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Femoral Vascular Closure Devices After Catheterization Procedure

Editor: Pradyumna Agasthi Updated: 8/2/2025 8:31:54 PM

Introduction

Cardiac catheterization is often required for various procedures, including angiography, angioplasty, valve replacement, valvuloplasty, ablation, and congenital heart repair. This procedure is necessary to assess and care for many patients presenting with myocardial infarction, heart disease, valvular disease, or congenital heart disease—with a common site of catheterization entry being the femoral artery. Catheterization is a procedure that is heavily performed in the field of interventional cardiology. After catheterization procedures, appropriate mechanisms are necessary to close the port of entry of the catheter into the femoral artery. As a result, the need for devices to assist in closing the femoral artery is continually evolving.

Initially, the only mechanism to assist in hemostasis at the catheter insertion site would be mechanical compression of the femoral artery. Although mechanical compression is sufficient in patients without certain comorbidities, it can be challenging in patients who are obese and on anticoagulation therapy. Additionally, patients treated through femoral access require a longer hospital stay than those who receive radial access. Manual compression would take longer to achieve hemostasis, increasing the strain on the healthcare system. Certain procedures, such as inserting left ventricular assist devices and mitral/aortic valve replacement procedures, require larger femoral vascular access sites, making mechanical compression cumbersome or a less effective method to achieve hemostasis.[1][2]

Femoral vascular closure devices can be divided into 2 broad categories: passive and active. Passive closure devices help achieve mechanical compression and reduce thrombosis to achieve effective hemostasis. However, passive devices do not hasten the time it takes to reach hemostasis. Active closure devices include suture devices, collagen plugs, and clips.

Anatomy and Physiology

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Anatomy and Physiology

The femoral artery is one of the main arteries of the lower limb. The common access site for cardiac catheterization is the common femoral artery. The common femoral artery is an extension of the external iliac artery (a terminal branch of the abdominal aorta). The inguinal ligament demarcates the start of the common femoral artery. Below the inguinal ligament and within the femoral triangle, the femoral artery breaks into the superficial and deep femoral arteries. As the superficial femoral artery enters the adductor hiatus, it becomes the popliteal artery. The deep femoral artery immediately branches into the medial and lateral circumflex femoral arteries. 

Positioning the femoral artery around other vessels is crucial within the femoral triangle. From lateral to medial, these structures are the femoral nerve, femoral artery, femoral vein, femoral canal, and the deep inguinal nodes. The femoral sheath encompasses the femoral artery and the femoral vein. This spatial relationship becomes important in complications that could occur during the insertion of a femoral artery closure device.[3]

Indications

The indication for using a femoral vascular closure device is to achieve hemostasis through the successful closure of the femoral artery puncture site and to decrease the time to achieve successful hemostasis. Hemostasis for large-bore access sites for structural interventions is routinely achieved using femoral vascular closure devices.

Contraindications

Because most femoral vascular devices are evolving and data is still being gathered, many of these devices do not have strict contraindications. However, there are certain issues of concern and times when these devices are not used.

The following properties of the access site make it less suitable for the use of novel femoral vascular closure devices:

  • Access obtained above the inguinal ligament
  • Access obtained through the superficial or deep femoral arteries
  • Access obtained from the lateral surface of the artery wall
  • Multiple attempts are required to obtain an access site in any part of the artery
  • Bacterial infection around the access site
  • Heavy calcification in the area of the access site

Caution should be taken during the following clinical situations:

  • Anticoagulation with warfarin
  • Thrombolysis
  • Bleeding diathesis
  • Peripheral vascular disease

Equipment

General equipment required for the femoral artery closure device includes:

  • Sterile gloves and sterile drapes
  • Ultrasound machine
  • Local anesthesia (ie, lidocaine), syringes, and needles
  • 4 x 4 gauze
  • Chlorhexidine 
  • Short and long J-tip wires
  • Tegaderm 
  • Specific vascular closure device kits

Although different closure device kits vary, the majority of kits contain the following:

  • Insertion sheath
  • Arteriotomy locator (modified dilator)
  • 6 French or 8 French with J-tip guide wire
  • Vascular closure device

Personnel

The personnel necessary for femoral vascular closure device placement include an interventional cardiologist, a radiology technician, and nursing staff. First assistants, such as physician assistants, residents, or fellows, may also be present.

Preparation

Necessary personnel must scrub before entering the procedure room. After donning sterile gowns and gloves, the catheterization procedure can begin. Before the catheterization procedure, it is essential to palpate the femoral pulse and pulses at various sites along the course of the artery, including the popliteal, tibial, and dorsalis pedis arteries. The insertion of a femoral vascular closure device is done either at the beginning of the procedure (especially large bore access) or immediately after the catheterization procedure has ended. The site must be prepared appropriately with sterile drapes around the site of insertion. Ultrasound and fluoroscopic guidance may be used.[4]

Technique or Treatment

Before exploring specific devices, it’s essential to understand manual compression—the gold standard for achieving hemostasis after catheterization and the fallback when device closure fails. After therapeutic interventions, sheath removal is deferred until the activated clotting time is below 180 seconds. Initially placed directly over and slightly proximal to the arteriotomy site, firm manual pressure is applied for approximately 10 minutes, followed by moderate pressure for an additional 5 minutes. If bleeding persists, extend the compression for an additional 15 minutes. Once hemostasis is achieved, a pressure dressing is applied, and patients are maintained on bed rest for at least 6 to 8 hours to ensure proper healing.[1]

Closure devices are broadly categorized as passive or active. Passive devices, such as mechanical clamps (eg, C-shaped arms) and pneumatic compression belts, mimic manual pressure. Hemostatic pads coated with procoagulants are also used; however, randomized trials have not shown them to improve outcomes over manual compression alone significantly.

Active closure devices function via internal mechanical means to seal the arteriotomy. Examples of active closure devices include:

  • Collapsible disc systems
    • These are inserted through the existing sheath over a guidewire. Once the device enters the lumen, a radiopaque disc is deployed and gently retracted to rest against the intimal surface of the vessel wall. Fluoroscopic or angiographic confirmation ensures proper placement. An outer sleeve then delivers procoagulant agents (eg, protamine sulfate) into the surrounding subcutaneous tissue to reverse local anticoagulation and accelerate hemostasis. After the disc is deflated and the device is withdrawn, manual compression is applied for an additional 5 minutes.[5]
  • Collagen plug systems 
    • These follow a similar insertion protocol. Once in position, a collagen plug is deployed between the arterial wall and the skin surface. The device is held in place for 30 to 45 seconds to hydrate the collagen, after which a push rod separates the plug from the delivery system. The plug remains in the tissue, promoting hemostasis and resorption over time.[6] Second-generation versions use polyethylene glycol coatings to seal the arterial puncture more effectively.[7]
  • Polyglycolic acid devices
    • These work by releasing a polyglycolic acid plug that aligns externally to the arteriotomy, inducing thrombosis and vascular closure.
  • Clip-based devices 
    • These deploy wing-like extensions that press against the vessel wall. Once positioned, the device retracts and approximates the wings with a clip to close the access site.[8]
  • Suture-mediated devices 
    • This device does not use an existing catheter that is in place. Suture devices are inserted directly into the arteriotomy site with the help of a guidewire. A marker with pulsatile blood flow ensures the device is in the arterial lumen. Pressing a lever at the edge of the device deploys a footplate with suture cuffs on each side, which house the suture loops. Pushing the plunger deploys the needles from the device, which pierce through the artery wall on either side of the arteriotomy site and come in contact with the suture cuffs. Upon retraction of the needles and the device, the suture ends follow, going through the artery wall on opposite sides of the artery access site. The sutures are retrieved, tied, and pushed toward the access site.[9].
    • These devices are advantageous for patients requiring reaccess, which is not feasible with plug-based devices.[10] 

The following is a summary of the universal technique to employ a femoral vascular closure device after a catheterization procedure:

  • Maintain guidewire access while removing or exchanging the sheath.
  • Insert the closure device over the wire into the arteriotomy.
  • Deploy the closure mechanism according to the device type:
    • Plug-based
      • Intraarterial anchor plus extravascular plug
    • Suture-based
      • Sutures are deployed, retrieved, and tied
    • Clip-based
      • Clip approximates and closes vessel edges
  • Confirm hemostasis clinically or with ultrasound; brief manual compression may still be a supplementary measure.
  • Monitor the patient for bleeding, hematoma, or ischemic complications before mobilization.

This structured approach optimizes vascular access site management while minimizing complications such as bleeding, hematoma, pseudoaneurysm, or limb ischemia. Proper device selection, adherence to technique, and vigilant postprocedural monitoring are essential for safe and effective outcomes.

Complications

One of the most common complications associated with femoral vascular closure devices is groin infection, underscoring the importance of adhering to strict sterile technique, including wearing proper attire, thorough skin preparation, and meticulous draping during device placement. Infections are reported more frequently with closure devices than with manual compression techniques.[11] Distal limb ischemia is another potential complication, typically resulting from thrombosis or distal embolization at or beyond the arteriotomy site.

This risk is heightened in the presence of heavily calcified vessels, making such conditions a relative contraindication to device use. Compared to manual compression, closure devices have a higher incidence of ischemic complications.[11] Other potential adverse events include bleeding, hemorrhage, and pseudoaneurysm formation. However, manual compression generally makes these complications more frequent than vascular closure devices.[12] In severe cases, especially when ischemia or vascular injury occurs, surgical intervention—including possible bypass grafting—may be required to restore distal perfusion and manage complications effectively.

Clinical Significance

With the growing need for catheterization procedures, it has become evident that the appropriate management of the arteriotomy site is essential. Although a variety of vascular closure devices exist, as discussed in this article, it is worth noting that manual compression remains the "gold standard" of treatment. Intriguingly, results from several studies have found no overall benefit in clinical outcomes using vascular closure devices compared to manual compression; however, the use of femoral access closure devices noted a significant reduction in time to hemostasis and time to ambulation. Therefore, interventional cardiologists and vascular surgeons must familiarize themselves with the different types of devices used and their benefits and risks for specific patient groups.[13][14]

Enhancing Healthcare Team Outcomes

Effective use of femoral vascular closure devices after catheterization requires a coordinated, multidisciplinary approach to ensure optimal patient outcomes and procedural safety. Clinicians must possess the technical skills to select the appropriate closure device based on individual patient anatomy, bleeding risk, and procedural complexity. Accurate device deployment and recognition of early signs of complications, such as hematoma or limb ischemia, are critical. Interventionalists must communicate clearly with nursing staff to ensure proper post-procedural monitoring and documentation, especially during transitions from the cath lab to recovery settings.

Nurses play a vital role in patient-centered care by providing real-time assessments of the access site, managing postprocedure positioning, and educating patients on activity restrictions and signs of delayed complications. Pharmacists contribute by managing anticoagulant and antiplatelet regimens before and after the procedure to balance the risks of bleeding and thrombosis. Radiologic technologists assist with imaging guidance during device deployment, while all team members benefit from structured communication protocols, such as time-outs and handoff tools. High-functioning interprofessional collaboration enhances team performance, improves patient satisfaction, reduces complications, and promotes a safe and efficient recovery following vascular access closure.

References


[1]

Noori VJ, Eldrup-Jørgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. Journal of vascular surgery. 2018 Sep:68(3):887-899. doi: 10.1016/j.jvs.2018.05.019. Epub 2018 Jun 29     [PubMed PMID: 30146036]

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Zlotorowicz M, Czubak-Wrzosek M, Wrzosek P, Czubak J. The origin of the medial femoral circumflex artery, lateral femoral circumflex artery and obturator artery. Surgical and radiologic anatomy : SRA. 2018 May:40(5):515-520. doi: 10.1007/s00276-018-2012-6. Epub 2018 Apr 12     [PubMed PMID: 29651567]


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Klein-Wiele O, Baliota M, Kara K, Käunicke M, Schäfer H, Garbrecht M, Abdulghafor M, Garmer M, Hailer B. Safety and efficacy of clip-based vs. suture mediated vascular closure for femoral access hemostasis: A prospective randomized single center study comparing the StarClose and the ProGlide device. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2018 Feb 15:91(3):402-407. doi: 10.1002/ccd.27116. Epub 2017 May 13     [PubMed PMID: 28500743]

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Mankerious N, Mayer K, Gewalt SM, Helde SM, Ibrahim T, Bott-Flügel L, Laugwitz KL, Schunkert H, Kastrati A, Schüpke S, Instrumental Sealing of ARterial puncture site –CLOSURE device versus manual compression (ISAR-CLOSURE) Trial Investigators. Comparison of the FemoSeal Vascular Closure Device With Manual Compression After Femoral Artery Puncture - Post-hoc Analysis of a Large-Scale, Randomized Clinical Trial. The Journal of invasive cardiology. 2018 Jul:30(7):235-239     [PubMed PMID: 29760286]

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Steppich B, Stegmüller F, Rumpf PM, Pache J, Sonne C, Lesevic H, Braun D, Hausleiter J, Kasel AM, Ott I. Vascular complications after percutaneous mitral valve repair and venous access closure using suture or closure device. Journal of interventional cardiology. 2018 Apr:31(2):223-229. doi: 10.1111/joic.12459. Epub 2017 Nov 16     [PubMed PMID: 29148095]


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Al-Lamee R, Nowbar AN. Vascular Closure Devices for Transfemoral Angiography. Circulation. Cardiovascular interventions. 2018 Aug:11(8):e007085. doi: 10.1161/CIRCINTERVENTIONS.118.007085. Epub     [PubMed PMID: 30354792]