Abstract 3343: The Paracor Ventricular Support System: Initial US Experience
Introduction: The HeartNet™ Ventricular Support System (Paracor Medical, Inc, Sunnyvale CA) is a nitinol mesh device designed to improve clinical outcomes in patients with LV systolic dysfunction. The device is implanted via mini-thoracotomy using a custom designed delivery system and provides gentle elastic restraint to favorably alter wall stress in patients with symptomatic heart failure (HF). We report the initial U.S. experience in 30 patients (pts).
Methods: Pts with LV systolic dysfunction (EF ≤35%) and Class II or III HF on conventional medical and device therapy exhibiting progression of disease were enrolled. Pts with severe MR, coronary artery bypass graft dependent or recent cardiac procedure or event were excluded.
Results: Successful implantation was accomplished in 29/30 patients. 6 month results to date are below:
Conclusions: Implantation of the HeartNet™ is feasible. Early data suggest improvement in clinical parameters and trends in reverse remodeling. A randomized controlled trial of the HeartNetTM in the management of HF due to LV systolic dysfunction is planned.