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- Title
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.
- Authors
Menicanti, L.; Mocanu, I.; Miraldi, F.; Marasco, S.; Hinson, A.; Lee, R.J.; Sabbah, H.N.; Mann, D.L.
- 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.Table 1:Operative morbidity and mortalityAlgisyl-LVR (n = 30)Usual care (n = 30)P-valueMean operative time (min)81 ± 26Anaesthesia time (min)194 ± 25Mean ICU stay (days)3.1 ± 2.9Intraoperative 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*0.00.000290-day mean change 6 MWT+74.9 m**–4.3 m0.002* 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.
- Publication
Interactive Cardiovascular & Thoracic Surgery, 2014, Vol 19, Issue suppl_1, pS68
- ISSN
1569-9293
- Publication type
Article
- DOI
10.1093/icvts/ivu276.228