Lotus Edge TAVR system demonstrates efficacy, safety in early analysis
Early European use of the Lotus Edge transcatheter aortic valve replacement system demonstrated good short-term safety and efficacy and low rates of paravalvular leak, according to research presented at the virtual TCT Connect.
However, the need for new permanent pacemaker implantation remained high within this cohort.
“The salient features of this initial experience with this new technology and implantation technique are that the Lotus Edge system (Boston Scientific) is associated with satisfactory clinical outcomes and hemodynamic results, and very low rates of clinically significant paravalvular leak in an anatomically complex patient cohort,” Xavier Armario, MD, clinical research fellow in structural heart disease at Galway University Hospital in Galway, Ireland, and colleagues wrote in a simultaneous publication in JACC: Cardiovascular Interventions. “The requirement for new permanent pacemaker implantation, however, remains high.
“In this study, the Lotus Edge system showed similar clinical outcomes at 30 days when compared with its predecessor, the Lotus valve, in the RESPOND registry despite operators having to relearn how to use the device after a 2-year hiatus on commercial implants,” Armario and colleagues wrote.
For this analysis, investigators enrolled 286 consecutive patients in Europe (mean age, 81 years; 42% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 5.2) with the new system.
At baseline, the average aortic valve area was 0.7 cm2 and the mean transvalvular pressure gradient was 45.9 mm Hg; moderate to severe aortic regurgitation was present in 11.5% of participants; and 47.9% of patients had complex anatomy.
Researchers observed that in-hospital mortality occurred in 1.4% of participants and stroke occurred in 3.1%.
According to the study, life-threatening bleeding occurred in 0.7% of participants, major bleeding in 3.1% and major vascular complications were reported in 2.1% of the cohort.
No cases of stage 2 or 3 acute kidney injury, MI or valve mispositioning were observed.
Investigators found that the rate of 30-day mortality was 2.4% among patients who underwent TAVR with the Lotus Edge system, of which 2.1% were classified as CV death.
Moreover, 12% of participants remained in NYHA class III or IV at 30 days after discharge.
In total, 84.4% of patients experienced no or trace paravalvular leak, according to the study.
Among the entire cohort, 25.9% of patients underwent new permanent pacemaker implantation. Among permanent pacemaker-naive participants, 30.8% underwent implantation.
Researchers noted that indications for permanent pacemaker implantation included development of third-degree atrioventricular block (66.2%); second-degree atrioventricular block (9.5%); first-degree atrioventricular block with left bundle branch block or right bundle branch block (17.6%); and isolated left bundle branch block (6.8%).
Moreover, Valve Academic Research Consortium 2 (VARC-2) device success was achieved among 89.5% of patients, early safety was 92.7% and clinical efficacy was 75.2%, according to the study.
“Early European experience with the Lotus Edge aortic valve system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data and very low rates of clinically relevant paravalvular leak in an anatomically complex patient cohort,” Armario and colleagues wrote. “The requirement for new permanent pacemaker implantation remained high. Further study will evaluate whether increasing operator experience with the device and the new implantation technique can reduce the incidence of new permanent pacemaker implantation.”
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Armario X, et al. Abstracts. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).