VASCULAR_DEVICE_CLOSURE., cardiologypptx

cardio

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: M anual 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. V ascular 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

12. 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

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

14. 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 ).

15. 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

16. 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

17. 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

18. 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 )

19. 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

20. 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

21. 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

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

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

24. 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

25. 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

26. 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.

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

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

29. 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

30. 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

31. 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 )

32. 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.

33. 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.

34. 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)

35. ANGIOSEAL: Insertion sheath Angioseal device A nchor , collagen plug , suture Arteriotomy locator Guidewire

36. 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.

37. 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

38. 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 %

39. MYNX

40. 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.

41. 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 %

42. 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.

43. 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 %

44. 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

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

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

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

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

49. 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.

50. 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 ).

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

52. 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%).

53. 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

54. THANK YOU .