2008projectindex097DiMaio

Medical Student Research Fellowship for Summer 2007

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. Interagency Registry of Mechanically Assisted Circulatory Support

3. Mitral Valve Surgery Study

4. Chronic Rejection Study: Lung Transplant

Human subjects IRB approved project number (where applicable):

Study Title IRB Number

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

pending
2. . Interagency Registry of Mechanically Assisted Circulatory Support
032006-044
3. Mitral Valve Surgery Study
062007-085
4. Chronic Rejection Study: Lung Transplant 042006-006

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. Interagency Registry of Mechanically Assisted Circulatory Support
Project Summary

PURPOSE: The goal of the Intermacs is to provide a national registry of patients receiving a mechanical circulatory support device (MCSD) to treat end-stage heart failure. The registry will collect and analyze clinical and laboratory data and tissues samples from patients who are receiving MCSDs for end-stage heart failure at 60-70 participating hospitals. It is anticipated that the registry will collect data, blood, and tissue samples from approximately 2000 new patients per year for a period of four years.
BACKGROUND: Over the last two decades, MCSDs have been developed to augment or supplant falling myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, a bridge to recovery, and most recently as permanent implantation or "destination therapy" for intractable heart failure.
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.
CRITERIA FOR INCLUSION OF SUBJECTS: Study participation is limited to patients receiving or have received a ventricular assist device at this facility.
CRITERIA FOR EXCLUSION OF SUBJECTS: There is no exclusion for age, gender, race, ethnicity, or any other demographic limit.

SOURCES OF RESEARCH MATERIAL: Research material will be obtained from subject interview, physical examinations, operative reports, medical records, lab reports, radiology reports and questionnaires. The data used will be kept separate from information that could identify individual subjects by name. The data obtained may be used for research in the future and will be supplied to the sponsor, NHLBI and Intermacs data base.
RECRUITMENT OF SUBJECTS: Investigators will use information from children's hospital, Parkland Health & Hospital System, St. Paul University hospital and Zale Lipshy Hospital. The subjects will be patients of the primary investigator and subinvestigators. The physician or research coordinator will obtain informed consent to be a part of the data base. Patients will be inpatients. All prospective patients will be patients of the investigator. Patients meeting preliminary study requirements will be approached by a study investigator and provided with a verbal and/or written study description. Subjects will provide written informed consent before proceeding with study assessments.
A copy will be given to the subject, and one will be kept in medical records. The patients will be contacted to be part of the database prior to surgery. No information pertaining to the databases will be collected prior to informed consent.

POTENTIAL RISKS: There are no risks associated to being a part of this data base although the subject's records will be kept confidential; there is the potential of unintentional disclosure of confidential information.
SPECIAL PRECAUTIONS: The Observational Study Monitoring Board (OSMB) will monitor the data submitted for quality assurance purposes.
PROCEDURES TO MAINTAIN CONFIDENTIALITY: All data information will have subject identifiers (name, MR#, etc.) removed from any document that is sent to the sponsor or regulatory agency or IRB. The IRB and the sponsor may review some or all of the research information. A regulatory agency or the sponsor may review a patient's study record for information necessary to the study and assurance of the quality of the information. Information gained from this data base, including executed consent forms, will be securely stored in the coordinator's office and released only to the investigator, NHLBI or their designee. Review of medical records or any other research records pertaining to the data base subject will be done on-site for verification purposes only. Photocopies will not be allowed unless a certain document is absolutely necessary for data analysis and all patient identifiers will be removed prior to removing from campus.
POTENTIAL BENEFITS: BIOSTATISTICS: The knowledge gained from the registry may help those with advanced heart failure. A potential indirect benefit is that the knowledge gained may help doctors and scientists better understand how the MCSD improve or do not improve life for heart failure patients.
RISK/BENEFIT ASSESSMENT: The only risk to the patient for participating in the registry is the very minimal risk of broken confidentiality. Every precaution will be taken to protect the participates' information. There is no direct benefit to the patient for participating in the registry. It is possible that the knowledge of potentially helping others with mechanical circulatory support devices in the future could bring some positive feeling.

3. Mitral Valve Surgery Study
Project Summary

AIM:
To determine the echocardiographic predictors of postoperative change in left ventricular function, in patients undergoing mitral valve surgery for severe mitral regurgitation.

BACKGROUND:
Left ventricular function as measured by left ventricular ejection fraction and left ventricular end systolic dimension have been traditionally used as predictors of surgical outcome and postoperative left ventricular function. With the development of left ventricular dysfunction the risk of developing postoperative heart failure and postoperative left ventricular dysfunction increases significantly.

Early detection of myocardial dysfunction in patients with mitral regurgitation can be helpful in the timing of surgery in these patients. Mitral annular velocities as measured by tissue Doppler imaging has been shown to correlate with left ventricular contractility. Tissue Doppler imaging can identify development of left ventricular dysfunction and thus should predict postoperative outcomes and the change in left ventricular function

STUDY DESIGN:
This will be a retrospective study looking at the ability of echocardiographic measures to predict the change in left ventricular function in patients undergoing mitral valve surgery for severe mitral regurgitation.

All patients who have had surgery for severe mitral regurgitation at Parkland, Zale and St.Paul Hospitals in the last 4 years will be included in the study. Patients will be identified from surgical registry and from querying the CIMS database for patients who have had transesophageal echocardiogram for severe mitral regurgitation and/or mitral valve surgery and will be included in the study.

Patient's demographic data, co-morbid conditions, New York Heart Association heart failure classification will be obtained by chart review. Echocardiographic measures will be obtained from the CIMS database and by reviewing each individual echocardiogram that is available. Angiographic assessment of left ventricular function and severity of mitral regurgitation will also be obtained from the CIMS database if such data is available. Once the dataset is built all direct patient identifiers such as name, medical record number, social security number will be deleted.

DATA ANALYSIS:
Descriptive statistics will be reported for all demographic, echocardigraphic and angiographic measures. Categorical variables will be compared using the chi-squared test. Continuous variables will be compared student's t test if they have a normal distribution and by non-parametric tests if they are not normally distributed.

CONFIDENTIALITY:
During the building of the dataset only the principal investigator and the cardiology research fellows will have access to the identifiable information for quality assurance purposes. Once the dataset is created all patient identifiers will be deleted and each patient will be given a study ID number. The dataset without any patient identifiers will be used for analyses of the data.

RISKS AND BENEFITS:
There is no direct patient risk from this study. There is no benefit to the individuals who will be in the study database. The new knowledge could be of benefit to future patients with severe mitral regurgitation undergoing mitral valve surgery and the data from this study could enable us to design future prospective studies.

4. Chronic Rejection Study: Lung Transplant

Project Summary

Purpose: To show that patients who have HLA antibodies post transplantation will have chronic graft failure.

Background: Evidence have accumulated in recent years that HLA antibodies may be responsible for the chronic failure of renal transplants as shown by 40 publications (Terasaki, Humoral Theory of Transplantation, Am J Transpl 2003; 3: 665-673) In the 13th Workshop, a prospective study showed that those patients who had HLA antibodies had a significantly higher graft failure rate than those who did not have HLA antibodies (Terasaki, Ozawa, Am J Transplantation 4:448, 2004). With the recent availability of improved antibody detection methods and new ability to detect anti- MIC antibodies, we wish to demonstrate conclusively, in a larger series of patients, that the presence of HLA and MIC antibodies does indeed predict chronic graft failure. This has not yet been fully investigated in Lung transplant recipient.

Significance: If it is shown that patients with HLA antibodies fail at a higher rate, clinicians will be convinced to monitor their patients and to intervene with other immunosuppression to eliminate the antibodies. Also, among those who have no antibodies, immunosuppression might be reduced.

Concise Summary of Project: One serum sample (approx. 2 teaspoons) will be obtained from patients who are at least 6 months post-transplant. Baseline information will be collected. These samples will be tested for HLA and MIC antibodies, these samples will be destroyed after completion of the study. One year later information regarding patient and graft status will be collected. Patient participation will require 1 serum sample and 2 visits, (baseline and 1 year f/u). The incidence of rejection and graft failure will be compared between patients who had HLA antibodies and those who did not.

Criteria for Inclusion: Criteria for inclusion include ? 18 years of age and subjects who have currently functioning grafts who had been transplanted at least 6 months previously.

Criteria for Exclusion: None.

Sources of Research Material: Research material will be obtained from subject interview, assessment, doctors' progress notes, nursing notes, lab test results, ICU flow sheets, operative reports, anesthesiology notes, cardiac procedure notes/reports, electrocardiograms, radiology reports/films, medication administration records and discharge summaries. Data used for this study will be kept separate from information that could identify individual subjects by name.

Recruitment of Subjects: Subjects will be recruited by the Heart & Lung clinic at St Paul's Professional buildings and St. Paul University Hospital. These subjects will be the investigators's patient. The physician or research coordinator will obtain informed consent. Subjects will provide written informed consent before proceeding with study assessments. A copy will be given to the subject, one will be kept in the source documents, and the original will be kept in medical records.

Potential Risks: The risks associated with drawing blood include pain, the possibly of infection, bruising, or bleeding from the site. There is also the slight possibility of the formation of a blood clot or feeling faint. Blood for this study will be drawn at the same routine blood draws for clinical specimens are being performed, or will be obtained from previously drawn specimens when possible, thus reducing this risk.
Procedures to Maintain Confidentiality: All study records will be identified by subject initials and study identification number. The IRB and the sponsor may review some or all to the research information. A regulatory agency or the sponsor may review a patient's study record for information necessary to the study and assurance of the quality of the information. Subject identifiers (name, MR#, ect.) will be removed from any document that is sent to the sponsor or regulatory agency. Information gained from this study, including executed consent forms, will be securely stored in the coordinator's office and released only to the investigator, study site personnel, study sponsors or their designee. Review of medical records or any other research records pertaining to the research subject will be done on-site for verification purposes only. Photocopies will not be allowed unless a certain document is absolutely necessary for data analysis and all patient identifiers will be removed prior to removing from campus.

Potential Benefits: It is not anticipated that the subjects will receive any direct medical benefit from participating in the study other than their contribution to medical knowledge.

Risk/Benefit Assessment: The risks associated with venipuncture are minimal. However, the specimens collected from these procedures are invaluable in understanding the immune processes underlying transplant rejection.
Based on the risk to benefit ratio it is anticipated that the benefits of the knowledge gained by this research will outweigh the risks.