Louis Mullie

Therapeutic Interventions for Frail Elderly Patients: Part I. Published Randomized Trials

The body of literature for frailty as a prognostic marker continues to grow, yet the evidence for frailty as a therapeutic target is less well defined. In the setting of cardiovascular disease, the prevalence of frailty is elevated and its impact on mortality and major morbidity is substantial. Therapeutic interventions aimed at improving frailty may impart gains in functional status and survival. Randomized clinical trials that tested one or more therapeutic interventions in a population of frail older adults were reviewed. The interventions studied were exercise training in 13 trials, nutritional supplementation in 4 trials, combined exercise plus nutritional supplementation in 7 trials, pharmaceutical agents in 8 trials, multi-dimensional programs in 5 trials, and home-based services in 1 trial. The main findings of these trials are explored along with a discussion of their relative merits and limitations.

Therapeutic Interventions for Frail Elderly Patients: Part II. Ongoing and Unpublished Randomized Trials

There is increasing momentum to measure frailty in clinical practice given its proven value as a predictor of outcomes, particularly in elderly patients with cardiovascular disease. The number of randomized clinical trials targeting frail older adults has been modest to date. Therefore, we systematically searched the ClinicalTrials.gov registry in order to review the frailty intervention trials that had been actively initiated or completed but not yet published. The interventions studied were exercise training in 2 trials, nutritional supplementation in 3 trials, combined exercise plus nutritional supplementation in 5 trials, pharmaceutical agents in 5 trials, multi-dimensional programs in 2 trials, and home-based services in 3 trials. Their respective study designs, populations, interventions, and planned outcomes are presented in this article.

Psoas Muscle Area and All-Cause Mortality After Transcatheter Aortic Valve Replacement: The Montreal-Munich Study.

BACKGROUND Psoas muscle area (PMA) is a novel measure of frailty that can be efficiently measured from computed tomography images to help predict risk in older adults referred for transcatheter aortic valve replacement (TAVR). The objective of this study was to determine if PMA would be incrementally predictive of mortality and morbidity after TAVR. METHODS The pre-TAVR computed tomography scans of 208 consecutive patients at 2 hospitals in Montreal and Munich were analyzed to measure the cross-sectional area of the left and right psoas muscles on a single axial slice at the level of L4. The primary outcome was all-cause mortality assessed according to sex-stratified Cox regression models adjusted for the Society of Thoracic Surgeons predicted risk of mortality. RESULTS The mean age was 80.7 ± 6.8 years with 55% women and a total of 57 deaths over a mean follow-up of 504 days. PMA was lower in nonsurvivors compared with survivors among women (12.9 vs 14.5 cm(2); P = 0.047) but not men (21.7 vs 22.4 cm(2); P = 0.50). The association between PMA and all-cause mortality in women persisted after adjustment for Society of Thoracic Surgeons risk (hazard ratio, 0.88 per cm(2); 95% confidence interval, 0.78-0.99). An association between PMA and bleeding complications was seen in men (odds ratio, 0.78; 95% confidence interval, 0.62-0.97). Sensitivity analyses with PMA normalized to body mass index yielded similar results. CONCLUSIONS This study has shown that PMA is a marker of frailty associated with midterm survival in women who undergo TAVR. Further research is warranted to pursue PMA as a prognostic marker and therapeutic target in this vulnerable population.