LIVE therapy overview
LIVE therapy is a hybrid procedure, based on teamwork between a cardiac surgeon, an interventional cardiologist and an imaging cardiologist/radiologist. It is performed in a hybrid operative room (OR) under general anesthesia. It requires a small left thoracotomy and, depending on the strategy, a right internal jugular vein access (RIJV). The procedure is guided by multimodality imaging, with constant fluoroscopic and transesophageal echocardiography (TEE) monitoring.
LV shape and size are restored on a beating heart, without ECC by plication and exclusion of the scarred myocardium. This is achieved by implantation of a series of titanium microanchors (5 mm × 25 mm) brought together over a poly-ether-ether-ketone (PEEK) tether (1.7 mm × 1.0 mm) to exclude the scarred myocardium. This is either achieved as a LV-LV approximation, or as a RV-LV approximation, depending on the scar distribution. In the RV-LV approach, internal anchors are deployed over-the-wire, through the RIJV, on the right side of the ventricular septum (Figure 1 ).
The LIVE procedure most recent results were presented at the European Society of Cardiology 2020 Congress.[7] No early or intra-hospital mortality was reported. A mean of 2.3 anchor pairs (median 2) were used to reshape the LV. Echocardiographic data showed an increase in LV ejection fraction (EF) from 31.4±9.2% to 40.0±12.4% (change +29.8%, p<0.001) and LV end-systolic volume index (LVESVI) reduction from 66.6±29.3 ml/m2 to 40.7±21.5 ml/m2 (change −38%, p<0.001) and LV end-diastolic volume index (LVEDVI) reduction from 92.8±39.2 ml/m2 to 60.6±25.9 ml/m2 (change −33.2%, p=0.001) after the procedure. In the mean follow-up period of 9.8 months, NYHA class improved a median of 1 grade and there was no late mortality.
Recently, to robustly demonstrate that the LIVE procedure with the Revivent TC™ system is more effective than GDMT alone for the treatment of ischemic HF, a randomized controlled trial - Revivent TC versus Guideline Determined Medical Therapy (REVIVE-HF, NCT03845127) - has been developed and started patient enrolment in 2019. Results are expected in 2022.