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Few data is available comparing the latest generation Edwards SAPIEN 3 -S3 with Edwards SAPIEN XT- S XT in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI).
To evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN 3 compared with the earlier generation Edwards SAPIEN XT prosthesis.
Between September 2012 and March 2015, we selected consecutive high-risk or non-operable patients with severe aortic stenosis undergoing TAVI with Edwards SAPIEN 3 and SAPIEN XT prosthesis in the Institut Mutualiste Montsouris. Valve Academic Research Consortium endpoints were used.
Of 200 patients who underwent TAVI, 142 were performed with Edwards (66 SAPIEN 3 and 76 SAPIEN XT). Patients treated with SAPIEN 3 had significantly more peripheral artery disease (65,2% vs 36,8%; p= 0,001) and smaller aortic valve area (0,67 ± 0,19 vs 0.76 ± 0.14 cm2; p=0,007). The MDCT analysis showed higher rate of calcified iliofemorale arteries (47,9 %vs 26,5%, p= 0,008) in the S3. Device success rate was higher in the S3 (98,5% versus 90%, p=0.02). S3 versus SXT reduced significantly the occurrence of paravalvular regurgitation after TAVI (34% versus 65 %, p=0.001). At 30 days, there was less major and life-threatening bleedings in S3(p=0,02) with a trend towards a higher rate of transfusion in the SXT (13,1% vs 6,1%,p=0,15). The major vascular complications (6% versus 8%, p=0,27), stroke (3% versus 2,6%, p=0,88) and death (3% versus 5,1%, p=0,5), permanent pacemaker implantation (10,6 vs 14,5, p=0,46) did not differ between S3 and SXT.
In our study, TAVI with Edwards SAPIEN 3 was associated with higher rate of device success and lower rate of paravalvular regurgitations and major bleeding compared with SAPIEN XT.