Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicentre registry
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Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicentre registry. / Kuhn, Christian; Frerker, Christian; Meyer, Anne-Kathrin; Kurz, Thomas; Schäfer, Ulrich; Deuschl, Florian; Abdel-Wahab, Mohammed; Schewel, Dimitry; Elghalban, Ahmed; Kuck, Karl-Heinz; Frey, Norbert; Frank, Derk.
in: EUROINTERVENTION, Jahrgang 14, Nr. 3, 08.06.2018, S. e301-e305.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicentre registry
AU - Kuhn, Christian
AU - Frerker, Christian
AU - Meyer, Anne-Kathrin
AU - Kurz, Thomas
AU - Schäfer, Ulrich
AU - Deuschl, Florian
AU - Abdel-Wahab, Mohammed
AU - Schewel, Dimitry
AU - Elghalban, Ahmed
AU - Kuck, Karl-Heinz
AU - Frey, Norbert
AU - Frank, Derk
PY - 2018/6/8
Y1 - 2018/6/8
N2 - 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.
AB - 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.
KW - Aged, 80 and over
KW - Aortic Valve
KW - Aortic Valve Stenosis
KW - Heart Valve Prosthesis
KW - Humans
KW - Prosthesis Design
KW - Registries
KW - Transcatheter Aortic Valve Replacement
KW - Treatment Outcome
U2 - 10.4244/EIJ-D-17-01153
DO - 10.4244/EIJ-D-17-01153
M3 - SCORING: Journal article
C2 - 29808820
VL - 14
SP - e301-e305
JO - EUROINTERVENTION
JF - EUROINTERVENTION
SN - 1774-024X
IS - 3
ER -