TENDER Study, Evolution at One Year

The use of transcatheter mitral valve intervention for the treatment of mitral valve regurgitation (MR) continues to evolve; at present guidelines only recommend it for inoperable or high surgical risk patients.   

So far, many devices have been assessed, some of which have shown promising results, but only for poor surgical candidates. 

Researchers looked into the TENDER registry; 195 patients with symptomatic MR were included. 135 (62.3%) met the “on label” criteria, established by the device maker (native valve with no prior intervention, MR ≥3+, ejection fraction ≥30%, diameter ≤70 mm, absence of primary MAC and MR with end-diastolic diameter >30 mm), while 60 “real world” patients did not meet some of any of these criteria. 

Safety primary end point was cardiovascular mortality at one year and performance primary end point was MR severity reduction at one year. 

Both groups were similar, mean age was 77, 60% were men, mortality STS was 5.6%, and 28% had diabetes, 57% CAD, 25% prior CABG, 13.8% prior stroke, 59% renal function deterioration and 25% had prior pacemaker or ICD implantation. They were all in functional class III-IV.

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The cause of MR was primary in 41%, secondary in 38.7%, and the rest were mixed cases. 

“Real world” patients presented higher BNP levels, 7% had prior mitral valve intervention (5% edge-to-edge and 2% percutaneous annuloplasty), and 12% had experienced a failed percutaneous treatment. 

Technical success was 95%, with 1.5% conversion rate and one case of device migration. 

At 30 days, cardiovascular mortality resulted 6.7%, all-cause mortality 9.3%, and 1.55% suffered a disabling stroke, 14% presented major bleeding and 9% required dialysis because of kidney failure, and 1.6% experienced MI.

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After one year, the primary end point resulted 16.9%, and the performance end point reached 97.9%, with no significant differences between groups. There was a 68% reduction in hospitalizations for cardiac failure vs. the year before, and 98% presented mitral regurgitation ≤1+, and there was significant improvement in functional class, with no differences between groups. 


This large real world registry reported high technical success, long lasting, with complete elimination of mitral regurgitation and clinical benefits, and 17% mortality rate at one year. This evolution showed comparable results between the “on label” and the “real world” patients, which shows this procedure offers a safe and effective treatment option. 

Dr. Carlos Fava - Consejo Editorial SOLACI

Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.

Original Title: Transapical Mitral Valve Replacement 1-Year Results of the Real-World Tendyne European Experience Registry.

Reference: Michaela M. Hell, et al. J Am Coll Cardiol Intv 2024;17:648–661.

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