The article integrates the MRI data available from 3 patients in the SYM-08-001 (first-in-man) study into a validated mathematical model to reconstruct the patients’ left ventricular geometry before and 3- and 6 months after Algisyl treatment. The model quantifies cardiac function using end-diastolic volume (EDV), end-systolic volume (ESV), regional wall thickness, sphericity index and regional myofiber stress. The conclusion states the following:
Our results support the novel concept that the injection of material into the LV free-wall with CABG is an effective strategy for inducingLV reverse remodeling that improves the LV cardiac function and results in a decreased myofiber stress. Although the power of this finding is limited by the small sample size, the effects of this treatment are interesting and remarkable. The results of a recently initiated, randomized,controlled study to evaluate Algisyl-LVR™ solely as a method of LV augmentation for patients with severe heart failure (AUGMENT-HF) should provide definitive conclusions about the clinical benefits of Algisyl-LVR™ therapy.
The article is available from ScienceDirect here.
For those interested in the mathematical model itself, an additional peer-reviewed publication in video format is available at the Journal of Visualized Experiments (JoVE), here.