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Transcatheter valve-in-valve versus redo-surgical valve replacement for mitral bioprosthetic valve dysfunction: rationale and design of the SURVIV randomised trial
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DOI：10.4244/EIJ-D-25-01090.png)
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Abstract
En 中文
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.
Keywords:
bioprosthetic valve dysfunction
cardiac surgery
clinical outcomes
mitral valve disease
randomised controlled trial
transcatheter valve replacement
valve-in-valve
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