Transfemoral TAVI without pre-dilatation using balloon-expandable devices: a case-matched analysis

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Balloon aortic valvuloplasty (BAV) is typically mandatory before transfemoral TAVI with balloon-expandable devices.
• BAV may be associated with severe procedural adverse events.

Purpose of the Study:

• To investigate the feasibility and safety of direct transfemoral (TF) TAVI without pre-dilatation using balloon-expandable devices.
• To compare outcomes of direct TF-TAVI without pre-dilatation versus conventional TF-TAVI.

Main Methods:

• A case-matched analysis comparing 26 patients undergoing direct TF-TAVI without pre-dilatation to a control group of 1153 patients who had conventional TF-TAVI.
• Study devices included Edwards Sapien XT and Sapien 3.
• Data reported according to VARC-2 definitions.

Main Results:

• Device success rates were high and comparable between groups (96.2% vs. 92.3%).
• The direct TF-TAVI group showed significantly lower procedure time, fluoroscopy time, and contrast agent volume.
• 30-day all-cause mortality and disabling stroke rates were similar between groups.

Conclusions:

• Direct transfemoral TAVI without pre-dilatation is a feasible and safe alternative.
• This technique offers reduced procedural radiation and contrast exposure.
• Hemodynamic and clinical outcomes are non-inferior to conventional TF-TAVI.