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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

Authors:

Abstract

Background The Less Invasive Ventricular Enhancement (LIVE™, 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 LIVE™ 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 TC™. Our results suggest benefits for outcome in symptomatic HFrEF patients with myocardial scarring and large ventricles compared to OMT.
Heart Failure and Cardiomyopathies
810
JACC March 12, 2019
Volume 73, Issue 9
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
Poster Contributions
Poster Hall, Hall F
Saturday, March 16, 2019, 3:45 p.m.-4:30 p.m.
Session Title: Heart Failure and Cardiomyopathies: Therapy 2
Abstract Category: 14. Heart Failure and Cardiomyopathies: Therapy
Presentation Number: 1187-512
Authors: Felix Hennig, Lukas Stoiber, Tomas Lapinskas, Seyedeh Mahsa Zamani, Christoph Klein, Christoph Schmitz, Christoph Knosalla,
Lon Annest, David Schickling, Volkmar Falk, Burkert Pieske, Sebastian Kelle, German Heart Institute Berlin, Berlin, Germany, Charité
University Medicine Berlin, Berlin, Germany
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.
... Data provided by studies available only in the abstract were similar, reducing LV volumes and LVEF improvement [14][15][16][17]. Moreover, the LIVE procedure was associated with 88.7% and 87.1% survival rates at 1-and 2-years follow-up, respectively [14]. ...
... A comparable survival rate at two years (88%) was found in a multicentre trial [18]. One study [17] compared the LIVE procedure's efficacy with optimal medical therapy and revealed that LVEF was improved at follow-up only in patients treated invasively. ...
Article
Left ventricular (LV) aneurysm following acute myocardial infarction (MI) represents a less common complication, but with worse clinical outcomes. Ventricular surgical reconstruction is not always the intervention of choice due to high surgical risk. There were proposed less invasive LV aneurysm exclusion techniques such as the less invasive ventricular enhancement (LIVE) procedure. Our paper represents the first systematic approach to investigate the efficacy and safety of LIVE procedure using Revivent TCTM anchor system for LV aneurysm exclusion. Studies were considered if they reported original data regarding LIVE procedure’s efficacy and/or safety using the Revivent TCTM system in patients with LV aneurysms. Five studies met the inclusion criteria. The procedure is associated with a reduction in LV volumes and an improvement in LV ejection fraction (LVEF). The means of preoperative LVEF varied between 22.8% and 35.6%, while postoperative LVEF means ranged between 34% and 45.9% (P < 0.005) across studies. All included papers reported a significant difference between preoperative and postoperative LV end-systolic volume index (P ≤ 0.001) and LV end-diastolic volume index (P ≤ 0.001). Three out of four studies achieved statistical significance (P ≤ 0.001) when comparing preoperative (means range: 2.6–3.4) and postoperative (means range: 1.4–1.9) New York Heart Association (NYHA) class. One study reported a survival rate of 90.6 (95% CI, 84.6–97.0) at 12 months following the procedure. LIVE appears to be a promising and appropriate treatment strategy for a complex condition, which could extend the indication of LV aneurysm exclusion in the future.
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