Cardiovascular revascularization medicine : including molecular interventions · 2026
Effectiveness and safety of REVIVENT-TC system for the left ventricular reconstruction in ischaemic heart failure. A literature review.
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Kakoudaki Tania, Poon Shi Sum, Kumar Pankaj
Аннотация
BACKGROUND: Surgical ventricular reconstruction (SVR) is not always feasible in patients with ischaemic cardiomyopathy and left ventricular (LV) aneurysm, due to high surgical risk. The Revivent-TC Transcatheter Ventricular Enhancement System is a less invasive alternative option.
METHODS: We conducted a systematic literature search using PubMed, Ovid Medline and Google Scholar between January 2013 up to May 2025 to assess the effectiveness and safety of Revivent-TC System. Inclusion criteria included symptomatic patients with ischaemic left ventricular (LV) systolic impairment and anterior or anteroseptal scar, with appropriate anatomy confirmed by cardiac magnetic resonance (CMR), who were treated with the device. Outcomes included echocardiographic parameters, procedural data, adverse events and survival.
RESULTS: Eight studies (276 patients) were included: seven observational and the prospective non-randomised dual-arm ALIVE trial. Mean age was 61.8 years; 73% were male with LV ejection fraction (EF) ranging from 22.8% to 35.6%. Procedural success ranged from 96 to 100%, with procedure-related mortality of 2.5%. Conversion to full median sternotomy was required in 1.4% due to complications such as right ventricular (RV) perforation, acute mitral regurgitation and right ventricular (RV) failure. Surgical re-intervention was required in 4.3% of patients. Overall mortality during follow-up was 6.5%. Statistically significant improvement in LVEF and LV volumes was observed across observational studies, persisting up to 5 years post-operatively. Improvements in exercise tolerance, NYHA functional class and quality of life were also observed. However, the ALIVE trial did not demonstrate a significant clinical benefit over guideline-directed medical therapy (win ratio 1.13; p = 0.32), with cardiovascular mortality and HF hospitalisation numerically favouring the control group.
CONCLUSIONS: The Revivent-TC system is associated with LV volume reduction and functional improvements in selected patients, offering a less invasive alternative to surgical ventricular reconstruction. However, the evidence base consists predominantly of small observational studies, and the only controlled trial did not demonstrate significant benefit on hard clinical endpoints. Longer-term randomised data, including a guideline-directed medical therapy comparator arm, are needed before definitive conclusions about efficacy can be drawn.
METHODS: We conducted a systematic literature search using PubMed, Ovid Medline and Google Scholar between January 2013 up to May 2025 to assess the effectiveness and safety of Revivent-TC System. Inclusion criteria included symptomatic patients with ischaemic left ventricular (LV) systolic impairment and anterior or anteroseptal scar, with appropriate anatomy confirmed by cardiac magnetic resonance (CMR), who were treated with the device. Outcomes included echocardiographic parameters, procedural data, adverse events and survival.
RESULTS: Eight studies (276 patients) were included: seven observational and the prospective non-randomised dual-arm ALIVE trial. Mean age was 61.8 years; 73% were male with LV ejection fraction (EF) ranging from 22.8% to 35.6%. Procedural success ranged from 96 to 100%, with procedure-related mortality of 2.5%. Conversion to full median sternotomy was required in 1.4% due to complications such as right ventricular (RV) perforation, acute mitral regurgitation and right ventricular (RV) failure. Surgical re-intervention was required in 4.3% of patients. Overall mortality during follow-up was 6.5%. Statistically significant improvement in LVEF and LV volumes was observed across observational studies, persisting up to 5 years post-operatively. Improvements in exercise tolerance, NYHA functional class and quality of life were also observed. However, the ALIVE trial did not demonstrate a significant clinical benefit over guideline-directed medical therapy (win ratio 1.13; p = 0.32), with cardiovascular mortality and HF hospitalisation numerically favouring the control group.
CONCLUSIONS: The Revivent-TC system is associated with LV volume reduction and functional improvements in selected patients, offering a less invasive alternative to surgical ventricular reconstruction. However, the evidence base consists predominantly of small observational studies, and the only controlled trial did not demonstrate significant benefit on hard clinical endpoints. Longer-term randomised data, including a guideline-directed medical therapy comparator arm, are needed before definitive conclusions about efficacy can be drawn.