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

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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.

Key Words

aortic
outcomes
procedural outcomes
procedural risk
transcatheter mitral clip
transcatheter valves
TVT
valve in valve

Abbreviations and Acronyms

ACC
American College of Cardiology
DCRI
Duke Clinical Research Institute
NCD
National Coverage Decision
STS
Society of Thoracic Surgeons
STS PROM
Society of Thoracic Surgeons Predicted Risk of Mortality
TAViV
transcatheter aortic valve-in-valve
TAVR
transcatheter aortic valve replacement
TMC
transcatheter mitral leaflet clip
TMViR
transcatheter mitral valve-in-ring
TMViV
transcatheter mitral valve-in-valve
TVT
transcatheter valve therapy
VARC
Valve Academic Research Consortium

Cited by (0)

Dr. Grover is the recipient of a Thoracic Surgery Foundation grant for medical mission work in Nepal, funded by Edwards. Dr. Vemulapalli has received research grants from Abbott Vascular, the American College of Cardiology, and The Society of Thoracic Surgeons; and has served as a consultant for Novella and Premiere Research. Dr. Mack has served as the co-principal investigator for the Partner 3 trial and COAPT trial. Dr. Thourani has served as a consultant for Edwards. Dr. Ruiz has received institutional educational grants from Medtronic; and institutional grants from Philips. Dr. Hanzel has served as an unpaid proctor for the Watchman device from Boston Scientific. Dr. Bavaria is a primary investigator for Edwards Lifesciences and Medtronic; and a sub primary investigator for St. Jude Medical and Boston Scientific. Dr. Peterson has served as the co-principal investigator of the Data Coordinating Center for The Society of Thoracic Surgeons-American College of Cardiology Transcatheter Aortic Valve Replacement. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

This article is copublished in the Journal of the American College of Cardiology and The Annals of Thoracic Surgery.

Listen to this manuscript's audio summary by JACC Editor-in-Chief Dr. Valentin Fuster.