PERFORM-TAVR: Home based exercise and protein supplementation improves physical performance in frail adults post-TAVR

By Lucas Marinacci on

Key Points:

  • Many frail patients experience poor physical performance after TAVR, even when the procedure is a technical success. 
  • In frail, older patients undergoing TAVR, a combined program of home based exercise and protein supplementation 4 weeks before and 12 weeks after the procedure significantly improved standardized physical performance scores compared to a control of lifestyle education.

Prior prospective cohort studies have found that frailty is a powerful predictor of poor outcomes and physical decline following transcatheter aortic valve replacement (TAVR).  Whether periprocedural interventions meant to counteract frailty can improve outcomes is unknown.

On April 8, 2024, the principal results of the “Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing TAVR: The PERFORM-TAVR Trial” were presented at ACC Scientific Sessions 2024.  The purpose of this study was to test whether an exercise- and diet-based anti-frailty intervention could improve functional outcomes following TAVR. 

Patients aged 70 or older with objective evidence of physical frailty by validated scores were randomized to an intervention of lifestyle education, protein rich oral nutrition supplementations, and a partially supervised homebased exercise program or a control of lifestyle education alone. Those with advanced NYHA Class IV symptoms, cirrhosis, significant CKD, inability to walk without assistance, more than 2 falls in the past year, significant language barrier, or moderate to severe cognitive impairment were excluded.  The primary outcome was the Short Physical Performance Battery (SPPB ) score as measured by blinded assessors at 12 weeks.  A modified intention to treat analysis using regression adjusted for baseline score, age, sex, BMI, and study center was performed. 

A total of 180 patients were included in the primary analysis.  More than 70% were older than 80 and 45% were female. They completed a mean of 22 exercise sessions.  The mean baseline SBBP score was 7.1 in both the intervention and control group, and increased to 8.1 for the intervention group at 12 weeks, but remained 7.1 for the control group.  After multivariable adjustment and using multiple imputation for missing data, this represented a significant improvement (+0.9 points, [95% CI 0.3-1.6], p=0.006).  The gain of 1 point on this scale is considered a clinically meaningful change, as it correlated with a 14% reduction in death or readmission for patients with heart failure and an increase of 16 meters in 6 minute walk distance. Limitations include COVID related interruptions to the study protocol and a 14% missing rate due to early drop out or the competing risk of mortality.  

Dr. Jonathan Afilalo, MD of McGill University, concluded: “A home-based exercise intervention with protein supplementation was safe  and improved physical performance at 12 weeks in frail TAVR patients.  Despite high technical success and low procedural complications, TAVR alone did not improve physical performance metrics of strength, mobility, and balance.  This trial supports a shift towards a more holistic treatment paradigm that addresses frailty to optimize functioning and quality of life following TAVR.”