Transcatheter aortic valve implantation in severe calcified annulus using the Lotus valve system: Increased incidence of fatal major vascular complications

OBJECTIVES: This study reports the outcome of a highly selected transcatheter aortic valve implantation (TAVI) population. BACKGROUND: In patients with aortic valve stenosis and severe calcification of the left ventricular outflow tract and/or the annulus, the Boston Scientific Lotus valve provided a low paravalvular leakage rate omitting the risk of annular rupture. METHODS: Until now more than 3,600 TAVI procedures were performed at our institution. Between 8/2015 and 2/2017, 634 TAVI procedures were performed, of which 80 TAVI patients with severe calcifications consecutively received the Lotus valve. Valve Academic Research Consortium (VARC)-2 criteria of these procedures were prospectively documented in our institutional TAVI registry. One year follow-up for the Lotus treated patients was completed. RESULTS: Mean age was 82.0 ± 5.5 years. Device success was 95.0%. Conversion was required in two cases (2.5%). New permanent pacemaker implantation rate was 33.3%. Vascular complications occurred more frequent in comparison to non-Lotus treated patients (13.8 vs. 8.1%; p < .05): five minor and six major vascular complications (6.3 and 7.5%), including four fatal aortic injuries (three acute aortic dissections type A, one rupture of the aortic arch). Seventy-two-hour and 30-day mortality rates were also higher in Lotus patients (6.3 and 12.5% vs. 0.3 and 2.5%; each p < .05). One-year mortality in Lotus patients was 22.5%. CONCLUSIONS: In TAVI procedures with the Lotus valve occurrence of vascular complications including lethal aortic injuries and mortality rates were considerably high. Furthermore, in every TAVI procedure careful examination of the aorta should be mandatory and be a part of planning it.