Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience.

The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system. The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device. A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported. Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n = 7]) and stroke (3.5% [n = 10]). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Author Disclosures Dr. Khogali is a proctor for Medtronic and Boston Scientific. Dr. Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and is a consultant for Abbott Vascular, Boston Scientific, PulseCath BV, Medtronic, and Daiichi-Sankyo. Dr. Cotton is a proctor for Boston Scientific; and has received speaker fees from Abbott Vascular and Medtronic. Dr. Frerker has received lecture honoraria and travel support from Boston Scientific, Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr. Grygier is a consultant and proctor for Boston Scientific and Medtronic; and has received consulting fees and institutional research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr. Bjursten is a consultant and proctor for Boston Scientific; and has received institutional research grants from Boston Scientific. Dr. Jeger has received speaker honoraria and research support from B. Braun; and has received speaker honoraria from Cardionovum. Dr. Teles has received consulting fees and institutional research grants from Medtronic, Boston Scientific, and Abbott Vascular. Dr. Petronio is a consultant for Medtronic, Boston Scientific, and Abbott Vascular. Dr. Pilgrim has received research grants to the institution from Boston Scientific, Biotronik, and Edwards Lifesciences; has received speaker fees from Boston Scientific and Biotronik; and is a consultant for HighLife SAS. Dr. Søndergaard has received consulting fees and institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Mylotte is a consultant for Medtronic, Boston Scientific, and Microport. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.