Novel Vascular Access Management

The Boomerang system facilitates manual compression while leaving nothing behind.

By David E. Allie, MD; Ron Smalling, MD; Chris J. Hebert, RT, R-CIS; and Craig M. Walker, MD
 

We report our recent experiences with vascular access management utilizing a novel technology that simply and safely converts the existing arteriotomy sheath size from 4 F to 10 F to an arteriotomy the size of an 18-gauge needle without leaving anything behind. This vascular access management system greatly simplifies and facilitates manual compression from the standpoint of the patient, physician, cath lab, and hospital. The potential clinical importance of the novel Boomerang (Cardiva Medical, Mountain View, CA) vascular access management system is underscored when considering that after a plethora of vascular closure devices (VCDs) have been introduced during the last decade, it is estimated that 70% of all diagnostic and interventional cases still utilize traditional manual compression as their primary mode of vascular access management.

THE BOOMERANG WIRE SYSTEM
The Boomerang System is an 18-gauge (.051-inch) wire designed to address the shortcomings of current vascular access management tools, primarily VCDs (Table 1). The Boomerang Wire is not a VCD because it leaves nothing behind once it is removed. In comparison, VCDs are generally active fixation devices based on sutures, collagen plugs, staples, or clips. VCDs manipulate the arterial wall in ways that can cause trauma, scarring, and/or lead to a nidus for infection. Unlike VCDs, the Boomerang Wire employs a passive mechanism—a temporary collapsible polyurethane-sheathed nitinol disc—to tamponade the arteriotomy site and stop the pressurized pulsatile blood flow from escaping the access site hole. The Boomerang Wire can be used on a variety of sheath sizes (4-10 F).

The Boomerang Wire is exchanged for the existing sheath at the end of the diagnostic or interventional procedure, making this a simple, easy-to-use technology. The 18-gauge wire is passed through the existing sheath, and the temporary nitinol disc is deployed. Without touching the groin with any compression, the sheath is removed over the Boomerang Wire. The operator then gently grasps the green marked portion of the wire and exerts light pressure upward to allow the disc to seat in the artery, thereby sealing the arteriotomy site. While holding the green gripper and exerting gentle upward pressure on the spring wire, temporary hemostasis is achieved. A small plastic, atraumatic skin clip is placed on the unique spring portion of the wire to maintain an occlusive tamponade until the device is removed. The disc has been designed so that no traumatic damage to the artery results from the disc if inadvertently pulled through the puncture site. That said, a pull-through is the only risk from this device and if it occurs, manual compression is simply applied, allowing a noncatastrophic failure mode.

After a dwell time of usually 10 to 15 minutes for diagnostic patients, removal of the device is accomplished by a three-step process: (1) placing a fingertip optimally above the arteriotomy site, (2) applying nearly occlusive pressure, and (3) collapsing the disc by clicking the exposed end of the Boomerang Wire (Figure 1). The wire is then removed and light manual compression is applied to the arteriotomy site for 5 to 10 minutes in diagnostic nonanticoagulated patients and for 10 to 15 minutes in previously anticoagulated interventional patients. A light dressing is then applied to the site. Because manual compression times are shorter after removing the Boomerang Wire, physical staff effort and injury potential are reduced, and patient comfort is improved. In addition, bed rest for patients is typically less than 2 hours after using the Boomerang Wire, compared with 4 to 6 hours for patients receiving only manual compression.

In the interventional patient, the Boomerang Wire is managed similarly to a sheath awaiting removal, with the Boomerang Wire being removed after the same period of time as the sheath would normally be removed. Because the distal limb continues to receive unobstructed blood flow during this period (unlike an indwelling sheath patient), optimal perfusion can be achieved. This becomes important in patients with antegrade or brachial sticks, small arteries, or in patients who require larger sheaths, especially in patients with PVD in whom blood flow is already compromised.

The Boomerang Wire system harnesses the natural elastic recoil of the tunica elastica found in muscular arteries, while simultaneously excluding pressurized blood from trying to escape through the arteriotomy site, thus allowing the perivascular arterial tissues and space to return safely to their presheath states and avoid unnecessary subcutaneous hemorrhage, therefore decreasing the potential for scarring. This elastic recoil phenomenon has been coined the “Boomerang effect” (Figure 2). The Boomerang operator (usually a physician but possibly a trained staff member with appropriate training and demonstrated competence) can deploy the Boomerang Wire in less than 1 minute (usually in <30 seconds). Once the Boomerang Wire is removed, managing the small, 18-gauge arteriotomy hole is much easier on the staff and the patient than is postprocedure site management through manual compression of a much larger arteriotomy site. Keep in mind that the introducer sheath is sized by its internal diameter, but the opening that a sheath makes in the artery is nearly 1 mm larger. The average 6-F (2-mm) sheath creates nearly a 9-F (3-mm) arteriotomy.

The Boomerang 610 Data
The first-generation, 56 Boomerang Wire received FDA clearance in November 2004, but recently, the 610 Boomerang Wire has become available, allowing vascular access management of up to 10-F sheath sizes utilizing the same small 18-gauge needle size wire system. The 610 system is now utilized almost exclusively by all active, high-volume Boomerang labs.

To date, a Boomerang 610 real world registry from five major US sites has enrolled 415 patients (diagnostic, 272 patients; interventional, 143 patients). The average dwell time and average hold time for the diagnostic cases were 19.1 minutes and 8.2 minutes, respectively, and 120 minutes and 13 minutes, respectively, for the interventional cases. There was only one (0.25%) major complication (nonsurgical retroperitoneal hematoma) and two (0.49%) minor complications (both small hematomas). Fewer than 5% (4.7%) of the cases required an additional 5 to 10 minutes of hold time.

POTENTIAL ADVANTAGES
There are multiple potential advantages of the Boomerang vascular access management system (Table 2). Several clinical observations have become readily obvious, especially in treating our complicated critical limb ischemia (CLI) patients who may require nontraditional vascular access (brachial or antegrade CFA approach). We also treat our CLI patients with bivalirudin and a 12-hour to 18-hour GP IIb/IIIa infusion, much like acute coronary syndromes, and we have had to develop a vascular access management system to limit potential bleeding complications.1 Our experience with all current VCDs, especially in PVD, is that the risks of complications far outweigh any potential benefits of VCDs, therefore, we have all but eliminated VCDs from our lab.

Prior to the Boomerang device, we historically would wait several hours for the effects of heparin to subside before sheath removal and would apply longer-duration manual compression with a C-clamp to achieve vascular access management in the CLI patient while GP IIb/IIIa infusions were continued. The Boomerang system has significantly improved vascular access management in this CLI clinical setting by eliminating the C-clamp and the longer-duration, strenuous manual compression often required to attain adequate hemostasis. The Boomerang can be comfortably left in place as long as clinically indicated until limited manual compression is applied. This strategy has allowed us to decrease complications, avoid VCD deployment, and improve our patient and staff satisfaction. We believe that leaving a Boomerang device to dwell in the artery is always better for the patient than having any sheath dwelling in the vessel.

CONCLUSION
The 610 Boomerang vascular access management system is a novel method of achieving vascular access hemostasis that is not a true VCD and greatly facilitates and minimizes manual compression. The potential to decrease vascular access management complications by greatly facilitating manual compression without leaving anything behind and decreasing work-related musculoskeletal injuries to our health care staff are but several advantages of this system. The Boomerang vascular access management system appears ideal for the long-term management of the cardiovascular patient by helping preserve the integrity of vascular access sites for successful procedures today and in the future.

For additional reading, see the article “Manual Compression May Not Be Benign” in the April 2003 issue of Endovascular Today.

David E. Allie, MD, is Director of Cardiothoracic and Endovascular Surgery at the Cardiovascular Institute of the South in Lafayette, Louisiana. He has disclosed that he holds no financial interest in any product or manufacturer mentioned herein. Dr. Allie may be reached at (800) 582-2435; david.allie@cardio.com.

Ron Smalling, MD, is from St. John’s Clinic-Cardiology, Springfield, Missouri. He has disclosed that he holds no financial interest in any product or manufacturer mentioned herein. Dr. Smalling may be reached at (417) 820-3911; hearthawk@sbcglobal.net.

Chris J. Hebert, RT, R-CIS, is Director of Cardiothoracic Services at the Cardiovascular Institute of the South in Lafayette, Louisiana. He has disclosed that he holds no financial interest in any product or manufacturer mentioned herein. Mr. Hebert may be reached at (800) 582-2435; chris.hebert@cardio.com.

Craig M. Walker, MD, is Medical Director, Founder, and President of the Cardiovascular Institute of the South in Houma, Louisiana. He has disclosed that he holds no financial interest in any product or manufacturer mentioned herein. Dr. Walker may be reached at (800) 445-9676; craig.walker@cardio.com.

1. Allie DE, Hebert CJ, Lirtzman MD, et al. A safety and feasibility report of combined direct thrombin and GP IIb/IIIa inhibition with bivalirudin and tirofiban in peripheral vascular disease intervention: treating critical limb ischemia like acute coronary syndrome. J Invas Cardiol. 2005;17:427-432.
 

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