• Press Center
• Press Release Archive
• Media Kit
• SAAAVE Act Campaign
• Press Releases from 2008 Annual Meeting
• JVS Press Releases
• SVS Position Statements
• Contact Us

An implantable wireless sensor that monitors blood pressure in an aneurysm sac is safe and useful in guiding endovascular repair of an abdominal aortic aneurysm (AAA), according to a study published in the February issue of the Journal of Vascular Surgery.

The prospective, non-randomized study used acute wireless pressure measurements to confirm aneurysm sac exclusion and to determine if intraoperative pressure measurements obtained with the sensor correlated with angiography findings during and at the completion of stent graft placement. Seventy-six patients from 12 clinical centers were studied.

The accuracy of the sensor measurement was confirmed by comparing measurements obtained with an angiographic catheter. In addition, the sensor data and the angiographic findings were in agreement as to the presence of serious endoleaks in 92 percent of the cases. Through the 30-day follow-up period there were no device related safety issues.

“This trial demonstrates that this wireless sensor for aneurysm sac measurement is safe and feasible, and can be used to diagnose the location and type of endoleak during endovascular aneurysm repair,” said Takao Ohki, professor and chief in the vascular surgery department of Jikei University School of Medicine, Toyko, and professor of surgery at Albert Einstein College of Medicine, North Shore/LIJ Hospital in Long Island, N.Y.

Study researchers noted that surgeons currently use contrast dye injection and x-ray imaging (angiography) to monitor endoleaks, but the technique is not foolproof. These methods, they said, have an inability to quantify the significance of the endoleak. Also, artifacts caused by bowel gas may mimic an endoleak and thus may lead to misdiagnosis. Repeated contrast injection, which are required for angiography may impair renal (kidney) function.    

“The benefit of endovascular repair of an AAA includes the fact that the treatment can be performed through a small incision in the groin area, rather than the large abdominal incision used in open surgical repair,” said Dr. Ohki. “However, one downside to the endovascular approach is the occurrence of an endoleak, where blood still flows into the aneurysm, not eliminating the risk of aneurysm rupture and death.”

Dr. Ohki added that the APEX data was submitted to the Food and Drug Administration, which allowed this technology to become commercially available for stent graft implantation procedures. Future studies will focus on using sac pressure monitoring as an alternative to computed tomography for long-term aneurysm surveillance.

The abdominal aorta is the portion of the artery that runs through the abdomen and supplies blood to the lower body. When a weak area of the artery expands or bulges, it becomes an AAA. Approximately 200,000 cases of AAA are diagnosed annually in the United States and the disease is responsible for nearly 15,000 deaths each year. In an endovascular (within the vessel) aneurysm repair, a stent graft is placed in the vessel to exclude the aneurysm from the main circulation and de-pressurize it, thus preventing it from rupturing.