Dr. Molly Schultheis, a cardiothoracic surgeon at the Englewood-based health facility, is a principal investigator for the trial and leads the health system’s participation in the multisite initiative.
According to the American Association for Thoracic Surgery, women make up only 5% of cardiothoracic surgeons in the U.S. Schultheis is the only female cardiothoracic surgeon in Bergen County and among just 125 in the nation.
“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,” Schultheis said. “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 and single arterial grafting. 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,” Dr. Adam Arnofsky, chief of cardiothoracic surgery at Englewood Health, said. “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.”
Sponsored by Weill Medical College of Cornell University, ROMA: Women is an international, multicenter, 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.