Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial.

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.

Multicomponent intervention for frail and pre-frail older adults with acute cardiovascular conditions: The TARGET-EFT randomized clinical trial.

BACKGROUND: Hospitalization for cardiovascular disease (CVD) may be complicated by hospital-acquired disability (HAD) and subsequently poor health-related quality of life (HRQOL). While frailty has been shown to be a risk factor, it has yet to be studied as a therapeutic target to improve outcomes. OBJECTIVES: This trial sought to determine the effects of an in-hospital multicomponent intervention targeting physical weakness, cognitive impairment, malnutrition, and anemia on patient-centered outcomes compared to usual care. METHODS: A single-center parallel-group randomized clinical trial was conducted in older patients with acute CVD and evidence of frailty or pre-frailty as measured by the Essential Frailty Toolset (EFT). Patients were randomized to usual care or a multicomponent intervention. Outcomes were HRQOL (EQ-5D-5L score) and disability (Older Americans Resources and Services score) at 30 days post-discharge and mood disturbances (Hospital Anxiety and Depression Scale) at discharge. RESULTS: The trial cohort consisted of 142 patients with a mean age of 79.5 years and 55% females. The primary diagnosis was heart failure in 29%, valvular heart disease in 28%, ischemic heart disease in 14%, arrhythmia in 11%, and other CVDs in 18%. The intervention improved HRQOL scores (coefficient 0.08; 95% CI 0.01, 0.15; p = 0.03) and mood scores (coefficient -1.95; 95% CI -3.82, -0.09; p = 0.04) but not disability scores (coefficient 0.18; 95% CI -1.44, 1.81; p = 0.82). There were no intervention-related adverse events. CONCLUSION: In frail older patients hospitalized for acute CVDs, an in-hospital multicomponent intervention targeted to frailty was safe and led to modest yet clinically meaningful improvements in HRQOL and mental well-being. The downstream impact of these effects on event-free survival and functional status remains to be evaluated in future research, as does the generalizability to other healthcare systems. CLINICAL REGISTRATION NUMBER: NCT04291690.

De-frailing intervention for hospitalized cardiovascular patients in the TARGET-EFT randomized clinical trial.

AIMS: Frailty is disproportionately prevalent in cardiovascular disease patients and exacerbated during hospital admissions, heightening the risk for adverse events and functional decline. Using the Essential Frailty Toolset (EFT) to target physical weakness, cognitive impairment, malnourishment, and anaemia, we tested a multicomponent targeted intervention to de-frail older adults with acute cardiovascular conditions during their hospital admission. METHODS AND RESULTS: The TARGET-EFT trial was a single-center randomized clinical trial at the Jewish General Hospital, Montreal, Canada. We compared a multicomponent de-frailing intervention with usual clinical care. Intervention group patients received exercise, cognitive stimulation, protein supplementation, and iron replacement, as required. In this study, the primary outcome was frailty, as assessed by the SPPB score (Short Physical Performance Battery) at discharge, and the secondary outcome was the SARC-F score (Strength, Assistance walking, Rising from chair, Climbing, Falls) assessed 30 days later. The analysis consisted of 135 patients (mean age of 79.3 years; 54% female) who survived and completed the frailty assessments.Compared with control patients, intervention group patients had a 1.52-point superior SPPB score and a 0.74-point superior SARC-F score. Subgroup analysis suggested that patients with low left ventricular ejection fraction may have attenuated benefits, and that patients who underwent invasive cardiac procedures had the greatest benefits from the intervention. CONCLUSION: We achieved our objective of de-frailing older cardiac inpatients on a short-term basis by improving their physical performance and functioning using a pragmatic multicomponent intervention. This could have positive impacts on their clinical outcomes and ability to maintain independent living in the future. ONE SENTENCE SUMMARY: The multicomponent intervention targeted to the deficits of vulnerable older adults hospitalized with acute cardiovascular diseases successfully de-frailed them on a short-term basis, which can have positive implications on their post-discharge health outcomes.

Prognostic Value of Handgrip Strength in Older Adults Undergoing Cardiac Surgery.

BACKGROUND: Although multidimensional frailty scales have been proven to predict mortality and morbidity in cardiac surgery, there is a need for rapid tools that could be easily administered at the point of care. Handgrip strength (HGS) is an attractive option that can be measured in acutely ill and bed-bound patients, although it has yet to be validated in a large cardiac surgery cohort. METHODS: This is a post hoc analysis of a multicentre prospective study in older patients undergoing coronary artery bypass grafting and/or valve surgery from 2011 to 2019. HGS was measured before surgery and classified by sex-stratified cutoffs. The primary outcome was 1-year mortality and secondary outcomes were 30-day mortality, discharge disposition, and prolonged length of stay. RESULTS: There were 1245 patients included in the analysis (mean age 74.0 ± 6.6 years; 30% female). Weak HGS was associated with advanced age, heart failure, kidney disease, malnutrition, and various frailty scales. In those with weak vs normal HGS, respectively, 1-year mortality was 17% vs 6%, 30-day mortality was 10% vs 3%, prolonged length of stay was 34% vs 19%, and discharge to a health care facility was 45% vs 26% (all P < 0.001). After adjustment, HGS was predictive of 1-year and 30-day mortalities, with odds ratios of 2.44 (95% confidence interval [CI] 1.39-4.29) and 2.83 (1.38-5.81), respectively. HGS cutoffs of < 26 kg in men and < 16 kg in women had the highest predictive performance. CONCLUSIONS: HGS is a simple and effective tool to identify patients at higher risk of mortality and protracted recovery after cardiac surgery.