Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1-year results from the CHOICE-MI registry.
Medical therapy
Mitral regurgitation
Mitral valve surgery
Transcatheter edge-to-edge repair
Transcatheter mitral valve implantation
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
revised:
21
03
2022
received:
24
01
2022
accepted:
21
03
2022
pubmed:
27
3
2022
medline:
24
5
2022
entrez:
26
3
2022
Statut:
ppublish
Résumé
Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0-83.0, EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
887-898Subventions
Organisme : British Heart Foundation
ID : FS/CRTF/22/24312
Pays : United Kingdom
Investigateurs
Daniel Kalbacher
(D)
Stefan Blankenberg
(S)
Benedikt Koell
(B)
Niklas Schofer
(N)
Dirk Westermann
(D)
Marcel Weber
(M)
Johanna Vogelhuber
(J)
François Pontana
(F)
Eric Van Belle
(E)
Sung-Han Yoon
(SH)
Anthony Chuang
(A)
Robert H Boone
(RH)
Paul Jansz
(P)
Ning Song
(N)
Sara Hungerford
(S)
Stephan Windecker
(S)
David Reineke
(D)
Michael Reardon
(M)
Neal S Kleiman
(NS)
Alessandra Sala
(A)
Eustachio Agricola
(E)
Francesco Maisano
(F)
Ronak Rajani
(R)
Bernard Prendergast
(B)
Kjell A Rein
(KA)
Maria I Koerber
(MI)
Laurin Ochs
(L)
Keti Vitanova
(K)
Magdalena Erlebach
(M)
Pinak Shah
(P)
Morgan Harloff
(M)
Guillaume Bonnet
(G)
Mathieu Pernot
(M)
Melchior Jonveaux
(M)
Felix Kreidel
(F)
Tobias Ruf
(T)
Matteo Pozzi
(M)
Razvan Dragulescu
(R)
Tomas Holubec
(T)
Heike Strohschnitter
(H)
Claudia Walther
(C)
Alberto Pozzoli
(A)
Ivan Wong
(I)
Kai Friedrichs
(K)
Mark Peterson
(M)
Axel Unbehaun
(A)
Markus Kofler
(M)
Informations de copyright
© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
Références
Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, Gentile F, et al. 2020 ACC/AHA Guideline for the management of patients with valvular heart disease. J Am Coll Cardiol. 2021;77:e25-e197.
Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022;43:561-632.
Mirabel M, Iung B, Baron G, Messika-Zeitoun D, Détaint D, Vanoverschelde JL, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28:1358-65.
Goel SS, Bajaj N, Aggarwal B, Gupta S, Poddar KL, Ige M, et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine the potential role of mitraclip for this unmet need. J Am Coll Cardiol. 2014;63:185-6.
Sorajja P, Vemulapalli S, Feldman T, Mack M, Holmes DR, Stebbins A, et al. Outcomes with transcatheter mitral valve repair in the United States: an STS/ACC TVT Registry report. J Am Coll Cardiol. 2017;70:2315-27.
Chiarito M, Pagnesi M, Martino EA, Pighi M, Scotti A, Biondi-Zoccai G, et al. Outcome after percutaneous edge-to-edge mitral repair for functional and degenerative mitral regurgitation: a systematic review and meta-analysis. Heart. 2018;104:306-12.
Reichart D, Kalbacher D, Rübsamen N, Tigges E, Thomas C, Schirmer J, et al. The impact of residual mitral regurgitation after MitraClip therapy in functional mitral regurgitation. Eur J Heart Fail. 2020;22:1840-8.
Ludwig S, Sedighian R, Weimann J, Koell B, Waldschmidt L, Schäfer A, et al. Management of patients with mitral regurgitation ineligible for standard therapy undergoing TMVI screening. EuroIntervention. 2022. https://doi.org/10.4244/EIJ-D-21-00708.
Ben-Ali W, Ibrahim R, Rodès-Cabeau J, von Bardeleben RS, Mylotte D, Granada J, et al. Transcatheter mitral valve implantation systematic review: focus on transseptal approach and mitral annulus calcification. Curr Cardiol Rep. 2021;23:37.
Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, et al. 2-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation. J Am Coll Cardiol. 2021;78:1847-59.
Zahr F, Song HK, Chadderdon SM, Gada H, Mumtaz M, Byrne T, et al. Thirty-day outcomes following transfemoral transseptal transcatheter mitral valve replacement: Intrepid TMVR Early Feasibility Study results. JACC Cardiovasc Interv. 2022;15:80-9.
Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, et al. Early experience with new transcatheter mitral valve replacement. J Am Coll Cardiol. 2018;71:12-21.
Ludwig S, Ruebsamen N, Deuschl F, Schofer N, Kalbacher D, Schaefer A, et al. Screening for transcatheter mitral valve replacement: a decision tree algorithm. EuroIntervention. 2020;16:251-8.
Coisne A, Pontana F, Tchétché D, Richardson M, Longère B, Vahdat O, et al. Transcatheter mitral valve replacement: factors associated with screening success and failure. EuroIntervention. 2019;15:e983-9.
Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 2: Endpoint definitions: a consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015;66:308-21.
Sorajja P, Moat N, Badhwar V, Walters D, Paone G, Bethea B, et al. Initial feasibility study of a new transcatheter mitral prosthesis: the first 100 patients. J Am Coll Cardiol. 2019;73:1250-60.
Mark H, Brown RA, Lal S, Sathananthan J, Ye J, Cheung A, et al. Transcatheter mitral valve replacement: an update on current techniques, technologies, and future directions. JACC Cardiovasc Interv. 2021;14:489-500.
Blackstone EH, Suri RM, Rajeswaran J, Babaliaros V, Douglas PS, Fearon WF, et al. Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement. Circulation. 2015;131:1989-2000.
Gössl M, Thourani VH, Babaliaros V, Conradi L, Chehab B, Dumonteil N, et al. Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification. EuroIntervention. 2021. https://doi.org/10.4244/EIJ-D-21-00745.
Sorajja P, Gössl M, Babaliaros V, Rizik D, Conradi L, Bae R, et al. Novel transcatheter mitral valve prosthesis for patients with severe mitral annular calcification. J Am Coll Cardiol. 2019;74:1431-40.
Global EXPAND: Next-Gen MitraClip Cuts MR, Boosts QoL at 1 Year. October 16, 2020. https://www.tctmd.com/news/global-expand-next-gen-mitraclip-cuts-mr-boosts-qol-1-year. Accessed 30 March 2022.
Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38:2739-91.
Niikura H, Gössl M, Kshettry V, Olson S, Sun B, Askew J, et al. Causes and clinical outcomes of patients who are ineligible for transcatheter mitral valve replacement. JACC Cardiovasc Interv. 2019;12:196-204.
Ludwig S, Koell B, Sedighian R, Weimann J, Schofer N, Schaefer A, et al. Characteristics and outcomes of patients ineligible for transcatheter mitral valve replacement (TMVR): implications for future device innovation. J Invasive Cardiol. 2021;33:E294-301.
Coats AJS, Anker SD, Baumbach A, Alfieri O, von Bardeleben RS, Bauersachs J, et al. The management of secondary mitral regurgitation in patients with heart failure: a joint position statement from the Heart Failure Association (HFA), European Association of Cardiovascular Imaging (EACVI), European Heart Rhythm Association (EHRA), and European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur Heart J. 2021;42:1254-69.