JUST ACCEPTED ARTICLE
ABSTRACT
Bioprosthetic mitral valves are prone to structural valve deterioration (SVD) over time, which can lead to bioprosthetic valve dysfunction (BVD) requiring reintervention. Redo-surgical mitral valve replacement (rMVR) is currently the standard treatment, although associated with a significant mortality in high-risk patients. Transcatheter mitral valve-in-valve (mViV) has emerged as an alternative to rMVR in patients with failed bioprostheses, but randomized studies comparing the two treatments are lacking. The SURVIV trial (ClinicalTrials.gov identifier NCT04402931) is an investigator-initiated, prospective, multicenter, open-label randomized controlled trial that will enroll 150 patients with mitral BVD suitable for rMVR or transcatheter mViV. Participants will be randomized 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 practice with contemporary medical devices. The primary endpoint is the composite of all-cause of 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; rehospitalization 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 randomized trial to compare transcatheter mViV procedure with surgical rMVR for mitral BVD and may provide further clinical evidence to guide management of patients with failed mitral bioprostheses.
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