The document discusses the evolution and advantages of vascular closure devices (VCDs) in achieving hemostasis after arterial procedures, emphasizing their utility over traditional manual compression methods. It details various types of VCDs, including active and passive devices, their mechanisms, and comparative outcomes related to complications and recovery times. The document also highlights complications associated with endovascular procedures and patient selection criteria to minimize risks.

1. VASCULAR DEVICE CLOSURE
MODERATOR : DR.SENGOTTUVELU/ DR SENTHIL
PRESENTOR: DR PRATHABAN

2. INTRODUCTION:
• Angiography is currently one of the most common procedures in diagnostic and
interventional cardiology, vascular surgery and interventional radiology.
• Traditionally, hemostasis at the access site has been achieved via manual
compression, the gold standard.
• However, a wide array of vascular access closure devices have been created to
assist the proceduralist in achieving hemostasis.
• These devices can be useful for patients with large body habitus, patients on
anticoagulation and antiplatelet therapy, or when extended bed rest is undesirable
such as in the case of a patient with extensive pressure ulcers.

3. INTRODUCTION:
• Manual compression needs to be applied for an extended period or with
considerable force.
• Complications that can result from inadequate manual compression include
hematoma and pseudoaneurysm formation.
• Studies have shown that use of these devices is safe even when patients have
received thrombolytic therapy.
• Vascular access closure devices are usually employed whenever a sheath that is a
6F catheter or larger is used for an arterial procedure.

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

5. 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
• 3 min per F for arterial,
• 2 min per F for venous.
Full pressure for 5 min, then
• 75% for 5 min,
• 50% for 5 min,
• 25% for 3-5 min.

6. WHY DEVICE CLOSURE ?
• 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)

7. ADVANTAGE OF VCD:
• Shorten time to hemostasis
• Reduced bleeding and access site complications
• Early patient ambulation and reduced discomfort
• Does not depend on anticoagulation

8. EVOLUTION OF VCD:

9. VCD –TYPES
• ACTIVE: physically close the arteriotomy with the use of a suture or a nitinol
clip.
• PASSIVE: deploy a plug, sealant, or gel at the arteriotomy site without actively
closing the arteriotomy.
• 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.

10. ACTIVE VCD

11. PASSIVE VCD

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

15. PASSIVE CLOSURE DEVICES
• Enhance manual hemostasis
• Hemostasis pads
• Compression devices
• Usually used in conjunction with manual compression

16. HEMOSTASIS PADS
• Pads are coated with pro-coagulant materials
• Enhance process of hemostasis
• Used in conjunction with manual compression
• Chito-Seal (Abbott Vascular)
• Clo-Sur PAD (Scion Cardio-Vascular, Miami, Fla)
• Syvek patch (Marine Polymer Technologies, Inc., Dankers, Mass)
• Neptune Pad (Biotronik, Berlin, Germany)
• D-Stat Dry (Vascular Solutions, Minneapolis, Minn).

17. CHITO SEAL
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

18. SYVEK PATCH
• 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

20. CLO SUR PAD.
• 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

21. D STAT DRY
• Contains thrombin
• Activates the intrinsic coagulation coagulation cascade
• Also contains silver chloride– works as an antimicrobial agent.
• OTHERS:Neptune PAD (calcium alginate), Quick Clot, V+ PAD (D-glucosamine
enriched fibres)

22. • 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

23. COMPRESSION DEVICES
• Used as a substitute to manual compression (hands free manual pressure)
• Can provide longer and sustained compression
• Easy and less cumbersome for the operator
• Femostop system
• Clamp ease
• Compass system
• Safeguard dressing
• X-press device

24. FEMOSTOP SYSTEM
• 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. FEMOSTOP SYSTEM
Ensure proper
compression of
access site.
- Large
hematoma
-Excessive pain
despite
analgesia

26. FEMOSTOP SYSTEM
• Diagnostic cases- 20-30 mins
• Interventional cases- 30-60 mins
• Interventional cases on OAC- 60-90 mins

27. CLAMP EASE
• 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

29. 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.

30. COMPRESSION DEVICES
• Reduces burden on the operator
• Reduces hand fatigue
• Able to take care of more patients
• Patient discomfort ++

31. ACTIVE CLOSURE DEVICE
• COLLAGEN BASED DEVICES-ANGIOSEAL, VASOSEAL
• POLYGLYCOLIC ACID- MYNX, EXOSEAL, DUETT
• SUTURE BASED DEVICES- PROGLIDE, PROSTAR
• CLIP BASED DEVICES-STARCLIP, EVS

32. PATIENT SELECTION
• 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

33. BOOMERANG
• 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. STARCLOSE SE
• Delivers an extravascular flexible nitinol clip to the adventitial surface of the
vessel wall to complete a circumferential arteriotomy closure.
• The StarClose is designed for closure of 5- to 6-French sheath sizes.
• The main advantage of the StarClose is that there is no implanted intraluminal
material.
• A theoretical disadvantage is that there is a residual permanent metal implant
• The CLIP trial (RCT of 596 patients) randomized to closure with StarClose or MC
• Reduced times to hemostasis and ambulation (1.5 vs 15.5 and 163 vs 269 min)

36. SUTURE MEDIATED -PERCLOSE PROGLIDE
• Delivers a single pretied non-biodegradable monofilament polypropylene suture
to close the arteriotomy.
• Licensed in the closure of sheath sizes from 5-French to 21-French.
• Sheath sizes greater then 8-French require at least two devices using the pre-close
technique particularly in the setting of endovascular aneurysm repair.
• Following completion of the procedure, the sheath is removed over a wire, whilst
the predeployed sutures are tensioned.

37. The advantage of this pre-close technique:
 Large sheath sizes can be closed percutaneously.
 A guide wire can be retained during tensioning of the sutures to allow
insertion of a further VCD or temporary sheath to stop bleeding.

38. COLLAGEN BASED VCD
ANGIOSEAL:
• 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)

39. ANGIOSEAL:
• Insertion sheath
• Angioseal device
• Anchor, collagen plug, suture
• Arteriotomy locator
• Guidewire

40. ANGIOSEAL
• 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.

41. ANGIOSEAL
• 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

42. MYNX
• 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%

43. MYNX

44. MECHANISM
• 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.

45. EXOSEAL
• 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%

47. • 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.

50. FISH
• 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%

52. DUETT
• 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

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

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

55. DEPLOYMENT
Step 3 :
Pull back sheath
slightly With light tension on
device, procoagulant
liquid is injected
through side port of
sheath

56. DEPLOYMENT
Step 4 :
After ensuring hemostasis,
deflate balloon,
Pull back entire system while
maintaining manual
compression proximally

57. MANTA
• 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.

59. • 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).

61. COMPLICATIONS
• Bleeding is the most common vascular complication related to endovascular
procedures comprising ~70% of all complications, followed by pseudoaneurysm
(~20%).
• 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

62. COMPLICATIONS
• 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%).

63. 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, 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

64. • THANK YOU .