Protein and exercise to reverse frailty in older men and women undergoing transcatheter aortic valve replacement: The PERFORM-TAVR Trial
Reported from ACC.24
Panos Xaplanteris provides his take on the results of PERFORM-TAVR presented by Jonathan Afilalo at ACC.24 in Atlanta.
Why this study? – the rationale/objective
Transcatheter aortic valve implantation (TAVI) has emerged as the mainstay of treatment in older patients with comorbidities at high, intermediate, and even low surgical risk that have severe aortic valve stenosis. Following implantation, cardiac output is restored and this translates to lower mortality and improvement in symptoms, notably shortness of breath. Nonetheless, and despite improved hemodynamics post-TAVI, 35% of patients have subsequent functional decline at one year; this percentage rises to >50% for frail patients as judged by dedicated clinical scores according to the FRAILTY-AVR trial.
The rationale of the PERFORM-TAVR trial presented at ACC.24 by Dr Jonathan Afilalo is that an improvement in functional status could be expected in frail patients undergoing TAVI by supplementing their diet with protein and offering a structured physical exercise program before (pre-hab: pre-surgical rehabilitation) and after (post-hab: post-surgical rehabilitation) the TAVI procedure.
How was it executed? – the methodology
210 patients from 11 Canadian hospitals were enrolled in this randomized parallel-group clinical trial from 2019 to 2022. After an initial screening at the hospital, patients were randomized to either the protein oral supplementation (beverage containing 20 g of protein one month pre- and three months post-TAVI) and exercise therapy (1-hour sessions twice per week at home for 3 months post TAVI and accelerometer for step count) group or to the usual care group.
Outcomes were assessed at 3 and 6 months by blinded therapists using standardized questionnaires during home visits. The trial included patients >= 70 years old who were physically frail (SPPB score of =<8 or SF-36 score =<55). Patients that were decompensated or non-ambulatory NYHA class IV, COVID-10 positive, with severe renal impairment, uncontrolled diabetes, cirrhosis, moderate/severe cognitive impairment, or significant mobility issues were excluded.
85 patients received the intervention and 95 were in the control group; 70% were in their eighties or nineties and 45% were women. In the intervention group, the median duration of protein supplementation was 9 days before TAVI and 99 days after TAVI; 23 sessions of supervised exercise were done post-TAVI and these patients also did 20 min/day of unsupervised exercise and 2128 steps per day. The primary outcome was the change in frailty as assessed by the SPPB score at 3 months; the secondary outcome was the change in the SF36-PCS score at 3 months.
What is the main result?
At three months post-TAVI, the intervention with protein and exercise resulted in better physical performance as demonstrated by an improvement of 1.02 points in the SPPB score compared to the control group (by using multiple imputation analyses to account for patients with missing data) or by 1.41 when only cases with complete evaluation were analyzed. Of note, an improvement by 1 point in the SPPB score translates into important functional benefits, such as increasing the 6-minute walk distance from 36 to 52 meters.
In a similar fashion, the SF36-PCS score was improved by the intervention by 5.8 points compared to the control group in multiple imputation analysis. No serious adverse events were observed, and all-cause mortality was comparable between groups.
Critical reading and the relevance for clinical practice
- The PERFORM-TAVR trial underlines the importance of a holistic approach for older frail patients undergoing a TAVI procedure. By addressing not only the stenotic valve but the underlying frailty as well, short-term benefits in physical performance are to be gained. This is relevant for patients, given the fact that the majority prioritize quality of life over longevity after TAVI.
- The concept of pre-habilitation (before TAVI) to maximize functional improvement is appealing and should be part of the TAVI workup for interventionalists.
- The study was performed during the COVID-19 pandemic; as a result, some patients missed their 3-month evaluation at home and these scores had to be imputed. Virtual delivery of exercise therapy was also used during the pandemic. It is conceivable that the true impact of the intervention on physical performance may differ from the one reported if all visits had been performed.
- It is unknown if the beneficial impact of the intervention will persist in the long term, after having stopped protein supplementation and exercise.
- The extrapolation of results to non-American patients/lifestyles should be done with caution.
No comments yet!