Antonio Mangieri1, Francesco Melillo2, Claudio Montalto3, Paolo Denti3, Fabien Praz4, Alessandra Sala3, Mirjam G Winkel4, Maurizio Taramasso5, Ana Paula Tagliari5, Neil P Fam6, Antonio Popolo Rubbio7, Federico De Marco7, Francesco Bedogni7, Stefan Toggweiler8, Joachim Schofer9, Christina Brinkmann9, Horst Sievert10, Nicolas M Van Mieghem11, Joris F Ooms11, Jean-Michel Paradis12, Josep Rodés-Cabau12, Eric Brochet13, Dominique Himbert13, Leor Perl14, Ran Kornowski14, Alfonso Ielasi15, Damiano Regazzoli16, Luca Baldetti2, Giulia Masiero17, Giuseppe Tarantini17, Azeem Latib18, Alessandra Laricchia19, Angie Gattas20, Didier Tchetchè20, Nicolas Dumonteil20, Giannini Francesco21, Eustachio Agricola3, Matteo Montorfano3, Philipp Lurz22, Gabriele Crimi23, Francesco Maisano2, Antonio Colombo16. 1. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy; IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy. Electronic address: antonio.mangieri@gmail.com. 2. IRCCS, San Raffaele Scientific Institute, Milan, Italy. 3. Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 4. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. 5. Cardiac Surgery Department, University Hospital of Zurich, University of Zurich, Zurich, Switzerland. 6. Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 7. Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Italy. 8. Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland. 9. MVZ-Department Structural Heart Disease, Asklepios Clinic St Georg, Hamburg, Germany. 10. Cardiovascular Center Frankfurt, Frankfurt, Germany and Anglia Ruskin University, Chelmsford, United Kingdom. 11. Department of Interventional Cardiology, Erasmus University Medical Centre, Rotterdam, the Netherlands. 12. Quebec Heart & Lung Institute, Laval University, Québec City, Québec, Canada. 13. Cardiology Department University Hospital Bichat, Paris, France. 14. Rabin Medical Center, Petah Tikva, Israel. 15. Istituto Clinico Sant'Ambrogio, Milan, Italy. 16. IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy. 17. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy. 18. Department of Cardiology, Montefiore Medical Center, Bronx, New York, USA. 19. Department of cardiology, Melegnano Hospital, Milan, Italy. 20. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France. 21. Maria Cecilia Hospital, GVM care and research, Cotignola, Italy. 22. Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany. 23. Cardiovascular Disease Unit, Istituto di Ricerca e Cura a Carattere Scientifico Ospedale Policlinico San Martino, IRCCS Italian Cardiology Network, Genova, Italy.
Abstract
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.
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.