Transcatheter valve-in-valve versus redo-surgical valve replacement for mitral bioprosthetic valve dysfunction: rationale and design of the SURVIV randomised trial

Abstract

Bioprosthetic mitral valves are prone to structural valve deterioration (SVD) over time, which can lead to bioprosthetic valve dysfunction (BVD) requiring reintervention. Surgical redo-mitral valve replacement (rMVR) is currently the standard treatment, although it is associated with significant mortality in high-risk patients. Transcatheter mitral valve-in-valve (mViV) has emerged as an alternative to surgical rMVR in patients with failed bioprostheses, but randomised studies comparing the two treatments are lacking. The SURVIV trial is an investigator-initiated, prospective, multicentre, open-label, randomised controlled trial that will enrol 150 patients with mitral BVD suitable for surgical rMVR or transcatheter mViV. Participants will be randomised 1:1 to transseptal mViV with a balloon-expandable transcatheter heart valve or to conventional surgical rMVR. Procedures will be performed according to local best practices with contemporary medical devices. The primary endpoint is the composite of all-cause mortality or disabling stroke at 12 months. Key secondary endpoints are major complications (cardiovascular death, disabling stroke, life-threatening or major bleeding, acute kidney injury stage 2 or 3, and major vascular complications) at 30 days, according to Mitral Valve Academic Research Consortium criteria; rehospitalisation for cardiovascular causes at 12 months; echocardiographic and/or tomographic signs of prosthetic valve thrombosis and early SVD at 3 and 12 months; and health-related quality of life (EQ-5D-5L) at 3 and 12 months. Clinical follow-up will continue up to 10 years. SURVIV is the first randomised trial to compare a transcatheter mViV procedure with surgical rMVR for mitral BVD and may provide further clinical evidence to guide the management of patients with failed mitral bioprostheses. ClinicalTrials.gov: NCT04402931.