Vascular Closure: A Call to Arms...and Legs
Pub Date: Monday, October 4, 2010
Author: Navin K. Kapur, MD
Patel MR, Jneid H, Derdeyn CP, et al; on behalf of the American Heart Association Diagnostic and Interventional Cardiac Catheterization Committee of the Council on Clinical Cardiology, Council on Cardiovascular Radiology and Intervention, and Council on Peripheral Vascular Disease. Arteriotomy closure devices for cardiovascular procedures: a scientific statement from the American Heart Association. Circulation 2010: published online before print October 4, 2010, 10.1161/CIR.0b013e3181f9b345.
All interventional procedures conducted in the modern cardiac catheterization laboratory require vascular access. Despite the scrutinizing microscope of clinical trials and evidence-based medicine in the field of interventional cardiology, multiple approaches to optimizing vascular access are applied to patients worldwide in a non-systematic manner. Didactic sessions at major international meetings continue to focus on the basics of gaining access to the common femoral artery, yet to date, no consensus exists on the best manner with which to open the door and, as importantly, "how to close the door behind you on the way out."
Limitations to the currently existing database of studies examining the safety and efficacy of vascular closure device include: 1) the lack of randomized, controlled studies, 2) changes in closure device technology, 3) variable operator experience, 4) small, underpowered studies, 5) and evolving antithrombotic regimens. As a result, the authors of this Scientific Statement from the American Heart Association are unable to reach any conclusive statements at the level of evidence A, which is defined as "good scientific evidence suggesting that the benefits of an intervention substantially outweigh the potential risks." Challenged by these limitations, Patel and colleagues have provided a comprehensive review of the vascular closure device landscape, outlined broad recommendations for the use of arteriotomy closure devices, and provided detailed recommendations for the next generation of clinical trials evaluating the use of closure devices.
Several aspects of this scientific statement address important gaps in our current knowledge base and approach to studies of vascular closure devices. First, the proposed 'gradient of risk' with definitions of low, moderate, and high risk patient populations should serve as a guide for clinical practice as well as future studies designed to assess the efficacy and safety of closure devices. Second, the overview of the existing database for manual compression and both active and passive closure devices highlights the lack of large, randomized, appropriately powered studies to rigorously test the risks and benefits of each approach. Third, the discussion regarding appropriate endpoints in clinical studies sets the stage for the vascular closure trials with a particular emphasis on the clinical events listed in Table 5 of the manuscript. Taken together, the authors of this scientific statement have provided a realistic pathway for investigators to design the next generation of randomized studies.
Furthermore, increasing experience with radial artery access, use of larger bore sheaths for non-coronary interventions, improved antithrombotic algorithms for coronary intervention, and adoption of imaging techniques for gaining vascular access will impact the success of vascular closure devices. For example, vascular closure is more likely to fail when vascular access requires multiple attempts, access above the inguinal ligament and below the femoral bifurcation, or through-and-through sticks of the femoral artery. Recently, the use of ultrasound-guided arteriotomy was studied in the Femoral Arterial Access With Ultrasound Trial (FAUST), which demonstrated reduced time to access, risk of venipunctures, and vascular complications with ultrasound guidance. Stricter definitions and guidelines regarding appropriate methods of vascular access will further enhance the likelihood of success with vascular closure devices.
As detailed in this scientific statement, use of vascular closure devices over the next decade will likely continue, however, expanded use of these devices will require appropriately designed, large, randomized controlled trials focusing on safety, efficacy, and economic impact.
- Tricoci P, Allen JM, Kramer JM, et al. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA 2009;301(8):831-41.
- Seto AH, Abu-Fadel MS, Sparling JM, et al. Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial). J Am Coll Cardiol Intv 2010;3:751-758.
-- The opinions expressed in this commentary are not necessarily those of the editors or of the American Heart Association --