Case ReportBioprosthesis leaflet thrombosis following self-expanding valve-in-valve transcatheter aortic valve replacement in patient taking factor Xa inhibitor and warfarin: A case report☆
Introduction
Transcatheter aortic valve replacement (TAVR) is an effective treatment strategy for specific groups of patients with symptomatic severe aortic stenosis [1]. The minimally invasive technique provides an attractive alternative to surgical valve replacement. The safety of such procedure has been proven in multiple randomized clinical trials and now approved for commercial use in patients considered at intermediate risk for surgical aortic valve replacement (SAVR) [2]. Long-term follow-up data at 5 years from the PARNTER I trial demonstrated similar clinical outcomes to SAVR and valve durability based on 2-dimensional and Doppler echocardiographic imaging [3]. However, an association of reduced leaflet motion on routine computed tomography (CT) imaging and post-operative stroke was identified in a cohort of patients from the PORTICO IDE trial, raising questions about previously undescribed structural abnormalities or leaflet thrombosis in all bioprosthetic valves.
A subsequent observational study published in The New England Journal of Medicine in 2015 revealed a similar phenomenon of reduced leaflet motion in 40% of patients in the PORTICO IDE clinical trial and 13% of patients from two prospective registries [4]. In addition, there was a higher incidence of transient ischemic attack (TIA) or stroke in the pooled registry patients with restricted leaflet motion compared to those with normal leaflet motion. Normal leaflet motion was restored with appropriate warfarin therapy in all patients with follow-up imaging. More recently, prospective registry data reported an incidence of 13% in TAVR valves and 100% resolution with warfarin treatment [5]. The exact mechanisms, treatment, and overall clinical implications of this problem remain under investigation.
The development of subclinical leaflet thrombosis has raised concerns regarding the durability of transcatheter valves. Similarly, the patients receiving valve-in-valve treatment by transcatheter approach likely result in hemodynamics and thrombogenic properties that are not fully understood, resulting in another subset of patients requiring additional attention. The following case is an example of bioprosthetic leaflet thrombosis of a valve-in-valve self-expanding device in a patient on therapeutic oral anticoagulation in the form of a Factor Xa inhibitor.
Section snippets
Case presentation
The patient is an 87-year-old female with symptomatic severe aortic stenosis. Her initial screening echocardiogram demonstrated normal left ventricular size and function with estimated ejection fraction of 55–60%. Her mean aortic valve gradient was 45 mmHg with peak transvalvular gradient of 4.3 m/s and calculated aortic valve area of 0.8 cm2. There was concomitant severe eccentric mitral regurgitation and estimated pulmonary systolic pressure of 45 mmHg. Her medical history included permanent
Discussion
The case described above is unique in that it involves a patient who underwent sub-acute placement of a transcatheter valve-in-valve device and developed while on the oral anticoagulant apixaban leaflet thrombosis, which progressed while on warfarin. The initial discovery of reduced bioprosthetic leaflet motion and potential thrombosis in TAVR devices has led to amendments in current TAVR trial protocols and initiation of dedicated prospective studies to elucidate appropriate diagnostic and
Conclusion
Subclinical bioprosthetic leaflet thrombosis in TAVR patients is not completely understood. The case presented highlights the development of leaflet thrombosis in a patient with valve-in-valve self-expanding TAVR device that occurred while on oral anticoagulant factor Xa inhibitor. It is evident that more work is needed to define the true incidence of this phenomenon, the specific populations at risk, the clinical significance, appropriate diagnostic strategies, and the best management for
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Disclosures: Ron Waksman: Consultant: Abbott Vascular, Amgen, Biosensors International, Biotronik, Boston Scientific, Corindus, Lifetech Medical, Medtronic Vascular, Philips Volcano, Symetis; Speakers Bureau: AstraZeneca; Grant Support: Biosensors International, Biotronik, Boston Scientific, Edwards Lifesciences, Abbott Vascular.
The other authors do not have any conflicts to disclose.