Self-expanding TAVR Preferred Over Surgery

Self-expanding transcatheter aortic valve replacement (TAVR) in high-risk aortic stenosis patients produces a more consistent survival rate compared with standard surgery, according to 2-year data presented at the American College of Cardiology meeting in San Diego, CA.

While valve replacement is the common route taken as aortic stenosis becomes severe, many patients’ health profiles make standard surgical valve replacement a gamble.

Michael J. Reardon, MD, FACC professor and Allison Family Chair of Cardiovascular Research at Houston Methodist Hospital and colleagues conducted the CoreValve US Pivotal High Risk Trial, randomly assigning patients with a heightened risk of death from open-heart valve replacement to TAVR or the standard surgical procedure.

They reported death rates at one year were considerably lower for the 390 TAVR patients than for the 357 patients who had open-heart surgery. Also, year 2 data include 3 more patients, 2 of whom received a smaller second-generation CoreValve that wasn’t available earlier.

Reardon said, “Survival is statistically better with TAVR and sustained at 2 years. We found that the survival advantage actually increases for TAVR—that the absolute difference in all-cause death rates between the two groups has widened, with 4.8% more people surviving with TAVR than surgery at one year and 6.4% more surviving with TAVR at 2 years.”

The self-expanding device also had significantly lower rates for other endpoints: 10.9% rate of strokes and 29.7% major adverse cardiovascular or cerebrovascular events compared to the 16.6% stroke risk rate for surgery patients and 38.6% major adverse events of surgery patients.

“Durability is an issue, and we saw no evidence of TAVR valve deterioration,” Reardon said.

However, one area in the clinical trials where surgery consistently has better performance results than TAVR is in leaking around the new valve. According to Reardon, “Moderate to severe paravalvular leakage with TAVR was low at one year at 6% and stayed low at 2 years at 6.1%. We had very few cases of moderate or more leaks, and this may be why we don’t see a mortality signal with leakage.”

I think this really does move the needle forward. We have seen for the first time FAVR will be superior, so it will speak to how we will be doing it long-term to make it durable,” remarked Athena Poppas, MD, FACC, FASE, Cardiovascular Institute at Rhode Island Hospital.

Research did indicate that TAVR, with the self-expanding valve, “should be the preferred treatment in patients with symptomatic severe aortic stenosis at increased risk from surgery”. However, as these are only initial findings, longer follow-up (5 years) will be underway to confirm that this valve maintains its alternative-to-surgery benefits.