Mid-term outcomes of patients with Lotus and Evolut transcatheter valves

Summary

Long-term data on Lotus® (Boston Scientific, USA) transcatheter aortic valve prostheses are lacking. Our study suggests that higher cardiovascular mortality rates during mid-term follow-up were associated with Lotus compared with Evolut valves. Higher gradients on the Lotus valves at the end of follow-up suggest the possibility of accelerated prosthesis degeneration.

Introduction

The Lotus® valve (Boston Scientific, USA), designed for transcatheter aortic valve implantation (TAVI), was promising because of the repositionable and fully retrievable prosthesis with excellent procedural [1, 2] and 1-year follow-up results [2, 3]. The Lotus valve also included an adaptive seal to effectively minimize paravalvular leak (PVL) [4] and thus enabled TAVI also in complex anatomies such as stenosis of bicuspid aortic valve [5–7]. However, long-term data on Lotus are lacking compared with results for other currently used TAVI valves [8–10]. With the extension of TAVI indications to younger, lower-risk patients [11], data on long-term transcatheter valve durability are essential [12]. Although the Lotus valve was recalled in 2020 [13, 14] and is not available for clinical use, thousands of valves were implanted over the last decade.

Aim

We evaluated the mid-term outcomes of patients with Lotus and compared them with those of patients with Evolut R® valves (Medtronic, USA).

Material and methods

Design

We conducted a single-centre, retrospective, observational study comparing outcomes of patients with severe aortic stenosis (AS), who underwent TAVI with Lotus or Evolut R valves. The study was approved by a multicentre Ethics Committee and was conducted in accordance with the principles of the Declaration of Helsinki.

Patients and procedures

A total of 197 consecutive patients with severe AS, who underwent TAVI between August 2015 and January 2020, were enrolled in this study. Patients were either admitted haemodynamically stable for planned diagnostic evaluation or admitted acutely with decompensated heart failure. Diagnosis of severe AS was made according to echocardiographic criteria. The indication for TAVI was established as a consensus of members of the heart team. All TAVI procedures were performed by highly experienced interventional cardiologists in a single tertiary centre. Clinical, demographic, and echocardiographic data were recorded at baseline and during follow-up. Patients had...


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