Improvements in catheter design could decrease rate of adverse events, including neurologic,
vascular complications.

R etrograde transfemoral transcatheter aortic valve replacement can be performed with acceptable mortality in high-risk aortic stenosis patients, according to Martin B. Leon, MD, CRF founder and professor of medicine at Columbia University Medical Center.

In a pooled analysis of the REVIVAL II (n = 55), REVIVE II (n = 90), and Canadian Special Access (n = 99) clinical trials, freedom from death at 1 year was similar across the entire population (range, 73% to 74.7%, Figure).

Clinical outcomes included 63 major adverse cardiac events: 51 deaths (12% in the first 30 days), seven MIs, and 14 strokes. “Neurologic and vascular complications remain frequent,” Leon said. “These are things we should work on for the future.” The mortality rate in these high-risk patients, though, was acceptable, he noted. The device used in the study was the RetroFlex THV Delivery System (Edwards Life Sciences).

Using EuroSCORE, about onequarter of patients had a risk profile less than 20%, and 54% had a logistic EuroSCORE of 20% to 40%. Leon said EuroSCORE is difficult to use as an absolute risk profile score because it does not capture all the variables.

The researchers had 88% implant success and 26 unsuccessful deployments, including failed vascular access in 10 patients.

Feasibility studies

REVIVE II and REVIVAL II are similar feasibility studies in Europe and North America. The primary endpoints are death, MI, stroke or urgent cardiac surgery at 30 days, 3, 6 and 12 months.

Canadian Special Access is a compassionate-use study in Vancouver using a similar procedural technique and follow-up protocol to the other two studies.

Pooled data show the average patient age was 83.2 years; 47% were women. The patients were included if they had severe aortic stenosis and were at high risk for surgery. Thirtyfour percent of patients had undergone prior surgery, and 28% had chronic obstructive pulmonary disease.

“Long-term survival in this patient population is limited by their comorbidities,” Leon said. “[It should be] a core consideration as we plan clinical trials in these patients … and improvements in catheter design may decrease some of these complications, particularly the vascular complications and maybe even the strokes, and further improve survival.”