A late-breaking study, presented May 12 at the Society of Cardiovascular Angiography and Interventions meeting in New Orleans, showed that factors related to individual patients—and not the specific type of valve used—determined 30-day outcomes for transcatheter aortic valve replacement (TAVR).
The analysis from the BRAVO-3 trial included 500 patients featured 500 patients who underwent transfemoral TAVR with balloon expendable (BE) valves and 282 with non-BE valves. Selection of the valves were left to each operator.
“This is not a one-size-fits-all situation,” said Roxana Mehran, MD, professor of medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Icahn School of Medicine at Mount Sinai. “It is not the differences in the valves, but differences in the patients. When we select the valve based on the patient’s characteristics, the outcomes are positive.”
Patients who received non-BE valves were generally older but had a lower rate of diabetes. They also were more likely to have chronic obstructive lung disease, lower left ventricular ejection fraction and lower body weight.
Non-BE valve patients were also more likely to require a second implant during the procedure, but the two groups did not have significant differences in the adjusted endpoints.
The 30-day outcomes for both groups were as follows:
- Stroke: 3 percent for BE patients; 3.6 for non-BE patients.
- Death: 3.8 percent for BE; 7.1 percent for non-BE.
- BARC major bleeding: 9 percent for BE; 10.6 for non-BE.
- Major vascular complications: 8.4 percent for BE; 11 for non-BE.
- MACE: 6.8 percent for BE; 10.6 for non-BE.
- NACE: 14.2 percent for BE; 17.7 for non-BE.