Η νέα μας μελέτη που δημοσιεύθηκε στο International Journal of Cardiology, είναι η μεγαλύτερη διεθνώς και μελέτησε 4434 ασθενείς που υποβλήθηκαν σε επέμβαση αντικατάσταση αορτικής βαλβίδας (TAVI) με αυτοεκπτυσσόμενες βαλβίδες. Διερεύνησε την απόδοση της βαλβίδας 34mm EvoluteR. -->
Our new study about the performace of the 34 mm #EvolutR has been published.
From the largest registry (HORSE) so far including 4434 patients who underwent TAVR for native severe AS, we investigated the procedural outcomes of 572 patients, with large annuli, treated with the 34 mm EvolutR.
Objectives: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota).
Background: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting.
Methods: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes.
Results: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157).
Conclusions: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation.