麻豆传媒

WASHINGTON -- No signs of valve degeneration were found in older devices for transcatheter aortic valve replacement (TAVR) in the long term, a study found, while a separate analysis suggested durable improvements in quality of life.

According to the PARTNER [Placement of AoRTic TraNscathetER Valve Trial] 1 data, the mean gradient of aortic valves immediately fell from 12.1 mmHg to 9.2 mmHg after TAVR, and 5 years later it crept back up to 10.3 mmHg, reported , of Duke Clinical Research Institute.

Similarly, the dimensionless valve index of the valve rose from 0.51 to 0.54 after intervention before dropping back to 0.51 at 5 years.

Altogether, the "early favorable changes" indicated that TAVR initially worked -- and hemodynamic metrics suggested "freedom from structural valve deterioration as would be expected for mid-term follow up in bioprostheses," Douglas said at the annual meeting.

Furthermore, patients who died or required re-interventions had mean gradients that were last recorded to be even lower than those of event-free survivors up to 3 years of follow-up, while dimensionless valve index had no relationship with outcomes, she said.

"The association of these distinct hemodynamic patterns with death likely reflects a primary causative role for low-flow/low-output states due to underlying or concomitant disease rather than valve deterioration. Similar patterns were seen in surgical aortic valve replacement [SAVR] patients in PARTNER 1A."

Douglas performed a retrospective analysis of data from the PARTNER IA, IB, and Continued Access trials. Included were patients at high surgical risk who received a first-generation Sapien valve with serial post-implant echo data (n=2,404) and were followed for a median of 2.9 years.

"This is one step of 30 steps we're going to have to take," , of Beth Israel Deaconess Medical Center in Boston commented at a TCT press conference. "We're now extending the follow-up to 5, 6, and 10 years in the low-risk trial. ... Following patients rigorously in [that] trial is essential.

"Certainly EuroPCR created a lot of headline news. Danny Dvir needs to be congratulated for raising the issue.... It was a good start to a discussion, but [the current dataset] has the denominator and numerator, and that is what we need," Popma concluded.

Quality of life stayed boosted at 2 years after TAVR and even surpassed surgery in some respects, according to a separate presentation at the TCT meeting.

TAVR and SAVR patients from the PARTNER 2A trial both self-reported improved quality of life by year 2 with no significant difference between groups, according to their Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.

However, the overall distribution of patients who improved rather than worsened favored TAVR at all time points: 1 month (P<0.001), 1 year (P=0.04), and 2 years (P=0.04), reported , of Saint Luke's Mid America Heart Institute in Kansas City, Mo.

There was a significant interaction between treatment effect and access site (P<0.001): transfemoral TAVR patients had a much better KCCQ score at 1 month (difference of 14.1 points, P<0.001) than their SAVR peers -- although that advantage dissipated by 12 months.

Transthoracic TAVR recipients did not have a better quality of life than the surgery cohort at any point, Cohen noted.

PARTNER 2A included patients at intermediate surgical risk who were randomized to transfemoral TAVR (n=775), transapical/transaortic TAVR (n=236), or SAVR (n=1,021). Operators implanted Sapien XT and Sapien 3 valves in the cath lab.

"Taken together with previous data, these findings demonstrate that for intermediate-risk patients suitable for a transfemoral approach, TAVR provides both early and late benefits compared with SAVR from the patient's perspective," Cohen concluded.

"The lack of benefit among patients ineligible for the transfemoral approach suggests that a transthoracic approach may not be preferable to SAVR in such patients -- at least in the short to intermediate term."

And, suggested , of Mayo Clinic College of Medicine in Rochester, Minn., during the session, that may be fitting as the transfemoral approach continues to rise in popularity, while transthoracic rates are "truly plummeting."