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FEMORAL CLOSURE DEVICES
BALAKUMARAN. J
Manual compression
Easy, “ golden standard” .
Have to wait for the ACT to decrease.
Patient and doctor discomfort
6 hours bedrest : back pain and urinary retention
15–30 min for a 6 Fr sheath
Pressure should be app.
3 min per F for arterial,
2 min per F for venous.
For 6 F
Full pressure for 5 min, then
75% for 5 min,
50% for 5 min,
25% for 3-5 min.
Manual Compression
Remains the “gold standard” in achieving hemostasis of an arteriotomy site
The sheath can be removed:
-immediately after a diagnostic procedure
-delayed (often 4-6 hours) after an intervention.
Firm manual pressure is placed 2 cm proximal to the skin entry site:
Pressure should be maintained longer for:
-larger sheath sizes
-anticoagulation
-Bed rest is recommended for 6–8 hours
Vascular Closure Devices – GEN CONCEPTS
Improve patient comfort
Shortens the time needed for hemostasis, ambulation and discharge
Risks of groin infection and leg ischemia
PASSIVE
Hemostasis Pads
Chito Seal
CloSur PAD
Syvek Patch
Neptune Pad
D-Stat
Compression devices
Femostop system
Clamp ease
Compass system
Safeguard dressing
X-press device
ACTIVE
Intestine Submucosa
FISH
Clip
Starclip
EVS
Suture
Perclose ProGlide
Perclose Prostar
Cardiva catalyst-III
Plug
Collagen
AngioSeal
VasoSeal
Polyglycolic Acid
Mynx
Exoseal
Duett
After 20 years of experience, the safety of VCDs remains controversial
and some may increase the risk of limb ischemia and groin infection.
Do the benefits of VCDs outweigh the risks?
Do VCDs benefit certain patients more than others?
Are all VCDs created equal?
PASSIVE CLOSURE DEVICES
PASSIVEHemostasis Pads
Chito Seal
CloSur PAD
Syvek Patch
Neptune Pad
D-Stat
Compression devices
Femostop system
Clamp ease
Compass system
Safeguard dressing
X-press device
Passive Vascular Closure Devices
Hemostasis pads.
The pads are coated with procoagulant material to enhance coagulation and
hemostasis.
Compared with MC, these pads improved patient and physician comfort.
Hemostasis pads did not shorten the time to ambulation compared with MC.
No insertion of foreign material into the body and immediate repeat arterial
puncture if necessary.
Hemostatic pads
It will cause local vasoconstriction and potentiates clot formation.
The clinical utility of hemostasis pads is questionable since their influence on
hemostasis is small and they do not reduce the time to ambulation
Passive Vascular Closure Devices
Chito-Seal: Abbott Vascular, Redwood City, California
Clo-Sur PAD: Scion Cardiovascular, Miami, Florida
SyvekPatch: Marine Polymer Technologies, Inc., Dankers,
Massachusetts
Neptune Pad: Biotronik, Berlin, Germany
D-Stat Dry: Vascular Solutions, Minneapolis, Minnesota
Chitoseal
It is a sterile non woven dressing coated with chitosan.
Chitosan is a linear polysaccharide made by treating crustacean shells with the alkali sodium hydroxide.This
chitosan act as a positively charged molecule which attracts the negatively charged RBCs, platelets thus increasing
the hemostatic properties.
Since it derives from crab shell there is a chance of allergic reaction.
For small vessels like radial and brachial artery.
Significant improvement in hemostasis by using chitosan pads.
D –Stat Dry
Each D-Stat Dry Silver hemostatic bandage (D-Stat Dry Silver) consists of
Lyophilized pad consisting of thrombin, silver chloride, sodium
carboxy methylcellulose and calcium chloride.
Compressed for a minimum of 6 min to 10 min. Ambulated after 4 hrs.
THE CLO-SUR PAD
The Clo-Sur P.A.D. consists of naturally occurring biopolymer
polyprolate acetate.
This linear biopolymer is cationically charged, and it is this chain of
positive charges, which gives it potent blood-coagulating properties.
The Clo-Sur P.A.D. has received clearance by the U.S. Food and Drug
Administration for use in local management of bleeding wounds, such
as vascular access sites.
Decrease time to ambulation and discharge for patients undergoing
percutaneous vascular procedures.
Syvek patch
Made of poly-N-acetyl glucosamine, which causes local vasoconstriction and
potentiates clot formation.
Should be applied directly over the puncture site and compressed for 10 minutes
after compression.
The fibers from this marine polymer are proven to accelerate platelet activation, red
blood cell aggregation and vasoconstriction.
Syvek patch
HOW TO USE IT
The technique for use is as follows:
1. Proximal pressure is held above the puncture site and the sheath is then removed.
2. The pad is then placed over the puncture site and proximal pressure is released.
3. A small amount of blood is allowed to contact the pad.
4. Constant pressure is then held for a minimum of 10 minutes. More time may be
required depending on sheath size and ACT.
5. Pressure is then released and hemostasis is confirmed.
6. The site is then covered with a sterile dressing.
7. The dressing is left in place for 24 hours.
Passive Vascular Closure Devices: Compression Devices
FemoStop Compression System
The Clamp Ease device
Compass system.
Safeguard dressing.
High technical success rates approaching 100%
Not shorten the time to hemostasis, ambulation or discharge compared with MC;
they simply replace human compression with mechanical compression
Relieve healthcare workers from performing MC, allowing them to care for more
patients and relieving hand fatigue, but they are less comfortable for patients.
Compared to MC:
Chito-Seal, Clo-Sur PAD or SyvekPatch
same complication rates
D-Stat Dry - reduced vascular complication rates
Neptune Pad - increased the risk of minor bleeding
Neptune Pad and Clo-Sur PAD
improved patient and physician comfort.
J Invasive Cardiol. 2010 Dec;22(12):599-607.
PASSIVE
Hemostasis Pads
Chito Seal
CloSur PAD
Syvek Patch
Neptune Pad
D-Stat
Compression devices
Femostop system
Clamp ease
Compass system
Safeguard dressing
X-press device
The FemoStop System
Radi Medical Systems, Inc., Reading,
Massachusetts.
Inflated to ~70 mmHg while the sheath is removed.
Then to suprasystolic pressure for ~2 minutes.
Deflated to the mean arterial pressure for 15 minutes (pedal pulse is palpable)
Slowly deflated to 30 mmHg for 1–2 hours
Finally carefully removed
In general, 20-30 minutes for diagnostic cases, 30-60 minutes for interventional
cases, and 60-90 minutes for interventional cases in patients who have been on
warfarin.
DEFLATION- Lower pressure every 2-3 minutes until the dome is completely
deflated.
The Clamp Ease device
Pressure Products Inc., Rancho Palos Verdes, California
Consists of a flat metal pad that is placed under the patient for stability,
and a C-arm clamp with a translucent pressure pad.
As the sheath is removed, the C-arm clamp is lowered so that the
pressure pad compresses the access site.
These compression devices have high technical success rates approaching 100%,do not shorten the
time to hemostasis, ambulation or discharge compared with MC; they simply replace human
compression with mechanical compression.
Major complication rates associated with the compression devices are low.
While compression devices relieve healthcare workers from performing MC, allowing them to care
for more patients and relieving hand fatigue, they are less comfortable for patients.
Compass system
Advanced vascular dynamics, Vancouver, WA.
A handle and detachable sterile, disposable disk.
Apply same way as applying manual compression.
Safe guard dressing
Datascope interventional Mahwah, NJ.
A built in inflatable bulb and a sterile dressing, it provides adjustable pressure to the site.
Availbale in 12 cm and 24 cm.
Hands-free adjustable pressure of the puncture site
Clear window allows better visibility of the puncture site
Safeguard maintains a consistent pressure
Adhesive provides a secure fit and minimizes movement
X-PRESS DEVICE
Apply the device and rotate the handle to appropriate pressure.
Can be visualised.
Stationary position for 2 hrs and ambulatory position for 2 hrs.
ACTIVE CLOSURE DEVICES
ACTIVE
Intestine Submucosa
FISH
Clip
Starclip, EVS
Suture
Perclose ProGlide
Perclose Prostar
Cardiva catalyst-IIIPlug
Collagen
AngioSeal
VasoSeal
Polyglycolic Acid
Mynx
Exoseal
Duett
Active Vascular Closure Devices
Cardiva Catalyst (Boomerang) III.
The Cardiva Catalyst (Cardiva Medical, Inc., Sunnyvale, California) uniquely facilitates hemostasis through the existing arterial
sheath, although MC is still required. (upto 7 F ).
The device is inserted through the existing sheath. Once the tip is within the arterial lumen, a conformable 6.5 mm biconvex disk is
deployed similar to an umbrella.
The sheath is removed and the disk is gently pulled against the arterial wall where it is held in place by a tension clip. The disk,
which is coated with protamine sulfate, provides temporary intravascular tamponade, facilitating physiologic vessel contraction and
thrombosis.
After 15 minutes of “dwell time” (120 minutes for interventional cases) the device is withdrawn and light MC is held for 5 minutes.
Most patients can ambulate 90 minutes after a diagnostic procedure with
this device.
The Cardiva Catalyst device does not leave any material behind in the
body which minimizes the risk of ischemic and infectious complications
and allows for repeat vascular access
ACTIVE
Intestine Submucosa
FISH
Clip
Starclip, EVS
Suture
Perclose ProGlide
Perclose Prostar
Cardiva catalyst-III
Plug
Collagen
AngioSeal
VasoSeal Polyglycolic Acid
Mynx
Exoseal
Duett
Active Vascular Closure Devices Collagen Plug Device
Angio-Seal device
St. Jude Medical, Minnetonka, Minnesota
Angio-Seal
The Angio-Seal device (St. Jude Medical, Minnetonka, Minnesota) contains a small, flat, absorbable
rectangular anchor (2 x 10 mm) an absorbable collagen plug.
First, the existing arterial sheath is exchanged for a specially designed 6 Fr or 8 Fr sheath with an
arteriotomy locator. Once blood return confirms proper positioning within the arterial lumen, the
sheath is held firmly in place while the guidewire and arteriotomy locator are removed.
The Angio-Seal device is inserted into the sheath until it snaps in place. Next, the anchor is deployed
and pulled back against the arterial wall. As the device is withdrawn further the collagen plug is
exposed just outside the arterial wall and the remainder of the device is removed from the tissue track.
Although Angio-Seal labeling indicates compatibility with 8 Fr or smaller
procedural sheaths, the Angio-Seal has been used successfully to close 10 Fr
arteriotomies utilizing a “double wire” technique.
VasosealDatascope, Montvale, NJ, USA
Extravascular collagen plug
Delivery followed by short period of manual compression
5F to 8F
Vasoseal
A guidewire is introduced into the indwelling catheter. Upstream manual compression is
applied by an assistant. The VasoSeal tissue dilator is advanced over the wire and through the
tissue tract until there is blood return or until the skin marker on the dilator is flush with the
skin surface.
Occasionally, there is resistance as the dilator passes through the fascia and the dermatotomy
may need to be enlarged and/or gentle dissection of the tract performed with use of a
hemostat.
Blood return through the dilator does not always occur because of the device’s small size, so
it is important to observe the skin marker and not be too aggressive in advancing the dilator.
The collagen delivery cartridge is then inserted into the sheath and the collagen is deployed by means of a
plunger.
Manual compression is relaxed at this time, and, if there is additional bleeding, a second collagen plug is
inserted.
The sheath is then removed from the tissue tract, and gentle, nonocclusive pressure is maintained for 15 to
30 seconds while it is determined if adequate hemostasis has been achieved.
The entire procedure usually takes less than 1 minute and is not uncomfortable for the patient. A sterile
dressing is applied and the patient is moved to a stretcher. The patient’s head is allowed to be elevated up to
45º immediately. The patient is able to ambulate after 1 hour of bedrest and is discharged shortly thereafter.
Delivers collagen to the outside surface of the vessel
Collagen reabsorbs over a six-week period
Does not leave anything inside the artery,
Do not increase the size of the arterial puncture,
No surgical suturing after the procedure.
ACTIVE
Intestine Submucosa
FISH
Clip
Starclip
EVS
Suture
Perclose ProGlide
Perclose Prostar
Cardiva catalyst-III
Plug
Collagen
AngioSeal
VasoSeal
Polyglycolic Acid
Mynx
Exoseal
Duett
Collagen plug device: Mynx.
The Mynx Vascular Closure Device (AccessClosure, Mountain View, California)
features a polyethylene glycol sealant (“hydrogel”) that deploys outside the artery
while a balloon occludes the arteriotomy site within the artery .
The Mynx device is inserted through the existing procedural sheath and a small
semicompliant balloon is inflated within the artery and pulled back to the arterial
wall, serving as an anchor to ensure proper placement. The sealant is then delivered
just outside the arterial wall where it expands to achieve hemostasis.
Finally, the balloon is deflated and removed through the tract leaving behind only
the expanded, conformable sealant.
MYNX DEVICE
Device success was achieved in 91–93%.
Mean time to hemostasis was 1.3 minutes and mean time to ambulation was 2.6 hours.
The Mynx device leads to rapid hemostasis and ambulation, but additional studies are
needed to confirm its safety.
The Mynx is indicated for interventional and diagnostic procedures and, in addition to
the 6/7 Fr model, a 5 Fr device was recently introduced.
Polyethylene glycol sealant (“hydrogel”)
that deploys outside the artery .
Balloon occludes the arteriotomy site
within the artery
Polyglycolic Acid (PGA) plug device: ExoSeal.
The ExoSeal device (Cordis Corporation, Miami Lakes, Florida) delivers a synthetic,
bioabsorbable plug to the extravascular space adjacent to the arteriotomy using visual
guidance .
No anchor left inside the artery
Two unique visual indicators enable precise positioning
Easy-to-learn deployment helps efficiently achieve procedural success
Simple 3-step procedure
Available in 3 French sizes (5-7 F).
The Plug exhibits partial to advanced absorption at 30 days, with complete absorption
between 60 and 90 days post-implant .
EXOSEAL
DuettVascular Solutions Inc., Minneapolis, Minnesota, USA
Insert the Duett catheter into
the artery via the existing
introducer sheath.
Inflate the balloon.
Withdraw the Duett catheter
and sheath as a unit until the
balloon is positioned firmly
against the inner arterial wall
Collagen and thrombin
Injection of procoagulant contains thrombin and collagen.
Seals artery and tissue tract
Balloon then removed
Delivery followed by short period of manual compression
5F to 9F
ACTIVE
Intestine Submucosa
FISH Clip
Starclip, EVS
Suture
Perclose ProGlide
Perclose Prostar
Cardiva catalyst-III
Plug
Collagen
AngioSeal
VasoSeal
Polyglycolic Acid
Mynx
Exoseal
Duett
FISH
The FISH device (Morris Innovative, Bloomington, Indiana) is
indicated for diagnostic procedures using 5–8 Fr procedural sheaths and
uses a bioabsorbable extracellular matrix “patch” made from porcine
small intestinal submucosa (SIS).
The “patch”, which resembles a roll of wrapping paper, is inserted
through the arteriotomy so that it straddles the arterial wall, then a wire
is pulled to release the “patch” from the device. Next, a compression
suture is pulled which incorporates the patch firmly in place.
The Femoral Introducer Sheath and Hemostasis Device (FISH) is used to stop
bleeding at a puncture site following 5, 6, or 8 French diagnostic, cardiac
catheterization procedures.
Concern is that the patch resides on both sides of the vessel wall i.e portion of
the patch remains intravascular.
Mean time for ambulation is 2.4 hrs.
FISH
ACTIVE
Intestine Submucosa
FISH
Clip
Starclip
EVSSuture
Perclose ProGlide
Perclose Prostar
Cardiva catalyst-III
Plug
Collagen
AngioSeal
VasoSeal
Polyglycolic Acid
Mynx
Exoseal
Duett
Active Vascular Closure Devices
Starclose-Abbott Vascular, Redwood City, California -
4mm nitinol clip implant.
The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression
The safety of repuncture at any time through any part of a
previously deployed StarClose Clip, and the safety of subsequent
closure of this repuncture using the StarClose Vascular Closure
System, have not been fully established.
STARCLOSE
Success = 87%–97% (majority interventional);
Length of stay = 157 min.
Persistent oozing at the arteriotomy site = 38%
Significantly lower rate of successful hemostasis
(Starclose 94%, Angio-Seal 99%, MC 100%; p = 0.002 )
In some patients oozing persisted for over 24 hours
At 1 month : Starclose had less pain at the puncture ( versus MC)
Case reports : femoral artery laceration, arterial occlusion due to device capture of the
anterior and posterior arterial walls, and high-grade stenosis causing debilitating
symptoms 3 weeks after closure . Catheter Cardiovasc Interv 2006;68:677–683
EVS VASCULAR SYSTEM
The EVS (Expanding Vascular Closure System) does not rely upon the
formation of thrombus toachieve hemostasis nor does it rely on suturing.
It is a mechanical closure device employing a very small staple and it is
radioopaue.
The staple is made from titanium alloy, one of the most biocompatible
materials that can be implanted in the human body from 6-8 Fr.
The mean time to hemostasis was 4.4 minutes
for EVS patients, compared with 20.7 minutes
for manual compression patients.
The mean time to ambulation was 2.4 hours for
EVS patients compared with 6.0 hours for MC
patients.
The staple is designed to penetrate into no
more than two of the three layers that make up
a vessel.
ACTIVE
Intestine Submucosa
FISH
Clip
Starclip
EVS
Suture
Perclose ProGlide
Perclose Prostar
Cardiva catalyst-III
Plug
Collagen
AngioSeal
VasoSeal
Polyglycolic Acid
Mynx
Exoseal
Duett
Active Vascular Closure Devices -Sutures
Perclose -Abbott Vascular
Perclose Proglide
Prostar
The 6 Fr ProGlide is designed for 5–8 Fr sheaths.
The Prostar for 8.5–10 Fr sheaths
PROSTAR
Risks of Individual Vascular Complications in Relation to VCDs
Bleeding is the most common vascular complication related to
endovascular procedures comprising ~70% of all complications, followed
by pseudoaneurysm (~20%).
When analyzing only trials that reported an intention-to-treat approach, the
risk of hematoma was higher and the risk of pseudoaneurysm was higher
with VCDs.
VCDs increased the risk of groin infection and tended to increase the risk of
leg ischemia and a complication requiring surgical repair
The indications for surgery in the MC patients were primarily pseudoaneurysm
(71%), hemorrhage (32%) and arterial venous fistula (15%), all of which tended to
occur more often with MC compared with VCDs.
Infectious complications (5%) and limb ischemia (7%) were infrequent indications
for surgery following MC but were significantly more common in the VCD patients
that required surgery (infectious in 39%, ischemia in 28%).
When both diagnostic and interventional cases were considered, Perclose and
Angio-Seal significantly decreased the incidence of major complications,
whereas VasoSeal significantly increased the risk.
In interventional cases, the risk of major complications was not affected by
Perclose was reduced with Angio-Seal and was increased with VasoSeal.
The Angio-Seal device has a high rate of deployment success, which is significantly better than that of Perclose Proglide. Angio-Seal allows for earlier hemostasis and ambulation compared with both compression and Perclose Proglide and is associated with greater patient satisfaction compared with compression.
In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.
Based on the meta-analysis of 30 randomized trials, there is only marginal evidence that APCDs are effective and there is reason for concern that these devices may increase the risk of hematoma and pseudoaneurysm.
Handbook of Interventional Radiologic Procedures
Journal of invasive cardiology, vol.22, Issue 12,December 2010.
Minimizing the Risk for Vascular Access-Site Complications
Femoral angiography should be performed before using an active VCD to confirm that the
arteriotomy is in the common femoral artery, superior to the femoral artery bifurcation,
inferior to the inferior epigastric artery and to confirm the absence of peripheral arterial
disease and in particular vascular calcification at the access site.
The clinical factors associated with the greatest
risk for vascular complications include female gender,
advanced age (≥ 70 years), and
low body surface area (< 1.6 m2) .
Operator Experience/Learning Curve plays a role.
Conclusion
For instance, VCDs may have been avoided if vessel wall injury was apparent or if a femoral
angiogram demonstrated high risk.
Despite these limitations, the registry results reflect the incidences of vascular complications in the
“real world” and indicate that, with appropriate patient selection, VCDs are associated with a low risk
for vascular complications.
The results of the meta-analyses differ from those of the individual underpowered studies, which
almost uniformly concluded that the safety of the VCD studied was equivalent to or noninferior to
MC.
In the absence of puncture site-related risk factors, VCDs as a whole appear to have little
influence on complication rates, and patients at high baseline risk for bleeding due to clinical
factors may benefit from these devices.
.
