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

Objectives: This comparative case-matched analysis investigated feasibility and safety of direct transfemoral (TF) transcatheter aortic valve implantation (TAVI) without pre-dilatation using balloon-expandable devices.

Background: Presently, balloon aortic valvuloplasty (BAV) is considered mandatory preceding transfemoral TAVI with balloon-expandable devices. However, procedural severe adverse events may be associated with BAV.

Methods: 26 consecutive patients (study group) received direct TF-TAVI using Edwards Sapien XT (n = 17) or Sapien 3 (n = 9) devices (61.5% female, 81.3 ± 6.3 years, logEuroSCORE I 15.3 ± 13.2%). A control group of patients after conventional TF-TAVI was retrieved from our database containing 1153 TAVI patients and matched to the study group regarding baseline and procedural data. Data reporting adheres to VARC-2 definitions.

Results: Device success was 96.2% (25/26) and 92.3% (24/26) in study and control groups, respectively (p = 1.00). Procedure time (60.0 ± 54.0 vs. 70.0 ± 29.1 min; p = 0.41), fluoroscopy time (13.3 ± 5.8 vs. 17.8 ± 6.9 min; p = 0.01) and amount of contrast agent (118.7 ± 47.9 vs. 153.0 ± 53.2 ml; p = 0.02) were lower in the study group. All-cause 30-day mortality was 7.7% (2/26) in both groups, disabling stroke was observed in 3.8% (1/26) and 7.7% (2/26) in study and control groups, respectively. Resultant transvalvular mean gradient and effective orifice area (EOA) were 11 ± 5 vs. 11 ± 5 mmHg and 1.6 ± 0.3 vs. 1.5 ± 0.3 cm(2). Paravalvular leakage ≥ grade II was observed in 0 and 7.7% (2/26; p = 0.49).

Conclusions: TF-TAVI without pre-dilatation was feasible and safe in this consecutive series of patient regardless of aortic valve morphology, for example. extent of valvular calcification or baseline EOA. This technique resulted in significantly lower fluoroscopy times and amounts of contrast agent while yielding non-inferior hemodynamic and clinical outcome.