Frederick L Grover1, Sreekanth Vemulapalli2, John D Carroll3, Fred H Edwards4, Michael J Mack5, Vinod H Thourani6, Ralph G Brindis7, David M Shahian8, Carlos E Ruiz9, Jeffrey P Jacobs10, George Hanzel11, Joseph E Bavaria12, E Murat Tuzcu13, Eric D Peterson2, Susan Fitzgerald14, Matina Kourtis15, Joan Michaels14, Barbara Christensen14, William F Seward15, Kathleen Hewitt14, David R Holmes16. 1. Department of Surgery, School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado; Denver Department of Veterans Affairs Medical Center, Denver, Colorado. Electronic address: Frederick.Grover@ucdenver.edu. 2. Duke University Medical Center, Durham, North Carolina. 3. School of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado. 4. University of Florida, Jacksonville, Florida. 5. Baylor Scott and White Health, Plano, Texas. 6. Emory University, Atlanta, Georgia. 7. University of California, San Francisco, California. 8. Massachusetts General Hospital, Boston, Massachusetts. 9. Structural and Congenital Heart Center, Hackensack University Medical Center and The Joseph M. Sanzari Children's Hospital, Seton Hall Hackensack University-School of Medicine, Hackensack, New Jersey. 10. Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland; Division of Cardiovascular Surgery, Department of Surgery, Johns Hopkins All Children's Heart Institute, All Children's Hospital and Florida Hospital for Children, St. Petersburg, Tampa, and Orlando, Florida. 11. Beaumont Hospital, Royal Oak, Michigan. 12. Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. 13. Cleveland Clinic, Abu Dhabi, United Arab Emirates. 14. American College of Cardiology, Washington, DC. 15. The Society of Thoracic Surgeons, Chicago, Illinois. 16. Mayo Clinic, Rochester, Minnesota.
Abstract
BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%. CONCLUSIONS: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.
BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%. CONCLUSIONS: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.
Authors: Harun Kundi; Jeffrey J Popma; Kamal R Khabbaz; Louis M Chu; Jordan B Strom; Linda R Valsdottir; Changyu Shen; Robert W Yeh Journal: JAMA Cardiol Date: 2019-01-01 Impact factor: 14.676
Authors: Wolfgang von Scheidt; A Welz; M Pauschinger; T Fischlein; V Schächinger; H Treede; R Zahn; M Hennersdorf; J M Albes; R Bekeredjian; M Beyer; J Brachmann; C Butter; L Bruch; H Dörge; W Eichinger; U F W Franke; N Friedel; T Giesler; R Gradaus; R Hambrecht; M Haude; H Hausmann; M P Heintzen; W Jung; S Kerber; H Mudra; T Nordt; L Pizzulli; F-U Sack; S Sack; B Schumacher; G Schymik; U Sechtem; C Stellbrink; C Stumpf; H M Hoffmeister Journal: Clin Res Cardiol Date: 2019-08-13 Impact factor: 5.460
Authors: Harun Kundi; Linda R Valsdottir; Jeffrey J Popma; David J Cohen; Jordan B Strom; Duane S Pinto; Changyu Shen; Robert W Yeh Journal: Circ Cardiovasc Qual Outcomes Date: 2018-10