Overview: This retrospective observational study examines label expansions and post-market assessments of implantable cardioverter defibrillators and pacemakers. The project has two distinct aims. First, the project aims to demonstrate the feasibility of linking Abbott implantable cardioverter defibrillator (ICD) and pacemaker remote monitoring (Merlin.netTM) data with The Center for Medicare and Medicaid Services (CMS) Medicare data. Second, the project will assess the association between stored device diagnostics and clinical and economic outcomes.
Impact for NESTcc: The use of the link between remote-monitoring data with CMS Medicare data will explore association between stored device diagnostics and clinical and economic outcomes, which will lead to the novel exploration of linkages of device-generated data with claims data to support clinical evidence generation.
Organization(s): Abbott, Department of Population Health, Duke Center for Arrhythmia Research & Treatment Innovation, Duke University/Duke Clinical Research Institute (DCRI)
Principal Investigator(s): Brett Atwater, MD (Duke) and Jonathan Piccini, MD (Duke)