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We read with interest the recent article by Looby et al. [1] regarding the use of the Angioseal (St. Jude Medical) vascular closure device and agree that the published literature on efficacy and safety following antegrade puncture is sparse. We would, however, like to express some concerns regarding the conclusions reached in the article, in particular, the closing statement:
…the Angioseal vascular closure device is a safe, efficient, and uncomplicated means of arteriotomy closure post antegrade puncture.
While in our experience the Angioseal device has proved useful in select patient groups, it is not without risk, and drawing conclusions on the basis of a cohort of 46 patients has the potential to miss a high rate of serious complication [2]. Over the past 18 months vascular interventional radiologists at our institution have deployed more than 250 Angioseal devices and have experienced 3 serious complications, all in patients with antegrade punctures. In two patients the common femoral arteries became occluded after device deployment. Attempts were made to reopen the artery following contralateral puncture; in both cases stents were successfully deployed following balloon angioplasty of the occlusion, restoring patency. In the third patient it was not possible to achieve hemostasis following deployment, despite manual compression. This patient required surgical exploration, which revealed that the device was positioned outside the artery. As noted by Looby et al. [1] we are not alone in experiencing such complications, and vessel occlusion, hematoma, and pseudoaneurysm formation have all been reported previously [3, 4].
During the same time period two other complications occurred at our institution following Angioseal use by other clinicians. One patient developed persistent bleeding from a puncture site following cardiac catheterization and required surgical intervention. A further patient developed short-distance claudication following Angioseal deployment after cerebral angiography. Angiography demonstrated a dissection flap at the site of puncture; this was successfully treated with a stent.
Looby et al. comment that the Angioseal device should be used with caution if the common femoral artery contains multiple plaques [1]. We have found that it is possible to visualize the footplates during deployment and directly observe correct positioning using ultrasound, and as a result problems with the device being “snagged” by plaques can be recognized. Ultrasound can also be used to identify compromise of the arterial lumen or hematoma formation.
In summary, although we recognize that the Angioseal device is useful in certain patient groups, it is not without risk of serious complication. To establish the true rates of complication following its use for antegrade puncture, larger studies are required.
References
Looby S, Kneeling AN, McErlean A, Given MF, Geoghegan T, Lee MJ (2008) Efficacy and safety of the Angioseal vascular closure device post antegrade puncture. CardioVasc Interv Radiol 31:558–562
MacEneaney PM, Malone DE (2000) Applying “evidence-based medicine” theory to interventional radiology. Part 2: a spreadsheet for swift assessment of procedural benefit and harm. Clin Radiol 55:938–945
Abando A, Hood D, Weaver F, Katz S (2004) The use of the Angioseal device for femoral artery closure. J Vasc Surg 40:287–290
Ratnam LA, Raja J, Munneke GJ, Morgan RA, Belli A-M (2007) Prospective nonrandomised trial of manual compression and Angio-Seal and Starclose arterial closure devices in common femoral punctures. CardioVasc Interv Radiol 30:182–188
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Thurley, P.D., O’Neill, R., Habib, S. et al. Re: Looby et al.: “Efficacy and Safety of the Angioseal Vascular Closure Device Post Antegrade Puncture”. Cardiovasc Intervent Radiol 31, 1255–1256 (2008). https://doi.org/10.1007/s00270-008-9411-8
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DOI: https://doi.org/10.1007/s00270-008-9411-8