1Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland; 2Universitätsmedizin Mainz Klinik für Diagnostische und Interventionelle Radiologie Mainz, Deutschland; 3Universitätsmedizin Mainz Klinik und Poliklinik für Herz- und Gefäßchirurgie Mainz, Deutschland
Introduction:
Leaflet thrombosis of the transcatheter aortic valve prosthesis can be observed in a small percentage of patients but represent a clinically relevant diagnosis. We here analysis the potential of anticoagulant therapy to reverse leaflet thrombosis.
Methods and results:
We searched our center’s database for all clinical apparent TAVR-thromboses (apparent by clinical hint and/or elevated gradients in follow-ups and proved by typical morphology of thrombosis in CT-scan) between 1/2018 and 7/23. Overall, 73 Patients (3.0% of the total cohort) were identified with apparent TAVR-thrombosis (43.8% females, mean age 80.2 +/- 6.8 years, mean EuroSCORE II 4.9 +/- 4.3, 4.1% Valve-in-Valve procedure). Of those, 47 had echocardiographic follow-up (in mean 100 +/- 85 days to follow-up) and entered the analysis. 27 (57%) were treated by NOAC, 17 (36%) by VKA, of those 20 (42%) combined to ASS or a P2Y12 inhibitor. We defined a group of echocardiographic “responders” in patients with a reduction in mean gradient over the TAVR-prosthesis of at least 20% at follow-ups compared to the echo at diagnosis of thrombosis.
60% of the patients (n=27) had a reduction of gradients by at least 20% at follow-up. While there were no significant differences in most baseline- and periprocedural parameters (e.g., female sex 37.0 vs. 38.9%, p>0.99, Euroscore II (2.8 (2.1/4.1) vs. 3.3 (1.5/7.7), p=0.660, renal impairment 92.6 vs. 77.8%, p=0.199, atrial fibrillation 3.7 vs. 22.2, p=0.141, tumor 14.8 vs. 27.8%, p=0.449, congenital/functional bicuspidy 34.6 vs. 18.8%, p=0.316, BE-Prosthesis 96.3 vs. 83.3%, p=0.286, Valve-in-Valve TAVR in 3.7 vs. 11.1%, p=0.555), patients with gradient-reduction were more likely to have lower intial levels of sPAP (32 (29/41) vs. 35mmHg (31/48), p=0.022) and bigger anatomies (minimal annulus diameter 21.3 (20.5/23.5) vs. 20.8mm (19.8/21.7), p=0.073, mean RC-height 19 (17/20) vs. 16mm (14/20), p=0.047).
Novel intake of OAC after diagnosis of TAVR-thrombosis was strongly associated with gradient-reduction (92.3 vs. 66.7%, p=0.048; OR=6.0 (1.1/34.3), p=0.044), while patients developing thrombosis despite pre-medication on OAC were overrepresented in the group of those without relevant gradient-reduction (96.3 vs. 72.2%, p=0.031). No statistically significant effect of an additional therapy with P2Y12-inhibitors (OR 1.16 (0.31/4.35), p=0.831) could be proven. Early diagnosis of thrombosis < 90 days post TAVR was strongly associated with gradient-reduction (OR 10 (1.9/52.3), p=0.006). No difference could be found when comparing VKA vs. DOAC as anticoagulant after diagnosis of TAVR-thrombosis (OR 1.1 (0.3/3.7), p=0.939).
Discussion and conclusion:
TAVR-thrombosis has a relevant rate patients not responding to anticoagulant therapy by relevant gradient-reduction, especially those developing thrombosis despite pre-medication of OAC. Early diagnosis of thrombosis and novel medication of OAC are strongly predictive for successful treatment, while no differences comparing VKA vs. DOAC and/or additional therapy with a P2Y12-inhibitor could be proven in this retrospective database.