The Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration (FDA)-approved transcatheter valve devices performed in the United States. Data for all patients in whom commercially approved devices were used from 2012 through the end of 2015 are entered in the TVT Registry. The following are points to remember:

1. Number of sites performing TVT (as of 12/31/2015):
   • Transcatheter aortic valve replacement (TAVR): 418 sites.
   • Transcatheter mitral leaflet clip: 176 sites.
   • Transcatheter mitral valve-in-valve or valve-in-ring: 98 sites.
   • Transcatheter aortic valve-in-valve procedures: 292 sites.


2. TAVR:
   • A total volume of 54,782 TAVR procedures had been entered into the registry at the end of 2015. The annual volume increased from 4,627 in 2012 to 24,808 in 2015.
   • For TAVR procedures, the median STS overall predicted risk of 30-day mortality (PROM) was 6.5%, and decreased from 7.1% in 2012 to 6.3% in 2015 (p < 0.0001).
   • For TAVR procedures, the observed 30-day mortality was 5.7%, and decreased from 7.5% in 2012 to 4.6% in 2015 (p < 0.0001). The 1-year mortality was 22.6%, and decreased from 25.8% in 2012 to 21.6% in 2014 (p < 0.0001). The 30-day stroke rate was 2.1%, and decreased from 2.3% in 2012 to 1.9% in 2015 (p < 0.03).
   • The 30-day rate for new pacemaker requirement associated with TAVR was 11.8%, and increased from 8.8% in 2013 to 12.0% in 2015.


3. Mitral leaflet clip:
   • Beginning in November 2013, a total of 3,697 patients underwent mitral leaflet clip procedures.
   • The 30-day mortality and 30-day stroke rates associated with mitral leaflet clip procedures were 5.0% and 0.7%, respectively, and did not change significantly over the limited time span between 2014 and 2015.
   • Mitral regurgitation was believed to be no more than grade 2+ (moderate) in 86.2% of patients, and the mean gradient no more than 5 mm Hg in 73.8% of patients.


4. Mitral valve-in-valve or valve-in-ring procedures:
   • Transcatheter mitral valve-in-valve or valve-in-ring procedures were performed among 349 patients in 2014 and 2015, with STS Predicted Risk of Mortality (PROM) of 11.1%.
   • The 30-day mortality was 8.5%.
   • At least moderate (grade 2+) mitral regurgitation was present after the procedure in 2.6%.

Since approval by the FDA, the numbers of transcatheter valve therapies including TAVR, mitral valve clipping, and transcatheter mitral valve-in-valve or valve-in-ring procedures have increased, with more sites performing more procedures among patients at progressively lower estimated surgical risk. For TAVR (with longer post-approval data available), 30-day mortality and stroke risks decreased somewhat, but rates of pacemaker implantation increased.

Keywords: Cardiac Surgical Procedures, Device Approval, Heart Valve Diseases, Mitral Valve Insufficiency, Mortality, Pacemaker, Artificial, Stroke, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement

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