Paravalvular aortic regurgitation (PAR) after TAVR has been associated with increased mortality. The Sapien 3 device (Edwards Life-sciences) is different than the prior devices released by the same manufacturer in that it has a skirt designed to prevent paravalvular leak, improved coaxial alignment, and more accurate positioning.

To evaluate paravalvular aortic regurgitations after 30-day after TAVI using the Edwards SAPIEN 3 prosthesis.

Prospective monocentric study including 66 high-risk or non-operable patients with severe aortic stenosis undergoing TAVI using Edwards SAPIEN 3 prosthesis via transfemoral access, between September 2014 and March 2015.

Mean age of patient was 84±7,1 years (70% female). The MDCT estimated an aortic annular diameter 25,07±2mm. Mean logistic EuroSCORE was 15,8±10,8. In our study, the device success rate was 98.5%. The pros-thesis has been deployed correctly in all cases and no failure of valve or embolization had occurred. Post TAVR, mean transaortic gradient decreased from 46,0±12,33mmHg to 8,2±3,37mmHg (p<0.001). No patient had moderate or severe PAR. At 30 days follow up, transthoracic echocardiography (TTE) showed that the PAR was absent or trivial in 66% of patients and mild in the remainder. Possible reasons for this low PAR rate include: 1) the outer polyethylene terephthalate sealing cuff, which enhances paravalvular sealing; 2) more accurate positioning; and 3) improved sizing with adjunctive MDCT.

In our study, TAVI with Edwards SAPIEN 3 demonstrated lower paravalvular aortic leak rates than earlier generation devices in patients at high risk for surgery.