TY - JOUR
T1 - Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system
T2 - 1 year outcomes
AU - Messika-Zeitoun, David
AU - Nickenig, Georg
AU - Latib, Azeem
AU - Kuck, Karl Heinz
AU - Baldus, Stephan
AU - Schueler, Robert
AU - La Canna, Giovanni
AU - Agricola, Eustachio
AU - Kreidel, Felix
AU - Huntgeburth, Michael
AU - Zuber, Michel
AU - Verta, Patrick
AU - Grayburn, Paul
AU - Vahanian, Alec
AU - Maisano, Francesco
N1 - Funding Information:
Conflict of interest: D.M.-Z. is a consultant for Edwards Lifesciences, Mardil and Cardiawave and receives research grants from Edwards Lifesciences and Abbott vascular. G.N: none. A.L. is consultant Abbott Vascular, Medtronic and Mitraltech and receives research grants from Abbott Vascular, Medtronic, Edwards Lifesciences and Mitraltech. K.-H. K. is consultant for St. Jude Medical, Abbott Vascular and Medtronic. S.B., R.S. , and G.L.C. none. E.A.: honoraria from Edwards Lifesciences. F.K. is consultant for Edwards LifeSciences, Abbott and Cardiac Implants. M.H.: none. M.Z. is a proctor for Valtech. P.V. is an Edwards Lifesciences employee. P.G. reports grants from ValTech Cardio (now Edwards Lifesciences), during the conduct of the study; grants and personal fees from Abbott Vascular, grants and personal fees from Edwards Lifesciences, grants and personal fees from Medtronic, other from Neochord, outside the submitted work. A.V. is consultant for Edwards Lifesciences, Abbott vascular and Mitraltech. F.M. is consultant Edwards Lifesciences and has financial interest in Valtechcardio and Edwards Lifesciences.
Publisher Copyright:
© 2018 The Author(s). All rights reserved.
PY - 2019/2/1
Y1 - 2019/2/1
N2 - Aims: The CardiobandTM (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016. Methods and results: Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guidelinerecommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year [but worsened by at least one grade in 11 patients (22%)]. Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (-19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01). Conclusion: In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.
AB - Aims: The CardiobandTM (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016. Methods and results: Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guidelinerecommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year [but worsened by at least one grade in 11 patients (22%)]. Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (-19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01). Conclusion: In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.
KW - Mitral regurgitation
KW - Transcatheter therapy
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U2 - 10.1093/eurheartj/ehy424
DO - 10.1093/eurheartj/ehy424
M3 - Article
C2 - 30124798
AN - SCOPUS:85057765785
SN - 0195-668X
VL - 40
SP - 466
EP - 472
JO - European heart journal
JF - European heart journal
IS - 5
ER -