Saints Breakthrough Treatment

Saints is one of first medical facilities in Mass. to participate in clinical study on early treatment of small abdominal aortic aneurysms

Saints Medical Center in Lowell is one of the first hospitals in New England to participate in a new clinical study designed to evaluate whether early treatment of small abdominal aortic aneurysms (AAA) - those smaller than 5 centimeters in diameter that meet certain conditions - using endovascular repair is superior to periodic surveillance, or "watchful waiting."

An aortic aneurysm is an abnormal expansion of the aorta, the largest artery in the body, and an extremely serious condition that kills more that 15,000 people each year in the United States.  Aneurysms usually develop slowly and without symptoms. In affected individuals, the aortic wall weakens and starts to bulge. Often, the eventual endpoint of AAA expansion is rupture, a catastrophic situation in which the artery bursts and causes severe internal bleeding, usually leading to death.

Saints Vascular Surgeon Paul Burke Jr., MD, and Interventional Radiologist Greg Walker, MD, successfully implanted the stent graft system at Saints Medical Center in a 65-year-old patient on December 27, 2005. The patient was reported doing well and will be one of 150 patients to be enrolled in the study.  To date, 25 patients (14 patients with small AAA and 11 patients in a control group with larger AAA) have been enrolled and treated, and all have done extremely well postoperatively.

Dr. Burke said participation in trials such as this is important to the growth of the Saints Center of Excellence in Cardiovascular Services.

"Our participation in this important trial helps us continue to provide the latest in vascular treatments to our patients and, at the same time, advance the effort to provide more options to patients with this serious condition," said Dr. Burke. 

An article recently published in the Journal of Vascular Surgery confirms that there is a need for further study on early intervention for Abdominal Aortic Aneurysms. "There has been debate about the need for endovascular grafting in patients with smaller aneurysms and debate is a good thing," said Dr. Ken Ouriel of the Cleveland Clinic. "But there currently exists no good evidence to support claims from either side. The ultimate questions we are asking are: 'When does the risk of an endovascular procedure become less than the risk of observing the patient without definitive treatment?  At what size aneurysm?'  That's what we want to establish because that's the point when physicians should intervene."

The Saints study is a prospective trial comparing early stent graft intervention to the current medical standards and will enroll nearly 150 patients. The primary endpoint is the cumulative occurrence of the composite of rupture or aneurysm-related death within three years. Among the secondary objectives are all-cause mortality and aneurysm-related mortality in smokers vs. non-smokers, aneurysm rupture, duration of hospital stay, procedure duration, and many other endpoints related to the use of stent graft.

"Dr. Burke and I have been treating patients with AAA by means of endovascular repair, using an aortic stent-graft since 2002, and have successfully treated more than 200 patients with the disease to date. With this minimally invasive means of testing this potentially lethal disease, our patients have had excellent results with fast recovery time and few associated complications. We hope that treatment of smaller aneurysms will extend that benefit further," said Dr. Walker.

Traditional AAA treatment has generally been recommended when a patient's aneurysm reaches a diameter of between five and six centimeters, since at this point the risk of rupture is believed to be greater than the risk of open surgical repair. However, the recent introduction of minimally-invasive, catheter-based endovascular technology has made it possible to treat aneurysms and prevent rupture with lower mortality and morbidity rates compared to open surgery. The results of the less-invasive Saints Medical Center study could alter thinking if the use of endovascular stent graft systems instead of open surgery proves positive in these patients.

The AneuRx AAA Stent Graft system provides an alternative treatment to major open surgery. The woven polyester graft tube material is delivered via catheter following a small incision in the leg to provide access to the femoral artery, and positioned in the aorta. When placed within the aneurysm, the stent graft provides a permanent, alternative conduit for blood flow with the vasculature. More than 50,000 AneuRx systems have been implanted worldwide.