2009projectindex051DiMaio

Medical Student Research Fellowship for Summer 2009

Mentor: J. Michael DiMaio, MD; Brian Bethea, MD
Department: Department of Cardiovascular and Thoracic Surgery
Room number: HA9.0
Mail Code: 8879
Phone number: 214.645.7700
E-mail: Michael.dimaio@utsouthwestern.edu; brian.bethea@utsouthwestern.edu; michelle.harp@utsouthwestern.edu
Project title:
1. Bronchial Carcinoid Tumors: Factors Affecting Survival
2. Prognostic Factors and Survival in Patients with Small Round Cell Tumors
3. Penetrating Cardiac Trauma: Benefits of Intervention by CVT Surgeon
4. Interagency Registry of Mechanically Assisted Circulatory Support
5. Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation
6. Management of Excessive Bleeding following Cardiopulmonary Bypass: A Pilot Feasibility Study
Human subjects IRB approved project number (where applicable):
1. Bronchial Carcinoid Tumors: Factors Affecting Survival - pending
2. Prognostic Factors and Survival in Patients with Small Round Cell Tumors - pending
3. Penetrating Cardiac Trauma: Benefits of Intervention by CVT Surgeon - 042008-019
4. Interagency Registry of Mechanically Assisted Circulatory Support - 032006-044
5. Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation - pending
6. Management of Excessive Bleeding following Cardiopulmonary Bypass: A Pilot Feasibility Study - pending

Animal subjects IRB approved project number (where applicable):
Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)
1. Bronchial Carcinoid Tumors: Factors Affecting Survival - patient-based research
2. Prognostic Factors and Survival in Patients with Small Round Cell Tumors - patient-based research
3. Penetrating Cardiac Trauma: Benefits of Intervention by CVT Surgeon - patient-based research
4. Interagency Registry of Mechanically Assisted Circulatory Support - patient-based research
5. Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation - patient-based research
6. Management of Excessive Bleeding following Cardiopulmonary Bypass: A Pilot Feasibility Study - patient-based research

Brief Description of Project:
1. Bronchial Carcinoid Tumors: Factors Affecting Survival
Concise Summary of Project:
The purpose of this study is to complete a broad chart review of all the patients who have undergone bronchial carcinoid resection in the UT Southwestern Hospital System from 1998 - 2009. This study will look at the pathological lymph node status as well as other factors which may lead to decreased survival. We will compare the two types of carcinoid tumors (typical vs atypical) with the aim of indicating which has the best outcomes while taking into account the complications and morbidity involved with each tumor.
2. Prognostic Factors and Survival in Patients with Small Round Cell Tumors
Concise Summary of Project:
The purpose of this study is to complete a broad chart review of all the patients who have been treated for small round cell tumors within the UT Southwestern Hospital System from 2000 - 2008. Treatment includes systemic therapy, and local therapy including both radiation therapy as well as surgical resection. This study will look at the extent of the disease, results of multimodality therapy as well as other factors which may lead to decreased survival. The aim this study is to study the clinical characteristics, survival and prognostic factors influencing the outcomes of patients treated with small round cell tumors.
3. Penetrating Cardiac Trauma: Benefits of Intervention by CVT Surgeon
Concise Summary of Project:
The purpose of this study is to complete a broad chart review of all the patients who have suffered penetrating traumatic cardiac injury and have been treated at UT Southwestern Medical Center's Hospitals between 1997 and 2008. This study will compare the survival rates and outcomes of patients treated surgically for penetrating TCI immediately by trauma physicians and outcomes of those who received surgical intervention by a cardiothoracic team. The study will take into account the type of medical management used, the length of time between presentation of penetrating TCI and repair of the associated lesion, and the presence of other traumatic injury. We will use biostatistics to compare morbidity and mortality in various patient groups. Our aim is to determine whether cardiac surgery performed by a trauma team or performed by intervention of CVT surgeons has the best outcome, while taking into account the complications and morbidity involved in each instance.
4. Interagency Registry of Mechanically Assisted Circulatory Support
Concise Summary of Project:
This is an observational registry of clinical events. Patients will be asked to sign an informed consent document that includes permission to:
" Collect clinical data from their medical chart.
" Administer a short quality of life questionnaire.
" Administer the trail neurocognitive test.
" Bank remnant surgical material (blood and tissue samples) at the NHLBI repository.
The blood and tissue collection will take place during MCSD implantation and explantation of the device. Any inconvenience, danger, or discomfort occurring from the surgery and clinical processes will be documented. Patients will sign a separate consent form for the blood and tissue banking.

5. Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation - patient-based research
Concise Summary of Project:
Subjects who have valvular heart disease and require replacement of their heart valve are being invited to participate in this study. Their treatment will be similar to that provided to patients who have their heart valves replaced with any other commercially available prosthetic heart valve.
Before surgery, the patient will have routine diagnostic tests to assess the status of their heart valves. Then surgery with implantation of the Prosthesis. The patient's progress will be closely monitored and recorded at a total of 7 visits over 5 years.

At the 3 month visit they will be randomly assigned to one of two anticoagulation drug therapies depending upon the type of implant they receive and their general health apart from the valve. These two therapies are the standard anticoagulant therapy now used based on the recommendations of the American Heart Association or a therapy with a reduced dose of anticoagulation. Laboratory blood samples will be drawn and other diagnostic tests will be done during the appropriate preoperative and follow-up visits. The diagnostic tests will be an INR(International Normalized Ratio), which is a laboratiory test that measures the time it takes for blood to clot and compares it to an average. To find the INR a small sample of blood is taken from a fingertip or vein. The time it takes the blood to clot is measured. Then a ratio-an INR-is established. The higher the INR, the longer it takes the blood to clot. This can help prevent clots that may lead to strokes. and echocardiograms at 1, 3 and 5 years following surgery to assess valve function. The drug therapy may require additional laboratory blood tests as ordered by your physician. After the 12-month visit, all patients will be seen on a yearly basis for at least five years. Autopsies are requested should death occur during the study period to confirm any potential complication related to the study.

The anticoagulant therapies include three treatment groups for patients with: 1.) low risk of clotting having an aortic valve replacement, 2.) higher risk of clotting having an aortic valve replacement, and 3.) either a mitral valve replacement or replacement of both (double) valves. Each treatment group will have a control group that uses the presently recommended antithrombotic drug therapy of the American Heart Association, Coumadin® and aspirin. Each patient will be randomly assigned to the treatment or the control group indicated by the criteria above.
The treatment drug therapy for the low risk aortic valve replacement group is a combination of two presently used drugs - aspirin and Plavix®. The treatment drug therapy for the high risk aortic valve replacement group, the mitral or double valve replacement is a reduced dose of Coumadin and aspirin.

6. Management of Excessive Bleeding following Cardiopulmonary Bypass: A Pilot Feasibility Study - patient-based research
Concise Summary of Project:
This project is designed to enroll up to 400 patients at 4 medical centers (up to 150 at UTSW) that are at high risk for excessive blood loss following CPB surgery. Our hypothesis is that our approved transfusion protocol can be adhered to even in an environment with rapid blood loss. We will document our adherence to our treatment protocol at 15 points in the intraoperative transfusion algorithm. In addition we will collect data regarding the impact of our protocol on blood loss/transfusion and the incidence of excessive bleeding despite conventional treatment (with blood products). The anesthesiologist will be responsible for administering the blood products based on the transfusion protocol. The protocol will be in effect until 8 units of fresh frozen plasma (FFP), 2 units of (apheresis) platelet concentrates and 10 units of cryoprecipitate have been administered (see Intraoperative Bleeding Management Algorithm - "OR Round #2"). Patients that still have excessive bleeding beyond this point will be deemed "resistant to conventional therapy" and data collection for the primary endpoint will end at this juncture. Subsequent transfusions and treatments for persistent and excessive blood loss will be at the discretion of the treating anesthesiologists and surgeons based on each institutions current practice and institutional protocols.
In addition, a medical record review will be performed to gather preoperative clinical and laboratory data to screen patients for possible enrollment into the study. The medical records will also be used to document relevant intraoperative and postoperative clinical (blood loss/transfusion, complications, etc) and laboratory information (see attached Data Collection Sheet)All of the data from the study will be collected during the surgical hospital admission. Their will no additional laboratory tests performed that are outside our current standard of care. Blood product utilization will be based on FDA indications.

Previous Research Activities with Medical Students:

Infective Endocarditis: Clinical Course and Results of Surgical Management
Pain Management Techniques used in the Postoperative Period following Thoracotomy Procedures -
A Retrospective Analysis and Follow up
Clinical Management of Laryngotracheal Trauma: Case Report and Literature Review
Lung Cancer in Heart Transplant Patients: The Use of CT Screening
Traumatic Aortic Injury: Management of Blunt Aortic Injury - A Paradigm Shift?
Pleural Effusions: Effective Palliation of Malignant Pleural Effusions With the Pleurx Catheter
Esophageal Cancer: Clinical Impact of Combined Modality Therapy for Esophageal Cancer
Renal Cell Carcinoma: Contemporary Techniques Improving the Safety of Surgical Management of Tumor Thrombi

Early steroid withdrawal improves late survival after heart transplantation: 14 year results
Renal function is preserved following heart transplantation using IL-2 receptor blockade

Previous Publications with Medical Students:

MANUSCRIPTS ACCEPTED FOR PUBLICATION
1. G. Wheatley, C. W. Yancy, M. A. Wait, D. M. Meyer, M. E. Jessen, M. C. Paul, P. Kaiser, R. A. Bhojani, M. Drazner, W. S. Ring and J. M. DiMaio Renal function is preserved following heart transplantation using IL-2 receptor blockade. J of Heart and Lung Transplantation. Volume 23, Issue 2, Supplement 1, February 2004, Page S140.

2. D.H. Rosenbaum, R.A. Bhojani, P. Kaiser, E. Dikmen, M.C. Paul, C. Yancy, W.S. Ring and J.M. DiMaio. Routine chest CT screening in high risk cardiac transplant patients may improve survival. J of Heart and Lung Transplantation. Volume 24, Issue 2, Supplement 1, February 2005, Pages S47-S48.

3. Bhojani RA, Rosenbaum DH, Dikmen E, Paul MC, Atkins BZ, Zonies D, Estrera AS, Wait MA, Meyer DM, Jessen ME, DiMaio JM. Contemporary Assessment of Laryngotracheal Trauma. J Thoracic and Cardiovascular Surgery. Volume 130, Issue 2, August 2005, 426-432.

4. Khwaja S, Rosenbaum DH, Paul MC, Bhojani RA, Estrera AS, Wait MA, DiMaio JM. Surgical treatment of thoracic empyema in HIV-infected patients: Severity and treatment modality is associated with CD4 status. Chest. 2005; 128:246-249.

5. Rosenbaum DH, Bhojani RA, Dikmen E, Paul MC, Wait MA, Meyer DM, Jessen ME, Yancy CW, Ring WS, DiMaio JM. Routine chest CT screening in high risk cardiac transplant patients may improve survival. J of Heart and Lung Transplantation. 2005; 24(12): 2043-2047.

6. Sallach SM, Dobrilovic N, Hirsch BR, Paul MC, Cabell C, Pappas P, DiMaio JM, Peterson GE. Echocardiographic outcome predictors in surgically treated patients with infective endocarditis. J Am Coll Cardiol. 2005; 45(3):280A.

7. Dobrilovic N, Hirsch BR, Sallach SM, Paul MC, Peterson GE, Wait MA, Jessen ME, Ring WS, Cabell C, Pappas P, DiMaio JM. Outcomes and risk assessment of diabetic patients treated surgically for infective endocarditis. Circulation. 2005; 111(20):316E.

8. Dobrilovic N, Hirsch BR, Sallach SM, Paul MC, White MD, Peterson GE, Wait MA, Ring WS, Jessen ME, Pappas P, Cabell C, DiMaio JM. Predictors of adverse and favorable outcomes in patients undergoing surgery for infective endocarditis. J Cardiovasc Surg. 2005.

9. Lubahn JG, Sagalowsky AI, Rosenbaum DH, Dikmen E, Bhojani RA, Paul MC, Dolmatch BL, Josephs SC, Benaim E, Levinson BS, Hamilton TT, Wait MA, Ring WS, DiMaio JM. Contemporary techniques improving the safety of surgical management of tumor thrombi in renal cell carcinoma. Accepted for publication in the J Thoracic and Cardiovascular Surgery.

10. Rosenbaum DH, Adams BC, Mitchell JD, Jessen ME, Paul MC, Kaiser PA, Pappas PA, Meyer DM, Wait MA, Drazner MH, Yancy CW, Ring WS, DiMaio JM. Effects of early steroid withdrawal after heart transplantation. Accepted for publication in the Annals of Thoracic Surgery.

11. Rosenbaum DH, Mitchell JD, Adams BC, Paul MC, Jessen ME, Kaiser PA, Meyer DM, Wait MA, Drazner MH, Yancy CW, Ring WS, DiMaio JM. Effects of Basiliximab induction therapy at mid-term follow up in cardiac allograft recipients. Submitted to the Journal of Heart and Lung Transplantation.