Sung-Han Yoon1, Brian K Whisenant2, Sabine Bleiziffer3, Victoria Delgado4, Niklas Schofer5, Lena Eschenbach3, Buntaro Fujita6, Rahul Sharma1, Marco Ancona7, Ermela Yzeiraj8, Stefano Cannata9, Colin Barker10, James E Davies11, Antonio H Frangieh12, Florian Deuschl5, Tomaz Podlesnikar4, Masahiko Asami13, Abhijeet Dhoble14, Anthony Chyou15, Jean-Bernard Masson16, Harindra C Wijeysundera17, Daniel J Blackman18, Rajiv Rampat19, Maurizio Taramasso20, Enrique Gutierrez-Ibanes21, Tarun Chakravarty1, Guiherme F Attizzani22, Tsuyoshi Kaneko23, S Chiu Wong15, Horst Sievert24, Fabian Nietlispach20, David Hildick-Smith19, Luis Nombela-Franco25, Lenard Conradi26, Christian Hengstenberg27, Michael J Reardon10, Albert Markus Kasel12, Simon Redwood9, Antonio Colombo7, Saibal Kar1, Francesco Maisano20, Stephan Windecker13, Thomas Pilgrim13, Stephan M Ensminger6, Bernard D Prendergast9, Joachim Schofer8, Ulrich Schaefer5, Jeroen J Bax4, Azeem Latib7, Raj R Makkar28. 1. Department of Interventional Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California. 2. Division of Cardiovascular Diseases, Intermountain Heart Institute, Salt Lake City, Utah. 3. Clinic for Cardiovascular Surgery, German Heart Center, Munich, Germany. 4. Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. 5. Department of General and Interventional Cardiology, University Heart Center, Hamburg, Germany. 6. Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany. 7. Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, San Raffaele Hospital, Milan, Italy. 8. Hamburg University Cardiovascular Center, Hamburg, Germany. 9. Department of Cardiology, St. Thomas' Hospital, London, United Kingdom. 10. Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas. 11. Division of Cardiac and Thoracic Surgery, University of Alabama-Birmingham, Birmingham, Alabama. 12. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 13. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 14. Department of Cardiology, University of Texas Health Science Center, Houston, Texas. 15. Greenberg Division of Cardiology, New York-Presbyterian Hospital, Weil Cornell Medicine, New York, New York. 16. Division of Cardiology, Centre Hospitalier de l'université de Montreal, Montreal, Quebec, Canada. 17. Division of Cardiology, Sunnybrook Health Science Centre, Toronto, Ontario, Canada. 18. Cardiology Department, Leeds Teaching Hospital, Leeds, United Kingdom. 19. Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom. 20. University Heart Center, University Hospital Zurich, Zurich, Switzerland. 21. Department of Cardiology, Hospital General Universitario Gregorio Maranon, Madrid, Spain. 22. The Valve and Structural Heart Interventional Center, University Hospitals Case Medical Center, Cleveland, Ohio. 23. Division of Cardiac Surgery, Brigham and Women's Hospital, Boston, Massachusetts. 24. Department of Cardiology and Vascular Medicine, CardioVascular Center, Frankfurt, Germany. 25. Division of Cardiology, Hospital Clinicio San Carlos, Madrid, Spain. 26. Department of Cardiothoracic Surgery, University Heart Center Hamburg, Hamburg, Germany. 27. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany. 28. Department of Interventional Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California. Electronic address: raj.makkar@cshs.org.
Abstract
BACKGROUND: Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. OBJECTIVES: This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). METHODS: From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. RESULTS: A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). CONCLUSIONS: The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.
BACKGROUND: Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. OBJECTIVES: This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). METHODS: From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. RESULTS: A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). CONCLUSIONS: The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.
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