Comparison of transcatheter aortic valve implantation with the newest-generation Sapien 3 vs. Direct Flow Medical valve in a single center cohort. (1st April 2017) - Schulz, Eberhard
Abstract: Background: The latest generation transcatheter heart valves including Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM) were designed to allow precise implantation at the intended position and to minimize prosthesis dysfunction as well as procedural complications. Our aim was to compare short-term functional and clinical outcomes of these 2 transcatheter aortic valve systems. Methods: Of 174 patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) at our institution between August 2013 and June 2015, 113 were treated with ES3 and 61 with DFM. Device success, residual aortic regurgitation and early safety endpoints were defined according to the updated VARC-2 criteria and prespecified as primary endpoints. Results: Patients treated with ES3 had a significantly higher rate of procedural success (ES3 94% vs. DFM 79%, p = 0.005), mainly driven by lower postprocedural gradients (ES3 8.6 ± 0.5 mm Hg vs. DFM 14.6 ± 1.4 mm Hg by invasive recordings; p = 0.00012) and no incidence of more than mild aortic regurgitation. The occurrence of safety endpoints at 30 days was low and comparable in the DFM vs. ES3 group (ES3 88% vs. DFM 95% of patients without endpoints, p = 0.26). No significant differences were observed in 30 day mortality, stroke or the incidence of new permanent pacemaker implantation. Conclusions: These single-center experience data show a higher rate of device success for ES3 treated patients, while 30 day safety outcome was similar in both groups. Long-term follow-up and larger scale multicenter experience will have to assess possible effects of these observations on long-term clinical outcomes.