TY - JOUR
T1 - Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification
AU - Yoon, Sung Han
AU - Whisenant, Brian K.
AU - Bleiziffer, Sabine
AU - Delgado, Victoria
AU - Dhoble, Abhijeet
AU - Schofer, Niklas
AU - Eschenbach, Lena
AU - Bansal, Eric
AU - Murdoch, Dale J.
AU - Ancona, Marco
AU - Schmidt, Tobias
AU - Yzeiraj, Ermela
AU - Vincent, Flavien
AU - Niikura, Hiroki
AU - Kim, Won Keun
AU - Asami, Masahiko
AU - Unbehaun, Axel
AU - Hirji, Sameer
AU - Fujita, Buntaro
AU - Silaschi, Miriam
AU - Tang, Gilbert H.L.
AU - Kuwata, Shingo
AU - Wong, S. Chiu
AU - Frangieh, Antonio H.
AU - Barker, Colin M.
AU - Davies, James E.
AU - Lauten, Alexander
AU - Deuschl, Florian
AU - Nombela-Franco, Luis
AU - Rampat, Rajiv
AU - Nicz, Pedro Felipe Gomes
AU - Masson, Jean Bernard
AU - Wijeysundera, Harindra C.
AU - Sievert, Horst
AU - Blackman, Daniel J.
AU - Gutierrez-Ibanes, Enrique
AU - Sugiyama, Daisuke
AU - Chakravarty, Tarun
AU - Hildick-Smith, David
AU - De Brito, Fabio Sandoli
AU - Jensen, Christoph
AU - Jung, Christian
AU - Smalling, Richard W.
AU - Arnold, Martin
AU - Redwood, Simon
AU - Kasel, Albert Markus
AU - Maisano, Francesco
AU - Treede, Hendrik
AU - Ensminger, Stephan M.
AU - Kar, Saibal
AU - Kaneko, Tsuyoshi
AU - Pilgrim, Thomas
AU - Sorajja, Paul
AU - Van Belle, Eric
AU - Prendergast, Bernard D.
AU - Bapat, Vinayak
AU - Modine, Thomas
AU - Schofer, Joachim
AU - Frerker, Christian
AU - Kempfert, Joerg
AU - Attizzani, Guilherme F.
AU - Latib, Azeem
AU - Schaefer, Ulrich
AU - Webb, John G.
AU - Bax, Jeroen J.
AU - Makkar, Raj R.
N1 - Funding Information:
Conflict of interest: The department of Cardiology of the Leiden University Medical Center received unrestricted research grants from Edwards Lifesciences, Biotronik, Medtronic and Boston Scientific. B.K.W. has served as a consultant for Edwards Lifesciences and Boston Scientific. S.B. has serves as a consultant to Medtronic and as a proctor for JenaValve, Highlife, and Boston Scientific. V.D. has received speaking fees from Abbott Vascular. A.D. has served as a proctor and consultant for Abbott Vascular, Edward Lifesciences, and Keystone Heart; physician review Committee for Keystone Heart REFLECT Trial. N.S. received travel compensation from Edwards Lifesciences and St. Jude Medical, as well as speaker honoraria and travel compensation from Boston Scientific. T.S. has received speaker honoraria and travel grants from Edwards and Medtronic, as well as travel grants from Boston Scientific. W.-K.K. has served as proctors for Symmetis and St. Jude Medical. A.U. and J.K. have served as proctors for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. G.H.L.T. has served as a proctor for Edwards Lifesciences. C.M.B. is on the Advisory Board of Medtronic and Boston Scientific and on the Speakers’ Bureau of Abbott Vascular. J.E.D. has served as a consultant for Edwards and the Medtronic advisory board. A.L. has received a consulting fees from P&F. L.N.-F. has served as a proctor for Abbott Vascular and has received speaking fees from Edwards Lifesciences. J.-B.M. has served as a consultant for Edwards Lifesciences. F.D. has served as a proctor and consultant for Edwards Lifesciences and Neovasc and received a travel grant from Abbott, Boston Scientific, Edwards Lifesciences, and Neovasc, and participated in clinical trials (TIARA II CE Mark trial and TENDYNE CE Mark trial). H.C.W. has received research grants from Edwards Lifesciences and Medtronic. H.S. has received study honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott Vascular, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Celonova, Cibiem, Comed B.V., CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Renal Guard, Rox Medical, Vascular Dynamics, and Vivasure Medical. D.J.B. and D.H.-S. have served as a proctor for Medtronic and Boston Scientific. F.S.B.Jr has served as proctor for Edwards Lifesciences and Medtronic. T.C. has
Funding Information:
received research support from Edwards Lifesciences. S.R. and B.D.P. have received speaker fees from Edwards Lifescience, Boston Scientific and Symetis. M.A. has received travel compensation from Edwards Lifesciences, served as a proctor for Edwards Lifesciences, and a proctor and consultant for St. Jude Medical and received speaker honoraria from JenaValve. A.M.K. has served as a consultant and proctor for Edwards Lifesciences and received research support from Edwards Lifesciences. F.M. has served as a consultant for Edwards Lifesciences, Medtronic, St. Jude Medical, Abbott Vascular, and Veltech and has received royalties from Edwards Lifesciences. H.T. has served as a proctor and consultant for Edwards Lifesciences. S.M.E. has served as a proctor for JenaValve, received speaker Honoria from Edwards Lifesciences, JenaValve, and Symetis, and received travel compensation from Edwards Lifesciences, JenaValve, and Symetis. S.K. has received research grants and consulting fees from Abbott Vascular and St. Jude Medical. T.K. has served as a proctor and speaker for Edwards Lifescience, Abbott and Medtronic. T.P. has received research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik, and has received speaker fees from Boston Scientific and Biotronik. P.S. has served as a consultant for Abbott Vascular, Medtronic, Boston Scientific, and Integer and has received research grants and speakers fee from Abbott Vascular, Medtronic, Boston Scientific, and Integer. V.B. has served as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and 4tech. T.M. has served as a consultant for Boston Scientific. C.F. has received speaker honoraria and travel grants from Edwards Lifesciences, Medtronic and Abbott Vascular. G.F.A. has served as a proctor for Edwards Lifesciences and Medtronic, on the speaker Bureau for Medtronic and Abbott Vascular, and as a consultant to St. Jude Medical. A.L. has served as a consultant for Medtronic, Abbott Vascular and Edwards Lifesciences. U.S. has served as a proctor and consultant for Edwards Lifesciences, Jena Valve Technology, Boston Scientific, St. Jude Medical, Medtronic, Biotronik and has received travel support and speakers honoraria from Edwards Lifesciences, Jena Valve Technology, Boston Scientific, St. Jude Medical, Medtronic, Biotronik, Direct Flow Medical. J.G.W. has served as a consultant to and received research funding from Edwards Lifesciences. R.R.M. has received grants from Edwards Lifesciences and personal fees from St. Jude Medical and Medtronic. R.W.S has received consulting fees and research support from Abbott Vascular and Edwards Lifesciences. All other authors declared no conflict of interest.
Publisher Copyright:
© 2018 The Author(s). All rights reserved.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019
Y1 - 2019
N2 - Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P< 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P< 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P< 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P<0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P< 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P= 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.
AB - Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P< 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P< 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P< 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P<0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P< 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P= 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.
UR - http://www.scopus.com/inward/record.url?scp=85060970112&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehy590
DO - 10.1093/eurheartj/ehy590
M3 - Journal articles
C2 - 30357365
AN - SCOPUS:85060970112
SN - 0195-668X
VL - 40
SP - 441
EP - 451
JO - European Heart Journal
JF - European Heart Journal
IS - 5
ER -