2008projectindex058DiMaio

Medical Student Research Fellowship for Summer 2008

Mentor: J. Michael DiMaio, MD
Department: Cardiovascular and Thoracic Surgery
Room number: HA9.254
Mail Code: 8879
Phone number: 214.645.7731
E-mail: Michael.dimaio@utsouthwestern.edu

Project title:

1. Penetrating Cardiac Trauma: Benefits of Intervention by CVT Surgeon

2. Surgical management of empyemas - a 15 year analysis

3. Does rigid plate fixation of the sternum aide in healing for sternal nonunion as a result of cardiac intervention or trauma?

4. Treatment options for permanent atrial fibrillation - a long-term follow up study

5. PET-CT scans - a new way to predict if pulmonary masses are neoplastic disease or granulomatous disease

Human subjects IRB approved project number (where applicable):

Study Title IRB Number

1. Penetrating Cardiac Trauma: Benefits of Intervention by CVT Surgeon

pending
2. Surgical management of empyemas - a 15 year analysis
062005-024

3. Does rigid plate fixation of the sternum aide in healing for sternal nonunion as a result of cardiac intervention or trauma?
pending

4. Treatment options for permanent atrial fibrillation - a long-term follow up study
pending

5. PET-CT scans - a new way to predict if pulmonary masses are neoplastic disease or granulomatous disease
052004-030

Project Type
Clinical Research

Brief Description of Project:

Please see attached

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.

MANUSCRIPTS SUBMITTED FOR PUBLICATION/ IN PREPARATION
1. Sallach SM, Dobrilovic N, Hirsch B, Paul MC, Cabell C, Pappas P, DiMaio JM, Peterson G. Clinical characteristics, morbidity and mortality of surgically treated patients with infective endocarditis and paravalvular extension of infection. Submitted.

2. Dobrilovic N, Hirsch B, Sallach SM, Paul MC, Peterson G, Wait MA, Ring WS, Jessen ME, Pappas P, Cabell C, DiMaio JM. Perioperative complications predictive of mortality among surgically treated infective endocarditis patients. Submitted.

3. Dobrilovic N, Hirsch B, Sallach S, Paul MC, Peterson G, Wait MA, Ring WS, Jessen ME, Pappas P, Cabell C, DiMaio JM. Diabetics have increased incidence of intracardiac fistulae and coronary artery disease in a large series of surgically treated infective endocarditis patients. Submitted.

4. Dobrilovic N, Hirsch B, Sallach SM, Paul MC, Peterson G, 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. Submitted.

5. Sallach SM, Dobrilovic N, Hirsch B, Paul MC, Cabell C, Pappas P, DiMaio JM, Peterson G. Clinical features and outcomes of right-sided infective endocarditis requiring surgical therapy. Submitted.

6. Terry Olivas, Michelle C. Paul, Jamel Lowery, J. Michael DiMaio. Effective palliation of malignant pleural effusion with the Pleurx Catheter. In Preparation.

7. Shamsuddin Khwaja, Alykhan S. Nagji, Erkan Dikmen, Rehal A. Bojani, Michelle C. Paul, Michael A. Wait, J. Michael DiMaio. Successful application of flexible bronchscopic dilation and tracheobronchial stenting with the utilization of newer Holmium: YAG laser in the relief of symptoms from tracheobronchial obstructive lesions. Submitted. Rejected, working on Reviewer's comments.

8. Timothy T. Hamilton, Pooja D. Thakrar, Nikola Dobrilovic, Michelle C. Paul, Matthias Peltz, Michael E. Jessen, Michael A. Wait, J. Michael DiMaio. Management of blunt aortic injury in 2004: a paradigm shift? In Preparation.

9. Nguyen PD, Roeser M, Paul MC, Cho LC, Frawley WH, Antoine JE, Valdivieso M, DiMaio JM. Clinical impact of combined modality therapy for esophageal cancer. In Preparation.

ABSTRACTS/PRESENTATIONS
1. Wheatley GH, Yancy CW, Wait MA, Meyer DM, Jessen MD, Paul MC, Kaiser P, Bhojani RA, Drazner M, Ring WS, DiMaio JM. Renal function is preserved following heart transplantation using IL-2 receptor blockade. (Presented at the 2004 24th Annual Meeting and Scientific Session of the International Society for Heart and Lung Transplantation, San Francisco, CA; April 21-24, 2004).

2. Khwaja S, Nagji AS, Paul MC, Bhojani RA, Hoopman JE, Wait MA, DiMaio JM. Successful application of flexible bronchoscopic dilatation and tracheobronchial stenting with the utilization of newer Holmium-YAG laser in the relief of symptoms from tracheobronchial obstructive lesions. (Presented at the 2004 Annual Chest Meeting, Seattle, WA; October 23-26, 2004).

3. Lubahn JG, Sagalowsky AI, Dikmen E, DiMaio JM. Contemporary surgical management of tumor thrombi in renal cell carcinoma. (Presented at Texas Academy of Internal Medicine, Dallas, TX; November 5, 2004).

4. Hamilton TT, Thakrar PD, Dobrilovic N, Paul MC, Wait MA, DiMaio JM. Management of traumatic aortic injuries 2004: a paradigm shift? (Presented at the North Texas ACS COT Resident Paper Competition, UT Southwestern Medical Center, Dallas, TX; November 6, 2004).

5. Dobrilovic N, Hirsch B, Sallach SM, Paul MC, Peterson G, Wait MA, Ring WS, Jessen ME, Pappas P, Cabell C, DiMaio JM. The presence of a new murmur may predict improved survival among patients treated surgically for infective endocarditis. (Presented at American College of Chest Physicians, Cardiac and General Thoracic Surgery Update 2004, Scottsdale, AZ; December 10-12, 2004).

6. Dobrilovic N, Hirsch BR, Sallach SM, Paul MC, Peterson GE, Wait MA, Ring WS, Jessen ME, Pappas P, Cabell C, DiMaio JM. Outcomes comparison of aortic valve versus mitral valve involvement among surgically treated infective endocarditis patients. (Presented at the Resident Session, 66th Annual Meeting, Society of University Surgeons, Nashville, TN; February 9-12, 2005).

7. Hamilton TT, Thakrar PD, Dobrilovic N, Paul MC, Wait MA, DiMaio JM. Management of traumatic aortic injuries 2004: a paradigm shift? (Presented at the 44th Annual Meeting of the North Texas Chapter of the American College of Surgeons, Dallas, TX; February 25-26, 2005).

8. Dobrilovic N, Hirsch BR, Sallach SM, Paul MC, Peterson GE, Wait MA, Ring WS, Jessen ME, Pappas P, Cabell C, DiMaio JM. Outcomes comparison of aortic valve versus mitral valve involvement among surgically treated infective endocarditis patients. (Presented at the 44th Annual Meeting of the North Texas Chapter of the American College of Surgeons, Dallas, TX; February 25-26, 2005).

9. Hamilton TT, Thakrar PD, Dobrilovic N, Paul MC, Wait MA, DiMaio JM. Management of traumatic aortic injuries 2004: a paradigm shift? (Presented at the ACS COT Resident National Paper Competition, Washington, D.C.; March 3-5, 2005).

10. 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. (Abstract accepted for presentation: Annual Scientific Session, American College of Cardiology, Orlando, FL; March 6-9, 2005).

11. Rosenbaum DH, Bhojani RA, Kaiser PA, Dikmen E, Paul MC, Yancy CW, Ring WS, DiMaio JM. Routine chest CT screening in high risk cardiac transplant patients may improve survival. (Presented at the 2005 International Society for Heart and Lung Transplantation 25th Annual Meeting, Philadelphia, PA; April 6-9, 2005).

12. 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. (Presented at the 6th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Annual Meeting, Washington, D.C.; May 14-16, 2005).

13. Dobrilovic N, Hirsch BR, Sallach SM, Paul MC, Peterson GE, Wait MA, Jessen ME, Ring WS, Cabell C, Pappas P, DiMaio JM. Diabetics have increased incidence of intracardiac fistulae and coronary artery disease in a large series of surgically treated infective endocarditis patients. (Presented at the 8th International Symposium on Modern Concepts in Endocarditis and Cardiovascular Infections, Charleston, SC; May 22 - 24, 2005).

14. Dobrilovic N, Hirsch BR, Sallach SM, Paul MC, Peterson GE, Wait MA, Cabell C, DiMaio JM. Perioperative complications correlating with mortality among surgically treated infective endocarditis patients. (Presented at the 3rd Biennial Meeting, Vancouver, Canada; June 17-20, 2005).

15. 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. (Presented at the 15th World Congress of the World Society of Cardio-Thoracic Surgeons Annual Meeting, Vilnius, Lithuania; June 19-23, 2005).

16. Rosenbaum DH, Adams BC, Mitchell JD, Kaiser PA, Paul MC, Meyer DM, Jessen ME, Wait MA, Drazner MH, Yancy CW, Ring WS, DiMaio JM. Early steroid withdrawal improves late survival after heart tansplantation. (Presented at the 52nd Annual Meeting of the Southern Thoracic Surgical Association, Orlando, FL; November 12, 2005).

17. Rosenbaum DH, Adams BC, Mitchell JD, Paul MC, Kaiser PA, Meyer DM, Jessen ME, Wait MA, Drazner MH, Yancy CW, Ring WS, DiMaio JM. Does basiliximab decrease acute rejection and improve renal function in cardiac transplant recipients at mid-term follow up. (Presented at the 6th Annual ASTS State of the Art Winter Symposium, Scottsdale, AZ; January 21, 2006).

18. Nagji A, Khwaja S, Bhojani RA, Dikmen E, Paul MC, Hoopman JE, Wait MA, DiMaio JM. Successful application of the advanced holmium:YAG Laser in conjunction with tracheobronchial dilation and stenting in the relief of symptoms from tracheobronchial obstructions. (Presented at The Society of Thoracic Surgeons Annual Meeting, Chicago, IL; January 30, 2006).

19. 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. (Presented at the International Society of Heart and Lung Transplantation Annual Meeting, Madrid Spain; April 7-11, 2006).

20. Rosenbaum DH, Bhojani RA, Dikmen E, Kaiser PA, Paul MC, Wait MA, Meyer DM, Jessen ME, Yancy CW, Rosenblatt RL, Torres F, Perkins S, Ring WS, DiMaio JM. Routine chest CT screening in high risk cardiac transplant recipients may improve survival. (Presented at the 14th SPORE Investigators' Workshop, Baltimore, MD; July 16-19, 2006).

1. Penetrating Cardiac Trauma: Benefits of Intervention by CVT Surgeon

Project Summary

PURPOSE: The objective of this study is to retrospectively determine whether management of penetrating traumatic cardiac injury (TCI) by cardiothoracic surgeons as compared to trauma surgeons has had an effect on patient outcome between January 1997 and 2008 at UT Southwestern Medical Center's Hospitals.
BACKGROUND: The number of cases per year in the United States of penetrating traumatic cardiac injury is increasing, and most of these patients die at the scene. Those who survive to present at the emergency department are generally younger patients, but their survival is dependent on recognition and treatment of the TCI and is positively associated with recordable life signs and blood pressure. Unfortunately, presentation of TCI at the emergency department can be complicated by the poly-trauma these patients sometimes sustain, although gun shots and in particular stab wounds tend to result in isolated organ lesions in contrast to blunt trauma. Additionally, operative management can result paraplegia, acute renal failure, or any number of other complications, and post-operative delayed sequelae are common. The best method of surgical management has yet to be elucidated; more studies are required to determine the best procedures and timelines to use while at the same time reducing complications and morbidities of treatment.
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. 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.
CRITERIA FOR INCLUSION OF SUBJECTS: Subjects will be required to have been treated for penetrating traumatic cardiac injury at one of the UT Southwestern Medical Center's Hospitals between 1997 and 2008. Age, gender, race, ethnic background, life expectancy, organ function, nutritional status, or performance will not be considered as inclusion criteria. The only requirement is to have been treated for penetrating traumatic cardiac injury at a UT Southwestern Medical Center Hospital between 1997 and 2008.
CRITERIA FOR EXCLUSION OF SUBJECTS: Healthy individuals who were not treated for penetrating traumatic cardiac injury at a UT Southwestern Medical Center Hospital between 1997 and 2008 will not be included in this study.
SOURCES OF RESEARCH MATERIAL: Existing records and medical data will be used. Study investigators and coordinators will have access to the patients' medical records. Patient identifiers (i.e. name, medical record number, and social security number) will be collected and recorded on a master list separate from the data collection form. This master list will be kept locked in the study coordinator's office. Each patient will be identified on the data collection sheet only by a random code. The data to be reviewed and recorded on the data collection sheet will include a chart review of their complete medical histories, physicians' progress notes and physical examination reports, laboratory data, medication administration information, x-rays, MRI and CT scans, angiography, and other test results. Use of this data will be restricted to research purposes only and patient identifiers will be destroyed when the research is completed (6 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio will recruit his own patients with the assistance of the sub-investigators and study coordinators. We do not wish to contact these patients.
POTENTIAL RISKS: The risks associated with this research are minimal as long as there is no breach of confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would comprise a high or moderate level of expected risk. In order to protect the participants' private health information from potential harm, the information will be stored securely and kept confidential. Only the researchers will have access to the data.
SPECIAL PRECAUTIONS: The subjects' right to confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.

PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in connection with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subjects' initials and study identification number. Information gained from this study, including the completed data collection forms, will be kept locked in the study coordinator's office and released only to the investigator and study site personnel. Review of medical records or any other research records pertaining to the research subject will be done on-site for verification purposes only. All patient identifiers will be removed prior to removal of research material from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be kept strictly confidential and no disclosures of personal identity will be allowed.

Members and staff of the IRB may review these records in an effort to maintain quality control.
POTENTIAL BENEFITS: There is no direct benefit to patients expected for their participation in this study. The data accumulated in this study may help other similarly affected patients and society as a whole by revealing new information that will allow physicians to contribute to the better understanding and treatment of traumatic aortic injury with concomitant treatment of comorbid injuries.
BIOSTATISTICS: We will use biostatistics to compare morbidity and mortality in various patient groups.
RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and treatment of traumatic aortic injury.

2. Surgical management of empyemas - a 15 year analysis

PROJECT SUMMARY

PURPOSE: The objective of this study is to take a retrospective look at the occurrence, presentation, and outcomes of surgical treatment empyema at Parkland Health and Hospital System from 1990-2005.
BACKGROUND: For centuries, empyema has been recognized as a serious problem. Around 500 BC, Hippocrates recommended treating empyema with open drainage. Since then, the treatment of empyema remained essentially unchanged until the middle of the 19th century. In 1876, Hewitt described a method of closed drainage of the chest in which a rubber tube was placed into the empyema cavity and drained via the water seal drainage. In the early 20th century, surgical therapies for empyema (eg, thoracoplasty, decortication) were introduced. Empyema has a high rate of mortality associated with it, causing the death of 11-50% of infected patients. Few studies have been undertaken to evaluate the efficacy and long-term outcomes of surgical intervention to empyema.
CONCISE SUMMARY OF PROJECT: The purpose of this study is to examine the surgical procedures performed as well as the complications and long-term outcomes of such interventions. Additionally, the study will examine the unique patient population seen at the county hospital and the differences between these patients and those previously studied. The study consists of a retrospective chart review of patients treated surgically for empyema between the years of 1990-2005. All patients underwent valve surgical decortication for empyema.
CRITERIA FOR INCLUSION OF SUBJECTS: Subjects will be required to have been treated for empyema at Parkland Health and Hospital System from 1990-2005. Age, gender, race, ethnic background, life expectancy, organ function, nutritional status, or performance will not be taken into account. The only requirement is to have been surgically treated for empyema Parkland Health and Hospital System from 1990-2005.
CRITERIA FOR EXCLUSION OF SUBJECTS: Patients with empyema who have not been treated surgically will not be included. Healthy individuals without empyema will not be included in this study.
SOURCES OF RESEARCH MATERIAL: Existing records and medical data will be used. Study investigators and coordinators will have access to the patient's medical records. The data will contain patient identifiers, name, medical record number, social security number. The data to be reviewed will include a chart review of their complete medical history, physician's progress notes/physical examination report, laboratory data, medication administration information, x-ray, MRI and other test results. Use of this data will be restricted to research purposes only and patient identifiers will be destroyed when the research is completed (12 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio will recruit his own patients with the assistance of the sub-investigators and study coordinators. We do not wish to contact these patients.
POTENTIAL RISKS: The risks associated with this research are minimal as long as there is no breach of confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would comprise a high or moderate level of expected risk. In order to protect the participant's private health information from potential harm, the information will be stored securely and kept confidential. Only the researchers will have access to the data.
SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.

PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in connection with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subject initials and study identification number. Information gained from this study, including the completed data collection forms will be kept locked in the study coordinator's office and released only to the investigator, and study site personnel. Review of medical records or any other research records pertaining to the research subject will be done onsite for verification purposes only. All patient identifiers will be removed prior to removing from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be held strictly confidential and no disclosures of personal identity will be allowed.

Members and staff of the IRB may review these records in an effort of quality control.
POTENTIAL BENEFITS: There are no direct benefits expected to patients for their participation in this study. The data accumulated in this study may help other similarly affected patients and society as a whole by revealing new information so that physicians may contribute to the better understanding and treatment of empyema.
BIOSTATISTICS: We will use biostatistics to compare morbidity and mortality in various patient groups.

RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and surgical treatment of empyema.

PROGRESS REPORT

UPDATE (June 2006):

In the past year, 221 charts have been reviewed and completed. We have not contacted any patients and we would like to continue gathering data until June of 2007.

There has been no change in the patient risk/benefit analysis. All patient information has been kept confidential according to HIPAA.

3. Does rigid plate fixation of the sternum aide in healing for sternal nonunion as a result of cardiac intervention or trauma?
PROJECT SUMMARY

PURPOSE: The objective of this study is to take a retrospective look at the occurrence, presentation, and outcomes of management of patients with sternal nonunion treated with open reduction and internal rigid plate fixation at University Hospital - St. Paul, Parkland Memorial Hospital and the Dallas Veteran's Medical Center from 2000 to January 2007.
BACKGROUND: Sternal nonunion as the result of cardiac intervention or trauma remains a morbid condition with serious sequelae. Patients often report pain with breathing, coughing and/or movement. Management with open reduction and internal rigid plate fixation is a possible solution for this problem. Few studies have been undertaken to evaluate the efficacy and long-term outcomes of this treatment.
CONCISE SUMMARY OF PROJECT: The purpose of this study is to examine the patients who have required rigid sternal plate fixation following open heart surgery in order to determine if there are certain high-risk comorbidities which would indicate the use of this device for sternum re-approximation. Surgical procedures performed as well as the complications and long-term outcomes of such interventions will be reviewed. The study consists of a retrospective chart review of open heart surgical patients treated with a rigid sternal fixation between the years of 2000 through January 2007.
CRITERIA FOR INCLUSION OF SUBJECTS: Subjects will be required to have undergone open heart surgery with rigid sternal plate fixation from 2000 to January 2007. Age, gender, race, ethnic background, life expectancy, organ function, nutritional status, or performance will not be taken into account. The only requirement is open heart surgery patients whose sternum is re-approximated with a rigid plate fixation device University Hospital - St. Paul, Parkland Memorial Hospital or the Dallas Veteran's Medical Center from 2000 to January 2007.
CRITERIA FOR EXCLUSION OF SUBJECTS: Open heart surgical patients whose sternum is not re-approximated with a rigid plate fixation device.
SOURCES OF RESEARCH MATERIAL: Existing records and medical data will be used. Study investigators and coordinators will have access to the patient's medical records. The data will contain patient identifiers, name, medical record number, social security number. The data to be reviewed will include a chart review of their complete medical history, physician's progress notes/physical examination report, laboratory data, medication administration information, x-ray, MRI and other test results. Use of this data will be restricted to research purposes only and patient identifiers will be destroyed when the research is completed (12 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio will recruit his own patients with the assistance of the sub-investigators and study coordinators. We do not wish to contact these patients.
POTENTIAL RISKS: The risks associated with this research are minimal as long as there is no breach of confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would comprise a high or moderate level of expected risk. In order to protect the participant's private health information from potential harm, the information will be stored securely and kept confidential. Only the researchers will have access to the data.
SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.
PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in connection with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subject initials and study identification number. Information gained from this study, including the completed data collection forms will be kept locked in the study coordinator's office and released only to the investigator, and study site personnel. Review of medical records or any other research records pertaining to the research subject will be done onsite for verification purposes only. All patient identifiers will be removed prior to removing from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be held strictly confidential and no disclosures of personal identity will be allowed.
Members and staff of the IRB may review these records in an effort of quality control.
POTENTIAL BENEFITS: There are no direct benefits expected to patients for their participation in this study. The data accumulated in this study may help to identify similar high-risk open heart patients and, eventually, society as a whole; by revealing which high-risk comorbidities might indicate the use of a rigid sternal fixation.
BIOSTATISTICS: We will use biostatistics to compare morbidity and mortality in various patient groups.
RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and surgical treatment for sternal nonunion following cardiac intervention or trauma.

4. Treatment options for permanent atrial fibrillation - a long-term follow up study

PROJECT SUMMARY

PURPOSE: The objective of this study is to retrospectively review the occurrence, presentation, and outcomes of atrial fibrillation treated surgically at University Hospital - St. Paul, Parkland Memorial Hospital and the Dallas Veteran's Medical Center from 2000 to January 2007.
BACKGROUND: Patients who suffer from atrial fibrillation unresponsive to pharmacological and/or catheter-based treatment can be treated surgically. The Cox-Maze III procedure has the best long-term results for the treatment of atrial fibrillation. More recently, bipolar radiofrequency energy ablation has been proposed as a replacement for the Cox-Maze III procedure. Our cardiothoracic surgeons have utilized both of these procedures for permanent correction of atrial fibrillation.
CONCISE SUMMARY OF PROJECT: The purpose of this study is to review our patients surgically treated for atrial fibrillation. We will examine their atrial fibrillation classification as well as other concomitant procedures performed. In addition, we will look at their follow up care at 3, 6, 9 and 12 months following surgery. The study consists of a retrospective chart review of patients with atrial fibrillation surgically treated between the years of 2000 through May 2006.
CRITERIA FOR INCLUSION OF SUBJECTS: Subjects will be required to have undergone surgical intervention for atrial fibrillation between the years of 2000 to May 2006. Age, gender, race, ethnic background, life expectancy, organ function, nutritional status, or performance will not be taken into account. The only requirement is surgical intervention for patients with atrial fibrillation at University Hospital - St. Paul, University Hospital - Zale Lipshy, Parkland Memorial Hospital or the Dallas Veteran's Medical Center from 2000 to May 2006.
CRITERIA FOR EXCLUSION OF SUBJECTS: Open heart surgical patients were not surgically treated for atrial fibrillation.
SOURCES OF RESEARCH MATERIAL: Existing records and medical data will be used. Study investigators and coordinators will have access to the patient's medical records. The data will contain patient identifiers, name, medical record number, social security number. The data to be reviewed will include a chart review of their complete medical history, physician's progress notes/physical examination report, laboratory data, medication administration information, x-ray, MRI and other test results. Use of this data will be restricted to research purposes only and patient identifiers will be destroyed when the research is completed (12 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio will recruit his own patients with the assistance of the sub-investigators and study coordinators. We do not wish to contact these patients.
POTENTIAL RISKS: The risks associated with this research are minimal as long as there is no breach of confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would comprise a high or moderate level of expected risk. In order to protect the participant's private health information from potential harm, the information will be stored securely and kept confidential. Only the researchers will have access to the data.
SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.

PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in connection with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subject initials and study identification number. Information gained from this study, including the completed data collection forms will be kept locked in the study coordinator's office and released only to the investigator, and study site personnel. Review of medical records or any other research records pertaining to the research subject will be done onsite for verification purposes only. All patient identifiers will be removed prior to removing from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be held strictly confidential and no disclosures of personal identity will be allowed.
Members and staff of the IRB may review these records in an effort of quality control.
POTENTIAL BENEFITS: There are no direct benefits expected to patients for their participation in this study. The data accumulated in this study will hopefully identify similar patients and, eventually, society as a whole; by revealing which surgical intervention for atrial fibrillation is best.
BIOSTATISTICS: We will use biostatistics to compare morbidity and mortality in various patient groups.
RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and surgical treatment options for patients with atrial fibrillation.
5. PET-CT scans - a new way to predict if pulmonary masses are neoplastic disease or granulomatous disease

PROJECT SUMMARY
PURPOSE: The objective of this study is, through retrospective analysis, to determine the effectiveness of PET-CT data in differentating if patients with pulmonary masses have neoplastic disease or active granulomatous disease.
BACKGROUND: PET scanning is the current imaging procedure of choice for differentiation of benign from malignant pulmonary tumor. In lesions greater than 1.5 cm PET has a negative predictive value greater than 95%. However the positive predictive value is only 80 to 85 % as a result of false positive PET scans due primarily to granulomatous disease.
The PET scan diagnosis of cancer is based on the increased accumulation of glucose as measured by the Standard Uptake Value (SUV). Unfortunately active granulomatous disease may also have a high SUV. Thus some patients may undergo unnecessary surgery for a benign inflammatory condition that is PET scan positive. Computerized Axial Tomography (CT) scanning has been used in the past to distinguish granuloma from neoplasm based on the increased density of calcification within the granuloma. The success of this approach has been modest, at best, since many granulomas do not have enough calcium to be distinguished as benign. Recently PET-CT scans have been performed as a combined examination with the CT data used primarily to provide anatomic information for aid in interpreting the PET. The CT density data in conjunction with the PET SUV has not been used to aid in characterizing the lesion histology.
CONCISE SUMMARY OF PROJECT: We propose to review retrospectively the PET- CT data on patients with pulmonary masses that have been verified by histologic diagnosis. We are interested in determining if some combination of SUV and CT density and morphology can aid in differentiation of neoplasm from granulomatous or other benign processes.
CRITERIA FOR INCLUSION OF SUBJECTS: To be included in this study, patients must have received a PET-CT scan positive for pulmonary masses. In addition, the pulmonary masses must have proven histologic diagnosis. And finally, the patient must have been treated at one of the UT Southwestern Medical Center's Hospitals between January 2003 and April 2004. Age, gender, race, ethnic background, life expectancy, nutritional status, performance status, organ function, or recovery from prior treatment will not be taken into account in determining who is eligible for this study.
CRITERIA FOR EXCLUSION OF SUBJECTS: Patients who have pulmonary masses, but did not received a PET-CT scan, or have a histologic diagnosis will not be included in this study.
SOURCES OF RESEARCH MATERIAL: Existing medical records will be used. Study coordinators and research investigators will have access to patient medical records. The data will contain patient identifiers that will be recorded: social security numbers and medical record numbers. The data to be reviewed will include a chart review of the patient's complete medical history, physician's progress notes/ physical examination reports, laboratory data, medication administration information, x-ray, MRI and other test results will be recorded. The information to be collected will be recorded onto a data collection form (attached). The subject will be assigned a project identifier, which will be recorded on the form, and will correspond to a master list which will be locked in the study coordinator's office. Use of this data will be restricted to research purposes only and all patient identifiers will be destroyed at the completion of this project (6 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio, with the assistance of the research coordinator, will recruit his own patients who have been treated for pulmonary masses, discovered by PET-CT scans and have histologic diagnosis. We do not wish to contact these patients.

POTENTIAL RISKS: The risks involved in this research are minimal, as long as there is no breach in patient confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would compromise a high or moderate level of expected risk. In order to protect the patient's private health information from potential harm, the information will be stored securely and kept confidential. Only researchers will have access to this information.
SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.
PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in association with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subject initials and study identification number. Information gained from this study, including the completed data collection forms will be kept locked in the study coordinator's office and released only to the investigator, and study site personnel.
Review of medical records or any other research records pertaining to the research subject will be done onsite for verification purposes only. All patient identifiers will be removed prior to removing from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be held strictly confidential and no disclosures of personal identity will be allowed.
Members and staff of the IRB may review these records in an effort of quality control.
POTENTIAL BENEFITS: There are no direct benefits for those whose medical records are reviewed. However, the knowledge gained from this research may help other similarly affected patients and society as a whole by revealing new information so that physicians may contribute to the better understanding and treatment of pulmonary masses.
BIOSTATISTICS: Application of statistics to the analysis of biological and medical data will be used. Characteristics to be analyzed will include morbidity and mortality among patients with pulmonary masses.
RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and treatment of pulmonary masses.

PROGRESS REPORT

UPDATE (March 2005): In the last year, 125 retrospective chart reviews have been completed. We have not contacted any patients. The data is has been preliminarily analyzed and manuscripts are being prepared. We would like to continue gathering data for this study until March of 2006. There has been no change in the patient risk/benefit analysis. All patient information has been kept confidential according to HIPAA.

PROGRESS REPORT

UPDATE (March 2007):

In the last two years, 330 retrospective chart reviews have been completed. We have not contacted any patients. We are continuing to review charts. We would like to continue gathering data for this study until March of 2008.

We have preliminary analyzed our data. With these preliminary results, we wrote two separate abstracts and submitted them to two different national radiology meetings. We are still awaiting a response of acceptance or rejection for these abstracts.

There has been no change in the patient risk/benefit analysis. All patient information has been kept confidential according to HIPAA regulation.