April 3, 2016 – The study could address recent concerns about valve problems in TAVR patients.
A retrospective, registry-based study of 10,099 patients by the DCRI’s Sreekanth Vemulapalli, MD, (pictured) examined the durability of heart valves introduced during transcatheter aortic valve replacement (TAVR), a minimally invasive surgical procedure for aortic stenosis, and whether TAVR valve deterioration is associated with adverse cardiac events.
The study found that valve deterioration following TAVR occurred in 2.1 percent of patients in the post-procedure to 30-day timeframe, and in 2.5 percent in the 30-day to one-year timeframe. Valve deterioration did not seem to be associated with an excess of cardiovascular events, based on cumulative incidence of a composite measure including death, stroke, myocardial infarction, and aortic valve re-intervention. Patient factors linked to valve deterioration included atrial fibrillation or flutter, age, severe lung disease, and high body mass index (BMI).
The results of this study, which analyzed data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVR) Registry, were presented on Sunday at the annual Scientific Sessions of the American College of Cardiology in Chicago.
“Several recent reports have raised concerns about potential valve abnormalities in patients following TAVR,” Vemulapalli said. “Our findings – including the low incidence of valve deterioration and apparent lack of association with major cardiovascular events up to 18 months after the procedure – may help to inform TAVR care. The information on patient risk factors may aid in patient selection, surveillance and preventive strategies.”
Introduced in 2011, TAVR was a major breakthrough for patients with aortic stenosis who are not suitable candidates for standard valve replacement surgery. Aortic stenosis – the narrowing of the aortic valve opening – is one of the most common and serious valve disease problems, restricting blood flow from the heart to the rest of the body. In an approach similar to placing a stent in an artery, TAVR delivers a collapsible replacement valve to the heart through a catheter without removing the damaged valve.
Limitations to the study include the fact that it was a retrospective analysis using site-reported surveillance echo data, and that the causes of valve deterioration could not be identified. Large, prospective studies using advanced imaging will be necessary to fully elucidate the incidence, mechanisms and consequences of valve deterioration.
In addition to Vemulapalli, other Duke authors on the paper were: David Dai, MS, and Pamela S. Douglas MD, on behalf of the STS/ACC TVT Registry.