Cardiovascular Research at KU Hospital and Medical Center

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Slide 1 : Cardiovascular Research: A Translational Initiative 2008 The University of Kansas Hospital and Medical Center James L. Vacek, MD
Slide 2 : James L. Vacek, MD 4/08 2 Translational Cardiovascular Research at The University of Kansas Medical Center and HospitalA Proposal
Slide 3 : James L. Vacek, MD 4/08 3 Translational Cardiovascular Research at The University of Kansas Medical Center and HospitalMust be a partnership!
Slide 4 : James L. Vacek, MD 4/08 4 Translational Cardiovascular Research The National Institutes of Health has made translational research a priority Bench to bedside enterprise The interface between basic science and clinical medicine Translate research into practice
Slide 5 : James L. Vacek, MD 4/08 5 Translational Research2 definitions: T1: The transfer of new understandings of disease mechanisms gained in the laboratory into the development of new methods for diagnosis, therapy and their first testing in humans T2: The translation of results from clinical studies into everyday clinical practice and health decision making JAMA 2008:299,211-13
Slide 6 : James L. Vacek, MD 4/08 6 T2 Translational Research The laboratories for T2 translational research are the community and ambulatory care settings Involves population based interventions and practice-based research networks Initiate and evaluate interventions in real-world situations
Slide 7 : James L. Vacek, MD 4/08 7 Cardiovascular Research Activities - July 1st Kickoff Organize - biggest time commitment to present Research staff Provide overview for project feasibility and value CV fellows Database planning and implementation – 2nd largest time/effort Coordinate research program with CV Section and Dept of Medicine Interactions with other MAC and University staff – promote collaboration Plan research section development – develop 1, 3, 5 years plans Develop space for research staff – 1st floor Eaton complex, see blueprints Determine and develop fellows’ research needs Newsletter – 1st issue prepared Web page – CV research information of other investigators, staff, patients Statistical support Pre-existing statistics programs Obtain and train in JMP statistics program (SAS) Assess and monitor pre-existing skills of fellows Liaisons with University Biostatistics department Outside consultant Enhanced research intern experience
Slide 8 : James L. Vacek, MD 4/08 8 Research Activities Projects Papers Abstracts Reviews Protocols – Internal and industry sponsored Introduction of Drs Wiley and Lakkireddy to Animal Facilities and Director Discussion of benevolent support for CV research with Janice Benjamin, Jennifer Staley, John Florio. Join the KU Human Subjects Committee as full member
Slide 9 : James L. Vacek, MD 4/08 9 Cardiovascular Research at The University of Kansas Medical Center and Hospital Proposal – A Translational Model 4 Key Components: Research Faculty Comprehensive Database Cardiovascular Research Area Growth of the CV Fellowship Program
Slide 10 : James L. Vacek, MD 4/08 10 Research Faculty We have identified 3 areas of research interest which MAC/KU cardiology will have as goals for direction, focus, support, and academic productivity. Each will be lead by a junior investigator with the skills and energy to develop these areas, and who will work with a senior group member as a mentor. Dr James Vacek will serve as the overall director of these efforts. Each of these young investigators has already demonstrated substantial research productivity. A prime objective is an initial commitment of 10% of the young investigator’s time devoted to their research, with a goal of moving to 25% each over the next 3 years. 1
Slide 11 : James L. Vacek, MD 4/08 11 Research Faculty 1. Electrophysiology – Dr Dhanunjaya Lakkireddy.  Dr Loren Berenbom will serve as support/mentor 2. Interventional – Dr Mark Wiley.   Dr. Kamal Gupta will function in the senior advisor role for Mark. 3. Cardiac Imaging – Dr Jayant Nath.   Dr Thomas Rosamond will be senior partner. These investigators’ projects will be direct translational efforts, evaluating and implementing real-world interventions on the leading edge of cardiovascular medicine into the care of patients at the Medical Center, as well as in the community and region 1
Slide 12 : James L. Vacek, MD 4/08 12 Research Faculty The research faculty must have committed time for clinical investigation, with adequate support staff and resources to be successful. Doing research should not be a financial or perceptual negative for the physician 1
Slide 13 : James L. Vacek, MD 4/08 13 Cardiovascular Comprehensive Database (CV Data Warehouse) This is being developed by a physician database specialist, Dr Warren Chen, who is merging data from present information repositories (Hospital and MAC) to provide a resource for ongoing clinical investigation. A schematic of this database is attached. This database will allow design and study of investigations into population based clinical epidemiological and evidence derived aspects of patient care, to be applied to hospital and community practice settings (direct translational research model) 2
Slide 14 : James L. Vacek, MD 4/08 14 CV Research Database Schematic 2
Slide 15 : James L. Vacek, MD 4/08 15 CV Database Interface and transfer of logician data to new CV Data Warehouse (Dr Warren Chen, Jennifer Staley, Joyce Blakely) Interface and transfer of ACC/STS (PATS) data to CVDW Plans for link with SMS/Epic data with CVDW Obtain full-featured statistics program (JMP) for CV research First data runs/requests from CVDW for studies and projects Evaluation of utility of Stroke database Development of global atrial fibrillation database, encompassing both catheter based and surgical interventions (EP staff, Dr Muehlebach, Carrie Kilgore, Jennifer Staley, John Florio) Integration of ICD/pacemaker databases into CVDW Establishment of link to national social security death index to study mortality-related outcomes Evaluate staff needs for database development, data entry, and patient follow up Use AHA “get with the guidelines” data to develop abstracts and manuscripts 2
Slide 16 : James L. Vacek, MD 4/08 16 CV Database Needs Data collection personnel Data entry staff Staff to perform follow up Statistician Report writer 6-10 FTE’s for these roles are needed 2
Slide 17 : James L. Vacek, MD 4/08 17 Cardiovascular Research Area The 1st floor Eaton area (prior EP labs) is to be renovated and prepared for use by CV research personnel. The proposed area will include: Conference/work room Fellows’ rooms Space/workstation/computer for 12 CV fellows Space/workstation/computer for interventional/EP fellows Space/workstation/computer for 2 research fellows Space/workstation/computer for 2 research interns (medical students/residents/etc) Research Personnel Jennifer Staley, Research Director Caroline Murray, Regulatory Assistant Research Nurses and support staff (6-8) performing commercial study work as well as support of fellows and investigator initiated projects Statistician Data collectors and follow-up staff (4-6) Report writer/Draft writer Warren Chen: CV database manager/architect Break room with refrigerator, microwave, table/chairs for 8-10 people Restrooms Blueprints for these areas are attached. 3
Slide 18 : James L. Vacek, MD 4/08 18 3
Slide 19 : James L. Vacek, MD 4/08 19 Growth of the Cardiovascular Fellowship Program The CV fellowship program should expand from the present size of 7 fellows in 2007 to 12 by 2009 and 15 by 2011. Appropriate key clinical and research faculty should be provided via ACGME guidelines to support this growth. The fellows will have programmed at least 6 months and usually 12 months devoted to research, focusing on translational initiatives. Support for the additional fellows should come from all available resources, including the University, the Hospital, grants, industry sponsors, and philanthropy 4
Slide 20 : Commitment to Develop CV Research Program at KU Hospital and Medical Center $3 -5 Million Over Next 3 Years
Slide 21 : James L. Vacek, MD 4/08 21 This process should be approved and in place by July 1, 2008Without a strong initiative and aggressive support from the Hospital, momentum will shift to the University, other potential community partners, and/or a new dedicated CV Section Academic Chief
Slide 22 : James L. Vacek, MD 4/08 22 What Have We Done?
Slide 23 : James L. Vacek, MD 4/08 23
Slide 24 : James L. Vacek, MD 4/08 24 Sponsored Trials
Slide 25 : James L. Vacek, MD 4/08 25 Sponsored Trials (cont’d)
Slide 26 : James L. Vacek, MD 4/08 26 SMAC HF Study Publication Topics Updated 10/2007
Slide 27 : James L. Vacek, MD 4/08 27 Investigator Projects
Slide 28 : James L. Vacek, MD 4/08 28 Manuscripts Accepted
Slide 29 : James L. Vacek, MD 4/08 29 Manuscripts Accepted (cont)
Slide 30 : James L. Vacek, MD 4/08 30 Manuscripts in Progress
Slide 31 : James L. Vacek, MD 4/08 31 Abstracts in Progress
Slide 32 : James L. Vacek, MD 4/08 32 Abstracts Accepted
Slide 33 : James L. Vacek, MD 4/08 33 Abstracts Accepted (cont)
Slide 34 : James L. Vacek, MD 4/08 34 Abstracts Accepted (cont)
Slide 35 : James L. Vacek, MD 4/08 35 Individual Projects PROPEL ICD lead implant – OR at time of surgery vs. later EP implant procedure (internally developed project supported by Medtronic). Several meetings with Kathleen Dalton, Matt Earnest, Loren Berenbom. Analysis and revision of database, preparation of abstract, statistical analysis. Yoga and Atrial Fibrillation Develop project using yoga techniques (biofeedback modulation) as a means of improving atrial fibrillation control. Coordinate proposal organization and funding with investigators (Dr Lakkireddy, Vanga and others) and CV research staff, write protocol, prepare for HSC approval, plan implementation. TASER related projects Dr. Lakkireddy had begun TASER related research at the Cleveland Clinic. Remaining data and manuscripts from that institution have been developed into abstracts, papers, and book chapters, and future projects centered at KU planned, protocols written, funding explored, and HSC approval process initiated.
Slide 36 : James L. Vacek, MD 4/08 36 Individual Projects Atrial Fibrillation in the Elderly and under-use of Coumadin VA derived data analyzed and abstract and manuscript prepared in junction with Dr. Mazda Biria and Dr Ahmad Batrash of the KC VA hospital. Both abstract and paper submitted. Multiple re-writes and revisions supervised as well as data analysis and preparation. Atrial Fibrillation and biphosphanate use 2 separate studies on 2 separate data sets (in conjunction with KU Department of Pharmacology) with Drs Patricia Howard, Brian Barnes, and Amit Kumar. Abstracts in preparation with complete manuscripts planned. Initial dataset from CTS PATS database, expanded subset from entire logician dataset. Omega 3 Fatty Acid use and Survival Study initiated with Dr Vinod Raxwal and Dr William Harris on impact of fish oil supplement use on cardiovascular events and survival in MAC logician dataset. Initial data runs revealed concerns with logician database information completeness and accuracy, and led to intensive evaluation and analysis of the logician dataset and accurate mapping to new CV data warehouse
Slide 37 : James L. Vacek, MD 4/08 37 Individual Projects Atrial Fibrillation and statin/omega 3 FA use 2 separate studies on 2 separate data sets (in conjunction with KU Department of Pharmacology) with Drs Patricia Howard, Brian Barnes, and Amit Kumar, this grew from initial work with the AF/bisphosphanate datasets. Abstracts in preparation with complete manuscripts planned. Initial dataset from CTS PATS database, expanded subset from entire logician dataset. Also involved work with Dr Scott Soloman, Internal Medicine resident who is interested in CV fellowship. Diastolic Dysfunction and Statins Collaborative project with KU Department of Pharmacology and Cardiovascular Medicine studying the impact of statin treatment on the expression and outcomes of diastolic dysfunction. Detailed literature review and initial data analysis from logician dataset has led to preparation and submission of an abstract and review article. Peripheral Vascular Disease Review Article Manuscript has been developed, submitted, and accepted for publication in collaboration with Drs Amit Kumar and Mark Wiley
Slide 38 : James L. Vacek, MD 4/08 38 Individual Projects Tricuspid Atresia and Single Ventricle Case Report Article has been written, submitted, and tentatively accepted for publication, lead authored by Dr Inna Porter, former KU Internal Medicine House officer and now Hospitalist. Health Care in Belarus contrasted with the in the US Article has been written, submitted, and tentatively accepted for publication, lead authored by Dr Inna Porter, former KU Internal Medicine House officer and now Hospitalist. Quality of Life (via KCCQ) in patients with diastolic dysfunction Internally developed project with Dr Mazda Biria studying quality of life in patients with diastolic dysfunction. Project developed and data request submitted
Slide 39 : James L. Vacek, MD 4/08 39 Individual Projects The Impact of CRT device implant on diastolic dysfunction. We know that CRT improves systolic LV function, does it also benefit diastolic dysfunction. Project developed with Dr Mazda Biria and initial data request submitted and returned. Preliminary statistical analysis suggests significant improvement in DD parameters. Plan abstract submission in next month and manuscript preparation as further analysis occurs. Pacemaker Pocket Revision paper Comparison of different methods of treating the pacemaker pocket for device removal and re-implant (basically cleansing vs removal of fibrous capsule) undertaken by Dr Lakkireddy and several collaborators. Initial data analysis and preparation of manuscript based in part on previously derived data has led to submission of a paper. Plans ongoing for prospective study solely including KU patients.
Slide 40 : James L. Vacek, MD 4/08 40 Individual Projects Case report preparation with CT Surgery (Dr Michael Gorton) We have previously prepared with CV fellow lead authorship two separate manuscripts of unique case studies which have been published in peer reviewed journals. We have discussed with Dr. Gorton ongoing collaboration in this fashion, which he supports. Two new case reports are being considered Does labeling of content of vending machine snack foods change buying practice? This was an idea of Rachel Sosland which we have developed and pursued in collaboration with Dr Edward Ellerbeck and the Department of Preventive Medicine. Discussion of implementing this has been undertaken both with the KU Hospital cafeteria management and the vending machine suppliers. This is a hospital wide project (similar to smoking bans) to see if identifying healthy and non-healthy vending machine food options changes dietary behavior
Slide 41 : James L. Vacek, MD 4/08 41 Individual Projects Cardiovascular Outcomes and Diabetic treatment This is a retrospective analysis based on the logician dataset done in collaboration with Drs Ashley Simmons and Warren Chen studying cardiac outcomes in diabetics treated with insulin vs the various oral hypoglycemic agents. Project has been defined and initial data run requested. Takotsubo cardiomyopathy Case report, review of literature, and review article based on unique case presenting to KU Hospital November 2007. Draft of manuscript prepared and literature review performed. Plan to develop abstract and paper for submission. Work done with Dr Jimmy Mbgori, Internal Medicine resident and Karen Chawdry, medical student.
Slide 42 : James L. Vacek, MD 4/08 42 Individual Projects SMAC (Self Management Strategies Across Chronic Diseases) Heart Failure NIH Trial This is a single center, NIH funded ($3.5 million) prospective project undertaken in collaboration with Drs Carol Smith and Edward Ellerbeck studying whether group training interventions improve outcomes in patients with heart failure. This is a long term project with grant preparation in 2005, submission and approval in 2007, and active implementation at present. Initial data is available for analysis and manuscript preparation discussed and planned with Drs Smith, Amit Kumar, and Mazda Biria. We hope to develop multiple abstracts and papers from what is a very robust dataset. I have been the actual primary CV participant in the project, engaging in multiple meetings, discussions, membership on the Data Safety Committee, grant-related document review, and NIH required documentation
Slide 43 : James L. Vacek, MD 4/08 43 Individual Projects Involvement of Dr Kyle Stanley Zimmerman (incoming CV Fellow) in basic laboratory research with Dr Dan Stechshulte on COX-2 and alternate mediators of aggregator response, to continue through CV fellowship Acceptance of Dr Ashley Simmons (CV Fellow) into the K-30 Kansas Clinical Research Curriculum Program (NIH Funded) as a provisional investigator in collaboration with Drs Matt Mayo, David Meyers, and James Vacek
Slide 44 : James L. Vacek, MD 4/08 44 Regular Research Meetings
Slide 45 : James L. Vacek, MD 4/08 45 Periodic Research Meetings
Slide 46 : James L. Vacek, MD 4/08 46 Periodic Research Meetings
Slide 47 : James L. Vacek, MD 4/08 47 Meetings with Fellows / Residents Since taking the role of CV Research Director, I have maintained and open-door policy towards CV fellows, Internal Medicine Residents, medical students, and CV research staff. Every assigned research rotation has included multiple scheduled and unscheduled discussion and working sessions with all of the CV fellows, the CV research fellow Dr Mazda Biria, research interns (including Dr Subba Vanga) and residents such as Drs. Curtis Solomon, Kyle Zimmerman, Jimmy Mbogori, and Mat Good.
Slide 48 : James L. Vacek, MD 4/08 48 Hard Copy Provided on Request 1.Research section proposal and 1,3,5 year (multiphase) plan prepared for Department of Medicine, the University of Kansas Hospital, and The University of Kansas Medical Center a. overview of 3 phase plan b. young investigators c. blueprint of proposed CV research center d. CV database (Data Warehouse) flow sheet 2. CV research newsletter initial issue 3. Weekly CV database project report sample (from Dr. Warren Chen) 4. Spreadsheet of investigator initiated studies 5. Spreadsheet of industry sponsored trials 6. List of recently prepared abstracts and papers
Slide 49 : James L. Vacek, MD 4/08 49 Cardiovascular Research at The University of Kansas Medical Center and Hospital Proposal – A Translational Model 4 Key Components: Research Faculty Comprehensive Database Cardiovascular Research Area Growth of the CV Fellowship Program
Slide 50 : Commitment to Develop CV Research Program at KU Hospital and Medical Center $3 -5 Million Over Next 3 Years
Slide 51 : James L. Vacek, MD 4/08 51 This process should be approved and in place by July 1, 2008Without a strong initiative and aggressive support from the Hospital, momentum will shift to the University, other potential community partners, and/or a new dedicated CV Section Academic Chief
Slide 52 : James L. Vacek, MD 4/08 52 Let’s “Translate” Our Partnership into Success!Thank You!

 


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