Basics of vascular closure devices, Angioseal, Vasoseal, D-star dry, Syvek patch

1. Dr. Rohit Walse

2.  Introduction
 Evolution
 Passive devices
 Active devices
 Data

3.  Access site related complications are one of the important events
relating to procedure related morbidity.
 Most commonly seen with large bore access – femoral artery.
 Manual compression has been considered the gold standard for
achieving hemostasis.

4.  Incidence of major complications – 1-17%
 Femoral site complications :-
Diagnostic – 1.8%. Intervention – 4%
 Bleeding rates = 2-14%

5.  Manual compression is dependent on operator technique and
expertise.
 Cumbersome
 Requires prolonged bed rest, patient discomfort
 Increase in structural interventions, use of MCS devices - need
of large bore access (>10F)

6.  1st introduced in 1990s
 Aim – reduce time, labor and patient discomfort associated
with manual compression
 VCD technology has undergone development over time
 Development and use of VCD has been lagging behind in
comparison to other fields of interventional cardiology.

7.  Shorten time to hemostasis
 Reduced bleeding and access site complications
 Early patient ambulation and reduced discomfort
 Does not depend on anticoagulation

8.  Passive devices
 Active devices
- Suture based
- Collagen plug based
- Clips

9. Both passive and
active VCD have been
developed together
over the years

10.  Passive closure devices  Active closure devices

11. Passive closure devices Active closure devices
 Enhance hemostasis with
prothrombotic material or
mechanical compression
(augments natural hemostasis
process)
 Immediate hemostasis not
achieved
 Prolonged bed rest warranted
 Achieve hemostasis by closing
arteriotomy site
 Immediate hemostasis is
achieved
 Early ambulation

12.  Enhance manual hemostasis
 Hemostasis pads
 Compression devices
 Usually used in conjunction with manual compression

13.  Pads are coated with pro-coagulant materials
 Enhance process of hemostasis
 Used in conjunction with manual compression

14.  Placed over puncture site
 Coated with Chitosan gel
 Positively charged
chitosan molecules which
attract negatively charged
RBC and platelets towards
it
 Expedites clot formation
and achieves hemostasis

15.  Topical hemostasis pad
 Contains poly-N-acetylglucosamine fibers in a lyophilised 3-
D structure
 Achieves faster hemostasis
 Can be used in patients with ACT upto 300
 Allows almost immediate sheath removal after procedure

17.  Topical hemostasis pad
 Contains polyprolate, known chitosan biopolymer
 Positive charge attracts negatively charged RBC and platelets –
enhances hemostasis
 Also provides an antimicrobial barrier over access sites

18.  Contains thrombin
 Activates the intrinsic
coagulation coagulation
cascade
 Also contains silver chloride
– works as an antimicrobial
agent

19.  Neptune PAD (calcium alginate)
 Quick Clot
 V+ PAD (D-glucosamine enriched fibres)

21.  Comparison of Chito-seal and Clo-sur pad with manual compression
 Time to hemostasis significantly reduced (16.2 +/- 4.9, 16.0 +/- 5.3,
18.3 +/- 5.7 min)
 Major and minor bleeding rates similar
 Overall time to ambulation was similar in all groups
 Removal of sheath at higher ACT levels enabled early ambulation post
PCI
Nyugen et al. Catheter Cardiovasc Interv. 2007 May

22.  Clo-Sur PAD compared with manual compression
 Hemostasis time was 10.15+/-1.96 min (control group:
16.20+/-1.79 min)
 Ambulation was possible after 2.13+/-0.50 h (control group:
8.57+/-3.47 h)
 Access-site bleeding with hematoma (device: n=3; control:
n=9)
 No major complications noted
Balzer et al. European Radiology, March 2007

23.  Used as a substitute to manual compression (hands free manual
pressure)
 Can provide longer and sustained compression
 Easy and less cumbersome for the operator
 Various devices available – FemoStop, ClampEase, SafeGuard

24.  Adjustable belt allows placement
of device over arterial access site.
 Digital manometer helps to
accurately maintain desired
pressure
 Transparent dome allows
visualization of access site

25. Ensure proper
compression of
access site.
- Large
hematoma
- Excessive pain
despite
analgesia

26.  Diagnostic cases- 20-30 mins
 Interventional cases- 30-60 mins
 Interventional cases on OAC- 60-90 mins

27.  Metal plate is placed under the
patient such that C-arm is directly
above the access site
 As sheath is removed, C-arm clamp
with pressure pad is lowered down
on the access site
 Transparent pad allows
visualization of access site

28.  Comparison of mechanical clamp compression vs hand pressure
 Primary end point was a composite of ultrasound-defined femoral
vascular complications
 Compared to manual compression, mechanical clamp hemostasis
reduced the primary adverse end point by 63% (p = 0.041)
 Reduces operator burden
Pracyk et al. JACC April 1998

29.  Reduces burden on the operator
 Reduces hand fatigue
 Able to take care of more patients
 Patient discomfort ++

30.  Collagen based devices-Angioseal, Vasoseal
 Polyglycolic acid- Mynx, Exoseal, Duett
 Suture based devices- Proglide, Prostar
 Clip based devices-Starclip, EVS

31. Femoral angiogram - to assess femoral anatomy and site of
puncture
Precaution to be exercised if -
 High or low puncture
 Femoral artery calcium
 Significant peripheral arterial disease
 Small femoral arteries
 Access via vascular graft
 Bleeding diathesis, patient on Gp IIb/IIIa inhibitors

32.  Wire based device which causes internal
tamponade of arteriotomy site
 Device has nitinol wire and nitinol braided
mesh disc
 Site specific compression between
arteriotomy and tissue tract – internal
compression
 Recoil of arteriotomy site – boomerang
effect
 Manual compression needed after device
removal
 For 4-10 F arteriotomies

34.  Collagen based device which closes arteriotomy site
 Consists of absorbable anchor, absorbable collagen plug and suture
 Used for closure of 6-8F arterial access sites
 Needs to be stored in cool place (10-25ºC)

35.  Insertion sheath
 Angioseal device
– anchor, collagen
plug, suture
 Arteriotomy
locator
 Guidewire

39.  All components of angioseal device are absorbed within 90 days
 Re puncture can be done at the same site – 1 cm higher than previous
one
 No definite contraindications for angioseal use
 Femoral sheath angiogram should be taken before deciding on usage
of vascular closure device.

40.  Angioseal not to be used if puncture site is above inguinal ligament –
risk of RP hematoma.
 Angioseal not to be used if puncture site below bifurcation of femoral
artery
- anchor may not deploy correctly
- collagen may get deposited in the vessel (cause arterial ischemia)

41. Patients with peripheral vascular disease –
Angioseal can be used if
- Femoral arteries > 5mm diameter
- Luminal narrowing <40% within 5mm of puncture site

42. Device non deployment
- On pulling back the sheath, the device comes out along with it
(does not anchor)
- Remove the angioseal device – give manual compression
- Can occur in variable vessel anatomy where anchor does not
engage the vessel wall properly

43. Anchor fracture/embolism
- During removal of device, in case of non deployment, anchor
can get fractured or embolise
- Watch for symptoms and signs of limb ischemia
- Embolised anchor rarely causes tissue ischemia
- If limb ischemia develops, Rx – anticoagulation f/b
percutaneous retrieval/surgical removal

44. Infection at access site –
May need surgical removal of device
Collagen deposition in artery or thrombosis at puncture site –
May require thrombolysis, mechanical thrombectomy or surgical
removal

45. Collagen protruding from skin surface:
May occur in very thin patients
Attempt to push in the collagen as much as possible with tamper
tube
Do not apply vigorous pressure – anchor may get fractured
Do not cut off the collagen – interwoven sutures may get disrupted
and the integrity of anchor/collagen sandwich may be lost

46.  Closure of arteriotomies > 8F
 2 wires are inserted through sheath – sheath removed
 Angioseal device is placed over one wire
 After collagen plug deployment – look for adequate
hemostasis
 If hemostasis achieved, pull out other wire carefully while
maintaining pressure on collagen plug
 If hemostasis not achieved, insert another Angioseal device
over other wire

47.  Angioseal vs manual compression (n=435)
 Device success rate = 96%
 Time to hemostasis was significantly shorter in Angioseal group
 Complication rates were lower in Angioseal – bleeding and hematoma

48.  Collagen based vascular device
 Contains Polyethylene glycol, water soluble, bio-inert polymer
 Combination of mechanical closure with an extravascular sealant
 Tamponade balloon on inside, polymer sealant on outside
 Used for closure of 5-7F arterial access sites
 Device success = 91-93%1
1Scheinert D et al. Catheter Cardiovasc Interv
2007;70:627–633.

50.  Once the sealant enters the tissue tract,
the body’s temperature and pH level
cause the Grip Tip to soften and
securely adhere to the vessel wall,
effectively gripping the artery and
providing active closure.
 The sealant’s porous structure absorbs
blood and subcutaneous fluids. The
sealant swells three to four times its
original size, filling the tissue tract.

51.  Collagen plug based device
 5-7F arteriotomies
 12 cm working length needed
 No anchor left inside the artery
 2 unique visual indicators for precise positioning
 Device success = 94%1
1Wong et al. JACC Cardiovasc Interv 2009;2:785–
793.

53.  Step 1 – Insert Exoseal device through sheath until marker
band
 Step 2 – Retract sheath upto sheath adaptor on device. Back
bleed noted. Indicator wire uncovered in artery
 Step 3 – Pull back entire assembly until back bleed slows
down or stops. Continue retraction till graphic pattern in
indicator window changes from black-white to solid black.
 Step 4 – Plug deployment. Indicator wire automatically retracts
back and plug gets deployed.

56.  Uses bioabsorbable extracellular matrix patch, made from
small intestinal submucosa.
 Used for 5-8F arteriotomies
 Patch straddles arteriotomy site and suture incorporates the
patch firmly at site
 Portion of patch remains intravascular
 No documented complications
 Success rates = 98%1
1Bavry et al. J Invasive Cardiol 2008;20:152–156.

57.  Collagen based device which closes both arteriotomy and tissue tract
 Uses a liquid procoagulant for sealing
 Procoagulant – combination of collagen and thrombin
 Consists of low profile balloon and sleeve
 Recommended for 5-9F arteriotomies
 Does not leave any residual material intravascular or extravascular

58. Step 1 –
Insert device into sheath upto black marker. Inflate balloon with saline

59. Step 2 –
Balloon withdrawn till tip of sheath (1st resistance)
Whole system withdrawn till balloon anchors against arterial
wall (2nd resistance)

60. Step 3 –
 Pull back sheath
slightly
 With light tension on
device, procoagulant
liquid is injected
through side port of
sheath

61. Step 4 –
After ensuring hemostasis,
deflate balloon
Pull back entire system while
maintaining manual
compression proximally

62.  N = 630
 Time to hemostasis significantly lower in device group vs manual
compression
 Time to ambulation was also lower in device group
 Major complications = 3.6%(DUETT) vs 1.7% (MC) [p=0.22]
 Similar benefits in diagnostic and interventional procedures

63.  Collagen based closure device
 Used for large bore arteriotomies
(12-25F)
 Available in 2 sizes – 14 F and 18
F
 Radiopaque stainless steel lock –
acts as marker for future access.

65.  Over the wire deployment
 Deployment similar to angioseal device
 Introducer sheath for puncture site localization
 Device insertion
 Anchor deployment at 1cm deeper than puncture depth
 Pull back device – collagen gets deployed
 Lock advanced via lock advancement tube

66.  50 patients who underwent BAV or TAVR
 Large bore arteriotomies (12-19F)
 Successful deployment in all patients
 Mean time to hemostasis – 2min 23 sec
 Major vascular complication – 1 patient (surgical repair)

67.  N = 263
 Manta VCD used in EVAR,TEVAR and TAVR procedures (majority
TAVR ~ 80%)
 Success rate = 97.7%
 Majority had single device usage (99.6%)
 Major vascular complications noted in 4.2% (managed with covered
stent, balloon tamponade or surgical repair)
 Mean effective sheath outer diameter was 22F

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