Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

Composite measure of all-cause death, any stroke, VARC-3 type 1 (only overt bleeding that requires a transfusion of 1 unit of whole blood/red blood cells (BARC 3a), type 2 and 3 bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or reintervention for aortic valve dysfunction.

Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)

Proportion of participants classified as "green cases" (redo-TAVR or ViV-TAVR feasible without leaflet modification) based on predefined CT scan criteria, including annular dimensions, coronary access, and valve frame interactions.

Number of participants who experience all-cause mortality at each follow-up time point.

Number of participants with any stroke (ischemic or hemorrhagic) as defined by clinical assessment and imaging confirmation.

Number of participants experiencing bleeding events classified as VARC-3 type 1 (BARC 3a), type 2 and 3.

• Scoring System: Valve Academic Research Consortium (VARC) scale:
• 1

• Overt bleeding not requiringing surgical or percutaneous intervention, but requiring medical intervention, leading to hospitalization, an increased level of care, or medical evaluation
• Overt bleeding requiring a transfusion of 1 unit of whole blood/RBC
• 3

• Overt bleeding in a critical organ, such as intracranial, intraspinal, intraocular, pericardial or intramuscular with compartment syndrome
• Overt bleeding causing hypovolemic shock or severe hypotension
• Overt bleeding requiring reoperation, surgical exploration, or re-intervention for the purpose of controlling bleeding
• Post-thoracotomy chest tube output ≥2 L within 24-h
• Overt bleeding requiring a transfusion of ≥5 units of whole blood/RBC
• Overt bleeding associated with a haemoglobin drop ≥5 g/dL
• Higher scores indicate worst outcomes

Number of participants with acute kidney injury (AKI) stage 2-4 based on VARC-3

• Scale Information: AKI from Valve Academic Research Consortium 3 (VARC-3):

• Scoring System:
• Stage 1: AKI that fulfils at least one of the following criteria:
• Increase in serum creatinine ≥150-200% (≥1.5-2.0x increase) within 7 days compared with baseline
• Increase of ≥ 0.3mg/dL (≥26.4 μmol/L) within 48 h of the index procedure

o Stage 2: AKI that fulfils the following criterion:

• Increase in serum creatinine >200-300% (>2.0-3.0x increase) within 7 days compared with baseline

o Stage 3: AKI that fulfils at least one of the following criteria:

• Increase in serum creatinine >300% (>3.0x increase) within 7 days compared with baseline
• Serum creatinine ≥4.0 mg/dL (≥354 μmol/L) with an acute increase of ≥0.5 mg/dL (≥44 μmol/L)

• Stage 4: AKI requiring new temporary or permanent renal replacement therapy
• Interpretation: Higher stages indicate more severe kidney injury

Number of participants requiring rehospitalization due to procedure-related complications.

Number of participants requiring reintervention (redo-TAVR, SAVR, or valve explantation) due to aortic valve dysfunction.

Number of participants in whom redo-TAVR is deemed feasible based on CT scan evaluation.

Feasibility will be assessed using predefined anatomical criteria, including:

Annular dimensions Coronary access Valve frame interactions Need for leaflet modification techniques Feasibility will be categorized as: "Feasible without modification," "Feasible with modification," or "Not feasible.

Number of participants who require a new permanent pacemaker implantation (PPI) within 1 month post-procedure due to conduction system disturbances (e.g., high-degree atrioventricular block, left bundle branch block).

Indications for PPI will be based on standard clinical guidelines.

Number of participants experiencing major vascular complications within 1 month post-procedure, as defined by VARC-3 criteria.

o Scoring System: Valve Academic Research Consortium-3 (VARC-3) criteria o Definition: MAJOR vacular complication: One of the following:

• Aortic dissection or aortic rupture • Vascular injury or compartment syndrome resulting in death,VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment • Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible end-organ damage • Unplanned endovascular or surgical intervention resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment • Closure device failure resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment

Mean and peak aortic valve gradients (mmHg) will be measured by transthoracic echocardiography (TTE) at each follow-up time point.

Values will be reported as mean ± standard deviation (SD).

Number of participants stratified by paravalvular leakage (PVL) grade (None, Mild, Moderate, Severe), as assessed by TTE.

PVL severity will be determined based on echocardiographic parameters defined by the VARC-3 criteria.

Effective orifice area (EOA) (cm²) measured using the continuity equation on TTE.

Values will be reported as mean ± standard deviation (SD).

Number of participants experiencing significant structural valve deterioration (SVD) as defined by VARC-3 criteria.

SVD will be assessed by transthoracic echocardiography (TTE) Number of participants requiring redo-TAVR or surgical valve explantation within 5 years and 10 years post-procedure.

Proportion of participants in whom redo-TAVR or ViV-TAVR is feasible, with or without requiring leaflet modification techniques, based on CT scan evaluation. Classification will be based on predefined anatomic and hemodynamic feasibility criteria.

Number of participants with HALT detected on CT scan in both TAVR and SAVR groups. HALT will be defined as the presence of hypo-attenuated leaflet thickening observed on post-procedure CT imaging.

• Outcome Measure: Mean change in mean transvalvular gradient (mmHg) in participants with and without HALT, measured by transthoracic echocardiography (TTE).
• Time Frame: 1 month post-procedure
• Unit of Measure: mmHg
• Interpretation: A higher mean transvalvular gradient suggests increased valve obstruction.

• Outcome Measure: Mean change in peak transvalvular gradient (mmHg) in participants with and without HALT, measured by transthoracic echocardiography (TTE).
• Time Frame: 1 month post-procedure
• Unit of Measure: mmHg
• Interpretation: A higher peak transvalvular gradient indicates greater hemodynamic burden on the valve.

• Outcome Measure: Mean change in effective orifice area (cm²) in participants with and without HALT, measured by transthoracic echocardiography (TTE).
• Time Frame: 1 month post-procedure
• Unit of Measure: cm²
• Interpretation: A lower EOA suggests impaired valve opening and increased risk of stenosis.

• Outcome Measure: Mean transvalvular gradient (mmHg) measured by TTE post-implantation.
• Time Frame: 1 month post-procedure
• Unit of Measure: mmHg
• Interpretation: Higher gradients indicate increased obstruction.

• Outcome Measure: Peak transvalvular gradient (mmHg) measured by TTE post-implantation.
• Time Frame: 1 month post-procedure
• Unit of Measure: mmHg
• Interpretation: Higher peaks indicate more severe stenosis.

• Outcome Measure: Effective orifice area (cm²) measured by TTE post-implantation.
• Time Frame: 1 month post-procedure
• Unit of Measure: cm²

Mean commissural misalignment angle (degrees) measured by CT scan to evaluate THV positioning relative to native aortic valve commissures.