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70 E.N. Brountzos and E. Alexopoulou
Stent-Related Complications
Complications related to the use of stents include
• Stent dislodgement during deployment
• Stent migration
• Stent fracture
Restenosis
• Restenosis may occur after PTA alone or may occur within stents (instent
restenosis).
• Restenosis may be due to the progression of disease or to the formation of
neointimal hyperplasia (NIH).
Key Points
• Eccentric lesions respond less well to PTA.
• Antegrade access is generally preferable to contralateral access for infrain-
guinal lesions.
• Never withdraw the guidewire back across the lesion before the procedure
is finished.
• Always check the run-off vessels at the end of the procedure for distal
embolization.
• Stents are indicated if angioplasty fails.
• Primary insertion of stents is indicated in selected cases such as iliac artery
occlusions and ostial renal artery stenoses.
Acknowledgements The authors thank Mr Dimitrios Trakadas M.Arch.NTUA for the preparation
of the illustrations.
Suggested Readings
1. Block PC, Myler RK, Stertzer S, et al. (1981) Morphology after transluminal angioplasty in
human beings. N Engl J Med 305: 382–385
2. Bolia A (1998) Percutaneous intentional extraluminal (subintimal) recanalization of crural
arteries. Eur J Radiol 28: 199–204
3. Bhat R, McBride K, Chakraverty S, Vikram R, Severn A (2007) Primary cutting balloon angio-
plasty for treatment of venous stenoses in native hemodialysis fistulas: long-term results from
three centers. Cardiovasc Intervent Radiol 30: 1166–1170
General Principles of Angioplasty and Stenting 71
4. Cole PE, Darcy M (2001) Angioplasty: Pathophysiology and techniques. In: Michael Darcy,
Suresh Vedantham, John Kaufman (eds) SCVIR Syllabus: Peripheral vascular interventions
2nd edition, Society of CV and Interventional Radiology, pp. 53–69
5. Kaufman JA (2004) Vascular interventions. In: Kaufman JA, Lee MJ (eds) Vascular &
Interventional Radiology: The Requisites, Mosby, Philadelphia, Pennsylvania, pp. 83–118
6. Kinney TB, Rose SC (1996) Intraarterial pressure measurements during angiographic evalua-
tion of peripheral vascular disease: techniques, interpretation, applications, and limitations. Am
J Roentgenol 166: 277–284
7. Pentecost MJ, Criqui MH, Dorros G et al. (1994) Guidelines for peripheral percutaneous
transluminal angioplasty of the abdominal aorta and lower extremity vessels: a statement
for health professionals from a special writing group of the Councils on Cardiovascular
Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and
Epidemiology and Prevention, the American Heart Association. Circulation 89: 511–531
8. Reekers JA, Bolia A (1998) Percutaneous intentional extraluminal (subintimal) recanalization:
how to do it yourself. Eur J Radiol 28: 192–198
9. Waston HR, Bergqvist D (2000) Antithrombotic agents after peripheral transluminal angio-
plasty: a review of the studies, methods and evidence for their use. Eur J Vasc Endovasc Surg
19: 445–450
Arterial Closure Devices
Stephen P. D’Souza and Dare M. Seriki
Introduction
• Worldwide, between 7.5 and 8 million catheter-based vascular procedures are
performed a year. Only around 20–25% of these procedures utilize a Vascular
Closure Device (VCD) for access site hemostasis.
• The use of larger sheaths and the widespread use of periprocedural anticoagula-
tion have increased the risk of bleeding complications, resulting in the need for
better methods of hemostasis.
• Complication rates related to hemostasis for diagnostic angiograms range from
0 to 1.1% and increase to 1.3–3.4% for therapeutic procedures.
• While the outcomes of VCD studies have shown increased patient satisfac-
tion, early ambulation and decreased hospital resource utilization, compared
with manual compression, there is limited evidence that hemorrhage and other
puncture-site complications are reduced by VCDs. Indeed, the use of VCDs is
associated with a new group of complications related to the devices themselves.
Manual Compression
• The method considered the gold standard, described by Seldinger et al in 1953,
involves manual compression over the puncture site, for 10–30 min, followed by
overnight bed rest. This method achieves hemostasis due to the formation of a
fibrin and platelet plug following exposure of the blood to the collagen in the
arterial wall at the puncture site.
• Traditional bed rest times after manual compression are set arbitrarily.
• The evidence suggests that overnight bed rest is unnecessary. For example, in a
study of early mobilization following manual compression of 6F arterial punc-
tures post-angioplasty, 90% of 128 patients were ambulant at 4 h following
gradual mobilization after 2 h of supine bed rest. This was achieved with no
major puncture-site complications and no delayed complications.
73
R.A. Morgan, E. Walser (eds.), Handbook of Angioplasty and Stenting Procedures,
Techniques in Interventional Radiology, DOI 10.1007/978-1-84800-399-6_7,
C
Springer-Verlag London Limited 2010
74 S.P. D’Souza and D.M. Seriki
Types of Vascular Closure Device
Vascular closure devices fall into two main categories:
1. Active Devices
Achieve hemostasis immediately and involve some kind of mechanical seal.
• Suture alone
b
Perclose AT and Prostar XL10 (Abbott Vascular, Redwood City,
California).
• Extravascular collagen alone
• Suture−collagen combinations
b
Angioseal (St. Jude Medical, St. Paul, Minnesota)
• Surgical staple or clip:
b
StarClose (Abbott Vascular, Redwood City, California)
b
EVS-Angiolink (Medtronic Co., Minneapolis, Minnesota)
2. Passive Devices
These do not achieve immediate hemostasis.
• Augmented manual compression:
b
External patches with prothrombotic coatings − Syvek Patch, (Marine
Polymer Technologies, Danvers, Massacheusetts).
b
Wire-stimulated track thrombosis-Boomerang ClosureWire (Cardiva
Medical, Mountain View, California).
• Mechanically assisted manual compression − these will not be discussed
further:
b
Femstop − (RADI Medical Systems, Uppsala, Sweden)
b
Clamp-ease (Pressure Products, Rancho Palos Verdes, CA)
b
Sandbags and pressure dressings
Active Vascular Closure Devices
Prostar XL10 and Perclose A-T
Both are suture-mediated devices and create a purely mechanical seal.
Arterial Closure Devices 75
Prostar XL10:
• The device consists of a 10F shaft holding two pairs of needles connected by
two braided polyester suture loops and a rotating barrel that is used to facilitate
the positioning of the device before needle deployment and to guide the needles
during their travel through the subcutaneous tract.
• Device deployment:
1. At the end of the procedure, the sheath is removed and the device is inserted
over a standard guidewire.
2. Dilatation of the subcutaneous tract is needed to accept the oversize barrel.
3. Correct positioning of the device with the barrel against the arterial wall is
confirmed when pulsatile blood exits the marker lumen (this occurs when
the distal end of the marker lumen enters the artery).
4. The needles are deployed, passing from within the device in the arterial lumen
through the arterial wall and back into the barrel.
5. They take the suture ends with them and exit from the top of the device.
6. The needles are cut from the sutures that are then freed from the device.
7. The surgical knots are tied using a slipknot. The knots are slipped (pushed)
down onto the arterial wall while the device is removed.
8. The knots are tightened with a knot pusher, achieving hemostasis, and the
suture ends are cut short.
• This device can be used to close very large arteriotomies and has been used to
perform endovascular aneurysm repair using a totally percutaneous technique
without the need for a surgical femoral arteriotomy.
• The availability of the Prostar device varies widely worldwide. At the present
time, it is very difficult to acquire the device in the UK.
Perclose A-T (Fig. 1):
• This is a smaller device and is designed to be used to close puncture sites 6–8F
in diameter.
• With the Perclose A-T (auto-tie) a slipknot is already created within the device,
which enables a more rapid, easier, and single-handed operation.
• The device is inserted over a guidewire, which can be reintroduced during the
procedure if a problem is encountered.
• The device can also be used to close larger arteriotomies using the technique
known as predeployment:
b
Predeployment involves inserting the suture into the arterial wall at the start
of the procedure.
b
Providing the stitch is not “tied and locked”, the puncture site can be dilated
to a larger French size.
76 S.P. D’Souza and D.M. Seriki
Fig. 1 (a, b) Diagrammatic representation of the deployment of a Perclose AT device
b
Once the procedure is completed, hemostasis is achieved by the tightening the
predeployed suture.
• Thus the 6F device can be pre-deployed prior to dilation of an arteriotomy up to
12F.
• It is also possible to use more than one device at a time in order to close even
larger arteriotomies.
• Similar to the Prostar XL10, the Perclose A-T can be used to perform endovas-
cular aneurysm repair using a combination of the predeployment technique and
more than one device.
• Perclose devices have been used successfully to close puncture s ites in other
locations such as the brachial and popliteal arteries.
Arterial Closure Devices 77
• The devices have also been used to close inadvertent subclavian artery punctures
created during central venous catheter insertion.
Angioseal
This device creates a mechanical seal by sandwiching the arteriotomy between a
biodegradable polymer anchor, which remains inside the vessel, and an extravascu-
lar collagen sponge. The collagen augments the mechanical seal by inducing platelet
adhesiveness and is held in place by a self-tightening suture (Fig. 2).
• The device is available in 6 and 8F versions.
• It consists of a delivery system and three bioabsorbable components.
• The delivery system consists of
b
A 0.035-inch guidewire
b
An insertion sheath
b
A dilator with a marker lumen (which locates the arteriotomy)
• The bioabsorbable components consist of
b
A flat 10 mm × 2mm× 1 mm anchor (footplate)
b
A collagen plug
b
A suture that maintains tension between these two components
• Device deployment:
1. At the end of the procedure the insertion sheath/dilator combination is inserted
over a guide wire.
2. The sheath is inserted until blood exits from the marker hole at the proximal
end of the dilator.
Fig. 2 Diagrammatic representation of the deployment of an Angioseal device
78 S.P. D’Souza and D.M. Seriki
3. The entire system should be gently withdrawn over the guidewire until the
passage of blood from the marker hole stops.
4. After this point has been reached, the device should be reinserted 1.5 cm into
the artery.
5. The guide wire and dilator are removed.
6. While holding the sheath fixed in position, the carrier tube containing the
anchor, plug, and suture is inserted into the sheath.
7. The anchor is deployed into the arterial lumen and is pulled back to abut
against the wall of the artery over the arteriotomy site.
8. The carrier tube and the sheath are withdrawn to reveal a tamper tube that is
used to tamp the collagen plug against the outer arterial wall and locks into
place.
9. The suture is cut below the skin.
• The anchor is reabsorbed in a process that is physically complete at approx-
imately 30 days and chemically complete at approximately 90 days post-
procedure.
• Arterial re-puncture within 90 days is not recommended, because of the risk of
displacement of the anchor. It may be possible to identify and avoid the anchor
using ultrasound, if arterial puncture at the same site is required urgently before
this interval.
• The current device is the Angioseal STS PLUS platform.
• A more recent development is the Angioseal VIP (V-twist Integrated Platform).
This version features a larger collagen plug that conforms to the vessel by twisting
down onto the arterial wall. Apart from this design change the deployment is the
same as the STS device.
StarClose
• The StarClose system (Abbott Vascular, Redwood City, California) is designed
to deliver a 4 mm diameter nitinol staple onto the outside of the vessel.
• The device can close a 6F puncture site.
• The system is designed for single-operator use and closure time should be less
than 60 sec.
Passive VCD
Boomerang ClosureWire
• This is a relatively new device.
• The Boomerang ClosureWire consists of a collapsed nitinol disc on an intro-
ducer/deployment wire (Fig. 3).
• Device deployment:
Arterial Closure Devices 79
Fig. 3 (a, b) Diagrammatic
representation of the
deployment of a Boomerang
CloseWire
1. The device is introduced into the artery through the sheath at the end of the
procedure.
2. Once the wire is in place, the nitinol disc is opened to form a flat, low-profile
disc within the vessel.
3. Upon removal of the arterial sheath, the Boomerang disc is positioned against
the arterial wall forming a temporary hemostatic seal until the natural
elastic recoil of the arteriotomy, known as the Boomerang Effect, returns the
arteriotomy to the size of an 18-gauge needle.
4. Following the procedure, the device is completely removed leaving no
residual foreign body and minimal scarring.
5. Final hemostasis is achieved by a few minutes of occlusive finger pressure.
• A recent modification of the device, the Boomerang Catalyst wire, incorpo-
rates an active agent that can initiate hemostasis in the track. The surface of
the Boomerang Catalyst wire adjacent to the arteriotomy site has a negatively
80 S.P. D’Souza and D.M. Seriki
charged proprietary compound, which activates factor XII thereby promoting
hemostasis.
• The device has been used to close arteriotomies up to 10F with only a few minutes
of manual compression required following removal of the device.
• The main drawback of the device is that elastic recoil at the arteriotomy site may
take 20–30 min and therefore hemostasis may be time consuming, arguably with
no tangible benefit versus conventional manual compression.
Patch Technology
In the past there has been some interest in so-called patch technologies which
encompass a group of products that augment manual compression:
• They consist of celluloid polymer patches coated with agents that are applied
externally and accelerate the coagulation process when blood comes into contact
with the patch, along the puncture tract.
• Manual compression is still required.
• However, they have a number of advantages:
b
Ease of use.
b
They can be used in anticoagulated patients.
b
They can be used in patients on anti-platelet therapy.
b
No foreign body is left in situ.
b
There are no stipulations regarding repeat arterial puncture at the same site cf
Angioseal.
b
One size fits all.
• At present, there is no clinical evidence that the time to ambulation is reduced
with these devices.
Syvec Patch
• The Syvec Patch consists of a celluloid polymer patch coated with poly-N-Acetyl
glucosamine (pGlcNAc).
• When it comes into contact with blood, it invokes both clot formation and local
vasoconstriction as part of its overall hemostatic effect.
• Following the procedure, the sheath is removed and the saline moistened Syvec
Patch is applied and held in place with manual compression for 4 min.
• Manual compression is maintained if blood continues to ooze.
• Once hemostasis is achieved, the patch is left in place with a non-occlusive
dressing for 24 h.