Decreased device related thrombus and enhanced neo-endocardial tissue maturation with a new generation left atrial appendage closure (LAAC) device. An anticoagulation and antiplatelet free canin study

Abstract

Abstract Introduction Device related thrombus (DRT) has been reported in up to 7% of patients post LAAC even while on anticoagulation. Clinical predictors of DRT are poorly understood and may be related to patient, procedural and device factors. A next generation WATCHMAN LAAC device (NG) is identical in shape and geometry to the current WATCHMAN FLX device (CW) but has a device coating designed to make it hemocompatible and less thrombogenic. Objective To evaluate the incidence and burden of WM surface thrombus formation as detected longitudinally by TEE and at necropsy in a canine model implanted with the NG device. Methods The study included 12 canine (6 implanted with CW and 6 implanted with NG) that underwent serial TEE follow up at 14, 28 and 45 days to evaluate surface thrombus on WM face. This was a challenged canine model designed to induce thrombus with no anticoagulation or antiplatelet use throughout the study. D-dimer levels were measured at 7 days and 45 days and compared to baseline measurements. Results All devices were successfully implanted. TEE follow up at 14 days showed noticeably reduced thrombus burden on the NG device compared to CW (fig.1) with even further diminution by 28 days in the NG (6/6) as compared to only in 1/6 in the CW group (fig.2). After 45 days in-life, the post-fixation trim en-face images show a smooth, glistening neoendocardial covering (absence of acute thrombus material) in all (6/6) NG compared to only 2/6 in the CW (fig.3). The CW had 3/6 devices with exuberant, bulging calcified thrombus mass one of which was considered to be a mobile DRT. D Dimer levels at 7 and 45 days were significantly lower relative to baseline in the NG compared to CW. Conclusion The NG device compared to the CW device was associated with markedly less thrombus formation at 14 days and no thrombus formation at 28 days post implant on no anticoagulant and no antiplatelet therapy along with a more mature uniform tissue coverage at 45 days. The WATCHMAN FLX Pro device coating is a promising step to reduce DRT even without the use of anticoagulation and antiplatelets and merits further investigation in human studies. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Boston Scientific