Patients who underwent transcatheter aortic valve replacement (TAVR) in the U.S. from 2012 to 2014 tended to be at least 80 years old and have multiple comorbidities, a high predicted risk of mortality and a poor self-reported health status, according to a registry analysis.
Lead researcher David R. Holmes, Jr., MD, of the Mayo Clinic in Rochester, Minn., and colleagues published their results online in the Journal of the American College of Cardiology and the Annals of Thoracic Surgery on Nov. 30.
They evaluated the transcatheter valve replacement (TVT) registry, which was launched in December 2011 and developed by the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The TVT registry includes data on patient characteristics, procedural variables, quality of life and other outcomes.
In 2014, 348 centers in 48 states performed transcatheter aortic valve replacement (TAVR) surgeries. The researchers mentioned the TVT registry was involved in four FDA post-approval studies for the Sapien (Edwards Lifesciences), CoreValve (Medtronic) and MitraClip (Abbott Vascular) TAVR devices.
As of the end of 2014, the registry had data on 26,414 patient records for all of the major TAVR devices, including the Sapien, Sapien XT and CoreValve. The registry did not include information on 10,000 additional TAVR procedures because they were performed as part of investigational device exemption trials.
Of the patients who underwent TAVR from 2012 to 2014, the mean age was 82, and 50.5 percent were male. In addition, 91 percent were at least 70 years old and 68 percent were at least 80 years old. Fewer than 5 percent of patients were black.
Common comorbidities among patients undergoing TAVR included prior revascularization, prior stroke, diabetes, peripheral arterial disease, moderate or severe chronic lung disease and prior MI.
In addition, 82.5 percent percent of patients were in New York Heart Association functional class III or IV and 81.6 percent of patients had evidence of frailty as evidenced by a slow 5-minute walk test.
The mean STS risk score was 8.34 percent. The researchers noted the median STS risk score decreased from 2012 to 2014.
“This is probably related in part to the expansion of TAVR to high- risk patients, from its initial restriction to inoperable or prohibitive-risk patients,” they wrote.
They added there was a 92.7 percent device success rate, which they defined as the device being in the correct anatomic position and a satisfactory intended performance of the valve.
Although approximately one-third of patients had a hospital complication, fewer than 2 percent had a procedure-related cardiac complication.
The researchers cited a few limitations, including the possible inclusion of confounding but unmeasured variables in patient selection and procedural performance. The study also did not have core laboratories for image analysis, had site-reported events and only had partially audited data. Further, the data only included commercial TAVR patients and did not include patients who received investigational devices.
“[The registry] provides a broad overview of the evolving technology of TAVR and can be used as a benchmark for U.S. TAVR clinical practice patterns and patient outcomes,” the researchers wrote. “The TVT Registry is central to a novel approach for post-market surveillance and is the foundation for continuing efforts to provide timely and actionable learning on the basis of scientific evidence throughout the full product life cycle of new emerging technology.”