Transcatheter aortic valve implantation with the LOTUS Edge system: early European experience

Abstract

Abstract Aims To evaluate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the recently commercialised LOTUS EdgeTM system. Methods and results We performed a multicentre, single-arm, retrospective registry to generate early information on patients undergoing TAVI with the LOTUS EdgeTM system following its commercial release in July 2019. Novel features of this second-generation device include increased flexibility of the delivery catheter, enhanced visualisation of the locking mechanism and the depth guard technology to reduce left ventricular outflow tract interaction and, potentially, reduce the risk of permanent pacemaker (PPM) implantation. All endpoints were defined according to the VARC-2 definitions and were reported by the treating site. A total of 286 consecutive patients from 18 participating centres were included. The mean age and STS score were 81.2±6.9 years and 5.2±5.4%, respectively. Most procedures were performed under local anaesthesia (97.2%) via transfemoral access (98.6%). Successful vascular access, valve delivery and deployment and system retrieval were achieved in 97.6% of cases. 30-day rates of all-cause mortality (2.1%, N=6) and stroke (3.5%, N=10) were acceptable. Disabling, life-threatening or major bleeding occurred in 3.8% and major vascular complications in 2.1%. The incidence of new PPM implantation was 27.1% among all patients and 32.2% among pacemaker-naive patients. After TAVI, the mean transvalvular pressure gradient was 11.9±5.6 mmHg and the mean aortic valve area was 1.9±0.9 cm2. The rate of moderate paravalvular leak was 2.1% with no cases of severe paravalvular leak. Conclusions Early experience with the LOTUS EdgeTM system demonstrated acceptable 30-day clinical outcomes with impressively low rates of paravalvular leak. The requirement for new PPM remained high in this early experience. Further study is required to understand if improving operator experience with the device can reduce PPM rates. Funding Acknowledgement Type of funding source: None