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OBJECTIVE: Preballooning (PB) of the stenotic aortic valve can be considered common standard during transcatheter aortic valve implantation (T-AVI). T-AVI without preballooning (noPB) using the Edwards SAPIEN XT prosthesis has been described previously. Aim of this study was to evaluate the outcomes of next generation SAPIEN 3 valve implantation without preballooning.
METHODS: Since january 2013 a total of 66 patients received SAPIEN 3 valve implantation at our center using the transapical approach. Patients were treated using the standard preballooning technique (PB, n=17, 25.8%) or without (no PB, n=49, 74.2%).
RESULTS: Baseline characteristics of patient groups were comparable (38% female, mean age 83 years, STS score 7.5%, logistic EuroSCORE 29.9%). Patients in the PB group were almost exclusively treated in our earlier experience with this device. Overall 30-day mortality was 4.5% (6.1% for no-PB vs. 0% PB, p=0.56). Causes of death were neither related to the valve nor to the implantation technique. Aortic regurgitation was grade 1 or less in 100% (PB) versus 93.9% (no-PB), p=0.56. Contrast use was 75±24ml (PB) versus 50±24ml (no-PB), p<0.001 and radiation dose was 75±50 Gy*cm² (PB) versus 32±22 Gy*cm² (no-PB), p<0.001. Postdilatation was required in one patient only (no-PB), p=1.0. The rate of new pacemaker implantations was 41.2% (PB) versus 12.2% (no-PB), p=0.03. Periprocedural stroke occurred in 5.9% (PB) versus 2.0% (no-PB), p=0.45.
CONCLUSIONS: Direct transapical SAPIEN 3 valve implantation without preballooning is feasible and safe. The no-preballooning technique leads to further simplification of the procedures.