Among nearly 100,000 transfemoral TAVR cases included in the analysis, the researchers found that hospitals in the group with the lowest volume had the highest 30-day mortality rate, at 3.19 percent, compared to hospitals in the group with highest volumes at 2.66 percent. This represents a relative reduction in patient mortality of 19.45 percent between the lowest- and highest-volume centers.
“This was the most comprehensive analysis of the outcomes of more than 100,000 people recently receiving TAVR in the U.S.,” said John Carroll, M.D., professor of medicine at the University of Colorado School of Medicine and director of Interventional Cardiology at the UCHealth University of Colorado Hospital.
“The results definitively reaffirm an inverse relationship between the volume of procedures and the risk of death following the procedure,” added Carroll, who is also the vice-chair of the STS-ACC TVT Registry Steering Committee. “The study’s conclusive data should be incorporated by CMS in their final coverage policy to provide Americans with the best results from this transformative non-surgical therapy for the increasingly common condition of aortic stenosis, one of the most serious valve disease problems.”
“These findings suggest a clear relationship between the volume of TAVR procedures and death at 30 days, both at the hospital level and at the individual operator level, and should be factored into the CMS revised National Coverage Determination related to TAVR until a validated quality outcome metric can be established,” said co-author Michael Mack, M.D. “This relationship held true even after eliminating the first 12 months, meaning this is not just a ‘learning curve.’”
In addition to Vemulapalli, Carroll and Mack, study authors include Zhuokai Li, David Dai, Andrzej S. Kosinski, Dharam J. Kumbhani, Carlos Ruiz, Vinod H. Thourani, George Hanzel, Thomas G. Gleason, Howard C Herrmann, Ralph G. Brindis and Joseph E. Bavaria.
Funding for the study was provided by the Society of Thoracic Surgeons and American College of Cardiology through the National Cardiovascular Data Registry.
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