As physician-scientists, we encounter questions about our patients' health and conditions, study the questions in the laboratory and then try to apply our findings back to the care of our patients. Research in the Division of Cardiothoracic Surgery at UNC includes these areas:
1) Lung transplantation: UNC is known both nationally and internationally for its lung transplantation program, particularly because of its treatment of patients with Cystic Fibrosis. Since he came to UNC in 1989 to run its lung transplant program, Thomas M. Egan, M.D. (at center in photo, working with John Abano, M.D., left, and Boming Dong, M.D., Ph.D., right) has conducted research to study the hypothesis that lungs might be suitable for transplant even if retrieved at intervals after death and circulatory arrest. This could greatly expand the lung donor pool, offering many more people with end-stage lung disease the opportunity to have new lungs.
Dr. Egan has shown that lungs are still viable after circulation stops because lung cells obtain oxygen after death from air in the air sacs and airways (other organs require blood circulation to obtain oxygen).
In 2013, the University of North Carolina, with Dr. Egan as principal investigator, received a $4 million, three-year grant from the National Institutes of Health (National Heart, Lung, and Blood Institute) to study assessment and transplantation of lungs from people who have died suddenly, outside the hospital, and have not been on mechanical ventilation. These are known as non-heart-beating donors (NHBDs).
Dr. Egan's lab has perfused and ventilated human lungs outside the body (ex vivo) to determine if they are suitable for transplant; the lab also has worked to show the safety of transplanting these lungs. Currently, solid organs for transplant come primarily from patients who have suffered brain death and have been on mechanical ventilation before controlled circulatory arrest. However, many lungs from these donors cannot be used for transplant because of inflammation or infection during a prolonged interval of brain death. Lungs retrieved from NHBDs may not only be much more plentiful; they may be superior to lungs currently being transplanted from brain-dead donors.
Duke University (R. Duane Davis, M.D., principal investigator for the subaward), Carolina Donor Services, the regional organ procurement organization, and Lung Banks of America, a non-profit oganization, will have subawards on the grant. Wake County Emergency Medical Services, law enforcement, the medical examiner’s office and other government entities have cooperated to ensure the project is successful. Lungs from the non-heart-beating donors that are found acceptable after ex-vivo assessment will be transplanted at UNC and Duke to patients who have consented to use of the lungs under FDA- and IRB-approved protocols. Outcomes will be compared to patients contemporaneously transplanted with lungs from conventional organ donors. If the trial is successful, it could lead to a broader study at more institutions.
The grant is “More and Better Lungs: Ex-Vivo Perfusion of Lungs from Non-Heart-Beating Donors” (NHLBI grant 1 UM1 HL113115-01A1).
2) Surgery simulation training: Richard H. Feins, M.D., is principal investigator of an eight-institution study of use of simulators to teach cardiothoracic surgery skills to resident physicians as a way to improve patient safety. The three-year study is funded by the Agency for Healthcare Research and Quality. The other institutions are Johns Hopkins University, Massachusetts General Hospital, Mayo Clinic, University of Rochester, Stanford University, Vanderbilt University, and the University of Washington.
The grant is "Improved Patient Safety by Simulator Based Training in Cardiac Surgery" (AHRQ grant 5R18HS020451-03).
3) Congenital Heart Disease: Pediatric congenital heart disease patients are a high‐risk group of patients who receive care in a complex system of hospital units with a number of multidisciplinary care teams. The goal of Project TICKER, Teamwork to Improve Cardiac Kids' End Results, is to improve the care of these patients by implementing a family‐centered safe practice infrastructure incorporating teamwork training and integrated clinical pathways (ICPs). Pediatric heart surgeon Michael R. Mill, M.D., pediatric nurse practitioner Karla Brown and other staff members who care for pediatric heart patients are involved in the project, which provides tailored teamwork training and designs and implements patient care plans, known as integrated clinical pathways, to decrease unnecessary variations in care. Multiple hospital teams, patients, and families are partners on this project, which is supported by the Agency for Healthcare Research and Quality. Read more.
Acute coronary syndrome outcomes for Medicare patients: Brett Sheridan, M.D. was co-principal investigator on a major study funded by NIH (National Institutes for Aging) that examined the influence of specific therapeutic strategies in elderly people who suffer from acute coronary syndrome (ACS). The multidisciplinary research team analyzed national Medicare data to discern the influence of demographics, physiology and specific (competing) treatments on outcomes of the elderly presenting with heart disease.
Examination of pulmonary blood flow physiology in congenital heart disease: This project, on which Michael Mill, M.D., and Brett Sheridan, M.D., were co-investigators, utilized a large animal model of the Fontan procedure. A clinical arm of the study involved Cardiac Magnetic Resonance Imaging of patients who had undergone the Fontan procedure, in an effort to correlate the laboratory findings with clinical practice and further define optimal construction of the Fontan circulation. The research, funded by NIH, was performed in conjunction with the Department of Biomedical Engineering at UNC and includes researchers at Georgia Tech, Emory and the Children’s Hospital of Philadelphia.
We also have been involved in a number of clinical trials, including:
Prevent IV: Project of ex-vivo vein graft engineering via transfection of E2F decoy. This project examined the role of cell-cycle inhibition on saphenous vein graft patency used for coronary artery bypass surgery.
STICH: The surgical treatment for ischemic heart disease study is an NIH-sponsored trial that randomizes patients with coronary artery disease and poor left ventricular function to receive either best medical therapy, coronary artery bypass surgery, or coronary artery bypass surgery with ventricular reconstruction. The latter group, at the time of surgery, has excision of scar tissue from previous heart attack in order to make the heart work more efficiently. UNC has been one of the leaders in recruitment and involvement with this trial.
Primo-CABG II: A Multicenter, Randomized, Double-Blind trial of Pexelizumab in Patients undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass. This project studied the use of complement inhibition (associated with the inflammatory response) on outcomes following coronary artery bypass surgery.
Reliant: Randomized evaluation of the Novacor Left Ventricular Assist System (LVAS) in a non-transplant population. This trial compared the use of two different ventricular assist devices as destination therapy for patients not eligible for heart transplant.
Jarvik 2000 Multicenter Pivotal Study: This study examined the efficacy of a new generation axial flow pump for patients with decompensated heart failure as a bridge to heart transplantation.
Freedom Trial: Randomized, prospective trial of operative versus percutaneous multivessel revascularization in diabetic patients.