First-In-Man New Approach for Direct Aortic TAVI 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 designed to provide access to aorta from a short incision in the neck for direct aortic TAVI. The aim is to provide all the advantages of Direct Aortic (DA) TAVI without the pain associated with chest incisions currently used to perform DA-TAVI i.e. mini-sternotomy and mini-thoracotomy.
METHODS: Two patients with critical aortic stenosis (STS risk 11.2% and 6.7%) were selected for TAVI using the new DA approach. A 5-6 cm incision was made in the skin crease similar to transcervical thymectomy (TCT); the device was introduced and sternum elevated; dissection was directed under the sternum to expose the aorta using illumination modes programmed into the device and on screen visualisation provided by the device. Having successfully exposed the aorta, a double purse string suture was placed in the aorta and DA TAVI performed in conventional fashion. Primary outcomes were evaluated according to the latest VARC criteria.
RESULTS: TAVI implantation using self expanding prosthesis was successful in both patients with absence of procedural or peri-procedural mortality, correct positioning of a single valve prosthesis in the proper anatomical location and intended performance of the prosthetic heart valve (no prosthesis-patient mismatch, mean aortic valve gradients of 7mmHg and 4mmHg with no aortic regurgitation in either case). Patients were extubated on the table and experienced little or no pain after the procedure. Both patients were discharged after surgery in sinus rhythm without need for pacemaker. Follow up at 30 days showed no significant change in haemodynamic performance.
CONCLUSIONS: This novel device system provided direct access to the aorta for TAVI to be performed successfully. Exposure of the aorta without chest incision should make for swift recovery and early discharge from hospital similar to transfemoral TAVI or other cardiothoracic procedures performed via this route, such as TCT.
|Patient||Implant size||Mean gradient post procedure||Evidence of paravalvar leak||Pacemaker requirement|
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