Author + information
- Christoph Schmitz1,
- Mauro Biffi2,
- Davide Pacini2,
- Roberto Di Bartolomeo2,
- Petr Neuzil3,
- Ivo Skalsky3,
- Louis Labrousse4,
- Horst Sievert5,
- Christian Frerker6,
- Tobias Schmidt6,
- Karl-Heinz Kuck6,
- Giedrius Davidavicius7,
- Gintaras Kalinauskas8,
- Kestutis Rucinskas9 and
- Lon Annest10
- 1BioVentrix, Inc., Munich, Germany
- 2University of Bologna, Bologna, Bologna, Italy
- 3Na Homolce Hospital, Prague, Czech Republic
- 4Hospital Haut Lévêque, Bordeaux-Pessac, France
- 5CardioVascular Center Frankfurt CVC, Frankfurt/Main, Germany
- 6Asklepios Klinik St. Georg, Hamburg, Germany
- 7United States
- 8Vilnius Universtiy Hospital, Vilnius, Lithuania
- 9Vilnius University Heart Surgery Center, Vilnius, Lithuania
- 10BioVentrix, New York, New York, United States
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 and later using a hybrid transcatheter approach. We report survival and functional and echocardiographic results at 2 years post-procedure.
All patients had symptoms of heart failure NYHA class II/III as well as echo and MRI or CT demonstrating scar in the anteroseptal wall. Coronary lesions were always treated before the procedure. Significant MR was an exclusion criteria. LIVE was achieved using the BioVentrix Revivent Myocardial Anchoring System. Titanium anchors were delivered to the right side of the interventricular septum. An external anchor was fitted onto a tether to allow apposition of the LV free wall to the scarred septum.
89 patients were treated from August 2010 till March 2016. Baseline EF was 30±8%, LVESVI was 70±26 ml/m2, and LVEDVI was 95±31 ml/m2. Four patients (4.5%) died in-hospital and 1 (1.1%) had a stroke. Two-year survival was 87%. In 35 patients who have completed 2-year echo follow up, EF improved by 19%, LVESVI reduced by 31%, and LVEDVI reduced by 21%. NYHA class reduced from 2.6±0.5 to 1.8±0.7 (p<0,001), 6-minute walk test increased from 372±82 minutes to 425±94 minutes (p=0.002), and Minnesota Living with Heart Failure score reduced from 44±21 to 27±20 (p<0.001). Serial echocardiograms and functional evaluations at 6, 12, and 24 months demonstrated sustained improvements.
Sustained improvement of echocardiographic and functional parameters and excellent survival are obtained with the Less Invasive Ventricular Enhancement technique. In patients with no significant MR and/or myocardial ischemia, ventricular reduction and reshaping, when performed off-pump using the Revivent myocardial anchors, demonstrates long term decrease in heart failure symptoms.
STRUCTURAL: Heart Failure