by the hemostatic puncture closure device Angio-Seal. Catheter Cardiovasc Interv. 2000;49(2):142–147.[CrossRef][Medline]
- Desideri A, Tonello D, Coscarelli S, et al. Early mobilization after percutaneous catheterization and vascular closure with a novel device (Star-Close). Am J Cardiol. 2005; 96(10):1408–1409.[CrossRef][Medline]
- StarClose Vascular Closure System [instructions for use]. Redwood City, CA: Abbott Vascular; 2007:1–17.
- Roubin G. Rapid ambulation after CAS. Endovasc Today. 2005;4:45–46.
- Perclose Proglide 6F Suture-Mediated Closure System [instructions for use]. Redwood City, CA: Abbott Vascular; 2005:1–10.
- Angio-Seal [instructions for use]. Minnetonka, MN: St Jude Medical Center; 2005:1–16.
- Cardiovascular/Cardiology News. FDA Approves StarClose Vascular Closure System, Abbott, December 26, 2005. http://www.medicalnewstoday.com/medicalnews.php?newsid=35381. Accessed October 28, 2008.
- 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(12):1658–1663.[CrossRef][Medline]
- Rickli H, Unterweger M, Sütsch G, et al. Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions. Catheter Cardiovasc Interv. 2002;57(3):297–302.[CrossRef][Medline]
- Resnic F, Arora N, Matheny M, et al. A cost minimization analysis of the Angioseal vascular closure device following percutaneous coronary intervention. Am J Cardiol. 2007; 99(6):766–770.[CrossRef][Medline]
- Tagney J, Lackie D. Bed-rest post-femoral arterial sheath removal—what is safe practice? A clinical audit. Nurs Crit Care. 2005; 10(4):167–173.[Medline]
- Cardiac Cath Lab Post PCI Orders [physician’s order form]. Hartford, CT: Hartford Hospital; 2005.
- Vanderbilt University Medical Center. AngioSeal hemostatic puncture closure device, cl30-13.02 page, December 11, 2006. http://vumcpolicies.mc.vanderbilt.edu/E-Manual/Hpolicy.nsf/AllDocs/F1C0ADD32DF2B7E28625692D00603E46.
- Discharge Instructions: Cardiac Cath/PTCA [critical path-consumer/patient teaching materials, forms] Glendale, CA: Glendale Adventist Medical Center; 1997.
- Tremko L. Understanding diagnostic cardiac catheterization. Am J Nurs. 1997;92(2):16–19.
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