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Arterial Closure Device Insertion

  • Author: Venkat Rajaram, MD, MS; Chief Editor: Karlheinz Peter, MD, PhD  more...
 
Updated: Jul 10, 2013
 

Background

An increasing number of diagnostic and therapeutic procedures in the cardiovascular system are performed percutaneously because of greater safety and improvement in minimally invasive technology. Over 7 million such procedures are performed worldwide every year.

Despite the growing popularity of radial access, the vast majority of these procedures are still performed through the common femoral artery in the groin.[1]

Manual compression was once traditionally used to close the common femoral artery at the conclusion of the procedure. This method required that the patient avoid ambulation for at least 6 hours. Because of the increasing sophistication of anticoagulant agents used in percutaneous interventions, prompt and successful hemostasis without complications became necessary.

Vascular closure devices were developed as a solution to this problem. Percutaneous left ventricular assist devices (LVADs) such as Impella and the percutaneous aortic/mitral valve replacement procedures require large access sizes. Manual compression is not an ideal option in these situations, and an appropriate closure device can obviate the need for surgical closure of the access site.

The use of closure devices is bound to increase because of increasing awareness and comfort levels among operators, along with improvements made to the closure devices themselves.

Many devices on the market are designed to achieve access closure and hemostasis. This article discusses two of the most frequently used arterial active closure devices—Angioseal (a collagen plug–based device) and Proglide (a suture-based closure device).

Types of closure devices

Passive closure devices are used to assist in manual compression by enhancement or promotion of coagulation (eg, Syvek Patch [Marine Polymer Technologies, Danvers, Massachusetts]), by wire-stimulated track thrombosis (eg, Catalyst II and III [Cardiva Medical, Mountainview, California]), or by enhanced manual compression (eg, FemoStop [St. Jude Medical, St. Paul, Minnesota]). These devices do not afford immediate closure but improve on manual compression.

Active closure devices include collagen-based devices such as Angio-Seal (St. Jude Medical, St. Paul, Minnesota) or suture-based devices such as Proglide or Starclose (Abbott Vascular, Redwood City, California) or polyethylene glycol (PEG)–based Mynx Cadence (AccessClosure, Inc, Mountain View, California). These can achieve hemostasis within 5 minutes, with minimal or no manual compression.

This does not represent a comprehensive list, as the number of devices is growing.

Anatomy

The entry point of the sheath into the common femoral artery needs to be below the inguinal ligament, defined by the lower border of the inferior epigastric artery[3] and above the bifurcation of the common femoral artery into profunda femoris and superficial femoral artery. Ideally, the entry point of the sheath needs to be at or just below the middle of the femoral head. The proper entry point of the access sheath needs to be verified using femoral angiography.

Ideal closure device

An ideal closure device would have the following properties:

  • Achieve early and complete hemostasis without discomfort to the patient
  • Safe to administer without any complications
  • Applicable to both diagnostic and interventional procedures
  • Easy to use, without a significant learning curve
  • Unlikely to fail
  • Widely applicable regardless of the type of stick or anatomy
  • Inexpensive
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Indications

General indications for arterial closure devices include the following:

  • To close the common femoral artery puncture site in order to achieve complete hemostasis safely after a diagnostic or interventional angiographic procedure
  • To reduce time to hemostasis and time to ambulation
  • To improve patient comfort
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Contraindications

Closure devices have no specific contraindications. However, there are several warnings and precautions, which may vary by the device being used.

General warnings are as follows:

  • Do not use if puncture site is at or distal to the common femoral bifurcation into superficial femoral artery and profunda femoris
  • Do not use if access is obtained above the inguinal ligament
  • Do not use if bacterial contamination of the sheath is suspected
  • Do not use if there is a posterior wall puncture or multiple attempts were used to obtain arterial puncture
  • Do not use an expired or contaminated device

Table 1. Device-Specific Precautions (Open Table in a new window)

Clinical Condition Angioseal Proglide
Concurrent warfarin therapy Use caution Data not available
Allergy to beef/collagen Use caution Data not available
Pregnancy/lactation Use caution Data not available
Thrombolysis Use caution Data not available
Vascular graft Use caution Data not available
Inflammatory/autoimmune Use caution Data not available
Uncontrolled hypertension (systolic >180) Use caution Data not available
Bleeding diathesis Use caution Data not available
Peripheral vascular disease Use caution Use caution
Calcified iliac artery Use caution Use caution

Avoid Angioseal in thin individuals, as the collagen may become palpable, perhaps feeling like a knot.

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Outcomes

The potential beneficial outcomes of vascular closure devices include a reduced time to ambulation after angiography, reduced complication rates following femoral access closure, and cost-effectiveness.

Clearly reduced time to ambulation stands to reason and is established. Studies have validated a reduction in complication rates with the use of closure devices compared to manual compression in the setting of diagnostic angiography.[4] The complication rates of closure devices and manual compression in the setting of interventional procedures are comparable.

Cost effectiveness of vascular closure devices has not been formally studied. However, as closure devices allow earlier ambulation and possible earlier discharge, the length of stay is reduced and turnaround time improved, leading to potential cost savings. In addition, if the practice of discharging patients home the same day they undergo percutaneous coronary intervention becomes the norm, it could lead to significant cost savings in the future, as closure devices would facilitate this process.

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Complications

Access-site complications were reported in 6% of cases in one series and are clearly the leading cause of morbidity after angiography.[2]

Potential complications of arterial closure devices include the following:

  • Failure of the device to achieve hemostasis
  • Hematoma
  • Pseudoaneurysm formation
  • Infection
  • Arteriovenous fistula
  • Collagen deposition and thrombosis in artery (Angioseal) (diagnosis confirmed with duplex ultrasonography; treatment options include thrombolysis, percutaneous thrombectomy, surgery)
  • Anchor fracture or embolism (Angioseal) (unlikely to produce ischemia)
  • Suture breakage (Perclose)
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Contributor Information and Disclosures
Author

Venkat Rajaram, MD, MS Interventional Fellow, Department of Cardiology, Temple University Medical Center

Venkat Rajaram, MD, MS is a member of the following medical societies: American College of Cardiology, Society for Cardiovascular Angiography and Interventions

Disclosure: Nothing to disclose.

Coauthor(s)

Neeraj Tandon, MBBS Chief, Cardiology Section, Associate Professor of Medicine, Medical Service, Overton Brooks Veterans Affairs Medical Center

Neeraj Tandon, MBBS is a member of the following medical societies: American College of Cardiology, Society for Cardiovascular Angiography and Interventions

Disclosure: Nothing to disclose.

Chief Editor

Karlheinz Peter, MD, PhD Professor of Medicine, Monash University; Head of Centre of Thrombosis and Myocardial Infarction, Head of Division of Atherothrombosis and Vascular Biology, Associate Director, Baker Heart Research Institute; Interventional Cardiologist, The Alfred Hospital, Australia

Karlheinz Peter, MD, PhD is a member of the following medical societies: American Heart Association, German Cardiac Society, Cardiac Society of Australia and New Zealand

Disclosure: Nothing to disclose.

References
  1. Patel MR, Jneid H, Derdeyn CP, Klein LW, Levine GN, Lookstein RA, et al. Arteriotomy closure devices for cardiovascular procedures: a scientific statement from the American Heart Association. Circulation. 2010 Nov 2. 122(18):1882-93. [Medline].

  2. Meyerson SL, Feldman T, Desai TR, Leef J, Schwartz LB, McKinsey JF. Angiographic access site complications in the era of arterial closure devices. Vasc Endovascular Surg. 2002 Mar-Apr. 36(2):137-44. [Medline].

  3. Sherev DA, Shaw RE, Brent BN. Angiographic predictors of femoral access site complications: implication for planned percutaneous coronary intervention. Catheter Cardiovasc Interv. 2005 Jun. 65(2):196-202. [Medline].

  4. Tavris DR, Gallauresi BA, Lin B, et al. Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 2004;16:459–64.

  5. Turi ZG. Optimizing vascular access: routine femoral angiography keeps the vascular complication away. Catheter Cardiovasc Interv. 2005 Jun. 65(2):203-4. [Medline].

  6. Applegate RJ, Rankin KM, Little WC, Kahl FR, Kutcher MA. Restick following initial Angioseal use. Catheter Cardiovasc Interv. 2003 Feb. 58(2):181-4. [Medline].

 
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Angioseal Equipment
Angioseal technique
Perclose equipment
Perclose technique
Table 1. Device-Specific Precautions
Clinical Condition Angioseal Proglide
Concurrent warfarin therapy Use caution Data not available
Allergy to beef/collagen Use caution Data not available
Pregnancy/lactation Use caution Data not available
Thrombolysis Use caution Data not available
Vascular graft Use caution Data not available
Inflammatory/autoimmune Use caution Data not available
Uncontrolled hypertension (systolic >180) Use caution Data not available
Bleeding diathesis Use caution Data not available
Peripheral vascular disease Use caution Use caution
Calcified iliac artery Use caution Use caution
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