Transfemoral—but Not Transthoracic—TAVR Has Early Quality-of-Life Advantage Over Surgery in Intermediate-Risk Patients
WASHINGTON, DC—In patients with severe symptomatic aortic stenosis and intermediate surgical risk, both TAVR and surgery lead to major improvements in quality of life that are sustained for at least 2 years, an analysis of the PARTNER 2A trial shows.
However, the less-invasive approach seems to have an advantage over surgery among those eligible for transfemoral access, according to data presented by David Cohen, MD (Saint Luke’s Mid America Heart Institute, Kansas City, MO), here at TCT 2016. The boost in quality of life is greater with TAVR in the first month in that subgroup, although the disparity disappears by 1 year.
But when considering clinical status—which combines mortality and quality of life—transfemoral TAVR maintains an advantage over surgery through 2 years of follow-up. No such advantage was seen for patients who underwent a transapical or transaortic procedure.
“The lack of benefit among patients who were ineligible for a transfemoral approach suggests that a transthoracic approach may not be preferable to surgical AVR in such patients, at least in the short-to-intermediate term that we studied in this trial,” Cohen said at a press conference. “Further studies will be necessary to determine whether use of other alternative access sites like subclavian, carotid, or transcaval can overcome these limitations of the transthoracic approach.”
Importance of Quality of Life
Cohen said that a gain in quality of life may be more important even than survival for many older patients with aortic stenosis. Prior studies have shown that TAVR substantially improves quality of life in patients who are inoperable and leads to an early benefit versus surgery in those who have a high surgical risk, albeit only in patients who can undergo transfemoral procedures.
The purpose of the current analysis was to see whether those findings also apply to lower-risk patients, Cohen said.
He and his colleagues examined data from PARTNER 2A, which showed that TAVR was noninferior to surgery in terms of 2-year death or disabling stroke in patients at intermediate surgical risk (predicted risk of operative mortality greater than 4% based on a heart team assessment). Participants were stratified based on eligibility for transfemoral access and then randomized.
The current analysis included the 1,833 patients who had baseline data available on quality of life, which was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36, and EuroQOL. Patients had significant impairments at baseline.
By 1 month, quality of life improved in both the TAVR and surgical groups, although the gain was greater with TAVR (by 11.4 points on the KCCQ overall summary score). By 2 years, both groups had scores that were about 19 points higher compared with baseline, which is considered a large improvement.
The interaction between treatment effect and access site was significant (P < 0.001), and a pattern similar to that seen in the overall findings was observed in the transfemoral subgroup only, consistent with results from prior research, Cohen said.
‘Stay Out of the Chest’
An additional analysis showed that among patients undergoing surgery, quality of life improved to a similar extent regardless of eligibility for transfemoral access. In contrast, among patients undergoing TAVR, those who had a transthoracic procedure had stunted gains.
“I think the fairest conclusion . . . is [that] there doesn’t seem to be a benefit of doing TAVR, that I can measure, if you can’t do it transfemorally,” Cohen said after his presentation, adding that that goes for quality of life as well as survival.
One of the messages of the study seems to be to “stay out of the chest,” Cohen said. He noted that there is some emerging evidence to suggest that other nontransfemoral approaches that do not involve opening the chest can provide benefits similar to those achieved with transfemoral TAVR.
When asked at a press conference about the decision between TAVR and surgery in a patient with intermediate risk who is not eligible for transfemoral access, David Holmes Jr., MD (Mayo Clinic, Rochester, MN), pointed to the role of the heart team and consideration of local results with alternative access approaches. “That’s an important discussion,” he said, “and I think that’s probably site- and surgeon-dependent.”
Cohen DJ. Health status benefits of transcatheter vs. surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk: results from the PARTNER 2 trial. Presented at: TCT 2016. November 1, 2016. Washington, DC.
- PARTNER 2 was funded by Edwards Lifesciences.
- Cohen reports relationships with Abbott Vascular, AstraZeneca, Boston Scientific, Daiichi Sankyo/Eli Lilly, Edwards Lifesciences, Medtronic, Biomet, and Cardinal Health.
- Holmes reports no relevant conflicts of interest.