TY - JOUR
T1 - Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty
T2 - Insight From an International Registry
AU - Mangieri, Antonio
AU - Melillo, Francesco
AU - Montalto, Claudio
AU - Denti, Paolo
AU - Praz, Fabien
AU - Sala, Alessandra
AU - Winkel, Mirjam G.
AU - Taramasso, Maurizio
AU - Tagliari, Ana Paula
AU - Fam, Neil P.
AU - Rubbio, Antonio Popolo
AU - De Marco, Federico
AU - Bedogni, Francesco
AU - Toggweiler, Stefan
AU - Schofer, Joachim
AU - Brinkmann, Christina
AU - Sievert, Horst
AU - Van Mieghem, Nicolas M.
AU - Ooms, Joris F.
AU - Paradis, Jean Michel
AU - Rodés-Cabau, Josep
AU - Brochet, Eric
AU - Himbert, Dominique
AU - Perl, Leor
AU - Kornowski, Ran
AU - Ielasi, Alfonso
AU - Regazzoli, Damiano
AU - Baldetti, Luca
AU - Masiero, Giulia
AU - Tarantini, Giuseppe
AU - Latib, Azeem
AU - Laricchia, Alessandra
AU - Gattas, Angie
AU - Tchetchè, Didier
AU - Dumonteil, Nicolas
AU - Francesco, Giannini
AU - Agricola, Eustachio
AU - Montorfano, Matteo
AU - Lurz, Philipp
AU - Crimi, Gabriele
AU - Maisano, Francesco
AU - Colombo, Antonio
N1 - Publisher Copyright:
© 2022 American College of Cardiology Foundation
PY - 2022/2/28
Y1 - 2022/2/28
N2 - Objectives: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. Background: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. Methods: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. Results: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. Conclusions: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.
AB - Objectives: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. Background: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. Methods: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. Results: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. Conclusions: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.
KW - MitraClip
KW - cardiac surgery
KW - mitral regurgitation
KW - mitral valve
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U2 - 10.1016/j.jcin.2021.11.040
DO - 10.1016/j.jcin.2021.11.040
M3 - Article
C2 - 35210047
AN - SCOPUS:85124241290
SN - 1936-8798
VL - 15
SP - 411
EP - 422
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 4
ER -