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Outcomes After HighLife Trans-Septal Mitral Valve Replacement
Quick Takes
- The HighLife transcatheter mitral valve system is a two-component system consisting of a subannular polymer ring, in which the nitinol frame-based trileaflet bovine mitral bioprosthesis is sutured in.
- The current study using the transfemoral approach, included predominantly male patients with mostly functional MR and demonstrated technical success rates of 90% in a highly selective group of patients.
- Among patients surviving to 1 year, all patients had less than grade 2 MR, mean gradient was 5 mm Hg, and none had LVOT obstruction or need for re-intervention. Major bleeding and vascular complication rate was 13%, mortality rate was 17%, and procedural success at 30 days was 70%.
Study Questions:
What is the safety and performance of the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system among patients with moderate to severe or severe symptomatic mitral regurgitation (MR) and high surgical risk?
Methods:
The study was a prospective, multicenter, nonrandomized feasibility study evaluating the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR. Echocardiographic data were assessed by an independent core laboratory at 1 year.
Results:
Thirty patients (mean age 75.6 years, 27% females, median Society of Thoracic Surgeons score 5.5%) with severe MR (89% secondary MR, mean left ventricular ejection fraction 41%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system could be implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, five patients (17%) had died. None of the implanted patients required mitral valve re-intervention. All implanted patients had none/trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract (LVOT) obstruction (mean gradient 2.0 mm Hg).
Conclusions:
One-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no LVOT obstruction, and no need for mitral valve re-intervention. Additional patient outcomes and longer follow-up is needed to confirm these findings
Perspective:
The HighLife transcatheter mitral valve system is a two-component system consisting of a subannular polymer ring, in which the nitinol frame-based trileaflet bovine mitral bioprosthesis is sutured in. A prior study using this system was via transapical approach. The current study using the transfemoral approach, included predominantly male patients with mostly functional MR and demonstrated technical success rates of 90% in a highly selective group of patients. Among patients surviving to 1 year, all patients had less than grade 2 MR, mean gradient of 5 mm Hg, and none had LVOT obstruction or need for re-intervention. Major bleeding and vascular complication rate was 13%, mortality rate was 17%, and procedural success at 30 days was 70%. Additional data in a larger number of patients with other etiologies of MR and comparison with mitral transcatheter edge-to-edge repair will be needed prior to clinical use of the HighLife transcatheter mitral valve system.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Heart Valve Diseases, Mitral Valve Insufficiency
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