AHA Issues Statement on Arteriotomy Closure Devices for Cardiovascular Procedures

November 2, 2010—The American Heart Association (AHA) has issued a scientific statement on arteriotomy closure devices (ACDs) for cardiovascular procedures. Writing committee chair Manesh R. Patel, MD, et al published the statement in Circulation (2010;122:1882-1893).

According to the statement, 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 sutures, collagen plugs, nitinol clips, and other mechanisms to achieve hemostasis. Despite the widespread use of both passive and active ACDs, there are incomplete data on their safety and efficacy and few published recommendations regarding the indications for the use of these devices, their comparative effectiveness versus manual compression, and the endpoints of clinical interest for patients undergoing vascular closure.

The AHA's scientific statement provides an overview of vascular access and patient risk for vascular complications, the available evidence for ACDs, recommendations for their use based on the available evidence, and the trials and endpoints needed to inform future clinical practice.

According to the statement, cardiovascular procedures offer the potential to improve patient outcomes and are increasing in frequency as new devices are developed and vascular territories are approached. Currently, ACDs have the potential to improve patient comfort. Novel devices and methods for achieving hemostasis are under investigation.

However, the statement concluded that the available evidence is limited to specific patient populations, often studied in a nonrandomized fashion, without methodological follow-up and standardized clinical outcomes. This limits the widespread routine use of these devices in clinical practice. The goal of future research should be to examine ACDs using adequately powered randomized studies in relevant populations with varying risk and to evaluate clinically relevant outcomes in a blinded fashion.

Click here to access the complete statement online in Circulation.