A home-based exercise program plus protein supplementation was safe for frail older adults undergoing transcatheter aortic valve replacement (TAVR) and improved strength, mobility, and balance compared with TAVR alone.
“This is the first randomized controlled trial to target frail older patients with an intervention aimed at counteracting their frailty to improve their outcome following TAVR,” Jonathan Afilalo, MD, McGill University and Jewish General Hospital in Montreal, told attendees on April 8 at the American College of Cardiology (ACC) Scientific Session 2024.
Physical performance in this study, called PERFORM-TAVR, was assessed using the Short Physical Performance Battery (SPPB), which includes a three-part balance test, gait speed test, and chair stand test.
“The rationale for the trial stems from the FRAILTY-AVR study that we conducted some years ago, in which we observed that despite a 96% technical success rate of the TAVR procedure, two out of five patients were reporting poor outcomes at 6-12 months.”
“For all types of poor outcomes — deaths, poor functional status, or poor quality of life — we found that frailty was among the top predictors,” he said. “So, the conceptual framework was to intervene on the frailty at the same time that we intervened on the heart and move these frail patients away from poor outcomes toward favorable outcomes.”
Physical Performance Measures Improved
The randomized clinical trial with blinded ascertainment of outcomes was conducted at 11 hospitals across Canada from 2019 to 2022. The primary outcome was the SPPB scale score (0-12, with 12 being the best) at 12 weeks.
Secondary outcomes included physical and mental aspects of quality of life, cognitive functioning, activity, sarcopenia, and a clinical composite, Afilalo explained.
A total of 180 patients (45% women) were included and randomized to the intervention or usual care. The mean age was 83 years, with 70% either octogenarians or nonagenarians. Patients also had high rates of multimorbidity and frailty, with an SPPB score of 8 or less.
All patients received lifestyle education, and those in the intervention group received two additional components: A protein-rich oral nutritional supplementation through a beverage they consumed twice daily and a home-based exercise intervention with a supervised component in which a therapist would visit the home for 1 hour twice weekly for 12 weeks after TAVR, plus an unsupervised walking program that was monitored with an accelerometer.
Although protein supplementation was supposed to be given for 4 weeks prior to TAVR, “this was less than expected, with a median of 9 days,” Afilalo said. “That’s because the TAVR procedure happened faster than expected.”
“But protein supplementation was exactly as we expected after TAVR, for a median of 99 days,” he said. “The amount of supervised exercise after TAVR was as expected, as well, with a median of 23 sessions delivered out of a maximum of 24. In addition, patients were performing a modest amount of unsupervised exercise, with a median of 20 minutes or 2128 steps per day, measured by the accelerometer.”
As has happened with many studies, “COVID hit right in the middle of our trial, and you could imagine that frail, elderly, sick patients were not crazy about having a stranger come into their home, administer touchy-feely performance tests.” However, for the purposes of the trial, the team was able to impute missing data from related data including questionnaires or proximate physical performance tests.
“When we adjusted for all the different covariates, we observed that the SPPB score improved by 1.02 points in the intervention compared to the control group,” Afilalo said. “If we looked at a complete case analysis, without the multiple imputation, the effect was even greater, an improvement of 1.41 points.”
In more familiar metrics, 1 SPPB point is equivalent to increasing the 6-minute walk distance by 36-52 m, he said. “It’s equivalent to reducing death or readmission in heart failure patients by 14%. And if you follow the REHAB-HF trial, this is the same primary outcome measure used in that trial and approximately the same effect size observed as with a full-blown cardiac rehabilitation program.”
However, the intervention did not improve secondary outcome measures of cognitive function.
From a safety perspective, no serious adverse events — ie, arrhythmias, ischemic events, heart failure exacerbations — before and after TAVR were related to the intervention.
“We’re in the process of analyzing a number of subgroups,” Afilalo told attendees. Specifically, the team is looking at whether effects are modified by a participant’s baseline frailty level, presence or absence of heart failure, adherence to the unsupervised component, and the presence of sarcopenia.
A Way to Measure Frailty, Sarcopenia
Session chair George D. Dangas, MD, PhD, a professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai in New York City and director of Cardiovascular Innovation at the Cardiovascular Institute of the Mount Sinai Medical Center, commented on the study for theheart.org | Medscape Cardiology.
Dangas highlighted the importance of sarcopenia, noting that it may have been among the reasons that recovery wasn’t as expected in many patients after TAVR in the earlier study. “A program that increases muscle mass could enhance recovery or perhaps ease the recovery itself,” he said in an interview.
With regard to the PERFORM program, he acknowledged that the protein component had to start at a specific time prior to TAVR because it was a clinical trial, “and if that part runs for a few weeks, it’s a way of knowing whether participants can tolerate the supplement and whether they like it.”
“But it’s more important to continue the full intervention after TAVR because that’s when the cardiac output is going to go high and that’s when the nutrients can be better absorbed, and they can do a better job at the muscle level and defy the frailty,” he said. “Starting before is a nice idea and you can get some feedback, but the patients haven’t had the aortic stenosis relief, and maybe, they can’t tolerate them as fluids.”
A major benefit of the PERFORM, he said, is that “for many years, there was no way to objectively measure frailty and sarcopenia, which are not the same, but are closely related. There are several scores, but which one do we use?”
“In this study, they were able to use a specific way to calculate it, and they used specific exercises that improved those specific calculations. That makes it a little bit more goal-oriented, which is huge.”
The approach can be adapted by physical therapists and in rehabilitation settings, he suggested. “There’s nothing complicated about it; they just need to be energized and follow it. I think this could be a sort of a generalized upgrade if you will or a generalized focusing of posterior recovery in frail patients in order to improve this aspect of care.”
The PERFORM-TAVR trial was funded by a peer-reviewed project grant from the Canadian Institutes of Health Research [CIHR] & academic support from the Lady Davis Institute for Medical Research at the Jewish General Hospital. The investigators reported no conflicts of interest relevant to this presentation.
Marilynn Larkin, MA, is an award-winning medical writer and editor whose work has appeared in numerous publications, including Medscape Medical News and its sister publication MDedge, The Lancet (where she was a contributing editor), and Reuters Health.
