Hot Line: TEER is non-inferior to surgery in patients with secondary mitral regurgitation
01 Sep 2024
Transcatheter edge-to-edge repair (TEER) is commonly used to treat patients with secondary mitral regurgitation (MR), but there has been no randomised trial comparing it with traditional surgery.
The investigator-initiated MATTERHORN trial recruited patients with secondary MR, LVEF ≥20%, with symptoms of heart failure (NYHA class ≥2) despite optimal guideline-directed medical therapy, who were considered at high surgical risk by the local Heart Team. Patients were randomised to mitral TEER or surgical mitral valve therapy (mitral valve repair or replacement at the surgeon’s discretion).
The primary efficacy endpoint was the composite of death, hospitalisation for heart failure, mitral reintervention, assist device implantation and stroke at 1 year. The primary composite safety endpoint, assessed at 30 days, included death, myocardial infarction, major bleeding, stroke or transient ischaemic attack, rehospitalisation, all reinterventions, non-elective cardiovascular surgery, renal failure, deep wound infection, mechanical ventilation >48 hours, gastrointestinal complications requiring surgery, new-onset atrial fibrillation (AF), septicaemia and endocarditis.
In total, 210 patients were randomised, with an average age of 70.5 years and 40% were female. The mean LVEF was 43% and 86% were NYHA class III or IV. The median EuroSCORE II score was 3%. In the surgical group, 72% underwent mitral valve repair and 28% underwent mitral valve replacement.
There was no significant difference in the primary efficacy endpoint.
The primary efficacy endpoint occurred in 16.7% of patients in the TEER group and 22.5% in the surgical group at 1 year (odds ratio [OR] 0.69; 95% CI 0.33–1.44; p=0.320), with non-inferiority confirmed (p<0.01 for non-inferiority).
There was no significant difference in the recurrence of MR grade ≥3 at 1 year: 8.9% of patients in the TEER group vs. 1.5% in the surgical group (OR 6.22; 95% CI 0.75– 51.95; p=0.091). After 1 year, 73.2% of patients in the TEER group and 87.3% of patients in the surgical group had MR grade ≤ 1.
The primary safety endpoint occurred in significantly more patients in the surgical group (54.8%) than in the TEER group (14.9%; p<0.001), which was largely driven by more major bleeding (29% vs. 3%, respectively), all reinterventions (19% vs. 8%) and new-onset AF (33% vs. 9%).
Study presenter, Professor Volker Rudolph (Heart and Diabetes Center NRW - Bad Oeynhausen, Germany), said: “In the MATTERHORN trial, we were able to show non-inferiority between the two techniques for improving MR – both methods worked well – with some safety benefits favouring TEER.”
Principal Investigator, Professor Stephan Baldus (University of Cologne - Cologne, Germany), concluded: “This is the first randomised trial to demonstrate the non-inferiority of TEER and surgery in patients with secondary MR. These new data may become important to guide decision making as European guidelines1 currently recommend TEER may be considered in patients who are judged inoperable or at high surgical risk by the Heart Team.”
References
- Vahanian A, et al. Eur Heart J. 2022;43:561–632.
