A Comparison of Vascular Closure Devices Commonly Used in Interventional Radiology
Published date : 27 August 2013
Article date : 27 August 2013
Authors:
Dr. James G McGarry, BE, MB BCh, MRCS, PhD. Specialist Registrar (SpR) in Radiology*
Dr. Bhaskar Ganai, MB BCh, MRCS, FRCR, EBIR. Consultant Interventional Radiologist*
Dr. Mark F Given, MB BCh, MRCSI, FFR RCSI, EBIR. Consultant Interventional Radiologist*
*Department of Radiology, Beaumont Hospital, Dublin 9, Ireland
Disclosures: None
Overview
Vascular closure devices (VCDs) were first introduced in the 1990s. Shorter haemostasis and early mobilisation led to their broad uptake, particularly in cardiology, but it was not until 2004 that metanalyses of their efficacy and safety were first published. In patients undergoing coronary angiography, VCDs were found to be as effective as manual compression in achieving haemostasis, but there was no significant difference in the incidence of complications.1 In fact some analyses had suggested a higher incidence of haematoma and pseudoaneurysm with VCDs, but this was not statistically conclusive.1 However, outcomes in cardiology patients are not necessarily applicable to interventional radiology (IR) patients (where radial access is less frequently used, and antegrade femoral punctures are more common), and it was not until 2011 that the first systematic review of VCDs in IR patients was published by Das et al.2 The conclusions were limited by heterogeneity between studies, and the need for more level 1 randomised controlled trials (RCTs) was emphasised. Overall there was no difference in incidence of complications with VCDs relative to manual compression, but there was a non-significant trend towards fewer complications with Angioseal (St Jude Medical, Minnnesota).
Despite this somewhat equivocal evidence, there continues to be growth in use of VCDs among IRs, driven seemingly by convenience and perceived cost-savings associated with earlier haemostasis and shorter time to ambulation. New innovative and mainly extra-luminal approaches to arteriotomy closure are continually emerging, all striving for higher technical success rates and fewer complications than manual compression (for example, Mynx by AccessClosure, Boomerang by Cardiva Medical, FISH by Morris Innovative, and Fastseal by Vascular Closure Systems), in addition to newer generations of the more established devices such as Angioseal (Abbott Vascular, California). A recent editorial by Dr Douglas Muir discussed suture-based VCDs used in large bore arteriotomy procedures such as EVAR or TAVI. In this editorial we focus on the three VCDs we most commonly use in our institution for arteriotomy closure, namely Angioseal, ExoSeal (Cordis Corporation, Florida) and StarClose (Abbott Vascular, California) devices. We discuss briefly the evidence base for each device, and describe our own experiences in their use.
Angioseal
Introduction:
Angioseal is the most established of VCDs having first achieved FDA approval in 1996. The device, available in both 6 and 8 Fr seals an arteriotomy by sandwiching a polymer intra-luminal anchor (on the intimal surface of the artery) with a collagen plug on the external adventitial surface. The delivery device incorportares an arteriotomy locator with a drip hole to allow visual confirmation of positioning. The intra-luminal anchor is deployed, and the collagen plug is tamped down onto the arteriotomy. A black marker in the suture indicates optimal positioning. The collagen plug subsequently swells into the tract overlying the arteriotomy site causing platelet aggregation. The excess retaining suture is then cut at skin level.
The patient can ambulate within 20 minutes and discharged within 1 hour. All components are resorbed within 60 to 90 days. Newer generations of the device include Angioseal VIP (with improved arteriotomy coverage due to a larger collagen footprint), and Angioseal Evolution (an automated collagen compaction system to allow single-handed deployment).
Evidence base:
There has been multiple RCTs and observational studies documenting the technical success of Angioseal in achieving haemostasis. In one large retrospective cardiology series of 4,525 patients, successful haemostasis was as high as 97%.3 Smaller series in IR cohorts also support a high level of technical success.4 The Angioseal device was also included in a 2011 systematic review, and was the only VCD for which there was a non-significant trend towards fewer complications than manual compression.2
Our experience:
- We find Angioseal technically effective and reliable. The substantial evidence base for its safety and efficacy is reassuring. We frequently use it for <8 Fr arteriotomy closures.
- We have also used Angioseal off-label for >8Fr closures without any difficulties, including closure of a 12 Fr subclavian arteriotomy following removal of a misplaced vascular catheter.
- We are aware of reports of device kinking in the obese,5 but have not had any such difficulties in our practice. In fact, we tend to preferentially use Angioseal in obese patients for whom effective manual compression would be challenging.
- We have deployed the Angioseal extensively for antegrade femoral punctures at our institution for several years with good results.6
- Anecdotally, our vascular surgery colleagues have noted residual inflammation, scarring and collagen plug remnants at the closure site beyond the 90 days specified for complete bioabsorption. This has not impeded vascular access during surgery.
- We have anecdotal experience of cases of iatrogenic intra-luminal stenosis and occlusion following deployment of Angioseal. This is more likely to occur in already diseased vessels, but can also occur in normal vessels.
ExoSeal
Introduction:
The ExoSeal device gained CE marking in 2011 and is available in 5, 6 and 7 Fr sizes. The device comprises a polyglycolic acid (PGA) bioabsorbable plug, and a delivery system that allows its exact positioning of the plug over an arteriotomy site (where it is anchored by the neurovascular bundle sheath). It is generally inserted through a Cordis vascular sheath, and an intra-luminal nitinol guide wire is deployed. Device and sheath are then gradually retracted to the arterial wall, and correct positioning is confirmed by both a visual indicator and a change in blood flow characteristics. The plug is then deployed, device removed, and 2 minutes of non-occlusive manual compression is advised. Ambulation is proposed by the manufacturer at 6 hours or later. The PGA plug is subsequently hydrolysed and resorbed over a 3-month period.
Evidence base:
The multicentric ECLIPSE trial by Wong et al.7 randomised 401 patients undergoing peripheral or coronary procedures to either ExoSeal or manual compression. There was successful haemostasis in 94% of deployments. There was no significant difference in incidence of major adverse events or requirement for surgical repair between groups. It is worth noting that this trial was underpowered for rare vascular complications, and further large randomised trials are required. Also patients with femoral arterial disease, moderate calcifications at sheath insertion, or whose femoral artery was recently accessed within the prior 30 days were excluded from the trial.7
Our experience:
- We are aware that there is not the same evidence base for ExoSeal (to date) as for the more established Angioseal, and that in the flagship ECLIPSE trial, technical success was 94%, despite the exclusion of higher risk patients.
- The main advantage of ExoSeal is that closure is achieved with extra-luminal material only. This would intuitively lower risk of complications such as intra-luminal stenosis, and distal embolisation.
- Optimal positioning of the ExoSeal device requires slow and careful assessment of the change in blood flow characteristics that occurs with adjustment of hand positioning, and can lead to a small amount of blood loss. In inexperienced hands, the resultant blood loss can be quite significant.
- The longer time to ambulation with ExoSeal (6 hours) is a disadvantage, particularly for day case patients. However, we have allowed earlier ambulation without complications.
- There is a restricted list of sheaths compatible with ExoSeal, which must be less than 12cm length, which may be inconvenient for some institutions. We incidentally use the Cordis AvantiTM sheaths, which are compatible and recommended.
- A high technical success with ExoSeal in antegrade punctures has been reported.8 However, we do not routinely use ExoSeal in closing antegrade punctures in the obese, as the tip of the ExoSeal is quite rigid and can puncture the procedural sheath with the steeper puncture angles that are often required.
StarClose SE
Introduction:
The StarClose device received CE marking in 2004, and is licensed for vascular closure of <6 Fr arteriotomies. It achieves hemostasis with a 4 mm extravascular nitinol clip implant. Wings are deployed within the lumen to aid correct positioning. On deployment, the clip grasps the arteriotomy edges and pulls the vessel wall together to achieve hemostasis. The locator wings simultaneously collapse to allow device removal.
Evidence base:
In the largest StarClose multicentre RCT (the CLIP study) comprising 483 patient at 17 sites, device success was 86.8%.9 In a separate prospective trial of 450 patients, there was successful deployment in 83% of patients. There was persistent oozing at the arteriotomy site reported in 38%.10 In a small retrospective study, the device failed in 11 of 143 deployments (7.7%), with one patient requiring emergent surgery for device retrieval.11 Further anecdotal reports of femoral artery laceration, arterial occlusion and high-grade stenoses have also been described.12 However, in the aforementioned systematic review,2 there was insufficient quality data available to draw definitive conclusions about the incidence of complications with StarClose.
Our experience:
- We find StarClose technically effective. However, in our opinion it may not be as reliable as Angioseal or ExoSeal. This could also be inferred by the evidence base to date.
- It is critically important to avoid applying excessive downward pressure during deployment, as this will increase the risk of occluding the artery by stapling both walls together.
- Starclose can deliver a painful pinch on deployment, and we often tend to administer additional local anaesthetic prior to its deployment.
- It may be helpful to use ultrasound to visualise StarClose deployment, especially if a stent has been placed close to the arteriotomy.
- A major advantage of StarClose that it achieves haemostasis without implanting intra-luminal material. However, we are conscious of the potential increased infection risk with a permanent metal implant. Additionally our vascular surgery colleagues dislike the permanent nature of the nitinol clip device, although this has not had surgical implications to date.
- We have had a few cases whereby the delivery system and the nitinol clip have interlocked. This was remedied by forcibly removing the delivery system while pressing on the arteriotomy site, with no subsequent sequelae.
Conclusions:
- In our institution, VCDs are primarily used to enable early ambulation and early discharge. However, there is no convincing level 1 evidence to date that VCDs significantly reduce complications relative to manual compression.
- Angioseal, with an intra-luminal anchor and extravascular collagen plug is the most established VCD with the broadest evidence base. It has a technical success rate of up to 97%,3 and a trend towards fewer complications than manual compression. A potential drawback is the intra-luminal footplate, which in our experience can result in iatrogenic intra-luminal stenoses and occlusions, particularly when used off-label.
- Exoseal, as a more recent device, lacks a broad evidence base. With a reasonably high technical success of 94%, its main benefit is an extra-luminal bioabsorbable closure plug. Drawbacks include a slightly cumbersome positioning mechanism, and a recommended 6 hour time to ambulation. We avoid its use in the obese.
- StarClose, featuring an extraluminal nitinol clip implant, appears to have lower technical success (~87%) and may have a higher rate of complications than other VCDs. Its benefit of an extra-luminal closure mechanism is offset by the permanent implantation of a nitinol clip.
- In our view, the decision to use a particular VCD should comprise a risk-benefit analysis for each patient depending on their clinical circumstances and particular risk factors for puncture site related complications.
References:
1. Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. 2004. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: sys- tematic review and meta-analysis. JAMA 291:350–357
2. Das R, Ahmed K, Athanasiou T, Morgan RA, Belli AM. 2011. Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: a systematic review and meta-analysis. Cardiovasc Intervent Radiol 34:723-38.
3. Applegate RJ, Grabarczyk MA, Little WC, Craven T, Walkup M, Kahl FR, Braden GA, Rankin KM, Kutcher MA. 2002. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization. J Am Coll Cardiol 40:78–83.
4. Upponi SS, Ganeshan AG, Warakaulle DR, Phillips-Hughes J, Boardman P, Uberoi R. 2007. Angioseal versus manual compression for haemostasis following peripheral vascular diagnostic and interventional procedures--a randomized controlled trial. Eur J Radiol 61:332-4.
5. Minko P, Katoh M, Gräber S, Buecker A. 2012. Obesity: an independent risk factor for insufficient hemostasis using the AngioSeal vascular closure device after antegrade puncture. Cardiovasc Intervent Radiol 35:775-8.
6. Looby S, Keeling AN, McErlean A, Given MF, Geoghegan T, Lee MJ. 2008. Efficacy and safety of the angioseal vascular closure device post antegrade puncture. Cardiovasc Intervent Radiol 31:558-62.
7. Wong SC, Bachinsky W, Cambier P, Stoler R, Aji J, Rogers JH, Hermiller J, Nair R, Hutman H, Wang H; ECLIPSE Trial Investigators. 2009. 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 2:785-93.
8. Maxien D, Behrends B, Eberhardt KM, Saam T, Thieme SF, Reiser MF, Treitl M. 2012. Evaluation of the 6-F ExoSeal vascular closure device in antegrade femoral artery punctures. J Endovasc Ther 19:836-43.
9. Hermiller JB, Simonton C, Hinohara T, Lee D, Cannon L, Mooney M, O'Shaughnessy C, Carlson H, Fortuna R, Zapien M, Fletcher DR, DiDonato K, Chou TM. 2006. The StarClose Vascular Closure System: interventional results from the CLIP study.Catheter Cardiovasc Interv 68:677-83.
10. Deuling JH, Vermeulen RP, Anthonio RA, van den Heuvel AF, Jaarsma T, Jessurun G, de Smet BJ, Tan ES, Zijlstra F. 2008. Closure of the femoral artery after cardiac catheterization: a comparison of Angio-Seal, StarClose, and manual compression. Catheter Cardiovasc Interv 71:518-23.
11. Chiu AH, Coles SR, Tibballs J, Nadkarni S. 2010. The StarClose vascular closure device in antegrade and retrograde punctures: a single-center experience. J Endovasc Ther 17:46-50.
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