Key result
Transapical Tendyne valve-in-ring implantation achieves ~100% technical success in high-risk recurrent mitral regurgitation.
Why the study?
Re-do operations for recurrent mitral regurgitation after ring-based annuloplasty are often denied due to high risk, and balloon-expandable transcatheter valve-in-ring alternatives face limitations such as paravalvular leakage and LVOT obstruction. The feasibility and outcomes of using the transapical, repositionable Tendyne valve for off-label mitral valve-in-ring procedures required evaluation.
Does transapical mitral valve-in-ring implantation using the Tendyne system safely and effectively reduce mitral regurgitation and improve clinical outcomes in high-risk patients with recurrent severe mitral regurgitation after surgical ring-based annuloplasty?
Observational (n=16)
Blinded central core laboratory for imaging analysis
Yes
Does transapical mitral valve-in-ring implantation using the Tendyne system safely and effectively reduce mitral regurgitation and improve clinical outcomes in high-risk patients with recurrent severe mitral regurgitation after surgical ring-based annuloplasty?
Transapical mitral valve-in-ring implantation using the low-profile Tendyne system is feasible and effective in eliminating recurrent mitral regurgitation without LVOT obstruction in high-risk patients, provided rigid/semi-rigid rings are at least 36 mm (or >=30 mm for flexible bands).
Answers are grounded in this paper and cite their sources.
Supports feasibility of Tendyne valve-in-ring in selected high-risk recurrent MR; leaves open need for randomized trials before practice change.
Objectives Mitral regurgitation (MR) is commonly treated with ring-based annuloplasty. In case of recurrent MR, re-do operations are often denied due to high risk. Transcatheter valve-in-ring (V-i-R) procedures offer an alternative. This study assessed the feasibility and outcomes of using the transapical, repositionable Tendyne valve for off-label mitral V-i-R procedures, as an alternative to balloon-expandable valves like SAPIEN, which face limitations such as paravalvular leakage and LVOT obstruction. Methods The TEND-RING registry is a retrospective, international study with prospective follow-up, including 16 high-risk patients from eight European centers who underwent Tendyne V-i-R procedures between 2017 and 2024. Procedural, 30-day, and long-term outcomes were analyzed. Results Patients were elderly (median age 79.5), predominantly male (81%), with significant comorbidities (STS Risk of Mortality 5.6%, 4.4–7.2%) and severe MR (3 + /4 +). Procedural success was 100%, with no LVOT obstruction or device embolization. MR was reduced to mild or none in all patients. 30-day mortality was 6.3%. Over a median 11-month follow-up, five deaths occurred (31.3%), three from cardiovascular causes (18.75%). Surviving patients showed sustained MR reduction and improved symptoms (89% in NYHA I/II). Ring size analysis suggested a minimum of 36 mm for rigid/semi-rigid rings, while flexible bands allowed successful implantation in sizes as small as 30 mm. Conclusions Tendyne V-i-R procedures are technically feasible, effective, and safe in selected high-risk patients with recurrent MR. Ring size thresholds identified may guide patient selection and procedural planning in future interventions.
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Maier et al. (2026) conducted an observational in Recurrent severe mitral regurgitation after surgical ring-based annuloplasty (n=16). Transapical Tendyne transcatheter mitral valve-in-ring implantation was evaluated on Technical success (successful Tendyne implantation without procedural mortality or need for emergency surgery/intervention). Transapical Tendyne mitral valve-in-ring implantation achieved 100% technical success, 93.3% 30-day device success, and 6.3% 30-day mortality in high-risk patients with recurrent MR.
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