The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy: Initial first in man clinical results

Background: A tissue engineering approach to augment the left ventricular wall has been suggested as a means to treat patients with advanced heart failure. This study evaluated the safety and feasibility of Algisyl-LVR (TM) as a method of left ventricular augmentation in patients with dilated cardiomyopathy undergoing open-heart surgery. Methods and results: Eleven male patients (aged 44 to 74 years) with advanced heart failure (NYHA class 3 or 4), a left ventricular ejection fraction (LVEF) of <40% and requiring conventional heart surgery received Algisyl-LVR delivered into the LV myocardial free wall. Serial echocardiography, assessment of NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24-hour Holter monitoring were obtained at baseline, days 3 and 8 (for echocardiography and Holter monitoring), and at 3, 6, 12, 18 and 24 months. A total of 9 (81.8%) patients completed 24 months of follow-up. Two patients withdrew consent after day 8 and at the 3 month visit. Operative mortality was 0% (n=10 with 30 day follow-up). There were no adverse events attributed to Algisyl-LVR. Mean LVEF improved from 27.1 (+/- 7.3) % at screening to a mean LVEF of 34.8 (+/- 18.6) % 24 months post-discharge. Improvements of NYHA class were corroborated with improvements in KCCQ summary scores. Holter monitor data showed a significant decrease in the episodes of nonsustained ventricular tachycardia following administration of Algisyl-LVR. Conclusions: Administration of Algisyl-LVR to patients with advanced HF at the time of cardiac surgery is feasible and safe; warranting continued development of Algisyl-LVR as a potential therapy in patients with advanced HF. (C) 2015 Elsevier Ireland Ltd. All rights reserved.