Tendyne TMVR: One Year Predictors of Therapeutic Benefit
26 August 2019
Transcatheter mitral valve replacement is an emerging technology for the treatment of mitral valve regurgitation. Numerous devices are in development and in various stages of clinical investigation. The Tendyne system (Tendyne Holdings, LLC, a subsidiary of Abbott Vascular, Roseville, Minnesota) is a fully repositionable and retrievable, transapical transcatheter mitral valve replacement platform. In a recent report of the first 100 high-risk patients enrolled in the Tendyne global feasibility trial, one year freedom from all-cause mortality was 72.4%. Importantly, 88.5% of survivors were in NYHA functional class I or II at 1 year. Tendyne offers patients with severe mitral regurgitation a life-saving treatment option, replacing their native mitral valve without open heart surgery to reduce their heart failure symptoms.
A new study published in the May 2019 issue of Eurointervention sought to identify which patients benefit the most from this therapy. The authors examined predictors of 1-year outcome in 100 patients treated with the Tendyne transcatheter bioprosthesis. The study evaluated the clinical and imaging characteristics to identify those patients who are more likely to benefit from the device, namely be alive at 1 year and be free from heart failure hospitalization during the follow-up.
Results indicate that patients that benefit the most are those with severe MR, defined by echocardiography ( composite of effective regurgitant orifice area ≥0.3cm2 or regurgitant volume ≥45ml). The presence of a dilated heart (increased left ventricular end-diastolic dimension) was an additional element associated with benefits by univariate analaysis. These results are relevant for daily practice,, asTendyne TMVI may address a therapeutic gap existing for patients with severe LV dilatation where suboptimal results may be observed with transcatheter MV repair with the MitraClip (Abbott, Santa Clara, CA).
Two recent randomised clinical trials on transcatheter mitral valve repair with the MitraClip. The COAPT trial showed a significant reduction in mortality at 2 years in patients randomized to Mitraclip versus guideline directed medical therapy (GDMT) alone, however patients with advanced left ventricular dilation were excluded. Inferior outcomes of the MitraClip group were observed in a subset of patients with larger ventricles and less than severe MR. In turn, these patients were shown to derive benefit from the Tendyne valve.
The MITRA-FR trial similarly randomised patients to MitraClip +GDMT vs. GDMT alone. This study permitted enrollment of patients with more advanced degrees of ventricular dilatation. Results showed that the Mitraclip did not improve the rate of death or unplanned hospitalization for heart failure at 1 year. Though there are significant differences in theCOAPT and MITRA-FR Trials trials, their similarities highlight that in patients with worse ventricles and less than severe MR, transcatheter mitral repair may not be the ideal therapy.
Therefore, the results published in Eurointervention may suggest that the Tendyne valve offers a solution for a therapeutic gap in the management of high-risk patients with severe MR and left ventricular dilatation.