Paul Sorajja1, Michael Mack2, Sreekanth Vemulapalli3, David R Holmes4, Amanda Stebbins3, Saibal Kar5, D Scott Lim6, Vinod Thourani7, Patrick McCarthy8, Samir Kapadia9, Paul Grayburn10, Wesley A Pedersen11, Gorav Ailawadi6. 1. Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota. Electronic address: paul.sorajja@allina.com. 2. Baylor Heart Hospital, Plano, Texas. 3. Duke University, Durham, North Carolina. 4. Mayo Clinic, Rochester, Minnesota. 5. Cedars-Sinai Medical Center, Los Angeles, California. 6. University of Virginia, Charlottesville, Virginia. 7. Emory University, Atlanta, Georgia. 8. Northwestern University, Chicago, Illinois. 9. Cleveland Clinic, Cleveland, Ohio. 10. Baylor University Medical Center, Dallas, Texas. 11. Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.
Abstract
BACKGROUND: Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). OBJECTIVES: The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. METHODS: Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. RESULTS: Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. CONCLUSIONS: In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.
BACKGROUND:Transcatheter mitral valve (MV) repair with the MitraClip received approval in 2013 for the treatment of prohibitive-risk patients with primary mitral regurgitation (MR). OBJECTIVES: The aim of this study was to report the initial U.S. commercial experience with transcatheter MV repair. METHODS: Data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with this percutaneous mitral valve repair device were analyzed. RESULTS: Of 564 patients (56% men, median age 83 years), severe symptoms were present in 473 (86.0%). The median Society of Thoracic Surgeons Predicted Risk of Mortality scores for MV repair and replacement were 7.9% (interquartile range: 4.7% to 12.2%) and 10.0% (interquartile range: 6.3% to 14.5%), respectively. Frailty was noted in 323 patients (57.3%). Transcatheter MV repair was performed for degenerative disease, present in 90.8% of patients. Overall, MR was reduced to grade ≤2 in 93.0%. In-hospital mortality was 2.3%; 30-day mortality was 5.8%. Other 30-day events were stroke (1.8%), bleeding (2.6%), and device-related complications (1.4%). The median length of stay was 3 days (interquartile range: 1 to 6 days), with 84.0% patients discharged home. Overall, procedure success occurred in 90.6%. Variables associated with reduction in MR were end-diastolic dimension, MR severity, clip location, and case volume. CONCLUSIONS: In this study of the initial commercial U.S. experience, it was found that procedural success was achieved in approximately 91% of patients, and the majority of patients were discharged home with moderate or less MR. These data support the effectiveness of this therapy in appropriately selected high-risk patients in a commercial setting. Further study is required to determine the long-term impact of transcatheter MV repair in this patient population.
Authors: Jakob Ledwoch; Jennifer Franke; Edith Lubos; Peter Boekstegers; Miriam Puls; Taoufik Ouarrak; Stephan von Bardeleben; Christian Butter; Joachim Schofer; Ralf Zahn; Hüsseyin Ince; Jochen Senges; Horst Sievert Journal: Clin Res Cardiol Date: 2017-12-05 Impact factor: 5.460
Authors: Rebecca T Hahn; Feroze Mahmood; Susheel Kodali; Roberto Lang; Mark Monaghan; Linda D Gillam; Madhav Swaminathan; Robert O Bonow; Ralph Stephan von Bardeleben; Jeroen J Bax; Paul Grayburn; William A Zoghbi; Partho P Sengupta; Y Chandrashekhar; Stephen H Little Journal: JACC Cardiovasc Imaging Date: 2019-12