Vascular Closure Devices

Safe and effective arterial access closure and hemostasis continue to present a challenge for interventional radiologists. Arterial access is required for a wide range of procedures ranging from interventional oncology and peripheral arterial disease to aneurysm repair and trauma. Arterial access sheaths range from 4 Fr. for diagnostic angiography to 12 to 25 Fr. for endograft delivery. Although manual compression (MC) has been the gold standard for achieving hemostasis for smaller arteriotomies since the inception of interventional radiology, vascular closure devices (VCDs) were introduced in the early 1990s, and a large body of evidence and experience has accumulated to support their use. Advantages and disadvantages exist for both methods of arteriotomy closure (Table 3.1).

Table 3.1 Advantages and Disadvantages of Manual Compression and Vascular Closure Devices

Method

Advantages

Disadvantages

Manual compression

-Gold standard

-Limited learning curve

-No device cost

-Patient discomfort

-Delayed time to hemostasis

-Delayed time to ambulation

-Anticoagulation must be reversed (ACT <180)

-Decreased workflow

Vascular closure devices

-Immediate hemostasis

-Hemostasis possible with anticoagulation

-Decreased time to ambulation

-Improved patient comfort

-Improved workflow may offset device costs

-Device cost

-Learning curve for each device

-Immediate repuncture not recommended for all devices

-Potential for severe complications

Indications

VCD can be used without reservation when the following criteria are met:

1. Common femoral artery (CFA) puncture

a. Between the inferior epigastric artery takeoff (below the inguinal ligament) and the femoral bifurcation (see Figure 3.1)

b. If there is a high femoral bifurcation (above the femoral head), consider ipsilateral superficial femoral artery (SFA) puncture or contralateral access.

2. Retrograde access

3. Artery diameter 5 mm or larger

4. No large atherosclerotic plaque on the anterior wall of the access site

a. Consider using ultrasound-guided puncture technique to avoid plaque.

Off-label Uses for Vascular Closure Device

Many VCD instructions for use manuals will not include these situations, but there is an improving evidence base for use outside of retrograde CFA access.

1. Low puncture—SFA

a. SFA puncture closure okay if >5 mm (1)

2. Antegrade puncture

a. Several reports support VCDs after antegrade puncture (CFA or SFA) (2)

3. Nonfemoral artery puncture closure using VCDs has been described.

a. Brachial artery (3)

b. Popliteal artery (4)

c. Axillary artery (5)

4. High puncture—external iliac artery

a. MC likely to be ineffective—risk for retroperitoneal hematoma that can be life-threatening

b. Reports of using Angio-Seal in this clinical scenario when patient characteristics are favorable (1)

c. Surgical treatment may be necessary.

FIGURE 3.1 • Common femoral angiogram, performed through the indwelling sheath. The puncture (black circle) is appropriate for device closure, between the takeoff of the inferior epigastric artery (asterisk) and the femoral bifurcation (<), in a vessel >5 mm in caliber. Please note this puncture could also be closed with MC as it enters the CFA directly over the femoral head. (Angiogram courtesy of San Francisco General Hospital, San Francisco, CA.)

Contraindications

There are no absolute contraindications to VCD use. If any of the below conditions exist, consider an alternate hemostasis strategy such as MC:

1. Contaminated field

a. Infected VCD needs to be treated surgically with high morbidity and not insignificant mortality.

2. Severe calcified atherosclerotic peripheral artery disease in the CFA

a. MC may be more appropriate.

b. Recent reports suggest VCD use may be safe in this population (6).

3. Small CFA, less than 5 mm

4. Multiple puncture attempts required for initial access

5. Back wall puncture

6. Prior angioplasty, stent or bypass graft in the CFA

7. Uncontrolled hypertension systolic blood pressure (SBP) >180 mm Hg

8. Morbid obesity—body mass index (BMI) >40

Procedure

The following general steps should be taken prior to device delivery as part of the VCD procedure:

1. Perform an ipsilateral CFA angiogram to assess puncture site location and vessel caliber (Fig. 3.1).

a. 5 to 10 mL contrast hand injection through the sheath

b. Can be documented at the start of the case through a micropuncture sheath prior to upsizing to the procedural sheath

c. Oblique projections often necessary to separate sheath and CFA for clear identification of the access entry site

2. Consider re-prepping the groin with a ChloraPrep and fresh sterile towels.

3. Consider glove change or removal of outer gloves if double gloved.

4. Bluntly dissect the soft tissue tract between the skin and the arteriotomy.

a. Crucial for successful delivery of several of the VCDs

b. Helps alert operator to incomplete hemostasis, readily seen as bleeding from the puncture site

5. Readminister subcutaneous lidocaine into the soft tissues for anesthesia.

6. Exchange the existing sheath over a wire for the VCD or insert the VCD into the sheath depending on the device being used.

7. Deploy the device—see following sections for specific instructions and diagrams for several of the commonly used devices from each category.

8. Bed rest for 1 to 2 hours, followed by ambulation trial

9. Assess groin for evidence of delayed hematoma or pseudoaneurysm (PSA) prior to discharge.

Types of Devices

Several categories of VCD are currently manufactured, each with their own mechanism of action, applications, and learning curves.

1. Active approximators (Table 3.2)

These devices mechanically close the arteriotomy as material is fixed to the vessel wall. With Angio-Seal, the arteriotomy is sandwiched between an intravascular footplate and collagen plug. With suture- and clip-mediated devices, the arteriotomy itself is cinched closed. Active approximators are considered the most secure form of VCD but carry the highest risk of serious complication.

2. Passive approximators (Table 3.3)

These devices deploy a sealant, gel, or plug at the extravascular aspect of the arteriotomy to achieve hemostasis. Adjunctive MC is often held for 1 to 3 minutes. These devices have the highest risk of incomplete hemostasis.

3. Nondepositional hemostasis aids (Table 3.4)

This is a heterogeneous group of devices that do not leave any material behind at the end of the procedure.

4. Hemostatic patches (Table 3.5)

These patches are placed externally over the dermatotomy prior to MC. Substances interact with blood products to aid in hemostasis.

5. Mechanical compression aids (Table 3.6)

These devices allow MC to be performed by the device rather than an operator.

Table 3.2 Active Approximators

Device		Manufacturer	Mechanism	Sheath Size (Fr.)	Comments
StarClose SE		Abbott Vascular	Clip	5, 6	Extravascular clip cinches arteriotomy closed
Angio-Seal		St. Jude Medical	Footplate/plug	6, 8	Arteriotomy sandwiched between footplate and collagen plug
	-VIP	St. Jude Medical
	-Evolution
Perclose		Abbott Vascular	Suture	5-8	Braided polyester or monofilament sutures
	-ProGlide	Abbott Vascular			Braided polyester or monofilament sutures
	-A-T
Prostar XL		Abbott Vascular	Suture	8.5-10	Braided polyester suture, used for larger sheaths
FemoSeal		St. Jude Medical	Intra- and extravascular discs	7	Biodegradable polymer discs

Table 3.3 Passive Approximators

Device		Manufacturer	Mechanism	Sheath Size (Fr.)	Comments
Mynx		Access Closure	Sealant	5-7	Polyethylene glycol deployed while intravascular balloon creates temporary hemostasis
	-Grip	Access Closure
	-Ace
FISH		Morris Innovative	Sealant	5-8	Extracellular matrix closure patch premounted on procedural sheath
EXOSEAL		Cordis	Sealant	5-8	Polyglycolic acid deployed through existing sheath
FastSeal		Vascular Closure Systems	Bioabsorbable plug	6, 8	Plug deployed through existing sheath. Safety tether allows removal if malpositioned.
VASCADE		Cardiva	Collagen plug	5-7	Collagen plug deployed while intravascular mesh disc creates temporary hemostasis