Abstract 19753: First in Man Experience with Left Ventricular Reconstruction in Patients with Systolic Heart Failure Using a Novel Approach of Biopolymer Hydrogel Implantation
Background: The prevention or reversal of left ventricular (LV) remodeling by means of wall stress reduction is an important target in the treatment of heart failure (HF). We previously demonstrated that a tissue engineering approach of direct intramyocardial injections of an alginate hydrogel restored LV geometry, improved LV function and prevented progressive LV remodeling in dogs with chronic HF. This study reports on “a first in man” initial prospective safety and feasibility evaluation of therapy in patients with HF.
Methods: A total of 6 patients with ischemic (n=4) and non-ischemic (n=2) dilated cardiomyopathy, NYHA class III or IV, received ventricular restoration using a novel biopolymer (Algisyl-LVR) at the time of either coronary artery bypass or valve surgery. 10 to 15 injections of the biopolymer (0.3 cc per injection) were placed into the LV wall along the circumference of the LV free wall halfway between the apex and base. Assessment of LV size and function were obtained during echocardiography before surgery and 3 days, 8 days, and 3 months after surgery. Assessment of NYHA classification and Kansas City Cardiomyopathy Questionnaire (KCCQ) were obtained in all patients.
Results: Improvements in LV size and function were observed as early as 3 days following surgery for all patients (Table). At the time of this report, all 6 patients had completed 3 months follow-up and demonstrated sustained improvements in LV size and function that were accompanied by statistically significant improvements in clinical status and quality of life. All 6 patients enrolled in the study are alive without the need for additional major cardiac procedure. The review of findings from the six patients enrolled in the study indicates a satisfactory tolerability and safety profile.
Conclusions: Reconstruction of LV geometry using a novel in situ biopolymer implantation (Algisyl-LVR) at the time of concomitant cardiac surgery is associated with sustained improvement (up to 3 months) in LV function, a reduction in LV volumes and improvement in clinical status and quality of life. This early experience with this novel approach to LV reconstruction, favors continued clinical development for the treatment of advanced HF.
- © 2010 by American Heart Association, Inc.