ACC 2017: Study supports safety and effectiveness of TAVR in real-world patients

March 18, 2017 – Patients with lung disease or who have undergone previous heart surgery may also derive additional benefits from TAVR.

A new study by DCRI researchers found no significant difference in rates of death, stroke, or days alive and out of hospital to one year in intermediate- and high-risk patients treated with transcatheter aortic valve replacement (TAVR) and those receiving surgical aortic valve replacement (SAVR).

The results of this study, based on data from the Transcatheter Valve Therapies Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, were presented on Saturday at the 66th annual Scientific Sessions of the American College of Cardiology (ACC), in Washington, D.C..

Patients receiving TAVR, a minimally invasive surgical procedure for aortic stenosis, were more often discharged directly to home, reflecting a less demanding post-operative recovery. These findings were consistent across most patient subgroups, including those with the full spectrum of intermediate to high pre-operative surgical risk. The study – led by the DCRI’s J. Matthew Brennan, MD, MPH, assistant professor of medicine at the Duke University School of Medicine (pictured) – examined a broad cohort of 9,464 intermediate- and high-risk patients in the United States with severe aortic stenosis who were eligible for treatment with either TAVR or SAVR.

“Our primary finding was that TAVR does appear to be safe and effective in patients at moderate and high risk, which is consistent with randomized data,” Brennan said. “The overall risk of stroke was low, reflecting device improvements. Our analysis also found that patients with significant lung disease and prior cardiac surgery might derive additional benefit from TAVR, rather than SAVR, for selected outcomes. These highly credible findings underscore the importance of meticulous methodology when evaluating treatment effects using non-randomized data.”

The results largely echo those of three previous randomized clinical trials, and support the safety and effectiveness of TAVR in unselected real-world patients. They counter those of a German Aortic Valve Registry (GARY) study suggesting that patients treated with TAVR might have a higher one-year risk of mortality compared with those receiving SAVR.

The treatment of aortic valve disease is developing rapidly, with ongoing modifications in device technology for both minimally invasive SAVR and TAVR. As devices continue to evolve, the relative risks and benefits of the two procedures may change. Diligent monitoring of outcomes will continue to help direct future device innovation in this field.

This analysis was a part of a larger effort – the ADVICE Trial – to help patients, caregivers and their providers to understand the risks and benefits of these two treatment options in real-world clinical practice. An educational website (valveadvice.org) and a decision assistance tool are being launched at the ACC meeting to use ‘big data’ to personalize the treatment of aortic valve disease. The decision assistance tool will give patients their individualized one-year risks of death, stroke, days alive and out of hospital, and likelihood of discharge to home with SAVR or TAVR. The tool is available as a mobile app and a web-based tool.

In addition to Brennan, Duke authors on the ACC paper were: David Dai, PhD; Laine Thomas, PhD; Alice Wang, MD; Sean O’Brien, PhD; Roland Matsouaka, PhD; Michael Pencina, PhD; and Eric Peterson, MD, MPH, FAHA, FACC.

This research was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1306-04350).