Various types of current Vascular Closure Devices

1. Dr. Asad Moosa

2. Overview..
 Session divided into 2 presentations.
 First a view on VCDs with their categories, uses, indications and complications.
 Further for better understanding other presentation is based on videos of these
VCDs.

3. Manual Compression
 Traditional Approach
 Apply pressure for up to 10-20 mins.
 Bed rest up to 4-24 hrs depending on sheath size and coagulation status.
 Labor and time intensive with potential limitations ( Unable to comply with bed rest
and Obese)
 Hemostasis by formation of fibrin and platelet plug after blood is exposed to collagen
at puncture site in the arterial wall.
 Complications:
 Hematomas
 Retroperitoneal Hemorrhage
 Pseudo aneurysm
 Vessel Occlusion
 AV fistula formation

4. Vascular Closure Devices
 First introduced in 1995
 Decrease the time to hemostasis and ambulation.
 Reduce access site complications.
 The theoretical ideal VCD:
 Easy to use with minimal training
 Comfortable for patient and operator.
 Offers secure hemostasis regardless of vessel quality.
 Allows immediate ambulation with no short or long-term risks
 But there is no ideal device at present, and indeed this theoretical ideal may be
unattainable.
 The devices can be divided into groups as intravascular and extravascular plugs,
suture mediated/mechanical, and compressive assistance

5. 1)Plug-Based VCDs
A)Angio-Seal Evolution- VIP, and STS Plus (St. Jude Medical, St.
Paul, Minn)
 Devices create a mechanical seal by sandwiching the arteriotomy between
a bio absorbable anchor and a collagen sponge.
 Dissolve within 60 to 90 days.
 Should not be used in small arteries (<5 mm) or arteries
with significant occlusive disease as the anchor can
catch on the side walls.
 Leading to failure with continued bleeding or vessel
occlusion.
 The device comes in 6F and 8F versions.
 RCT of 435 patients:[1]
 High deployment success rate (96 %)
 Shorter time to hemostasis with 76 % of patients having immediate haemostasis
(within 1 min).
 Reduced number of complications for patients with AngioSeal compared to MC.
1. Kussmaul WG, Buchbinder M, Whitlow PL, et al. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a
randomized trial of a novel hemostatic device. J Am Coll Cardiol. 1995;25:1685–92

6. B)Exoseal (Cordis Corp., NJ, USA)
 Places a polyglycolic acid plug outside the arteriotomy and is held in place by femoral
fascia.
 This plug hydrolyze and resorbed within 60 to 90 days.
 Available in 5F, 6F, and 7F sizes.
 Potential advantage:
 Do not have an intravascular implant thereby diminishing the risks of anchor-
related luminal narrowing, occlusion or embolism.
 Two minutes of non-occlusive MC is advised following deployment, and ambulation
is proposed by the manufacturers at 6 h or later.
 The ECLIPSE trial (multicenter RCT of 401 patients) randomized to closure with
Exoseal or MC.[2]
 Mean time to hemostasis and time to ambulation were significantly shorter in the Exoseal
arm of the study (4.4 vs 20.1 min and 2.5 vs 6.2 h, respectively).
 There were no major complications reported in this study.
2. Wong SC, Bachinsky W, Cambier P, et al. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis
after percutaneous femoral procedures: the ECLIPSE (Ensure’s Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009;2:785–93.

8. C)MynxGrip (AccessClosure, Santa Clara, Calif)
 Use extravascular polyethylene glycol, a water-soluble, bioinert, nonthrombogenic polymer, to
seal the tissue track.
 The device comes in a 5F and 6F version.
 The Mynx Sealant consists of freeze-dried polyethylene glycol.
 On placement blood infiltrates the porous structure and the sealant expands to three to four
times its size, expanding and filling the tissue track to provide effective hemostasis.
 When it is fully expanded, the sealant consists of 95% blood and fluids and 5% polyethylene
glycol sealant.
 As blood collects within the porous matrix, the coagulation produces hemostasis and a
platform for vessel healing.

9.  Sealant is absorbed within 30 days.
 A non-randomised single-arm prospective trial of 190 patients (Mynx device) [3]
 Successful deployment in 93 % of cases.
 Mean time to haemostasis and time to ambulation of 1.3 min and 2.6 hours.
 The primary advantage of the Mynx VCD:
 Absence of intraluminal material, thereby reducing the risks of luminal narrowing,
vessel occlusion or distal embolisation.
 However, there are reports of distal embolisation occurring with the Mynx VCD
3.Scheinert D, Sievert H, Turco MA, et al. The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx. Cathet
Cardiovasc Interv. 2007;70:627–33.

10. D)FISH (femoral introducer sheath and hemostasis) device (Morris
Innovative, Bloomington, Ind)
 Indicated for diagnostic procedures with 5F to 8F procedural sheaths.
 Bioabsorbable extracellular matrix made from porcine small intestinal submucosa.
 The patch resembles a roll of wrapping paper and is
inserted through the arteriotomy so that it straddles
the arterial wall.
 A wire is pulled to release the patch from the device,
followed by a compression suture that incorporates the
patch firmly in place in the artery wall.
 The intravascular plug is absorbed in 30 days.

11.  The intravascular component is very flexible, potentially allowing for closure in small
or diseased vessels.
 In a multi-center RCT of 297 patients randomized to FISH or MC:[4]
 Mean time to hemostasis and mean time to ambulation were reduced for the FISH
cohort compared to MC (8.9 vs 17.2 min and 2.4 vs 4.3 hours)
 There were no significant differences in the rates of adverse events between the two
cohorts in this study
4. Bavry AA, Raymond RE, Bhatt DL, et al. Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: the multicenter randomized clinical trial
of the FISH device. J Invasive Cardiol. 2008;20(4):152–6.

12. 2) Suture Mediated
 Allow closure by deploying the device before dilatation of the vessel with a larger sheath,
so-called preclose technique.
A) Perclose Proglide (Abbott Vascular, IL, USA)
 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 pre-
deployed sutures are tensioned.

13.  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.

14. B) Prostar (Abbott Vascular):
 Is a 10F and places two braided sutures at 90-degree angles to each other to close the
arteriotomy.
 Indicated for the closure of 8.5 to 10-French sheath common femoral artery access sites.
 As with the Perclose Proglide, larger sheath sizes up to 24-French have been closed
successfully using the pre-close technique.
 Although only one Prostar XL device is required as each Prostar XL delivers two sutures.
 The drawbacks of this device and SMCDs:
 There are a greater number of procedural steps which increase the complexity of the
VCD
 Introduce a potentially longer learning curve
 There is a potential risk of infection related to the implanted suture material, and in
one series, the infection rate was 0.5 %

15. 2) Mechanical Closure
A) StarClose SE (Abbott Vascular)
 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)
 With no significant differences in the rates of complications compared to MC

17. 3) Compressive Assistance
A) Catalyst III (Cardiva Medical, Inc., Sunny- vale, Calif)
 Facilitates hemostasis by downsizing the arteriotomy while re-establishing flow distally
 Although manual compression is still required.
 The device is inserted through the existing sheath.
 Once the tip is within the arterial lumen, a conformable
nitinol 6.5-mm disk is deployed.
 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 the device is allowed to sit in the artery for 15 to 120 minutes, depending on the
anticoagulation status, the disk is collapsed, the device is withdrawn, and light manual
pressure is held for 5 minutes.

18. B) FemoStop.
 The FemoStop plus Compression System take the place of manual external
compression.
 These devices are placed over the puncture site and adjusted with a circumferential
strap, followed by pressure bag inflation.

19. Topical Hemostatic Aids
 There are also topical hemostatic aids that promote coagulation independent of
compression.
 Several hemostasis pads exists:
 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).
 Syvek patches contain poly- N-acetyl glucosamine fibers derived from microalgae that
activate platelets and promote red blood cell aggregation.
 The D-Stat product consists of thrombin on a cellulose scaffold or suspended in a
collagen gel, both of which work by initiating the extrinsic coagulation cascade.

20. Vascular Closure Devices: A Comparative Overview

21. Complications
 Two meta-analyses of randomized trials compared the incidence of individual
complications in patients treated with manual compression versus closure devices.[5]
 Closure devices tended to increase the incidence of local bleeding and did not appear
to significantly influence hematoma, pseudo- aneurysm, or arteriovenous fistula
formation.
 Closure devices also increased the risk of groin infection and tended to increase the
risk of leg ischemia and a complication requiring surgical repair.
5.Vaitkus PT: A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and
percutaneous coronary intervention. J Invasive Cardiol 16:243–246, 2004.

22. Thank you!