Harnessing passion and real-world data to transform post-market surveillance of cardiac implanted electronic leads

Excerpt

Cardiac implanted electronic device (CIED) leads undergo extensive pre-clinical and pre-market testing and evaluation. However, these evaluations cannot ensure post-approval safety, particularly when preclinical testing either does not reproduce or is not designed to anticipate specific failure mechanisms [1]. Both the Fidelis and Riata implantable cardioverter defibrillator lead recalls are salient examples where post-approval safety concerns were identified despite the absence of pre-clinical concerns [2, 3]. In the USA, mechanisms for post-market surveillance include the Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE), FDA’s Center for Devices and Radiological Health Medical Product Safety Network (MedSun Project), manufacturer annual product performance reports, and FDA-mandated post-approval studies (condition of device approval since 2008[4]). Each provides important data but also has important limitations. For example, MAUDE is a voluntary reporting system with incomplete data and no denominator needed to estimate frequency of a given adverse or failure event. On the other hand, prospective post-approval studies suffer from modest sample sizes and relatively short follow-up. The challenge of timely, sensitive, accurate, and cost-effective post-market surveillance impacts patients, clinicians, manufacturers, health systems, and regulators alike. …