Tears in the aorta which affect thousands of people each year coast to coast, may soon be treated with a much less invasive technique that could dramatically improve patients' chances of survival.
A national study being directed by a vascular surgeon at Thomas Jefferson University Hospital is exploring a new minimally invasive method that could spare patients the trauma and risk of open chest surgery.
Joseph V. Lombardi, M.D., Director of the Jefferson Aortic Center (www.jeffersonhosptal.org/aortic) is the National Principal Investigator (PI) in the U.S. Food and Drug Administration--approved clinical study assessing the safety and effectiveness of an endovascular stent-graft to treat aortic dissection, a condition that led to the sudden death of actor John Ritter.
“This pathology specific endovascular device has the potential to eliminate the need for highly invasive, open chest surgery to repair one of the most deadly aortic diseases in the U.S.,” said Dr. Lombardi, assistant professor of Surgery, Jefferson Medical College of Thomas Jefferson University. “In Philadelphia alone, up to 60 patients per year are treated for aortic dissection with emergency procedures, which have numerous risks, high mortalities and long recovery periods. This device could help limit our need for invasive procedures and save many lives.”
According to the American Heart Association, aortic dissection affects up to 10,000 people annually in the United States. Though the disease is rare among the country's population, its mortality rate is high, creating a need for new and innovative treatments.
Aortic dissection is a laceration of the aorta, the largest artery in the body and the primary transporter of blood away from the heart. A tear in this artery causes blood to flow between the layers of its wall, eventually splitting the layers apart. Blood then collects in these new channels, compressing blood vessels that feed vital organs. It is an extremely serious medical condition that can quickly result in death.
Dr. Lombardi is also responsible for a parallel clinical trial including eight European and two Australian sites. As the global principal investigator, Dr. Lombardi's role is to oversee all clinical aspects of both trials and making any necessary adjustments as it moves forward. He will continuously update the national and international medical community on the trial's progress and will prepare the results for submission to the FDA. Robert Larson, M.D., assistant professor of Surgery, Jefferson Medical College of Thomas Jefferson University, will be serving as the Site PI for Jefferson University Hospital. A multidisciplinary team of physicians, cardiothoracic surgeons, cardiologists and anesthesiologists will all be involved with Drs. Lombardi and Larson.