December 3, 2019
One-Year Outcomes Published for BioVentrix's Revivent TC System
December 4, 2019—BioVentrix, Inc., developer of a less invasive system for left ventricular remodeling, announced the publication of positive 1-year results from its CE Mark approval study of the Revivent TC transcatheter ventricular enhancement system. The study by Patrick Klein, MD, et al is available online ahead of print in the European Journal of Heart Failure. The Revivent TC device was approved in Europe in 2016.
According to the company, the investigators concluded in the study, “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 a sternotomy or cardiopulmonary bypass is an important advance for the treatment of patients suffering from ischemic cardiomyopathy heart failure.”
As summarized by BioVentrix, the prospective, multicenter, single-arm study 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. The study was composed of 89 patients at 22 centers in 12 countries in the European Union. 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 a cardiopulmonary bypass to implant the device.
BioVentrix reported that the study showed the following patient outcomes at 12 months:
- 100% of patients demonstrated a significant and sustained reduction in LV volumes
- 27% reduction in LV end-systolic volume index (74 ± 28 ml/m² body-surface area [BSA] vs 54 ± 23 ml/m² BSA; P < .001)
- 24% reduction in LV end-diastolic volume index (106 ± 33 ml/m² BSA vs 80 ± 26 ml/m² BSA; P < .0001)
- 16% improvement in LV ejection fraction (29 ± 8% vs 34 ± 9%; P < .005)
- 90.6% survival
- 27% improvement in New York Heart Association (NYHA) functional class (average class of 2.6 vs 1.9); at baseline, 59% of patients were NYHA class III versus at 1 year, 79.4% were NYHA 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 < .001)
- 18% improvement in exercise capacity as measured by the 6-Minute Walk Test (342 vs 403 meters; P < .001)
- 50% improvement in average mitral regurgitation (MR) grade at 6 months in the 68 patients who entered the study with measurable functional MR of at least grade 1+ (1.12 vs 0.57); at 12 months, there was a 24% improvement (1.12 vs 0.86)
- 97% procedural success
- Median length of hospital stay was 14 days; however, a subsequent postmarket study has seen the length of stay decrease substantially as interventionists gain more experience
BioVentrix advised that it is currently enrolling patients in the REVIVE-HF postmarket study in Europe. This is a randomized controlled, prospective, multicenter, dual-arm study evaluating the Revivent TC system against guideline-directed medical therapy. The study is expected to enroll 180 patients.
In the United States, the Revivent TC system is investigational and is not approved for sale. The company is currently enrolling patients in the United States pivotal ALIVE trial.
The company’s LIVE (less-invasive ventricular enhancement) procedure uses the Revivent TC 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. Microanchors 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.