Acute Kidney Injury Genomics and Biomarkers in TAVR Study
Acute Kidney Injury Genomics and Biomarkers in TAVR Study
In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly
 utilized alternative procedure for replacing a stenotic aortic valve. This study collects
 clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in
 order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR
 and to identify key clinical and procedural predictors of AKI. This study seeks to identify
 blood and urine biomarkers that can be used for early detection of AKI around the time of the
 procedure. The study seeks to assess for novel genetic variants associated with development
 of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and
 biomarkers that are associated with adverse cardiovascular events after TAVR and to further
 explore how these events may inter-relate with acute kidney injury.
This study enrolls patients who have aortic stenosis who undergo TAVR at the University of
 Texas Southwestern Medical Center University Hospital. Development of post-TAVR AKI defined
 according to the Kidney Disease: Improving Global Outcomes (KDIGO) SCr based and urine output
 based criteria will be ascertained. Patients will be followed during primary hospitalization
 and during the 5 years following TAVR for adverse kidney outcomes as well as potentially
 related adverse cardiovascular outcomes. Clinical and procedural data is collected for each
 study patient. All subjects will have paired blood and urine collection done pre-TAVR, 6
 hours after aortic valve prosthesis deployment, and on post-procedure days 1 and 2. Subjects
 who develop AKI will also have paired blood and urine samples collected on days 3, 4 and 5.
 Patients receive follow-up questionnaires by mail or email asking about hospitalizations as
 well as visits to cardiology, nephrology and primary care physicians. Questionnaires will
 also ask about health-related quality of life using validated study questionnaires. Patient
 follow-up will occur at regular intervals until 5 years after TAVR procedure.
Inclusion criteria: Subjects are eligible to participate if they are undergoing TAVR for
 aortic stenosis at the University of Texas Southwestern Medical Center.

 Exclusion Criteria:

 1. The patient cannot or will not provide informed consent.

 2. The patient is aged less than 18 years.

 3. The patient's pre-procedural hematocrit is less than 25%.

 4. The patient has known hepatitis C and/or human immunodeficiency virus infection

 5. In the opinion of the principal investigator, the patient will be unlikely to complete
 long-term follow up for medical or social reasons.