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.