Objective: Preballooning (PB) of the stenotic aortic valve can be considered common standard during transcatheter aortic valve implantation (T-AVI). Transcatheter aortic valve implantation without preballooning (noPB) using the Edwards SAPIEN XT prosthesis has been described previously. The aim of this study was to evaluate the outcomes of next-generation SAPIEN 3 valve implantation without PB.
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 PB technique (n = 17 [25.8%]) or no PB (n = 49 [74.2%]).
Results: Baseline characteristics of patient groups were comparable (38% women; mean age, 83 years; STS score, 8%, logistic EuroSCORE I and II, 30% and 8%, respectively). Patients in the PB group were exclusively treated in our earlier experience with this device. Overall 30-day mortality was 4.5% (6.1% for noPB vs. 0% PB; P = ns). Aortic regurgitation was grade 1 or less in 100% (PB) versus 93.9% (noPB); P = ns Median contrast use was 70 (60-95) mL (PB) versus 50 (40-50) mL (noPB); P < 0.001; and median radiation dose was 32.0 (17-57) Gy × cm (PB) versus 26.6 (16-36) Gy × cm (noPB); P < 0.001. Postdilatation was required in one patient only (noPB). The rate of new pacemaker implantations was 41.2% (PB) versus 12.2% (noPB); P = 0.03. Periprocedural stroke occurred in one patient in each group (6% PB vs 2.0% no-PB); P = ns.
Conclusions: Direct transapical SAPIEN 3 valve implantation without PB is feasible and safe. The no-PB technique leads to further simplification of the procedures.