228 * SAFETY OF A NOVEL SURGICAL THERAPY FOR THE TREATMENT OF ADVANCED HEART FAILURE: REVIEW OF SURGICAL MORBIDITY AND MORTALITY OF ALGISYL-LVR FROM THE AUGMENT-HF TRIAL

Abstract

Objectives: Therapeutic options for patients with severe heart failure (HF), refractory to pharmacological therapies, are limited. Algisyl-LVR is a novel device under development for left ventricular (LV) augmentation of patients with advanced HF secondary to dilated cardiomyopathy. Algisyl-LVR is a proprietary biopolymer that is injected into the LV-free-wall as a permanent implant. Preclinical and clinical studies of Algisyl-LVR suggest that the addition of non-contractile material to the failing myocardium increases wall thickness, reduces wall stress and attenuates LV-remodelling with improvements in LV function Methods: AUGMENT-HF is a multicentre randomised controlled trial of Algisyl-LVR in patients with HF of ischaemic or non-ischaemic origin. Thirty patients with an LVEDDi of 30-40 mm/m2, mean NYHA class 3.0 ± 0.4, and a mean ejection fraction (EF) of 25.9 ± 5.7% were randomised to LV augmentation with Algisyl-LVR via limited anterior thoracotomy. Algisyl-LVR hydrogel implants were placed into the LV wall along the circumference of the LV free wall as a total of 10-18 implants (0.3 ml each). Thirty patients with LVEDDi of 30-40 mm/m2, mean NYHA class 2.9 ± 0.5, and a mean EF of 26.5 ± 5.6% were randomised to stable, evidence-based therapy (no surgery) as controls Results: Algisyl-LVR implants were successfully performed in all 30 active treatment patients. Table 1 summarises procedural morbidity and mortality observed in patients receiving Algisyl-LVR along with the post-procedural changes in functional capacity. Conclusion: These results demonstrate the safety of this novel surgical procedure employing Algisyl-LVR implants via a limited anterior thoracotomy in patients with severe HF. (Table Presented).