The field of hemostasis management has evolved at a speed nearly parallel to other interventional cardiology technologies over the past decade. There is now an arsenal of products available to healthcare providers who manage vascular access in settings where percutaneous procedures are performed. These products range from hemostasis patches applied with manual pressure post-procedure to more complicated vascular closure devices deployed in the catheterization suite. Either way, the default technique remains that of external compression, which can be time-consuming and not without its own complications.1 This article describes a mechanical compression system that offers an inexpensive solution to minimizing patient discomfort while maintaining vascular access outcomes and improving time efficiencies over manual compression.
Although some patient trials have shown a cost-effective role for hemostasis devices through improved patient ambulation and discharge rates, the incidence of vascular complications has remained constant.2 In fact, when closure devices fail, the problems may be more complex and subsequently more deleterious to patients. As a result, their use is widely varied.3
Extravascular compression, with or without the potentially augmented effect of hemostasis patches, remains the gold standard of vascular sheath removal. Although manual pressure is widely used, especially for smaller diagnostic sheaths, the technique is inexact and often stressful to the patient and operator should hemostasis be difficult to achieve in the setting of larger sheath removal and/or aggressive anticoagulation.4 These circumstances may exist with a high activated clotting time (ACT) and excessive bleeding, intra-aortic balloon pump (IABP) removal, or arterial insufficiency.
The use of a mechanical compression device in these and many other scenarios can be beneficial in achieving primary hemostasis with minimum discomfort to the patient and at a lower cost than a closure device. The FemoStop® plus Compression System (Radi Medical Systems Inc., Reading, MA) is a device that, when used properly, can objectively achieve the fine balance of hemostasis with preservation of distal perfusion.
At a list price of $74.50, the FemoStop plus is a second generation device and consists of a non-compliant inflatable transparent dome that is fastened via a belt over the sheath insertion site. The dome has a port connected to a manometer and pump. When inflated, this dome applies pressure directly over the arteriotomy. The procedure is described below. (NOTE: Before using FemoStop plus compression system, carefully read the Instructions for Use and follow your facility’s sheath removal protocol.)
Utilizing the Device
The same preliminary steps for FemoStop application should be undertaken as those for manual compression. These include:
1. Confirmation of an appropriate ACT (This article is based on the personal experience of James Armstrong, Chief PA, Division of Cardiovascular Medicine, Caritas St. Elizabeth's Medical Center, Boston, MA.
James Armstrong discloses that Caritas St. Elizabeth's Medical Center has received an educational grant from Radi Medical Systems, Inc.
1. Spokojny AM, Sanborn TA. Management of the Arterial Puncture Site. Journal of Interventional Cardiology 1994; 7(2).
2. Chamberlain JR, Lardi AB, McKeever LS, et al. Use of vascular sealing devices versus assisted manual compression in transcatheter coronary interventions requiring abciximab. Catheterization and Cardiovascular Interventions June 1999;47(2):143-147.
3. Amin FR, et al. Femoral hemostasis after transcatheter therapeutic intervention: a prospective randomized study of the angio-seal device vs. the femostop device. International Journal of Cardiology 2000;76:235-240.
4. Sridhar K, et al. Peripheral vascular complications after intracoronary stent placement: prevention by use of a pneumatic vascular compression device. Catheterization and Cardiovascular Diagnostics November 1996;39(3):224-229.