A comparison of outcomes among unselected intermediate- and high-risk patients treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) indicates that the treatment options appear to result in similar 1-year outcomes.

Since FDA approval in 2011, transcatheter aortic valve replacement (TAVR) has become a mainstay of treatment for aortic stenosis, with randomized trials supporting its use in high- and intermediate-risk patients. However, the generalizability of the results from these trials into clinical practice has yet to be determined. Additionally, data from the German Aortic Valve Registry (GARY) published in late 2016 suggested that intermediate-risk patients treated with TAVR appeared to have a higher mortality rate than those treated with surgical aortic valve replacement (SAVR).

 

Shedding Some Light

For a study published in the Journal of the American College of Cardiology, J. Matthew Brennan, MD, MPH and colleagues sought to determine the 1-year outcomes of patients in the general population who were treated with TAVR when compared with those of patients treated with SAVR. “We also wanted to know within certain subgroups of patients if there were any advantages to one treatment over the other,” adds Dr. Brennan. To do so, the researchers compared death, stroke, days alive and out of the hospital to 1 year, and discharge home among nearly 9,500 propensity-matched intermediate- and high-risk patients who underwent TAVR or SAVR. To eliminate treatment bias, they focused on patients who were candidates for both procedures. “Patients in the GARY registry who underwent TAVR were not the same as those who underwent SAVR, which we believe affected the GARY data.”

Dr. Brennan and colleagues found no differences between TAVR and SAVR patients in 1-year rates of mortality (17.3% vs 17.9%, respectively) or stroke (4.2% vs 3.3%), or in proportion of days alive and out of the hospital to 1 year. “Transcatheter valves appear to be performing in contemporary US clinical practice the way they did in clinical trials,” says Dr. Brennan.

While study findings were consistent across most subgroups,  patients with prior lung disease appeared to have better outcomes with TAVR. “We did see a slightly higher rate of stroke at 1 year when compared with SAVR,” says Dr. Brennan. “The difference was not statistically significant, but the stroke curves were spreading apart. In clinical practice, we periodically see patients with clots on their transcatheter valves, suggesting that blood thinner regimens may not be optimal in TAVR patients.”

 

One Key Difference

Mirroring what they have seen in clinical practice, Dr. Brennan and colleagues found that TAVR patients were more likely than SAVR patients to be discharged home after treatment (69.9% vs 41.2%). “The recovery period with TAVR is much less demanding, and as a result of the physiologic stress of surgery, we saw that SAVR patients had a higher mortality rate over the first 3 months,” adds Dr. Brennan (Figure). “By 1 year after the procedure, that difference isn’t seen, but there is an early benefit to TAVR for patients who are frailer or are going to have trouble coming through the procedure.”

 

Looking Ahead

Evaluation of transcatheter valves in lower-risk patients, optimal anticoagulation strategies following TAVR to reduce stroke risk, and ensuring that patients know when there are case-specific advantages to either SAVR or TAVR are areas in need of additional research, according to Dr. Brennan. “Our study was part of a bigger program to create risk models and decision-support tools for patients and caregivers that facilitate educating patients on their expected outcomes with SAVR or TAVR,” he notes. “We’ve created, and will soon launch, a suite of free, publicly available calculators that will do just that. We also developed the site ValveAdvice.org, where patients, caregivers, and clinicians can learn more about making the decision between SAVR and TAVR.”

Dr. Brennan suggests that TAVR appears to be a reasonable choice for most intermediate- and high-risk patients with aortic stenosis. “I think we should be relieved that the GARY results were not correct and that we can safely treat these patients with TAVR or refer them to operators who do,” he says.

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