Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation

Time to mobilization

Time to first mobilization in minutes after procedure; mobilization is defined as walking short distances on the patients room or on the corridor. Transfers between bed and chair are not measured as mobilization.

Time frame: "during index hospitalization, approximately 3 days - often hours after TAVI procedure"

Total duration of hospitalization

Duration of index hospitalization in days.

Time frame: "during index hospitalization, approximately 3 days"

Composite endpoint of all clinically relevant bleeding of the access sites; either diagnostic or pacemaker access site or primary (TAVI) access site

Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding of either the diagnostic access, pacemaker access or primary (TAVI) access.

Time frame: "Through 30 days"

Clinically relevant bleeding not related to the randomized access sites

Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding not related to the diagnostic access or pacemaker access.

Time frame: "Through 30 days"

All-cause mortality

Deaths within the first 30 days after procedure from any cause.

Time frame: "30 days"

All stroke

All cerebrovascular accidents within the first 30 days after procedure.

Time frame: "30 days"

Valve Academic Research Consortium-3 (VARC) type 2-4 bleeding

Bleeding criteria following the VARC-3 criteria. Type 2 bleeding is classified as bleeding requiring transfusion. Type 3 bleeding is defined as bleeding in a critical organ, causing hypovolemic shock, requiring reoperation or significant transfusion. Type 4 bleeding is defined as overt bleeding leading to death.

Time frame: "30 days"

Major vascular, access-related, or cardiac structural complications

Major vascular complications: * Aortic dissection or aortic rupture. * Vascular (arterial or venous) injury, unplanned endovascular or surgical intervention, closure device failure, distal embolization or compartment syndrome resulting in death, VARC type ≥ 2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment. Major access-related complications: • Non-vascular structure, non-cardiac structure perforation, injury, or infection resulting in death, VARC type ≥ 2 bleeding, irreversible nerve injury or requiring unplanned surgery or percutaneous intervention Major cardiac structural complications: • Cardiac structure perforation, injury, new pericardial effusion, coronary obstruction or compromise resulting in death,VARC type ≥ 2 bleeding, haemodynamic compromise or tamponade, or requiring unplanned surgical or percutaneous intervention.

Time frame: "30 days"

Acute kidney injury stage 3 or 4

All cases of acute kidney injury stage 3 or 4 within 30 days after procedure.

Time frame: "30 days"

Moderate or severe aortic regurgitation

All cases of moderate or severe aortic regurgitation within 30 days after procedure.

Time frame: "30 days"

New permanent pacemaker due to procedure-related conduction abnormalities

All permanent pacemaker placements in the first 30 days after procedure due to procedure-related conduction abnormalities.

Time frame: "30 days"

Surgery or intervention related to the device

All cases of surgery or interventions related to the device within 30 days after procedure.

Time frame: "30 days"