Boomerang Wire device boasts many benefits

Device offers effective access to site management with fewer complications than manual compression.

The Boomerang Wire System provides clinicians with effective access to arteriotomy site-specific management and has demonstrated fewer complications than manual compressions in patients undergoing femoral artery catheterization.

Nothing is left behind that can cause an inflammatory response, an infection or that needs to be surgically removed, said Carol Renner, RN, BSN, director of clinical affairs at Cardiva Medical Inc., the manufacturer.

“Over standard manual compression, this device allows the patient to ambulate earlier and go home earlier because you are closing a smaller hole,” Renner told Cardiology Today. “We basically reduced the size of the large dilated sheath hole to an 18 gauge needle stick and even reduced the scarring left by manual compression.”

George Vetrovec

The guide wire-like functionality and low profile, conformable and collapsible disc provide a safe and minimally invasive approach to vascular access management. The device is designed to be more comfortable and cost-effective for patients undergoing percutaneous procedures.

“We’ve had recent experience with the Boomerang, and the staff and patients are pleased with it. The real advantage is it leaves nothing behind,” said George W. Vetrovec, MD, chairman of the division of cardiology at Virginia Commonwealth University Pauley Heart Medical Center, Richmond, Va. “It’s simple to use, and the potential for a problem is pretty small.”

Product benefit and use

The Boomerang device is inserted into the artery through the existing arterial sheath used during the catheterization procedure. Once inside the artery, the distal tip of the wire opens a flat, low-profile disc. The disc is then positioned against the opening of the femoral artery, which forms a tight seal and provides immediate hemostasis in the catheterization laboratory in less than 60 seconds.

“The device is not a closure device, it is used for arterial access management in cath labs and radiology labs,” Renner said. “It temporarily tamponades the arteriotomy while allowing for natural, precise, elastic recoil of the arterial wall and tissue tract.”

An external Boomerang Clip placed at the surface of the skin puncture site holds the tension in place. Targeted pressure on the arteriotomy and natural recoil of the tissue tract help reduce blood leakage into the tissue. When the device is collapsed and completely removed from the artery, it leaves no debris in the tissue or artery, eliminating risk of infection and major complications caused by biomaterials or sutures.

“Infection doesn’t happen very often with closure devices, but once is too much,” said Vetrovec, also a member of the Interventional Cardiology section of the Cardiology Today editorial board. “It certainly makes sheath pulling much easier because it saves time and effort and is very comfortable for patients.”

After a specified device dwell time, depending on the patient’s procedure and overall condition, manual compression is used to achieve standard hemostasis, according to Renner. The Boomerang Wire System also eliminates the need for a separate introducer sheath to upsize the tissue tract if immediate re-access is desired.

“One of the big advantages is you can use the Boomerang one day and go back into the site the next day,” Renner said. “It is patient-friendly and reduces the hole size arteriotomy and tissue tract. It requires less manual compression time, thereby giving an advantage to the clinician by reducing cause of repetitive stress injury.”

It also does not interfere with the body’s natural clotting process. Compared with suture or collagen mediated vascular closure devices, the Boomerang Wire System can also be used in a broader range of patients, such as those who require re-access, and for arterial puncture sites at or below the bifurcation, mild or moderate peripheral vascular disease, immunosuppression, varying puncture depth and small or tortuous vessels.

“From a clinical perspective, less is more when you are taking care of patients because we are doing more and more interventional procedures on patients, and I like to know that I can easily go back into the artery,” Renner said.

Limitations of use include those who have had a double wall stick, and those who have a high stick because there is no way to do manual compression. It may take longer to achieve hemostasis in patients with extremely severe peripheral vascular disease, because they may not be able to achieve hemostasis, and those who are hypertensive, because BP pushes against the fresh clot, according to Renner.

The Boomerang device during real-time insertion.
Images courtesy of David E Allie, MD, and Chris J Herbert, department of cardiothoracic and endovascular surgery, Cardiovascular Institute of the South/Lafayette, LA.

Boomerang data

Findings from the Boomerang I and Boomerang II clinical trials demonstrated shorter hold times, earlier ambulation times and reduced complications. Researchers did not see any major complications like retroperintoneal bleeds, surgical removal of the device and/or transfusion from blood loss.

“Complications associated with use were generally comparable to those more commonly associated with manual compression,” Renner said. “We had reduced minor complications, such as hematomas greater than 6 cm.”

“It is not going to prevent complications such as a back wall stick or a stick in between the artery and the vein, but for a straight stick into the artery, it really makes the procedure a lot easier, more comfortable for the patient. [It] takes less time and achieves quicker ambulation,” Vetrovec said.

A recent study published in Catheterization and Cardiovascular Interventions evaluated the safety and efficacy of the device in 96 patients undergoing diagnostic cardiac catheterization and found that in 99% of the patients, the device was successfully deployed and hemostasis was achieved. The researchers observed in an accelerated ambulation protocol minor complications in 5% of the patients, specifically rebleeding at the access site during bedrest requiring repeat manual compressions. They did not observe any major complications, large hematomas or any complications among 19 patients who received device-assisted closure or among the six patients with moderate to severe peripheral vascular disease and/or vessel wall calcification.

Availability, future studies

A clinical study is ongoing in Rockford, Ill., to evaluate the economic advantage of using the device. This study is in early-phase trials. The Boomerang II trial is a large multi-center registry, underway to further evaluate the device’s use.

Vetrovec suggested that future studies include a large, experienced registry comparing the Boomerang Wire device with standard sheath pulling with other closure devices to evaluate complication rates.

The FDA approved the Boomerang Wire System in October 2005 to assist clinicians in managing and closing femoral artery puncture sites following percutaneous procedures, such as angioplasty, angiography or stenting. It is available in 200 U.S. centers and in Asia. – by Tara Grassia

For more information:

• Doyle BJ, Godfrey MJ, Lennon RJ, et al. Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization. Catheter Cardiovasc Interv. 2007;69:203-208.