Real-world heart procedure results consistent with scientific research

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The first one-year outcomes data of transcatheter heart valve replacement (TAVR) in nearly all U.S. patients undergoing this procedure shows that real-world outcomes are comparable to or slightly better than those found in clinical trials, according to registry data presented at the American College of Cardiology’s 63rd Annual Scientific Session. However, specific baseline characteristics of patients undergoing TAVR are associated with differing degrees of death and survival and may be important considerations for patient counseling and shared decision making about the procedure, according to the authors.TAVR is a minimally invasive procedure recently approved for the treatment of severe, symptomatic aortic stenosis in patients who are not candidates for open heart surgery. With the diffusion of this new technology from research to practice, there has been some concern that patients undergoing TAVR in clinical trials may fare better than those in real-world settings. While in-hospital outcomes for TAVR in U.S. clinical practice are consistent with those in landmark clinical trials, little is known about longer term results.Researchers investigated one-year outcomes of TAVR among Medicare patients by reviewing data from the Transcatheter Valve Therapy (TVT) Registry linked with Medicare claims data. The TVT Registry — developed to track patient safety and outcomes related to TAVR — collects and reports data on patient demographics, procedure details, facilities and physicians.After reviewing outcomes data for 5,980 patients across 224 sites at one year following TAVR, researchers found that outcomes were similar to those in randomized controlled trials. Based on the TVT Registry data, the in-hospital death rate was 5.3 percent, and the in-hospital stroke rate was 1.7 percent at the time of the TAVR procedure. At nearly six months following TAVR, a vast majority of patients who had successful procedures were still living and had been able to avoid repeat hospitalization. At one year following TAVR, 26.2 percent of patients had died and 3.6 percent had suffered a stroke.”Regulatory agencies have been incredibly concerned over what happens when you open high risk technology to broader groups of patients, physicians and medical centers,” said David R. …


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