AIMS: The recently released Medtronic CoreValve Evolut R 34 mm is the largest self-expanding transcatheter heart valve ever developed. Clinical data for this device size are scarce. We therefore aimed to evaluate the clinical performance and safety of the new device. METHODS AND RESULTS: We report on the first 101 consecutive patients treated with transfemoral transcatheter aortic valve implantation (TAVI) using the 34 mm Evolut R device in a multicentre registry. Clinical parameters were determined before the procedure and echocardiography was performed at baseline and discharge. VARC-2 criteria were assessed at 30 days. Mean age was 80.7 years; mean logistic EuroSCORE was 19.8%. Procedural duration was 71.6 min. Echocardiography at discharge revealed a mean AVA of 2.0 cm2, moderate aortic regurgitation (AR) in 4.0% and severe AR in 1.0%. VARC-2 device success was achieved in 92.1%, while the early safety endpoint occurred in 11 patients (10.9%). New permanent pacemakers were implanted in 17 patients (18.7%). Thirty-day mortality was 2.0%, a stroke occurred in 3.0%, with a disabling stroke in one patient. The incidence of major vascular complications and bleeding was 1.0% and 5.0%, respectively. CONCLUSIONS: Initial experience with the new self-expanding CoreValve Evolut R 34 mm valve is characterised by high procedural success, good haemodynamic performance and a low early complication rate.
AIMS: The recently released Medtronic CoreValve Evolut R 34 mm is the largest self-expanding transcatheter heart valve ever developed. Clinical data for this device size are scarce. We therefore aimed to evaluate the clinical performance and safety of the new device. METHODS AND RESULTS: We report on the first 101 consecutive patients treated with transfemoral transcatheter aortic valve implantation (TAVI) using the 34 mm Evolut R device in a multicentre registry. Clinical parameters were determined before the procedure and echocardiography was performed at baseline and discharge. VARC-2 criteria were assessed at 30 days. Mean age was 80.7 years; mean logistic EuroSCORE was 19.8%. Procedural duration was 71.6 min. Echocardiography at discharge revealed a mean AVA of 2.0 cm2, moderate aortic regurgitation (AR) in 4.0% and severe AR in 1.0%. VARC-2 device success was achieved in 92.1%, while the early safety endpoint occurred in 11 patients (10.9%). New permanent pacemakers were implanted in 17 patients (18.7%). Thirty-day mortality was 2.0%, a stroke occurred in 3.0%, with a disabling stroke in one patient. The incidence of major vascular complications and bleeding was 1.0% and 5.0%, respectively. CONCLUSIONS: Initial experience with the new self-expanding CoreValve Evolut R 34 mm valve is characterised by high procedural success, good haemodynamic performance and a low early complication rate.