Bioventrix has announced online publication of positive one-year results from its CE mark study of the Revivent TC System in the European Journal of Heart Failure. The paper will be published in print in the January issue.
A press statement from the company details that the authors of the study concluded in the paper: “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,” adding: “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.”
The press release explains that 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 trial was a prospective, multicentre, single-arm study of 89 patients at 22 centers in 12 countries in the EU and 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 ischaemic cardiomyopathy (enlarged and weakened left ventricle with reduced capacity to pump blood after a heart attack). Of the 86 patients successfully treated with the system, 51 patients 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.
Patient outcomes at 12 months in the study were that:
- 100% of patients demonstrated significant and sustained reduction in LV volumes
- 16% improvement in LVEF (29 ± 8% vs 34 ± 9%, P<0.005)
- 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 (41 vs. 27 points, p<0.001)
- 18% improvement in exercise capacity as measured by the Six Minute Walk Test (342 meters vs. 403 meters, p<0.001))
- 50% improvement in average mitral regurgitation (MR) grade in the 68 patients who entered the study with measurable functional MR (FMR) of at least grade 1+ at six months (1.12 vs. 0.57) and 24% improvement at 12 months (1.12 vs. 0.86)
- 97% procedural success
- Median length of hospital stay was 14 days; however, subsequent postmarket study has seen length of stay decrease substantially as implanters gain more experience
The company statement adds that 50% of patients treated with percutaneous coronary intervention (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 rehospitalisation. Positive remodeling of the heart has been shown to improve LV function and heart failure symptoms. The only currently available option is surgical ventricular remodeling, which is highly invasive.
The company is currently enrolling patients in the REVIVE-HF postmarket study in Europe, a randomised, controlled, prospective, multi-centre, dual-arm study evaluating the Revivent TC system against guideline-directed medical therapy. The study is expected to enroll 180 patients. In the USA, the company is currently enrolling patients in a pivotal trial of the Revivent TC system, the ALIVE Trial.