Transapical Beating-Heart Mitral Valve Replacement in Austria

Background: Transcatheter transapical mitral valve replacement with a novel system anchored with a tether in the apical incision was recently CE marked in the European Union. We report the first 15 patients implanted in Austria since CE mark approval in two centers.

Method: All patients were implanted according to the manufacturer's specifications after thorough heart team discussion and exclusion of alternative treatment options. Patients were included in local registries and follow-up was performed according to current guidelines.

Results: Fifteen patients (7 females, 47%) with a mean age 75 ± 8 years and a body mass index of 24.5 ± 4.3 kg/m² were implanted and analyzed. No failed implantation was recorded. Surgical risk was increased (STS score: 7.9 ± 2.7%; EuroSCORE II: 9.3 ± 4.2%), and all patients were in NYHA class III prior to implantation. Preoperative NT-proBNP was increased to 6,118 ± 7,736 pg/mL. Patients with mitral annular calcification and/or mitral stenosis were also included after direct discussion of the anatomy, predilatation was performed if required with a 28 mm balloon. All patients were successfully implanted with the prespecified size. No relevant left ventricular outflow tract obstruction occurred in any patient. Two patients required retrieval and repositioning due to incomplete unfolding or dislocation in the left atrium. One patient received a transapical TAVR in the same procedure prior to mitral valve implantation.

No mitral regurgitation was reported and a mild paravalvular leakage without clinical consequences was seen in four patients (27%).

All patients survived until 30 days after the procedure, but one patient died in sepsis after 46 days, leading to an in-hospital mortality of 7%. Intensive care and hospital stay were 4.4 ± 7.6 and 18.6 ± 15.4 days, respectively. No further interventions were required and patients are currently under long-term follow-up schedule, which will be presented during the meeting.

Conclusion: The novel, CE marked transapical mitral valve replacement system is a valid option to treat patients with contraindication for conventional surgery and/or transcatheter edge-to-edge repair. Furthermore, functional results are excellent and might outperform the edge-to-edge repair. This surgical procedure will probably expand in the near future and long-term results are awaited.