Enhancing Public Health Through Timely Detection: Assessing the Value of Real-World Evidence With a Cardiovascular Defibrillator Leads Case Study

Speaker(s)

Gressler L1, Marinac-Dabic D2, Resnic F3, Williams S4, Yang K5, Weichold F6, Avilas-Tang E2, Mack C7, Coplan P8, Panagiotou O2, Pappas G9
1University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, AR, USA, 2U.S. Food and Drug Administration, Silver Spring, MD, USA, 3Lahey Health, Burlington, MA, USA, 4MITRE, Tuscon, AZ, USA, 5MITRE, McLean, VA, USA, 6MDEpiNet, Silver Springs, MD, USA, 7IQVIA, Chapel Hill, NC, USA, 8Johnson & Johnson, Fort Washington, PA, USA, 9FDA, Silver Spring, MD, USA

Presentation Documents

OBJECTIVES: The unexpected failure of a cardiac defibrillator lead serves as a compelling case study demonstrating the value of real-world evidence (RWE) from a public health perspective. This research compares the actual time taken to identify a safety signal (real case scenario) against the hypothetical duration if data from the National Cardiovascular Disease Implantable Cardioverter Defibrillator Registry (NCDR ICD) had been employed (counterfactual scenario), leading to the voluntary recall of the device.

METHODS: The premature failure of the Fidelis cardiac defibrillator lead was identified through data from three clinical centers, with the signal detected 36 months post-approval. The counterfactual scenario estimated the time needed to detect the same signal if the NCDR ICD, a national registry with 900+ participating hospitals, underwent prospective, active surveillance. Three scenarios ("conservative," "likely," and "optimistic") were simulated, calculating the reported ICD lead implants to the NCDR ICD Registry and outlining various lead failure rates for the Fidelis lead. The DELTA active surveillance system was used to monitor the accruing, simulated ICD Registry, calculating risk-adjusted rates of adverse clinical events reported quarterly.

RESULTS: An elevated Fidelis lead failure rate emerged in the initial six months, potentially enabling DELTA to alert the Food and Drug Administration (FDA) and the manufacturer within 11 months post-launch. This could have saved over 790 days and potentially shielded nearly 200,000 patients from the defective device. In the most conservative scenario, DELTA would have alerted the FDA and the manufacturer approximately 700 days post-launch, 23 months before the FDA's awareness of the issue.

CONCLUSIONS: This case study highlights the tangible value of RWE in public health in terms of post-market surveillance. The shorter detection time, had the full NCDR been utilized, aligns with documented cases, showcasing the significance of RWE in averting potential harm and supporting timely regulatory action.

Code

RWD139

Topic

Epidemiology & Public Health, Health Technology Assessment, Medical Technologies, Real World Data & Information Systems

Topic Subcategory

Distributed Data & Research Networks, Medical Devices, Safety & Pharmacoepidemiology, Value Frameworks & Dossier Format

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory), Medical Devices