Outcomes and Off-Label Use of Medical Devices in Percutaneous Fetal Interventions for Congenital Heart Disease: A Systematic Review, Meta-Analysis, and Needs Identification Using the Biodesign Approach

Abstract

Abstract. There is a significant lack of medical devices designed for percutaneous fetal cardiac interventions, forcing clinicians to repurpose pediatric or adult devices for use in the fetal population, often at considerable risk to these patients. To help quantify this gap and drive innovation in this field, we conducted a systematic review (following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines) performing an electronic search across PubMed, Scopus, and the Cochrane databases to (1) evaluate the outcomes of off-label use of medical devices not specifically designed for fetal use in interventions addressing severe congenital heart disease (CHD) and (2) using the Stanford Biodesign methodology to identify the unmet needs that could inspire new device solutions for percutaneous fetal interventions. The search yielded 985 results, with 53 studies reviewed after screening using the established criteria. The study revealed significant rates of technical complications and adverse events that appear attributable to limitations of current devices used for percutaneous fetal cardiac intervention. This highlights the urgent need for minimally invasive cardiac devices designed exclusively for percutaneous fetal interventions. These devices should address complications and challenges in interventions for CHD, including issues with fetal positioning and cardiac access for valvular and septal procedures. These solutions should also target problems related to visualization, enable device miniaturization, and provide precision in distal device positioning and control, within a systems engineering framework to holistically address the needs of this underserved and vulnerable patient population.