We have read with interest the article by Cooper and Miller entitled "Infectious Complications Related to the Use of the Angio-Seal Hemostatic Puncture Closure Device" published in a recent issue [1]. They reported on two cases of groin infections requiring surgical repair after deployment of Angio-Seal for hemostatic puncture closure in a series of 108 patients. As a conclusion, the authors abandoned the use of Angio-Seal at their center.
In our own large experience with this device as the routine tool for puncture closure after diagnostic cardiac catheterization or coronary angioplasty since 1995, we found no infectious complications associated with the use of Angio-Seal in a series of 1,818 deployments [2]. This is also consistent with the previously published data. In a review of the current literature [3], we found a total of 10 cases of groin infections following the use of the Angio-Seal device in 4,965 patients (0.20%), including the 2 cases reported by Cooper and Miller [1]. This incidence is comparable to the frequency of groin infections seen after conventional treatment of arterial puncture sites (0.05%-0.29%) [4 -6].
We therefore believe that the use of the Angio-Seal device is not associated with an increased risk of infectious complications despite implantation of an intravasal foreign body. We agree with Cooper and Miller [1] that repeat sterilization of the puncture site should be applied and strict sterile deployment of the device is required in order to minimize the risk of infectious complications, as is performed in our institution.
In the view of the safety and efficacy of the Angio-Seal device reported in several randomized and observational studies, abandoning of the device from daily practice does not seem to be justified.