Prospective Evaluation of the Eyeball Test for Assessing Frailty in Elderly Patients with Valvular Heart Disease Background Frailty is a common occurrence in elderly patients Approximately half of the patients being screened for transcatheter valve therapies are frail Cardiac surgical risk scores and subjective clinical assessments guide whether patients are evaluated for transcatheter valve therapies vs. surgery Cardiac Risk Scores do not take frailty into account Frailty assessment of TAVR candidates to date has been mainly based on the traditional eyeball test 1
Significance Increasing use of transcatheter aortic valve replacement (TAVR) in the treatment of elderly high-risk patients with aortic stenosis The less-invasive nature of TAVR is bringing more of these patients into the clinic for evaluation and therapy Frailty There is no accepted definition of frailty nor a consensus about specific clinical measures or laboratory markers for its diagnosis There is extensive overlap and interactions between disability, comorbidity, and frailty The most commonly used definition of frailty is based on the criteria of Fried et al., which assess up to 5 domains: 1. Nutritional status (weight loss) 2. Energy (exhaustion) 3. Physical activity (leisure time activity) 4. Mobility (gait speed) 5. Strength (grip strength) 2
Previous Study Green et al. assessed frailty in 159 patients who received TAVR as part of the PARTNER (Placement of AoRTic TraNscathetER Valve Trial) 4 factors were measured pre-tavr: gait speed with a 15-ft timed walk test, weakness by dominant hand-grip strength test, decline in independence in ADL, and serum albumin for malnutrition and wasting Green et al. derived a frailty score, where highest (maximum score = 12) represented the most frail and lowest score represented the least frail in their cohort. The mortality rate at 1-year follow-up was as low as 3% among patients with low frailty scores, as compared with 13% among patients with high frailty scores Study Objective To determine the incremental utility of objective criteria for frailty assessment 3
Patient Population Age 18 yrs Willing and capable of signing informed consent Patient undergoing routine clinical evaluation at Minneapolis Heart Institute (MHI) Patient has diagnosis of valvular heart disease or coronary artery disease, and is being considered for percutaneous or surgical interventional procedure (e.g., percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), valve replacement) Data Analysis Providers examined each patient and independently graded frailty with a Likert scale (1 to 7, with 7 being most frail) and assessed surgical risk (low, intermediate, high, prohibitive) Each patient underwent prospective, objective measurement of frailty with assessments of 15-foot and 6-min walk times, handgrip strength, activities of daily living (Katz index), and SF-12 quality-of-life Providers were informed of the objective frailty data, and were asked to re-grade frailty 4
Results Frailty scores on the Likert scale decreased (i.e., less frailty) once the provider became aware of the objective data (3.7±2.0 vs. 3.4±2.0; p=0.003) For the binary classification of frailty (i.e., frail or not), the net reclassification rate after awareness of the objective data was 41%. A change of 2 points on the Likert scale occurred in 22% Handgrip strength was the most common objective measure used for net reclassification Overall, reclassification of surgical risk occurred in 26% of patients with awareness of objective frailty measures Baseline Assessment N=101 Passed Handgrip strength assessment Failed Handgrip strength assessment Frail 26 21 Not Frail 23 30 Total incorrect: 56 Baseline Assessment N=101 Passed Katz ADL assessment Failed Katz ADL assessment Frail 41 8 Not Frail 50 1 Total incorrect: 42 Baseline Assessment N=101 Passed 15 Foot Walk Failed 15 Foot Walk Frail 21 28 Not Frail 48 3 Total incorrect: 24 5
Conclusions The eyeball test was insufficient for assessing frailty in ~40% of elderly patients being considered for surgery In addition to physical status, other domains such as cognitive ability, mood, and mental health should be considered to obtain a more complete assessment of frailty Objective frailty measures should be routinely considered in the assessment of these patients, and further study on their incremental value for risk prognostication is needed References 1. Mack M. Frailty and aortic valve disease.j Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S7-10. 2. Afilalo J. Frailty in patients with cardiovascular disease: Why, when, and how to measure. Curr Cardiovasc Risk Rep 2011;5:467:72. 3. Bergman H, Ferrucci L, Guralnik J, et al. Frailty: an emerging research and clinical paradigm- issues and controversies. J Gerontol A Biol Scie Med Sci 2007;62:731-7. 4. Katz S. Assessing self-maintenance: Activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc 1983;31:721-26. 5. Fried L.P., Tangen C.M., Walston J., Frailty in older adults: evidence for a phenotype. J Gerontol Med Sci. 2001;56A:M146-M156. 6. Rodés-Cabau J, Mok M. Working Toward a Frailty Index in Transcatheter Aortic Valve Replacement: A Major Move Away From the Eyeball Test. J Am Coll Cardiol Intv. 2012;5(9):982-983. 7. Green P, Woglom AE, Genereux P, et al. The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience. J Am Coll Cardiol Intv 2012;9:974 81. 6
Acknowledgements Paul Sorajja, MD Lisa Tindell Melissa Buescher MHI clinic staff MHIF research staff QUESTIONS? 7
All patients N=101 Age (yr) 76.8 ±13.8 Men no. (%) 60 (60) Hypertension no. (%) 89 (89) Diabetes no. (%) 29 (29) Atrial fibrillation no. (%) 54 (54) COPD no. (%) 18 (18) O 2 -dependent 3 (3) CAD no. (%) 58 (58) Prior PCI no. (%) 37 (37) Prior CABG no. (%) 19 (19) >1 prior sternotomy 5 (5) ICD no. (%) 3 (3) PPM no. (%) 8 (8) BMI 28.7 ±6.6 Creatinine g/dl 1.1 ±0.5 LVEF (%) 58 ±12 Left ventricular hypertrophy 27 (27) Moderate or severe AS no. (%) 41 (41) Moderate or severe MR no. (%) 30 (30) Other valvular disease no (%) 29 (29) STS-PROM (%) 5.2 ±3.8 8