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December 11, 2016

TVT Registry Publishes Annual Report on Aortic and Mitral Procedures

December 9, 2016—The 2016 Annual Report of the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been accepted for publication and is available online in the Journal of the American College of Cardiology (JACC).

The report by Frederick L. Grover, et al focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve procedures in the United States. Data for all patients receiving commercially approved devices from 2012 through December 31, 2015 are entered in the TVT Registry. 

The STS/ACC TVT Registry captures all procedures with US Food and Drug Administration–approved transcatheter valve devices performed in the United States. The registry is mandated as a condition of reimbursement by the Centers for Medicaid and Medicare Services. The TVT Registry is an innovative registry that monitors quality, patient safety, and trends for these rapidly evolving new technologies, noted the investigators.

As summarized in JACC, the 54,782 trasncatheter aortic valve replacement (TAVR) patients demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) from 7% to 6% and TAVR PROM (TVT PROM) from 4% to 3% (both P < .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 postprocedure pacemaker insertion increased from 8.8% in 2013 to 12% in 2015. The 2,556 patients who underwent transcatheter mitral clip treatment in 2015 were similar to 2013 to 2014 patients with hospital mortality of 2% with mitral regurgitation reduced to a gradient ≤ 2 in 87% of patients (P < .0001). 

The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk with an STS PROM for transcatheter mitral valve repair of 11%. The observed hospital mortality rate was 7.2% and was 8.5% 30-days post procedure.

TAVR patients’ expected risks of mortality and actual in-hospital mortality decreased. Transcatheter mitral clip procedures had a low mortality with a reduction in mitral regurgitation to a grade ≤ 2 in 87% of patients. Mitral valve-in-valve or valve-in-ring patients were high risk for mortality, but actual hospital mortality was lower, reported the TVT Registry investigators in JACC.

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December 12, 2016

United States Pivotal Trial Begins for Essential Medical's Manta Vascular Closure Device

December 12, 2016

United States Pivotal Trial Begins for Essential Medical's Manta Vascular Closure Device


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