Paul Sorajja1, Sreekanth Vemulapalli2, Ted Feldman3, Michael Mack4, David R Holmes5, Amanda Stebbins2, Saibal Kar6, Vinod Thourani7, Gorav Ailawadi8. 1. Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota. Electronic address: paul.sorajja@allina.com. 2. Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. 3. Evanston Hospital, Evanston, Illinois. 4. Heart Hospital Baylor Plano, Dallas, Texas. 5. Mayo Clinic, Rochester, Minnesota. 6. Cedars Sinai Medical Center, Los Angeles, California. 7. Medstar Washington Hospital Center, Washington, DC. 8. University of Virginia, Charlottesville, Virginia.
Abstract
BACKGROUND: Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices. OBJECTIVES: The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation. METHODS: Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses. RESULTS: The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation. CONCLUSIONS: Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy.
BACKGROUND: Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices. OBJECTIVES: The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation. METHODS: Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses. RESULTS: The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation. CONCLUSIONS: Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy.
Authors: Dariusz Dudek; Waldemar Banasiak; Wojciech Braksator; Jacek Dubiel; Tomasz Grodzicki; Piotr Hoffman; Mariusz Kuśmierczyk; Grzegorz Opolski; Piotr Ponikowski; Jacek Różański; Jerzy Sadowski; Wojciech Wojakowski; Marcin Grabowski; Katarzyna Bondaryk; Jacek Walczak; Izabela Pieniążek; Maciej Grys; Anna Lesiak-Bednarek; Piotr Przygodzki Journal: Cardiol J Date: 2019-02-14 Impact factor: 2.737
Authors: Thilo Noack; Philipp Kiefer; Christian Besler; Philipp Lurz; Sergey Leontyev; Mohamed Abdel-Wahab; David Michael Holzhey; Joerg Seeburger Journal: Indian J Thorac Cardiovasc Surg Date: 2019-09-10
Authors: Serdar Akansel; Simon H Suendermann; Markus Kofler; Karel M Van Praet; Marian Kukucka; Volkmar Falk; Jörg Kempfert Journal: Turk Gogus Kalp Damar Cerrahisi Derg Date: 2020-04-22 Impact factor: 0.332
Authors: Dagmar F Hernandez-Suarez; Sagar Ranka; Yeunjung Kim; Azeem Latib; Jose Wiley; Angel Lopez-Candales; Duane S Pinto; Maday C Gonzalez; Harish Ramakrishna; Cristina Sanina; Brenda G Nieves-Rodriguez; Jovaniel Rodriguez-Maldonado; Roberto Feliu Maldonado; Israel J Rodriguez-Ruiz; Istoni da Luz Sant'Ana; Karlo A Wiley; Pedro Cox-Alomar; Pedro A Villablanca; Abiel Roche-Lima Journal: Cardiovasc Revasc Med Date: 2020-06-15