ACC 2014 – Real-world TAVR results consistent with earlier trials

March 31, 2014 – 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.

Real-world outcomes for patients who undergo transcatheter aortic valve replacement (TAVR) are comparable to or slightly better than those found in clinical trials, according to a late-breaking trial presented Monday at the annual Scientific Sessions of the American College of Cardiology in Washington, DC. However, certain 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.

The DCRI’s Matthew Brennan, MD, MPH (pictured); David Dai, PhD; and Eric Peterson, MD, MPH, were among the study’s authors. David Holmes, MD, of the Mayo Clinic presented the findings.

matt-brennan-archiveTAVR is a minimally invasive surgical procedure in which a surgeon replaces the aortic valve without using cardio-pulmonary bypass. It is typically performed in patients with severe symptomatic aortic stenosis who cannot undergo traditional open-chest surgery. The procedure is relatively new, having been approved by the Food and Drug Administration in 2011. Earlier studies established TAVR’s safety and efficacy in certain populations, but no long-term outcomes studies in larger populations have been completed until now.

In this study, the researchers examined the number of adverse events at one year after TAVR, how much time patients spent alive and out of the hospital at six months after TAVR, and what, if any, associations existed between 1-year outcomes and patient characteristics. To do this they obtained patient data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, a joint project of the STS and ACC that includes information on TAVR procedures from across the nation. The researchers focused on patients enrolled in the registry between November 2011 and July 2013 who were aged 65 years or older and whose records were linked with Medicare claims. After excluding records with incomplete data, they obtained a study population of 5,980 patients.

They found that the rate of death among these patients was similar to what was found in the earlier PARTNER trial of high-risk patients, while stroke rates were substantially lower. Most patients were still alive one year after the procedure and not rehospitalized. Age, lung disease, renal failure, nontransfemoral access, and higher Framingham risk scores were predictive of mortality at one year. Male sex was also associated with higher risk of death, but lower risk of stroke at one year.

“These results suggest that long term outcomes are encouraging in this cohort,” Brennan said. “We don’t see any cause for concern from this data. Although some patient subgroups were identified at higher risk, it’s still likely that their outcomes with treatment are superior.”