Recently approved for the treatment of severe, symptomatic aortic stenosis in patients who are not candidates for open heart surgery, transcatheter heart valve replacement (TAVR) soon developed concerns among physicians that its successful clinical trials would not fare as well in real-world settings. Using data from the STS/ACC TVT Registry  linked with Medicare claims data, one-year outcomes of the procedure showed that nearly all U.S. patients did in fact achieve comparable to or slightly better outcomes than those made in the clinical trials. The results of the registry data were presented March 31 as part of ACC.14 in Washington, DC.

Researchers reviewed the outcome data of 5,980 patients across 224 sites following TAVR. Based on TVT Registry data, the in-hospital death rate was 5.3 percent, with the in-hospital stroke rate reaching 1.7 percent. At the six month marker following TAVR, the majority of patients who had successful procedures were still living without repeated hospitalization. At the one year mark, 3.6 percent of patients had suffered a stroke and 26.2 had died.

"Regulatory agencies have been incredibly concerned over what happens when you open high risk technology to broader groups of patients, physicians and medical centers," says David R. Holmes, MD, past president of the ACC, Scripps Professor of Medicine, Mayo Clinic, Rochester, MN, and lead investigator of the study. "This data is comforting in that we went from a relatively small number of clinical trial participants receiving TAVR in a few expert medical centers to a relatively large number of real-world patients in over 200 clinical settings with very similar results."

In addition, replicating the positive results of clinical trials, the researchers also discovered that specific factors were at play for the endured incidence of stroke and/or death, including gender, age and kidney function. First, the older a patient was at the time of his or her TAVR procedure, the higher the death rate. Patients under age 75 had a mortality rate of 21.5 percent, while those over age 95 had a 31.9 percent mortality rate. Males had a higher mortality rates than women, but women had higher rates of stroke. Patients with abnormal kidney function – especially for patients in need of dialysis, were also at a higher risk of stroke or death.

"By virtue of identifying factors associated with stroke and mortality, we now have data that we can use for developing tools in terms of risk prediction models so we can better educate patients and families in terms of making good, important decisions about their treatment options," adds Holmes. "We can also educate physicians to appropriately communicate the risk-benefit ratio to patients, which is hugely important as we move toward the concept of shared decision making in health care."

Keywords: Odds Ratio, Registries, Decision Making, Risk Assessment, Medicare, Cardiac Surgical Procedures, Heart Valves