Home exercise plus protein supplementation helps patients with frailty undergoing TAVR
Click Here to Manage Email Alerts
Key takeaways:
- A home-based exercise intervention with protein supplementation improved physical performance at 12 weeks.
- The population was older patients with frailty undergoing transcatheter aortic valve replacement.
ATLANTA — A home-based exercise intervention with protein supplementation improved physical performance at 12 weeks for older patients with frailty who underwent transcatheter aortic valve replacement, according to the PERFORM-TAVR trial.
“The rationale for the trial stems from the FRAILTY-AVR prospective cohort study ... in which we observed that despite a 96% technical success rate for the TAVR procedure, two out of five patients were reporting poor outcomes at 6 to 12 months,” Jonathan Afilalo, MD, FACC, associate professor of medicine and director of the Geriatric Cardiology Fellowship Program at McGill University in Montreal, said during a presentation at the American College of Cardiology Scientific Session. “We found that frailty was among the top predictors [of poor outcomes]. The conceptual framework here is to intervene on the frailty at the same time we intervene on the heart, and curb these patients away from poor outcomes toward favorable outcomes.”
Afilalo and colleagues randomly assigned 210 patients with frailty about to undergo TAVR, of whom 180 could be analyzed for the primary outcome (mean age, 83 years; 70% octogenarians or nonagenarians; 45% women), to receive an intervention or be in the control group. All patients received lifestyle education pertaining to diet and physical activity. The intervention group also received a protein-rich nutritional supplement (Ensure Enlive, Abbott) to be consumed twice daily and a home-based exercise program, which consisted of a supervised 1-hour visit from an exercise therapist twice per week and unsupervised walking with an accelerometer to track step counts.
The primary outcome was the Short Physical Performance Battery (SPPB) score, which included three balance tests, a gait speed test and a chair stand test, at 12 weeks.
Protein supplementation occurred a median of 9 days before TAVR and 99 days after it, whereas supervised exercise lasted a median of 23 sessions (of a possible 24) and unsupervised exercise lasted a median of 20 minutes and 2,128 steps per day, Afilalo said, noting the period between initiation of supplementation and performance of TAVR was shorter than expected, limiting the amount of “prehab” that could be done.
“When it came to measuring our key outcomes ... we had difficulties, as COVID hit right in the middle of our trial,” he said. “You can imagine that frail, elderly and sick patients are not crazy about having a stranger come in their home to administer touchy-feely performance tests. Fortunately, when there was missing data ... we had a lot of neighboring data from either questionnaires or proximate physical performance tests that we could use to intelligently impute the missing data. We did have to pivot to offer virtual delivery of exercise therapy, which worked in many cases.”
Physical performance improved
The SPPB score improved by 1.02 points in the intervention group compared with the control group at 12 weeks (95% CI, 0.37-1.66; P = .002), Afilalo said during the presentation, noting the effect was even greater without the multiple imputation (1.41; 95% CI, 0.59-2.23; P = .001).
Increasing the SPPB score by 1 point is equivalent to increasing 6-minute walk distance by 36 m to 52 m, reducing death or readmission by 14% in patients with HF and achieving the same effect as produced by a more comprehensive cardiac rehabilitation program in the REHAB-HF trial, he said.
The SF-36 physical component score was improved by 5.8 points at 12 weeks in the intervention group compared with the control group (95% CI, 0.14-11.5; P = .045), but there was no difference between the groups in change in SF-36 mental component score or Montreal Cognitive Assessment (MoCA) cognitive function score at 12 weeks, he said.
There were no serious adverse events definitely or probably related to the intervention, and there was no difference between the groups in all-cause mortality (P = .49), Afilalo said.
“A home-based exercise intervention with protein supplementation was safe and improved physical performance at 12 weeks in frail TAVR patients,” Afilalo said during the presentation. “Of particular note, despite a high technical success rate and low procedural complications, TAVR alone did not improve physical performance metrics for strength, mobility and balance at 12 weeks. I think that’s an important point if we’re striving to improve our patient-centered outcomes. I think this leads toward a shift toward a more holistic treatment paradigm that addresses not only the heart, but also the frailty to optimize functioning and quality of life post-TAVR.”
‘A tremendous success’
In a discussion after the presentation, James N. Kirkpatrick, MD, FACC, professor of medicine and director of the echocardiography laboratory at the University of Washington Medical Center, said the study was “a tremendous success.”
“Although this was done in patients with TAVR who for the most part were quite elderly, this sort of ‘prehab’ concept applies [broadly],” he said. “Improving frailty is going to improve the outcomes of patients undergoing all sorts of interventional procedures. As low as 7% of patients undergoing TAVR are actually interested in life prolongation. The rest of them, their primary motivation is function and quality of life. We need to keep that in mind, because we need to do something to optimize these results.”
Collapse
Afilalo J, et al. Featured clinical research III. Presented at: American College of Cardiology Scientific Session; April 6-8, 2024; Atlanta.
Click Here to Manage Email Alerts