Transapical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved into a routine procedure for selected high-risk elderly patients. The recently introduced SAPIEN™ delivery system (Ascendra II+™) with an added nose cone seems to facilitate direct valve implantation without prior balloon valvuloplasty (BAV). Here, we report our initial experience with this device.METHODS
A total of 128 patients were enrolled in the study in 2012 and 2013 and were designated Cohort I. For a subset of 79 patients, exact cardio- computed tomography-based measurements were available; these patients were assigned to Cohort II. All patients received SAPIEN XT™ valves using the TA approach. TA-AVI without pre-ballooning was performed in 31.2% (Cohort I) and 31.6% (Cohort II) of patients. To adjust for baseline variables, propensity score (PS)-based pair matching was used.RESULTS
All valves were implanted successfully. The use of PS matching resulted in bias reduction for both cohorts. For Cohort I, there were no significant differences in the primary end points, which were aortic valve incompetence ≥2+, Pmean postimplantation, major stroke, transient ischaemic attack (TIA), requirement for post-dilatation and necessity for new pacemaker implantation. As expected, fluoroscopy time was significantly lower in no-BAV patients. In Cohort II, the 30-day TIA rate was lower in the no-BAV group.CONCLUSIONS
Direct TA implantation of the SAPIEN valve without pre-ballooning is feasible, safe, does not seem to compromise functional outcomes and may be associated with fewer neurological events.