Implantation of an “undersized” prosthesis has been proposed as a major cause of moderate to severe para-valvular AR after transcatheter aortic valve implantation (TAVI). We evaluated the impact of a prospective and systematic “oversizing” implantation policy of the EDWARDS-SAPIEN prosthesis on para-valvular aortic regurgitation (AR) inconsecutive patients.

To grade AR, 2D transthoracic echocardiography was performed before, before discharge and 1 month after the procedure. Aortic annulus diameter was measured by TEE at baseline. The “oversizing” policy was defined as the following: 1) Patients with an annulus > 24mm during the screening were excluded from TAVI; 2) A 26mm prosthesis was used in all patient with an annulus >21mm and the TA approach could be preferred when appropriate; 3) in patients with an annulus 21mm, a 26mm prosthesis was also used every time the predilatation with a 23mm balloon suggested that the largest prosthesis could be accommodated.

A 26mm prosthesis was used in 16/22 (73%) and a 23mm prosthesis in 6/22 (27%). “Oversizing” as estimated by the cover index (100x [prosthesis diameter – annulus diameter by TEE/prosthesis diameter]) was 12.4±4.3%.

At baseline the mean annulus diameter was 22.0±1.3 and a significant AR was observed in 9/22 patients (41%). It was mild, moderate or severe respectively in 5 patients (23%), 3 patients (13%) and 1 patient (5%). AT 1 month followup a significant AR was observed in 5/18 patients (27%). It was mild, moderate or severe respectively in 5 patients (27%), 0 patient (0%) and 0 patient (0%) all cases. Only mild ARs appeared at 1 month in 5 out of the11 patients with no AR at baseline.

Using a systematic “oversizing” policy resulted in no moderate to severe AR after 1 month follow-up. These data provide additional support to the concept that systematic “oversizing” of the Edwards-SAPIEN valve is an important safety measure.