Impact of less invasive ventricular enhancement TM (live TM) compared to optimal medical therapy on cardiac output in patients with hfref - preliminary results of a 12-month multi-center CMR trial

Abstract

Background: The Less Invasive Ventricular Enhancement (LIVETM, Bioventrix Inc.) technique with the Revivent TC™ system provides a new hybrid, off-pump, catheter-based approach to improve symptoms in HFrEF patients with myocardial scarring (akinesia/dyskinesia) and dilated left ventricles. AIm of the study was to assess the impact of the LIVETM technique vs. optimal medical therapy (OMT) on left ventricular (LV) cardiac output at 12 months post-procedure. Methods: We analyzed data of 40 HFrEF-patients enrolled in a multicenter trial. The LV cardiac output was assessed with the Revivent TC™ in 20 patients, while 20 matched control group participants received OMT only. A standardized CMR protocol was performed at baseline and at 12-month follow up in both groups. Results: LVEF improved significantly by 48% in Revivent patients (23.3 ± 9.8 % vs. 34.6 ± 10.3 %; p < 0.001), but had not changed in controls (33.0 ± 8.9 % vs 35.2 ± 7.8 %; p = 0.383) at 1-year follow up. Regarding LV cardiac output (median), a borderline significant increase by ~ 8% was seen in the surgical group (CO: 4.6 ± 2.0 l/min vs. 5.3 ± 1.9 l/min; p = 0.06 but rather a decrease by ~ 10 % in the control group (CO: 5.3 ± 2.1 l/min vs. 4.8 ± 1.5 l/min; p = 0.238) (Figure). Conclusion: We demonstrate a significant improvement in LV function by 48% and an increase in cardiac output by around 8% 1 year after using the Bioventrix Revivent TCTM. Our results suggest benefits for outcome in symptomatic HFrEF patients with myocardial scarring and large ventricles compared to OMT.