LAUSR

The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation (TAVI) Trial) was a multicenter, randomized, clinical trial designed to evaluate the safety and efficacy of TAVI with or without balloon aortic valvuloplasty (BAV) in patients with symptomatic, severe aortic valve stenosis. To investigate by echocardiography the functional changes of self-expanding prosthetic valves during the first year after TAVI with or without BAV. One hundred seventy one consecutive patients with severe aortic stenosis were enrolled at 4 centers and randomized to TAVI using self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). Transthoracic echocardiography was obtained at baseline, 30 days and 1 year after TAVI. Of 171 patients, 86 patients were randomized to pre-BAV group and 85 to no-BAV group. Over the one year, 7 (4%) patients died and in 18 (10%) there was no available paired 30 day/1 year echo. At baseline echocardiography the peak and mean aortic valve gradient and the aortic valve area (AVA) in no-BAV group were 77.31±22.56 mmHg, 47.23±14.98 mmHg and 0.69±0.16cm2 and in pre-BAV group 81.97±23.17 mmHg, 49.39±14.78 mmHg and 0.65±0.15cm2 respectively. One year after TAVI, patients in no-BAV and pre-BAV group showed stable peak and mean aortic valve gradients similar to those at 30 days (from 16.36±7.88 to 14.51±6.6 mmHg vs. 17.17±8.88 to 15.95±9.97 mmHg and from 8.87±4.23 to 7.99±4.04 mmHg vs. 9.39±4.79 to 8.38±5.02 mmHg respectively, P<0.001 vs. baseline). The AVA was similarly stable in one year follow up in no-BAV group (from 1.85±0.43cm2 to 1.85±0.44cm2, P<0.001 vs. baseline) and in pre-BAV group (from 1.86±0.49cm2 to 1.84±0.39cm2, P<0.001 vs. baseline). The incidence of moderate or severe paravalvular regurgitation remained unchanged in both groups (from 4.7% to 5.7% in no-BAV group and from 5.8% to 6.6% in pre-BAV group). In both pre-BAV and no-BAV groups the improvement in hemodynamics of self-expanding prosthetic valves remained durable during the one year echocardiographic follow up assessment. Type of funding source: Private company. Main funding source(s): MEDTRONIC