[Türkçe] | |
Turkish Society of Cardiology Young Cardiologists Bulletin Year: 7 Number: 5 / 2024 |
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Dr. Ravza Betül Akbaş Name of the Study: MATTERHORN trial- Transcatheter versus surgical mitral valve repair in patients with heart failure and secondary mitral regurgitation Published in Congress: ESC 2024 Link: Full text https://www.nejm.org/doi/abs/10.1056/NEJMoa2408739 Background: Current guidelines recommend mitral valve surgery and transcatheter edge-to-edge mitral valve repair for patients with secondary mitral regurgitation and heart failure. However, the number of randomized studies comparing these two interventions in this patient population is insufficient. The MATTERHORN study evaluated whether transcatheter edge-to-edge repair is non-inferior to mitral valve surgery in patients with secondary mitral regurgitation who are at high surgical risk. Methods: This study, a non-inferiority trial, was designed as a randomized, prospective study conducted across 16 centers in Germany. It aimed to compare transcatheter edge-to-edge repair (intervention group) with surgical mitral valve repair or replacement (surgical group) in heart failure patients with secondary mitral regurgitation who remained symptomatic despite optimal medical therapy. Patients were included if they met the criteria of having clinically significant secondary mitral regurgitation parameters on echocardiography or if they had been hospitalized at least twice in the past year for acute heart failure. Additionally, patients were required to have a left ventricular ejection fraction of at least 20% and to be in NYHA class 2 or higher despite optimal medical therapy. Patients with other significant valvular diseases or those who had undergone coronary revascularization within the past month were excluded from the study. The primary endpoint was defined as a composite of death, heart failure-related hospitalization, mitral valve re-intervention, assist device implantation, and stroke within one year following the procedure. The primary safety endpoint was the composite of major adverse events occurring within 30 days after the procedure. Results: A total of 210 patients were randomized in the study. The mean age of the patients was 70.5±7.9 years, with a left ventricular ejection fraction of 43%±11.7, and 39.9% of the patients were female. Within one year, the incidence of experiencing at least one component of the primary endpoint was 16.7% in the intervention group compared to 22.5% in the surgical group, confirming non-inferiority with a p-value of <0.001. The primary safety endpoint events occurred in 14.9% of the patients in the intervention group, compared to 54.8% in the surgical group (p<0.001). Conclusion: In heart failure patients with secondary mitral regurgitation, transcatheter edge-to-edge mitral valve repair is non-inferior to mitral valve surgery regarding the composite outcomes of death, recurrent heart failure hospitalizations, stroke, re-intervention on the valve, or assist device implantation. Additionally, it offers certain safety advantages. Interpretations: European guidelines recommend transcatheter intervention for secondary mitral regurgitation only in patients who are not suitable for surgery, whereas American guidelines suggest surgical intervention only for patients who are anatomically unsuitable for transcatheter repair. This study may assist in guiding treatment decisions by providing insights into the safety outcomes of transcatheter edge-to-edge mitral valve repair compared to mitral valve surgery. |
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