2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Grover, FL; Vemulapalli, S; Carroll, JD; Edwards, FH; Mack, MJ; Thourani, VH; Brindis, RG; Shahian, DM; Ruiz, CE; Jacobs, JP; Hanzel, G; Bavaria, JE; Tuzcu, EM; Peterson, ED; Fitzgerald, S; Kourtis, M; Michaels, J; Christensen, B; Seward, WF; Hewitt, K; Holmes, DR; STS/ACC TVT Registry,

Published Date

  • March 14, 2017

Published In

Volume / Issue

  • 69 / 10

Start / End Page

  • 1215 - 1230

PubMed ID

  • 27956264

Pubmed Central ID

  • 27956264

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2016.11.033

Language

  • eng

Conference Location

  • United States