Single Center Experience Performing Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge (LE) Platform in High-Risk Patients with Symptomatic Severe Aortic Stenosis

We retrospectively reviewed consecutive patients with AS who underwent TAVR with LE between August 28, 2019 and March 11, 2020. All patients were deemed high-risk for SAVR by a heart team using the STS-PROM score and the Reprise III inclusion criteria.

35 patients underwent TAVR with LE. The mean age was 76.9±9.1 years, 54.3% of patients were women, and the mean STS-PROM score was 8.9 ± 2.2. Baseline EF was 45%, mean aortic valve area was 0.7 ± 0.6 cm(2), and mean transvalvular pressure gradient was 51.5 ± 16.2 mmHg.
The mean 30-day transvalvular aortic pressure gradient was 10.6 ± 5.7 mmHg, and the mean valve area was 1.8 ± 0.6 cm(2). A total of 97% patients had none or trace perivalvular leak (PVL) at 30 days and 91% of patients were NYHA class I or II. Of note was the absence of significant PVL even in patients with difficult anatomy.At 30-days, VARC-2 results showed the all-cause mortality rate was 5.7% (2 of 35 patients, 1 patient with worsening right ventricular failure and acute respiratory failure and 1 patient with massive pulmonary embolism), disabling stroke rate was 0%, major vascular complication rate was 5.7% (2 of 35 patients). There were no procedural related deaths. A total of 17.6% (6 of 34 patients with no prior pacemaker) underwent new permanent pacemaker implantation at 30-days.
Our initial experience suggests that TAVR using LE is a reliable option to surgery in high-risk AS patients with low incidence of complications and high success rates. Despite our limited number of patients, our data is consistent with results of clinical trials like Reprise II, however, so far we have noted a reduced need for new permanent pacemaker.