TY - JOUR
T1 - Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system
T2 - Early results of the feasibility trial
AU - Maisano, Francesco
AU - Taramasso, Maurizio
AU - Nickenig, Georg
AU - Hammerstingl, Christoph
AU - Vahanian, Alec
AU - Messika-Zeitoun, David
AU - Baldus, Stephan
AU - Huntgeburth, Michael
AU - Alfieri, Ottavio
AU - Colombo, Antonio
AU - La Canna, Giovanni
AU - Agricola, Eustachio
AU - Zuber, Michel
AU - Tanner, Felix C.
AU - Topilsky, Yan
AU - Kreidel, Felix
AU - Kuck, Karl Heinz
N1 - Publisher Copyright:
© 2015 Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: [email protected].
PY - 2016/3/7
Y1 - 2016/3/7
N2 - Aims Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. Methods and results The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. Conclusions This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.
AB - Aims Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. Methods and results The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. Conclusions This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.
KW - Direct annuloplasty
KW - Secondary mitral regurgitation
KW - Transcatheter mitral repair
UR - http://www.scopus.com/inward/record.url?scp=84962191189&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehv603
DO - 10.1093/eurheartj/ehv603
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C2 - 26586779
AN - SCOPUS:84962191189
SN - 0195-668X
VL - 37
SP - 817
EP - 825
JO - European Heart Journal
JF - European Heart Journal
IS - 10
ER -