Reviews of the Terumo Angio-Seal | Which Medical Device
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Closure devices
The Angio-Seal was one of the first closure devices to appear on the market in the mid to late nineties. Originally marketed by Tyco it was bought by St Jude in 2000, a company probably better known for its manufacturing of prosthetic heart valves. The device has been through a succession of refinements, the current VIP( V-twist Integrated Platform) received US FDA approval in March 2006 having been launched in 2005. Of all the ‘collagen plug’ based closure devices on the market the Angio-Seal has been around for longest and consequently there is more published about it’s efficacy and complications mainly as one would expect largely from the Cardiology literature.
The Angio-Seal was one of the first closure devices to appear on the market in the mid to late nineties. Originally marketed by Tyco it was bought by St Jude in 2000, a company probably better known for its manufacturing of prosthetic heart valves. The device has been through a succession of refinements, the current VIP( V-twist Integrated Platform) received US FDA approval in March 2006 having been launched in 2005 . Of all the ‘collagen plug’ based closure devices on the market the Angio-Seal has been around for longest and consequently there is more published about it’s efficacy and complications mainly as one would expect largely from the Cardiology literature.
The device seals the arteriotomy by sandwiching a ‘co-polymer anchor’ on the intimal surface of the artery and collagen plug on the external adventitial surface. Both components are bio-absorbable, which takes between 60 and 90 days. On the newer VIP device the application of the collagen plug results in it twisting into a spiral as it comes to lie over the arteriotomy. The theoretical advantage being a greater coverage providing more reliable haemostasis. St Jude report a coverage of 8.3mm diameter of the collagen plug which equates to a 24 French outer diameter hole. The VIP device does not require a self-retaining clip like its predecessor the Angioseal STS. St Jude don’t advise closing a vessel of less than 5mm diameter as this can prevent deployment of the ‘anchor’.
Unlike its predecessor St Jude claim the Angio-Seal to be effective in anticoagulated patients. Additionally re-puncture 1cm away from the original puncture site is felt to be safe.
The product comes in 6F and 8F sizes. Both can be placed over an 0.035’ guidewire. Initially a calibrated sheath loaded with a vessel locater is inserted. The vessel locator indicates the sheath to be within the artery by virtue of arterial blood seen from a small external hole in its proximal end. The vessel locator is then removed and the device itself inserted via the sheath.
Advancing the device until an audible click is heard releases the ‘anchor’ out of the end of the sheath and hopefully within the lumen of the artery. Pulling the hub back resulting in two further ‘clicks’ locks the anchor in place. The collagen plug is then released by gentle traction of the device and sheath together. The ‘tamping ‘ down of the collagen plug with a green compaction tube ensures the collagen is in the correct position over the arteriotomy and held in place with the ‘slip knot’ at the end of the retaining suture. The excess retaining suture can then be cut at skin level following removal of the compaction tube.
St Jude advise that the patient can ambulate within 20 minutes and be discharged within an hour.
Hoffers review in 2003 (1) summarises success rates and complications of all the major closure devices. Successful haemostasis is achieved in 96-98% of cases with previous generations of the Angio-Seal device. This is exclusively for retrograde CFA punctures in Cardiac studies. Very little is published regarding antegrade puncture and what little there is reports very small numbers although a good success rate is achieved. (2,3).
Numerous case reports document its successful closure of brachial, popliteal, axillary and subclavian arteriotomies.
Complications are reported as less than 1% for embolistaion and <0.5% for infection.
The angioseal VIP works well and is easy to use. Complications can be serious but are low. The newer device may prove increasingly useful for Interventionalists for antegrade punctures and for closing arteriotomies greater than 8F diameter.
Photographs and step by step instructions were kindly supplied by:
Dr Richard Harries,
Diana, Princess of Wales Hospital, Grimsby, UK
No Conflict Declared
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