BioVentrix has announced that updated clinical data from the “STICH” trial, now in press and soon to be published in the Journal of Thoracic and Cardiovascular Surgery, concludes: “In patients undergoing coronary artery bypass graft (CABG) plus surgical ventricular reconstruction (SVR), a survival benefit was realised compared with bypass alone in patients where the left ventricular volume was reduced below 70mL/m2”
“STICH” refers to surgical treatment for ischemic heart failure. Funding for the STICH study was provided by grants from the National Heart, Lung, and Blood Institute (NHLBI).
A company press released reported that in patients treated with CABG and SVR, those who achieved a postoperative LVESVI (Left Ventricular End-Systolic Volume Index) of less than 60mL/m2 showed a 64% reduction in mortality (9.8% vs. 27%) at four years as compared with those whose LVESVI was 60ml/m2 or greater. BioVentrix has previously reported a superior left ventricular volume reduction mean of 56mL/m2 in its First-in-Man study. Consequently, the press release reported, the independent STICH study’s updated results underscore the potentially critical clinical impact of BioVentrix’s Revivent myocardial anchoring system, which makes possible Less Invasive Ventricular Enhancement (LIVE), an SVR procedure that restores the left ventricle from damage done by a heart attack to a more optimal volume and conical shape, thereby enhancing performance of the heart’s non-damaged myocardium and improving quality of life.
“There has been considerable debate over whether SVR in conjunction with CABG decreases mortality or hospitalisation rates compared with CABG alone,” said Vasco Gama, Cardiovascular Interventional Unit, Department of Cardiology, Gaia Hospital Center, Vila Nova de Gaia, Portugal. “The STICH data analysis demonstrates that there are patient populations who truly benefit from surgical ventricular reconstruction. For example, survival rates show improvement in ischemic cardiomyopathy patients with post-op LVESVI of less than or equal to 70mL/m2. As a cardiologist seeking less-invasive therapy, I find the Revivent technology to be well-suited for such patients. Long-term follow-up data show that Revivent achieves left ventricular scar exclusion, significant left ventricular volume reduction, and symptomatic improvement in patients. Equally important, these impressive clinical outcomes are achieved without cardiopulmonary bypass or ventriculotomy.”