Early clinical outcomes in the first 50 patients enrolled in the RESPOND EDGE registry

Background: Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. LOTUS Edge, a development of the Lotus Valve System, is repositionable and fully retrievable, with a deployment mechanism (Depth Guard) designed to optmize implant depth.

Objective: The RESPOND EDGE registry collects clinical and device performance data following TAVI with LOTUS Edge in ‘routine’ clinical practice. This pre-specified interim analysis presents discharge data from the first 50 enrolled patients.

Methods and

Results: RESPOND EDGE is a single-arm, post-market registry of 200 TAVI patients at up to 20 European centers. The primary safety endpoint is 30-day all-cause mortality. The primary effectiveness endpoint is the mean aortic valve (AV) pressure gradient at discharge, as assessed by an independent core laboratory. Other key endpoints include device performance, valve hemodynamics, grade of paravalvular leak (PVL), and VARC-2 clinical efficacy and safety. Clinical follow-up will extend to 2 years.
In the first 50 enrolled patients (mean age: 81.1 years, 48% female, baseline STS score: 3.6±3.1), 100% (50/50) had successful vascular access, delivery and deployment of the LOTUS Edge valve and retrieval of the delivery device. There were no procedural deaths, re-hospitalizations, or repeat procedures for valve-related dysfunction. The discharge stroke rate was 4% (2/50). A permanent pacemaker was implanted at discharge in 18% (9/50); the rate among pacemaker-naïve patients was 22.5% (9/40).
Mean AV gradient at discharge was 10.4±4.9 mmHg (P<0.0001 vs prespecified performance goal of 18.0 mmHg). At discharge 84.8% of patients had no/trace PVL, 15.2% had mild PVL, and no patients exhibited ≥moderate PVL.

Conclusion: This pre-specified 50-patient analysis represents the largest reported clinical experience to date with LOTUS Edge. These initial observations demonstrate no safety or efficacy concerns, with overall good early clinical outcomes, excellent valve hemodynamics and a low rate of PVL.