All types of diagnostic and therapeutic interventions require arterial access. Manual compression has been the traditional way to achieve hemostasis after catheter-based procedures, yet this method has limitations. For instance, it often requires extended bed rest, causes patient discomfort, and can lead to bleeding complications like hematoma and pseudoaneurysm. However, this changed with the arrival of arteriotomy closure devices (ACDs). An ACD allows for the quick, reliable closure of the arterial puncture site. In many cases, it provides a safer alternative for vascular access site management. Therefore, this blog will highlight the types, mechanisms, advantages, and clinical considerations for using arteriotomy closure devices.
What is an Arteriotomy Closure Device?
An arteriotomy closure device is a medical tool that closes the intentional hole made in an artery during catheterization procedures. In other words, the arterial puncture is also known as an arteriotomy. As a result, it is critical to close the arteriotomy as securely as possible to prevent bleeding and other complications. These closure devices aim to reduce time to hemostasis, minimize complications, and promote early patient mobility. Currently, doctors use arterial puncture and sheath insertion with the modified Seldinger technique as the standard method for performing invasive cardiovascular procedures. Due to ongoing improvements in both 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 will likely increase with the aging of the population. The vast majority of these procedures use femoral arterial access. Consequently, effective arterial hemostasis techniques are essential for high-quality patient care. Unfortunately, vascular access complications remain the leading cause of morbidity after a cardiac catheterization procedure. Some series have reported complication rates as high as 6%.Choice of Site and Arterial Access
To perform both diagnostic and interventional percutaneous cardiovascular procedures, operators usually obtain arterial access at the common femoral or radial artery. In recent years, there has been significant interest in using the transradial approach for cardiac catheterization and endovascular interventions in the United Statesa practice that is standard in many other countries. A recent meta-analysis reported a significant reduction in bleeding complications with the use of the transradial approach. For example, these patients do not have ACDs deployed, and they likely experience less bleeding. This is in part due to the relative ease of radial site compression and possibly the use of smaller-caliber devices with the radial approach. Although randomized data exist that link the access site and vascular complications, operators perform the majority of procedures from locations based on their experience and comfort levels.Types of Arteriotomy Closure Devices
Arteriotomy closure devices come in different forms based on their mechanism of action. Broadly, the main types are:Suture-Mediated Closure Devices:
These devices use a small suture to close the arterial puncture site from within the artery. A frequently used device in this category is the Perclose ProGlide by Abbott.- Mechanism: The device advances over the guidewire. Once it is in the artery, a small needle delivers a suture through the arterial wall. The suture is then tightened externally, thus closing the hole.
- Advantages: Permanent closure, useful for larger arteriotomies, and usable in complex cases.
- Considerations: Requires operator skill; has a mild learning curve; furthermore, there is a potential for complications with the suture.
Collagen-Based Closure Devices:
For instance, the Angio-Seal by Terumo is a popular collagen-based device. These devices contain a small collagen plug placed near the arterial puncture site to assist in clotting and seal the hole.- Mechanism: A bioabsorbable anchor is placed inside the artery, and the collagen sponge is compressed outside the vessel wall. This action sandwiches the arteriotomy to seal it.
- Advantages: Fast deployment; bioabsorbable materials limit the presence of a foreign body.
- Considerations: May cause arterial occlusion or embolization if deployed incorrectly.
Clip-Based Closure Devices:
Devices like the StarClose by Abbott use a small nitinol clip to close the arteriotomy.- How it works: The clip positions itself around the artery's outer wall, mechanically closing the puncture site.
- Advantages: No intraluminal components, minimal vessel trauma.
- Considerations: May not be suitable for heavily calcified arteries.
Sealant-Based Devices:
These are less common but use materials such as polyethylene glycol or other sealants that polymerize to close the puncture site.- How it works: The sealant is injected into the arteriotomy site and quickly hardens to create a seal.
- Advantages: Easy to use, ideal for smaller puncture sites.
- Considerations: Limited data and availability.
Key Developments in Arteriotomy Closure Devices
Several recent milestones have shaped the field of ACDs:- Boston Scientific -WATCHMAN FLX Left Atrial Appendage Closure Device. In November 2024, Boston Scientific Corporation announced positive three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX?? Left Atrial Appendage Closure (LAAC) Device.
- Cordis -MYNX CONTROL VENOUS Vascular Closure Device. In July 2024, Cordis announced FDA PMA approval for its MYNX CONTROL VENOUS Vascular Closure Device (VCD), approved for access sites ranging from 6F to 12F.
- Terumo -Expansion in Puerto Rico. In February 2024, Terumo Medical Corporation broke ground on a new manufacturing facility in Caguas, Puerto Rico. This move was driven by growing global demand for the Angio-Seal Vascular Closure Device (VCD).
Enablers of Arteriotomy Closure Devices
Various factors are contributing to the rising use and development of ACDs:- Increase in Cardiovascular Procedures: The rising number of cardiovascular interventions, from angioplasty to catheterization, has created a growing demand for reliable closure devices. These tools seal arterial puncture sites after procedures, thereby lowering complication rates and enabling faster patient recovery. As a result, the global ACD market has expanded significantly.
- Advances in Medical Technology: Continuous innovation has improved ACD design and functionality. For instance, new products now incorporate bioabsorbable materials, improved delivery systems, and advanced sealing technologies. These features enhance procedural safety and efficiency. Moreover, they support broader adoption as clinical practice evolves.
- Increase in Chronic Diseases: Conditions such as diabetes, hypertension, and obesity are on the rise. Consequently, more patients are undergoing cardiovascular procedures that require arterial access. Thus, the demand for effective closure solutions will continue to grow.
