Molly Schultheis, MD, cardiothoracic surgeon at Englewood Health, serves as a principal investigator for the trial
February 21, 2024 — Englewood Health is among the first health systems in New Jersey to enroll patients in ROMA: Women, an international research study on coronary artery bypass graft (CABG) surgery in women.
Molly Schultheis, MD, a cardiothoracic surgeon at Englewood Health, is a principal investigator for the trial and leads the health system’s participation in the multi-site initiative. To date, Englewood Health has enrolled the highest number of trial participants among all health systems in New Jersey.
“For women who have significant narrowing of the arteries in their heart and require cardiac surgery, our intention is to ensure long-term improvement of blood flow to the heart muscle,” says Dr. Schultheis. “Understanding how women’s physiology uniquely responds to procedures used to restore blood flow is incredibly important as we focus on continuously improving outcomes for women with heart disease.”
CABG surgery is used to improve blood flow to the heart. The graft uses blood vessels from other parts of the body, such as the arm, chest, or leg, to bypass the blockage in the artery, allowing cardiothoracic surgeons to “revascularize” one or more arteries in the heart. Traditionally, studies on arterial revascularization have been based on data from surgeries on men or studies including both men and women.
The ROMA: Women study aims to compare two methods of performing CABG in women: multiple arterial grafting (MAG) and single arterial grafting (SAG). SAG refers to the use of one arterial vessel to bypass a coronary artery, while MAG refers to the employment of two or more arterial vessels.
The study hypothesizes that MAG will yield better clinical outcomes than SAG. Investigators in the trial are assessing the impact these methods have on cardiac and cerebrovascular events, quality of life, and symptoms in different subgroups.
“This is an international study of vast importance,” says Adam Arnofsky, MD, chief of cardiothoracic surgery at Englewood Health. “Dr. Schultheis is among few female cardiac surgeons in the U.S. Her contributions to the data in this first-of-its-kind clinical trial to determine the best surgical approach for women with coronary artery disease is significant.”
According to the American Association for Thoracic Surgery, women make up only five percent of cardiothoracic surgeons in the U.S. Dr. Schultheis is the only female cardiothoracic surgeon in Bergen County and among just 125 in the nation.
Sponsored by Weill Medical College of Cornell University, ROMA: Women is an international, multi-center, randomized clinical trial nested in the ROMA trial and includes all women enrolled in the parent ROMA trial. The seven-year ROMA: Women study, seeks to enroll 2,000 patients.
To learn more, visit clinicaltrials.gov/study/NCT04124120.