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Page 6 of 9 Benito-González et al. Mini-invasive Surg 2020;4:67 I http://dx.doi.org/10.20517/2574-1225.2020.54

A B C

P P P

Figure 2. Kaplan-Meier curves displaying survival free from heart failure or death. A: Heart failure rehospitalizations. Frail patients
experienced higher prevalence during follow-up; B: All cause mortality. Frail patients showed higher death rate than non frail patients; C:
Composite end-point (death/readmission due to heart failure). Frail patients showed worse outcome.

our report were the following: (1) the prevalence of frailty in this series was high (about 2 out of 5 patients);
(2) no differences in procedural outcomes and short-term device success rates were observed between
frail and non-frail patients; (3) NYHA functional class significantly improved in both groups at 6-months
follow-up after PMVR; and (4) frailty was significantly related to a higher risk of HF readmission or death
from any cause during long-term follow-up.

Prevalence of frailty among patients with cardiovascular disease ranges between 25% to 50%, depending
on the scales used and the clinical setting . In addition, many reports have shown a higher incidence of
[10]
adverse events in frailty patients with ischemic heart disease, HF, or those undergoing cardiac surgery, or
percutaneous intervention for either coronary or structural heart disease [11-14] . In the latter scenario, several
studies have pointed out that patients deemed as frail who undergo percutaneous aortic valve replacement
have worse prognosis than those that do not meet frailty criteria [14,15] . Similar findings have been reported in
[16]
patients undergoing PMVR. In this regard, Metze et al. observed a prevalence of frailty according to the
FRIED score of 45.5% in a cohort of more than 200 patients who received MitraClip®. In this series, device
success rates were similar among frail and non-frail patients, and a significant improvement was observed
in both groups in the NYHA functional class, 6-min walk test, and quality of life questionnaires. However,
frailty was significantly related to a higher probability of readmission for HF or death from any cause
during a median follow-up of more than 1 year. Likewise, in our study, the presence of frailty according
to the FRAIL score was associated with a more than two-fold increase in the incidence of the composite
endpoint, despite similar short-term procedural results and functional improvement.

Multiple frailty scales have been validated in different clinical settings . Some, such as the FRIED score,
[3]
focus on physical strength and walking speed. This “uni-dimensional” approach has a higher predictive
value in some scenarios of cardiovascular disease, although their use in daily practice is limited by its
[17]
greater complexity and time demands . On the other hand, the “multidimensional” approach, including
the FRAIL scale, considers that frailty is an accumulation of comorbidities, deficits and symptoms
involving one or more domains of human functioning. These scores are based on clinical questionnaires
and the subjective judgment of the healthcare provider. The advantages of this approach are that it is simple
to perform and can be used in patients with any stage of disability as a screening test. To the best of our
knowledge, this is the first study to evaluate the prognosis impact of the FRAIL score in PMVR.

In between both scores, a modified FRAIL scale has been recently suggested, adding a rapid physical
test (e.g., the ability to get up from the chair), a questionnaire to address cognitive impairment, and two
[14]
laboratory parameters (serum albumin and hemoglobin) to the traditional score . This “Essential Frailty
Toolskit” demonstrated a greater predictive value for adverse events compared to other scales in patients
with severe aortic stenosis undergoing either surgical or percutaneous valve replacement. Further studies