SAN FRANCISCO—Patients who underwent transcatheter aortic valve replacement (TAVR) procedures fared better compared with those undergoing surgical aortic valve replacements (SAVR), according to data from the PARTNER Cohort A trial presented Nov. 10 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference. However, patients reported a lack of benefit, suggesting worse quality of life among patients ineligible for the transfemoral approach. The findings led researchers to conclude that the transapical approach many not be superior to SAVR.

“TAVR is a less invasive alternative to surgical valve replacement for high risk patients with severe aortic stenosis,” David J. Cohen, MD, of Saint Luke’s Mid-American Heart Institute in Kansas City, said as he presented quality of life results of the PARTNER Cohort A study during a late breaking clinical trial session.

“In PARTNER A, TAVR was found to be non-inferior to surgery for the primary endpoint of one-year mortality among patients at high surgical risk,” Cohen noted.  However, he said that there were differences in the rates of procedure-related complications and valve performance at one-year with some endpoints favoring TAVR and others SAVR.

Because quality of life data from the high surgical risk population included in Cohort A of the PARTNER trial had not yet been assessed, Cohen et al used the Kansas City Cardiomyopathy (KCC) questionnaire, which evaluated 23 measures including symptoms, overall perceptions of quality of life (QOL) and physical limitation, to obtain the patient’s perspective.

“The main results were that there were very highly significant interactions between treatment effect (the difference between TAVR and surgical valve replacement and the access site) for the primary endpoint and multiple secondary endpoints at a p value less than 0.01,” Cohen said. These results were primarily at the one-month and six-month time points, he noted. Cohen and colleagues performed the QOL analysis separately for the transfemoral approach (TF) and transapical approach (TA) subgroups.

Cohen reported the treatment effects between the TAVR and surgical performance at one, six and 12 months. “There were different patterns between the two access sites [TA and TF],” Cohen noted.

“What we saw was a very important and significant benefit in favor of TAVR over surgical AVR at one month with about a 10-point difference, which is a moderately large difference over a population for the KCC questionnaire,” Cohen offered. However, when six months rolled around, these differences diminished significantly, and at 12 months these differences were no longer significant, he said.

“There are two messages here,” Cohen said: there was a benefit of TAVR at one month and there was no difference at 12 months. However, he noted that the results for the transapical subgroup of patients were poles apart. “There was not a statistically significant difference in the quality of life at the-one month time point,” Cohen said, “although the trend strongly favored surgical AVR.”  While there was some difference at the six-month mark, at 12 months, data was similar.

Cohen noted that results between the subgroups were similar when:

• An analysis was restricted to patients who underwent attempted valve treatment (“As treated” cohort; n=607);
• “Worst case” values (at the 90th percentile) were imputed to all patients with missing data, which occurred in about 10 percent of patients; and
• Outcomes were evaluated categorically according to a binary (improvement) or a multilevel ordinal outcome.

“Taken together with previous data that have been reported, these findings demonstrate that in patients suitable for a transfemoral approach, transcatheter AVR provides important benefits over SAVR from the patient’s perspective,” Cohen offered.

“The lack of benefit and suggestion of worse QOL among patients who are ineligible for the TF approach suggests that a TA approach may not be preferable for surgical AVR in such patients.”

Cohen concluded that future studies should evaluate whether improvements in the TA approach could overcome the procedures' reported limitations.

“These results do validate that the transfemoral approach does improve quality of life over surgery, especially early on,” Michael J. Mack, MD, medical director of cardiovascular surgery at Baylor Health Care System and the Heart Hospital Baylor in Plano, Texas, said during a press conference. “It’s a less invasive procedure and patients recover quicker. That is what we have always thought and hoped for clinically would be the case.”

Mack cautioned that the transfemoral approach had a head start in the trial. “A lot of centers hadn't even started doing TA,” Mack offered. Additionally, Mack pointed out that there was a steep learning curve at this time, with 20 centers in the trial performing four or less TA procedures.

“The clear message was that TA was still on the learning curve,” Mack offered. While Mack said there still are concerns about TA, the majority of the previously published data has been fairly positive for TA.

“The transfemoral data are completely stable with surgery and even at one year with TA,” Joseph E. Bavaria, MD, of the University of Pennsylvania in Philadelphia,” offered. Barvaria said that the current trial was not powered to make conclusions about TA; however, there may be a “clear call to improve the TA operation,” Barvaria noted.

“TA in this population, at this time (the early stage of our learning)  was not better than surgery and in some measures is worse," Cohen concluded.