Procedural and thirty-day outcomes following transfemoral implantation of the fully repositionable and retrievable Lotus valve without routine pre-dilatation in a consecutive patient cohort: a single centre experience.
Ruparelia N., Thomas K., Newton JD., Grebenik K., Keiralla A., Krasopoulos G., Sayeed R., Banning AP., Kharbanda RK.
BACKGROUND / PURPOSE: The Lotus valve (Boston Scientific, Natick, MA, USA) is a contemporary transcatheter aortic valve implantation (TAVI) device that is fully repositionable and retrievable to aid implantation and optimise procedural results. The ability to implant the device without routine pre-dilatation is another possible advantage reducing associated risks and procedure times. The aim of this study is to report procedural and 30-day outcomes following TAVI in a consecutive patient group presenting with severe symptomatic aortic stenosis with the Lotus valve system without routine pre-dilatation. METHODS / MATERIALS: 146 consecutive patients that underwent TAVI at the John Radcliffe Hospital, Oxford between January 2015 - December 2016 were retrospectively analysed. RESULTS: The mean age was 81.1±7.4 years and the mean logistic EuroSCORE was 14.6±10. 134 (91.8%) of patients were treated under conscious sedation. 144 (98.6%) of procedures were successful. Two patients (1.4%) died during the follow-up period. None or mild residual aortic regurgitation was achieved in 98.6% of patients. The mean and peak transvalvular gradients were 8.6±3.6mmHg and 16.6±6.6mmHg respectively. Eight patients (5.5%) suffered a stroke. Over time, there was a reduction in major vascular complications (14.3% vs. 2.2%, p=0.03) and a trend toward shorter procedure times (97.6±44.3 vs. 86.8±31.4 minutes, p=0.14) and the administration of less contrast (104.4±45.2 vs. 91.7±37.6 millilitres, p=0.16). The overall new pacemaker implantation rate was 36.3%. CONCLUSIONS: The use of the Lotus valve as a 'workhorse' device without routine pre-dilatation is safe and efficacious and is associated with a very low incidence of residual aortic regurgitation and acceptable transvalvular haemodynamics.