Richard G Jung1, Trevor Simard2, Christopher Kovach3, Kelsey Flint4, Creighton Don5, Pietro Di Santo6, Marianna Adamo7, Luca Branca7, Francesca Valentini7, Tomás Benito-González8, Felipe Fernández-Vázquez8, Rodrigo Estévez-Loureiro9, Alessandra Berardini10, Nicolina Conti10, Claudio Rapezzi11, Elena Biagini10, Simon Parlow6, Risa Shorr12, Amos Levi6, Ana Manovel13, Rosa Cardenal-Piris13, Jose Diaz Fernandez13, Mony Shuvy14, Dan Haberman15, Alessandra Sala16, Mohamad A Alkhouli17, Claudia Marini18, Marta Bargagna18, Davide Schiavi19, Paolo Denti18, Sinisa Markovic20, Nicola Buzzatti18, Vincent Chan21, Mark Hynes22, Thierry Mesana21, Marino Labinaz6, Federico Pappalardo23, Maurizio Taramasso24, Benjamin Hibbert25. 1. CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada. 2. CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 3. Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado; Division of Cardiology, University of Washington, Seattle, Washington, USA. 4. Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado; Rocky Mountain Regional VA Medical Center, Medicine Services, Cardiology, Aurora, Colorado, USA. 5. Division of Cardiology, University of Washington, Seattle, Washington, USA. 6. CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 7. Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia, Italy. 8. Department of Cardiology, University Hospital of León, León, Spain. 9. Department of Cardiology, Alvaro Cunqueiro Hospital, Vigo, Spain. 10. Cardiology Unit, Cardio-Thoracic-Vascular Department, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. 11. Cardiological Center, Universitario di Ferrara, University of Ferrara, Italy; Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy. 12. University of Ottawa Health Sciences Library, Ottawa, Ontario, Canada. 13. Juan Ramon Jimenez University Hospital, Huelva, Spain. 14. Cardiovascular Research Centre, Heart Institute, Hadassah-Hebrew University Medical Centre, Jerusalem, Israel. 15. Heart Center, Kaplan Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel. 16. Department of Cardiovascular Anesthesia and Intensive Care, San Raffaele Scientific Institute, Milan, Italy. 17. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA. 18. Department of Cardiac Surgery, San Raffaele Scientific Institute, Milan, Italy. 19. Alfieri Heart Foundation, Milan, Italy. 20. Department of Internal Medicine II, University of Ulm, Ulm, Germany. 21. Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 22. Department of Anesthesiology, University of Ottawa Heart Institute, Ottawa, Ontario. 23. Department of Anesthesia and Intensive Care, IRCCS ISMETT, Palermo, Italy. 24. Department of Cardiac Surgery, San Raffaele Scientific Institute, Milan, Italy; University Heart Center Zurich, University Hospital of Zurich, Zurich, Switzerland. 25. CAPITAL Research Group, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada; Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Electronic address: bhibbert@ottawaheart.ca.
Abstract
OBJECTIVES: The aim of this study was to evaluate the outcome of transcatheter mitral valve repair (TMVr) in patients with cardiogenic shock and significant mitral regurgitation (MR). BACKGROUND: Patients in cardiogenic shock with severe MR have a poor prognosis in the setting of conventional medical therapy. Because of its favorable safety profile, TMVr is being increasingly used as an acute therapy in this population, though its efficacy remains unknown. METHODS: A multicenter, collaborative, patient-level analysis was conducted. Patients with cardiogenic shock and moderate to severe (3+) or severe (4+) MR who were not surgical candidates were treated with TMVr. The primary outcome was in-hospital mortality. Secondary outcomes included 90-day mortality, heart failure (HF) hospitalization, and the combined event rate of 90-day mortality and HF hospitalization following dichotomization by TMVr device success. RESULTS: Between January 2011 and February 2019, 141 patients across 14 institutions met the inclusion criteria. In-hospital mortality occurred in 22 patients (15.6%), at 90 days in 38 patients (29.5%), and at one year in 55 patients (42.6%). Median length of hospital stay following TMVr was 10 days (interquartile range: 6 to 20 days). HF hospitalization occurred in 26 patients (18.4%) at a median of 73 days (interquartile range: 26 to 546 days). When stratified by TMVr procedural results, successful TMVr reduced rates of in-hospital mortality (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.98; p = 0.04), 90-day mortality (HR: 0.36; 95% CI: 0.16 to 0.78; p = 0.01), and the composite of 90-day mortality and HF hospitalization (HR: 0.41; 95% CI: 0.19 to 0.90; p = 0.03). CONCLUSIONS: TMVr may improve short- and intermediate-term mortality in high-risk patients with cardiogenic shock and moderate to severe MR. Randomized studies are needed to definitively establish MR as a therapeutic target in patients with cardiogenic shock.
OBJECTIVES: The aim of this study was to evaluate the outcome of transcatheter mitral valve repair (TMVr) in patients with cardiogenic shock and significant mitral regurgitation (MR). BACKGROUND:Patients in cardiogenic shock with severe MR have a poor prognosis in the setting of conventional medical therapy. Because of its favorable safety profile, TMVr is being increasingly used as an acute therapy in this population, though its efficacy remains unknown. METHODS: A multicenter, collaborative, patient-level analysis was conducted. Patients with cardiogenic shock and moderate to severe (3+) or severe (4+) MR who were not surgical candidates were treated with TMVr. The primary outcome was in-hospital mortality. Secondary outcomes included 90-day mortality, heart failure (HF) hospitalization, and the combined event rate of 90-day mortality and HF hospitalization following dichotomization by TMVr device success. RESULTS: Between January 2011 and February 2019, 141 patients across 14 institutions met the inclusion criteria. In-hospital mortality occurred in 22 patients (15.6%), at 90 days in 38 patients (29.5%), and at one year in 55 patients (42.6%). Median length of hospital stay following TMVr was 10 days (interquartile range: 6 to 20 days). HF hospitalization occurred in 26 patients (18.4%) at a median of 73 days (interquartile range: 26 to 546 days). When stratified by TMVr procedural results, successful TMVr reduced rates of in-hospital mortality (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.98; p = 0.04), 90-day mortality (HR: 0.36; 95% CI: 0.16 to 0.78; p = 0.01), and the composite of 90-day mortality and HF hospitalization (HR: 0.41; 95% CI: 0.19 to 0.90; p = 0.03). CONCLUSIONS: TMVr may improve short- and intermediate-term mortality in high-risk patients with cardiogenic shock and moderate to severe MR. Randomized studies are needed to definitively establish MR as a therapeutic target in patients with cardiogenic shock.