Relation of Frailty to Outcomes After Transcatheter Aortic Valve Replacement (from the PARTNER Trial)

doi:10.1016/j.amjcard.2015.03.061

The American Journal of Cardiology

Volume 116, Issue 2, 15 July 2015, Pages 264-269

https://doi.org/10.1016/j.amjcard.2015.03.061 Get rights and content

Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe symptomatic aortic stenosis (AS) in patients who are inoperable or at high risk for surgery. However, the intermediate- to long-term mortality is high, emphasizing the importance of patient selection. We, therefore, sought to evaluate the prognostic value of frailty in older recipients of TAVR, hypothesizing that frail patients would experience a higher mortality rate and a higher likelihood of poor outcome 1 year after TAVR. This substudy of the Placement of Aortic Transcatheter Valves trial was conducted at 3 high-enrolling sites where frailty was assessed systematically before TAVR. In total, 244 patients received TAVR at the participating sites. Frailty was assessed using a composite of 4 markers (serum albumin, dominant handgrip strength, gait speed, and Katz activity of daily living survey), which were combined into a frailty score. The cohort was dichotomized at median frailty score. Outcomes measures were the time to death from any cause for >1 year of follow-up and poor outcome at 1 year. Poor outcome was defined as (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score <60, or (3) decrease of ≥10 points in the KCCQ-OS score from baseline to 1 year. At 1 year, the Kaplan-Meier–estimated all-cause mortality rate was 32.7% in the frail group and 15.9% in the nonfrail group (log-rank p = 0.004). At 1 year, poor outcome occurred in 50.0% of the frail group and 31.5% of the nonfrail group (p = 0.02). In conclusion, frailty was associated with increased mortality and a higher rate of poor outcome 1 year after TAVR.

Section snippets

Methods

The design and initial results of the PARTNER trial have been published previously.15, 16 The PARTNER trial enrolled patients with severe symptomatic AS into 2 cohorts: those at high surgical risk (cohort A) and those considered inoperable because of severe coexisting conditions (cohort B). Patients in cohort B with a suitable iliofemoral vessel were randomized to transfemoral TAVR with the Edwards-Sapien heart valve system (Edwards Lifesciences, Irvine, California) or to standard medical care.

Results

Of the 244 patients included in this analysis, overall, median gait speed was 0.38 m/s (IQR 0.23 to 0.64 m/s), median serum albumin was 3.9 g/dl (IQR 3.6 to 4.2 g/dl), and 172 (71%) performed all ADLs independently. In men, median grip strength was 23.6 kg (IQR 17.0 to 28.3), and in women, median grip strength was 12.2 kg (IQR 10.0 to 15.7; Table 1) The median frailty score was 5 (IQR 3 to 7). Accordingly, for the purposes of this study, 134 (120 cohort A and 14 cohort B) participants with a

Discussion

The present report, drawn from a cohort of 244 patients with severe symptomatic AS who underwent TAVR at 3 US sites, evaluated the association between frailty as estimated by the composite of gait speed, grip strength, ADLs, and albumin and outcomes after TAVR. We found that at 30 days, the rate of mortality and major complications did not differ between the frail and nonfrail groups; however, at 1 year, compared with those with a frailty score less than the median value, those with a frailty

Disclosures

The PARTNER trial was funded by the Edwards Lifesciences (Irvine, CA), and the protocol was developed collaboratively by the Sponsor and Steering Committee. The present analysis was designed and completed by the authors through the PARTNER Publications Office, which is co-located at the Columbia University Medical Center/The Cardiovascular Research Foundation and The Cleveland Clinic and supported by an unrestricted grant from the Edwards Lifesciences, administered by the Medstar Health

References (25)

M.A. Makary et al.
Frailty as a predictor of surgical outcomes in older patients
J Am Coll Surg
(2010)
J. Afilalo et al.
Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery
J Am Coll Cardiol
(2010)
S.H. Ewe et al.
Impact of left ventricular systolic function on clinical and echocardiographic outcomes following transcatheter aortic valve implantation for severe aortic stenosis
Am Heart J
(2010)
P. Green 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
JACC Cardiovasc Interv
(2012)
S. Stortecky et al.
Evaluation of multidimensional geriatric assessment as a predictor of mortality and cardiovascular events after transcatheter aortic valve implantation
JACC Cardiovasc Interv
(2012)
M.B. Leon et al.
Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the valve academic research consortium
J Am Coll Cardiol
(2011)
C.P. Green et al.
Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure
J Am Coll Cardiol
(2000)
J. Afilalo et al.
Frailty assessment in the cardiovascular care of older adults
J Am Coll Cardiol
(2014)
B.R. Lindman et al.
Futility, benefit, and transcatheter aortic valve replacement
JACC Cardiovasc Interv
(2014)
S.K. Kodali et al.
Two-year outcomes after transcatheter or surgical aortic-valve replacement
N Engl J Med
(2012)

R.R. Makkar et al.

Transcatheter aortic-valve replacement for inoperable severe aortic stenosis

N Engl J Med

(2012)

S.V. Arnold et al.

Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of aortic transcatheter valve) trial

Circulation

(2014)

Cited by (199)

Estimated prevalence of frailty and prefrailty in patients undergoing coronary artery or valvular surgeries/procedures: A systematic review and proportional meta-analysis
2024, Ageing Research Reviews
The aging population has led to an increasing number of older patients undergoing cardiac surgeries/procedures. Frailty and prefrailty have emerged as important prognostic indicators among these patients. This proportional meta-analysis estimated the prevalence of frailty and prefrailty among patients undergoing cardiac surgery.
We searched seven electronic databases for observational studies that used validated measure(s) of frailty and reported prevalence data on frailty and/or prefrailty in older patients undergoing coronary artery or valvular surgeries or transcatheter procedures. Meta-analyses were performed using a random-effects model.
One hundred and one articles involving 626,863 patients were included. The pooled prevalence rates of frailty and prefrailty were 28% (95% confidence interval [CI]: 23%–33%) and 40% (95% CI: 31%–50%), respectively, for patients scheduled for open-heart surgeries and 40% (95% CI: 36%–45%) and 43% (95% CI: 34%–53%), respectively, for patients undergoing transcatheter procedures. Frailty measured using a multidimensional approach identified a higher proportion of frail patients when compared with measures solely focused on physical frailty. Older age, female sex, and lower body mass index and hemoglobin concentrations were significantly associated with higher frailty prevalence. Moreover, countries with higher gross domestic product spent on healthcare exhibited a higher frailty prevalence.
Frailty represents a considerable health challenge among patients undergoing cardiac surgeries/procedures. Routine screening for frailty should be considered during perioperative care planning.
Higher Edmonton Frail Scale prior to transcatheter Aortic Valve Implantation is related to longer hospital stay and mortality
2024, International Journal of Cardiology
International guidelines for the management of valvular heart disease recommend frailty assessment prior to Transcatheter Aortic Valve Implantation (TAVI), however there is no consensus how to assess frailty. We investigated whether frailty status assessed with the Edmonton Frail Scale (EFS, range 0–17 points) relates to length of stay (LOS), short- and long-term mortality and adverse outcomes after TAVI.
In this study we included 357 patients between April 2016 till December 2018. EFS was assessed at baseline. Patients were classified into low (0–3), intermediate (4–7) or high frailty status (8‐17). LOS was defined as the number of days between admission and discharge. Mortality data were obtained up to four years after TAVI. Adverse events were defined by Valve Academic Research Consortium (VARC)-2 criteria and collected <30 days after TAVI.
Patients with higher frailty status had longer median LOS (days (IQR): low 5 (3), intermediate 6 (4) and high 7 (5), p < 0.001) and higher mortality: low vs intermediate vs high at 30 days 0.5%, 2.2%, 7.0% (p = 0.050), 1 year 3.7%, 10.0%, 15.2% (p = 0.052), 2 years 9.2%, 17.8%, 31.7% (p = 0.003), 3 years 17.2%, 24.0, 47.0% (p = 0.001) and 4 years 19.6%, 30.8%, 55.6% (p < 0.001). Frail patients received more often a pacemaker (2.6%, 6.6%, 13.5%, p = 0.048).
In clinical practice, the EFS is a useful tool to screen for frailty in TAVI patients. This tool may possibly be expanded to determine benefit versus harm-risk in these patients and whether specific pre-procedurally interventions are needed in order to reduce mortality.
Psoas Muscle Area as a Predictor of Transcatheter Aortic Valve Implantation Outcomes
2024, Heart Lung and Circulation
Frailty is a well-recognised predictor of outcomes after transcatheter aortic valve implantation (TAVI). Psoas muscle area (PMA) is a surrogate marker for sarcopaenia and is a validated assessment tool for frailty. The objective of this study was to examine frailty as a predictor of outcomes in TAVI patients and assess the prognostic usefulness of adding PMA to established frailty assessments.
Frailty assessments were performed on 220 consecutive patients undergoing TAVI. These assessments used four markers (serum albumin, handgrip strength, gait speed, and a cognitive assessment), which were combined to form a composite frailty score. Preprocedural computed tomography scans were used to calculate cross-sectional PMA for each patient. The primary outcomes were all-cause mortality at 1-year and post-procedure length of hospital stay.
Frailty status, as defined by the composite frailty score, was independently predictive of length of hospital stay (p=0.001), but not predictive of 1-year mortality (p=0.161). Albumin (p=0.036) and 5-metre walk test (p=0.003) were independently predictive of 1-year mortality. The PMA, when adjusted for gender, and normalised according to body surface area, was not predictive of 1-year mortality. Normalised PMA was associated with increased post-procedure length of stay within the female population (p=0.031).
A low PMA is associated with increased length of hospital stay in female TAVI patients but does not provide additional predictive value over traditional frailty scores. The PMA was not shown to correlate with TAVI-related complications or 1-year mortality.
The prognostic impacts of frailty on clinical and patient-reported outcomes in patients undergoing coronary artery or valvular surgeries/procedures: A systematic review and meta-analysis
2023, Ageing Research Reviews
Frailty is emerging as an important prognostic indicator for patients undergoing cardiac surgeries/procedures. We sought to evaluate the prognostic and differential impacts of frailty on patients undergoing coronary artery or valvular surgical procedures of different levels of invasiveness, and to explore the differential predictability of various frailty measurement models.
Eight databases were searched for prospective cohort studies that have adopted validated measure(s) of frailty and reported clinical, healthcare service utilization, or patient-reported outcomes in patients undergoing coronary artery or valvular surgeries/procedures.
Sixty-two articles were included (N = 16,679). Frailty significantly predicted mortality (short-term [≤ 30 days]: odds ratio [OR]: 2.33, 95% confidence interval [CI]: 1.28–4.26; midterm [6 months to 1 year]: OR: 3.93, 95%CI: 2.65–5.83; long-term [>1 year]: HR: 2.23, 95%CI: 1.60–3.11), postoperative complications (ORs: 2.54–3.57), discharge to care facilities (OR: 5.52, 95%CI: 3.84–7.94), hospital readmission (OR: 2.00, 95%CI: 1.15–3.50), and reduced health-related quality of life (HRQoL; standardized mean difference: −0.74, 95%CI: −1.30 to −0.18). Subgroup analyses showed that frailty exerted a greater impact on short-term mortality in patients undergoing open-heart surgeries than those receiving transcatheter procedures. Multidimensional and physical-aspect-focused frailty measurements performed equally in predicting mortality, but multidimensional measurements were more predictive of hospital readmission than physical-aspect-focused measurements.
Frailty was predictive of postoperative mortality, complications, increased healthcare service utilization, and reduced HRQoL. The impact of frailty on short-term mortality was more prominent in patients undergoing open-heart surgeries than those receiving transcatheter procedures. Multidimensional measures of frailty enhanced prognostic risk estimation, especially for hospital readmission.
Functional and metabolic frailty predicts mortality in patients undergoing TAVI: Insights from the OBSERVANT II study
2022, European Journal of Internal Medicine
Despite the prognostic role of frailty among elderly patients undergoing transcatheter aortic valve implantation (TAVI) is known, its assessment still represents a challenge due to the multitude of scales proposed in literature. The aim of this study was to define the prognostic impact of a simple combined frailty model including both functional and metabolic parameters in a large cohort of patients undergoing TAVI with new generation devices.
We examined 1-year survival of patients affected by aortic valve stenosis treated with new generation TAVI devices from the OBSERVANT II study. Frailty of patients undergoing TAVI was stratified in four groups according to a combination of functional (geriatric status scale - GSS) and metabolic (global nutritional risk index - GNRI) assessment. Among 1985 patients included in the analysis, 1008 (51%) had no significant frailty, 246 (12%) had only functional impairment, 522 (26%) had only metabolic impairment and 209 (11%) had both functional and metabolic impairment. The presence of combined functional and metabolic frailty was associated with a two-fold increased risk of 1-year all-cause mortality (HR 2.06 [95% CI 1.35–3.14]; p = 0.001). GNRI as a single parameter had a lower impact on mortality (HR 1.48 [95% CI 1.05 – 2.09]; p = 0.027), whereas GSS did not impact on mortality (HR 1.23 [95% CI 0.77–1.97]; p = 0.386).
In a large real-world cohort of patients undergoing TAVI with new generation devices, combined functional and metabolic frailty had a significant and incremental impact on 1-year mortality.
Five-meter walk test before transcatheter aortic valve replacement and 1-year noncardiac mortality
2022, JTCVS Open
The purpose of this study is to assess whether the 5-m walk test is associated with 1-year mortality after transcatheter aortic valve replacement.
Included in the analysis were 304 patients who received the 5-m walk test and underwent transcatheter aortic valve replacement from September 2012 to March 2019. They were classified into 3 groups based on their test score: ≤7, >7, and unable to walk. Preprocedure characteristics, postprocedure outcomes, and follow-up outcomes were compared between the groups.
For the 5-m walk test, 145 had a score ≤7 (Group N), 111 had a score >7 (Group S), and 48 were unable to walk (Group I). Average age in years was 80.2 ± 8.7 years in Group N, 81.2 ± 9.4 years in Group S, and 79.4 ± 9.2 in Group I (P = .23). The aortic valve mean gradient at discharge was 9.5 ± 4.1 mm Hg in Group N, 10.4 ± 5.5 mm Hg in Group S, and 8.2 ± 4.2 mm Hg in Group I (P = .05). The discharge survival was 97.2% in Group N, 96.4% in Group S, and 95.8% in Group I (P = .76). One-year survival was 92.8% in Group N, 84.1% in Group S, and 75% in Group I (P < .01) after adjusting for preprocedure characteristics. Noncardiac death was 5.1% in Group N, 13.1% in Group S, and 22.7% in Group I (P = .03). This indicates that the 5-m walk test was a risk factor for 1-year mortality. More specifically, a poor 5-m walk test score was associated with 1-year noncardiac mortality.
The 5-m walk test score before transcatheter aortic valve replacement was associated with 1-year mortality, especially noncardiac mortality. It may help identify patients at high risk for 1-year mortality.

View all citing articles on Scopus

: Clinical Trial Registration: ClinicalTrials.gov, Unique Identifier # NCT00530894.

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Valvular Heart DiseaseRelation of Frailty to Outcomes After Transcatheter Aortic Valve Replacement (from the PARTNER Trial)

Section snippets

Methods

Results

Discussion

Disclosures

J Am Coll Surg

J Am Coll Cardiol

Am Heart J

JACC Cardiovasc Interv

JACC Cardiovasc Interv

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

JACC Cardiovasc Interv

Two-year outcomes after transcatheter or surgical aortic-valve replacement

N Engl J Med

Transcatheter aortic-valve replacement for inoperable severe aortic stenosis

N Engl J Med

Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of aortic transcatheter valve) trial

Circulation

Valvular Heart Disease
Relation of Frailty to Outcomes After Transcatheter Aortic Valve Replacement (from the PARTNER Trial)