Background LIVE (Less Invasive Ventricular Enhancement) with Revivent TC™ is an innovative therapy for symptomatic ischemic Heart Failure (HF). It is designed to reconstruct a negatively remodeled left ventricle (LV) after an anterior myocardial infarction (MI) by plication of the scar tissue. Its indications are specific and, as with any other structural heart intervention, the success of the procedure starts with appropriate patient selection. We aim to present the indications of the technique, crucial aspects in patient selection and individual case planning approach. Methods and Results After clinical evaluation, transthoracic echocardiography is the first imaging modality to be performed in a potential candidate for the therapy. However, definitive indication and detailed case planning rely on late gadolinium-enhanced cardiac magnetic resonance imaging or multiphasic contrast-enhanced cardiac computed tomography. These imaging modalities also assist with relative or absolute contra-indications for the procedure. Individual assessment is done to tailor the procedure to the specifics of the LV anatomy and location of the myocardial scar. Conclusion LIVE procedure is a unique intervention to treat symptomatic heart failure and ischemic cardiomyopathy after anterior MI. It is a highly customizable intervention that allows a patient-tailored approach, based on multimodality imaging assessment and planification.
The evidence supporting surgical aneurysmectomy in ischemic heart failure is inconsistent. The aim of the study was to describe long-term effect of minimally invasive hybrid transcatheter and minithoracotomy left ventricular (LV) reconstruction in patients with ischemic cardiomyopathy. Twenty-three subjects with transmural anterior wall scarring, LV ejection fraction 15-45%, and New York Heart Association class ≥ II were intervened using Revivent TC anchoring system. LV end-systolic volume index was reduced from 73.2 ± 27 ml at baseline to 51.5 ± 22 ml after 6 months (p < 0.001), 49.9 ± 20 ml after 2 years (p < 0.001), and 56.1 ± 16 ml after 5 years (p = 0.047). NYHA class improved significantly at 5 years compared to baseline. Six-min walk test distance increased at 2 years compared to the 6-month visit. Hybrid LV reconstruction using the anchoring system provides significant and durable LV volume reduction during 5-year follow-up in preselected patients with ischemic heart failure. Legend: Hybrid left ventricular reconstruction using the anchoring system provides significant and durable LV volume reduction throughout 5-year follow-up in preselected patients with ischemic heart failure.
Objectives: Ischemic cardiomyopathy is the principal cause of heart failure. In patients with left ventricular (LV) dilatation, low ejection fraction (EF), and transmural scar in anteroseptal distribution, surgical ventricular reconstruction (SVR) can be considered, although it is an invasive surgical procedure. Less Invasive Ventricular Enhancement (LIVE) technique emerged as a unique intervention to exclude scarred myocardium, improving symptoms and quality of life. We aim to present LIVE contemporary short and mid-term outcomes.
The Revivent TC™ Transcatheter Ventricular Enhancement System (BioVentrix Inc.) is intended for use in heart failure with cardiac dysfunction a previous myocardial infarction. The resultant increased left ventricular systolic volume and discrete, contiguous, noncontractile (akinetic and/or dyskinetic) scar located in the anteroseptal, apical (may extend laterally) region of the left ventricle (LV) lends itself to Revivent. The procedure, called Less Invasive Ventricular Enhancement, consists of the implantation of a series of microanchors pairs to exclude the scarred myocardium, to reduce and reshape the LV. We present the procedure step-by-step, as team coordination between the cardiac surgeon and the interventional cardiologist is essential to ensure good procedural outcomes. This is a novel and new technique to address heart failure secondary to myocardial infarction.
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
Background Surgical ventricular reconstruction to remodel, reshape and reduce ventricular volume is an effective therapy in selected patients with ischemic heart failure (IHF). The BioVentrix Revivent System offers comparable efficacy to conventional surgical ventricular reconstruction aiming to exclude nonfunctioning myocardium, reshape ventricular size and reduce ventricular volume in selected patients with IHF, but is a less-invasive procedure on the beating heart. With this study we aimed to assess its functional effectiveness. Methods Patient were considered eligible for the procedure when they presented with symptomatic (at least NYHA II) left ventricular (LV) dilatation and dysfunction, caused by myocardial infarction (MI) that occurred at least 90 days prior to study enrollment, and with akinetic and/or dyskinetic scarred myocardium of at least 50% transmurality located in the antero-septal, anterolateral, and/or apical regions. The BioVentrix Revivent System consists of polyester-covered titanium anchor pairs that are drawn together to exclude scarred areas of the LV free wall. The anchors were implanted via sternotomy or, alternatively, through a combined mini-thoracotomy and transcatheter procedure. Results Eighty-nine patients were enrolled. At 2 years, a significant improvement in LVEF(30 ± 8% vs 34 ± 9%, p Conclusions Less invasive reconstruction with the BioVentrix Revivent system in patients with symptomatic IHF results in significant and sustained improvement of LV function, reduction in LV volumes with reduction of heart failure symptoms and improved quality of life at mid-term follow-up.
ABSTRACT Aims Surgical ventricular reconstruction to remodel, reshape, and reduce ventricular volume is an effective therapy in selected patients with chronic heart failure (HF) of ischaemic aetiology. The BioVentrix Revivent TC System offers efficacy comparable to conventional surgical ventricular reconstruction and is less invasive utilizing micro‐anchor pairs to exclude scarred myocardium on the beating heart. Here, we present 12‐months follow‐up data of an international multicenter study. Methods and results Patients were considered eligible for the procedure when they presented with symptomatic HF [New York Heart Association (NYHA) class ≥II], left ventricular (LV) dilatation and dysfunction caused by myocardial infarction, and akinetic and/or dyskinetic transmural scarred myocardium located in the anteroseptal, anterolateral, and/or apical regions. A total of 89 patients were enrolled and 86 patients were successfully treated (97%). At 12 months, a significant improvement in LV ejection fraction (29 ± 8% vs. 34 ± 9%, P < 0.005) and a reduction of LV volumes was observed (LV end‐systolic and end‐diastolic volume index both decreased: 74 ± 28 mL/m 2 vs. 54 ± 23 mL/m 2 , P < 0.001; and 106 ± 33 mL/m 2 vs. 80 ± 26 mL/m 2 , respectively, P < 0.0001). Four patients (4.5%) died in hospital and survival at 12 months was 90.6%. At baseline, 59% of HF patients were in NYHA class III compared with 22% at 12‐month follow‐up. Improvements in quality of life measures (Minnesota Living with Heart Failure Questionnaire 39 vs. 26 points, P < 0.001) and 6‐min walking test distance (363 m vs. 416 m, P = <0.001) were also significant. Conclusions Treatment with the Revivent TC System in patients with symptomatic HF results in significant and sustained reduction of LV volumes and improvement of LV function, symptoms, and quality of life.
For patients with heart failure (HF) due to ischemic cardiomyopathy (ICM), reconstruction and volume reduction of the scarred left ventricle (LV) may be beneficial. The Revivent “Less Invasive Ventricular Enhancement” procedure (BioVentrix, Inc, San Ramon, CA) , is a minimally invasive method
Introduction: After an acute coronary syndrome many patients with ischemic cardiomyopathy (ICM) suffer from heart failure with reduced ejection fraction (HFrEF). Beside surgical ventricular reconstruction (SVR) by open-chest-surgery as an option to improve myocardial function by restoring the shape and size of the heart in HFrEF patients, first results demonstrated a significant reduction of LV volumes and LVEF using the Revivent TC TM System compared to optimal medical therapy (OMT) in patients with aneurysms in the anterior region of the LV. Objectives: To assess the impact of the Revivent TC™ system (Bioventrix Inc.) as a Less Invasive Ventricular Enhancement (LIVE™) technique to improve systolic and diastolic LV-function in patients with HFrEF compared to treatment of patients with OMT. Methods: We analyzed data from 10 patients and 10 controls with ICM and LVEF ≤ 45% from a multi-center-trial as well as 12 healthy subjects. In total, 10 patients underwent LV reduction with the new LIVE™ technique. The control group patients received OMT only (natural course of disease). Global longitudinal strain (GLS) as advanced, quantitative CMR measurement has been performed both at baseline and 12 months to quantitatively assess LV function. In addition, hemodynamic forces (HF) as an equivalent to intraventricular pressure gradients derived from CMR-data have been evaluated. Results: After 12 months follow-up, LVEF improved after using the Revivent TM System (27.8 ± 10.6 % vs. 31.5 ± 10.9 %), but not in controls (31.8 ± 8.2 % vs 31.3 ± 6.7 %). Minimal invasive treated patients showed a significant reduction in HF (33.6 ± 9.4 vs. 28.5 ± 10.5, p=0.04) and improved GLS (-9.4 ± 3.5 % vs. -11.4 ± 4.7 %; p=0.08). No change was observed in controls (31.5 ± 7.3 vs. 31.9 ± 6.9, p=0.37 and -12.8 ± 2.8 % vs. -12.6 ± 2.1 %; p=0.38) (see Figure). Conclusion: We demonstrate an improvement of LV strain and hemodynamic forces 12 months after using the Revivent TC TM System in HFrEF-patients compared to OMT. The impact on outcome and exercise capacity of HFrEF-patients has to be proven in larger trials with longer follow-up.
A new technique described as Less Invasive Ventricular Enhancement (LIVE) was performed to reduce volume and reshape the left ventricle without cardiopulmonary bypass in post-myocardial infraction, ischemic cardiomyopathy heart failure patients. Access in the early stages was via median sternotomy
Introduction: Ischemic cardiomyopathy (ICM) is the most common type of heart failure with reduced ejection fraction (HFrEF). Surgical ventricular reconstruction (SVR) by open-chest-surgery is an op...
AIMS:To test the feasibility of a thoracoscopically assisted, off-pump, transcatheter ventricular reconstruction (TCVR) approach in an ovine model of left ventricular (LV) anteroapical aneurysm.METHODS AND RESULTS:Myocardial infarction (MI) was induced by coil occlusion of the middle left anterior descending artery and diagonals. Two months after MI creation, TCVR was performed via a minimal thoracotomy in eight sheep. Under endoscopic and fluoroscopic guidance, trans-interventricular septal puncture was performed from the LV epicardial scar. A guidewire was externalised via a snare placed in the right ventricle from the external jugular vein. An internal anchor was inserted over the wire and positioned on the right ventricular septum and an external anchor was deployed on the LV anterior epicardium. Serial pairs of anchors were placed and plicated together to exclude the scar completely. Immediately after TCVR, echocardiography showed LV end-systolic volume decreased from pre-procedure 58.8±16.6 ml to 25.1±7.6 ml (p<0.01) and the ejection fraction increased from 32.0±7.3% to 52.0±7.5% (p<0.01). LV twist significantly improved (3.83±2.21 vs. pre-procedure -0.41±0.94, p=0.01) and the global peak-systolic longitudinal strain increased from -5.64% to -10.77% (p<0.05).CONCLUSIONS:TCVR using minimally invasive access techniques on the off-pump beating heart is feasible and resulted in significant improvement in LV performance.
Objective: The loss of normal apical rotation is associated with left ventricular (LV) remodeling and systolic dysfunction in patients with congestive heart failure after myocardial infarction. The objective of the present study was to evaluate the effect of epicardial ventricular reconstruction, an off-pump, less-invasive surgical reshaping technique, on myocardial strain, LV twist, and the potential alteration of myocardial fiber orientation in an ovine model of LVanteroapical aneurysm.Methods: LV anteroapical myocardial infarction was induced by coil embolization of the left anterior descending artery. Eight weeks after occlusion, epicardial ventricular reconstruction was performed using left thoracotomy under fluoroscopic guidance in 8 sheep to completely exclude the scar. The peak systolic longitudinal/circumferential strains and LV twist were evaluated using speckle tracking echocardiography before (baseline), after device implantation, and at 6 weeks of follow-up.Results: Epicardial ventricular reconstruction was completed in all sheep without any complications. Immediately after device implantation, LV twist significantly increased (4.18 +/- 1.40 vs baseline 1.97 +/- 1.92; P = .02). The ejection fraction had increased 17% and LV end-systolic volume had decreased 40%. The global longitudinal strain increased from -5.3% to -9.1% (P < .05). Circumferential strain increased in both middle and apical LV segments, with the greatest improvement in the inferior lateral wall (from -11.4% to -20.6%, P < .001). These effects were maintained >= 6 weeks after device implantation without redilation.Conclusions: Less invasive than alternative therapies, epicardial ventricular reconstruction on the off-pump beating heart can restore LV twist and systolic strain and reverse LV remodeling in an ovine anteroapical aneurysm model.