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10 tips for building your own TAVR research program
Issi Barbash, MD MedStar Washington Hospital Center
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I/we have no real or apparent conflicts of interest to report.
Israel M. Barbash, MD I/we have no real or apparent conflicts of interest to report.
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Interest in TAVR is growing exponentially
Data derived from PubMed
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Procedure volumes Key to obtaining meaningful data
Requires significant procedure volumes Consider multi-center collaborations
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Multi-disciplinary team
Interventional cardiologist Non-invasive cardiologist Data analyst / statistician TAVR database CT surgeon Interventionl, Non invasive, data analyst, surgeon, HF, vascular surgeon Vascular surgeon HF cardiologist
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Excel sheet - Cheap but risky
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Web-based database – No tech support needed
Build web-based databases quickly and securely Flexible Export data to common data analysis packages Ad Hoc custom queries Advanced features - Auto-validation, calculated fields FREE
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Web-based database – tech support needed
100% flexible Secure
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Web-based database - 2 Requires dedicated personnel to build, maintain, troubleshoot
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Categories of data to collect
Baseline demographics & medical history Baseline medications Echo studies CT data Procedural data and complications In hospital course and complications Long term follow up (survival, hospitalizations, pacemaker, compliance with medications)
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Precise definitions for stroke Closure device failure
Jan. 2011 Oct. 2012 Precise definitions for stroke Closure device failure Acute kidney injury definitions Change in cTn and CK-MB threshold for definition of peri-procedural MI growing experience with TAVI studies has identified some definitions as ambiguous, of limited clinical utility, or in need of updating or extension. This need provided the rationale for a VARC-2
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Which parameters not to collect ?
Collecting excessive parameters may exhaust the system Some parameters are impossible to collect
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Data entry method Manual data collection
Automated export mechanism from EMR
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Patient pool resource Evaluation process of AS patients from initial referral to TAVR is complicated and prolonged Having all the data per patient in a single location can: Search for qualifying patients for new protocols / devices Minimize losing track of patients Enhance communication with ref MDs
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Long term follow up program
Mortality data is the most crucial Other parameters: HF symptoms Hospitalizations Pacemaker implantation Bleeding events Stroke and intracranial bleeds Mechanism Phone calls Office visits Mortality – state, country databases, phone calls
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Procedure volumes - Key to a successful program
Create broadened “Heart-Team” Choose appropriate database platform Create the right categories of data to be collected Parameters you want to collect Parameters you do not want to collect Enter data to the database the right way Collect data Prospectively Establish follow up mechanisms Perform quality control assessments TAVR is
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Final remarks Creating database requires multi-disciplinary collaboration and various resources Putting sufficient efforts in the planning phase would save pain later The advantages of having a AVR database are beyond research 1 - However – 2 -
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