Patient selection
Any patients suffering from heart failure symptoms with cardiac
dysfunction caused by a previous myocardial infarction resulting in
increased LV systolic volume and in a discrete, contiguous,
non-contractile, (akinetic and/or dyskinetic) scar located in the
antero-septal, apical (may extend laterally) region of the left
ventricle.
Transthoracic echocardiography (TTE) is utilized to assess for LV
dilatation, diminished ejection fraction (EF), LVESVI and LVEDVI,
regional wall akinesis or dyskinesis. It is a useful imaging modality to
guide further investigation to determine suitability for Revivent TC™
and to plan the LV reconstruction.
Cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE)
gives a higher resolution image, clearly indicating scar thickness,
extent and anatomy. It also gives excellent indication of LVESVI, LVEDVI
and EF. LGE is the gold standard for scar determination.
4D cardiac computed tomography (CT) scan carried out with a triphasic
injection of contrast media is a suitable alternative to CMR for
patients unable to undergo the latter.
The following are absolute contra-indications for the LIVE
procedure:
- Myocardial Infarction within 90 days prior to the procedure;
- Previous right neck surgery or previous left chest surgery that
precludes device placement;
- Thrombus or intra-ventricular mass in the left atrium or ventricle as
verified by echocardiography or equivalent that has not been
adequately treated with weeks of anticoagulant at therapeutic levels;
- Calcified ventricular wall in the area of intended scar exclusion as
verified by one or more appropriate imaging modalities.
The following are relative contra-indications for the LIVE
procedure:
- Chronic renal failure with a serum creatinine >2 mg/dL;
- Inoperable coronary disease with significant ischemia;
- Inadequate myocardial viability in regions remote from the scar;
- Cardiac Resynchronization Therapy (CRT) consisting of bi-ventricular
pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to
treatment;
- Patient intolerance or unwillingness to take anti-coagulation
medication;
- Functioning pacemaker leads in antero-apical RV, which, in the opinion
of the investigator, would interfere with anchor placement;
- Pulmonary Arterial Pressure > 60 mm Hg shown by right
heart catheterization to be precapillary or unresponsive to
vasodilator therapy;