Do valved stents compromise coronary flow?☆

Abstract
Objective: The aim of the present study is to evaluate a new self-expanding valved stent design for minimal invasive aortic valve implantation and its interference with coronary flow. Methods: An equine pericardial valve mounted onto a self-expanding nitinol stent (3F Therapeutics™, CA, USA), outer diameter 23 mm, was evaluated (A) in vitro in a dynamic pulsatile mock loop and (B) in vivo in six calves (75±2.5 kg). In four animals valve stents were implanted on-pump and in two animals off-pump after induction of ventricular fibrillation. Target site for deployment was the orthotopic aorta, over the native valves. In vivo assessment was performed with intracardiac (AcuNav™) and intravascular ultrasound including leaflet motion, planimetric valve orifice and residual-coronary\sinus-stent-index (RCSSI, distance stent to aortic wall/coronary diameter) calculations, coronary blood flow characteristics, transvalvular gradient, regurgitation and paravalvular leaking, in combination with continuous cardiac output measures. Macroscopic analysis was performed at necropsy. Results: Two-dimensional intracardiac ultrasound showed good leaflet motion, with full valvular opening and closing in five of six valves. Planimetric valve orifice was 1.75±0.4 cm2. There were no signs of coronary flow impairment with an RCSSI of 1.8±1.2. The implanted valved stents showed a low transvalvular gradient of 5.3±3.9 mmHg (mean, peak-to-peak) on invasive measurements and 4.7±2.5 mmHg in two-dimensional intracardiac sonography. One of six valves showed mild to moderate regurgitation and one of six valves a minor to moderate paravalvular leak due to size mismatch. Conclusions: This new self-expanding valved stent design allows for on- and off-pump aortic valve implantation in the orthotopic aorta, over the native valves without interference of the coronary blood flow and excellent acute valve function in properly sized devices.