New Report Details TAVR Outcomes
Health care providers will be able to have more informed discussions with patients about transcatheter aortic valve replacement (TAVR) thanks to a new report in JAMA. It offers the most comprehensive look yet at TAVR outcomes data in the United States.
Since FDA approval of the first device in 2011, more than 10,000 TAVRs have been performed in the United States alone. The innovative procedure has been used with increasing frequency to treat severe aortic stenosis in patients who aren’t good candidates for conventional surgical AVR.
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“Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in clinical trials,” the authors wrote. They wanted to review the most recent outcomes data and update the previous report of 30-day outcomes and present 1-year outcomes following TAVR.
Using data from the Transcatheter Valve Therapies Registry, the researchers linked the records of 12,182 patients with outcomes data from the Centers for Medicare & Medicaid Services.
These patients underwent TAVR at 299 medical centers across the country from November 2011 through June 30, 2013, and researchers followed the outcomes through June 30, 2014. The median age was 84, 95% were white, and 52% were women.
Given that these patients were at a high surgical risk and at advanced age, their baseline functional status was poor and comorbidities were common, including advanced heart failure and lung and kidney disease.
After TAVR, two thirds of patients were discharged to home and the 30-day death rate was 7%.
Results showed an overall 1-year mortality rate of 23.7% and a stroke rate of 4.1%. In the first year after TAVR, about a quarter of those who survived the procedure were rehospitalized once and 12.5% were rehospitalized twice.
The risk for death at 1 year was linked to older age, male sex, end-stage renal disease, and severe chronic obstructive pulmonary disease. The findings also showed that women had a higher risk for stroke than men.
The authors believe this new data will help patients and clinicians make a more informed decision about TAVR.
“Transcatheter aortic valve replacement has become transformational for patients who need a new valve and are at high risk for surgery or inoperable. But we have been lacking long-term data for this group of patients who are considering this procedure,” lead study author David R. Holmes, Jr., MD, a Mayo Clinic interventional cardiologist, said in a press release. “Before this study, we only had 30-day information. This is a milestone and will help us better guide patients and learn as physicians.”
—Colleen Mullarkey
Reference
Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O’Brien SM, Vemulapalli S, et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015 Mar 10;313(10):1019-28.