Arteriotomy Closure Devices for Cardiovascular Procedures: A Scientific Statement From the American Heart Association

Arterial puncture and sheath insertion by use of the modified Seldinger technique has become the standard method by which invasive cardiovascular procedures are performed.1 With improvement in techniques and devices, a significant number of patients with atherosclerotic disease are undergoing invasive vascular procedures. Approximately 7 million invasive cardiovascular procedures are performed worldwide each year, and this number is expected to increase with the aging of the population. The vast majority of these procedures are performed with femoral arterial access. Because the number of cardiovascular procedures performed via the femoral artery approach continues to increase, effective arterial hemostasis techniques are essential to high-quality patient care. In fact, vascular access complications, reported to be as high as 6% in some series, remain the leading cause of morbidity after a cardiac catheterization procedure.2 Manual compression has been considered the traditional technique to achieve closure of the arteriotomy site, requiring close observation and immobilization for success. Arteriotomy closure devices (ACDs) were introduced in 1995 to decrease vascular complications and reduce the time to hemostasis and ambulation. Subsequently, several generations of passive and active ACDs have been introduced that incorporate suture, collagen plug, nitinol clip, and other mechanisms to achieve hemostasis. According to a new Life Science Intelligence report entitled “2008 Global Vascular Closure Device Markets: US, Europe, Rest of World,” the global market for vascular closure devices will reach nearly $1 billion in 2013.3 Despite this widespread use of both passive and active ACDs, there are incomplete data on their safety and efficacy. Additionally, there are few published recommendations regarding the indications for the use of these devices, their comparative effectiveness versus manual compression, and the end points of clinical interest for patients undergoing vascular closure. Therefore, the present scientific statement provides an overview of vascular access and patient risk for …