European heart journal. Cardiovascular Imaging · 2016
Comparison of SAPIEN 3 and SAPIEN XT transcatheter heart valve stent-frame expansion: evaluation using multi-slice computed tomography.
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Kazuno Yoshio, Maeno Yoshio, Kawamori Hiroyuki, Takahashi Nobuyuki, Abramowitz Yigal, Babak Hariri, Kashif Mohammad, Chakravarty Tarun, Nakamura Mamoo, Cheng Wen, Friedman John, Berman Daniel, Makkar Raj R, Jilaihawi Hasan
Аннотация
AIMS: Stent-frame morphology of the newer-generation, balloon-expandable transcatheter heart valve (THV), the SAPIEN 3 (S3), after transcatheter aortic valve implantation (TAVI) is unknown. We evaluated the THV stent-frame morphology post TAVI of the S3 using multi-slice computed tomography (MSCT) compared with the prior-generation THV, SAPIEN XT (S-XT).
METHODS AND RESULTS: A total of 94 consecutive participants of RESOLVE registry (NCT02318342) had MSCT after balloon-expandable TAVI (S3 = 39 and S-XT = 55). The morphology of the THV stent-frame was evaluated for expansion area and eccentricity at the THV-inflow, native annulus, mid-THV and THV-outflow levels. Mean %-expansion area for the S3 and the S-XT was 100.9 ± 5.7 and 96.1 ± 5.5%, respectively (P < 0.001). In the S3 group, the THV-inflow level had the largest value of %-expansion area, which decreased from THV-inflow to mid-THV level (105.2 ± 6.4 to 96.5 ± 5.9%, P < 0.001). However, in the S-XT group, %-expansion area increased from THV-inflow level to mid-THV level (93.2 ± 6.2 to 95.1 ± 6.1%, P = 0.0058). On nominal delivery balloon volume, the S3 in 88.5% of cases had overexpansion at the THV-inflow level. The observed degree of THV oversizing of the S3 was significantly lower than the S-XT (6.3 ± 8.6 vs. 11.8 ± 8.5%, P = 0.0027). Nonetheless, the incidence of post-procedural paravalvular aortic regurgitation (PVR) ≥ mild following the S3 TAVI was also significantly lower than the S-XT TAVI (17.9 vs. 43.6%, P = 0.014).
CONCLUSION: The newer-generation, balloon-expandable device, the S3, has a flared inflow morphology, whereas the prior-generation device, the S-XT, has relatively constrained inflow morphology post TAVI. This may contribute to a lesser degree of PVR with the S3.
METHODS AND RESULTS: A total of 94 consecutive participants of RESOLVE registry (NCT02318342) had MSCT after balloon-expandable TAVI (S3 = 39 and S-XT = 55). The morphology of the THV stent-frame was evaluated for expansion area and eccentricity at the THV-inflow, native annulus, mid-THV and THV-outflow levels. Mean %-expansion area for the S3 and the S-XT was 100.9 ± 5.7 and 96.1 ± 5.5%, respectively (P < 0.001). In the S3 group, the THV-inflow level had the largest value of %-expansion area, which decreased from THV-inflow to mid-THV level (105.2 ± 6.4 to 96.5 ± 5.9%, P < 0.001). However, in the S-XT group, %-expansion area increased from THV-inflow level to mid-THV level (93.2 ± 6.2 to 95.1 ± 6.1%, P = 0.0058). On nominal delivery balloon volume, the S3 in 88.5% of cases had overexpansion at the THV-inflow level. The observed degree of THV oversizing of the S3 was significantly lower than the S-XT (6.3 ± 8.6 vs. 11.8 ± 8.5%, P = 0.0027). Nonetheless, the incidence of post-procedural paravalvular aortic regurgitation (PVR) ≥ mild following the S3 TAVI was also significantly lower than the S-XT TAVI (17.9 vs. 43.6%, P = 0.014).
CONCLUSION: The newer-generation, balloon-expandable device, the S3, has a flared inflow morphology, whereas the prior-generation device, the S-XT, has relatively constrained inflow morphology post TAVI. This may contribute to a lesser degree of PVR with the S3.