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Objective: Diastolic heart failure (DHF) accounts for 40-54% of HF cases. Patients with advanced DHF (NYHA class III and IV) have poor quality of life and high mortality. There are no guidelines for the use of either drugs or devices in these patients. Treatment is based on controlling co-morbidities and conditions that may exacerbate the disease, such as hypertension, diabetes, rapid atrial fibrillation and congestion.
A novel mechanical principle of transferring energy exerted by the left ventricle (LV) during systole to diastole to enhance diastolic performance was realized.
Methods: a transapically delivered three-arm elastic device, leaning on the internal surface of the LV wall was developed and evaluated in a large-scale preclinical safety study in more than 60 sheep.
Results: After screening, guided by fluoroscopy and echocardiography, the device is positioned inside the LV, with one arm located between the papillary muscles, another arm on the septum and the third arm on the free wall, avoiding the mitral valve and subvalvar apparatus. Bail-out is possible, if necessary. There were no safety events up to 12-month follow-up.
Conclusions: Previous clinical experience with an extra-ventricular device, using the same principle and implanted as an add-on to aortic valve replacement for aortic valve stenosis, revealed signs of efficacy. This was demonstrated by greater decrease in left-atrial area, regression of LV mass and of BNP levels compared to control group (aortic valve replacement only without device). Clinical study with the intra-ventricular device is to be initiated during 2012.