https://doi.org/10.1007/s00392-025-02625-4
1Universitätsklinikum Ulm Klinik für Innere Medizin II Ulm, Deutschland; 2Perth Mount Hospital Perth, Australien; 3Medical University of Warsaw Warschau, Polen; 4Universitätsklinikum Bonn Medizinische Klinik und Poliklinik II Bonn, Deutschland; 5Clinique Pasteur Toulouse, Frankreich; 6Medical University of Silesia Department of Cardiology and Structural Heart Diseases Katovice, Polen; 7University Hospital Gasthuisberg Dept. of Cardiology Leuven, Belgien; 8Adelaide St Andrew's Hospital Adelaide, Australien; 9Princess Alexandra Hospital Brisbane, Australien; 10St Vincent's Hospital Cardiology Sydney, Australien; 11AZ Sint Jan Brügge, Belgien; 12CHU Rennes Rennes, Frankreich; 13Brighton and Sussex University Hospitals Sussex Cardiac Centre Brighton, Großbritannien; 14Macquarie University Hospital Sydney, Australien; 15McGill University Health Center Quebec, Kanada
BACKGROUND A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to edge repair because of high surgical risk and inappropriate mitral valve anatomy. 1-year outcomes have previously demonstrated high technical success, excellent MR reduction and good safety profile of the HighLife TransSeptal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR (HighLife Feasibility Study (HL-2018-01) in Europe/Australia; NCT 04029363).
METHODS This prospective, multicenter (13 international sites), non-randomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in 30 patients with at least moderate-to-severe symptomatic MR in a 2-year follow-up. Echocardiographic data were assessed by an independent core laboratory.
RESULTS Within the HighLife TSMVR Feasibility Study 30 patients (mean age 75.6 years, 27 % females, median STS 5.5%, mean LVEF 41%) with at least moderate-to-severe MR (90% secondary MR) were treated. In 90% technical success was achieved. No intraprocedural deaths, myocardial infarctions and strokes occurred. One patient experienced pericardial effusion and conversion to surgery.
During the 2-year follow-up, all implanted patients had persistent excellent MR reduction ≤1+. Mean prosthesis gradient was stable at 4.8 mmHg 2 years after TSMVR (compared to 5.1 mmHg after 1 year of follow-up). Patients had sustained symptom relief indicated by NYHA class I/II in 82% after 2 years compared to NYHA class III/IV in 50% before HighLife TSMVR. After 2 years, a total of 11 patients (37%) had died: 3 patients died within the first month after TSMVR, additional 2 patients in the time up to 1 year, and further 6 patients in the second year.
In the second year after HighLife TSMVR, none of the implanted patients needed mitral-valve reintervention or surgery; none had severe bleedings or developed relevant paravalvular leaks requiring closure. Valve thrombosis or hemolysis did not occur within the 2-year follow-up. Left ventricular outflow tract obstruction was absent throughout the 2-year follow-up after HighLife TSMVR.
CONCLUSION 2-year results from the HighLife TSMVR Feasibility Study demonstrate durable performance of the HighLife mitral valve prosthesis and sustained symptom relief.