Transcatheter Aortic Valve Replacement With the LOTUS Edge System: Early European Experience

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• The LOTUS Edge system, a transcatheter aortic valve replacement device, was re-released in April 2019.
• This study reports the first European clinical experience with the LOTUS Edge system and its implantation technique.

Purpose of the Study:

• To evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) using the LOTUS Edge system.
• To assess clinical outcomes, including major adverse events and hemodynamic performance, in patients receiving the LOTUS Edge system.

Main Methods:

• A multicenter, single-arm, retrospective registry study.
• Inclusion of 286 consecutive patients undergoing TAVR with the LOTUS Edge system across 18 European centers.
• Analysis of clinical, echocardiographic, and computed tomographic data, with endpoints defined by Valve Academic Research Consortium-2 criteria.

Main Results:

• The study included 286 patients with a mean age of 81.2 years; 47.9% had complex anatomy.
• Thirty-day mortality was 2.4% and stroke rate was 3.5%.
• Excellent hemodynamic results were observed, with no severe paravalvular leak (PVL); however, new permanent pacemaker (PPM) implantation was required in 25.9% of patients.

Conclusions:

• The LOTUS Edge system demonstrated satisfactory short-term safety and efficacy in a complex patient cohort.
• Favorable hemodynamic results and very low rates of paravalvular leak were noted.
• High rates of permanent pacemaker implantation warrant further investigation into operator experience and technique optimization.