A combination of home-based exercise and protein supplements improves 12-week physical performance in frail, older adults who are undergoing transcatheter aortic valve replacement (TAVR), a new study shows. These results were presented by Jonathan Afilalo, MD, MSc, of the Jewish General Hospital, Montreal, in a Featured Clinical Research session Monday at the American College of Cardiology (ACC) Scientific Sessions 2024 in Atlanta. While TAVR is a relatively successful procedure, poor physical performance is often reported in older adults who undergo TAVR. Frail patients are especially vulnerable. The joint effects of exercise and heightened protein intake have yet to be examined in this population. The investigators in this study sought to determine the effects of protein supplementation plus exercise in older, frail patients undergoing TAVR. Patients who were 70 years or older and showed evidence of physical frailty were included. Randomization to protein-rich oral nutritional supplements for 4 weeks pre-TAVR and 12 weeks post-TAVR plus biweekly supervised home exercise sessions for 12 weeks post-TAVR or lifestyle education (control) took place. Physical performance in strength, mobility and balance measured by blinded exercise professionals was the primary outcome. This was measured using the Short Physical Performance Battery (SPPB) at 12 weeks. Modified intention-to-treat analyses were conducted using linear regression. Adjustments were made baseline SPPB score, age, sex, body mass index and center. Missing data were imputed by chained equations. A total of 210 patients were randomized, and nine patients died and 21 disenrolled prior to their intervention initiation or first follow-up. A total of 180 patients were analyzed (mean age=83 years; 45% female). In-person and virtual exercise sessions were offered during the COVID-19 pandemic, and the mean number of exercise sessions was 22. The range for SPPB score was 0-12, with the mean baseline score at 7.1 for both groups. At 12 weeks the score was 8.1 for the exercise/protein group and 7.1 for the control group. The multivariable-adjusted difference was 0.9 points between groups (95% confidence interval [CI]=0.3-1.6, p=0.006). Patients tolerated the intervention well, and it was safe. SPPB at 12 weeks using the model linear regression with multiple imputation for analysis showed improvement in the intervention group (hazard ratio [HR]=1.02; 95% CI=0.37-1.66, 0.002). Without imputation, the intervention group continued to show improvement (HR=1.41, 95% CI=0.59-2.23, p=0.001). Limitations of this study included the interference of the pandemic, which made it difficult to perform home visits for therapy, and that 14% of patients were not analyzed. The time between baseline visit and the TAVR procedure was also unpredictable. Overall, the intervention group experienced improved physical performance at 12 weeks. There was also high technical success and few procedural complications, but TAVR alone did not improve physical performance in strength, mobility or balance in this patient population. “This trial supports a shift towards a more holistic treatment paradigm that addresses frailty to optimize functioning and quality of life following TAVR,” Afilalo concluded. Photo Credit: Jason Wermers/CRTonline.org Photo Caption: Jonathan Afilalo, MD, MSc, presents results from the PERFORM-TAVR trial Monday at ACC.24 in Atlanta.