Appropriate Implantable Cardioverter-Defibrillator Programming for Veterans

About This Grant

Significance to VA: Implantable cardioverter-defibrillators (ICD) are life-saving devices that prevent sudden cardiac death by aborting life-threatening ventricular arrhythmias. ICD shocks can, however, occur inappropriately and are independently associated with increased morbidity and mortality. There have been several manufacturer specific randomized controlled trials (RCT) that examined different ICD programming strategies that reduced ICD shocks while maintaining ICD efficacy. Subsequently manufacturer-specific international society consensus ICD programming recommendations were published that differ from the RCTs and extrapolate the settings from one manufacturer to another, despite differences in ICD algorithms. There is a paucity of real-world data with long-term follow up examining both the settings studied in the RCTs and those recommended in the 2019 consensus recommendations. There are currently 26,000 Veterans with ICDs who are followed by the VA National Cardiac Device Surveillance Program Database (NCDSP) who have an approximately 15% annual mortality rate. The NCDSP is the largest nationwide database that includes all four contemporary ICD manufacturers and has long-term follow up, which is the ideal database to determine the optimal real-world ICD programming to improve Veteran morbidity and mortality. Innovation and Impact: This proposal aims to be the first to examine contemporary ICDs in a large database that includes all current manufacturers to identify the best real-world ICD programming. It is also the first proposal to develop an intervention to improve ICD programming throughout VA. Specific Aims: The main hypothesis of this proposal is that Veterans with ICDs not programmed according to the settings studied in the manufacturer specific RCTs are at a higher rate of adverse events. Aim 1: To (A) determine the proportion of Veterans with ICDs programmed according to different standards (1-per RCTs, 2- per society consensus statements, 3-other) and (B) identify predictors of ICD programming. Aim 2: To examine inappropriate ICD therapy (anti-tachycardia pacing (ATP) and shock) rates and mortality associated with each ICD programming category defined in Aim 1. Aim 3: To determine key drivers of ICD programming using mixed methods grounded in an implementation science framework and develop a clinician toolkit using human- centered design. Methodology: The population for Aims 1 and 2 is the 26,000 Veterans who have ICDs and are followed by the NCDSP. The NCDSP contains follow up data since 2002 and has been linked to the corporate data warehouse and centers for Medicare and Medicaid Services. Aim 1 will examine both current ICD programming throughout VA and the change in ICD programming over time. Propensity score weighting will be used for Aim 2 to determine time-to-event analysis with dual primary outcomes of inappropriate ICD therapies (both ATP and shocks) and mortality. Aim 3 will survey clinicians at device clinics at the 128 device clinics throughout VA. Semi-structured interviews with clinicians and electrophysiologists at the 5 centers with the highest rate of ICD programming according to the 2019 recommendations and 5 centers with the lowest rate will be performed to identify key drivers of ICD programming. Results from the survey and interviews will inform the development of a toolkit using human-centered design to improve ICD programming throughout VA. Path to Translation/Implementation: The toolkit developed in this proposal will form the basis of a IIR application to conduct a stepped-wedge cluster randomized trial throughout VA examining strategies to improve ICD programming.