Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Study Overview
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Brief Summary
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Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes. There is no consensus on the optimal transfusion strategy after bleeding. The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events.

Detailed Description
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Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis. Therefore, red blood cell (RBC) transfusion is often required, although it is associated with worsened outcomes. There is no consensus on the optimal transfusion strategy after bleeding: among patients undergoing cardiac surgery, the Transfusion Requirements in Cardiac Surgery (TRICS) III trial documented that a restrictive RBC transfusion strategy (if hemoglobin level was <7.5 g/dl) was noninferior to a liberal approach (if hemoglobin level was <9.5 g/dl) with respect to the composite occurrence of death, myocardial infarction (MI), stroke, or new-onset renal failure with dialysis. The Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) will be a multicenter retrospective registry enrolling consecutive patients who underwent TAVI; the primary aim of the study will be to test whether RBC transfusion is a marker or an independent predictor of adverse events. Patients will be stratified according to their lowest hemoglobin value (>9.5 g/dl, 7.5-9.5 g/dl and <7.5 g/dl) and to whether they received or not periprocedural RBC transfusion. The primary endpoint will be the 30-day occurrence of major adverse cardiovascular events (MACE), as death, myocardial infarction (MI), stroke, or acute kidney injury (AKI, as absolute increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours).

Official Title
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Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study

Conditions
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Transcatheter Aortic Valve Implantation (TAVI), Blood Transfusion, AKI, Prognosis, Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Blood Transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing transcatheter aortic valve implantation (TAVI) Exclusion Criteria: age<18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transfusion<br>Patients requiring blood transfusion after transcatheter aortic valve implantation (TAVI) | Procedure: Blood Transfusion<br>* Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)<br>|
| No Transfusion<br>Patients not requiring blood transfusion after transcatheter aortic valve implantation (TAVI) | Procedure: Blood Transfusion<br>* Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | all-cause death, myocardial infarction (MI), stroke, or acute kidney injury (AKI) | 30 days and end of follow-up (3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | all-cause death, cardiovascular death, non cardiovascular death | 30 days and end of follow-up (3 years) |