Mechanical Performance of Two Left Atrial Appendage Occlusion Systems: In Vitro Comparison of Tug Force, Radial Force, Sealing and Deformation

Ann Biomed Eng. 2018 Sep;46(9):1337-1347. doi: 10.1007/s10439-018-2057-z. Epub 2018 May 24.

Abstract

The aim of this study was to establish in vitro bench-tests of left atrial appendage occlusion (LAAo) devices regarding tug force, radial force and sealing capacity. Two LAAo devices, namely the WATCHMAN™ and the Occlutech®, of three different sizes underwent testing in novel dedicated in vitro setups. Radial force was assessed in a commercial radial force tester. At baseline, tug force of the WATCHMAN™ was significantly higher when compared to Occlutech® for all devices. Repeated resheathing resulted in a reduction of device-diameter in the WATCHMAN™ devices of max. 7.9%, whereas diameters of Occlutech® occluders remained unchanged. Tug force was not significantly impacted by resheathing in both devices. At baseline, sealing capacity in a bench-test using silicone LAA-models did not differ between the devices. Resheathing lead to an in vitro loss of sealing capacity of the WATCHMAN™ devices, increasing with resheathing and resulting in a max. peridevice leak of 91.1 ± 7.9%. Radial force was higher for the Occlutech® devices and decreased for WATCHMAN™ occluders after resheathing. The WATCHMAN™ occluder series showed progressive deformation, increased peridevice leakage and decreased radial force after resheathing, presumably as a result of diameter reduction. Tug force of the WATCHMAN™ was not impaired by resheathing and was significantly higher than that of the Occlutech® device.

Keywords: In vitro testing; LAA occlusion; Left atrial appendage; Peridevice leak; Radial force; Tug test.

MeSH terms

  • Animals
  • Aorta / surgery
  • Atrial Appendage / surgery*
  • Cattle
  • Equipment Design
  • Septal Occluder Device*