Mayra Guerrero1, Dee Dee Wang2, Mackram F Eleid3, Amit Pursnani4, Michael Salinger5, Hyde M Russell6, Susheel K Kodali7, Isaac George8, Vinayak N Bapat8, George D Dangas9, Gilbert H L Tang10, Ignacio Inglesis11, Christopher U Meduri12, Igor Palacios11, Mark Reisman13, Brian K Whisenant14, Anastasia Jermihov15, Tatiana Kaptzan16, Bradley R Lewis17, Carl Tommaso4, Philip Krause4, Jeremy Thaden3, Jae K Oh3, Pamela S Douglas18, Rebecca T Hahn7, Martin B Leon7, Charanjit S Rihal3, Ted Feldman19, William W O'Neill2. 1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. Electronic address: mayraguerrero@icloud.com. 2. Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan, USA. 3. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. 4. Division of Cardiology, NorthShore University HealthSystem, Evanston, Illinois, USA. 5. Division of Cardiology, Froedtert Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 6. Division of Cardiovascular Surgery, NorthShore University HealthSystem, Evanston, Illinois, USA. 7. Division of Cardiology, Columbia University Medical Center, New York, New York, USA. 8. Department of Surgery, Columbia University Medical Center, New York, New York, USA. 9. Division of Cardiology, Mount Sinai Health System, New York, New York, USA. 10. Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York, USA. 11. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA. 12. Division of Cardiology, Piedmont Hospital, Atlanta, Georgia, USA. 13. Division of Cardiology, University of Washington Medical Center, Seattle, Washington, USA. 14. Division of Cardiology, Intermountain Heart Institute, Salt Lake City, Utah, USA. 15. University of South Florida, Tampa, Florida, USA. 16. Cardiovascular Research Unit, Mayo Clinic, Rochester, Minnesota, USA. 17. Division of Biostatics and Informatics, Mayo Clinic, Rochester, Minnesota, USA. 18. Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA. 19. Edwards Lifesciences, Irvine, California, USA.
Abstract
OBJECTIVES: The aim of this study was to evaluate 1-year outcomes of valve-in-mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves. METHODS: A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.S. sites. RESULTS: Between February 2015 and December 2017, 31 patients were enrolled (median age 74.5 years [interquartile range (IQR): 71.3 to 81.0 years], 71% women, median Society of Thoracic Surgeons score 6.3% [IQR: 5.0% to 8.8%], 87.1% in New York Heart Association functional class III or IV). Access was transatrial (48.4%), transseptal (48.4%), or transapical (3.2%). Technical success was 74.2%. Left ventricular outflow tract obstruction (LVOTO) with hemodynamic compromise occurred in 3 patients (transatrial, n = 1; transseptal, n = 1; transapical, n = 1). After LVOTO occurred in the first 2 patients, pre-emptive alcohol septal ablation was implemented to decrease risk in high-risk patients. No intraprocedural deaths or conversions to open heart surgery occurred during the index procedures. All-cause mortality at 30 days was 16.7% (transatrial, 21.4%; transseptal, 6.7%; transapical, 100% [n = 1]; p = 0.33) and at 1 year was 34.5% (transatrial, 38.5%; transseptal, 26.7%; p = 0.69). At 1-year follow-up, 83.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.1 mm Hg (IQR: 5.6 to 7.1 mm Hg), and all patients had ≤1+ mitral regurgitation. CONCLUSIONS: At 1 year, ViMAC was associated with symptom improvement and stable transcatheter heart valve performance. Pre-emptive alcohol septal ablation may prevent transcatheter mitral valve replacement-induced LVOTO in patients at risk. Thirty-day mortality of patients treated via transseptal access was lower than predicted by the Society of Thoracic Surgeons score. Further studies are needed to evaluate safety and efficacy of ViMAC.
OBJECTIVES: The aim of this study was to evaluate 1-year outcomes of valve-in-mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves. METHODS: A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.S. sites. RESULTS: Between February 2015 and December 2017, 31 patients were enrolled (median age 74.5 years [interquartile range (IQR): 71.3 to 81.0 years], 71% women, median Society of Thoracic Surgeons score 6.3% [IQR: 5.0% to 8.8%], 87.1% in New York Heart Association functional class III or IV). Access was transatrial (48.4%), transseptal (48.4%), or transapical (3.2%). Technical success was 74.2%. Left ventricular outflow tract obstruction (LVOTO) with hemodynamic compromise occurred in 3 patients (transatrial, n = 1; transseptal, n = 1; transapical, n = 1). After LVOTO occurred in the first 2 patients, pre-emptive alcohol septal ablation was implemented to decrease risk in high-risk patients. No intraprocedural deaths or conversions to open heart surgery occurred during the index procedures. All-cause mortality at 30 days was 16.7% (transatrial, 21.4%; transseptal, 6.7%; transapical, 100% [n = 1]; p = 0.33) and at 1 year was 34.5% (transatrial, 38.5%; transseptal, 26.7%; p = 0.69). At 1-year follow-up, 83.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.1 mm Hg (IQR: 5.6 to 7.1 mm Hg), and all patients had ≤1+ mitral regurgitation. CONCLUSIONS: At 1 year, ViMAC was associated with symptom improvement and stable transcatheter heart valve performance. Pre-emptive alcohol septal ablation may prevent transcatheter mitral valve replacement-induced LVOTO in patients at risk. Thirty-day mortality of patients treated via transseptal access was lower than predicted by the Society of Thoracic Surgeons score. Further studies are needed to evaluate safety and efficacy of ViMAC.
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