Transcatheter mitral valve replacement (TMVR) with use of the Tendyne transcatheter mitral valve system was successful in treating mitral valve disease due to mitral annulus calcification (MAC), and significantly improved heart failure (HF) symptoms and quality-of-life (QOL), according to a first report of the primary outcomes of the SUMMIT-MAC trial presented at TCT 2025 and simultaneously published in JACC.

In what they believe is the first prospective clinical trial to evaluate the use of the Tendyne system for severe MAC, Paul Sorajja, MD, FACC, et al., analyzed 103 nonrandomized patients with severe MAC and mitral regurgitation (MR) or stenosis, who underwent treatment with Tendyne. All patients were at high surgical risk, and an echocardiography core laboratory performed assessments of mitral disease.

The primary endpoint was freedom from HF hospitalization and all-cause mortality at 12 months post-index procedure, and adverse events were adjudicated by an independent clinical events committee.

Of included patients (55% women, mean age of 78 years) in this multicenter, multicohort investigation, MR was present in nearly all at baseline (97%). Additionally, technical success was achieved in 94% of patients, with a 30-day mortality of 7%.

Of note, the primary endpoint was met: 60% at six months, beating the performance goal of 43%. Moreover, QOL improved significantly (18±24 points; p<0.0001) as did HF symptoms (NYHA Class I/II, 30% vs. 88%, paired baseline vs. 12 months; p<0.0001).

Sorajja and colleagues note the need for "safe and effective [TMVR] options" for this patient population. "The availability of this transcatheter option addresses a significant treatment gap for patients with severe MAC, who face high surgical risk and lack of effective medical therapy," they write.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT25, Angiography, Heart Valve Diseases