various vascular closure devices used in PCI

1. VASCULAR CLOSURE DEVICES

2. INTRODUCTION
• The description of the Seldinger technique in 1953 created a novel problem—
physicians were creating holes in the common femoral artery that finally needs to
be closed.
• The first, and still gold standard, method for addressing this problem is the use of
manual compression

3. • Arterial puncture with procedural sheath insertion is the standard technique by
which percutaneous cardiac interventions are performed.
• Today, a larger number of patients with atherosclerotic disease are now suitable
candidates for percutaneous interventions, due to improvements in both
interventional techniques and devices.
• However, complications related to vascular access and access site closure are the
leading cause of morbidity after cardiac catheterization procedures.

4. • The traditional method to achieve closure of the arteriotomy site has been
manual compression, which requires close observation and prolonged bed rest in
order to be successful.
• Vascular closure devices were introduced in the mid-1990s to reduce the
associated vascular complications, as well as the time required for hemostasis of
the arteriotomy site and ambulation, and improve patient comfort during the
actual closure as well as during the recovery period.
• Subsequently, several generations of vascular closure devices have been
introduced that incorporate various mechanisms to achieve hemostasis.

5. • Vascular access complications, reported to be as high as 6% in some series,
remain the leading cause of morbidity after a cardiac catheterization procedure.

6. VASCULAR CLOSURE DEVICE
• The vascular closure device (VCD) market has grown exponentially since its
inception in the early 1990s.
• The use of manual compression may be of limited utility in obese patients or
patients on anticoagulation, and the complexity of procedures performed with a
percutaneous endovascular approach has grown, often with an associated
increase in sheath size.

7. • In such situations, the ability for manual compression to achieve hemostasis may
be decreased.
• As the economic landscape of health care becomes more competitive, VCDs are
becoming increasingly valuable because their use can free up medical personnel
for other responsibilities. Early ambulation and improved comfort also boost
patient satisfaction

10. benefits of VCD
• The potential benefits of a VCD when compared to manual compression are
(1) increased patient comfort,
(2) immediate or early postprocedure mobility, and
(3) reduced bleeding and vascular complications

11. TYPES
• VCDs will be divided into three main categories.
- Active approximators physically close the arteriotomy with the
use of a suture or a nitinol clip.
- Passive approximators deploy a plug, sealant, or gel at the
arteriotomy site without actively closing the arteriotomy. Finally,
- external hemostatic devices are placed on top of the skin and are
designed to achieve hemostasis by providing mechanical pressure at
the arteriotomy site or by accelerating the clotting cascade.

13. ACTIVE APPROXIMATORS
• Active approximators are designed to replicate surgical closure of an
arteriotomy.
• By physically closing the arteriotomy, these devices theoretically do not require
the use of any manual compression.
• With these VCDs, the use of anticoagulation is not a concern, and a procoagulant
plug is not needed.
• As a result, groin scarring and discomfort related to inflammation are not a
concern with this device class

15. Suture-Based Devices
• Suture-based VCDs were some of the initial devices designed. They
percutaneously deploy a suture on either side of the arteriotomy site, mimicking
open surgical closure.
• The sutures are then pulled together, closing the arteriotomy site, and resulting in
mechanical hemostasis.

17. • Advantages of these suture-based devices include active closure, the option for
immediate reaccess, and the lack of any intra- or extraluminal implant material.
• The major disadvantage of these devices is the technical expertise required for
their deployment.
• Relatively large, nonrandomized studies comparing Angio-Seal to Perclose
ProGlide have been published but do not demonstrate consistent findings in
regard to success rates or rates of major complications.
• However, one randomized study by Martin et al comparing Angio-Seal to Perclose
ProGlide demonstrated an advantage for Angio- Seal in regard to deployment
success. This underscores the complexity associated with Perclose ProGlide
device deployment

18. Clip-Based Devices
• The StarClose SE (Abbott Vascular) deploys a 4-mm nitinol clip over the
arteriotomy and requires a sheath exchange, but leaves nothing intravascularly.
• The metallic clip remains in place indefinitely, potentially limiting the evaluation
of immediately adjacent structures on magnetic resonance imaging

21. • An advantage of this device, similar to that of the Perclose ProGlide devices, is a
- lack of device implantation into the arterial lumen.
- An additional advantage with StarClose SE is its deployment through the
procedural sheath, obviating the need for any sheath exchange.
A disadvantage of this device is that
- it is a permanent implant, which potentially impacts re-access and the ability
to use some magnetic resonance imaging protocols

23. PASSIVE APPROXIMATORS

24. • With this class of VCD, the plug is deployed on top of the arteriotomy, although
the arteriotomy is not physically closed.
• Hemostasis is achieved because the plug expands when deployed in the
subcutaneous tissues, and collagen in the plug accelerates the clotting cascade.
• If the plug is not collagen based, hemostasis is achieved through expansion of the
plug on top of the arteriotomy, not through clot acceleration

26. COLLAGEN PLUG- ANGIO-SEAL
• Angio-Seal (St. Jude Medical, Inc.) is the most widely used VCD.
• The device uses an intravascular anchor to secure an extravascular collagen plug
on top of the arteriotomy site.
• All components, including the intravascular anchor, are fully absorbed within 60
to 90 days. Use of an intravascular footplate to secure the plug atop the
arteriotomy is unique, representing both a strength and limitation of the device.
• Angio-Seal and the latest iteration (Evolution)are the VCD market leader by a
large margin (50.6% in 2010), due to both a high rate of primary success, as well
as its intuitive deployment mechanism

28. • Potential concerns particular to this device are
- misplacement or misalignment of the anchor within the arterial lumen,
- embolization of the anchor, and deployment of procoagulant collagen into
the arterial lumen.
• Fortunately, it appears that these complications are very rare.

29. VASCADE
• The VASCADE vascular closure system (Cardiva Medical, Inc.) is a fully integrated,
extravascular, bioabsorbable femoral access closure system.
• The system offers dual mechanism of action, mechanical and physiological

31. Sealant- or Gel-Based Devices

33. Mynx
• The Mynx (Cardinal Health) family of devices functions by delivering a
polyethylene glycol sealant to the extravascular space over the arteriotomy site.
• The sealant does not enhance coagulation, but conforms to the arteriotomy site,
sealing the vessel. The devices contain a new Grip sealant that is designed to
increase the sealant volume by up to 300% when the device is deployed.
• The sealant also advertises increased adherence of the plug to the arteriotomy.
One benefit of the MynxGrip device is that it does not require a sheath exchange,
and it also recently received approval to close femoral veins.
• The MynxAce device was recently added to the product line and features an easy-
to-use delivery system.

35. Exoseal
• The Exoseal VCD uses a similar mechanism by deploying a polyglycolic acid plug
over the arteriotomy. The deployment system is different from the Mynx device
in that visual indicators guide deployment. As a result, tactile feedback is not
needed, which may potentially shorten the operator learning curve

38. FISH
• Device uses an extracellular matrix closure patch premounted onto the access
sheath through which intervention is performed.
• The FISH (Femoral Introducer Sheath and Hemostasis) device (Morris Innovative,
Inc.,Bloomington, IN) provides an active method of closure that is implemented
using the intraluminal deployment of a ribbon created from porcine small
intestinal submucosa. This ribbon folds up as it is withdrawn into the arteriotomy
through backward tension on a compression suture, creating a resorbable plug in
the artery wall. The intravascular plug absorbs in 30 days.
• The FISH device also allows for the option of delayed sheath removal after
transport of the patient out of the catheterization laboratory and discontinuation
of anticoagulants.

39. The FISH device is currently only indicated for diagnostic
cases and is available in 5- to 8-F sizes

40. GEL
• The hydrogel PEG also provides distinct patient safety benefits, including that it:
►Is highly absorbent–when hydrated, the sealant is comprised of 95%
water and 5% PEG;
►Is non-thrombogenic–it does not create thrombin or actively initiate the
clotting cascade;
►Degrades hydrolytically with no enzymatic reaction (i.e., an inflammatory
response that results in scarring);
►Is bio-inert, i.e., it is bio-chemically inactive in the body;
►Has a well-established safety profile–PEG is widely used in many over-
the-counter health care products
►Unlike collagen, it does not promote bacterial growth. The PEG-
containing polymers have been shown to exhibit a lowdegree of protein
adsorption, cell adhesion, and bacterial adhesion

42. FastSeal
• It is a bioabsorbable plug that is advanced through the 6- or 7-F procedural
sheath, at which time, the plug expands intravascularly.
• The sheath is then withdrawn, and the plug locks into place at the arteriotomy
site, producing hemostasis. The intravascular component absorbs in 2 to 3 weeks,
and the extraluminal component absorbs in approximately 2 months.
• It is not yet received CE Mark or US Food and Drug Administration approval.
• There is a version of this device suitable for 18-F arteriotomy closure that is in
development as well.

44. COMPRESSION DEVICE

46. Compression-Assist Devices
• Compression-assist devices are a type of passive approximator that do not use a
retained suture, clip, or plug.
• The Axera 2 access system (Arstasis) creates a low-angle arteriotomy to achieve
hemostasis. Femoral artery access is achieved using a 19-gauge needle in a
conventional manner.
• Using the Axera 2 device, this access is converted to a shallow 10° to 15° access
through which the procedure will be performed. After the procedure is complete,
the sheath is removed, and manual pressure is held.
• The shallower angle hastens hemostasis due to increased arterial wall overlap
and tract compression by the radial pressure of pulsatile blood.

48. Catalyst (boomerang)
• The Catalyst II and Catalyst III devices (Cardiva Medical, Inc.) have an intravascular
nitinol disk at the end of an 18-gauge nitinol wire. After the procedure, the disk is
introduced into the artery, and gentle traction is then applied to the wire to
appose the disk to the arteriotomy.
• The device is left in place for 30 minutes and then removed in its entirety. The
family of devices can be delivered through 5- to 7-F procedural sheathes.
• Catalyst II is coated with kaolin and chitosan, used to promote coagulation by
activating the clotting cascade and causing platelet aggregation.
• Catalyst III is coated with an additional drug, protamine sulfate, acting locally to
neutralize heparin and further aid the body’s natural healing process.

51. HEMOSTASIS PADS
• ChitoSeal (Abbott Vascular, Redwood City, California),
• CloSur PAD (Scion Cardiovascular, Miami, Florida),
• SyvekPatch (Marine Polymer Technologies, Inc., Dankers, Massachusetts),
• Neptune Pad (Biotronik, Berlin, Germany) and
• Dstat Dry (Vascular Solutions, Minneapolis, Minnesota) can be used in
conjunction with MC.
The pads are coated with procoagulant material to enhance coagulation and
hemostasis

52. • Hemostasis pads did not shorten the time to ambulation compared with MC.
• The clinical utility of hemostasis pads is questionable since their influence on
hemostasis is small and they do not reduce the time to ambulation

53. COMPRESSION DEVICES
• The FemoStop plus Compression System (Radi Medical Systems, Inc., Reading,
Massachusetts) consists of a belt that wraps around the patient and a
transparent, inflatable pneumatic bubble .
• A hemostatic dressing is placed on the arteriotomy site, then the bubble is
positioned 1 cm above the arteriotomy.
• The bubble is inflated to ~70 mmHg while the sheath is removed, then to
suprasystolic pressure for ~2 minutes, and it is deflated to the mean arterial
pressure for 15 minutes (pedal pulse is palpable), then slowly deflated to 30
mmHg for 1–2 hours, and is finally carefully removed.

57. MANUAL COMPRESSION
• MC remains the “gold standard” in achieving hemostasis of an arteriotomy site.
• With MC, the sheath can be removed immediately after a diagnostic procedure
but is delayed (often 2–4 hours) after an interventional procedure to allow the
activated clotting time to decrease to < 170 seconds.
• As the sheath is removed, firm manual pressure is placed over the femoral artery,
typically 2 cm proximal to the skin entry site. Firm pressure is held for 10 minutes,
then slightly less firm pressure for 2–5 minutes, then light pressure while applying
a pressure dressing.

58. • Pressure should be maintained longer for larger sheath sizes and in the setting of
anticoagulation.
• If bleeding persists, MC is maintained for an additional 15 minutes.
• Once hemostasis is achieved bed rest is recommended for 6–8 hours.
• When VCDs fail, MC is used to achieve hemostasis.

60. Which Device to Use?
Patient and Vessel specific
Heavily anti-coagulated- invasive active approximation
Diseased vessel- passive approximation
Residual oozing- thrombosing sealing agent or topical
hemostatic patch
Operator experience/competence

61. requirement for VCD

62. Vascular Closure Device Related Complications
• An analysis was done of all patients requiring surgical intervention following
complications from percutaneous vascular access
• 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%).
• More complex surgical procedures were required for VCD patients, such as
interposition of bypass grafts

63. • In a retrospective analysis (VasoSeal 937, AngioSeal 742, Techstar 1001, MC 1019
patients, respectively), infections occurred in 0.3–0.4% of all VCD patients and in
none of the MC patients.
• Complications requiring surgical repair occur slightly more frequently with VCDs
compared with MC
• Although the risks of severe complications are low and probably decreasing as
operators gain experience, patients should be examined carefully for
complications after the use of a VCD, and VCDs should be avoided in patients
with puncture site related risk factors.
Catheter Cardiovasc Interv 2001

64. learning curve
• The AngioSeal device is easy to use and has high technical success.
• The Starclose device is also simple to use, but since oozing occurs frequently, the
Starclose device is better suited for diagnostic procedures than interventional
procedures with full anticoagulation.
• The Boomerang device can be used in the presence of peripheral vascular disease
and is preferred by many vascular surgeons because nothing is left behind in the
artery.
• With Perclose, access to the artery is maintained (guide wire remains in place),
even with device failure, and complications generally become evident
immediately, as opposed to delayed complications that may occur with other
VCDs.

65. conclusion
• MC remains the gold standard for achieving hemostasis at a vascular access site.
• The FemoStop and Clamp Ease have high success rates in achieving hemostasis
and can be used safely in most patients. Other than the FemoStop and Clamp
Ease, VCDs improve patient comfort.
• All active VCDs shorten the time to hemostasis and ambulation to a relatively
similar degree.

66. • In the absence of puncture siterelated 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 VCDs.
• VCDs increase the risk of leg ischemia, groin infection, and complications
requiring surgical repair, which are rare with MC.
• Screening with femoral angiography prior to VCD placement and avoidance of
VCDs in the presence of puncture siterelated risk factors might reduce the risk of
vascular complications

67. THANK YOU