Research Project
9253943
ABSTRACT Extracorporeal membrane oxygenation (ECMO) use continues to increase as a supportive measure for cardio-respiratory failure. Pediatric patients with severe acute left ventricular (LV) systolic dysfunction are often supported with venoarterial (VA) ECMO as a short-term bridge to recovery, transplant or a ventricular assist device (VAD). Although this often provides the much needed temporary gas exchange and increase in cardiac output to all important end organs, lack of egress of blood from the LV can lead to over-distension and elevated LV end diastolic pressure (LVEDP), which reduces myocardial oxygen delivery and recovery. The risk of progressive increase in left-sided filling pressures needs to be monitored closely to avoid the deleterious effects of left-heart distention. Left ventricular distention in patients with profoundly reduced left ventricular contractility is a major risk factor for poor myocardial recovery and failure to wean from ECMO. Mechanical decompression of the left-heart during ECMO is sometimes required to address ventricular distention and is often a life-saving intervention. For patients who do not have open access to the heart for surgical decompression (i.e. post-operative cardiac patients), left ventricular decompression is most commonly accomplished by percutaneous transseptal puncture followed by either septostomy or placement of a drain or device to keep the atrial communication patent. Due to the lack of a FDA-approved devices for this indication, all options of decompression represent off-label use of devices not specifically designed for this intervention The goal of this project is to design, test, and produce a line of pediatric and adult ventricular assist catheters (VAC) that can be used for short term left heart decompression in patients on VA ECMO for acute severe LV systolic dysfunction. The MC3 VAC line will include lengths and diameters to cover the entire spectrum of sizes required for the pediatric population for both low flow left heart decompression and high flow total ventricular assist. The largest size catheters will also support the adult patient so the line will be designed to truly match the entire patient spectrum. Phase I of the study will include capturing detailed design inputs for the population, by analyzing pediatric patient data from clinical cases at The University of Michigan. User requirements will be translated into design inputs/outputs by MC3's team of experienced cannula design engineers, who have designed several, commercially-successful cannula and introducer systems. Feasibility will be established by evaluating performance of the VAC against specific criteria unique to usage in the pediatric application. Phase II funding, if granted, will be sufficient to complete verification/validation testing, transfer to manufacture, and FDA and CE mark submissions. We have assembled a synergistic team of experts, clinicians, marketers, manufacturers and engineers who are uniquely qualified to carry out the proposed work.
