Mayra Guerrero1, Marina Urena2, Dominique Himbert2, Dee Dee Wang3, Mackram Eleid4, Susheel Kodali5, Isaac George6, Tarun Chakravarty7, Moses Mathur8, David Holzhey9, Ashish Pershad10, H Kenith Fang11, Daniel O'Hair12, Noah Jones13, Vaikom S Mahadevan14, Nicolas Dumonteil15, Josep Rodés-Cabau16, Nicolo Piazza17, Enrico Ferrari18, Daniel Ciaburri19, Mohammed Nejjari20, Augustin DeLago21, Paul Sorajja22, Firas Zahr23, Vivek Rajagopal24, Brian Whisenant25, Pinak Bipin Shah26, Jan-Malte Sinning27, Adam Witkowski28, Helene Eltchaninoff29, Danny Dvir30, Bena Martin31, Guilherme F Attizzani32, Diego Gaia33, Nagela S V Nunes34, Amir-Ali Fassa35, Faraz Kerendi36, Gregory Pavlides37, Vijay Iyer38, Georges Kaddissi39, Christian Witzke40, James Wudel41, Gregory Mishkel42, Bryan Raybuck43, Chi Wang44, Ron Waksman45, Igor Palacios46, Alain Cribier29, John Webb30, Vinnie Bapat6, Mark Reisman8, Raj Makkar7, Martin Leon5, Charanjit Rihal4, Alec Vahanian2, William O'Neill3, Ted Feldman47. 1. Division of Cardiology, Evanston Hospital, Evanston, Illinois. Electronic address: mayraguerrero@me.com. 2. Department of Cardiology, Bichat Hospital, Paris, France. 3. Division of Cardiology, Henry Ford Hospital, Detroit, Michigan. 4. Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. 5. Division of Cardiology, Columbia University Medical Center, New York, New York. 6. Cardiothoracic Surgery, Columbia University Medical Center, New York, New York. 7. Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California. 8. Division of Cardiology, University of Washington Medical Center, Seattle, Washington. 9. Division of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany. 10. Division of Cardiology, Banner University Medical Center, Phoenix, Arizona. 11. Division of Cardiac Surgery, Banner University Medical Center, Phoenix, Arizona. 12. Division of Cardiac Surgery, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin. 13. Division of Cardiology, Mount Carmel East Hospital, Columbus, Ohio. 14. Division of Cardiology, University of California San Francisco, San Francisco, California. 15. Groupe CardioVasculaire Interventionnel (GCVI), Clinique Pasteur, Toulouse, France. 16. Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. 17. Division of Cardiology, Royal Victoria Hospital, Montreal, Quebec, Canada. 18. Division of Cardiac Surgery, Cardiocentro Ticino Foundation, Lugano, Switzerland. 19. Division of Cardiac Surgery, Saint Francis Medical Center, Peoria, Illinois. 20. Division of Cardiology, Centre Cardiologique du Nord, St. Denis, France. 21. Division of Cardiology, Albany Medical Center Hospital, Albany, New York. 22. Division of Cardiology, Abbott Northwestern Hospital, Minneapolis, Minnesota. 23. Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon. 24. Division of Cardiology, Piedmont Heart Institute, Atlanta, Georgia. 25. Division of Cardiology, Intermountain Heart Institute, Salt Lake City, Utah. 26. Division of Cardiology, Brigham and Women's Hospital, Boston, Massachusetts. 27. Division of Cardiology, Heart Center, University Hospital Bonn, Bonn, Germany. 28. Division of Cardiology, Institute of Cardiology, Warsaw, Poland. 29. Division of Cardiology, University of Rouen's Charles Nicolle Hospital, Rouen, France. 30. Division of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada. 31. Division of Cardiac Surgery, National Institute of Cardiovascular Diseases, Bratislava, Slovakia. 32. Division of Cardiology, University Hospitals Case Medical Center, Cleveland, Ohio. 33. Division of Cardiac Surgery, Escola Paulista de Medicina, São Paulo, Brazil. 34. Division of Cardiology, Complexo Hospitalar de Niteroi, Niteroi, Brazil. 35. Division of Cardiology, Hôpital de La Tour, Geneva, Switzerland. 36. Division of Cardiac Surgery, Heart Hospital of Austin, Austin, Texas. 37. Division of Cardiology, The Nebraska Medical Center, Omaha, Nebraska. 38. Division of Cardiology, Buffalo General Medical Center, Buffalo, New York. 39. Division of Cardiology, Cooper University Hospital, Camden, New Jersey. 40. Division of Cardiology, Einstein Medical Center, Philadelphia, Pennsylvania. 41. Division of Cardiac Surgery, Nebraska Heart Hospital, Lincoln, Nebraska. 42. Division of Cardiology, Prairie Heart Institute, Springfield, Illinois. 43. Division of Cardiology, INOVA Fairfax Hospital, Falls Church, Virginia. 44. Department of Biostatistics and Research Informatics, Research Institute, NorthShore University HealthSystem, Evanston, Illinois. 45. Division of Cardiology, Medstar Washington Hospital Center, Washington, DC. 46. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts. 47. Division of Cardiology, Evanston Hospital, Evanston, Illinois.
Abstract
BACKGROUND: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. OBJECTIVES: The goal of this study was to evaluate 1-year outcomes in this registry. METHODS: This study was a multicenter retrospective review of clinical outcomes. RESULTS: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. CONCLUSIONS: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.
BACKGROUND: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. OBJECTIVES: The goal of this study was to evaluate 1-year outcomes in this registry. METHODS: This study was a multicenter retrospective review of clinical outcomes. RESULTS: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. CONCLUSIONS: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.
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