Feasibility of transcatheter aortic valve implantation without balloon pre-dilation: a pilot study.

OBJECTIVES: The purpose of this pilot study was to evaluate the feasibility and safety of transcatheter aortic valve implantation (TAVI) without balloon pre-dilation.

BACKGROUND: Balloon pre-dilation of the stenosed aortic valve is currently believed to be a necessary step for valve preparation before device placement in patients undergoing TAVI and, therefore, is considered an obligatory part of the procedure. However, clear evidence supporting this policy is lacking. In contrast, pre-dilation might be responsible in part for distal embolizations as well as atrioventricular conduction disturbances seen during TAVI procedures.

METHODS: A total of 60 consecutive patients (mean age 80.1 ± 6.4 years, 53% female, mean logistic EuroScore 23.3 ± 15.2%) undergoing TAVI using the self-expanding Medtronic CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) have been prospectively enrolled at 13 international centers.

RESULTS: Pre-procedural mean transaortic valve gradient was 47.8 ± 15.5 mm Hg, mean effective orifice area was 0.67 ± 0.15 cm(2). Technical success rate was 96.7% (58 of 60) of patients. Post-dilation was performed in 16.7% (10 of 60) of patients. Post-procedural mean valve gradient was 4.4 ± 2.0 mm Hg. Circular and noncircular valve configuration was present in 41 and 19 cases (68.3% vs. 31.7%), respectively, with similar effective orifice areas (1.74 ± 0.10 cm(2) vs. 1.71 ± 0.22 cm(2), p = NS). In-hospital mortality, myocardial infarction, stroke, and major vascular complications occurred in 6.7% (4 of 60), 0%, 5%, and 10% of patients. There was no valve embolization. New permanent pacing was needed in 11.7% (7 of 60) of patients.

CONCLUSIONS: Transcatheter aortic valve implantation without balloon pre-dilation is feasible and safe, resulting in similar acute safety and efficacy as the current standard approach of TAVI with pre-dilation.