The Society of Thoracic Surgeons (STS)/ ACC Transcatheter Valve Therapy (TVT) Registry 2016 Annual Report sheds light on a number of important trends and improvements in the patient outcomes and clinical care of transcatheter aortic valve replacement (TAVR) patients. The report, published recently in the Journal of the American College of Cardiology, focuses on patient characteristics, trends and outcomes of 54,782 transcatheter aortic and mitral valve catheter-based valve procedures in the U.S. from late 2011 through December 2015. Overall results show a significant decrease in TAVR in-hospital, 30-day, and one-year mortality over the four-year period. TAVR in-hospital deaths dropped from a high of 5.7 percent in 2012 to 2.9 percent in 2015, while 30-day mortality dropped from 7.5 percent in 2012 to 4. 6 percent in 2015. One-year mortality also decreased from 25.8 percent in 2012 to 21.6 percent in 2014. Report authors also note modest but significant decreases in acute kidney injury, major bleeding and stroke. Additionally, postoperative atrial fibrillation decreased from 6.9 percent in 2012-13 to 3.7 percent in 2015, but data showed an overall increase in 30-day new pacemaker insertion (8.8 percent in 2013 to 12 percent in 2015). “The improved results are likely related to greater experience, a lower-risk patient population, as well as improving technology and anesthetic techniques,” say Frederick L. Grover, MD, FACC, vice chair of the STS/ACC TVT Registry Steering Committee, et al. Positive outcomes were also seen in patients who underwent transcatheter mitral leaflet clip (TMC) procedures and transcatheter mitral valve-in-valve therapy/mitral valve-inring therapy (MViV/MViR). TMC was found to reduce severe mitral regurgitation in a high risk group of patients for an open procedure to grade 2 or less at a relatively low risk. Additionally, in the predominantly high-risk MviV/MViR patient population, in-hospital and 30-day mortality were considerably lower than their STS Predicted Risk of Mortality. Few patients who underwent MviV/MViR procedures experienced post-operative left ventricular outflow tract obstruction, in-hospital stroke or required dialysis. According to the report authors: “The MviV and MviR procedures appear promising for high risk patients with degenerated surgical aortic valve replacement, bioprosthetic prostheses or recurrent mitral insufficiency following annular ring repair, at least based on initial short term outcomes.” The report also highlights trends in TAVR operative characteristics, with data showing a continued increase in the use of the femoral artery access site for valve insertion from 75. 9 percent in 2012 to 86.6 percent in 2015. Transapical access decreased from 14.5 percent in 2012 to 6.1 percent in 2015. In patients undergoing MviV/MViR, 70.1 percent of patients had transapical access and 24.4 percent had transseptal access. Authors note a trend toward more transseptal access in 2015 (28.2 percent). “TAVR is a transformational technology success story having been approved in the U. S. only in 2011 to now having been used in 80,000 commercial patients,” says David R. Holmes Jr., MD, MACC, a past president of the ACC and chair of The STS/ACC TVT Registry Steering Committee. “The registry acts as 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.” Looking ahead, the report authors point out that the TVT Registry will continue “to mature, capturing real world patient characteristics, appropriateness, and outcomes.” They note that the registry is currently preparing to capture data for transcatheter tricuspid valve technology. In addition, “an in-hospital mortality risk model has been developed and other models are in development which will help individual hospital programs assess their performance compared to national peer groups, thereby serving as a tool for quality improvement,” they say.
Published by American College of Cardiology. View All Articles.
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