Promising Research to Stabilize Growth of Abdominal Aortic Aneurysms

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Photo caption:  Dr. Sheth, at work.   (Image provided by SLUHN)

St. Luke’s vascular surgeons were the first in the Northeast to enroll a patient in a research study that could revolutionize the care of patients with small to medium-sized abdominal aortic aneurysms (AAA).

The aorta is the largest blood vessel in the body, which comes out of the heart and travels down inside the body cavity. AAAs develop when the tissue that lines the aorta weakens and the aorta starts bulging out, forming the aneurysm, which often continues to enlarge and could eventually rupture. The most common area where this occurs is below the kidney arteries in the abdomen. The current standard of care for aneurysms less than 5-5.5 cm (about 2 inches in diameter) remains watchful waiting with periodic ultrasounds or CT scans. Once it becomes larger than 5.0 cm (women) and 5.5 cm (men), it may be considered for repair with either stent graft or open surgery.

Every year, over 200,000 people in the U.S. are diagnosed with an abdominal aortic aneurysm. A ruptured AAA is the 15th leading cause of death in the country, and the 10th leading cause of death in men older than 55. Famous people who have died from a AAA rupture include Albert Einstein, Lucille Ball and George C. Scott.

“The degradation of the tissue lining the aorta, made up of elastin and collagen (connective tissue proteins), results mostly from smoking, high blood pressure, genetic conditions and family history,” explained Sharvil Sheth, MD, St. Luke’s chief of vascular surgery.

Dr. Sheth is St. Luke’s principal investigator for this study, called stAAAble, sponsored by Nectero Medical, Inc. and launched at St. Luke’s University Health Network in late spring.  The study aims to evaluate the potential benefits of the investigational therapy in stabilizing AAA size and minimizing AAA-related events as compared to the conventional “watchful waiting” approach. Dr. Sheth’s colleagues, Lynne Doctor, MD, and Maggie Lin, MD, are also enrolling and treating participants in the study.

St. Luke’s is seeking male patients with AAA measuring 3.5-5 cm and female patients with AAA measuring 3.5-4.5 cm, to assess for possible inclusion in the stAAAble study. If accepted, they will be randomized to either minimally invasive same-day treatment with the new drug, called PGG (pentagalloyl glucose), or entered into the surveillance-only branch of the study. Patients who have been diagnosed with AAA, or suspect they have one, may contact St. Luke’s Vascular Center at 484-503-8281.

Patients randomized to the study’s treatment arm will have PGG delivered through a balloon catheter inserted through the femoral artery in the patient’s groin.

“The PGG mixture may help slow the breakdown of the elastin and collagen in the lining of the aorta,” explained Dr. Sheth. “Previous research treating 46 patients outside of the US with this approach has shown promising evidence that PGG may slow the growth of AAA so it doesn’t become dangerously large.”

Patients in both arms of the study will have their aneurysms measured by CT scans every six months for the first two years.

“This kind of groundbreaking research at St. Luke’s gives patients in the region access to innovative care without having to travel far from home,” Dr. Sheth said.

 

About St. Luke’s

Founded in 1872, St. Luke’s University Health Network (SLUHN) is a fully integrated, regional, non-profit network of more than 20,000 employees providing services at 15 campuses and 350+ outpatient sites. With annual net revenue of $4 billion, the Network’s service area includes 11 counties in two states: Lehigh, Northampton, Berks, Bucks, Carbon, Montgomery, Monroe, Schuylkill and Luzerne counties in Pennsylvania and Warren and Hunterdon counties in New Jersey. St. Luke’s hospitals operate the largest network of trauma centers in Pennsylvania, with the Bethlehem Campus being home to St. Luke’s Children’s Hospital.

Dedicated to advancing medical education, St. Luke’s is the preeminent teaching hospital in central-eastern Pennsylvania. In partnership with Temple University, the Network established the Lehigh Valley’s first and only four-year medical school campus. It also operates the nation’s oldest School of Nursing, established in 1884, and 52 fully accredited graduate medical educational programs with more than 500 residents and fellows. In 2022, St. Luke’s, a member of the Children’s Hospital Association, established the Lehigh Valley’s first and only free-standing facility dedicated entirely to kids.

SLUHN is the only Lehigh Valley-based health care system to earn Medicare’s five-star ratings (the highest) for quality, efficiency, and patient satisfaction. St. Luke’s is a Leapfrog Group and Healthgrades Top Hospital and a Newsweek World’s Best Hospital. The Network’s flagship University Hospital has earned the 100 Top Major Teaching Hospital designation from Fortune/PINC AI 10 years in a row, including in 2021 when it was identified as THE #1 TEACHING HOSPITAL IN THE COUNTRY. In 2021, St. Luke’s was also identified as one of the 15 Top Health Systems nationally. Utilizing the Epic electronic medical record (EMR) system for both inpatient and outpatient services, the Network is a multi-year recipient of the Most Wired award recognizing the breadth of SLUHN’s information technology applications such as telehealth, online scheduling and online pricing information.

 

Information provided to TVL by:
Sam Kennedy