The BioVentrix Revivent TC™, the first “less invasive” system for left ventricular remodeling, has yielded positive one-year results in an online publication of the European Journal of Heart Failure. Based on a CE Mark study, the paper will be published in print in the January issue of the journal.
Percutaneous coronary intervention (PCI), which implants a stent, is considered the standard of care for restoring blood flow to the heart after a heart attack. However, 50 percent of patients treated with PCI still develop large LV scars which cause the heart to dilate. Enlarged LVs are associated with more severe heart failure symptoms, higher mortality and more frequent re-hospitalization. Positive remodeling of the heart has been shown to improve LV function and heart failure symptoms. Hitherto the only available option is surgical ventricular remodeling, which is highly invasive.
Covered several times recently on our pages, Less Invasive Ventricular Enhancement, or the LIVE ™ procedure, uses the Revivent TC™ Transcatheter Ventricular Enhancement System to exclude scar tissue on the left ventricle that has occurred from a heart attack so the healthy portion of the heart can operate more efficiently. Micro-anchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has the potential to improve blood flow throughout the body.
The newly published prospective, multicenter, single-arm study of 89 patients at 22 centers in 12 countries in the European Union was designed to evaluate the efficacy and safety of the Revivent TC System for scar exclusion in the heart, volume reduction, and reshaping of the LV in selected patients with ischemic cardiomyopathy. Of the 86 patients successfully treated with the system, 51 received delivery via a sternotomy and 35 were treated using a less invasive, hybrid approach without sternotomy. None of the patients treated in this trial required cardiopulmonary bypass to implant the device.
Study highlights include the following patient outcomes :
- 97% procedural success
- 100% of patients demonstrated significant and sustained reduction in LV volumes at 12 months with 90.6% survival
- 27% improvement in New York Heart Association (NYHA) functional class (average class of 2.6 vs. 1.9) – 59% of subjects were NYHA class III at baseline; at one year, 79.4% were class I or II
- 36% improvement in quality of life as measured by the Minnesota Living with Heart Failure questionnaire (MLHF) (41 vs. 27 points, p<0.001)
- 18% improvement in exercise capacity as measured by the Six Minute Walk Test (6MWT – 342 meters vs. 403 meters, p<0.001))
The Revivent TC™ System has received the CE Mark and is approved for sale in Europe. It is considered investigational and is not approved for sale in the United States.
Authors of the study, entitled “Less Invasive Ventricular Reconstruction for Ischemic Heart Failure” concluded, “Treatment with the Revivent TC System in patients with symptomatic heart failure results in significant and sustained reduction of left ventricular (LV) volumes and improvement of LV function, symptoms, and quality of life.”
They added, “The ability to achieve these results without the need for sternotomy or cardiopulmonary bypass is an important advance for the treatment of patients suffering from ischemic cardiomyopathy heart failure.”
Source: BioVentrix, Inc.