One-year echocardiographic outcomes of transcatheter aortic valve implantation with or without predilatation of the aortic valve: insights from the multicenter, randomized DIRECT trial

Abstract Introduction Transcatheter aortic valve implantation (TAVI) has become the standard of care for high-risk and inoperable surgical patients and a valid alternative in intermediate-risk patients with severe aortic stenosis.The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation 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. Purpose To compare the one year echocardiographic findings among patients, who underwent TAVI using a self-expanding valve with or without BAV. Methods A total of 171 patients with severe aortic stenosis were randomly assigned at 4 tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). Follow up transthoracic echocardiography was performed 1 year after TAVI. Results Of 171 patients, 86 patients were randomized to pre-BAV group and 85 to no-BAV group. One year echocardiographic follow up was available in 146 patients. In one year follow up there was no significant difference between pre-BAV and no-BAV group in aortic valve area (1.84±0.39cm2 vs. 1.85±0.44cm2, p=0.79), peak aortic valve gradient (15.95±9.97 mmHg vs. 14.51±6.60 mmHg, p=0.35), mean aortic valve gradient (8.37±5.01 mmHg vs. 7.99±4.04 mmHg, p=0.64), aortic valve peak velocity (1.90±0.51 m/s vs. 1.80±0.42m/s, p=0.24), ejection fraction (54.19±8.36% vs. 53.19±9.58%, p=0.52) and pulmonary artery systolic pressure (41.86±14.34 mmHg vs. 40.71±12.40 mmHg, p=0.64). The incidence of moderate or severe paravalvular regurgitation (PVL) in 1 year follow up was 6.2% without significant difference between the 2 study groups (5.7% in the no-BAV group vs. 6.6% in the pre-BAV group, p=0.83). Conclusions Direct transcatheter aortic valve implantation has no impact on one-year prosthesis function and PVL in patients undergoing TAVI with self-expanding valve Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic