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

S 28 EACTS Surgical remodelling of the left ventricle Tuesday, 14 October 2014 228 SAFETY OFA NOVEL SURGICALTHERAPY FOR THE TREATMENTOF ADVANCED HEART FAILURE: REVIEW OF SURGICAL MORBIDITYAND MORTALITY OFALGISYL-LVR FROM THE AUGMENT-HF TRIAL L. Menicanti, I. Mocanu, F. Miraldi, S. Marasco, A. Hinson, R.J. Lee, H.N. Sabbah, D.L. Mann CardioThoracic Surgery, I.R.C.C.S. Policlinico San Donato, San Donato, Italy; CardioThoracic Surgery, Army’s Center for Cardiovascular Disease, Bucharest, Romania; Department of Surgery, University of Rome La Sapienza, Rome, Italy; Cardiothoracic Unit, The Alfred Hospital, Melbourne, Australia; Cardiovascular Research, LoneStar Heart, Inc, Laguna Hills, United States of America; Cardiac Electrophysiology, UCSF, San Francisco, United States of America; Cardiovascular Research, Henry Ford Health System, Detroit, United States of America; Cardiovascular Division, Washington University School of Medicine, St. Louis, United States of America 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/m, 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/m, 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. Table 1: Operative morbidity and mortality Algisyl-LVR (n = 30) Usual care (n = 30) Pvalue Mean operative time (min) 81 ± 26 Anaesthesia time (min) 194 ± 25 Mean ICU stay (days) 3.1 ± 2.9 Intraoperative SAEs No. patients (%) 1 (3.3%) 30-day serious adverse events No. patients (%) 8 (26.7%) 2 (6.7%) 90-day serious adverse events No. patients (%) 11 (36.7%) 5 (16.7%) 30-day mortality No. patients (%) 2 (6.7%) 2 (6.7%) 90-day mortality No. patients (%) 4 (13.3%) 2 (6.7%) 90-day mean change NYHA class –0.7* 0.0 0.0002 90-day mean change 6 MWT +74.9 m** –4.3 m 0.002 * P = 0.0001 vs baseline; ** P = 0.01 vs baseline. 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. Interactive CardioVascular and Thoracic Surgery Sunday A bsracts 01 –06