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Page 2 of 9 Scotti et al. Mini-invasive Surg 2020;4:49 I http://dx.doi.org/10.20517/2574-1225.2020.38

Table 1. 2018 HFA-ESC criteria for defining advanced heart failure
Presence of all of the following criteria despite optimal guideline-directed treatment
1. Severe and persistent symptoms of heart failure [NYHA class III (advanced) or IV]
2. Severe cardiac dysfunction (LVEF ≤ 30%), isolated RV failure (e.g., ARVC) or non-operable severe valve abnormalities or congenital
abnormalities or persistently high (or increasing) BNP or NT-proBNP values and severe diastolic dysfunction or LV structural abnormalities
according to HFpEF and HFmrEF ESC definitions
3. Episodes of pulmonary or systemic congestion requiring high-dose intravenous diuretics (or diuretic combinations) or episodes of low output
requiring inotropes or vasoactive drugs or malignant arrhythmias causing > 1 unplanned visit or hospitalization in the last 12 months
4. Severe impairment of exercise capacity of cardiac origin: 6 MWTD (< 300 m) or pVO 2 (< 12-14 mL/kg/min)
ARVC: arrhythmogenic right ventricular cardiomyopathy; BNP: B-type natriuretic peptide; ESC: European Society of Cardiology; HFA:
Heart Failure Association; HFmrEF: heart failure with mid-range ejection fraction; HFpEF: heart failure with preserved ejection fraction;
LV: left ventricular; LVEF: left ventricular ejection fraction; NT-proBNP: N-terminal pro-B-type natriuretic peptide; NYHA: New York Heart
Association; pVO 2 : peak exercise oxygen consumption; RV: right ventricular; 6MWTD: 6-min walk test distance.

[4,5]
survival and progressive worsening of left ventricle (LV) dysfunction . Therefore, it is crucial to treat
MR in a useful time window before these changes become irreversible . Among all the percutaneous
[5-7]
treatment options for MR, MitraClip (Abbott, Illinois, USA) is the most adopted device with > 100,000
procedures performed worldwide. The first two randomized clinical trials on edge-to-edge transcatheter
mitral valve repair (TMVR) vs. guideline-directed medical therapy (GDMT) in patients with heart failure
(HF) and severe MR (COAPT and MITRA-FR ) reported contrasting yet complimentary results. The
[8]
[9]
resultant effect is a growing interest in finding those who can benefit the most from this procedure. On the
contrary, little is known about those patients with advanced HF and poor prognosis treated with MitraClip
implantation. Although this procedure may be considered futile in some of these cases, it can act as
bridging therapy for further invasive treatments in others. The aim of this review is to analyze the impact of
SMR and its percutaneous treatment in this unconventional setting.

ADVANCED HEART FAILURE
The clinical course of HF is characterized by gradual worsening of cardiac function and symptoms. This
process may lead to a clinical phase where traditional treatments (e.g., GDMT, devices and surgery)
are no longer effective, and advanced therapies [e.g., mechanical circulatory support (MCS) and heart
transplantation (HTx)] or palliative care are needed. This clinical condition is called advanced HF.
The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles were
previously used to classify these patients based on the presence of HF with reduced ejection fraction
(HFrEF) and need for long-term MCS device implantation. To be more inclusive by extending this group
also to patients affected by HF with preserved ejection fraction (HFpEF), an updated definition of the
[10]
European Society of Cardiology has been released [Table 1].
Prevalence of advanced HF ranges between 1% and 10% of the overall HF population. This percentage is
growing because of better treatment and longer survival of these patients. Once these patients have been
identified, it is of utmost importance to acknowledge the appropriate timing for referring them to tertiary
care centers where advanced therapies can be adopted. A useful mnemonic (“I Need Help”) has been
proposed to verify the eligibility to immediate management and transfer based on the need for inotropic
therapy, end-organ dysfunction, poor ejection fraction, consistently low blood pressure and poor or
[11]
intolerance to GDMT [Table 2].

Despite the efforts spent to categorize this stage of disease, we must recognize the extreme variability that
exists between patients who are part of this group. In one extreme, there are young patients with idiopathic
heart disease or non-ischemic cardiomyopathies (chemotherapy-induced, myocarditis-related, etc.) in
the absence of further comorbidities. On the opposite side, we can find elderly people mainly affected by
ischemic heart disease and numerous concomitant co-pathologies [chronic kidney disease (CKD), diabetes
mellitus (DM), atrial fibrillation (AF), chronic obstructive pulmonary disease (COPD), peripheral vascular