| Contributors: |
Zito, A.; Buono, A.; Scotti, A.; Kim, W. -K.; Fabris, T.; De Biase, C.; Bellamoli, M.; Montarello, N.; Costa, G.; Alfadhel, M.; Koren, O.; Fezzi, S.; Bellini, B.; Massussi, M.; Bai, L.; Mazzapicchi, A.; Giacomin, E.; Gorla, R.; Hug, K.; Briguori, C.; Bettari, L.; Messina, A.; Villa, E.; Boiago, M.; Romagnoli, E.; Orbach, A.; Laterra, G.; Aurigemma, C.; De Carlo, M.; Renker, M.; Garcia Gomez, M.; Trani, C.; Ielasi, A.; Landes, U.; Rheude, T.; Testa, L.; Amat Santos, I.; Mangieri, A.; Saia, F.; Favero, L.; Chen, M.; Adamo, M.; Sonia Petronio, A.; Montorfano, M.; Makkar, R. R.; Mylotte, D.; Blackman, D. J.; Barbanti, M.; De Backer, O.; Tchetche, D.; Tarantini, G.; Latib, A.; Maffeo, D.; Burzotta, F. |
| Description: |
Background: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). Objectives: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis. Methods: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. Results: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)—mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09). Conclusions: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up. |