10 tips for building your own TAVR research program Issi Barbash, MD MedStar Washington Hospital Center

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.

Interest in TAVR is growing exponentially Data derived from PubMed

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

Procedure volumes Key to obtaining meaningful data Requires significant procedure volumes Consider multi-center collaborations

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

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

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

Excel sheet - Cheap but risky

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Web-based database – tech support needed 100% flexible Secure

Web-based database - 2 Requires dedicated personnel to build, maintain, troubleshoot

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

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)

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

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

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

Which parameters not to collect ? Collecting excessive parameters may exhaust the system Some parameters are impossible to collect

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

Data entry method Manual data collection Automated export mechanism from EMR

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

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

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

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

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

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 -