Use of a Silicon Microneedle Chip-Based Device for the Extraction and Subsequent Analysis of Dermal Interstitial Fluid in Heart Failure Patients

<b>Background/Objectives:</b> Dermal interstitial fluid (dISF) is probably the most interesting biofluid for biomarker analysis as an alternative to blood, enabling higher patient comfort and closer or even continuous biomarker monitoring. The prerequisite for dISF-based analysis tools is having convenient access to dISF, as well as a better knowledge of the presence, concentration, and dynamics of biomarkers in dISF. Hollow microneedles represent one of the most promising platforms for access to pure dISF, enabling the mining of biomarker information. <b>Methods and Results:</b> Here, a microneedle-based method for dISF sampling is presented, where a combination of hollow microneedles and sub-pressure is used to optimize both penetration depth in skin and dermal interstitial fluid sampling volumes, and the design of an open, prospective, exploratory, and interventional study to examine the detectability of inflammatory and cardiocirculatory biomarkers in the dISF of heart failure patients, the relationship between dISF-derived and blood-derived biomarker levels, and their kinetics during a cardiopulmonary exercise test (CPET) is introduced. <b>Conclusions:</b> The dISF sampling method and study presented here will foster research on biomarkers in dISF in general and in heart failure patients in particular. The study is part of the European project DIGIPREDICT-Digital Edge AI-deployed DIGItal Twins for PREDICTing disease progression and the need for early intervention in infectious and cardiovascular diseases beyond COVID-19.