In vitro evaluation of valve-in-valve combinations using a SAPIEN XT valve implanted within PERIMOUNT and Magna Ease pericardial bioprostheses.

Abstract

Implantation of a transcatheter heart valve to treat valve failure is an attractive option which is being used more frequently. Despite large clinical experience there is a paucity of in vitro data to support this treatment. Our aim was to provide in vitro performance data on the SAPIEN XT transcatheter heart valve implanted within two types of pericardial surgical heart valve. A SAPIEN XT was implanted within multiple sizes, i.e., 21, 23, 25 of Magna Ease and explanted calcified PERIMOUNT valves. Each combination underwent in vitro testing according to the ISO 5840 guidance. Combinations were evaluated for embolisation and acute and long-term haemodynamic performance. All combinations met the ISO 5840 minimum requirements for effective orifice area (EOA) and regurgitant fraction at the initiation of the study, after 20 million and 200 million cycles. EOA was above 1.4 cm2 for all valve combinations with Magna Ease and above 1.22 cm2 with PERIMOUNT combinations. Regurgitant fraction was ≤7% for SAPIEN XT-Magna Ease combinations and was ≤10% for SAPIEN XT-PERIMOUNT combinations, which also met the ISO requirements. No embolisation was observed. The largest migration was 1.2 mm. In vitro tests demonstrate excellent haemodynamic performance and durability in the six VIV combinations which are commonly seen in clinical practice.