Abstract 14180: Acute and Chronic Experimental Animal Results of the New Self-Expandable Acurate TATM Valve for Transapical Transcatheter Aortic Valve Implantation
Background: Transcatheter aortic valve implantation (TAVI) as a minimally invasive technique is currently expanding rapidly worldwide, however all currently available prostheses share some fundamental design limitations. We investigated the feasibility, safety and hemodynamic performance during follow-up of the innovative transapical Acurate TATMself-expandable device, which has the unique advantage of offering anatomically correct self-alignment within the aortic root.
Methods: Transapical aortic valve implantation was performed in six acute swine procedures (57-71 kg body weight) using the Acurate TATM valve prosthesis (Symetis, Ecublens, Switzerland), and in six sheeps (36-52 kg body weight), with follow-up times of 7, 14, 21, 28, 60 and 90 days. Valve implantation was performed under simultaneous transesophageal echocardiography (TEE) and angiographic guidance, without the need for rapid pacing. A partial sternotomy approach was used to access the left ventricular apex.
Results: All valve implantations were performed as planned and all animals survived the implantation procedure. After prosthesis deployment, no migration, embolization or coronary obstruction was observed during the observation period. Intraoperative TEE examination identified no signs of intravalvular leakage or valve dysfunction. Intraoperative transvalvular mean pressure gradients were 5.4±2.2 mmHg, and decreased during 7, 14, 21, 28, and 60 days follow-up (1.6±0.8, 1.8±0.8, 1.3±0.2, 1.8±0.7, and 1.6±0.8 mmHg, respectively) with a slight increase at day 90 (4.0±2.4 mmHg, P<0.05). Macroscopic examination at necropsy showed correct anatomical positioning of the valve stent without any signs of structural valve deterioration.
Conclusions: These first results of the new self-expandable transapical Acurate TATM device explore the feasibility and safety of anatomically correct, off-pump implantation, with optimal hemodynamic results. Further studies are necessary to investigate the durability of this new valve in the long-term.
- © 2012 by American Heart Association, Inc.