2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry
Frederick L Grover, Sreekanth Vemulapalli, John D Carroll, Fred H Edwards, Michael J Mack, Vinod H Thourani, Ralph G Brindis, David M Shahian, Carlos E Ruiz, Jeffrey P Jacobs, George Hanzel, Joseph E Bavaria, E Murat Tuzcu, Eric D Peterson, Susan Fitzgerald, Matina Kourtis, Joan Michaels, Barbara Christensen, William F Seward, Kathleen Hewitt, David R Holmes Jr, STS/ACC TVT Registry, Frederick L Grover, Sreekanth Vemulapalli, John D Carroll, Fred H Edwards, Michael J Mack, Vinod H Thourani, Ralph G Brindis, David M Shahian, Carlos E Ruiz, Jeffrey P Jacobs, George Hanzel, Joseph E Bavaria, E Murat Tuzcu, Eric D Peterson, Susan Fitzgerald, Matina Kourtis, Joan Michaels, Barbara Christensen, William F Seward, Kathleen Hewitt, David R Holmes Jr, STS/ACC TVT Registry
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.
Keywords: TVT; aortic; outcomes; procedural outcomes; procedural risk; transcatheter mitral clip; transcatheter valves; valve in valve.
Copyright © 2017 American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
Source: PubMed