a.SAPIEN

The SAPIEN (Edwards Lifesciences, Irvine, CA, USA) is a triple-leaflet bovine pericardium valve initially designed for aortic valve replacement in patients with severe aortic stenosis. The first off-label use of the SAPIEN XT in the IVC was published in 2013 in three patients [59]. After that initial experience, this technique was tested in a randomized controlled trial that included 28 patients comparing medical treatment versus percutaneous implantation of this valve in the IVC. The main endpoint of the trial was the exercise capacity evaluated by cardiopulmonary exercise test. Nevertheless, this study had to be suspended prematurely due to futility and to the recording of numerous complications in the device group [60]. The analysis of available data evidenced a systolic decrease in the hepatic vein flow, without reverse RV remodeling [61]. In a recent retrospective multicenter registry enrolling 25 patients with severe symptomatic TR undergoing heterotopic TTVI (72% SAPIEN XT/3, 24% TRICVALVE and 4% DIRECTFLOW) in the IVC (76%) or both VC (24%), the procedure was successful in 96% of the patients although in-hospital mortality was 16% [62].
