According to the European Society of Cardiology, around 18 million people worldwide suffer from mitral valve insufficiency. The mitral valve is the valve between the left atrium and the left ventricle. The two leaflets of the valve close when oxygen-rich blood is pumped from the lungs into the left ventricle, preventing blood from returning to the atrium. In the case of mitral valve insufficiency, the valve leaflets no longer close properly for various reasons. As a result, blood flows from the left ventricle back into the atrium with every heartbeat. This leads to increasing symptoms in affected patients, which can even lead to heart failure (cardiac insufficiency). Functional mitral valve insufficiency is caused by a weakening of the heart muscle, which leads to a change in the heart structure and thus to a functional disorder of the valve.
A leaky mitral valve is often found in patients with heart failure and worsens life expectancy. In addition, mitral regurgitation leads to worsening heart failure symptoms with hospitalisation. The minimally invasive MitraClip procedure for repairing the mitral valve has been available since 2008. In this procedure, a small clip is guided through the inguinal vein to the heart via a catheter and attached to the leaking valve. The clip brings the valve leaflets closer together and thus improves their closing function. This reduces the backflow of blood and relieves the heart, which in turn alleviates the symptoms of heart failure.
‘The question of whether catheter-based clip treatment reduces patient mortality and the need for hospital treatment was previously unclear, as there were two controversial studies: while the Mitra-FR study showed no benefit of the procedure, the COAPT study, on the other hand, indicated a clear benefit,’ says Prof. Dr Gerd Hasenfuß, Director of the Department of Cardiology and Pneumology and Chairman of the Heart Centerat the University Medical Center Göttingen (UMG). ‘With the RESHAPE-HF2 study, which was initiated and coordinated by the UMG Heart Centre, we wanted to provide clarity. The MitraClip procedure and other innovative procedures for the treatment of heart valve diseases are carried out with a high level of expertise at the UMG Heart Center.’
A research team from the Heart Centre of the UMG and the German Heart Centre of the Charité (DHZC) led by Prof. Dr Stefan Anker, cardiologist at the Clinic for Cardiology, Angiology and Intensive Care Medicine (Campus Virchow-Klinikum) of the Deutsches Herzzentrum der Charité, formerly Professor of Innovative Clinical Trials at the UMG, Prof. Dr Wolfgang Schillinger, Chief Physician Medicine I (Cardiology, Pneumology and Intensive Care Medicine) at the Helios Albert-Schweitzer-Klinikum Northeim, former senior physician in the Department of Cardiology and Pneumology at the UMG and Prof. Hasenfuß have now published the results of the RESHAPE-HF2 study.
Prof Dr Ulf Landmesser, Deputy Medical Director of the DHZC and Director of the Clinic for Cardiology, Angiology and Intensive Care Medicine (Benjamin Franklin Campus) is a member of the study's Steering Committee. One of the co-authors is Prof Dr Friedrich Köhler, Head of the Telemedicine Department at the DHZC.
The study showed that the number of hospital admissions was reduced by 41 per cent after treatment with the MitraClip and that the quality of life of those affected was significantly improved. ‘The results of the RESHAPE-HF2 study impressively demonstrate how the MitraClip procedure can help patients with severe heart failure and mitral regurgitation,’ says Prof Dr Stefan Anker. ‘This minimally invasive method is a valuable alternative, especially for patients who are not suitable for surgical intervention.’
At this year's European Society of Cardiology Congress (ESC Congress) in London, the researchers involved presented the most important results, which have now also been published in the renowned ‘New England Journal of Medicine’.
Original publication: A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation (Reshape-HF2) (Anker et al., New Engl J Med, 2024)
Source: joint press release of the UMG and DHZC (in German only)
