REdo transcatheter aortic VALVE implantation for the management of transcatheter aortic valve failure: Design and rationale of the REVALVE study.

BACKGROUND

The expansion of transcatheter aortic valve implantation (TAVI) into younger and lower risk patients increases the likelihood of future reintervention on the valve due to bioprosthetic valve failure (BVF). However, little is known about the feasibility and outcomes of redo TAVI for BVF.

METHODS

REVALVE is an investigator-initiated, open-label, prospective registry, enrolling 300 patients undergoing redo TAVI in approximately 75 centres in 11 countries in Europe and the Middle East. The primary endpoint is REVALVE success at 30-days, adapted from the Valve Academic Research Consortium-3 (VARC-3) criteria and defined as the correct positioning of a single prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient <20 mmHg, peak velocity < 3.0 m/s, doppler velocity index ≥0.25, <moderate aortic regurgitation), and freedom from mortality, coronary obstruction, unplanned coronary revascularisation, and surgery or intervention related to the device. The co-primary endpoint is a composite of freedom from mortality, stroke, and re-hospitalisation for valve or procedure-related causes at 1 year. Clinical and echocardiographic follow-up will continue to 5 years. Parallel cohorts will include patients presenting with TAV BVF who are managed by surgical explantation and aortic valve replacement (AVR), or by optimal medical therapy. Sub-studies will investigate computer-simulated modelling prior to redo TAVI, post-implant coronary catheterisation, and post-procedure multi-slice computed tomography.

CONCLUSIONS

The REVALVE study is a prospective multi-centre study investigating the management of TAV failure by redo TAVI, with parallel cohorts treated by surgical AVR and optimal medical therapy.

CLINICAL TRIAL REGISTRATION

www.

CLINICALTRIALS

gov; NCT06557798.