TVT Registry Annual Report Illustrates Valuable TAVR Trends and Improvements
The Society of Thoracic Surgeons (STS)/ACC Transcatheter Valve Therapy (TVT) Registry has revealed a number of important trends and improvements in the patient outcomes and clinical care of transcatheter aortic valve replacement (TAVR) patients, according to the 2016 Annual Report of the STS/ACC TVT Registry published Dec. 9 in the Journal of the American College of Cardiology.
This annual report focuses on patient characteristics, trends and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the U.S. from late 2011 through December 2015. The TVT Registry has three modules: TAVR, transcatheter mitral leaflet clip (TMC), and transcatheter mitral valve-in-valve therapy/transcatheter mitral valve-in-ring therapy (TMViV/TMViR).
The registry’s TAVR module shows that actual TAVR in-hospital, 30-day, and one-year mortality significantly decreased over time. Of note, one-year mortality decreased from 25.8 percent in 2012 to 21.6 percent in 2014 (p<.0001), and the report found modest but significant decreases in acute kidney injury and major bleeding over time. Moderate/severe aortic regurgitation has decreased over time with acceptable gradients at discharge. “The improved results are likely related to greater experience, a lower-risk patient population, as well as improving technology and anesthetic techniques,” said Frederick L. Grover, MD, FACC, vice chair of the STS/ACC TVT Registry Steering Committee, et al.
Positive results also were shown in the TMViV/TMViR module. Among the predominantly high-risk patient population, in-hospital and 30-day mortality were considerably lower than their STS Predicted Risk of Mortality. Few patients who underwent TMViV/TMViR procedures experienced post-operative left ventricular outflow tract obstruction, in-hospital stroke or required dialysis. The authors state that “the early results in this rather high-risk group of patients, who were able to avoid an open reoperation, are encouraging and this procedure appears to be an attractive treatment option for this group of patients.”
The report’s authors explain that a number of quality assurance programs are in place to continually improve the registry, including electronic data checks, proactive training and orientation for participating hospitals, data completeness assessment and reporting to sites, as well as an annual NCDR Data Managers Meeting. In addition, several data quality improvements are currently taking place.
Looking ahead to developing technology and other opportunities, data elements are being developed to capture transcatheter replacement and for metrics to report appropriate use criteria for TAVR procedures.
“TAVR is a transformation technology success story having been approved in the U.S. only in 2011 to now having been used in >80,000 commercial patients,” said David R. Holmes Jr., MD, MACC, a past president of the ACC and chair of the STS/ACC TVT Registry Steering Committee. “As part of the approval process, the TVT Registry was born under the auspices of ACC and STS to provide ongoing information about this evolving technology as well as to evaluate catheter-based options used to treat disease related to the other cardiac valve. The registry acts a lens showing us where we have been and where we are now, and it helps shape the future of where we are going. This annual report is a cornerstone of the mission of the TVT Registry to monitor our performance in optimizing health care of the growing number of patients with structural heart disease.”
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