INSTITUTION AND LOCATION:

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1 NAME: Faife, Alexandra M., Cimaglia, Natalie L., Oyadiran, Olamide S. POSITION TITLE: Principal Investigators EDUCATION/TRAINING INSTITUTION AND LOCATION: Alexander W. Dreyfoos School of the Arts St. Thomas Aquinas High School Archbishop Edward A. McCarthy High School University of Florida Center for Precollegiate Education and Training: Explorations in Biomedical Research Program FIELD OF STUDY Cardiology Personal Statement: Natalie Cimaglia hopes to attend the University of Florida for her undergraduate and graduate degrees. She intends on majoring in Pre Vet during her undergraduate years. She is interested in the field because animals seem to have a way of bringing people up when they are down. Natalie likes to be that person that wants to keep the man s best friend alive and healthy for as long as she can. She s a people pleaser. Natalie aims to open up a private veterinary practice in Los Gatos, California after earning her veterinary degree. Olamide Oyadiran s career has solely focused on improving the quality of people s lives. After perusing over several biomedical engineering TED talks (one specifically by Anthony Atala, M.D., Director of the Wake Forest Institute for Regenerative Medicine, and the W.H. Boyce Professor and Chair of the Department of Urology at Wake Forest University) and other youtube videos by reputable researchers, she quickly grew interest in the riveting field of BME. Captivated by the rapid advancements in the field of biomedical engineering, she has the fire in her belly to catalyze her career at the University of Florida for her B.S. and M.D.. Pursuing to become a biomedical engineer, she plans to better people s lives through this research proposal by deciphering an upgraded strategy for those diagnosed with carotid artery disease or aortic stenosis and need a diagnostic angiogram procedure before a TAVR. Alexandra Faife has an interest in pursuing a career in the field of cardiology, and becoming a cardiac surgeon or an interventional cardiologist. With experience working in the catheterization laboratory at Delray Medical Center, she has gained a passion for this field and helping others. She hopes to attend Columbia University once she graduates high school and go to medical school. After she graduates, she would like to do residency at Birmingham Women's Hospital in Boston, MA and continue her career there in cardiology once she finishes with residency.

2 Title of Project: Alternatives of Diagnostic Angiography Procedure: Using Barium Sulfate in Conjunction with Oxygen Through a Respirator Specific Aim: Hypothesis: Coronary artery disease and aortic stenosis are two diseases that are outcomes of plaque build up in a person s heart arteries and valves. We plan to use barium sulfate and oxygen gas that will replace the diagnostic angiography process and will obtain the same results as a non invasive procedure. The barium sulfate will not put patients who have a low ejection fraction at risk, like diagnostic angiography does. Specific Aim: Specific Aim 1: Barium sulfate in conjunction with oxygen gas will benefit the patient by not putting those with low ejection fraction (EF) at risk, like diagnostic angiography does. The barium sulfate will have the same purpose as a catheter but it will not affect the patient s health in anyway. The barium sulfate and oxygen is safer, cost effective, and possibly faster then the catheter approach. The aim is to test the hypothesis that a diagnostic angiography prior to a valve surgery is correlated with a severe increased risk of bleeding. Also, there is a high death risk thirty days after a diagnostic angiography in patients with severe aortic stenosis, low ejection fraction, and in those with a greater Society of Thoracic Surgeons (STS) score. Background: Diagnostic Angiography (DA) is a minimally invasive procedure used to diagnose aortic stenosis, coronary artery disease, and other cardiac related issues that help doctors understand the severity of plaque build up in the arteries and vessels of the heart. This blockage can cause shortness of breath, chest pain, dizziness, signs of fatigue, heart palpitations, and heart murmurs. When a patient sees a doctor about their symptoms, a doctor will request a echocardiogram, electrocardiogram, and/or chest x ray to find blood flow blockages with non invasive procedures. If these three don t provide enough information for the doctor on the diagnosis or severity of the heart condition, they ll request a cardiac catheterization which is a more invasive procedure than the others that will show any blockages in arteries to your heart. From this procedure, the doctor can find out the specific heart condition and gain an understanding of how to effectively treat this patient and choose the following treatment they need. The doctor inserts a long thin tube called a catheter up the patient s artery

3 or vein in their groin (most common), neck, or arm and threads their way to the heart. Once the catheter reaches the heart, the doctor will inject contrast through the tube into the patient s arteries and valves to see any blockages or issues with their condition. The doctor is able to see images of the heart on a screen while injecting contrast because the use of an x ray during this procedure that allows live images to be seen. When the patient s heart condition is too severe to be fixed with any balloon or stent placement in the arteries, the doctor will suggest a surgical approach. One of these surgical procedures is called a transcatheter aortic valve replacement (TAVR), which is a non open heart procedure that s minimally invasive and repairs an aortic valve without removing the damaged old one. This approach takes a replacement valve and places it into the aortic valve s place by using a catheter to expand the new valve and move the decrepit valve leaflets away. This allows the tissue in the new valve to endorse the functions of regulating blood flow. In a TAVR, a catheter is entered through the femoral artery in the groin, which is the same area most common diagnostic angiography procedures are done with. Since a TAVR avoids a sternotomy, it avoids the surgical separation of the chest and allows the surgeon to leave all the patient s chest bones in place. Although this procedure has less of a risk than a standard aortic valve replacement, patients that had a diagnostic angiography procedure prior to surgery and have severe aortic stenosis and high heart failure measurements gain a risk of complications, including mortality. Barium sulfate is a radiopaque agent, a drug utilized to diagnose medical conditions that blocks x rays because of it s opaque characteristic. This allows for doctors to see the contrast between a certain internal organ and any issues present with the area. It s usually taken orally so it can reach intestines, stomach, or esophagus for x ray imaging. The amount of intake of barium sulfate varies with the patient, but like regular contrast used in a diagnostic angiography, is tried to keep to a minimum. By using the approach of ingesting this radiopaque agent, our aim is to use the gaseous state instead for the purpose of our proposal. Although Barium Sulfate today is only produced in a solid and liquid state, but is yet to be discovered in a gaseous state. A patient that has severe aortic stenosis, coronary artery disease, or any risky heart condition can have barium sulfate as an alternative for diagnostic angiography procedures to reduce complications and risks. When a patient inhales barium sulfate, it ll travel to their lungs and through the left pulmonary veins of the heart. This reaches the left atrium which leads to the left ventricle where the x ray can view any blockages. From the left ventricle into the aorta is the aortic valve, which is where aortic stenosis takes place, so this will appear on the x ray and display any heart conditions. The approach being presented is a noninvasive procedure that does not involve any of the risk a diagnostic angiography presents, which ultimately provides a much safer diagnosis for the patient.

4 Research Strategy Significance: Significance to Human Health (1) Aortic stenosis is the most common cardiac valve disease in developed countries, affecting 3% of people older than 65 years old. Although the survival rate in patients with AS is comparable in age and sex matched control patients, the average overall survival rate in symptomatic persons without aortic valve replacement is two to three years. (2) Coronary artery disease, or simply, heart disease, is the No. 1 killer in America, affecting more than 13 million Americans. (3) 1 in 3 Americans or 800,000 people a year die each year from a heart disease. 4) More than 15,800,000 people have a known coronary artery disease but less than half of those people know they have one and only find out after a heart attack. Significance to increasing our understanding of why a diagnostic angiography before a TAVR is not recommended and a possible alternative for a diagnostic angiography procedure that does not put patients with coronary artery disease or aortic stenosis at risk. in an easier, safer, and cost effective way in barium sulfate form. 50% of diluted barium sulfate and 50% of oxygen will go directly into the left pulmonary veins and into the left atrium and ventricle of the heart to reach the aortic valve of the patient. This mixture is called Gas and Air and is common in use. Similar to how laughing gas or Nitrous Oxide (N 2 O) works for dental procedures such as wisdom teeth removal. Usually, barium tests are used to examine the GI, gastrointestinal system to detect conditions of reflux or narrowing. Barium is a white and transparent powder that will allow the heart to be displayed on a computed tomography. Barium tests will allow the interventional surgeon to evaluate the plaque in the coronary arteries. This procedure will be safer, easier, and more cost effective compared to a diagnostic angiography. The procedure is non invasive, risks less and it does not cause as many complications. With the amount of people diagnosed with coronary artery diseases and aortic stenosis, this new Gas and Air approach may be a better alternative to the diagnostic angiography procedure that has more complications than a barium sulfate, oxygen, and low ethanol mixture. Approach In Aim 1 of this proposal we will use barium sulfate with oxygen in a respirator. The barium sulfate would be converted into its gas form and mixed with oxygen. This air will be carried through the capillaries and through the left side of the heart. It will travel through the left lung first, then enter the left pulmonary veins. After, the air will travel to the left atrium, mitral valve, and the left ventricle. Finally, the air will be carried up to the aortic valve where the plaque build up is located and stop it from going into the

5 bloodstream. The barium sulfate will portray a contrast in the patient s lungs and heart. This contrast will give the doctor a better look at the intensity of the plaque/calcium build up in the heart valves and arteries. The contrast will show up on an x ray like a catheter would in a normal diagnostic angiography procedure. The risk of using the barium sulfate in these patients would be that those with barium allergies would have a bad reaction to it. Barium can have an effect on people, but the doctors would only use a tiny amount of barium sulfate to prevent patients from being at risk, whether they have allergies to the chemicals or not. According to an article documented by a reputable medical journal, Aortic Stenosis: Diagnosis and Treatment: American Family Physician, potential advantages of the diagnostic angiography before TAVR approach are 1) easier access to the coronary arteries before a transcatheter; 2) less risk of inadequate blood supply to the heart during rapid pacing and balloon inflation during a TAVR. Although there are some potential advantages of a diagnostic angiography before a TAVR, 1) bruising from the point of insertion of the diagnostic angiography (usually the groin or wrist) 2) hematomas, or blood outside of the blood stream in the presence of severe CAD or AS are the main potential complications of a diagnostic angiography before a TAVR. At the moment there are not any well known alternatives for diagnostic angiography but there are options that one may use during the procedure. It was reported that people that have diagnostic angiographies before TAVR s may have adverse effects. For stable patients in which diagnostic angiographies are anticipated it is recommended that the patient has the treatment with the intake of aspirin 2 hours before the procedure. For patients that are going to have a diagnostic angiography, in addition to aspirin, prasugrel or clopidogrel is recommended for patients that may undergo the procedure. diagnostic angiographies do not have procedural complications, in fact they are very effective and have been widely performed for numerous coronary procedures. For medical uses, diagnostic angiographies do not have any benefits compared to the consumption of appropriate medications for people with coronary artery disease or aortic stenosis. DA is the most accurate method to identify and understand aneurysms, AS and CAD. It is a relatively safe procedure, but does have risks that the patient is informed about before the procedure. On the other hand, study has shown that people with an unstable coronary artery disease or aortic stenosis that go with the diagnostic angiography procedure have a beneficial outcome.

6 Bibliography and References Cited "Angioplasty and Stent Placement for the Heart." Johns Hopkins Medicine. The Johns Hopkins University, The Johns Hopkins Hospital, and Johns Hopkins Health System. Web. 16 July "Aortic Stenosis: Diagnosis and Treatment." American Family Physician. Web. 15 July "Barium Sulfate: MedlinePlus Drug Information." U.S National Library of Medicine. U.S. National Library of Medicine, 22 June Web. 16 July "Maxwell, Yael. "Length of Time Between Staged percutaneous coronary intervention, TAVR Minimally Affects Short term Outcomes Journal News TCTMD." Length of Time Between Staged Percutaneous Coronary Intervention, TAVR Minimally Affects Short term Outcomes Journal News TCTMD. 23 Apr Web. 16 July Micromedex. "Barium Sulfate (Oral Route, Rectal Route)." Description and Brand Names Web. 16 July "Percutaneous Coronary Intervention (PCI) Causes, Symptoms, Treatment What Are the Complications of percutaneous coronary intervention? EMedicineHealth." EMedicineHealth. WebMD, Web. 16 July "Percutaneous Coronary Intervention in Patients With Severe Aortic Stenosis." percutaneous coronary intervention in Patients With Severe Aortic Stenosis. American Heart Association, Web. 16 July Percutaneous Transluminal Coronary Angioplasty (PTCA) Anatomy Video: MedlinePlus Medical Encyclopedia." U.S National Library of Medicine. U.S. National Library of Medicine. Web. 15 July "Severe Aortic Stenosis and Coronary Artery Disease Implications for Management in the Transcatheter Aortic Valve Replacement Era." Medscape Multispecialty. WebMD, Web. 16 July 2015 "TCT 2012 Research Highlights: A Slideshow Presentation." Medscape Cardiology. Web. 16 July 2015.

7 "What Is TAVR?" What Is TAVR? American Heart Association, 24 Apr Web. 16 July 2015.

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