The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform. A TAVI procedure is a minimally invasive treatment for aortic stenosis, where a new heart valve is inserted through a blood vessel in the groin. During this procedure, a wire (specifically, an LV-guidewire) is used to place the new heart valve. For this purpose, a regular LV-guidewire or a newer LV-guidewire with extra features, the Savvywire, can be used. All of these wires work well, are safe, and are already used in daily medical practice. Researchers will compare these LV-guidewires to see if the Savvywire adds additional value. Patients aged 50 or older who undergo a TAVI procedure via the femoral artery (blood vessel in the groin) can participate. Participants will receive the usual care and standard follow-up, only their data will be collected and analyzed.
Patients are asked for consent after the TAVI procedure. Procedural data is therefore collected retrospectively, while standard follow-up data (3 months after the procedure) is collected prospectively.
Study Type
OBSERVATIONAL
Enrollment
300
Catharina Hospital Eindhoven
Eindhoven, North Brabant, Netherlands
RECRUITINGRegister which TAVI LV-guidewires are used in contemporary practice
Register which type of TAVI LV-guidewire is used during the TAVI procedure (SavvyWire, Safari, Confida etc).
Time frame: At enrollment
To register LV-aortic pressure gradients (mmHg) during each procedural step in the SavvyWire group.
With the SavvyWire, continuous hemodynamic pressure measurements can be performed during the procedure in the aorta and the left ventricle. Pressure measurements (mmHg) during the following procedural steps will be collected: baseline, pacing during predilatation, after predilatation, pacing during TAVI deployment, after TAVI deployment, after equilibration and drift check, after possibele postdilatation.
Time frame: Collected during TAVI procedure, extracted at enrollment
To correlate hemodynamic pressure gradient after each procedural step (predilatation, 80% TAVI deployment, postdilatation) to standard baseline CT assessment of valvular calcifications
Time frame: At enrollment
Performance of the SavvyWire as LV-guidewire for TAVI device placement
Based on: guidewire kink yes/no, procedural success, complications during and after TAVI procedure and after standard 3 months follow-up (vascular complication, coronary obstruction, conversion to sternotomy, pacemaker, cva, mortality)
Time frame: At enrollment + after 3 months of standard follow-up
Performance of the SavvyWire in hemodynamic guidance
Based on: succesfull hemodynamic registrations, drift check (delta between aortic pressure measurement of Savvywire and standard pigtail in aorta used during TAVI procedure), more postdilatation in Savvywire group compared to regular LV guidewire group.
Time frame: At enrollment
Pacing performance of the SavvyWire
Based on: pacing frequency, loss-of-capture, the need for RV pacing
Time frame: At enrollment
To investigate the potential streamlining effect of the SavvyWire on TAVI workflow
Based on: skin-to-skin time, total contrast volume (mL), amount of radiation exposure (total DAP, total Air Kerma)
Time frame: At enrollment
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