Assessments of Thrombus Formation in TAVI

Kumamoto University23 enrolled

Overview

Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established. To establish the antithrombotic regimen in patients undergoing TAVI, 1. the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS). 2. the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Stenosis Heart Valve Diseases

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * twenty years and older * with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated) Exclusion Criteria: * withdrawn the informed consent * patients with trans-apical approach * critical illness condition (severe infectious disease, cancer, severe bleeding disorder) * transition to the surgical AVR

Outcomes

Primary Outcomes

Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI

To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.

Time frame: pre-, day 2, day 7, 1 month after device implantation

Secondary Outcomes

Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT

To measure the shear stress of aortic valve and aorta before and after TAVI by using CFD analysis of contrast-enhanced computed tomography (CT).

Time frame: pre-, day 7 after device implantation

Changes in von Willebrand factor multimer decrease

To measure the von Willebrand factor multimer decrease by using electrophoresis

Time frame: pre-, day 2 after device implantation

Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.

Time frame: within 30 days after device implantation