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Authors:
Thorsten Wahlers, Parvis Rahmanian, Georg Langebartels, Jens Wippermann and Axel Haverich on behalf of the European Study group

Objectives:
Cross-clamp and cardiopulmonary bypass time reduction may be of benefit for patients undergoing aortic valve replacement. The current study reports on the evaluation, early performance, and initial clinical outcome of a novel rapid-deployment aortic valve replacement (RD-AVR) system using a minimally invasive approach.
Methods:
RD-AVR was performed in a single center in Cologne, Germany and 14 patients ( mean age 79 years, age range 74-83, STS score 8+-8) were treated for aortic stenosis in a prospective, single-arm, ethics committees- approved investigational trial embedded in nationwide trial currently investigating 153 pts. RD-AVR was performed via sternotomy using conventional aortic cross-clamping and extracorporeal circulation in pts with severe aortic stenosis. Valve implantation was done through a transverse aortotomy with native leaflet excision and annular debridement, followed by supra-annular positioning of the valve using a rapid balloon delivery system and three guiding sutures. Once positioned, valve fixation is achieved by frame expansion using the balloon catheter prior to aortotomy closure.
Results:
The single center clinical outcome experience resulted in very short aortic cross clamp times for AVR and AVR plus CABG of 48+-37 min , respectively. Mean bypass times were 75+-54 min, respectively. Operative mortality on all patients was 1/11 and the procedural success was 13 out of 14. Follow up of performance on this cohort of patients is ongoing and will be presented and compared to nationwide trial results.
Conclusions:
The implantation of this novel rapid deployment aortic valve system demonstrates a reproducible procedure with excellent short-term results. RD-AVR is a new promising technology that can facilitate minimally invasive and small incision surgery for aortic valve replacement.