First-In-Man Transcervical SAVR using a Novel Access System
Otto E. Dapunt, MD1, Olev Luha, MD1, Adrian Ebner, MD2, Piotr Sonecki, MD3, Fraser W H Sutherland, MD4.
1Medical University of Graz, Graz, Austria, 2Universidad Nacional de Asuncion Medicina, Asuncion, Paraguay, 3Western Infirmary, Glasgow, United Kingdom, 4Golden Jubilee National Hospital, Glasgow, United Kingdom.
OBJECTIVE: To evaluate a novel device system for surgical aortic valve replacement (SAVR) using unique new less invasive access approach. The hypothesis is that SAVR can be performed through a short transverse incision in the neck, similar to that used for transcervical thymectomy (TCT).
METHODS: An entirely new device system was developed to provide retraction, step by step illumination and on screen visualisation for the new approach. Preliminary investigation in cadavers indicated that all modes of SAVR are feasible through this approach but procedure is easiest using sutureless valve. A detailed step-by-step operative plan for transcervical SAVR using sutureless valve was developed. Comprehensive risk analysis was performed and training implemented in Thiel preserved cadavers. For the first-in-man clinical case, a 63 year female with symptomatic critical aortic stenosis (STS risk 11%) was selected. Surgery was performed through a skin crease incision of the neck, the new device introduced and sternum elevated. Initial dissection was directed under the sternum, anterior to the innominate vein and the pericardium opened exposing the ascending aorta. Surgery was performed using illumination modes programmed into the device and on screen visualisation provided by the device. A 23mm Medtronic ENABLE sutureless valve prosthesis was implanted. Procedure success was evaluated according to the standardised composite endpoint definition of “device success” proposed by the Valve Academic Research Consortium, VARC 2011.
RESULTS: Access, delivery and deployment of the valve prosthesis was successful. Correct position of the valve in the proper anatomical location was confirmed by transoesophageal echocardiography immediately following the procedure. Intended performance of the valve was demonstrated (mean gradient 6mmHg, aortic valve area 2.5 cm2) with absence of moderate or severe prosthetic aortic regurgitation. Only one valve prosthesis was used.
CONCLUSIONS: Transcervical surgical aortic valve replacement with sutureless valve is feasible using this novel access system. The new approach has potential to offer patients substantially shorter length of stay and fewer, less serious complications, as has been observed in TCT. Further studies are merited.
Back to 2015 Cardiac Track Program Overview